markdown_content
stringlengths 924
63.5k
|
|---|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428032
**Acronym:** FuN HABIT-ILE
**Brief Title:** Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy
**Official Title:** Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** NEUROLAB_UNAB_001
#### Organization
**Class:** OTHER
**Full Name:** Universidad Nacional Andres Bello
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidad Nacional Andres Bello
#### Responsible Party
**Investigator Affiliation:** Universidad Nacional Andres Bello
**Investigator Full Name:** Rodrigo Araneda, PhD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.
**Detailed Description:** This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function.
A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months.
Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE.
### Conditions Module
**Conditions:**
- Cerebral Palsy
**Keywords:**
- HABIT-ILE
- Intensive motor therapy
- Motor skill learning
- Children
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will receive 130 hours of HABIT-ILE performed in two intervention periods as camp format for 6,5-hours/day, 5 days/week for two weeks. Each intervention period will be 6-months apart.
**Intervention Names:**
- Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
**Label:** Double period
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects will receive 65 hours of HABIT-ILE performed in one intervention period as camp format for 6,5-hours/day, 5 days/week for two weeks
**Intervention Names:**
- Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
**Label:** Single period
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Double period
**Description:** Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
**Name:** Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
**Other Names:**
- HABIT-ILE
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Single period
**Description:** Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
**Name:** Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
**Other Names:**
- HABIT-ILE
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function.
**Measure:** Changes in Gross Motor Function
**Time Frame:** Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
#### Secondary Outcomes
**Description:** The Both Hands Assessment is a valid test for children with mild to moderate bilateral manual abilities impairments. It can evaluate bimanual activity performance and the level of upper extremity asymmetry. It rates performance between 1 (does not do) and 4 (effective). The final score is converted to BoHA units (logit 0 - 100), where higher scores reflect better bimanual use.
**Measure:** Both Hands Assessment (BoHA)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
**Description:** The Melbourne 2 Assessment (MA2) assesses the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy, and range of movement during several tasks of reaching and manipulation. The result is obtained as a percentage of the function of each item. A higher percentage means a better unilateral performance of the upper extremity.
**Measure:** Melbourne 2 Assessment (MA2)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
**Description:** The TASC test assesses the selective voluntary motor control of upper limbs in individuals with cerebral palsy. The participant must execute eight movements in the upper extremity. The execution of each sequence will be assessed on a scale of 0, 1, or 2, from absence, impairment, or normality of voluntary selective motor control, respectively, with a maximum of 16 points per side and 32 points overall.
**Measure:** Test of Arm Selective Control (TASC)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** The SCALE test assesses the selective voluntary motor control of lower limbs in individuals with cerebral palsy. The participant must execute five movements in the lower extremity. The execution of each sequence will be assessed on a scale of 0, 1 or 2, from absence, impairment, or normality of voluntary selective motor control respectively, with a maximum of 10 points per side and 20 points overall.
**Measure:** Selective Control Assessment of the Lower Extremity (SCALE)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** The 6MWT measures the maximum distance a participant can walk in a 6-minute period in a 30-meter corridor at his or her own pace. More distance walked (in meters) indicates better performance.
**Measure:** Six minutes walk test (6MWT)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** The ANT assesses the efficiency of the three attentional networks: alerting, orienting, and executive control networks. It measures the accuracy (in terms of the amount of errors) and the reaction time (milliseconds) of each network. Fewer errors mean more accuracy, the lower the score, the faster the reaction time.
**Measure:** Attention network test (ANT)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** This parent's filled questionnaire measures the ability of the participant with cerebral palsy to perform activities of daily living that require the use of the upper extremities. The difficulty to perform the activities are rating as "Impossible", "Difficult" or "Easy". The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities.
**Measure:** ABILHAND-Kids questionnaire
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** This parent's filled questionnaire measures a child performance of daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance). The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities.
**Measure:** ACTIVLIM-CP questionnaire
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during these activities. It ranges from 20 to 80 (higher score means better performance).
**Measure:** Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** This parent's filled questionnaire measures participation of children and youth with or without disability, in the home, school and community, along with environmental factors within each of these settings. For each environment, it assesses how frequently they participate in a given activity (8-point scale; 0-7), how involved they are in that activity (5-point scale; 1-5), and whether they want to make a change in the type of participation they perform (6-point scale; 1-6). For each setting, the participation frequency (percentage), involvement (score 1-5), desires for change (percentage), and environmental supportiveness (percentage) are calculated.
**Measure:** Participation and Environment Measure - Children and Youth (PEM-CY)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction).
**Measure:** Canadian Occupational Performance Measure (COPM)
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
**Description:** The BRIEF-2 is a caregiver-reported questionnaire measuring executive functioning in children between 5 and 18 years old. It consists of 63 items arranged in nine scales: inhibition, self-monitoring, flexibility, emotional control, initiative, working memory, planning and organization, task supervision, and organization of materials. It is scored using T scores (Range= 34 - 90; Mean=50, Standard Deviation=10), where higher scores indicate greater problems with executive functioning.
**Measure:** Behaviour Rating Inventory of Executive Function (BRIEF-2)
**Time Frame:** Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5)
**Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of peak-to-peak amplitude of motor evoked potential will be measured in milliAmpere (mA).
**Measure:** Changes of peak-to-peak amplitude of motor evoked potential
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
**Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of resting motor threshold will be measured in percentage.
**Measure:** Changes of Resting Motor Threshold
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
**Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of latency in motor evoked potential will be measured in milliseconds.
**Measure:** Changes of latency in motor evoked potential
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
**Description:** A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in sensorimotor cortex area during manual tasks.
**Measure:** Changes of oxyhemoglobin concentration in sensorimotor cortex
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
**Description:** A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in prefrontal cortex area during manual tasks.
**Measure:** Changes of oxyhemoglobin concentration in prefrontal cortex
**Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children with medical diagnosis of bilateral cerebral palsy
* Cognitive capacity and language that allows understanding and following the therapist's instructions.
* Manual Ability Classification System (MACS) levels I to III
* Bimanual Fine Motor Function (BFMF) levels I to III
* Gross Motor Function Classification System (GMFCS) levels I to III
Exclusion Criteria:
* Severe visual problems
* Movement restriction due to orthopedic surgery in less than a year
* Treatment with botulinum toxin and/or baclofen pump in the last 6 months
* Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)
**Maximum Age:** 18 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rodrigo Araneda, PhD
**Phone:** +56 22 6618608
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Natalia Perez, MSc
**Phone:** +56 22 6618075
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Rodrigo Araneda, PhD
- **Role:** CONTACT
**Country:** Chile
**Facility:** Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello
**State:** Region Metropolitana
**Zip:** 7591538
#### Overall Officials
**Official 1:**
**Affiliation:** Universidad Nacional Andres Bello
**Name:** Rodrigo Araneda, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428019
**Brief Title:** A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
**Official Title:** A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL
#### Organization Study ID Info
**ID:** M24-287
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
#### Secondary ID Infos
**Domain:** EU CT
**ID:** 2024-512147-23-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-10-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AbbVie
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
### Conditions Module
**Conditions:**
- Chronic Lymphocytic Leukemia
**Keywords:**
- Chronic Lymphocytic Leukemia
- CLL
- Venetoclax
- ABT-199
- Obinutuzumab
- Acalabrutinib
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Obinutuzumab
**Label:** Arm A: Venetoclax + Obinutuzumab
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Acalabrutinib
**Label:** Arm B: Venetoclax + Acalabrutinib
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 6 week venetoclax ramp up.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Acalabrutinib
**Label:** Arm C: Venetoclax + Acalabrutinib
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 7 week venetoclax ramp up.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Acalabrutinib
**Label:** Arm D: Venetoclax + Acalabrutinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm A: Venetoclax + Obinutuzumab
- Arm B: Venetoclax + Acalabrutinib
- Arm C: Venetoclax + Acalabrutinib
- Arm D: Venetoclax + Acalabrutinib
**Description:** Oral: Tablet
**Name:** Venetoclax
**Other Names:**
- ABT-199
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm B: Venetoclax + Acalabrutinib
- Arm C: Venetoclax + Acalabrutinib
- Arm D: Venetoclax + Acalabrutinib
**Description:** Oral: Tablet
**Name:** Acalabrutinib
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Arm A: Venetoclax + Obinutuzumab
**Description:** Intravenous Infusion
**Name:** Obinutuzumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.
**Measure:** Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
**Time Frame:** Up to 28 Months
**Description:** Hyperkalemia (potassium \>6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per IRC assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.
**Measure:** Part 1: Percentage of Participants with Hyperkalemia-Venetoclax
**Time Frame:** Up to 28 Months
#### Secondary Outcomes
**Description:** TLS is defined per Howard criteria that require a clinical intervention per IRC assessment, at each dose level and at each laboratory monitoring point during ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.
**Measure:** Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS
**Time Frame:** Up to 28 Months
**Description:** Hyperkalemia (potassium \>6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.
**Measure:** Part 1: Percentage of Participants with Hyperkalemia
**Time Frame:** Up to 28 Months
**Description:** TLS-related events are defined as laboratory TLS per Howard criteria requiring clinical intervention per IRC assessment, hyperkalemia (potassium \>6.0 mmol/L) requiring clinical intervention per IRC assessment, laboratory TLS per Howard criteria irrespective of clinical intervention, Hyperkalemia (potassium \>6.0 mmol/L) irrespective of clinical intervention, clinical TLS per Howard criteria irrespective of clinical intervention, any single TLS-related lab abnormality requiring clinical intervention per Investigator.
**Measure:** Part 1: Percentage of Participants with TLS-Related Events
**Time Frame:** Up to 28 Months
**Description:** AEs of TLS is defined as a blood chemistry changes or symptom suggestive of TLS.
**Measure:** Part 1: Percentage of Participants with Adverse Events (AE) of TLS
**Time Frame:** Up to 28 Months
**Description:** Percentage of participants with reduction of tumor burden.
**Measure:** Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline
**Time Frame:** Up to 28 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.
* Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
* Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion, while individuals with lymph nodes \> 5 cm and CrCl \< 80 mL/min are excluded.
Exclusion Criteria:
- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ABBVIE CALL CENTER
**Phone:** 844-663-3742
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** AbbVie
**Name:** ABBVIE INC.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
**Description:** AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
**URL:** https://vivli.org/ourmember/abbvie/
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.abbvieclinicaltrials.com/study/?id=M24-287
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000015448
- Term: Leukemia, B-Cell
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphocytic Leukemia
- ID: M18116
- Name: Leukemia, Lymphocytic, Chronic, B-Cell
- Relevance: HIGH
- As Found: Chronic Lymphocytic Leukemia
- ID: M17975
- Name: Tumor Lysis Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18115
- Name: Leukemia, B-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1308
- Name: Chronic Lymphocytic Leukemia
- Relevance: HIGH
- As Found: Chronic Lymphocytic Leukemia
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000015451
- Term: Leukemia, Lymphocytic, Chronic, B-Cell
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: Extended
- ID: M288906
- Name: Obinutuzumab
- Relevance: HIGH
- As Found: Contraction
- ID: M42185
- Name: Acalabrutinib
- Relevance: HIGH
- As Found: Vinorelbine
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000579720
- Term: Venetoclax
- ID: C000543332
- Term: Obinutuzumab
- ID: C000604908
- Term: Acalabrutinib
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428006
**Acronym:** CALM
**Brief Title:** Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
**Official Title:** Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
#### Organization Study ID Info
**ID:** STUDY00160476
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2027-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Kansas Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Kansas Medical Center
**Investigator Full Name:** Catherine Siengsukon, PT, PhD
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).
### Conditions Module
**Conditions:**
- Multiple Sclerosis
- Insomnia
**Keywords:**
- Cognitive behavioral therapy for insomnia
- CBT-I
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.
**Intervention Names:**
- Behavioral: Cognitive behavioral therapy for insomnia
**Label:** Cognitive behavioral therapy for insomnia
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.
**Intervention Names:**
- Behavioral: Sleep and lifestyle education
**Label:** Sleep and lifestyle education
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cognitive behavioral therapy for insomnia
**Description:** The general sessions outlines are as follows with each session:
Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention
**Name:** Cognitive behavioral therapy for insomnia
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Sleep and lifestyle education
**Description:** The general sessions outlines are as follows with each session:
Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises
**Name:** Sleep and lifestyle education
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Disability will be assessed using the PDDS scale which is a single-item 9 point scale ranging from "normal" (score of 0) to "bedridden" (score of 8).
**Measure:** Patient-Determined Disability Steps (PDDS)
**Time Frame:** baseline
**Description:** Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥20 suggesting severe depression. It consists of 9 items with a score ranging from 0-27.
**Measure:** Patient Health Questionnaire (PHQ-9)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Anxiety symptoms will be assessed using the 7-item GAD-7, with a score of ≥15 indicating severe anxiety. This questionnaire consists of 7 items, and the score from each item is summed for an overall score ranging from 0-21 with a higher score indicating a higher level of anxiety
**Measure:** Generalized Anxiety Disorder Assessment (GAD-7)
**Time Frame:** baseline, Week 6, Month 6
**Description:** To assess adherence to the CBT-I intervention, the sleep log will be used to assess number of mornings/week got out of bed at agreed upon time and the number of times got out of bed if unable to sleep. A total percentage will be calculated and used as the outcome of interest.
**Measure:** Adherence to CBT-I intervention
**Time Frame:** Each CBT-I session Week 1-6
**Description:** Participants will be asked "In general, how healthy is your overall diet?" and will rate on a 5-point Likert scale (5 = "excellent", 4 = "very good", 3 = "good", 2 = "fair", 1 = "poor")
**Measure:** Diet quality
**Time Frame:** baseline
**Description:** Participants will mark on the sleep log at each assessment period the time period for eating breakfast, lunch, and dinner. Variability in mealtime will be quantified as the standard deviation from the individual's mean meal start time.
**Measure:** Eating regularity
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will mark on the sleep log the number of times they wake up to void their bladder during the sleep opportunity window.
**Measure:** Nighttime urination frequency
**Time Frame:** baseline, Week 6, Month 6
**Description:** PainDetect includes 13 items that assesses neuropathic pain. A total score ranges from -1 to 38, with higher scores indicating higher levels of neuropathic pain.
**Measure:** PainDetect
**Time Frame:** baseline, Week 6, Month 6
**Description:** Fibromyalgia Survey Questionnaire includes the assessment of the number of painful body regions. Scores ranges from 0-31. A higher score indicates worse symptoms.
**Measure:** Fibromyalgia Survey Questionnaire
**Time Frame:** baseline, Week 6, Month 6
**Description:** Measures max and average pain intensity during past 7 days. The T-score value, with a mean of 50 and standard deviation of 10 representing the rescaled raw score, will be reported.
**Measure:** PROMIS SF v.1.0 - Pain Intensity
**Time Frame:** baseline, Week 6, Month 6
#### Primary Outcomes
**Description:** The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
**Measure:** Insomnia Severity Index (ISI)
**Time Frame:** baseline, Week 6, Month 6
#### Secondary Outcomes
**Description:** The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality.
**Measure:** Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
**Measure:** Epworth Sleepiness Scale (ESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
**Measure:** Dysfunctional Beliefs About Sleep
**Time Frame:** baseline, Week 6, Month 6
**Description:** is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions.
**Measure:** Positive Affect and Negative Affect Schedule (PANAS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
**Measure:** Sleep Self-Efficacy Scale (SESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration
**Measure:** Actigraphy
**Time Frame:** baseline, Week 6, Month 6
**Description:** The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
**Measure:** Modified Fatigue Impact Scale (MFIS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
**Measure:** Fatigue Severity Scale (FSS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS
**Measure:** Multiple Sclerosis Impact Scale (MSIS-29)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
**Measure:** Cognitive Failures Questionnaire (CFQ)
**Time Frame:** baseline, Week 6, Month 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-65 years old
* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist
* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
* ≥10 on Insomnia Severity Index
* English speaking
* ≥31 on modified Telephone Interview of Cognitive Status23
* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
Exclusion Criteria:
* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
* \>3 on STOP BANG indicating increased risk of sleep apnea
* Restless legs syndrome as determined by RLS-Diagnosis Index
* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
* Parasomnia as determined by the Sleep Disorders-Revised
* Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
* History of other nervous system disorder such as stroke or Parkinson's disease
* Currently pregnant or intending to become pregnant in the next 6 months
* Severe mental illness such as schizophrenia or bipolar disorder
* Severe neurological or sensory impairments that would interfere significantly with testing
* Relapse and/or corticosteroid use in the past 8 weeks
* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
* Currently receiving a behavioral sleep health intervention
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eryen Nelson, MPH
**Phone:** 913-945-7349
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Catherine Siengsukon, PhD
**Phone:** 913-588-6913
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M10356
- Name: Sleep Initiation and Maintenance Disorders
- Relevance: HIGH
- As Found: Insomnia
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000007319
- Term: Sleep Initiation and Maintenance Disorders
- ID: D000012598
- Term: Sclerosis
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427993
**Brief Title:** Urine DNA Methylation Detection for Hematuria Evaluation
**Official Title:** Urine Exfoliated Cell DNA Methylation Detection for Urothelial Carcinomas Diagnosis in Patients With Hematuria--A Prospective, Single-center, Cohort Study
#### Organization Study ID Info
**ID:** CH_Hematuria_Metest
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhai Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients.
Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria.
Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves.
Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.
**Detailed Description:** 1. Background Hematuria is a common symptom of urinary system diseases and can be caused by various factors, including infection, stones, trauma, and tumors. Urothelial carcinoma (UC) is the most common malignant tumor of the urinary system, primarily occurring in the bladder, renal pelvis, and ureter. The early symptoms of UC are often not obvious, with hematuria being the most common symptom. However, current diagnostic methods such as urine cytology and cystoscopy have limitations in sensitivity and specificity for diagnosing UC. Additionally, cystoscopy is invasive and can cause discomfort for patients. DNA methylation biomarkers have shown potential in detecting UC, providing a non-invasive method to improve diagnostic sensitivity and specificity, especially in patients with hematuria.
2. Objective This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. By collecting preoperative urine samples from a small cohort of hematuria patients and performing DNA methylation testing, we aim to explore the feasibility and advantages of this method in clinical applications.
3. Methods
Study Design:
This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria.
Sample Size Calculation:
Based on our previous observations, the incidence of urothelial carcinoma in patients with hematuria is 20%-30%, slightly higher than reported in other literature. Therefore, we hypothesize that 25% of the patients in the hematuria cohort have UC. The group allocation ratio (R): N-/N+ = 75%/25% = 3.
Assumptions:
Area under the curve (AUC) under H0: 0.5 AUC under H1: 0.8 Power: 0.95 Significance level (Alpha): 0.05 Type of data: Continuous FPR range: 0.00 to 1.00
Results: Using PASS 15.0 software for sample size calculation to ensure sufficient statistical power. The calculated sample size is:
N+ (number of patients with UC): 14 N- (number of patients without UC): 42 Total sample size (N): 56
Considering a 20% dropout rate, the adjusted sample size is:
N+': 18 N-': 53 Total sample size (N'): 71
Inclusion and Exclusion Criteria:
Inclusion Criteria:
Aged between 18 and 99 years, with gross or microscopic hematuria (\>5/HP). Able to provide 50ml urine for testing before surgery. Consent to participate in the study and sign the informed consent form.
Exclusion Criteria:
With history of malignancy or concomitant malignancies other than UC. Severe urinary tract infection leading to sepsis. Patients with indwelling catheters, nephrostomy, or cystostomy. Severe liver or kidney failure or other conditions deemed unsuitable for the study.
Patients who did not undergo surgical treatment for various reasons. Samples with insufficient DNA content or other quality control failures.
Sample Collection:
Clinicians will collect fresh urine samples from enrolled hematuria patients and record their basic information, clinical information, and medical history.
Samples will be randomly numbered and provided to DNA methylation testing personnel to ensure blinding.
Testing Method:
Testing personnel will analyze urine samples using MSRE-qPCR based DNA methylation testing methods to evaluate DNA methylation levels.
Unblinding and Data Organization:
After the last sample is successfully enrolled and tested, non-recruiting personnel and testing personnel will unblind the samples and organize clinical and pathological information.
Data Analysis:
Using pathological results as the gold standard. Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers.
Use statistical methods (such as ROC curves) to evaluate the diagnostic performance of DNA methylation biomarkers and calculate the AUROC.
Ethics and Informed Consent:
This study has been approved by the hospital's ethics committee, and all participants must sign an informed consent form.
4. Conclusion This study aims to validate the effectiveness of urine DNA methylation testing in detecting urothelial carcinoma in patients with hematuria and provide evidence for its clinical application. The results of this preliminary study will offer essential data support and design optimization suggestions for future larger-scale studies.
### Conditions Module
**Conditions:**
- Hematuria
- Urothelial Carcinoma
- Bladder Cancer
- Ureter Cancer
- Renal Pelvis Cancer
**Keywords:**
- Hematuria
- Urothelial Carcinoma
- Urine DNA Methylation
### Design Module
#### Bio Spec
**Description:** Urine sediment DNA.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 71
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the AUROC value.
**Measure:** Diagnostic performance of DNA methylation test
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers.
**Measure:** Sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged between 18 and 99 years, with gross or microscopic hematuria (\>5/HP).
2. Able to provide 50ml urine for testing before surgery.
3. Consent to participate in the study and sign the informed consent form.
Exclusion Criteria:
1. With history of malignancy or concomitant malignancies other than UC.
2. Severe urinary tract infection leading to sepsis.
3. Patients with indwelling catheters, nephrostomy, or cystostomy. 4 Severe liver or kidney failure or other conditions deemed unsuitable for the study.
5. Patients who did not undergo surgical treatment for various reasons. 6. Samples with insufficient DNA content or other quality control failures.
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Qing Chen, Dr
- **Phone:** +86 18301921727
- **Role:** CONTACT
***Contact 2:***
- **Name:** Chuanliang Xu, Dr
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Changhai Hospital
**State:** Shanghai
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000014555
- Term: Urination Disorders
- ID: D000006470
- Term: Hemorrhage
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014515
- Term: Ureteral Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5551
- Name: Carcinoma, Transitional Cell
- Relevance: HIGH
- As Found: Urothelial Carcinoma
- ID: M9504
- Name: Hematuria
- Relevance: HIGH
- As Found: Hematuria
- ID: M17266
- Name: Ureteral Neoplasms
- Relevance: HIGH
- As Found: Ureter Cancer
- ID: M13297
- Name: Pelvic Neoplasms
- Relevance: HIGH
- As Found: Pelvis Cancer
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17305
- Name: Urination Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M17265
- Name: Ureteral Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5693
- Name: Transitional Cell Carcinoma
- Relevance: HIGH
- As Found: Urothelial Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002295
- Term: Carcinoma, Transitional Cell
- ID: D000014516
- Term: Ureteral Neoplasms
- ID: D000010386
- Term: Pelvic Neoplasms
- ID: D000006417
- Term: Hematuria
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427980
**Acronym:** CHARM
**Brief Title:** Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma
**Official Title:** Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma: a A Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail
#### Organization Study ID Info
**ID:** KY2023-265
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Tiantan Hospital
#### Responsible Party
**Investigator Affiliation:** Beijing Tiantan Hospital
**Investigator Full Name:** Weiming Liu
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** A prospective, randomized, double-blinded, placebo-controlled, multicenter trail is designed to compare differences of operation rate and clinical outcome from treatment up to 24 weeks between HXLS group and placebo group.
**Detailed Description:** The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH, in an effort to prevent surgery. We hypothesize that compared with placebo, Chinese herbal formula HXLS reduces operation rates and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and placebo group at 1:1 ratio.
### Conditions Module
**Conditions:**
- Chronic Subdural Hematoma
**Keywords:**
- Chronic Subdural Hematoma
- Chinese herbal formula
- HuoXue LiShui
- Pharmacotherapy
- Randomized controlled trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The investigators in charge of the recruitment and follow-up evaluation and participants will be blinded, along with the outcome assessors and data analysts.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 160
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (益母草, Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (炙水蛭, Hirudo, 1.5g), Tao Ren (桃仁, Semen persicae, 6.0g), and Hong Hua (红花, Carthamus tinctorius L, 6.0g).
**Intervention Names:**
- Drug: Chinese Herbal formula HuoXue LiShui
**Label:** HXLS group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (糊精 28.0g)
**Intervention Names:**
- Drug: Chinese Herbal formula Placebo
**Label:** placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HXLS group
**Description:** The intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (益母草, Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (炙水蛭, Hirudo, 1.5g), Tao Ren (桃仁, Semen persicae, 6.0g), and Hong Hua (红花, Carthamus tinctorius L, 6.0g).
**Name:** Chinese Herbal formula HuoXue LiShui
**Other Names:**
- HuoXue LiShui
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- placebo group
**Description:** The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g)
**Name:** Chinese Herbal formula Placebo
**Other Names:**
- Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of operation
**Measure:** Rate of operation
**Time Frame:** From baseline up to 24 weeks after the start of treatment with the study medication
#### Secondary Outcomes
**Description:** CSDH volume measured on head CT
**Measure:** Chronic subdural hematoma volume
**Time Frame:** At baseline, and at 4, 12, and 24 weeks
**Description:** Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
**Measure:** Change of Modified Rankin Scale (MRS) between group
**Time Frame:** At baseline, and at 1, 4, 8, 12, and 24 weeks
**Description:** Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
**Measure:** Change of Markwalder Grading Scale (MGS) between groups
**Time Frame:** At baseline, and at 1, 4, 8, 12, and 24 weeks
**Description:** A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'.
**Measure:** Change of Quality of life
**Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks
**Description:** The Barthel Index is scored from 0 to 100. \>60 is good, with mild dysfunction, able to perform some activities of daily living independently, and needing some help; 60-41 is moderate. 60-41 is classified as moderate, with moderate dysfunction, requiring a great deal of help to complete activities of daily living; ≤40 is classified as poor, with severe dysfunction, unable to complete most of the activities of daily living or needing help from others.
**Measure:** Change of performance in activities of daily living
**Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks
**Description:** Montreal Cognitive Assessment, MOCA score
**Measure:** Change of cognitive functioning
**Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks
**Description:** Number of falling incidents
**Measure:** Number of falling incidents
**Time Frame:** At 24 weeks
**Description:** Mortality
**Measure:** Mortality
**Time Frame:** At 24 weeks
**Description:** Rate of complications and adverse events between groups
**Measure:** Rate of complications and adverse events between groups
**Time Frame:** Within 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age between 18 years and 90 years and either gender.
2. Supratentorial, unilateral or bilateral CSDH verified on cranial CT or magnetic resonance imaging.
3. Stable vital signs and neurological deficit with GCS score ≥ 14 and modified Rankin Scale (mRS) score ≤ 2.
4. No risk of brain herniation and recent immediate needs for surgery evaluated by 2 attending neurosurgeons.
5. Written informed consent from patients or their next of kin according to the patient's cognitive status.
Exclusion Criteria:
1. Unstable vital signs or symptoms of brain herniation including severe headache, nausea and vomiting, or disturbed consciousness.
2. Progressive or apparent neurological deficit with GCS score \< 14 or mRS score \> 2.
3. Midline shift \> 10 mm on radiological image.
4. Previous treatment (surgery or medication) for CSDH.
5. Previous intracranial surgery for any other neurological disorders.
6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.
7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.
8. Malignant tumor.
9. Abnormal liver function or liver diseases including uncontrolled hepatitis (alanine transaminase \> 120U/L).
10. Severe renal impairment (estimated glomerular filtration rate \< 30ml/min or serum creatinine \> 150μmol/L).
11. Moderate or severe anemia (hemoglobin ≤ 90g/L).
12. Severe coagulopathy or high risk of life-threatening bleeding.
13. Existing poor medication condition or severe comorbidity so that treatment cannot be tolerated, or follow-up cannot be completed.
14. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, or other traditional Chinese medicine before randomization or who are expected to take such medications in the next 24 weeks.
15. Difficulty in swallowing oral medication.
16. Pregnancy or lactation.
17. Participating in another research.
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Liang Wu, M.D.
**Phone:** 15001333582
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weiming Liu, M.D.
**Phone:** 13701182770
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Luhe Hospital, Capital Medical University
**State:** Beijing
**Zip:** 101100
**Location 2:**
**City:** Lianyungang
**Country:** China
**Facility:** First People's Hospital of Lianyungang
**State:** Jiangsu
**Location 3:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Tiantan Hospital, Capital Medical University
**Zip:** 100070
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Tiantan Hospital
**Name:** Weiming Liu, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006470
- Term: Hemorrhage
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020198
- Term: Intracranial Hemorrhage, Traumatic
- ID: D000020300
- Term: Intracranial Hemorrhages
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9493
- Name: Hematoma
- Relevance: HIGH
- As Found: Hematoma
- ID: M9495
- Name: Hematoma, Subdural
- Relevance: HIGH
- As Found: Subdural Hematoma
- ID: M22027
- Name: Hematoma, Subdural, Chronic
- Relevance: HIGH
- As Found: Chronic Subdural Hematoma
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: LOW
- As Found: Unknown
- ID: M22025
- Name: Intracranial Hemorrhage, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000006408
- Term: Hematoma, Subdural
- ID: D000020200
- Term: Hematoma, Subdural, Chronic
- ID: D000006406
- Term: Hematoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427967
**Brief Title:** A Novel Social Emotional Learning Curriculum for Youth With Epilepsy
**Official Title:** Beyond Watching and Waiting: A Pilot Study of a Novel Social Emotional Learning Curriculum-Based Intervention Designed for Youth With Epilepsy at Increased Risk of Future Mental Illness
#### Organization Study ID Info
**ID:** H-43875
#### Organization
**Class:** OTHER
**Full Name:** Boston Medical Center
#### Secondary ID Infos
**Domain:** Charles F. Hood Foundation
**ID:** 4301210001
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Charles H. Hood Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** Boston Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor.
Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically.
The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored.
The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.
### Conditions Module
**Conditions:**
- Epilepsy
**Keywords:**
- Youth with epilepsy (YWE)
- Positive Youth Development
- Social-Emotional Learning
- Social Ecological Model
- Youth Thrive Framework
- Perceived Social Support
- Health-Related Quality of Life
- Adult Epilepsy Self-Management Measurement Instrument
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** One-group pretest-posttest
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE.
**Intervention Names:**
- Behavioral: Project Dream Team
**Label:** Novel Social-Emotional Learning (SEL) curriculum
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Novel Social-Emotional Learning (SEL) curriculum
**Description:** Five total sessions, 60-minutes each, with one session every 7 days (+/- 21 days between sessions), Session activities include discussion prompts, interactive learning methods, skill rehearsals, mindfulness / somatic exercises and lecture slides facilitated by a trained facilitator.
**Name:** Project Dream Team
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** The Youth Thrive (YT) Framework Survey Part 2: Youth Resilience, Cognitive and Social-Emotional Competence subscales will be used to assess this outcome. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a greater depth of knowledge, higher mastery over key skills and more frequent use of prosocial behaviors.
**Measure:** Change in social emotional skills and behaviors
**Time Frame:** Baseline, 4 months
**Description:** This outcome will be assessed using the 25 subscale items from the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65). The responses are Likert scale-rated from 0 to 5 for positively phrased items, and inversely scored for negatively phrased items. Each subscale will be scored individually and also totaled for a single composite score. Higher scores indicate higher use of effective epilepsy self-management strategies.
**Measure:** Change in leveraging social support for epilepsy self management
**Time Frame:** Baseline, 4 months
#### Primary Outcomes
**Description:** Number of sessions attended per participant.
**Measure:** Feasibility of study processes
**Time Frame:** 4 months
**Description:** A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable.
**Measure:** Acceptability of the intervention
**Time Frame:** 4 months
#### Secondary Outcomes
**Description:** This outcome will be assessed with the Youth Thrive (YT) Framework Survey Part 1: Social Connections and Concrete Supports combine subscales. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a higher level of PSS.
**Measure:** Change in perceived social support (PSS)
**Time Frame:** Baseline, 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able to read, write, and communicate in English at 3rd grade level
* Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication)
* Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment
* The pediatric neurologist feels the patient would benefit from program participation.
* Able to consistently join meetings on Zoom with functional audio and video reception
Exclusion Criteria:
* During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded.
**Maximum Age:** 26 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Laurie Douglass, MD
**Phone:** (617) 414-4590
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kiya Walker, MPH
**Phone:** (617) 414-4588
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Laurie Douglass, MD
- **Phone:** 617-414-4590
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Kiya Walker, MPH
- **Role:** CONTACT
**Country:** United States
**Facility:** Boston Medical Center, Neurology and remote
**State:** Massachusetts
**Zip:** 02118
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Medical Center, Department of Neurology
**Name:** Laurie Douglass, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12478
- Name: Nicotine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427954
**Acronym:** THRIVE
**Brief Title:** Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
**Official Title:** Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
#### Organization Study ID Info
**ID:** 24-091
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** United States Department of Defense
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts General Hospital
#### Responsible Party
**Investigator Affiliation:** Massachusetts General Hospital
**Investigator Full Name:** Jennifer Temel, MD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.
**Detailed Description:** Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE.
### Conditions Module
**Conditions:**
- Lung Cancer
**Keywords:**
- Quality of life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 250
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks.
**Intervention Names:**
- Behavioral: Digital Health App
**Label:** THRIVE Digital Health App
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.
**Label:** Usual Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- THRIVE Digital Health App
**Description:** access to a digital health app
**Name:** Digital Health App
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Coping (higher scores indicate greater use of coping strategy)
**Measure:** Brief Cope (Modified)
**Time Frame:** 12 weeks
**Description:** Self-efficacy (higher scores indicate greater self-efficacy)
**Measure:** Cancer Self-Efficacy Scale
**Time Frame:** 12 weeks
**Description:** Quality of Life (higher scores indicate better quality of life)
**Measure:** FACT-L
**Time Frame:** Over 24 weeks
**Description:** Physical Symptoms (higher scores indicate worse symptoms)
**Measure:** MDASI
**Time Frame:** Over 24 weeks
**Description:** Anxiety and Depression Symptoms (higher scores indicate worse symptoms)
**Measure:** HADS
**Time Frame:** Over 24 weeks
#### Primary Outcomes
**Description:** Quality of Life (higher scores indicate better quality of life)
**Measure:** Functional Assessment of Cancer Therapy - Lung (FACT-L)
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Physical Symptoms (higher scores indicate worse symptoms)
**Measure:** MD Anderson Symptom Inventory (MDASI)
**Time Frame:** 12 weeks
**Description:** Anxiety and Depression Symptoms (higher scores indicate worse symptoms)
**Measure:** Hospital Anxiety and Depression Scale (HADS)
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults (greater than or equal to 18 years)
* Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).
* Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).
Exclusion Criteria:
* Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12478
- Name: Nicotine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427941
**Brief Title:** A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors
**Official Title:** A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
#### Organization Study ID Info
**ID:** BGB-B2033-101
#### Organization
**Class:** INDUSTRY
**Full Name:** BeiGene
### Status Module
#### Completion Date
**Date:** 2026-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** BeiGene
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent proof-of-concept studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).
### Conditions Module
**Conditions:**
- Metastatic Hepatocellular Carcinoma
- Advanced Hepatocellular Carcinoma
- Alpha-fetoprotein (AFP)-Producing Gastric Cancer
- Extragonadal Yolk Sac Tumors
- Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer
- Metastatic Solid Tumor
**Keywords:**
- HCC
- GC
- GPC-3
- GPC3-positive squamous non-small cell lung cancer
- NSCLC
- BGB-B2033
- tislelizumab
- metastatic hepatocellular carcinoma
- Advanced Hepatocellular Carcinoma
- alpha-fetoprotein (AFP)-producing gastric cancer
- extragonadal yolk sac tumors
- Squamous Non-small-cell Lung Cancer
- Non-dysgerminomas squamous non-small cell lung cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ascending dose levels of BGB-B2033 monotherapy will be sequentially enrolled to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and initial anti-tumor effects
**Intervention Names:**
- Drug: BGB-B2033
**Label:** Part A (Monotherapy Dose Escalation and Safety Expansion)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Cohorts of BGB-B2033 in combination with tislelizumab will be sequentially enrolled to evaluate the safety, tolerability, PK, pharmacodynamics, and initial anti-tumor effects of this combination
**Intervention Names:**
- Drug: BGB-B2033
- Drug: Tislelizumab
**Label:** Part B (Combination Dose Escalation and Safety Expansion)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A (Monotherapy Dose Escalation and Safety Expansion)
- Part B (Combination Dose Escalation and Safety Expansion)
**Description:** Administered by intravenous infusion
**Name:** BGB-B2033
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part B (Combination Dose Escalation and Safety Expansion)
**Description:** Administered by intravenous infusion
**Name:** Tislelizumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria;
**Measure:** Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to approximately 2 years
**Description:** The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate of 30% or the highest dose administered, respectively.
**Measure:** Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033
**Time Frame:** Up to approximately 2 years
**Description:** The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
**Measure:** Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab
**Time Frame:** Up to approximately 2 years
#### Secondary Outcomes
**Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
**Measure:** Overall Response Rate (ORR)
**Time Frame:** Up to approximately 2 years
**Description:** DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to approximately 2 years
**Description:** DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** Up to approximately 2 years
**Description:** PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Up to approximately 2 years
**Measure:** Serum concentration of BGB-B2033
**Time Frame:** Up to approximately 2 years
**Measure:** Number of participants with anti-drug antibodies (ADAs) to BGB-B2033
**Time Frame:** Up to approximately 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
3. Participants with any of the following unresectable locally advanced or metastatic tumor types:
1. HCC
2. Histologically confirmed AFP-producing GC (serum AFP \> 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria)
3. Histologically confirmed germ cell tumor including extragonadal yolk sac tumors located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas
4. Histologically confirmed GPC3-positive squamous NSCLC
4. ≥ 1 evaluable lesion for dose escalation and ≥ 1 measurable lesion for safety expansion, per RECIST v1.1
5. ECOG Performance Status score ≤ 1
Exclusion Criteria:
1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137)
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. Active autoimmune diseases or history of autoimmune diseases that may relapse
4. Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
5. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Study Director
**Phone:** 1.877.828.5568
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** BeiGene
**Name:** Study Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000008113
- Term: Liver Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008107
- Term: Liver Diseases
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000013272
- Term: Stomach Diseases
- ID: D000008649
- Term: Mesonephroma
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: HIGH
- As Found: Hepatocellular Carcinoma
- ID: M20386
- Name: Endodermal Sinus Tumor
- Relevance: HIGH
- As Found: Yolk sac tumor
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T5605
- Name: Testicular Yolk Sac Tumor
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000009369
- Term: Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
- ID: D000006528
- Term: Carcinoma, Hepatocellular
- ID: D000013274
- Term: Stomach Neoplasms
- ID: D000018240
- Term: Endodermal Sinus Tumor
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M137899
- Name: Tislelizumab
- Relevance: HIGH
- As Found: Meet
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000707970
- Term: Tislelizumab
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427928
**Acronym:** anxiety in ped
**Brief Title:** Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial
**Official Title:** The Effect of Explaining the Perioperative Process With Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study
#### Organization Study ID Info
**ID:** HTSoner
#### Organization
**Class:** OTHER
**Full Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
**Investigator Full Name:** Hülya Tosun Söner
**Investigator Title:** Anesthesiology and Reanimation Spesialist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. Studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. Preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. The aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings.
### Conditions Module
**Conditions:**
- Anxiety
**Keywords:**
- perioperative anxiety
- pediatric
- general anhesthesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Explains the perioperative process with pictures
- Behavioral: The perioperative process is only explained
**Label:** Explains the perioperative process with pictures
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Behavioral: Explains the perioperative process with pictures
- Behavioral: The perioperative process is only explained
**Label:** The perioperative process is only explained
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Explains the perioperative process with pictures
- The perioperative process is only explained
**Description:** We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale.
**Name:** Explains the perioperative process with pictures
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Explains the perioperative process with pictures
- The perioperative process is only explained
**Description:** We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale.
**Name:** The perioperative process is only explained
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Activity Interested in his/her surroundings, curious, playing with toys, reading (or other age-appropriate activities); may wander around the waiting room or operating room or go to the parent to retrieve a toy; Can gravitate towards operating room equipment 1
He is indifferent to his surroundings, does not play, looks at the ground, plays with his hands and fingers, sucks his thumb; may sit very close to the parent while waiting. 2
Aimless movements directed from the toy towards the parent in an unfocused manner; crazy/exaggerated movements or tricks; writhing, moving on the couch; may push the mask or hug the parent during induction. 3
The person who actively tries to move away, pushing with his feet and arms, can use his whole body to move away; may not be able to separate from the parent who is running around in the waiting room without focusing, not paying attention to toys, or clinging desperately.4
Speech Reading (may not speak in relation to the activity), asking
**Measure:** Modified Yale Preoperative Anxiety Scale
**Time Frame:** While being taken from the preoperative room to the operating room and just before anesthetizing in the operating room
#### Secondary Outcomes
**Description:** 7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable
**Measure:** Riker agitation scala
**Time Frame:** after extubation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA I patients without any comorbidities who were operated on by the ENT,
* Patients between the ages of 5-12,
* And patients who could be contacted and did not have any anxiety problems were included.
Exclusion Criteria:
* Patients with liver and/or kidney failure, trauma patients, ASAII-III-IV patients, patients with bleeding disorders,
* those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .And patients who did not want to participate in the study were excluded from the study.
**Maximum Age:** 12 Years
**Minimum Age:** 5 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hülya Tosun Söner
**Phone:** +905352792102
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427915
**Acronym:** SODA-SWAP
**Brief Title:** Studying Glucose and Appetite Response With Alternatives to Soda Pop
**Official Title:** Studying GlucOse anD Appetite ResponseS With Alternatives to Pop (SODA-SWAP)
#### Organization Study ID Info
**ID:** BIO-2401
#### Organization
**Class:** INDUSTRY
**Full Name:** Olipop, PBC
### Status Module
#### Completion Date
**Date:** 2024-08-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** BioFortis
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Olipop, PBC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake.
### Conditions Module
**Conditions:**
- Healthy Nutrition
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One 12oz serving of soda consumed alone after a 4 hour fasting period
**Intervention Names:**
- Other: OLIPOP prebiotic soda
- Other: Traditional sugar-sweetened cola
**Label:** Soda consumption in fasted state
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period
**Intervention Names:**
- Other: OLIPOP prebiotic soda
- Other: Traditional sugar-sweetened cola
**Label:** Soda consumption with a defined carbohydrate rich meal
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Soda consumption in fasted state
- Soda consumption with a defined carbohydrate rich meal
**Description:** 12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus\*, Marshmallow Root\*, Calendula Flower\*, Kudzu Root\*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root\*, Stevia Leaf\*, Himalayan Pink Salt, Green Tea Caffeine\*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon\* (\*Extract)
**Name:** OLIPOP prebiotic soda
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Soda consumption in fasted state
- Soda consumption with a defined carbohydrate rich meal
**Description:** 12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine
**Name:** Traditional sugar-sweetened cola
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence).
**Measure:** Blood Glucose iAUC
**Time Frame:** For 2 hours post intervention
#### Secondary Outcomes
**Description:** Blood glucose maximum concentration
**Measure:** Blood Glucose Cmax
**Time Frame:** For 2 hours post intervention
**Description:** Time to maximum blood glucose concentration
**Measure:** Time to Blood Glucose Cmax (Tmax)
**Time Frame:** For 2 hours post intervention
**Description:** The maximum concentration above the average baseline glucose concentration within the 2-hour period following study product consumption, expressed as a percentage of the average baseline glucose concentration
**Measure:** Blood Glucose Rise 0-2 Hours
**Time Frame:** For 2 hours post intervention
**Description:** The difference between the lowest glucose concentration in hours 2-3 after study product consumption and the average baseline glucose concentration, expressed as a percentage of average baseline glucose concentration
**Measure:** Blood Glucose Dip 2-3 Hours
**Time Frame:** For time frame of 2 to 3 hours post intervention
**Description:** The number of participants with a reduction in glucose in hours 2-3 after study product consumption compared to the average baseline glucose concentration
**Measure:** Blood Glucose Reduction
**Time Frame:** For time frame of 2 to 3 hours post intervention
**Description:** The number of minutes after consumption of the study product that elapsed before the next meal of at least 50 kcal is consumed
**Measure:** Time Until Next Meal
**Time Frame:** Within same day post interevention
**Description:** Energy intake (kcals) within 3 to 4 hours post-product consumption
**Measure:** Energy Intake - Short Term
**Time Frame:** For time frame of 3 to 4 hours post intervention
**Description:** The total daily consumption covers the full period from 4 hours before the participant's breakfast to 20 hours after
**Measure:** Energy Intake - 24 Hours
**Time Frame:** Time frame from 4 hours before the participant's breakfast to 20 hours after participant's breakfast
**Description:** The change in hunger ratings from pre-meal to post meal where post meal is defined as the average of the hunger ratings in the 2- 3 hour time frame
**Measure:** Change in Perceived Hunger Level
**Time Frame:** For time frame of 2 to 3 hours post intervention
**Description:** The change in alertness ratings from pre-meal to post meal where the post meal is defined as the average alertness ratings in the 2-3 hour time frame
**Measure:** Change in Perceived Alertness Level
**Time Frame:** For time frame of 2 to 3 hours post intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female, ≥18 to ≤65 years of age at visit 1a.
2. Body mass index (BMI) of ≥25.0 kg/m2 to \<35.0 kg/m2 at visit 1a.
3. Fasting capillary (fingerstick) glucose \<126 mg/dL at visit 1a. One repeat will be allowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects are confirmed fasting or a separate day if subjects were not fasting). If a repeat is taken, the second reading will be used to determine eligibility.
4. Willing to wear a continuous glucose monitor (CGM) sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
5. Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
6. Non-user of marijuana and hemp products, including cannabidiol (CBD) products, within 60 d of visit 1a.
7. Willing to avoid alcohol 24 h prior to visit 1a/1b and throughout the study.
8. Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial.
9. Willing to use personal smart phone with operating system (Android version 12.0 or newer; Apple iPhone operating system (iOS) version 16 or newer) capable of downloading the Dexcom G7 CGM app and the Cronometer app for diet records.
10. Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Exclusion Criteria:
1. Inability to consume a standard 12 fl. oz. carbonated beverage with or without food within 15 min.
2. Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in the judgment of the Investigator or has been diagnosed with an eating disorder.
3. Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 d of visit 1a.
4. Known allergy or sensitivity to any of the ingredients in the study products and/or meals provided.
5. Weight loss or gain \>4.5 kg within 90 d of visit 1a.
6. Currently or planning to be on a weight loss or weight gain/ muscle-building regimen program during the study.
7. Use of vitamin C-containing supplements (including multivitamins) within 24 hours of visit 1a and during the study intervention period.
8. Shift workers with eating patterns not consistent with the study product consumption schedule.
9. History or presence of uncontrolled and/or clinically important endocrine, cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic, rheumatic, and/or biliary conditions that, in the opinion of the Principal Investigator, could interfere with the interpretation of the study results.
10. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1a.
11. Gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, inflammatory bowel disease (Crohn's or ulcerative colitis), celiac disease, history of gastric bypass surgery).
12. Use of oral or injectable steroids (topical and inhaled are allowed) within 90 d of visit 1a.
13. Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the CGM sensor) within 24 hours of visit 1a/1b and during the study intervention period. If use occurs during the intervention period (e.g., subject takes an aspirin), details of the use (e.g., time, amount, product) should be documented.
14. Unstable use of any prescription medications that affect blood glucose levels, whereby stable is defined as no change in regimen within 90 d prior to visit 1a. Examples include diabetes medications, glucagon-like-peptide-1 (GLP-1) agonists, medications for anxiety, attention deficit/hyperactivity disorder (ADHD), depression, and other mental health problems (e.g., clozapine, olanzapine, quetiapine, and risperidone), thyroid hormone replacement medications, statins, protease inhibitors, adrenergic receptor blockers, and isotretinoin.
15. History or presence of cancer, except non-melanoma skin cancer, within 2 years of visit 1a.
16. Exposure to any non-registered drug product or has participated in another intervention study within 30 d prior to visit 1a.
17. Signs or symptoms of an active infection of clinical relevance within 5 d of visit 1a. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to visit 1a.
18. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 11⁄2 oz. distilled spirits).
19. History of any major trauma or major surgical event within 60 d of visit 1a.
20. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
21. Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michael J Weiser, PhD
**Phone:** 303-834-7240
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Addison
**Contacts:**
***Contact 1:***
- **Name:** John Marshall
- **Phone:** 630-617-2000
- **Role:** CONTACT
**Country:** United States
**Facility:** Biofortis
**State:** Illinois
**Status:** RECRUITING
**Zip:** 60101
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T312
- Name: Tea
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
- ID: T115
- Name: Cinnamon
- Relevance: LOW
- As Found: Unknown
- ID: T176
- Name: Guar
- Relevance: LOW
- As Found: Unknown
- ID: T301
- Name: Stevia
- Relevance: LOW
- As Found: Unknown
- ID: T431
- Name: Stevioside
- Relevance: LOW
- As Found: Unknown
- ID: T89
- Name: Calendula
- Relevance: LOW
- As Found: Unknown
- ID: T205
- Name: Kudzu
- Relevance: LOW
- As Found: Unknown
- ID: T93
- Name: Cassava
- Relevance: LOW
- As Found: Unknown
- ID: T260
- Name: Prickly Pear
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427902
**Brief Title:** Inflammatory Biomarkers in Saliva at Depression
**Official Title:** Salivary Biomarkers of Gingival Inflammation Are Associated With Depression
#### Organization Study ID Info
**ID:** Depression
#### Organization
**Class:** OTHER
**Full Name:** Medipol University
### Status Module
#### Completion Date
**Date:** 2019-09-16
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-06-14
**Type:** ACTUAL
#### Start Date
**Date:** 2018-12-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medipol University
#### Responsible Party
**Investigator Affiliation:** Medipol University
**Investigator Full Name:** DUYGU ILHAN
**Investigator Title:** Asst. Prof
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study is to evaluate the inflammatory saliva biomarkers in depression and gingivitis.
The main question will be ; Will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis?
**Detailed Description:** Background: The neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. The present study was to evaluate the periodontal health status and the levels of Triggering receptor expressed on myeloid cells 1 (TREM-1), peptidoglycan recognition protein 1 (PGLYRP1) and interleukin-1 beta (IL-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals.
Methods: Forty-two depression patients were classified in two groups: depression with gingivitis (DG) and depression with periodontally healthy (DPH) patients. Additionally, 23 systemically and periodontally healthy (SPH) individuals were enrolled to the study. Periodontal parameters were recorded. Saliva samples were collected and salivary levels of TREM-1, PGLYRP1, IL-1β were measured using Enzyme-linked Immunosorbent Assay (ELISA) kits.
depression regardless of periodontal status.
### Conditions Module
**Conditions:**
- Gingivitis
- Depression
- Inflammation
- Inflammatory Response
### Design Module
#### Bio Spec
**Description:** Saliva
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 65
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.
the gingivitis group was determined by the criteria of pocket depth of 3 mm or less.
**Intervention Names:**
- Other: Periodontal clinical measurements, Saliva sampling
**Label:** depression with gingivitis (DG) group
#### Arm Group 2
**Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.
**Intervention Names:**
- Other: Periodontal clinical measurements, Saliva sampling
**Label:** depression with periodontally healthy (DPH) patients
#### Arm Group 3
**Description:** This group contists of individuals who are systemically and periodontally healthy
**Intervention Names:**
- Other: Periodontal clinical measurements, Saliva sampling
**Label:** systemically and periodontally healthy (SPH) individuals
### Interventions
#### Intervention 1
**Arm Group Labels:**
- depression with gingivitis (DG) group
- depression with periodontally healthy (DPH) patients
- systemically and periodontally healthy (SPH) individuals
**Description:** Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque
**Name:** Periodontal clinical measurements, Saliva sampling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.
**Measure:** SalivaryTREM-1
**Time Frame:** 06-09 2019
**Description:** Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.
**Measure:** Salivary PGLYRP1
**Time Frame:** 06-09 2019
**Description:** Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.
**Measure:** Salivary IL-1β
**Time Frame:** 06-09 2019
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months
Exclusion Criteria: Patients with
* psychotic disorders
* autism spectrum disorders
* other anxiety disorders
* bipolar disorder
* mental any organic mental disorder and
* smokers, substance users
**Healthy Volunteers:** True
**Maximum Age:** 53 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** This study was carried out on 65 participants in total, including 42 individuals who applied to Aydın State Hospital Psychiatry Outpatient Clinic, diagnosed with depressive disorder, were classified in 2 different groups; depression with gingivitis (DG), depression with periodontally healthy (DPH) patients and 23 systemically and periodontally healthy (SPH) individuals who applied to Adnan Menderes University Faculty of Dentistry.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Duygu Ilhan
**State:** Select State
**Zip:** 34365
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007239
- Term: Infections
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M9003
- Name: Gingivitis
- Relevance: HIGH
- As Found: Gingivitis
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005891
- Term: Gingivitis
- ID: D000007249
- Term: Inflammation
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427889
**Brief Title:** Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes
**Official Title:** A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants With a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons With Diabetes
#### Organization Study ID Info
**ID:** 2022-500907-27-01
#### Organization
**Class:** OTHER
**Full Name:** Malmö University
### Status Module
#### Completion Date
**Date:** 2026-08-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-11-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Malmö University
#### Responsible Party
**Investigator Affiliation:** Malmö University
**Investigator Full Name:** Tautgirdas Ruzgas
**Investigator Title:** Professor,Biomedical technology, Study director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.
### Conditions Module
**Conditions:**
- Diabetes Mellitus
- Skin and Connective Tissue Diseases
**Keywords:**
- Diabetes Mellitus
- Dry Skin
- Self Care
- Dry Feet
- Prevention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 98
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Topical on feet twice a day
**Intervention Names:**
- Drug: Canoderm
**Label:** Canoderm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Topical on feet twice a day
**Intervention Names:**
- Drug: Oviderm
**Label:** Oviderm
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Topical on feet twice a day
**Intervention Names:**
- Drug: Decubal
**Label:** Decubal
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Canoderm
**Description:** humectant
**Name:** Canoderm
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Oviderm
**Description:** humectant + antimicrobial
**Name:** Oviderm
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Decubal
**Description:** Non-humectant
**Name:** Decubal
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)
**Measure:** Xerosis Severity
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** Trans epidermal water loss (TEWL) (grams per square meter per hour)
**Measure:** Transepidermal water loss
**Time Frame:** 4 weeks
**Description:** Skin resistance in Ohms (Ω)
**Measure:** Skin resistance
**Time Frame:** 4 weeks
**Description:** Skin Capacitance in Farads (F)
**Measure:** Skin Capacitance
**Time Frame:** 4 weeks
**Description:** Skin pH (5-8)
**Measure:** Skin pH
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
* Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
* Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.
Exclusion Criteria:
* Known sensibility to any of the ingredients in the products.
* Other diagnosed skin disease on the feet.
* Active lesions on either foot.
* Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
* Potential study subjects judged unable to comply with treatment schedule and study specific information.
* Female of childbearing potential that do not use effective medically accepted contraception.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tautgirdas Ruzgas, Professor
**Phone:** +46406657431
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Malmo University
**Name:** Christine Kumlien, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: HIGH
- As Found: Connective Tissue Diseases
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427876
**Brief Title:** Fasenra Pediatric Japan Post-Marketing Study(PMS)
**Official Title:** FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients
#### Organization Study ID Info
**ID:** D3250C00100
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2027-03-17
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).
1. Development of unexpected related AEs\*
2. To grasp development of related AEs\* in the real-world post-marketing setting.
3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug
**Detailed Description:** This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).
1. Development of unexpected related AEs\*
2. To grasp development of related AEs\* in the real-world post-marketing setting.
3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug
### Conditions Module
**Conditions:**
- Bronchial Asthma
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other
**Measure:** Incidence of ADRs
**Time Frame:** from baseline to 1year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The evaluable patients in children aged ≥6 years to \<15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy)
Exclusion Criteria:
none
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The evaluable patients in children aged ≥6 years to \<15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy)
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-9479
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** AstraZeneca K.K.
**Name:** Shunsuke Hiroki
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
**IPD Sharing:** YES
**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
**URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Bronchial Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M287399
- Name: Benralizumab
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427863
**Brief Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation
**Official Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation in Adults: a Multi-center, Randomized, Placebo-controlled Clinical Study
#### Organization Study ID Info
**ID:** WMT-Anti-CC-202405
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Faming Zhang
#### Responsible Party
**Investigator Affiliation:** The Second Hospital of Nanjing Medical University
**Investigator Full Name:** Faming Zhang
**Investigator Title:** Professor, Gastroenterology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study
**Detailed Description:** All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, complete spontaneous bowel movements（CSBM), Constipation assessment scale (CAS), Patient-Assessment of Constipation Quality Of Life（PAC-QOL) and clinical outcomes were collected. After the treatment, the efficacy and safety were evaluated during the follow-up period.
### Conditions Module
**Conditions:**
- Chronic Constipation
**Keywords:**
- chronic constipation
- washed microbiota transplantation
- antibiotic pretreatment
- randomized controlled trial
- transendoscopic enteral tube
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days.
**Intervention Names:**
- Drug: Ornidazole
**Label:** Treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days.
**Intervention Names:**
- Drug: Placebo
**Label:** Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days
**Name:** Ornidazole
**Other Names:**
- washed microbiota transplantation
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days
**Name:** Placebo
**Other Names:**
- washed microbiota transplantation
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance.
**Measure:** Response rate of complete spontaneous bowel movements（CSBM）
**Time Frame:** One-week, Four-week and Eight-week post-WMT
**Description:** The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation.
**Measure:** The extent of change observed in Constipation assessment scale (CAS) of participants
**Time Frame:** One-week, Four-week and Eight-week post-WMT
**Description:** The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.
**Measure:** The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants
**Time Frame:** One-week, Four-week and Eight-week post-WMT
#### Secondary Outcomes
**Description:** Bristol stool form scale(BSFS) was used, which can be divided into seven types.
**Measure:** The extent of change observed in stool properties of participants
**Time Frame:** One-week post-WMT
**Description:** The rate of adverse events after antibiotic pretreatment
**Measure:** Rate of Adverse Events
**Time Frame:** One-week, Four-week and Eight-week post-WMT
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to enter the study:
1. Male and female, aged ≥18 years old, provided written informed consent;
2. Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions:
1) spontaneous bowel movement frequency \<3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2.
3. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded fromthe study:
1. Presence of outlet obstruction and constipation, such as rectal mucosal prolapse
2. Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation;
3. Constipation caused by other systemic diseases involving the digestive tract, such as nervous system diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis, etc.), mental disorders (such as depression, etc.), metabolic and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc.
4. Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment;
5. Has a history of major surgery within 3 months or a history of severe trauma, and recovery is not completely;
6. There are contraindications to colonic transendoscopic intestinal tube implantation, such as severe intestinal stenosis, obstruction, deep ulcer, and high risk of operation perforation; Severe ulcers or a large number of pseudopolyps exist in the fixed area of titanium clips, which are not suitable for fixation. The subjects' behavior was seriously uncontrolled.
7. Any of the following abnormalities in cardiac function and performance:
1. According to the New York Heart Association (NYHA) cardiac function classification, cardiac function grade Ⅲ or above;
2. new onset myocardial infarction or unstable angina pectoris within 6 months;
3. ECG showed QTc prolongation (QTc≥ 450ms in men and ≥470ms in women);
4. Drug-refractory atrial arrhythmias and drug-refractory ventricular arrhythmias (including grade 2 or higher atrioventricular block).
8. Patients with poor lung function that is considered by the investigator to have an impact on the study treatment, such as patients with acute exacerbation of COPD or patients requiring long-term use of oral or intravenous steroids for control (except inhalers/sprays);
9. No control autoimmune disease and/or need long-term use of hormone (except local external use sex);
10. Patients with metabolic diseases and poorly controlled by drugs (such as thyroid dysfunction), or patients with metabolic diseases accompanied by gastrointestinal function complications (such as gastrointestinal autonomic nerve dysfunction, diabetic gastroparesis, etc.);
11. Suffering from reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain;
12. Significant laboratory abnormalities that, in the judgment of the investigator, may affect the safety of the subjects or the completion of the clinical study, including:
A) the hemoglobin \< 100 g/L; B) Serum creatinine ≥1.5 times the upper limit of normal (ULN) C) abnormal liver function, defined as AST\>1.5×ULN and/or ALT\>1.5×ULN and/or total bilirubin \>1.5×ULN; D) blood clotting function: PLT acuities were 80 x 109 / L, APTT \> 1.5 x ULN, PT \> 1.5 x ULN, INR \> 1.5 x ULN; E) abnormal results or defecate occult blood stool and has prompted the clinical significance of the gastrointestinal tract.
13. Have active hepatitis (requiring or taking long-term treatment), HIV, or active tuberculosis;
14. A history of drug or alcohol abuse (i.e., drinking more than 14 servings per week of beer, 45 mL of 40% spirits, or 150 mL of wine) or substance abuse;
15. The known allergic to research similar drugs, drugs or accessories;
16. Use of anti-infective drugs (antibiotics, antifungal, antiviral) within 14 days before enrollment, or need anti-infective treatment at enrollment evaluation;
17. Drugs and supplements that affect gastrointestinal motility and function cannot be stopped during the study, including but not limited to: antibiotics such as erythromycin; Drugs that modulate the intestinal microecology, such as probiotics such as Bifidobacterium; The parasympathetic nerve inhibitors, some scopolamine and atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta; Opioid preparations; Drugs that inhibit gastric acid secretion;
18. Pregnant or lactating women, or refusing to use an effective contraceptive method within 3 months after the last dose of treatment;
19. 3 months prior to dosing involved in drug interventional clinical trials;
20. Suffering from malignant tumors;
21. There were other circumstances that the investigator considered inappropriate for participating in the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Faming Zhang, PhD
**Phone:** 086-025-58509883
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bota Cui
**Phone:** 086-025-58509884
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Country:** China
**Facility:** Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
**Zip:** 210011
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Nanjing Medical University
**Name:** Faming Zhang, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available.
**PMID:** 28000680
**Citation:** Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
**PMID:** 35014601
**Citation:** Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
**PMID:** 16169298
**Citation:** Bazzocchi G, Giovannini T, Giussani C, Brigidi P, Turroni S. Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial. Tech Coloproctol. 2014 Oct;18(10):945-53. doi: 10.1007/s10151-014-1201-5. Epub 2014 Aug 5.
**PMID:** 25091346
**Citation:** Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2.
**PMID:** 38500062
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6472
- Name: Constipation
- Relevance: HIGH
- As Found: Constipation
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000003248
- Term: Constipation
### Intervention Browse Module - Ancestors
- ID: D000000563
- Term: Amebicides
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000994
- Term: Antitrichomonal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12876
- Name: Ornidazole
- Relevance: HIGH
- As Found: Hydrogen Sulfate
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M3904
- Name: Amebicides
- Relevance: LOW
- As Found: Unknown
- ID: M4298
- Name: Antiprotozoal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4294
- Name: Antiparasitic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009950
- Term: Ornidazole
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427850
**Brief Title:** Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)
**Official Title:** Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 123678
#### Organization
**Class:** OTHER
**Full Name:** Ramathibodi Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Thanawan Longsuwan
#### Responsible Party
**Investigator Affiliation:** Ramathibodi Hospital
**Investigator Full Name:** Thanawan Longsuwan
**Investigator Title:** Doctor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.
**Detailed Description:** Detail : Randomization of Patients for intra-surgical site topical tranexamic acid injection
Objective : To compare the efficacy of topical tranexamic acid (TXA) injection into the surgical wound versus placebo injection in reducing blood loss and drainage output in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) surgery.
Methods:
Patient: Patients with degenerative spine conditions undergoing single-level MI-TLIF surgery, who received treatment at Ramathibodi Hospital and Chakri Naruebodindra Medical Institute from 2024 to 2027.
Randomization : Patients will be randomly by various block randomization (1:1) was performed using STATA 16.0 to ensure that the two groups were comparable in size and that the sequence of randomization was unpredictable.
Intervention :
Group 1 : Patients in this group will receive an injection of topical tranexamic acid (TXA) into the surgical site(50mg/ml) 10 ml after wound exposure and after wound decompression.
Group 2: Patients in this group will receive a placebo injection (Normal saline 10 ml) into the surgical site after wound exposure and after wound decompression.
Allocation Concealment :
A central randomization service will prepare sealed envelopes labeled with sequence numbers corresponding to the sample size. This method decreasing selection bias in assigning participants to the treatment groups. The envelopes were opened and equipment prepared after anesthesia was administered and before the surgeon began the incision.
Blinding :
The study participants and assessors will be blinded to treatment allocation. The surgeons were blinded by clear fluid as same in 2 groups but if tranexamic acid can be effective to decrease blood loss in intraoperation. So we cannot controlled blinding surgeons.
Primary outcome measurement: postoperative drainage (ml)
Secondary outcome measurement:
calculated total blood loss, intraoperative blood loss, blood transfusion rate, duration of drain maintenance, length of hospital stay, complication of tranexamic acid (TXA) and surgery.
Statistical Analysis:
Demographic Analysis :
For continuous data reported as Mean and Standard Deviation (S.D.) and analyzed by Independent t-test or Mann-Whitney U test.
For categorical data reported as Percentages and analyzed by Chi-square test.
Compare the results of the study:
Postoperative drainage (ml),calculated total blood loss (ml), intraoperative blood loss (mL) , duration of drain maintenance (day), length of hospital stay (day)were report to Mean and Standard Deviation (S.D.) analyzed by Independent t-test or Mann-Whitney U test for continuous data.
Complication of tranexamic acid (TXA) and surgery(%), blood transfusion rate (%) were reported to Percentages and analyzed by Chi-square test. Use STATA 16.0 software for statistical calculations.
### Conditions Module
**Conditions:**
- Degenerative Spine Diseases
- Surgical Wound
**Keywords:**
- Degenerative spine diseases
- Surgical wound
- Tranexamic acid (TXA)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** receive an injection of topical tranexamic acid (TXA) into the surgical site
**Intervention Names:**
- Drug: Tranexamic acid
**Label:** Topical tranexamic acid (TXA) injection
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** receive an injection Normal saline into the surgical site
**Intervention Names:**
- Drug: Normal saline
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Topical tranexamic acid (TXA) injection
**Description:** receive an injection of Tranexamic acid into the surgical site
**Name:** Tranexamic acid
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** receive an injection of Normal saline into the surgical site
**Name:** Normal saline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Fluid drainage after operation
**Measure:** postoperative drainage (mL)
**Time Frame:** 120 hours
#### Secondary Outcomes
**Description:** calculated total blood loss by Gross formular
**Measure:** calculated total blood loss (mL)
**Time Frame:** 120 hours
**Description:** Evaluated by anesthesiologists
**Measure:** intraoperative blood loss (mL)
**Time Frame:** Intraoperative time
**Description:** Duration time of drain insertion to off drain
**Measure:** duration of drain maintenance (day)
**Time Frame:** 120 hours
**Description:** Duration time of patients stay in hospital
**Measure:** length of hospital stay (day)
**Time Frame:** 120 hours
**Description:** The patients who had complication from tranexamic acid (TXA) and surgery in each group
**Measure:** complication of tranexamic acid (TXA) and surgery(%)
**Time Frame:** 120 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 30-80 years old
* Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
Exclusion Criteria:
* Revision surgery
* Patients who had high risk of complication from TXA
* History of seizure, PE, DVT, thromboembolic episode
* History of TXA allergy
* Patients who had high risk for bleeding
* U/D : CKD stage more than IIIb (GFR\< 45 ml/min/1.73m2), hepatic disease, bleeding disorder
* On anticoagulation drug or antiplatelet drug in 7 days before surgery
* Abnormal coagulation profile (INR \> 1.5) or CBC (platelet \< 100000)
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Thanawan Longsuwan, Doctor of medicine
**Phone:** (+66)892966855
**Role:** CONTACT
**Contact 2:**
**Name:** Kan Kaewroj, Diploma of Orthopaedics
**Phone:** (+66) 022011589
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
**PMID:** 30560029
**Citation:** Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
**PMID:** 15834339
**Citation:** Harms JG, Jeszenszky D. Die posteriore, lumbale, interkorporelle Fusion in unilateraler transforaminaler Technik. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. doi: 10.1007/s00064-006-0112-7. No abstract available. German.
**PMID:** 17332991
**Citation:** Holly LT, Schwender JD, Rouben DP, Foley KT. Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications. Neurosurg Focus. 2006 Mar 15;20(3):E6. doi: 10.3171/foc.2006.20.3.7.
**PMID:** 16599422
**Citation:** Moskowitz A. Transforaminal lumbar interbody fusion. Orthop Clin North Am. 2002 Apr;33(2):359-66. doi: 10.1016/s0030-5898(01)00008-6.
**PMID:** 12389281
**Citation:** Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
**PMID:** 35783004
**Citation:** Kleinert K, Theusinger OM, Nuernberg J, Werner CM. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010 Sep;6(2):190-8. doi: 10.1007/s11420-009-9151-6. Epub 2010 Jan 28.
**PMID:** 21886535
**Citation:** Dodd RY. The risk of transfusion-transmitted infection. N Engl J Med. 1992 Aug 6;327(6):419-21. doi: 10.1056/NEJM199208063270610. No abstract available.
**PMID:** 1625717
**Citation:** Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23. Erratum In: N Engl J Med. 2018 Feb 22;378(8):782.
**PMID:** 27774838
**Citation:** Danninger T, Memtsoudis SG. Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med. 2015 Apr;3(6):77. doi: 10.3978/j.issn.2305-5839.2015.01.25. No abstract available.
**PMID:** 25992376
**Citation:** Badeaux J, Hawley D. A systematic review of the effectiveness of intravenous tranexamic acid administration in managing perioperative blood loss in patients undergoing spine surgery. J Perianesth Nurs. 2014 Dec;29(6):459-65. doi: 10.1016/j.jopan.2014.06.003. Epub 2014 Nov 20.
**PMID:** 25458625
**Citation:** Xiong Z, Liu J, Yi P, Wang H, Tan M. Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta-Analysis. Biomed Res Int. 2020 Mar 9;2020:7403034. doi: 10.1155/2020/7403034. eCollection 2020.
**PMID:** 32219141
**Citation:** Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21.
**PMID:** 27099820
**Citation:** Gulabi D, Yuce Y, Erkal KH, Saglam N, Camur S. The combined administration of systemic and topical tranexamic acid for total hip arthroplasty: Is it better than systemic? Acta Orthop Traumatol Turc. 2019 Jul;53(4):297-300. doi: 10.1016/j.aott.2019.03.001. Epub 2019 Apr 4.
**PMID:** 30954338
**Citation:** Li J, Wang L, Bai T, Liu Y, Huang Y. Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion. J Orthop Surg Res. 2020 Aug 20;15(1):339. doi: 10.1186/s13018-020-01758-8.
**PMID:** 32819445
**Citation:** Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
**PMID:** 22611164
**Citation:** Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8.
**PMID:** 19996135
**Citation:** Cravens GT, Brown MJ, Brown DR, Wass CT. Antifibrinolytic therapy use to mitigate blood loss during staged complex major spine surgery: Postoperative visual color changes after tranexamic acid administration. Anesthesiology. 2006 Dec;105(6):1274-6. doi: 10.1097/00000542-200612000-00029. No abstract available.
**PMID:** 17122592
**Citation:** Murao S, Nakata H, Roberts I, Yamakawa K. Effect of tranexamic acid on thrombotic events and seizures in bleeding patients: a systematic review and meta-analysis. Crit Care. 2021 Nov 1;25(1):380. doi: 10.1186/s13054-021-03799-9.
**PMID:** 34724964
**Citation:** Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6.
**PMID:** 31934525
**Citation:** Montroy J, Hutton B, Moodley P, Fergusson NA, Cheng W, Tinmouth A, Lavallee LT, Fergusson DA, Breau RH. The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis. Transfus Med Rev. 2018 Feb 19:S0887-7963(17)30151-7. doi: 10.1016/j.tmrv.2018.02.003. Online ahead of print.
**PMID:** 29567052
**Citation:** Mallepally AR, Mahajan R, Rustagi T, Goel SA, Das K, Chhabra HS. Use of Topical Tranexamic Acid to Reduce Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion. Asian Spine J. 2020 Oct;14(5):593-600. doi: 10.31616/asj.2019.0134. Epub 2020 Mar 30.
**PMID:** 32213797
**Citation:** Wang F, Wang SG, Yang Q, Nan LP, Cai TC, Wu DS, Zhang L. Cytotoxicity and Effect of Topical Application of Tranexamic Acid on Human Fibroblast in Spine Surgery. World Neurosurg. 2021 Sep;153:e380-e391. doi: 10.1016/j.wneu.2021.06.125. Epub 2021 Jul 2.
**PMID:** 34224885
**Citation:** Schwarzkopf R, Dang P, Luu M, Mozaffar T, Gupta R. Topical tranexamic Acid does not affect electrophysiologic or neurovascular sciatic nerve markers in an animal model. Clin Orthop Relat Res. 2015 Mar;473(3):1074-82. doi: 10.1007/s11999-014-4098-4. Epub 2015 Jan 6.
**PMID:** 25560955
**Citation:** Ren Z, Li S, Sheng L, Zhuang Q, Li Z, Xu D, Chen X, Jiang P, Zhang X. Topical use of tranexamic acid can effectively decrease hidden blood loss during posterior lumbar spinal fusion surgery: A retrospective study. Medicine (Baltimore). 2017 Oct;96(42):e8233. doi: 10.1097/MD.0000000000008233.
**PMID:** 29049210
**Citation:** Sudprasert W, Tanaviriyachai T, Choovongkomol K, Jongkittanakul S, Piyapromdee U. A Randomized Controlled Trial of Topical Application of Tranexamic Acid in Patients with Thoracolumbar Spine Trauma Undergoing Long-Segment Instrumented Posterior Spinal Fusion. Asian Spine J. 2019 Feb;13(1):146-154. doi: 10.31616/asj.2018.0125. Epub 2018 Oct 24.
**PMID:** 30347526
**Citation:** Gybel M, Kristensen K, Roseva-Nielsen N. [Cardiac arrest caused by massive pulmonary embolism during treatment with tranexamic acid]. Ugeskr Laeger. 2013 May 13;175(20):1426-7. Danish.
**PMID:** 23663400
**Citation:** Taparia M, Cordingley FT, Leahy MF. Pulmonary embolism associated with tranexamic acid in severe acquired haemophilia. Eur J Haematol. 2002 May;68(5):307-9. doi: 10.1034/j.1600-0609.2002.01607.x.
**PMID:** 12144537
**Citation:** Krivokuca I, Lammers JW. Recurrent pulmonary embolism associated with a hemostatic drug: tranexamic acid. Clin Appl Thromb Hemost. 2011 Feb;17(1):106-7. doi: 10.1177/1076029609340902. Epub 2009 Oct 14.
**PMID:** 19833620
**Citation:** Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.
**PMID:** 34626756
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: HIGH
- As Found: Spine Disease
- ID: M1112
- Name: Surgical Wound
- Relevance: HIGH
- As Found: Surgical Wound
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013122
- Term: Spinal Diseases
- ID: D000072836
- Term: Surgical Wound
### Intervention Browse Module - Ancestors
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
### Intervention Browse Module - Browse Branches
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427837
**Brief Title:** Child Snack Variety Study
**Official Title:** Child Snack Variety Study
#### Organization Study ID Info
**ID:** ChildFood802
#### Organization
**Class:** OTHER
**Full Name:** Penn State University
### Status Module
#### Completion Date
**Date:** 2024-09-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Penn State University
#### Responsible Party
**Investigator Affiliation:** Penn State University
**Investigator Full Name:** Barbara J. Rolls
**Investigator Title:** Professor of Nutritional Sciences
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine how consumption of a snack food at a first course affects the hedonic ratings of that snack food compared to other foods, and how it affects intake of a second course. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.
### Conditions Module
**Conditions:**
- Eating Behavior
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The same snack food will be served in the second course
**Intervention Names:**
- Other: Same 2nd course
**Label:** Same 2nd course
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A different snack food will be served in the second course
**Intervention Names:**
- Other: Different 2nd course
**Label:** Different 2nd course
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Same 2nd course
**Description:** The same snack food will be served in the second course
**Name:** Same 2nd course
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Different 2nd course
**Description:** A different snack food will be served in the second course
**Name:** Different 2nd course
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Weight (grams) of food and water consumed
**Measure:** Change between interventions of snack intake by weight
**Time Frame:** Study weeks 1 and 2
**Description:** Energy (kcal) of food consumed
**Measure:** Change between interventions of snack intake by energy
**Time Frame:** Study weeks 1 and 2
#### Secondary Outcomes
**Description:** Change between interventions in liking (before to after consumption) of the 5 test foods, measured using a visual analog scale (0-100 points).
**Measure:** Change between interventions in liking of each test food
**Time Frame:** Study weeks 1 and 2
**Description:** Change in ranked preference (before to after consumption) of the 5 test foods.
**Measure:** Change between interventions in ranked preference of each test food from before to after consumption
**Time Frame:** Study weeks 1 and 2
**Description:** Change in fullness ratings (before to after consumption) measured using a 4-point scale ranging from empty to full.
**Measure:** Change between interventions in fullness ratings from before to after consumption
**Time Frame:** Study weeks 1 and 2
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children who are enrolled in a participating childcare center
* Children who are between the ages of 6 and 14 years old at the time of enrollment
Exclusion Criteria:
* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on study days
* Children who are not able to complete study measures (e.g. refuse to eat study foods, only use the anchors or have low variability for their liking ratings, etc.)
**Healthy Volunteers:** True
**Maximum Age:** 14 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cara Meehan
**Phone:** 814-863-8481
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427824
**Brief Title:** Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy
**Official Title:** Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** IRB23-0773
#### Organization
**Class:** OTHER
**Full Name:** University of Chicago
### Status Module
#### Completion Date
**Date:** 2026-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Chicago
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires.
**Detailed Description:** This study focuses on providing an educational program for participants/people with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. The goal of this study is to educate people with bladder cancer and ask them to also fill out questionnaires about the education program and if they used any of the strategies that learn during the study.
Participants in this study will be divided into two different study groups (one group that watches educational videos before surgery and one group that watches educational videos before surgery and also receives geriatric services and follow up visits after surgery). Each participant will be randomized (randomly assigned) to one of two study groups. That means that there is a 50/50 chance (like flipping a coin) that each participant will end up in either group.
### Conditions Module
**Conditions:**
- Bladder Cancer
**Keywords:**
- cystectomy
- radical cystectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 85
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before and after surgery.
**Intervention Names:**
- Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
- Other: Questionnaires
**Label:** Participants Who Watch Educational Videos Before Surgery
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this group will also attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before surgery.
In addition to attending the educational program (via video) and receiving informational handouts, participants in this group will also meet with the study doctor and/or members of the study team after surgery to help plan their hospital discharge and reinforce/use the strategies they learned in the educational session after surgery.
**Intervention Names:**
- Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
- Other: Geriatric Service/ Discharge Planning
- Other: Questionnaires
**Label:** Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants Who Watch Educational Videos Before Surgery
- Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
**Description:** An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery.
**Name:** Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
**Description:** A geriatric team will meet with participants after surgery to help them reinforce the strategies they learned in the education video sessions. As part of a geriatric service, this team will also help participants plan/coordinate their discharge from the hospital after surgery.
**Name:** Geriatric Service/ Discharge Planning
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Participants Who Watch Educational Videos Before Surgery
- Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services
**Description:** These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery.
**Name:** Questionnaires
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assess the feasibility of an educational program designed for participants undergoing radical cystectomy by measuring the number of participants referred to the study team/program.
**Measure:** Number of Participants Referred to Educational Program
**Time Frame:** 90 days
#### Secondary Outcomes
**Description:** Assess the acceptability of an educational program designed for participants undergoing radical cystectomy by measuring/surveying the number of study participants who completed at least some of the intervention.
**Measure:** Survey responses from participants who completed some or all of educational program
**Time Frame:** 90 days
**Description:** Assess the adoptability of an educational program designed for participants undergoing radical cystectomy by measuring the number of self-reported interventions that participants reported after the educational program
**Measure:** Number of self-reported interventions/strategies used among participants after watching educational videos
**Time Frame:** 90 days
**Description:** Assess impact of educational program by comparing the differences between hospital readmission rate at 30 days between both study cohorts.
**Measure:** 30-day Hospital Readmission Rates Among All Participants
**Time Frame:** 30 days
**Description:** Assess impact of educational program by comparing the differences between hospital readmission rate at 90 days between both study cohorts.
**Measure:** 90-day Hospital Readmission Rates Among All Participants
**Time Frame:** 90 days
**Description:** Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups.
**Measure:** Complication Rates Reported Among Participants
**Time Frame:** 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Participants capable of giving consent
* Participants undergoing radical cystectomy (both for curative and palliative intent) for bladder cancer diagnosed by tissue pathology with urinary diversion at the University of Chicago
* Participants undergoing neoadjuvant chemotherapy will be included
* Participants will be included regardless of gender, race or ethnicity
* Participants greater than or equal to 65 years of age
Exclusion Criteria
* Radical cystectomy for non-oncologic indications
* Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Piyush K Agarwal, MD
**Phone:** 773-702-3080
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Name:** Piyush Agarwal, MD
- **Phone:** 773-702-3080
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Chicago Medicine Comprehensive Cancer Center
**State:** Illinois
**Zip:** 60615
#### Overall Officials
**Official 1:**
**Affiliation:** University of Chicago
**Name:** Piyush Agarwal
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427811
**Acronym:** ASC4INDIA
**Brief Title:** Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation
**Official Title:** A Prospective, Multicenter, Single-arm, Open-label, Phase IV, Post-authorization Interventional Study to Assess the Safety and Efficacy of Asciminib in Indian Patients With Ph+ CML-CP (Without T315I Mutation), Previously Treated With Two or More Tyrosine Kinase Inhibitors and Ph+ CML-CP With T315I Mutation
#### Organization Study ID Info
**ID:** CABL001A2005
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2025-04-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Novartis Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Drugs Controller General of India (DCGI) has granted approval for Asciminib film-coated 40 mg tablets on 20 Oct 2023 with the condition to perform a Phase IV clinical study in Indian patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) per the India Prescribing Information (PI). The purpose of this prospective, multicenter, single-arm, open-label, Phase IV study is, therefore, to confirm the safety and efficacy of Asciminib in Indian patients with Ph+ CML-CP (without threonine-315 residue with isoleucine \[T315I\] mutation), previously treated with 2 or more tyrosine kinase inhibitors (TKIs) and patients with Ph+ CML-CP with T315I mutation.
**Detailed Description:** This is a Phase IV, prospective, multicenter, single-arm, open-label, post-authorization interventional study to assess the safety and efficacy of asciminib in Indian participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs and participants with Ph+ CML-CP with T315I mutation irrespective of the line of treatment.
The study will include 3 periods: a screening period (up to 21 days), a treatment period of up to 6 months with asciminib (with dosing according to mutation status), and a safety follow-up period for 30 days after the last dose of the study treatment. Completion of the safety follow-up period after the last dose of the study treatment will be considered as the End of Study (EOS).
After obtaining the written informed consent form (ICF) from the participant or their legally authorized representatives (LARs), the participants will undergo screening procedures to confirm their eligibility for the study.
The results of the breakpoint cluster region gene-Abelson proto-oncogene 1, nonreceptor tyrosine kinase gene (BCR::ABL1) real-time quantitative polymerase chain reaction (RQ-PCR) as well as the T315I mutation report need to be established and documented prior to enrollment into the study in the screening period in line with the inclusion criteria of the study. Participants with previously documented T315I mutated CML-CP will be directly considered for the screening procedures. If the status of the T315I mutation is not known, the participant will undergo a standardized Sanger sequencing/PCR/next-generation sequencing (NGS)-based T315I mutation test (as per the availability at the site).
### Conditions Module
**Conditions:**
- Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
**Keywords:**
- ABL001
- Asciminib
- Ph+ CML-CP
- T315I mutation
- Ph+ CML-CP without T315I mutation
- Ph+ CML-CP with the T315I mutation
- Myelogenous
- Chronic
- Chronic Myeloid Leukemia
- Ph1 Positive Myeloid Leukemia
- Philadelphia Positive Myeloid Leukemia
- BCR-ABL Positive
- Post-authorization Interventional Study
- Tyrosine Kinase Inhibitors
- TKI
- Chronic Leukemia
- Ph1 Positive Leukemia
- Without T315I mutation
- with the T315I mutation
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 85
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 80 mg once daily at approximately the same time each day or 40 mg twice daily per Investigator's discretion at approximately 12-hour intervals
**Intervention Names:**
- Drug: Asciminib
**Label:** Asciminib 80 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 200 mg twice daily at approximately 12-hour intervals
**Intervention Names:**
- Drug: Asciminib
**Label:** Asciminib 200 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Asciminib 200 mg
- Asciminib 80 mg
**Description:** Film-coated tablets with 40 mg dose strength taken orally
**Name:** Asciminib
**Other Names:**
- ABL001
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Frequency and severity of adverse events(AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs up to 6 months
**Measure:** Frequency and severity of adverse events(AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP without T315I mutation
**Time Frame:** up to 6 months
**Description:** Frequency and severity of AEs/SAEs in participants with Ph+ CML-CP with T315I mutation up to 6 months
**Measure:** Frequency and severity of AEs/SAEs in participants with Ph+ CML-CP with T315I mutation
**Time Frame:** up to 6 months
#### Secondary Outcomes
**Description:** Percentage of participants with dose interruptions, reductions, and discontinuation up to 6 months.
**Measure:** Percentage of participants with dose interruptions, reductions, and discontinuation (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** A CHR is defined as the presence of all of the following for ≥4 weeks: white blood count (WBC) \<10 x 109/L, platelet count \<450 x 109/L, basophils \<5%, no blasts and promyelocytes in peripheral blood, myelocytes + metamyelocytes \<5% in peripheral blood, no evidence of extramedullary disease, including spleen and liver.
**Measure:** Percentage of participants achieving a complete hematologic response (CHR) at 3 and 6 months (without T3151 mutation)
**Time Frame:** 3 months, 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample.
Early molecular response (EMR) is defined as ≤10% BCR::ABL1 international scale (IS).
**Measure:** Percentage of participants achieving early molecular response (EMR) at 3 and 6 months (without T3151 mutation)
**Time Frame:** 3 months, 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. The rate of MR2 is defined as ≥2 log reduction of BCR::ABL (transcript from standardized baseline or ≤1% BCR::ABL/ABL1 % by IS), measured by RQ-PCR.
**Measure:** Percentage of participants achieving molecular response (MR2) at 3 and 6 months (without T3151 mutation)
**Time Frame:** 3 months, 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Major molecular response (MMR) is defined as ≤0.1% BCR::ABL1 on the IS.
**Measure:** Percentage of participants achieving major molecular response (MMR) at 3 and 6 months (without T3151 mutation)
**Time Frame:** 3 months, 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample.
MR4 is defined ≤0.01% BCR::ABL1 on the IS. MR4.5 is defined as ≤0.0032% BCR::ABL1 on the IS.
**Measure:** Percentage of participants achieving molecular response of MR4 and MR4.5 at 3 and 6 months of the treatment period (without T3151 mutation)
**Time Frame:** 3 months, 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve complete hematologic response (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve early molecular response (EMR) (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve mplecular response (MR2) (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve major molecular response (MMR) (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve MR4 and MR4.5 (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of CHR (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of EMR (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MR2 (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MMR (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MR4 & MR4.5 (without T3151 mutation)
**Time Frame:** up to 6 months
**Description:** Percentage of participants with dose interruptions, reductions, and discontinuation up to 6 months.
**Measure:** Percentage of participants with dose interruptions, reductions, and discontinuation (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** A CHR is defined as the presence of all of the following for ≥4 weeks: white blood count (WBC) \<10 x 109/L, platelet count \<450 x 109/L, basophils \<5%, no blasts and promyelocytes in peripheral blood, myelocytes + metamyelocytes \<5% in peripheral blood, no evidence of extramedullary disease, including spleen and liver.
**Measure:** Percentage of participants achieving a CHR at 3 and 6 months of the treatment period (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample.
Early molecular response (EMR) is defined as ≤10% BCR::ABL1 international scale (IS).
**Measure:** Percentage of participants achieving EMR at 3 and 6 months of the treatment period (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. The rate of MR2 is defined as ≥2 log reduction of BCR::ABL (transcript from standardized baseline or ≤1% BCR::ABL/ABL1 % by IS), measured by RQ-PCR.
**Measure:** Percentage of participants achieving MR2 at 3 and 6 months of the treatment period (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Major molecular response (MMR) is defined as ≤0.1% BCR::ABL1 on the IS.
**Measure:** Percentage of participants achieving MMR at 3 and 6 months of the treatment period (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample.
MR4 is defined ≤0.01% BCR::ABL1 on the IS. MR4.5 is defined as ≤0.0032% BCR::ABL1 on the IS.
**Measure:** Percentage of participants achieving MR4 and MR4.5 at 3 and 6 months of the treatment period (with T315I mutation)
**Time Frame:** up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve CHR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve EMR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve MR2 during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** ime to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve MMR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Time to achieve MR4 and MR4.5 during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of CHR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of EMR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MR2 during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MMR during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
**Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline.
**Measure:** Duration of MR4 and MR4.5 during the treatment period (with T315I mutation)
**Time Frame:** Up to 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study.
* Male or female participants ≥18 years of age at the screening visit with a confirmed diagnosis of Ph+ CML-CP.
Participants must meet all of the following laboratory values as confirmed by the available reports of the peripheral blood test or bone marrow examination (performed within 12 months before the screening) at the screening visit to meet the criteria of Ph+ CML-CP:
* \<15% blasts in peripheral blood and/or bone marrow
* \<30% blasts plus promyelocytes in peripheral blood and/or bone marrow
* \<20% basophils in the peripheral blood
* ≥50 x 109/L (≥50,000/mm3) platelets#
* No evidence of extramedullary leukemic involvement, apart from hepatosplenomegaly.
#Transient prior therapy related thrombocytopenia (\<50,000/mm3 for ≤30 days prior to screening) is acceptable.
- a. For Ph+ CML-CP participants with T315I mutation, mutational analysis testing at any time point showing a documented T315I mutation.
b. For Ph+ CML-CP participants without T315I mutation, at least 2 prior ATP-site TKIs (i.e., imatinib, nilotinib, bosutinib, dasatinib, or ponatinib) with failure\* (adapted from the 2020 European LeukemiaNet \[ELN\] Recommendations) or intolerance\*\* to the most recent TKI therapy at the time of screening.
\*Failure for Ph+ CML-CP participants (CP at the time of initiation of last therapy) is defined as meeting at least one of the following criteria:
* Three months after the initiation of therapy: \>10% BCR::ABL1 on IS if confirmed within 1-3 months
* Six months after the initiation of therapy: BCR::ABL1 ratio \>10% IS
* Twelve months after initiation of therapy: BCR::ABL1 ratio \>1% IS
* At any time after the initiation of therapy, loss of CHR, MR2
* At any time after the initiation of therapy, the development of new BCR::ABL1 mutations which potentially cause resistance to current treatment
* At any time 12 months after the initiation of therapy, BCR::ABL1 ratio ≥1% IS or loss of MMR
* At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)
\*\*Intolerance is defined as:
* Non-hematologic toxicity: Participants with grade .3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management,including dose adjustments (unless dose reduction is not considered in the best interest of the participant if the response is already suboptimal)
* Hematologic toxicity: Participants with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by India PI.
* ECOG performance status of 0, 1, or 2.
* Evidence of typical BCR::ABL1 transcript (e14a2 and/or e13a2) at the time of screening which is amenable to standardized RQ-PCR quantification.
* Participants must have adequate end organ function as per the investigator's judgement.
* Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to the first dose of study treatment:
* Potassium (potassium increase of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dL or 3.1 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits)
* Magnesium, except for magnesium increase \>upper level of normal (ULN) - 3.0 mg/dL or \>ULN - 1.23 mmol/L associated with creatinine clearance (calculated using Cockcroft-Gault formula) within normal limits.
Exclusion Criteria:
* Known second chronic phase of CML after previous progression to CML-AP/CML-BC.
* Previous treatment with a hematopoietic stem-cell transplantation.
* Cardiac or cardiac repolarization abnormality, including any of the following:
* History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, and coronary artery bypass graft (CABG)
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
* QT corrected for heart rate by Fridericia's cube root formula (QTcF) at screening ≥450 msec (both male and female participants)
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
* Inability to determine the QTcF interval.1. Known second chronic phase of CML after previous progression to CML-AP/CML-BC.
* Previous treatment with a hematopoietic stem-cell transplantation.
* Cardiac or cardiac repolarization abnormality, including any of the following:
* History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, and coronary artery bypass graft (CABG)
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
* QT corrected for heart rate by Fridericia's cube root formula (QTcF) at screening ≥450 msec (both male and female participants)
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
* Inability to determine the QTcF interval
* Concomitant medication(s) with a "Known risk of TdP" (per www.crediblemeds.org) that cannot be discontinued or replaced 7 days prior to starting study treatment by safe alternative medication.
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g., uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension).
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
* Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
* Known presence of significant congenital or acquired bleeding disorder unrelated to cancer.
* History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery).
* Previous treatment with or known/suspected hypersensitivity to asciminib or any of its excipients.
* Participants must avoid consumption of grapefruit, Seville oranges, or products containing the juice of each during the entire study and 7 days before the first dose of study treatment, due to potential CYP3A4 interaction with the study treatment. Orange juice is allowed. Participants must avoid consumption of over-the-counter medications or herbal supplements as these can interact with each other and may alter the effects of asciminib.
* Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
* Pregnant or breastfeeding women.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception.
Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment). In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
* Male sterilization (vasectomy) of the male partner(s) of the female participant at least 6 months prior to screening. The vasectomized male partner should be the sole partner for that participant.
* Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example, hormone vaginal ring or transdermal hormone contraception. In the case of the use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least 6 weeks before taking study treatment. In the case of oophorectomy alone, women are considered menopausal and not of childbearing potential only when the reproductive status of the woman has been confirmed by a follow-up hormone level assessment.
- If a participant is presenting with symptoms suggestive of possible Coronavirus Disease (COVID-19) infection, advise ruling it out by appropriate testing recommended by health authorities.
* Nucleic acid amplification tests for viral RNA (polymerase chain reaction), to measure current infection with SARS-CoV-2
* Antigen tests for rapid detection of SARS-CoV-2
* Antibody (serology) tests to detect the presence of antibodies to SARS-CoV-2.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novartis Pharmaceuticals
**Phone:** +41613241111
**Role:** CONTACT
**Contact 2:**
**Name:** Novartis Pharmaceuticals
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Novartis Pharmaceuticals
**Name:** Novartis Pharmaceuticals
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
**IPD Sharing:** YES
**URL:** https://www.clinicalstudydatarequest.com
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000009196
- Term: Myeloproliferative Disorders
- ID: D000001855
- Term: Bone Marrow Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014178
- Term: Translocation, Genetic
- ID: D000002869
- Term: Chromosome Aberrations
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18123
- Name: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Relevance: HIGH
- As Found: Chronic Myeloid Leukemia
- ID: M13582
- Name: Philadelphia Chromosome
- Relevance: HIGH
- As Found: Philadelphia Chromosome
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12149
- Name: Myeloproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5134
- Name: Bone Marrow Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M16932
- Name: Translocation, Genetic
- Relevance: LOW
- As Found: Unknown
- ID: M6109
- Name: Chromosome Aberrations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T1309
- Name: Chronic Myeloid Leukemia
- Relevance: HIGH
- As Found: Chronic Myeloid Leukemia
- ID: T1311
- Name: Chronic Myeloproliferative Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015464
- Term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- ID: D000010677
- Term: Philadelphia Chromosome
### Intervention Browse Module - Ancestors
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M81032
- Name: Asciminib
- Relevance: HIGH
- As Found: Technetium
- ID: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000621806
- Term: Asciminib
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427798
**Brief Title:** Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
**Official Title:** Phase I/II Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma/ Paragangliomas Previously Treated With Systemic Radiolig and Therapy
#### Organization Study ID Info
**ID:** 10001711
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 001711-C
### Status Module
#### Completion Date
**Date:** 2039-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05-22
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** Background:
Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR.
Objective:
To test a drug (\[212Pb\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells.
Eligibility:
Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery.
Design:
Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function.
\[212Pb\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may nee to stay in th hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle.
Some participants will also get a related study drug (\[203Pb\]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body.
Follow-up visits will continue for 10 years....
**Detailed Description:** Background:
* Somatostatin receptors (SSTR) have been shown to be over-expressed in a number of human tumors, including gastrointestinal (GI) neuroendocrine tumors (NET) and pheochromocytoma/paragangliomas (PPGL)
* Targeted radioligand therapy (TRT) is a class of cancer therapeutic agents formed by attaching a radioactive isotope to a ligand that can target specific surface receptors such as SSTR on a tumor cell membrane. Efficacy is typically determined by the radiation dose deposited onto a tumor, which is determined by the radioactive isotope being used as well as the binding characteristics of the ligand-receptor/transporter pair
* While there have been clinical successes with treating gastrointestinal neuroendocrine tumors (GI NET) and PPGL with SSTR-targeting beta-emitting TRTs, tumors will invariably start to progress after some time. Re-treatment using the same beta-emitting agents at the time of progression can be done but has decreased efficacy compared to the TRT-naive setting
* Alpha emitters such as 212Pb emit alpha particles that are more damaging to tumor cells than beta emitters such as 177Lu. Therefore, TRT agents using alpha emitters are considered to be more potent and could be better than betas in the re-treatment setting
* VMT-alpha-NET is a peptide that binds to SSTR, which when attached to 212Pb becomes an alpha particle-emitting TRT that can be used to treat tumors that have SSTR surface expression
* \[203Pb\]VMT-alpha-NET is the chemically identical imaging surrogate for \[212Pb\]VMT-alpha-NET and has the same mechanism of action via binding to SSTR2. The nuclide 203Pb contained in \[203Pb\]VMT-alpha-NET emits gamma radiation suitable for single-photon emission computerized tomography (SPECT) imaging. These images can be used to assess drug product biodistribution throughout the body
Objectives:
* Phase I: To determine the maximal tolerated dose (MTD) of \[212Pb\]VMT-alpha-NET using a 3+3 dose escalation design in GI NET and PPGL in a re-treatment setting
* Phase II: To determine the Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors 1.1 of participants treated with \[212Pb\]VMT-alpha-NET at the MTD at the completion of 4 cycles of treatment, reported by disease groups
Eligibility:
* Age \>= 18 years
* Histopathologically confirmed GI NET or PPGL that are metastatic or inoperable
* At least 1 prior systemic radioligand therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status \<= 1
Design:
* This is an open-label, single-arm, single-center, phase I/II study evaluating the safety, preliminary efficacy, and pharmacokinetic properties of \[212Pb\]VMT-alpha-NET in GI NET and PPGL in a re-treatment setting
* Phase I participants will be accrued using a 3+3 dose escalation design with 3 dose levels to estimate MTD of \[212Pb\]VMT-alpha-NET. Once MTD is estimated, Phase II participants with GI NET and PPGL will be accrued in separate cohorts and treated at MTD of \[212Pb\]VMT-alpha-NET
* \[212Pb\]VMT-alpha-NET will be given IV every 8 weeks for a total of 4 administrations
* A subset of participants (Dosimetry Arm 1) will have \[203Pb\]VMT-alpha-NET administration followed by whole-body gamma scans combined with dosimetry SPECT/ Computed Tomography (CT) scans and collection of blood and urine samples prior to the first and the second doses of \[212Pb\]VMT-alpha-NET (Cycles 1-2)
* All participants will undergo serial whole-body dose rate measurements after \[203Pb\]VMT-alpha-NET and/or \[212Pb\]VMT-alpha-NET administration
* Participants will have timed clinical laboratory evaluations, imaging studies, and research blood, and urine samples while on the study therapy for safety and efficacy evaluations
* Following completion of treatment, participants will be seen at the NIH Clinical Center approximately 30 days later, every 12 weeks for years 1-3, every 6 months for years 4-6 for safety and efficacy assessments. Beyond 6 years, participants will be contacted annually through any NIH-approved platform to assess for overall survival and health status
* The overall study accrual ceiling will be set to 53 participants
### Conditions Module
**Conditions:**
- Somatostatin Receptor Positive
- Gastrointestinal Neuroendocrine Tumors
- Pheochromocytoma
- Paragangliomas
**Keywords:**
- 212Pb
- Targeted Therapy
- Image-Guided Dosimetry
- VMT- -NET
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 53
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Escalating doses of \[212Pb\]VMT-alpha-NET, imaging with \[203Pb\]VMT-alpha-NET.
**Intervention Names:**
- Drug: 68Ga-DOTATATE
- Drug: [203Pb]VMT-alpha-NET
- Drug: [212Pb]VMT-alpha-NET
**Label:** 1/Dosimetry Arm 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Escalating doses of \[212Pb\]VMT-alpha-NET.
**Intervention Names:**
- Drug: 68Ga-DOTATATE
- Drug: [212Pb]VMT-alpha-NET
**Label:** 2/Arm 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** \[212Pb\]VMT-alpha-NET at MTD.
**Intervention Names:**
- Drug: 68Ga-DOTATATE
- Drug: [212Pb]VMT-alpha-NET
**Label:** 3/Arm 3
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1/Dosimetry Arm 1
- 2/Arm 2
- 3/Arm 3
**Description:** 68Ga-DOTATATE PET/CT whole-body scanning will be done at target dose of 5 mCi. The whole-body PET/CT scan will be started approximately 60 minutes after the tracer injection and will take up to 2 hours.
**Name:** 68Ga-DOTATATE
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 1/Dosimetry Arm 1
**Description:** \[203Pb\]VMT-alpha-NET (6 mCi) will be given IV at 7 days prior.
**Name:** [203Pb]VMT-alpha-NET
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- 1/Dosimetry Arm 1
- 2/Arm 2
- 3/Arm 3
**Description:** \[212Pb\]VMT-alpha-NET will be given IV on Day 1 of every cycle for 4 cycles total at escalating doses in Phase I and at MTD during Phase II. One cycle is 8 weeks.
**Name:** [212Pb]VMT-alpha-NET
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The MTD will be presented as a recommended dose to be used as the recommended phase II dose (RP2D) for the combined participant population, as well as for each disease group being studied (GI-NET, PPGL).
**Measure:** Phase I: MTD of [212Pb]VMT-alpha-NET using a 3+3 dose escalation design in GI NET and PPGL in a re-treatment setting
**Time Frame:** DLT period (through 12 weeks after initial 212Pb]VMT-alpha-NET administration).
**Description:** The overall response rate will be presented as a percentage along with 95% confidence intervals. Only evaluable participants will be included.
**Measure:** Phase II: ORR by RECIST 1.1 of participants treated with [212Pb]VMT-alpha-NET at the MTD at the completion of 4 cycles of treatment, reported by disease groups
**Time Frame:** Baseline until progression or 6 years after receiving the first infusion of study drug.
#### Secondary Outcomes
**Description:** PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Kaplan-Meier curves of PFS will be constructed. Median PFS will be reported with 95% confidence intervals.
**Measure:** Progression Free Survival
**Time Frame:** Baseline until progression or 10 years after receiving the first infusion of study drug
**Description:** Descriptive tabulations of toxicity will be provided, along with the agent attribution determination and CTCAE grade for each toxicity event. The data will be presented as an absolute count of the event at a participant level as well as a percentage of total evaluable participants.
**Measure:** Safety of [203Pb]VMT-alpha-NET and [212Pb]VMT-alpha-NET
**Time Frame:** Study duration
**Description:** Kaplan-Meier curves of OS, will be constructed. Median OS will be reported with 95% confidence intervals.
**Measure:** Overall Survival
**Time Frame:** Baseline until progression or 10 years after receiving the first infusion of study drug
**Description:** PK data will be represented as a scatter plot graphing time vs. the amount of radioactivity found in blood and urine samples.
**Measure:** PK properties of [212Pb]VMT-alpha-NET via blood and urine sampling
**Time Frame:** After every infusion of [212Pb]VMT-alpha-NET
**Description:** Biodistribution and dosimetry data will be represented in a tabular format which indicates the percentage of the injected dose calculated to be in each of the major organs using gamma scan results. Radiation dose calculations will be performed using OLINDA/EXM software. Absorbed doses in organs and the whole body will be determined using the appropriate adult phantom (e.g., adult male, adult female). Tumor lesion absorbed doses will be determined using the sphere model in OLINDA.
**Measure:** Dosimetry properties of [212Pb]VMT-alpha-NET via SPECT/CT, using [203Pb]VMT-alpha-NET as a surrogate with and without the administration of amino acids (Dosimetry Arm 1 only)
**Time Frame:** In Dosimetry Arm 1 after every [203Pb]VMT-alpha-NET infusion
### Eligibility Module
**Eligibility Criteria:** * INCLUSION CRITERIA:
* Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paraganglioma (PPGL) cancers that are metastatic or inoperable per Standard of Care.
* Have received at least 1 prior systemic radioligand therapy for definitive therapeutic purposes. Note: Participants with prior external beam radiation treatment (EBRT) will also be eligible as long as they have had at least 1 prior administration of a systemic radioligand therapy.
* Must have at least 1 measurable lesion by RECIST 1.1 (phase II only).
* History of progression by imaging (e.g., RECIST 1.1) or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of \[203Pb\]VMT-alpha-NET.
* Evidence of somatostatin receptors (SSTR) expression on at least 50% of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging \[MRI\]) tumor, as indicated by a positive (uptake qualitatively identifiable as above the local background) on SSTR PET scan.
* Age \>= 18 years.
* ECOG performance status \<= 1.
* Participants must have adequate organ and marrow function as defined below:
* Leukocytes: 3,000/microliter
* Absolute Neutrophil Count: 1,500/microliter
* Platelets: 100,000/miroliter
* Hemoglobin: \>= 9.0 g/dL
* Total bilirubin: within normal institutional limits. Note: \<= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome
* AST: \<= 2.5 X institutional ULN
* ALT: \<= 2.5 X institutional ULN
* Creatinine: within normal institutional limits
OR
* Calculated creatinine clearance (glomerular filtration rate (eGFR): \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal
* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening.
* Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening.
* Participants seropositive for human immunodeficiency virus (HIV) must:
* be on effective anti-retroviral therapy; and
* have an undetectable viral load at screening.
* Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening.
-Participants seropositive for hepatitis C virus (HCV) must:
* received curative treatment; and
* have an undetectable HCV viral load at screening.
* Participants may enroll in this study while on another therapeutic trial in order to start the screening process. However, all other investigational agents should be stopped at least 28 days prior to receiving \[203Pb\]VMT-alpha-NET.
* Women of child-bearing potential (WOCBP) and men must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) at study entry and up to 6 months after the last dose of the study agent(s).
* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study agents.
* The ability of the participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-alpha-NET.
* Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
* QTc \> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used
* History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix.
* Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.
**Maximum Age:** 120 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Joy Zou, R.N.
**Phone:** (240) 760-6153
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Frank I Lin, M.D.
**Phone:** (240) 760-6166
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bethesda
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** National Cancer Institute Referral Office
- **Phone:** 888-624-1937
- **Role:** CONTACT
**Country:** United States
**Facility:** National Institutes of Health Clinical Center
**State:** Maryland
**Zip:** 20892
#### Overall Officials
**Official 1:**
**Affiliation:** National Cancer Institute (NCI)
**Name:** Frank I Lin, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data from this study may be requested by contacting the PI.
**Description:** .All IPD recorded in the medical record will be shared with intramural investigators upon request. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data from this study may be requested by other researchers after the completion of the primary endpoint.
### References Module
#### See Also Links
**Label:** NIH Clinical Center Detailed Web Page
**URL:** https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001711-C.html
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- ID: M13578
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: M13149
- Name: Paraganglioma
- Relevance: HIGH
- As Found: Paraganglioma
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: HIGH
- As Found: Gastrointestinal Neuroendocrine Tumor
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Gastrointestinal Neuroendocrine Tumor
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastrointestinal Neuroendocrine Tumor
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- ID: T4530
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: T4409
- Name: Paragangliomas 1
- Relevance: HIGH
- As Found: Paraganglioma
- ID: T2442
- Name: Gastro-enteropancreatic Neuroendocrine Tumor
- Relevance: HIGH
- As Found: Gastrointestinal Neuroendocrine Tumor
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000010673
- Term: Pheochromocytoma
- ID: D000010235
- Term: Paraganglioma
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000010190
- Term: Pancreatic Neoplasms
- ID: D000013274
- Term: Stomach Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15806
- Name: Somatostatin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427785
**Brief Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
**Official Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
#### Organization Study ID Info
**ID:** 2024-ke-75
#### Organization
**Class:** OTHER
**Full Name:** Beijing Chao Yang Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-11
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Chao Yang Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
**Detailed Description:** Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
### Conditions Module
**Conditions:**
- Remimazolam
- Anesthesia Awareness
- Sedative, Hypnotic, or Anxiolytic Withdrawal
**Keywords:**
- Wavelet Index
- Remimazolam
- Depth of Sedation
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then, remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period.
**Intervention Names:**
- Drug: Remimazolam besylate
**Label:** Remimazolam group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Remimazolam group
**Description:** Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period.
**Name:** Remimazolam besylate
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). Wavelet index (WLi) is a parameter that potentially could be used to regulate the sedative depth of anesthesia. The range of WLi values is 0-100, with a value of 0 indicating no EEG activity, a value of 100 indicating complete wakefulness, and a value of 40-60 taken to indicate an appropriate level of general anesthesia.
**Measure:** The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
**Time Frame:** Through study completion, an average of 1 day
#### Secondary Outcomes
**Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug administration to MOAA/S score ≤1 was recorded.
**Measure:** Mean time from initiation of drug administration to MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤1
**Time Frame:** Through study completion, an average of 1 day
**Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug withdrawal to MOAA/S score = 5 was recorded
**Measure:** The average time from drug withdrawal to full recovery
**Time Frame:** Through study completion, an average of 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA was classified as I-III
* The operation time was less than 120 minutes
* Informed consent is signed by all study participants
* Elective lower extremity surgery under spinal anesthesia was performed
Exclusion Criteria:
* Pregnant or lactating women
* Patients with Difficult Airways
* History of severe neurological and muscular diseases and mental retardation
* Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate \<50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
* Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
* Take diazole drugs and/or opioids in one month or nearly three months
* Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
* Patients who could not monitor the depth of anesthesia for various reasons
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This was an unrandomized, single-group study. The sample size was calculated using PASS 15™(NCSS, LLC. Kaysville, Utah, USA.) software. The degree of confidence (1-β) was set at 0.90, and the α value was set at 0.05. ρ0, the baseline correlation, was set to 0. The ρ1, alternating correlation, was set to 0.3 based on the expected minimum r value of 0.3 obtained in previous literature. Final calculations show that 112 pairs of data were needed to complete the experiments. Approximately 20 pairs of data were expected to be recorded per participant, and 30 participants were expected to be enrolled in this study. So, the sample size was adequate.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anshi Wu, doctor
**Phone:** 010-85231330
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007431
- Term: Intraoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M29299
- Name: Intraoperative Awareness
- Relevance: HIGH
- As Found: Anesthesia Awareness
- ID: M10465
- Name: Intraoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000058926
- Term: Intraoperative Awareness
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427772
**Brief Title:** Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
**Official Title:** Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
#### Organization Study ID Info
**ID:** Sallam
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Ahmed Sallam Abo El-azaiem Mohamed
**Investigator Title:** principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.
**Detailed Description:** Femoral neck fractures (FNF) have a significant incidence and a rising trend worldwide. FNF is associated with a high mortality and disability rate, decreasing the independence and quality of life for affected patients. Acute displaced intracapsular femoral neck fractures account for about half of all hip fractures, with the majority of these fractures in older patients being treated surgically with hip hemiarthroplasty(HA), total hip arthroplasty, or internal fixation. Hemiarthroplasty is also used to treat femoral neck nonunion, failed screw fixation, and pathological femoral neck fracture. The treatment aims are to reduce pain, allow early mobilization, and restore the patient's pre-injury level of function while limiting perioperative surgical and medical complications. Patients with FNF frequently undergo hemiarthroplasty to restore joint biomechanics. Two types of implants are used in hemiarthroplasty: monopolar and bipolar . The bipolar implants have a polyethylene bearing between the stem and head of the endoprosthesis, which allows the components to rotate. There are debatable findings and a lack of consensus on the optimal component for hemiarthroplasty. Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.
### Conditions Module
**Conditions:**
- Prosthetic-joint Infection
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** the presence of persistent discharge after 7 days diagnostic for early infection follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur study the risk factors in this group
**Intervention Names:**
- Procedure: bipolar hemiarthroplasty
**Label:** group 1 diseased group(infected)
#### Arm Group 2
**Description:** no infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur
**Intervention Names:**
- Procedure: bipolar hemiarthroplasty
**Label:** group 2 : control group (normal )
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group 1 diseased group(infected)
- group 2 : control group (normal )
**Description:** bipolar hemiarthroplasty for neck femur fracture
**Name:** bipolar hemiarthroplasty
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** investigators will take all cases with bipolar hemiarthroplasty after femoral neck fracture then follow up them for 4 weeks. An infection was categorized as early, if it occurred within 4 weeks after surgery After that investigators will classify them to infected (disease group) and non infected (control group) and studying risk factor predisposing to early infection after HA.
For diagnosis of infection : the presence of persistent discharge after 7 days
**Measure:** incidence of early infection after bipolar hemiarthroplasty
**Time Frame:** 4 weeks postoperative
**Description:** Age in years
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age
**Time Frame:** preoperative evaluation 1 week
**Description:** male or female
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :sex
**Time Frame:** preoperative evaluation 1 week
**Description:** present or not
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis.
**Time Frame:** preoperative evaluation 1 week
**Description:** present or not
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision)
**Time Frame:** preoperative evaluation 1 week
**Description:** yes or no
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption
**Time Frame:** preoperative evaluation 1 week
**Description:** present or no
**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection).
**Time Frame:** preoperative evaluation 1 week
**Description:** in hours
**Measure:** risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .
**Time Frame:** at time of operation
**Description:** yes or no
**Measure:** risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion.
**Time Frame:** at time of operation
**Description:** time in days
**Measure:** risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.
**Time Frame:** 1 week postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
* Patients or their legal representative able to give informed consent.
Exclusion Criteria:
* Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
* Patients with a pathological fracture due to malignancy.
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** * Study Setting: Department of Orthopedic and Trauma Surgery, Assiut University.
* Study subjects:
a. Inclusion criteria:
* Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
* Patients or their legal representative able to give informed consent. b. Exclusion criteria:
* Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
* Patients with a pathological fracture due to malignancy.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ahmed Sallam AboElazaiem, bachelor's
**Phone:** 01005732964
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006620
- Term: Hip Fractures
- ID: D000005264
- Term: Femoral Fractures
- ID: D000050723
- Term: Fractures, Bone
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000025981
- Term: Hip Injuries
- ID: D000007869
- Term: Leg Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M26370
- Name: Fractures, Bone
- Relevance: LOW
- As Found: Unknown
- ID: M8403
- Name: Femoral Neck Fractures
- Relevance: HIGH
- As Found: Fracture Neck of Femur
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M9696
- Name: Hip Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M8402
- Name: Femoral Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M23105
- Name: Hip Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T4756
- Name: Prosthetic Joint Infection
- Relevance: HIGH
- As Found: Prosthetic Joint Infection
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000005265
- Term: Femoral Neck Fractures
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427759
**Brief Title:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
**Official Title:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
#### Organization Study ID Info
**ID:** 241094084
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Abdelrahman Mostafa Shehata Mohammed
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Abdelrahman Mostafa Shehata Mohammed
**Investigator Title:** assistant lecturer
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1)
Anthropometric reference measurements can be applied in designing arm aesthetic surgery.
Classically, anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural . (2)a 2020).
**Detailed Description:** 2.4.1- Type of the study: 2.4. 2- Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital 2.4. 3- Study subjects:
a. Inclusion criteria:
* Group (A) this group will be available for measurements only with no interventions needed.
* Group (B) Include patients asking for arm aesthetic surgery .
* Group B1: patients will be submitted for liposuction only. liposuction is the preferred approach, particularly in young patients after massive weight loss.
* Group B2: patients will be submitted for liposuction and brachioplasty in same setting. When skin laxity is excessive, even in young patients, an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated.
* Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.
in borderline cases to take chance for skin retraction .
c. Sample Size Calculation: sample size was calculated using g power program version 3.1.9.7 in order to detect anthropometric measures of arm and compare these measures with post operative cases, assumed effect size 0.8 based on clinical assumption (novel study) , α error 0.2 power 0.8 and allocation 1:1:1 the sample size will be 40 patients for each group. 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Group (A) will be subjected to these measures
\*Arm length : Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
\*Arm circumference : upper arm circumference Mid arm Lower arm
* Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree. Group (B) will be subjected to
* Group B1: patients will be submitted for liposuction only.
* Group B2: patients will be submitted for liposuction and brachioplasty in the same setting.
* Group B3: patients will be submitted for liposuction then brachioplasty after 3, 6 and 12 months.
Pre-operative Assessment:
1. Patient history.
2. History of massive weight loss or any operation
3. Preoperative investigations
4. Informed consent.
5. Pre-operative photography. operative technique :- 1- most patients will take general anaesthesia . 2- then sterilization with betadine solution . 3 - pt positioned in supine position . 4- patient will be subjected according to its group to group(A): after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 .
group(B): after injection of tumescent fluids in the medial part of arm only(excised part ) - waiting 15 minute - then excision of medial part according to pinch test .
group (C): after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 .
excision of the excessed part medially will be done after 3 months .
Patients will be subjected to arm measures before and after operation
* Arm length :
Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
\*Arm circumference : upper arm circumference Mid arm Lower arm
* Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree
* Pinch Test:
* Excess skin :
* Site of maximum redundancy:(Upper - Middle - Lower) arm
* Grade of Lipodystrophy:
Grade 1 :minimal fat with no ptosis Grade 2A :moderate fat with ptosis less than 5 cm Grade 2B : moderate to severe fat with ptosis 5- 10 cm Grade 3: extreme fat with ptosis more than 10 cm Grade 4 : mild to moderate fat with ptosis more than 10 cm. (3) Then comparing of post operative measurements after 3 , 6 and 12 months with the anthropometric measures of group (A) .
### Conditions Module
**Conditions:**
- Arm Aesthetics
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** \*Group (A) Inclusion criteria of study: Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities .
**Label:** anthropometric measures
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** * Group (B) Include patients asking for arm aesthetic surgery .
* Group B1: patients will be submitted for liposuction of arms only.
* Group B2: patients will be submitted for liposuction and brachioplasty in same setting.
* Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.
**Intervention Names:**
- Procedure: arm aesthetic surgery
**Label:** arm aesthetic surgery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- arm aesthetic surgery
**Description:** liposuction of arms brachioplasty of arms
**Name:** arm aesthetic surgery
**Other Names:**
- liposuction, brachioplasty
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Group(A) anthropometric measures of arm length , arm circumference and forearm circumference .
Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
**Measure:** Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* group A : Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities .
* group B :Include patients asking for arm aesthetic surgery .
* Group B1: patients will be submitted for liposuction only.
* Group B2: patients will be submitted for liposuction and brachioplasty in same setting.
* Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.
Exclusion Criteria:
* 1) Males 2) Athletes 3) Current morbidities
**Gender Based:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Assiut University
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427746
**Acronym:** AIPO
**Brief Title:** Enhancing Prehospital Stroke Diagnosis
**Official Title:** Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting
#### Organization Study ID Info
**ID:** AREU_A.I.P.O.
#### Organization
**Class:** OTHER_GOV
**Full Name:** Agenzia Regionale emergenza Urgenza
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Agenzia Regionale emergenza Urgenza
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:
1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- stroke
- video call
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2197
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers
**Intervention Names:**
- Procedure: Standard
**Label:** Standard
#### Arm Group 2
**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch
**Intervention Names:**
- Procedure: Video call
**Label:** Video call
#### Arm Group 3
**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch
**Intervention Names:**
- Procedure: Video call + LARIO
**Label:** Video call + LARIO
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard
**Description:** Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home.
**Name:** Standard
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Video call
**Description:** Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke.
**Name:** Video call
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Video call + LARIO
**Description:** LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room.
**Name:** Video call + LARIO
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan
**Measure:** Accuracy of prehospital stroke diagnosis
**Time Frame:** within 2 hours from hospital admission
#### Secondary Outcomes
**Description:** LARIO is a stroke scale is a simple 5-item clinical scale that can be used to predict the presence of large vessel occlusion (LVO) in patients with acute ischemic stroke. A large vessel of the anterior cerebral circulation is defined as occlusion of the intracranial segment of the internal carotid artery, anterior cerebral artery segments A1 and A2, and middle cerebral artery segments M1 and M2. Final diagnosis is based on the cerebral angio CT scan
**Measure:** Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels
**Time Frame:** within 2 hours from hospital admission
**Description:** incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT
**Measure:** incidence of hemorrhagic stroke
**Time Frame:** within 2 hours hospital admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* suspected stroke
* rescued by basic life support vehicle
* consciousness
* informed consent
Exclusion Criteria:
* age \< 18 years
* rescued by an advanced life support vehicle
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anna Coppo, MD
**Phone:** 0267129001
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Giuseppe Ristagno, MD, PhD
**Phone:** 0267129001
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Paola Manzoni, MD
- **Phone:** 02 52872802
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michela Generali, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** SOREU Metropolitana
**Status:** RECRUITING
**Zip:** 20100
#### Overall Officials
**Official 1:**
**Affiliation:** AREU
**Name:** Anna Coppo, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427733
**Brief Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment
**Official Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment
#### Organization Study ID Info
**ID:** Sponsor
#### Organization
**Class:** OTHER
**Full Name:** Universidade do Vale do Sapucai
### Status Module
#### Completion Date
**Date:** 2024-05-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-02
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidade do Vale do Sapucai
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis.
**Detailed Description:** Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation.
### Conditions Module
**Conditions:**
- Stasis Dermatitis
**Keywords:**
- Stasis dermatitis
- Hyperpigmentation
- banana skin
- Musa sapientum
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SPF 30 and Placebo Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
**Intervention Names:**
- Biological: Placebo comparator
**Label:** Control Group without green banana peel
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** SPF 30 and pharmaceutical formulation with green banana peel In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.
**Intervention Names:**
- Biological: Active Comparator
**Label:** Study Group with green banana peel
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group without green banana peel
**Description:** SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
**Name:** Placebo comparator
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Study Group with green banana peel
**Description:** SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
**Name:** Active Comparator
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Macroscopic Analysis: The occurrence of stasis dermatitis will be determined by hyperpigmentation, measured using the Chromatic Palette. Changes in skin color vary from ecchymosis, hematomas, erythema, hyperpigmentation, hypochromia and cyanosis. The focus of our study being hyperpigmentation, the shades vary between brownish, grayish and reddish, depending on the evolution, clinical duration and skin color and severity of stasis dermatitis. The positioning of colors on a gradient scale in columns and lines favors the comparative process and location between nearby shades corresponding to the observed evidence. The inclusion of codes makes it possible to locate and classify skin colors in the situations in which they will be evaluated. In the final version that will be used, there are 72 color possibilities.
**Measure:** Occurence of stasis dermatitis
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with stasis dermatitis.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -
Exclusion Criteria:
* Patients who have other types of hyperchromia in the legs.
* Patients known to have an allergic reaction to bananas.
* Patients who give up, for any reason, to continue treatment.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pouso Alegre
**Country:** Brazil
**Facility:** Vale do Sapucaí University
**State:** Minas Gerais
**Zip:** 37550-000
#### Overall Officials
**Official 1:**
**Affiliation:** Vale do Sapucaí University
**Name:** Adriana R dos Anjos Mendonça, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M19760
- Name: Hyperpigmentation
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003872
- Term: Dermatitis
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M16255
- Name: Sunscreening Agents
- Relevance: LOW
- As Found: Unknown
- ID: T255
- Name: Plantain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427720
**Brief Title:** LINC00511/miR-185-3p Axis and miR-301a-3p Markers for Breast Cancer Diagnosis
**Official Title:** Competitive Endogenous Role of the LINC00511/miR-185-3p Axis and miR-301a-3p From Liquid Biopsy as Molecular Markers for Breast Cancer Diagnosis
#### Organization Study ID Info
**ID:** RHDIRB2020110301REC#259
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2021-07-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-05-25
**Type:** ACTUAL
#### Start Date
**Date:** 2019-09-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Prof. Nadia M. Hamdy, Ph.D.
**Investigator Title:** Professor of biochemistry and molecular biology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Breast cancer is a leading cause of death among women globally, with significant incidence in Egypt. It is characterized by aggressive behavior and resistance to treatment, necessitating early detection methods. Research has revealed that many cancer-related mutations are in non-coding DNA, including microRNAs (miRNAs) and long non-coding RNAs (LncRNAs). miRNAs like miR-185-3p and miR-301a, and LncRNAs such as LINC00511, are potential biomarkers for cancer diagnosis due to their roles in gene regulation and stability in circulation. This study aims to explore the diagnostic utility of these biomarkers in breast cancer.
**Detailed Description:** 1. Introduction 1.1. Background: Breast cancer is one of the leading causes of death for women globally, according to the world health organization (WHO), the number of cancer cases expected in 2025 will be 19.3 million cases. In Egypt, cancer is an increasing problem and especially breast cancer \[1\].
Breast cancer is the most common female malignant tumor and a major threat to women's health and its development is considerably aggressive local invasion, early metastases, and multidrug resistance to chemotherapy \[2, 3\]. Therefore, developments of minimally-invasive markers for early detection of breast cancer are of great interest.
The cancer genome Atlas (TCGA) revealed that many of the mutations and copy number changes found in cancer do not overlap with protein coding genes \[4\], but are frequently located in non-coding DNA-including non-coding RNA genes \[5\]. MicroRNAs (miRNAs) were among the first non-coding RNAs to be investigated cancer, and their roles as therapeutic targets or biomarkers in cancer \[6\].
MiRNAs are short, single-stranded RNA sequences (usually 19-23 nucleotides) that control gene expression in a variety of physiological and developmental process, thus having a critical role in posttranscriptional regulation of gene expression in a broad range of biological systems \[7, 8\]. MiRNAs mediate the repression of target mRNA by base pairing to complementary sequence in the 3'-UTR, causing transcript destabilization, translational repression or both \[9\]. It has been reported that miRNAs also modulate gene expression by binding to other regions, including protein-coding exons \[10\], and can even induce gene expression in mammalian cells \[11\].
Cell-free circulating miRNAs usually exist bound to ribonucleoprotien complexes or high-density lipoprotein or they are released from cells in lipid vesicles, micro-vesicles, exosomes or apoptotic bodies \[12-15\].Thus, circulating miRNAs may reflect homeostatic response of the organism, as well as signs of disease progression. Owing to their stability and resistance to endogenous RNAse activity, these miRNAs have been proposed as diagnostic and prognostic biomarkers for diseases, including cancer \[16\].
Among these miRNAs, MiR-185-3p has been identified as a tumor suppressor gene in various types of cancer. The expression of miR-185-3p was decreased in breast cancer cells MDA-MB-231, and MCF-7. Moreover, miR-185-3p was over-expressed in the LINC00511 silenced transfection, while decreased in the enhancedLINC00511 plasmid transfection \[17\].
MicroRNA-301a is another oncomiR that has been related to tumor progression in several types of cancer. For example, in prostate cancer, gastric cancer as well as pancreatic cancer \[18-21\]. However, its role in breast cancer is not fully investigated.
Long non-coding RNA (LncRNAs) are those longer than 200 nucleotides, and many of them can also act as primary transcripts to produce short RNAs. Generally, LncRNAs have been implicated in gene-regulatory roles, such as chromatin dosage compensation, imprinting, epigenetic regulation, cell cycle control, nuclear and cytoplasmic trafficking, and cell differentiation \[22\]. Furthermore, pre-mRNA interaction where the primary transcript is interacting with LncRNAs and ends up with a different functional spliced sequence or is degraded into endogenous small interfering RNAs, miRNA sponges, modulation of protein activity or localization and facilitation of riboprotein complex formation. Not in the least, LncRNAs can stand as precursors for smaller fragments like miRNAs or piRNAs. The main function of ciRNAs consists in miRNAs capturing through complementary interactions, functioning like miRNAs sponge \[23\]. LncRNAs have already been implicated in human disease including cancer \[24\].
Long intergenic noncoding RNA 00511 (LINC00511); is an oncogene that influences tumor size, metastasis, and poor prognosis. LINC00511 binds histone methyltransferase EZH2 and specifies the histone modification pattern on p57 \[25\]. It also acts as an oncogene in squamous cell carcinoma and pancreatic ductal adenocarcinoma \[26\]. In particular, little is known whether LncRNAs can serve as biomarkers for cancer prognosis or diagnosis. \[27\] 1.2. Problem: The role of these biomarkers are not investigated yet in breast cancer early diagnosis.
1.3. Hypothesis: Tumor Suppressor or Oncogenic Biomarkers and LncRNA used in early diagnosis of breast cancer"
2. Aim of the Work:
The ultimate aim of the work is to provide a clearer picture of the functions of miR-185-3p, miR-301a, in association with LINC00511in the early diagnosis of breast tumors with measuring both sensitivity and specificity.
3. Previous Studies Findings: in half page. No previous clinical studies were made on the aspect of the diagnostic utilities of the studied biomarkers.
4. Problem Statement:
The role of these biomarkers are not investigated yet in breast cancer early diagnosis in Egyptian patients.
5. Research Significance:
Primary Outcome:
• To identify Peripheral blood circulating Tumor Suppressor or Oncogenic Small Biomarkers breast cancer and to compare with normal control expression
Secondary Outcome:
• To calculate sensitivity and specificity of miR-185-3p, miR-301a, and LINC00511 as compared to the protein-based markers (CEA and CA15-3) as diagnostic markers.
6. Research Objectives:
1. Analyze the expression level of two miRNA (miR-185-3p, miR-301a) and their predicted interacted lncRNA (LINC00511) as minimal noninvasive molecular markers for diagnosing the primary breast cancer.
2. Compare miR-185-3p, miR-301a, and LINC00511 with the protein based markers (CEA and CA15-3) as diagnostic markers, regarding to sensitivity and specificity.
3. Study the relation between miR-185-3p, miR-301a, and LINC00511and the clinicopathological characters of breast cancer.
4. Research Methodology:
This study will first be approved by the Ethical Committee of Faculty of Pharmacy, Ain Shams University and by the Ethical Committee of National Cancer Institute, New Cairo. Moreover, it will be performed in adherence to the Declaration of Helsinki Guidelines, where two groups will be included and all subjects will give their written consent, to be archived.
Group 1 the control group: A total of 50 healthy volunteers' who are age matched healthy female volunteers not suffering from any disease or taking any medication.
Group 2 (Malignant Breast Tumor): 50 women with non-metastatic primary breast cancer Patients recently diagnosed who haven't yet received any chemotherapy or radiotherapy, attending the National Cancer Institute, New Cairo.
Full history will be taken for all cases and control. The characteristics of the breast cancer patients with regards to age, menopausal status, histopathological type, tumor size, lymph node metastasis and tumor grade, as well as estrogen receptor (ER) and progesterone receptor (PR) will be collected for data analysis.
Exclusion criteria
Patients with:
* Blood disorder diseases, -Any cancer other than breast cancer
* Liver Cirrhosis, Uterine \& Urinary bladder diseases
Methods:
Routine Work:
Blood Sampling:
5 ml blood will be collected into plain vaccutainer tubes for serum preparation. Serum samples will be stored at -80 ºC until biochemical assessment at the Biochemistry Department Research Lab, Faculty of Pharmacy, Ain Shams University.
Assay of miR-185-3p, miR-301a, and LINC00511by Quantitative PCR:
MiRNA and LncRNAs will be extracted from serum using Qiagen miRNeasy Mini Kit according to the manufactures' protocol and their concentration and purities will be detected by nanodrop spectrophotometer.
Enriched RNA will be reverse transcribed with miroRNA or LncRNAs reverse transcription kit according to the manufactures' protocol.
Expression of miRNA and LncRNAs will be quantified by qRT-PCR using human MicroRNA and LncRNAs assay kits and their specific primers.
The expression levels of the investigated miRNA will be evaluated using the ∆Ct method \[28\]. The cycle threshold (Ct) value is the number of qPCR cycles required for the fluorescent signal to cross a specific threshold. ∆Ct will be calculated by subtracting the Ct values of RNU6-2 and GAPDH from those of investigated miRNAs and LncRNAs, respectively. The ∆∆Ct will be calculated by subtracting the ∆Ct of the control samples from the ∆Ct of the cancer samples.
Examination of Hormone Receptors and Protein-based tumor Markers: Both estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER-2neu), in addition to CEA and CA15.3 tumor markers using ELISA kits will be obtained from National Cancer Institute, New Cairo.
SAMPLE SIZE ESTIMATION The aim of this study is to investigate the Role of some circulating MiRNAs from independent control and breast cancer cases with 1 control per experimental subject. Based on previous study(Hu et al. 2012) the oncogenic small biomarkers expression was normally distributed with standard deviation 2.9 and large effect size (1.09). If the true differences in the breast cancer group and control group means is 2.25 we will need to study 25 experimental subjects and 25 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.
As regards the tumor suppressor expression means was normally distributed with large effect size (1.4). If the true differences in the breast cancer group and control group means is 14 we will need to study 15 experimental subjects and 15 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.
Total sample size will be 80 cases, this number will be increased by 25% for expected losses, and total sample is 100 subjects, 50 subjects per group.
Sample size estimation was performed by G power\* sample size calculator.
Statistical Analysis:
SPSS 21.0 software package (SPSS,Chicago,IL) will be used to perform the statistical analyses. T-test or Mann-Whitney's U test will be used to compare the difference of continuous variables in two groups as appropriate. Pearson's Chi-square analysis or Fisher's exact test will be employed to compare the difference of categorical variables. Receiver operating characteristic (ROC) curve and area under the ROC curve (AUC) will be plotted to determine the best cutoff point that discriminates between cancer and non-cancer groups; the sensitivities and specificities will be calculated for the miRNAs and their diagnostic efficacy For all analyses, a two-tailed P value of 0.05 or less will be considered as statistically significant.
5. Research Time Plan/Frame i. Time plan Q/year Actions Q1 Preparation of the official documents for sample collection, data collection and ethical approval and calculate sample size for control and patients Q2 Sample collection from patients with selected criteria and separation of serum in aliquots Q3 Continue sample collections and separation of serum in aliquots + Extraction of RNA from the samples Q4 Collection of control samples and Extraction of RNA Q1 cDNA synthesis for all samples + qPCR Q2 Statistical analysis of the data and starting to write a paper + collection of related articles for thesis writing Q3 Publication of the paper and finalizing the thesis for revision
ii. Paper title: "The Diagnostic Utility of Tumor Suppressor or Oncogenic Small Biomarkers in Association with LncRNA in Breast Cancer"
Authors:
Marwa M. Mohamed, Dr. Eman Fouad Sanad, Dr. Reham Ali Abbas El-Shimy, Nadia M. Hamdy.
Corresponding Submitting Author: Prof. Nadia M. Hamdy First Author: Marwa M. Mohamed Contributing Author(S): Dr. Eman Fouad Sanad, Dr. Reham Ali Abbas El-Shimy
6. References List:
1. D. A. Ragab, M. Sharkas, S. Marshall, and J. Reen,"Breast cancer detection using deep convolutional neural networks and support vector machines," PeerJ, vol. 7, p. e6201, 2019.
2. A. E. Cyr and J. A.Margenthaler,"Molecular profiling of breast cancer, "Surgical Oncology Clinics of North America, vol. 23, no. 3. Pp. 451-462, 2014.
3. W. J. Gradishar,"Treatment of metastatic breast cancer, "in JNCCN Journal of the National Comprehensive Cancer Network, 2014, vol. 12, no. 5 SUPPL., pp, 759-761.
4. H. L. Martin, L. Smith, and D. C. Tomlinson, "Multidrug-resistant breast cancer: Current perspectives, "Breast Cancer: Targets and Therapy, vol. 6, no. 0. Pp. 1-13, 2014.
5. S. Nik-Zainal et al., "Landscape of somatic mutations in 560 breast cancer whole-genome sequences, "Nature, vol. 534, no. 7605, pp. 47-54, 2016.
6. M. T. Maurano et al., "Systematicc localization of common disease-associated variation in regulatory DNA," Science (80-.)., vol. 337, no. 6099, pp. 1190-1195, 2012.
7. M. V. Iorio and C. M. Croce, "MicroRNA dysregulation in cancer: Diagnostics, monitoring and therapeutics. A comprehensive review, "EMBO Molecular Medicine, vol. 4, no. 3. Pp. 143-159, 2012.
8. D. Baek, J. Villen, C. Shin, F. D. Camargo, S. P. Gygi, and D. P. Bartel, "The impact of microRNAs on protein output, "Nature, vol. 7209, pp. 64-71, 2008.
9. L. P. Lim et al., "Microarray analysis shows that some microRNAs downregulate large numbers of target mRNAs, "Nature, vol. 433, no. 7027, pp. 769-773, 2005.
10. W. Filipowicz, S. N. Bhattacharyya, and N. Sonenberg, "Mechanisms of post-transcriptional regulation by microRNAs: Are the Answers in sight?," Nature Reviews Genetics, vol. 9, no. 2. Pp. 102-114, 2008.
11. J. J. Forman, A. Legesse-Miller, and H. A. Coller,"A search for conserved sequences in coding regions reveals that the let-7 microRNA targets Dicer within its coding sequence, "Proc. Natl. Acad. Sci., vol. 105, no. 39, pp. 14879-14884, 2008.
12. S. Vasudevan, Y. Tong, and J. A. Steitz, "Switching from repression to activation: MicroRNAs can up-regulate translation, "Science (80-.)., vol. 318, no. 5858, pp. 1931-1934, 2007.
13. K. C. Vickers, B. T. Palmisano, B. M. Shoucri, R. D. Shamburek, and A. T. Remaley, "MicroRNAs are transported in plasma and delivered to recipient cells by high-denisty lipoproteins, "Nat. Cell Biol., vol. 13, no. 4, pp. 423-435, 2011.
14. H. Valadi, K. Ekstrom, A. Bossios, M. Sjostrand, J. J. Lee, and J. O. Lotvall, "Exosome-mediated transfer of mRNA and microRNAs is a novel mechanism of genatic exchange between cells., "Nat. Cell Biol., vol. 9, no. 6, pp. 654-9, 2007.
15. J. L. Lindenberg et al., "Funcional delivery of viral miRNAs via exosomes, "Proc. Natl. Acad. Sci., vol. 107, no. 14, pp. 6328-6333, 2010.
16. A. Turchinovich, L. Weiz, and B. Burwinkel, "Extracellular miRNAs: The mystery of their origin and function, "Trends Biochem. Sci., vol. 37, no. 11, pp. 460-465, 2012.
17. L. J. Chin and F. J. Slack, "A truth serum for cancer---- microRNAs have major potential as cancer biomarkers, "Cell Res., vol. 18, no. 10, pp. 983-984, 2008.
18. Lu et al, "Journal of Experimental \& Clinical Cancer Research" (2018)
19. Cui, L. et al. Expression of MicroRNA-301a and its Functional Roles in Malignant Melanoma. Cellular physiology and biochemistry: international journal of experimental cellular physiology, biochemistry, and pharmacology 40, 230-244, (2016).
20. Shi, Y. K., Zang, Q. L., Li, G. X., Huang, Y. \& Wang, S. Z. Increased expression of microRNA-301a in nonsmall-cell lung cancer and its clinical significance. Journal of cancer research and therapeutics 12, 693-698, (2016).
21. Chen, Z. et al. miR-301a promotes pancreatic cancer cell proliferation by directly inhibiting Bim expression. Journal of cellular biochemistry 113, 3229-3235, (2012).
22. Ma, X. et al. Modulation of tumorigenesis by the pro-inflammatory microRNA miR-301a in mouse models of lung cancer and colorectal cancer. Cell discovery 1, 15005, (2015).
23. O. Wapinski and H. Y. Chang, "Long noncoding RNAs and human disease," Trends in Cell Biology, vol. 21, no.6. pp. 354-361, 2011.
24. D. Gulei, N. Mehterov, S. M. Nabavi, A. G. Atanasov, and I. Berindan-Neagoe, "Targeting ncRNAs by plant secondary metabolites: The ncRNAs game in balance towards malignancy inhibition, "Biotechnology advances, vol. 36, no. 6. Pp. 1779-1799, 2018.
25. T. Derrien, R. Guigo, and R. Johnson, "The long non-coding rnas: A new (p)layer in the 'dark matter, "Frontiers in Genetics, vol. 2, no. Jan. 2012.
26. Ding J, Yang C, Yang S. LINC00511 interacts with miR-765 and modulate tongue squamous cell carcinoma progression by targeting LAMC2. J Oral Pathol Med. 2018;47:46876.
27. Zhao X, Liu Y, Li Z, Zheng S, Wang Z, Li W, Bi Z, Li L, Jiang Y, Luo Y, Lin Q, Fu Z, Rufu C. Linc00511 acts as a competing endogenous RNA to regulate VEGFA expression through sponging hsa-miR-29b-3p in pancreatic ductal adenocarcinoma. J Cell Mol Med. 2018;22:655-67
28. S. H. Kim et al., "Correlation of ultrasound finfings with histology, tumor grade, and biological markers in breast cancer, "ActaOncol. (Madar)., vol. 47, no. 8, pp. 1531-1538, 2008.
29. M. H. Zweig and G. Campbell, "Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine, "Clinical Chemistry, vol. 39, no. 4. Pp. 561-577, 1993.
(30)Hu, Z. B., J. Dong, L. E. Wang, H. X. Ma, J. B. Liu, Y. Zhao, J. H. Tang, X. Chen, J. C. Dai, Q. Y. Wei, C. Y. Zhang \& H. B. Shen (2012) Serum microRNA profiling and breast cancer risk: the use of miR-484/191 as endogenous controls. Carcinogenesis, 33, 828-834.
### Conditions Module
**Conditions:**
- Early Diagnosed Breast Cancer
**Keywords:**
- easy diagnosed
- stage I/II
- Non treated
### Design Module
#### Bio Spec
**Description:** Four milliliters of peripheral blood was withdrawn once from controls and BC patients, at the time patients were first diagnosed clinically with BC and before any medical (neo)adjuvant therapy or surgical intervention, under strict sterile conditions, following standard biosecurity and international safety procedures, into polymer gel vacutainers with a clot activator (Greiner Bio-One GmbH, Australia), left for 15 min at room temperature to clot, followed by a 10-min centrifugation at 10,000g at 4°C. Sera obtained were aliquoted into three clean Eppendorf tubes and stored at -80°C.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 95
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** free from any medical, psychosocial, emotional conditions, or cancer (age interval was 28-82) were included in the study as well, matched with BC patients' group in sex and race, menopausal status, and randomly chosen from the female Egyptian population.
**Label:** Control
#### Arm Group 2
**Description:** full family disease/cancer history was recorded, as well as patients' previous surgical procedures, other than breast surgery, that do not affect the tumor burden, such as splenectomy, tonsillectomy, cesarean birth, and plastic surgery, offspring numbers, menopausal or not, and taking hormonal contraceptives or not.
Patients' individual current cancer status and the tumor clinical assessment, done at the NCI, using the tumor-node-metastasis (TNM) categorization (43) and the Bloom-Richardson Scale for histological grading (44), were collected from patients' data files, after a biopsy was taken at the time of BC examination
**Label:** BC patients
### Outcomes Module
#### Primary Outcomes
**Description:** as minimal noninvasive molecular markers for diagnosing the primary breast cancer.
**Measure:** 1. Analyze the expression level of two miRNA (miR-185-3p, miR-301a) and their predicted interacted lncRNA (LINC00511)
**Time Frame:** 12 Month
**Description:** with the protein based markers (CEA and CA15-3) as diagnostic markers, regarding to sensitivity and specificity.
**Measure:** 2. Compare miR-185-3p, miR-301a, and LINC00511
**Time Frame:** 6 Month
**Description:** LINC00511and the clinicopathological characters of breast cancer.
**Measure:** 3. Study the relation between miR-185-3p, miR-301a, and LINC00511
**Time Frame:** 2 Month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* were being an adult female, with breast invasive carcinoma of no specific type, confirmed pathologically
Exclusion Criteria:
* Patients with:
* were blood disease, any cancer other than BC, liver cirrhosis, and uterine and urinary bladder diseases, or metastatic BC patients who received chemo/radiotherapy, or had previous mastectomy.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 82 Years
**Minimum Age:** 28 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The current retrospective cohort study included 70 female volunteer patients first diagnosed with primary BC, without any medical or surgical intervention, from the Clinical Oncology Department, NCI, Cairo University, Egypt. BC diagnosis is carried out with mammogram and MRI.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab
**Zip:** 11566
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6494
- Name: Contraceptive Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427707
**Brief Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.
**Official Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions as An Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** FMASU R84/2024
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Rania Maher Hussien, MD
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.
**Detailed Description:** In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries
### Conditions Module
**Conditions:**
- Intraoperative Bleeding
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** intravenous infusion of propofol, lidocaine and magnesium sulfate.
**Intervention Names:**
- Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate
**Label:** Group PLM (propofol-lidocaine-magnesium)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** intravenous infusion of Ketamine, lidocaine and magnesium sulfate
**Intervention Names:**
- Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate
**Label:** Group KLM (ketamine-lidocaine-magnesium)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate
**Intervention Names:**
- Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate
**Label:** Group DLM (Dexmeditomidine-lidocaine-magnesium)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group PLM (propofol-lidocaine-magnesium)
**Description:** intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding
**Name:** Intravenous Infusion of propofol, lidocaine, Magnesium sulfate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Group KLM (ketamine-lidocaine-magnesium)
**Description:** Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1.
**Name:** Intravenous infusion of ketamine, lidocaine, Magnesium sulfate
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Group DLM (Dexmeditomidine-lidocaine-magnesium)
**Description:** Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1
**Name:** Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate
**Other Names:**
- Precedex
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Degree of surgical field bleeding
**Measure:** surgical field using the average category scale (ACS).
**Time Frame:** During the operation
#### Secondary Outcomes
**Description:** Degree of sedation using Ramsy sedation score
**Measure:** sedation using Ramsy sedation score
**Time Frame:** First hour postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA I-II,
* scheduled for elective nasal surgery
Exclusion Criteria:
* Patients with uncontrolled hypertension.
* Patients with cardiac disease.
* Patients with renal, hepatic or cerebral insufficiency.
* Patients with coagulopathy or receiving drugs influencing blood coagulation.
* Anaemia, haemoglobinopathies or polycythemia.
* Pregnancy.
* Patients with known sensitivity to any of the study drug.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** RANIA M Hussien, MD
**Phone:** 01000544520
**Phone Ext:** 202
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Fathy Tash, MD
**Phone:** 26857539
**Phone Ext:** 202
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rania M Hussien, MD
- **Phone:** 026213948
- **Phone Ext:** 202
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Hala S El Ozairy, MD
- **Phone:** 01001191199
- **Phone Ext:** 202
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Ain Shams University
**Zip:** 69711
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006470
- Term: Hemorrhage
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007431
- Term: Intraoperative Complications
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M18560
- Name: Blood Loss, Surgical
- Relevance: HIGH
- As Found: Intraoperative Bleeding
- ID: M10465
- Name: Intraoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016063
- Term: Blood Loss, Surgical
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006993
- Term: Hypnotics and Sedatives
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000058647
- Term: Adrenergic alpha-2 Receptor Agonists
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000018686
- Term: Anesthetics, Intravenous
- ID: D000018681
- Term: Anesthetics, General
- ID: D000000778
- Term: Anesthetics, Dissociative
- ID: D000018691
- Term: Excitatory Amino Acid Antagonists
- ID: D000018683
- Term: Excitatory Amino Acid Agents
- ID: D000000927
- Term: Anticonvulsants
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M22662
- Name: Dexmedetomidine
- Relevance: HIGH
- As Found: Twice daily
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M10674
- Name: Ketamine
- Relevance: HIGH
- As Found: Provided
- ID: M18307
- Name: Propofol
- Relevance: HIGH
- As Found: Symptoms
- ID: M11270
- Name: Magnesium Sulfate
- Relevance: HIGH
- As Found: Aerobic exercise
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20766
- Name: Anesthetics, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M20761
- Name: Anesthetics, General
- Relevance: LOW
- As Found: Unknown
- ID: M4108
- Name: Anesthetics, Dissociative
- Relevance: LOW
- As Found: Unknown
- ID: M20771
- Name: Excitatory Amino Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
- ID: D000008278
- Term: Magnesium Sulfate
- ID: D000020927
- Term: Dexmedetomidine
- ID: D000007649
- Term: Ketamine
- ID: D000015742
- Term: Propofol
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427694
**Acronym:** IVORY-FINALE
**Brief Title:** Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study
**Official Title:** The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
#### Organization Study ID Info
**ID:** IVORY-FINALE (A096877)
#### Organization
**Class:** OTHER
**Full Name:** Cambridge University Hospitals NHS Foundation Trust
#### Secondary ID Infos
**Domain:** IRAS
**ID:** 339102
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2030-02-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cambridge University Hospitals NHS Foundation Trust
#### Responsible Party
**Investigator Affiliation:** Cambridge University Hospitals NHS Foundation Trust
**Investigator Full Name:** Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC
**Investigator Title:** Dr Joseph Cheriyan, Consultant Clinical Pharmacologist/Affilitated Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation we hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.
In this follow-up study, we aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.
**Detailed Description:** A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.
The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY.
Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups.
### Conditions Module
**Conditions:**
- Acute Coronary Syndromes
**Keywords:**
- Acute Coronary Syndromes
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Aldesleukin loading dose 1.5 x 10\^6 IU followed by maintenance dose of 1.5 x 10\^6 IU
**Intervention Names:**
- Drug: Aldesleukin
**Label:** Aldesleukin
#### Arm Group 2
**Description:** Dextrose 5%
**Intervention Names:**
- Drug: Dextrose 5% in water
**Label:** Placebo
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Aldesleukin
**Description:** IL2 antagonist
**Name:** Aldesleukin
**Other Names:**
- Proleukin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** matched placebo to active
**Name:** Dextrose 5% in water
**Other Names:**
- Dextrose
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of major adverse cardiovascular outcomes
**Measure:** Major adverse cardiovascular outcomes
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of major adverse cardiovascular outcomes
**Measure:** Major adverse cardiovascular outcomes
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of major adverse cardiovascular outcomes
**Measure:** Major adverse cardiovascular outcomes
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
#### Secondary Outcomes
**Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo
**Measure:** Death due to cardiovascular causes
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo
**Measure:** Deaths due to cardiovascular causes comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo
**Measure:** Deaths due to cardiovascular causes comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo
**Measure:** Resuscitated cardiac arrests comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo
**Measure:** Resuscitated cardiac arrests comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo
**Measure:** Resuscitated cardiac arrests comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of ischaemic strokes comparing IL2 to placebo
**Measure:** Ischaemic strokes comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of ischaemic strokes comparing IL2 to placebo
**Measure:** Ischaemic strokes comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of ischaemic strokes comparing IL2 to placebo
**Measure:** Ischaemic strokes comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo
**Measure:** Unplanned coronary vascularisations comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo
**Measure:** Unplanned coronary vascularisations comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo
**Measure:** Unplanned coronary vascularisations comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of all-cause deaths comparing IL2 to placebo
**Measure:** All-cause deaths comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of all-cause deaths comparing IL2 to placebo
**Measure:** All-cause death comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of all-cause deaths comparing IL2 to placebo
**Measure:** All-cause death comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
**Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure)comparing IL2 to placebo
**Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of hospitalisation due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
**Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of revascularisations for peripheral vascular disease comparing IL2 to placebo
**Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of revascularisations for peripheral vascular diseasecomparing IL2 to placebo
**Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of revascularisations for peripheral vascular disease comparing IL2 to placebo
**Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo
**Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo
**Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo
**Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of haemorrhagic strokes comparing IL2 to placebo
**Measure:** Haemorrhagic strokes comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of haemorrhagic strokes comparing IL2 to placebo
**Measure:** Haemorrhagic strokes comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of haemorrhagic strokes comparing IL2 to placebo
**Measure:** Haemorrhagic strokes comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo
**Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo
**Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo
**Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
**Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Time Frame:** 1 year from when initially dosed in preceding IVORY trial
**Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Time Frame:** 2 years from when initially dosed in preceding IVORY trial
**Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
**Time Frame:** 5 years from when initially dosed in preceding IVORY trial
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses
Exclusion Criteria:
* Patients who decline participation
* Patients who did not consent to being contacted about future research
* Patients who were withdrawn from the IVORY trial for any reason
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cambridge
**Country:** United Kingdom
**Facility:** Addenbrooke's Hospital
**State:** Cambridgeshire
**Zip:** CB20QQ
#### Overall Officials
**Official 1:**
**Affiliation:** Cambridge University Hospitals NHS Foundation Trust
**Name:** Joseph Cheriyan, MBChB, FRCP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** On completion of the study the data will be analysed and tabulated and a Final Study Report prepared. Data will be published in an open access journal.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M27545
- Name: Acute Coronary Syndrome
- Relevance: HIGH
- As Found: Acute Coronary Syndrome
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000054058
- Term: Acute Coronary Syndrome
- ID: D000013577
- Term: Syndrome
- ID: D000007249
- Term: Inflammation
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019380
- Term: Anti-HIV Agents
- ID: D000044966
- Term: Anti-Retroviral Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M225496
- Name: Aldesleukin
- Relevance: HIGH
- As Found: Platinum
- ID: M10411
- Name: Interleukin-2
- Relevance: LOW
- As Found: Unknown
- ID: M21350
- Name: Anti-HIV Agents
- Relevance: LOW
- As Found: Unknown
- ID: M25428
- Name: Anti-Retroviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000082598
- Term: Aldesleukin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427681
**Brief Title:** An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects
**Official Title:** An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects
#### Organization Study ID Info
**ID:** BH006-BE-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Zhuhai Beihai Biotech Co., Ltd
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Zhuhai Beihai Biotech Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).
### Conditions Module
**Conditions:**
- Bioavailability
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute)
**Intervention Names:**
- Drug: BH006 for injection
**Label:** BH006 for injection
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Fosaprepitant for injection：150 mg fosaprepitant intravenously 30 minutes (±1 minute) ; Palonosetron hydrochloride injection： 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds) .
**Intervention Names:**
- Drug: Fosaprepitant for injection+Palonosetron hydrochloride injection
**Label:** Fosaprepitant for injection+Palonosetron hydrochloride injection
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BH006 for injection
**Description:** According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
**Name:** BH006 for injection
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Fosaprepitant for injection+Palonosetron hydrochloride injection
**Description:** According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
**Name:** Fosaprepitant for injection+Palonosetron hydrochloride injection
**Other Names:**
- EMEND®+PALONOSETRON
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** All adverse events (AE) defined by CTCAE version 5.0.
**Measure:** Incidence of Adverse Events [Safety and Tolerability]
**Time Frame:** from the time of first study drug administration till end of study（ Day24 Visit or Early Termination Visit）
#### Primary Outcomes
**Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t).
**Measure:** Pharmacokinetic Analysis
**Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
**Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞).
**Measure:** Pharmacokinetic Analysis
**Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
**Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax).
**Measure:** Pharmacokinetic Analysis
**Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
#### Secondary Outcomes
**Description:** For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2).
**Measure:** Pharmacokinetic Analysis
**Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
**Description:** For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax).
**Measure:** Pharmacokinetic Analysis
**Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Willing and able to provide signed and dated informed consent prior to any study-related procedures.
2. Willing and able to comply with all study procedures.
3. Subjects and their spouses must agree to use adequate contraception 14 days prior to the first dose, for the duration of study participation, and for 6 months following completion of therapy.
4. Healthy subjects of either gender, ≥18 years of age, or ≤ 55 years of age.
5. Have a body weight (BW) of ≥ 45.0 kg(female) / ≥ 50.0 kg(male) and 18 ≤ body mass index (BMI) ≤ 28 kg/m2.
6. Subjects had normal vital signs (T: 35.9\~37.6℃; P: 50\~100 beats/min; BP: 90\~139mmHg/60\~89mmHg, all including critical values) and good organ function prior to enrollment:
* 12-ECG: QTc \<450 milliseconds for males and \<470 milliseconds for females;
* Platelets ≥ 100 × 109/L; neutrophil count ≥ 1.5 × 109/L; hemoglobin ≥ 110 g/L;
* Alanine aminotransferase, aspartate aminotransferase and bilirubin ≤ ULN;
* Subjects with abnormal values on physical examination and the rest of the laboratory tests were also enrolled if the investigator determined that the abnormality was not clinically significant in the context of past medical history.
Exclusion Criteria:
1. Those who are known to be allergic to the investigational drug, its excipients, or similar drugs, or those who suffer from allergic diseases or belong to an allergic constitution (such as allergies to two or more drugs, food, or pollen).
2. Those who have a history of clinically serious disease and have not been cured, or those who currently have a disease that may significantly affect the PK or safety evaluation of the study drug.
3. Those with abnormal and clinically significant vital signs, 12-ECG, and clinical laboratory tests.
4. Major surgery within 90 days prior to study entry; minor surgery within 2 weeks prior to study entry.
5. Subjects who have received a vaccination within 30 days prior to the first dose.
6. Subjects who have used or using any drug within 30 days prior to the first dose that may have a significant impact on the PK or safety evaluation of this study drug, including, but not limited to, CYP3A4 inhibitors/agonists, drugs that may alter activity of drug metabolizing enzyme of liver.
7. Subjects who have participated in and used any clinical trial drug within 90 days prior to the first dose, or plan to participate in other clinical trials during this study.
8. Those with a history of alcohol abuse, or regular drinkers within 90 days prior to the first dose (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who could not abstain during the test, or had a positive alcohol breath test. (1 unit = 1 unit of alcohol = about 285 mL of beer or about 100 mL of red wine or about 25 mL of beverage containing 40% (v/v) alcohol).
9. Subjects who are addicted to tobacco (more than 5 cigarettes or equivalent per day) within 30 days prior to the first dose, or who were unable to quit smoking during the trial.
10. Subjects who have lost/donated more than 450 mL of blood (except physiological blood loss in females) within 90 days prior to the first dose, or who have received a blood transfusion or used a blood product, or who plan to donate blood during the trial or within 30 days of the end of the trial.
11. Subjects who have taken a special diet (including pitaya, mango, grapefruit, etc.) or have had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion within 14 days prior to the first dose.
12. Consumption of food or beverages containing alcoholic products or caffeine or xanthine within 48 hours before the first dose.
13. Subjects have a history of drug abuse within the past five years or a positive drug abuse screen.
14. Subjects have presence of Hepatitis B surface antigen (HBsAg) or a Positive Hepatitis C antibody test result, or positive human immunodeficiency virus (HIV) antibody test, or Positive test for syphilis spirochete antibodies at screening.
15. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test result at screening.
16. Subjects have other clinical significant findings within the 12 months prior to screening that indicate clinically significant disease of the following (including, but not limited to, gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders); and suffering from any condition that increases the risk of haemorrhage such as haemorrhoids, acute gastritis, or gastric and duodenal ulcers, intractable constipation.
17. Subjects who have a history of needle sickness, blood sickness or have a problem in collecting blood.
18. Subjects who have an acute illness or concomitant medication from the screening phase until the first dose.
19. Subjects who are engaged in high-altitude work, vehicle driving and other operators of machinery associated with danger.
20. Subjects have other issues that may lead to non-compliance or be unsuitable for inclusion by investigators' judgement.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaohua Wei, PMD
**Phone:** +86 13500248359
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tianqi Hua, PM
**Phone:** +86 15928870240
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** The First Hospital of Jilin University
**Name:** Hong Zhang, PI
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000058831
- Term: Serotonin 5-HT3 Receptor Antagonists
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000064729
- Term: Neurokinin-1 Receptor Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1926
- Name: Palonosetron
- Relevance: HIGH
- As Found: Vagus
- ID: M44622
- Name: Fosaprepitant
- Relevance: HIGH
- As Found: T-cell leukemia
- ID: M1864
- Name: Aprepitant
- Relevance: HIGH
- As Found: T-cell leukemia
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M29246
- Name: Serotonin 5-HT3 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M30376
- Name: Neurokinin-1 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M16161
- Name: Substance P
- Relevance: LOW
- As Found: Unknown
- ID: M17988
- Name: Neurokinin A
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077924
- Term: Palonosetron
- ID: C000579707
- Term: Fosaprepitant
- ID: D000077608
- Term: Aprepitant
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427668
**Brief Title:** Safety, Tolerability, and Efficacy of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
**Official Title:** A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302
#### Organization Study ID Info
**ID:** SPG302-ALZ-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Spinogenix
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Spinogenix
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.
**Detailed Description:** This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:
Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles
Part B: a randomized expansion cohort of daily dosing for 28 day cycles
### Conditions Module
**Conditions:**
- Alzheimer Disease
**Keywords:**
- Alzheimer Disease
- synapse
- neural connectivity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration.
**Intervention Names:**
- Drug: SPG302
**Label:** Part A: Active SPG302 to be administered to adult participants with AD
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration.
**Intervention Names:**
- Drug: Placebo
**Label:** Part A: Placebo comparator to be administered to adult participants with AD
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.
**Intervention Names:**
- Drug: SPG302
**Label:** Part B: Expansion Cohort
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A: Active SPG302 to be administered to adult participants with AD
- Part B: Expansion Cohort
**Description:** synthetic small molecule
**Name:** SPG302
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part A: Placebo comparator to be administered to adult participants with AD
**Description:** Placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz.
**Measure:** Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint
**Time Frame:** 8 months
**Description:** The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. The higher the score the greater the impairment.
**Measure:** Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
**Time Frame:** 8 months
**Description:** The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment.
**Measure:** Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
**Time Frame:** 8 months
**Description:** Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale inquires about the level of actual or potential medical damage.
**Measure:** C-SSRS (Columbia Suicide Severity Rating Scale)
**Time Frame:** 8 months
**Description:** The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven point scale. A higher scale indicates a worsening of symptoms.
**Measure:** Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
**Time Frame:** 8 months
**Description:** The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance.
**Measure:** Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint
**Time Frame:** 8 months
**Description:** The Quality of Life in Alzheimer's Disease (QOL-AD) is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life.
**Measure:** Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
**Time Frame:** 8 months
#### Secondary Outcomes
**Description:** Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)
**Measure:** Safety and tolerability of SPG302
**Time Frame:** 8 months
**Description:** Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.
**Measure:** Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)
**Time Frame:** 8 months
**Description:** To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter.
**Measure:** Change in biomarkers in participants with AD from baseline to endpoint.
**Time Frame:** 8 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 45-85
* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.
* Life expectancy of \>2 years
* Able and willing to provide written informed consent
Exclusion Criteria:
* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding
**Maximum Age:** 85 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aimee Cayzer
**Phone:** +61 482 130 622
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** L:auren Priest, MD
**Phone:** +61 419 385 015
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Flinders Medical Center
**Name:** Lauren Priest, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427655
**Brief Title:** Benefit of the SALAD Technique on CPR Quality During Intubation in Contaminated Airway
**Official Title:** Benefit of the SALAD Technique on CPR Quality During Intubation in Contaminated Airway
#### Organization Study ID Info
**ID:** 20220903R
#### Organization
**Class:** OTHER
**Full Name:** Shin Kong Wu Ho-Su Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shin Kong Wu Ho-Su Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Management of airways in contaminated environments can compromise the quality of cardiopulmonary resuscitation (CPR). This study examined the effectiveness of SALAD (Suction Assisted Laryngoscopy Airway Decontamination) compared to intermittent suction in maintaining CPR quality during intubation in a simulated scenario of regurgitation. Following 2.5 hours of training in the SALAD technique, 36 emergency medicaltechnician-paramedics (EMT-Ps) were randomly assigned in equal numbers to two groups: one utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin. The manikin simulates regurgitation of gastric contents into the oropharynx during CPR. Primary outcomes assessed were CPR quality metrics, such as chest compression rate, depth, and interruption. Secondary outcomes included the success rate and time of intubation.
**Detailed Description:** The study was conducted in March 2024. Participants were emergency medical technician-paramedics (EMT-Ps) employed by fire departments across Taiwan, recruited on a nationwide basis. All participants provided signed informed consent forms. 36 EMT-Ps are involved in this study.
Simulation setup :
The CPR-induced regurgitation model was adapted from an Airway Larry Airway Management Trainer Torso (Nasco, Fort Atkinson, WI, USA) to simulate oropharyngeal regurgitation during CPR. To emulate the stomach, a manual pump was attached at the base of the manikin's torso. A transparent vinyl tube connected the manikin's esophagus to the pump's outlet port. A HQCPR device was used for CPR quality record.
Training program The 36 participants received 2.5 hours of SALAD training. The training included 5 rounds of intubation teaching and practice. The first two rounds of training involve using the SALAD technique with the video laryngoscope, while the third round used the C-MAC S video laryngoscope as a direct laryngoscope for practice. Technique adjustments can be made during the initial three rounds through monitoring with the video system. The fourth round will involve intubation using a direct laryngoscope with a size 3 Macintosh blade on the SALAD Simulator. The final round involved intubation on the CPR-induced regurgitation model, using a direct laryngoscope and employing the SALAD technique for intubation during chest compressions.
Simulation protocol After completing 2.5 hours of training, participants were randomly assigned to one of two groups for suction techniques: SALAD or intermittent suction. Randomization was conducted using the simple randomization method with a random number table. Participants assigned to the same suction technique group formed a resuscitation team, taking on roles as the airway manager, first chest compressor, or second chest compressor. Each participant rotated through these three roles during three simulation sessions.In each simulation, the airway manager was responsible for BVM ventilation and intubation. The first and second chest compressors performed chest compressions alternately, once every five CPR cycles, adhering to a 30:2 compression-to- ventilation ratio. The initial 30 chest compressions were followed by two ventilations, and suction was not performed during this phase, even if regurgitation was present. This was intended to simulate a scenario where the oral cavity was filled with regurgitant material during intubation, maintaining consistency across participants. After the first two ventilations, intubation could proceed while the team continued chest compressions. The airway manager could request a temporary reduction, lightening, or even cessation of chest compressions to facilitate intubation, or to continue up to 60 compressions without interruption if necessary. If the intubation attempt was unsuccessful, the airway manager had to administer two BVM ventilations before attempting intubation again. Depending on the group assignment, either SALAD or intermittent suction techniques were employed to assist in airway decontamination. After intubation, the airway manager assessed lung expansion using the BVM to verify successful intubation. A failed intubation was defined as any esophageal intubation or three unsuccessful intubation attempts. Each simulation concluded following either a successful or failed intubation.
Measurement The primary outcomes were CPR quality metrics, including chest compression rate, chest compression depth, and time of interruption. The secondary outcomes were the intubation success rate and intubation time. The rate and depth of the first 30 chest compressions (pre-intubation period) were measured. After the initial 30 compressions, interruptions for ventilation or airway management, as well as the quality of chest compressions during intubation, were also measured (intubation period). An intubation attempt was defined as the insertion of the laryngoscope blade into the mouth and its subsequent withdrawal during an unsuccessful attempt, or as the insertion of the laryngoscope blade followed by confirmation from the airway manager that the tube was inserted. Intubation time was defined as the period between the start and the end of an intubation attempt. Two video cameras were set up to record the entire simulation process. Two observers reviewed the video records independently to identify any intubation attempts. Disagreements were resolved by reaching a mutual consensus.
The HQCPR application on an Android device recorded chest compression depth, rate, and interruptions (defined as no chest compression for more than 1 second).
The data from both the video recordings and the HQCPR application were used in subsequent analyses.
Statistical analysis The characteristics of EMT-Ps were described using frequency and percentage for categorical variables, while mean values with standard deviation (SD) were used for continuous variables. Continuous data were compared using the independent t-test between the SALAD and intermittent suction groups, while categorical data were compared using the Fisher's exact test or the Chi-Squared test between these two groups. CPR quality metrics and intubation time were summarized using mean values with 95% confidence intervals (CI). Compression depth greater than or equal to 5 cm, first-pass intubation success, and esophageal intubation were presented as frequency and percentage. Continuous data were compared using the independent t test between the SALAD and intermittent suction groups, while categorical data were compared using Fisher's exact test between these two groups. CPR quality metrics between the pre-intubation period and the intubation period were analyzed using the paired t test in both the SALAD and intermittent suction groups. A two- tailed p-value of less than 0.05 indicated statistical significance. All data analyses and sample size determination were performed using MedCalc Statistical Software version 22.023 (MedCalc Software, Ostend, Belgium).
### Conditions Module
**Conditions:**
- Airway Aspiration
- Cardiopulmonary Arrest
**Keywords:**
- airway decontamination
- suction assisted
- resuscitation
- cardiopulmonary resuscitation quality
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Participants were randomized into two groups. One group utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** single
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 36
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** intermittent suction during intubation
**Label:** intermittent suction
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** SALAD suction during intubation
**Intervention Names:**
- Device: SALAD intubation
**Label:** SALAD
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SALAD
**Description:** SALAD suction during intubation
**Name:** SALAD intubation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** the proportion of time spent performing chest compressions during arrest
**Measure:** chest compression fraction
**Time Frame:** 3 hour
#### Secondary Outcomes
**Description:** the rate of successful intubation
**Measure:** success rate of intubation
**Time Frame:** 3 hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* emergency medical technician-paramedics experienced in advanced airway management and CPR
Exclusion Criteria:
* N/A
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Taipei
**Country:** Taiwan
**Facility:** Shinkong Wu-Ho-Su memorial hospital
**State:** Shih-Lin
**Zip:** 111
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Simons RW, Rea TD, Becker LJ, Eisenberg MS. The incidence and significance of emesis associated with out-of-hospital cardiac arrest. Resuscitation. 2007 Sep;74(3):427-31. doi: 10.1016/j.resuscitation.2007.01.038. Epub 2007 Apr 11.
**PMID:** 17433526
**Citation:** Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597.
**PMID:** 30167701
**Citation:** Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.
**PMID:** 19573949
**Citation:** Ruetzler K, Gruber C, Nabecker S, Wohlfarth P, Priemayr A, Frass M, Kimberger O, Sessler DI, Roessler B. Hands-off time during insertion of six airway devices during cardiopulmonary resuscitation: a randomised manikin trial. Resuscitation. 2011 Aug;82(8):1060-3. doi: 10.1016/j.resuscitation.2011.03.027. Epub 2011 Apr 6.
**PMID:** 21514986
**Citation:** Wang HE, Jaureguibeitia X, Aramendi E, Jarvis JL, Carlson JN, Irusta U, Alonso E, Aufderheide T, Schmicker RH, Hansen ML, Huebinger RM, Colella MR, Gordon R, Suchting R, Idris AH. Airway strategy and chest compression quality in the Pragmatic Airway Resuscitation Trial. Resuscitation. 2021 May;162:93-98. doi: 10.1016/j.resuscitation.2021.01.043. Epub 2021 Feb 11.
**PMID:** 33582258
**Citation:** Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
**PMID:** 30167699
**Citation:** Piegeler T, Roessler B, Goliasch G, Fischer H, Schlaepfer M, Lang S, Ruetzler K. Evaluation of six different airway devices regarding regurgitation and pulmonary aspiration during cardio-pulmonary resuscitation (CPR) - A human cadaver pilot study. Resuscitation. 2016 May;102:70-4. doi: 10.1016/j.resuscitation.2016.02.017. Epub 2016 Feb 26.
**PMID:** 26921473
**Citation:** Lin LW, DuCanto J, Hsu CY, Su YC, Huang CC, Hung SW. Compromised cardiopulmonary resuscitation quality due to regurgitation during endotracheal intubation: a randomised crossover manikin simulation study. BMC Emerg Med. 2022 Jul 9;22(1):124. doi: 10.1186/s12873-022-00662-0.
**PMID:** 35810275
**Citation:** DuCanto J, Serrano KD, Thompson RJ. Novel Airway Training Tool that Simulates Vomiting: Suction-Assisted Laryngoscopy Assisted Decontamination (SALAD) System. West J Emerg Med. 2017 Jan;18(1):117-120. doi: 10.5811/westjem.2016.9.30891. Epub 2016 Nov 8.
**PMID:** 28116021
**Citation:** Lin LW, Huang CC, Ong JR, Chong CF, Wu NY, Hung SW. The suction-assisted laryngoscopy assisted decontamination technique toward successful intubation during massive vomiting simulation: A pilot before-after study. Medicine (Baltimore). 2019 Nov;98(46):e17898. doi: 10.1097/MD.0000000000017898.
**PMID:** 31725637
**Citation:** Pilbery R, Teare MD. Soiled airway tracheal intubation and the effectiveness of decontamination by paramedics (SATIATED): a randomised controlled manikin study. Br Paramed J. 2019 Jun 1;4(1):14-21. doi: 10.29045/14784726.2019.06.4.1.14.
**PMID:** 33328824
**Citation:** Fiore MP, Marmer SL, Steuerwald MT, Thompson RJ, Galgon RE. Three Airway Management Techniques for Airway Decontamination in Massive Emesis: A Manikin Study. West J Emerg Med. 2019 Aug 6;20(5):784-790. doi: 10.5811/westjem.2019.6.42222.
**PMID:** 31539335
**Citation:** Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.
**PMID:** 26472993
**Citation:** Agostinucci JM, Weisslinger L, Marzouk N, Zouaghi H, Ekpe K, Genthillomme A, Adnet F, Guenin A, Reuter PG, Lapostolle F. Relation between chest compression rate and depth: the ENFONCE Study. Eur J Emerg Med. 2021 Oct 1;28(5):352-354. doi: 10.1097/MEJ.0000000000000802.
**PMID:** 33758145
**Citation:** McAlister O, Harvey A, Currie H, McCartney B, Adgey J, Owens P, Idris A. Temporal analysis of continuous chest compression rate and depth performed by firefighters during out of hospital cardiac arrest. Resuscitation. 2023 Apr;185:109738. doi: 10.1016/j.resuscitation.2023.109738. Epub 2023 Feb 16.
**PMID:** 36806652
**Citation:** Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.
**PMID:** 25252721
**Citation:** Voss S, Rhys M, Coates D, Greenwood R, Nolan JP, Thomas M, Benger J. How do paramedics manage the airway during out of hospital cardiac arrest? Resuscitation. 2014 Dec;85(12):1662-6. doi: 10.1016/j.resuscitation.2014.09.008. Epub 2014 Sep 26.
**PMID:** 25260723
**Citation:** Deakin CD, Nolan JP, Ji C, Fothergill RT, Quinn T, Rosser A, Lall R, Perkins GD. The effect of airway management on CPR quality in the PARAMEDIC2 randomised controlled trial. Resuscitation. 2021 Jan;158:8-13. doi: 10.1016/j.resuscitation.2020.11.005. Epub 2020 Nov 12.
**PMID:** 33189805
**Citation:** Donoghue A, Hsieh TC, Nishisaki A, Myers S. Tracheal intubation during pediatric cardiopulmonary resuscitation: A videography-based assessment in an emergency department resuscitation room. Resuscitation. 2016 Feb;99:38-43. doi: 10.1016/j.resuscitation.2015.11.019. Epub 2015 Dec 17.
**PMID:** 26703462
**Citation:** Robinson AE, Driver BE, Prekker ME, Reardon RF, Horton G, Stang JL, Collins JD, Carlson JN. First attempt success with continued versus paused chest compressions during cardiac arrest in the emergency department. Resuscitation. 2023 May;186:109726. doi: 10.1016/j.resuscitation.2023.109726. Epub 2023 Feb 9.
**PMID:** 36764570
**Citation:** Murphy DL, Bulger NE, Harrington BM, Skerchak JA, Counts CR, Latimer AJ, Yang BY, Maynard C, Rea TD, Sayre MR. Fewer tracheal intubation attempts are associated with improved neurologically intact survival following out-of-hospital cardiac arrest. Resuscitation. 2021 Oct;167:289-296. doi: 10.1016/j.resuscitation.2021.07.001. Epub 2021 Jul 14.
**PMID:** 34271128
**Citation:** Jost D, Minh PD, Galinou N, Alhanati L, Dumas F, Lemoine F, Tourtier J-P. What is the incidence of regurgitation during an out-of-hospital cardiac arrest? Observational study Resuscitation. 2015;96:70.
**Citation:** Ko S, Wong OF, Wong CHK, Ma HM, Lit CHA. A pilot study on using Suction-Assisted Laryngoscopy Airway Decontamination techniques to assist endotracheal intubation by GlideScope® in a manikin simulating massive hematemesis. Hong Kong Journal of Emergency Medicine. 2021;28(5):305-313.
**Citation:** Choi I, Choi YW, Han SH, Lee JH. Successful endotracheal intubation using suction- assisted laryngoscopy assisted decontamination technique and a head-down tilt position during massive regurgitation. Soonchunhyang Med Sci. 2020; 26 ( 2 ):75-9.
**Citation:** Frantz E, Sarani N, Pirotte A, Jackson BS. Woman in respiratory distress. J Am Coll Emerg Physicians Open. 2021 Jan 14;2(1):e12344. doi: 10.1002/emp2.12344. eCollection 2021 Feb. No abstract available.
**PMID:** 33490996
**Citation:** Vittinghus, S., Thomsen, J.E., Harpsø, M. Bo Løfgren. Does the age of medical emergency technicians influence the quality of chest compressions. Scand J Trauma Resusc Emerg Med. 2015;23 (Suppl 1): A9
#### See Also Links
**Label:** Related Info
**URL:** https://www.anesthesiologynews.com/Review-Articles/Article/07-23/Airway-Contamination-To-Stop-or-Continue-CPR-During-Intubation-Attempts/70740?ses=ogst
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9411
- Name: Heart Arrest
- Relevance: HIGH
- As Found: Cardiopulmonary Arrest
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006323
- Term: Heart Arrest
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427642
**Brief Title:** Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
**Official Title:** Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases
#### Organization Study ID Info
**ID:** MNCs-2024
#### Organization
**Class:** INDUSTRY
**Full Name:** Shandong Qilu Stem Cells Engineering Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Qilu Children's Hospital of Shandong University
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shandong Qilu Stem Cells Engineering Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.
### Conditions Module
**Conditions:**
- Hypoxic-Ischemic Encephalopathy
- Bronchopulmonary Dysplasia
- Short Bowel Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
**Intervention Names:**
- Biological: Mononuclear cells
- Device: Mild hypothermia therapy
**Label:** Experimental group for children with HIE
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C
**Intervention Names:**
- Device: Mild hypothermia therapy
**Label:** Control group for children with HIE
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient
**Intervention Names:**
- Biological: Mononuclear cells
- Device: Breathing support technique
**Label:** Experimental group for children with BPD
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Clinical routine treatment
**Intervention Names:**
- Device: Breathing support technique
**Label:** Control group for children with BPD
**Type:** ACTIVE_COMPARATOR
#### Arm Group 5
**Description:** Intravenous infusion of UCB-MNCs
**Intervention Names:**
- Biological: Mononuclear cells
- Procedure: Total parenteral nutrition
**Label:** Experimental group for children with SBS
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Clinical routine treatment
**Intervention Names:**
- Procedure: Total parenteral nutrition
**Label:** Control group for children with SBS
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group for children with BPD
- Experimental group for children with HIE
- Experimental group for children with SBS
**Description:** UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
**Name:** Mononuclear cells
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Control group for children with HIE
- Experimental group for children with HIE
**Description:** Mild hypothermia therapy via hypothermia therapy apparatus
**Name:** Mild hypothermia therapy
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Control group for children with BPD
- Experimental group for children with BPD
**Description:** Breathing support via ventilator
**Name:** Breathing support technique
**Type:** DEVICE
#### Intervention 4
**Arm Group Labels:**
- Control group for children with SBS
- Experimental group for children with SBS
**Description:** Liquid nutrition injected directly into the bloodstream
**Name:** Total parenteral nutrition
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Monitor oxygen, heart rate, temperature, rash, infection, etc
**Measure:** Incidence of adverse reactions
**Time Frame:** Within 12 hours after UCB-MNCs infusion
#### Secondary Outcomes
**Description:** Children with BPD: The incidence of various complications such as pneumothorax, necrotizing enterocolitis (NEC), intraventricular hemorrhage (grade 3 and above), persistent pulmonary hypertension (PPHN), retinopathy of prematurity (ROP)
**Measure:** Incidence of complications
**Time Frame:** a year
**Description:** Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT)
**Measure:** Imaging test results
**Time Frame:** 2 weeks and 6 months after UCB-MNCs infusion
**Description:** Children with HIE: The frequency of seizures will be measured via EEG. Seizures appear on EEG as a sudden and transient rise in the lower and/or upper borders of amplitude
**Measure:** Electroencephalography (EEG) results
**Time Frame:** 7 days UCB-MNCs infusion
**Description:** Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD
**Measure:** Ventilator supporting time
**Time Frame:** 1 month after UCB-MNCs infusion
**Description:** GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality
**Measure:** Change of Gross Motor Performance Measure (GMPM)
**Time Frame:** 1, 3, 6 months after UCB-MNCs infusion
**Description:** GMFM is a standardized measurement tool for assessing motor function for children with HIE. It consists of lying \& rolling, sitting, crawling \& kneeling, standing, etc. Higher value means better gross motor function
**Measure:** Change of Gross Motor Function Measure (GMFM)
**Time Frame:** 1, 3, 6 months after UCB-MNCs infusion
**Description:** pNF-H, marker of central nervous system axonal damage
**Measure:** Biomarker of HIE
**Time Frame:** 7 days after UCB-MNCs infusion
**Description:** AGER, marker of lung epithelial cell damage
**Measure:** Biomarker of BPD
**Time Frame:** 7 days after UCB-MNCs infusion
**Description:** Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS
**Measure:** Inflammatory indicators concentrations
**Time Frame:** 7 days after UCB-MNCs infusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.
For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent.
For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent.
Exclusion Criteria:
* For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.
For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) unable or unwilling to provide informed consent or unable to comply with trial requirements.
For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements.
**Maximum Age:** 28 Days
**Minimum Age:** 1 Day
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yujie Han, MD
**Phone:** +86 187 5414 6336
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaoying Li
- **Role:** CONTACT
**Country:** China
**Facility:** Qilu Children's Hospital of Shandong University
**State:** Shandong
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Qilu Children's Hospital of Shandong University
**Name:** Xiaoying Li, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000055397
- Term: Ventilator-Induced Lung Injury
- ID: D000055370
- Term: Lung Injury
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000002534
- Term: Hypoxia, Brain
- ID: D000000860
- Term: Hypoxia
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000008286
- Term: Malabsorption Syndromes
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M4185
- Name: Hypoxia
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: HIGH
- As Found: Ischemic Encephalopathy
- ID: M15586
- Name: Short Bowel Syndrome
- Relevance: HIGH
- As Found: Short Bowel Syndrome
- ID: M5273
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: HIGH
- As Found: Neonatal Disease
- ID: M5204
- Name: Brain Diseases
- Relevance: HIGH
- As Found: Encephalopathy
- ID: M22660
- Name: Hypoxia-Ischemia, Brain
- Relevance: HIGH
- As Found: Hypoxic Ischemic Encephalopathy
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28143
- Name: Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M28152
- Name: Ventilator-Induced Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M10279
- Name: Infant, Premature, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5783
- Name: Hypoxia, Brain
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M11278
- Name: Malabsorption Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: T874
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
- ID: T5206
- Name: Short Bowel Syndrome
- Relevance: HIGH
- As Found: Short Bowel Syndrome
### Condition Browse Module - Meshes
- ID: D000012778
- Term: Short Bowel Syndrome
- ID: D000001997
- Term: Bronchopulmonary Dysplasia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002545
- Term: Brain Ischemia
- ID: D000020925
- Term: Hypoxia-Ischemia, Brain
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427629
**Brief Title:** Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device
**Official Title:** Investigator-initiated Exploratory Clinical Trial to Observe Conjunctival Goblet Cell Density Using an Anterior Segment Imaging Device in Patients With Ocular Surface Disease (ODS) and Patients Scheduled for Ocular Surgery Without OSD
#### Organization Study ID Info
**ID:** 2311-108-1485
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Seoul National University Hospital
#### Responsible Party
**Investigator Affiliation:** Seoul National University Hospital
**Investigator Full Name:** Chang Ho Yoon
**Investigator Title:** Clinical associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Conjunctival goblet cells secrete mucin, vital for tear film stability. Dysfunction can cause tear film issues and lead to diseases like dry eye. Imaging these cells is crucial for diagnosis and treatment. 0.5% moxifloxacin eye drops, an FDA-approved antibiotic, are used to treat bacterial eye infections and prevent infections before surgeries. The investigators developed a non-invasive imaging method for goblet cells, validated in animals, and now plan to test it in humans for diagnosing and treating ocular surface diseases.
**Detailed Description:** Conjunctival goblet cells secrete mucin on the ocular surface, playing a role in forming the mucin layer of the tear film. The mucin layer is crucial for maintaining tear film stability, and dysfunction of conjunctival goblet cells can lead to instability of the mucin layer, causing problems in the tear film. Because various ocular surface diseases stem from tear film instability, imaging of conjunctival goblet cells is essential for diagnosing and treating conditions such as dry eye.
0.5% moxifloxacin eye drops are FDA-approved antibiotics belonging to the quinolone class, widely used to treat bacterial infections in various ocular diseases. Clinically, 0.5% moxifloxacin eye drops are commonly used for purposes such as secondary infection prevention in cases of corneal epithelial defects or perforations caused by ocular surface diseases, as well as for prophylaxis prior to various ophthalmic surgeries, including cataract surgery.
The investigators have previously pioneered non-invasive, high-speed, high-contrast imaging of conjunctival goblet cells. Previous studies have validated the performance and safety of this method by imaging conjunctival goblet cells in mice and rabbit animal models after the instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy. Furthermore, in this study, the investigators plan to conduct a study involving human subjects to apply our developed conjunctival goblet cell imaging technique for the diagnosis and evaluation of treatment outcomes in ocular surface diseases.
### Conditions Module
**Conditions:**
- Ocular Surface Disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 148
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients diagnosed with dry eye disease, sjogren syndrome, stevens-johnson syndrome, ocular graft versus host disease.
**Intervention Names:**
- Device: Imaging of conjunctival goblet cell
**Label:** Patients with ocular surface disease
**Type:** OTHER
#### Arm Group 2
**Description:** Patients without ocular surface disease and scheduled for cataract surgery which requires moxifloxacin administration
**Intervention Names:**
- Device: Imaging of conjunctival goblet cell
**Label:** Patients scheduled for ocular surgery without ocular surface disease
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients scheduled for ocular surgery without ocular surface disease
- Patients with ocular surface disease
**Description:** After instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy, conjunctival goblet cell imaging will be performed in patients with ocular surface disease and patients scheduled for ocular surgery without ocular surface disease
**Name:** Imaging of conjunctival goblet cell
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Severity of dry eye will be assessed based on tear break up time and corneal punctate erosion score
**Measure:** Association between conjunctival goblet cell density and severity of dry eye
**Time Frame:** At the time of imaging
#### Secondary Outcomes
**Description:** Conjunctival punctate erosion score (NEI scale, 0-15), schirmer test (mm), matrix metalloproteinase 9 assay (negative/trace/positive/strong positive), ocular surface disease index (0-100 score) will be assessed as additional parameters.
**Measure:** Difference of conjunctival goblet cell density according to disease and additional parameters related with ocular surface disease
**Time Frame:** At the time of imaging
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients aged 19 years or older.
* Patients who are currently using or scheduled to use 0.5% moxifloxacin eye drops for ophthalmic surgery (control group) or for ocular surface diseases (patient group: dry eye, Sjogren's syndrome, Stevens-Johnson syndrome, graft versus host disease).
* Patients who have agreed to understand and comply with the clinical trial protocol's plans for medical examinations and follow-up observations.
Exclusion Criteria:
* Pregnant or planning to become pregnant, and lactating women.
* Patients with intellectual disabilities and other psychiatric disorders who, at the discretion of the investigator, are deemed ineligible for participation in the clinical trial.
* Patients with hypersensitivity reactions to 0.5% moxifloxacin eye drops, or patients for whom administration is contraindicated.
* Patients for whom participation in the study is deemed impractical based on the judgment of other medical staff and neutral observers (excluding specified selection/exclusion criteria, based on medical reasons, ethical considerations, low compliance, and understanding of the study).
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chang Ho Yoon, MD PhD
**Phone:** 82220724309
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Seoul National University Hospital
**Name:** Chang Ho Yoon, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Repr
- Name: Reproductive Control Agents
### Intervention Browse Module - Browse Leaves
- ID: M1722
- Name: Moxifloxacin
- Relevance: LOW
- As Found: Unknown
- ID: M266292
- Name: Norgestimate, ethinyl estradiol drug combination
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427616
**Brief Title:** Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population
**Official Title:** Effects of Short Duration Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population
#### Organization Study ID Info
**ID:** 3547 Sara Noor
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To determine that the short duration moderate intensity soleus push-ups will have a better effect on blood glucose level as compared to sustained soleus push-ups.
**Detailed Description:** The soleus muscle is a slow oxidative muscle which possesses molecular machinery necessary for regulating blood borne substrates. It has the ability to increase the local oxidative metabolism for a long period of time without experiencing fatigue. The uniqueness lies in this muscle because of its inability to store glycogen and derives its energy directly from the glucose present in the bloodstream. This in turn helps in lowering the blood sugar by using the excess blood glucose as its primary source of fuel. The soleus muscle also stands out because of its high composition of slow oxidative fibers, around 88% of the fibers are slow twitch fibers, making it the only muscle in human body containing greater proportion of slow twitch fiber.
A specific exercise called soleus push-ups (SPU) can have a huge impact on boosting metabolism and regulating blood glucose level better than the total body muscle exercises, intermittent fasting, weight loss etc. According to the previous study it showed a significant effect on the overall blood chemistry when performed for 270 mins.
So,the purpose of this study will be to find the comparison of acute effects of sustained soleus push-ups with moderate resisted soleus push-ups on blood sugar level. To find whether moderate resisted soleus push-ups will give same or better results in short period of time.
### Conditions Module
**Conditions:**
- Health Behavior
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 39
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Moderate intensity involving weighted soleus push-ups is performed till patient MHR is achieved.
**Intervention Names:**
- Behavioral: Short Duration Moderate Intensity Soleus Push-ups
**Label:** Short Duration Moderate Intensity Soleus Push-ups (Group A)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Sustained soleus push-ups will be performed for up to 270 min.
**Intervention Names:**
- Behavioral: Sustained Soleus Push-ups
**Label:** Sustained Soleus Push-ups (Group B)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Short Duration Moderate Intensity Soleus Push-ups (Group A)
**Description:** Participants will start soleus push-ups in sitting positions. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, feet will be placed flat on the ground. Participants will then move their heels up and down continuously.
Soleus push-ups will be performed with moderate intensity using weights which will be placed on their laps.
Participants will perform this activity till their 60-80% of their maximum heart rate is achieved and maintained
**Name:** Short Duration Moderate Intensity Soleus Push-ups
**Other Names:**
- Group A
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Sustained Soleus Push-ups (Group B)
**Description:** Participants will start soleus push-ups in sitting. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, and feet will be placed flat on the ground. Participants will then move their heels up and down continuously for.
Sustained soleus push-ups will be performed with light intensity for up to 270 mins.
No external resistance will be added. Participants will be provided with a maximum of 4 min break time after every 90 mins intervention. In the meantime, their blood sample will be collected
**Name:** Sustained Soleus Push-ups
**Other Names:**
- Group B
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Adherence to the prescribed exercise will be monitored throughout the intervention period to assess compliance and determine if there are any differences in adherence between the two exercise groups.
**Measure:** Adherence to Exercise Protocol
**Time Frame:** Baseline to 6 hours
#### Primary Outcomes
**Description:** The primary outcome measure will be the change in blood sugar level, measured before and after the intervention period. This will provide insight into the direct impact of short duration moderate intensity soleus push-ups vs sustained soleus push-ups on blood sugar levels among young individuals.
**Measure:** Change in Blood Sugar Level
**Time Frame:** Baseline to 6 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: 18-35 years.
* Gender: both male and female.
* Healthy young adults.
* BMI: healthy weight.
Exclusion Criteria:
* Patient with cardiac issues.
* Any neurological issues.
* Knee injuries.
* Patient with any lower limb injuries.
* DVT and lower amputation.
* Any known diabetic patient.
**Healthy Volunteers:** True
**Maximum Age:** 26 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Waqar Ahmed Awan, PHD
**Phone:** 0333-534884
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sara Noor, DPT
**Phone:** 0306-1515493
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Waqar Ahmed Awan, PHD
- **Phone:** 03335348846
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sara Noor, Masters
- **Phone:** 03061515493
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Railway General Hospital
**State:** Punjab
**Status:** RECRUITING
**Zip:** 46120
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University Islamabad
**Name:** Waqar Ahmed Awan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427603
**Brief Title:** Sit Less and Move More: Feasibility Study
**Official Title:** Sit Less and Move More: A Feasibility Study on Physical Active Break Intervention and Improving Cardiometabolic Health
#### Organization Study ID Info
**ID:** RD/2022/2.12
#### Organization
**Class:** OTHER
**Full Name:** Hong Kong Metropolitan University
### Status Module
#### Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hong Kong Metropolitan University
#### Responsible Party
**Investigator Affiliation:** Hong Kong Metropolitan University
**Investigator Full Name:** Dr Bonny WONG Yee Man
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Intervention aiming to improve cardiometabolic health by reducing prolonged sitting
### Conditions Module
**Conditions:**
- Sedentary Behavior
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: physical activity
**Label:** activity group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- activity group
**Description:** workshops and mobile apps: break sedentary behavior by activity breaks
**Name:** physical activity
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** will be assessed using a scale "Feasibility, appropriateness, and acceptability of the intervention"
**Measure:** Intervention feasibility
**Time Frame:** T2: post-intervention (week 12)
#### Secondary Outcomes
**Description:** will be assessed using an accelerometer
**Measure:** Sedentary behavior
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using an accelerometer
**Measure:** Sedentary behavior
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
**Measure:** Sarcopenia score ranged from 0 to 20
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
**Measure:** Sarcopenia score ranged from 0 to 20
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood glucose
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood glucose
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood lipid
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood lipid
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood pressure
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using a portable blood monitoring device
**Measure:** Blood pressure
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using a hand-held dynamometer
**Measure:** Muscle strength (handgrip strength)
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using a hand-held dynamometer
**Measure:** Muscle strength (handgrip strength)
**Time Frame:** T2: post-intervention (week 12)
**Description:** will be assessed using Time-Up-to-Go (TUG)
**Measure:** Physical performance
**Time Frame:** T1: baseline (before the study begins)
**Description:** will be assessed using Time-Up-to-Go (TUG)
**Measure:** Physical performance
**Time Frame:** T2: post-intervention (week 12)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. are community-dwelling older adults aged 65 years or above,
2. are smartphone users,
3. sit for \>= 6 hours per day
4. are overweight
Exclusion Criteria:
1. are unable to walk independently with/without walking aids due to a physical disability;
2. have health conditions that hinder the adherence to intervention
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ho Man Tin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bonny YM Wong, PhD
- **Phone:** (852) 3970 2976
- **Role:** CONTACT
***Contact 2:***
- **Name:** Bonny YM Wong, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Hong Kong
**Facility:** School of Nursing and Health Studies, Hong Kong Metropolitan University
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427590
**Brief Title:** Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects
**Official Title:** A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects
#### Organization Study ID Info
**ID:** ASC47-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Gannex Pharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Gannex Pharma Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period.
This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.
**Detailed Description:** The study will consist of five cohorts, each with different doses of ASC47. Cohorts 1 and 2 have 6 subjects, of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. Cohorts 3, 4 and 5 have 8 subjects, of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo.
### Conditions Module
**Conditions:**
- NASH
**Keywords:**
- ASC47
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 4 subjects will receive the dose 1 of ASC47, and 2 subjects will receive the placebo.
**Intervention Names:**
- Drug: ASC47
- Drug: Matching placebo
**Label:** cohort 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 4 subjects will receive the dose 2 of ASC47, and 2 subjects will receive the placebo.
**Intervention Names:**
- Drug: ASC47
- Drug: Matching placebo
**Label:** cohort 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 6 subjects will receive the dose 3 of ASC47, and 2 subjects will receive the placebo.
**Intervention Names:**
- Drug: ASC47
- Drug: Matching placebo
**Label:** cohort 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** 6 subjects will receive the dose 4 of ASC47, and 2 subjects will receive the placebo.
**Intervention Names:**
- Drug: ASC47
- Drug: Matching placebo
**Label:** cohort 4
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** 6 subjects will receive the dose 5 of ASC47, and 2 subjects will receive the placebo
**Intervention Names:**
- Drug: ASC47
- Drug: Matching placebo
**Label:** cohort 5
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- cohort 1
- cohort 2
- cohort 3
- cohort 4
- cohort 5
**Description:** single subcutaneous injection of ASC47
**Name:** ASC47
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- cohort 1
- cohort 2
- cohort 3
- cohort 4
- cohort 5
**Description:** single subcutaneous injection of Placebo
**Name:** Matching placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
**Time Frame:** up to 57 days
**Description:** Evaluate the ECG QT Interval after single doses of ASC47.
**Measure:** ECG QT Interval
**Time Frame:** up to 57 days
**Description:** Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
**Measure:** Blood cell
**Time Frame:** up to 57 days
**Description:** Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
**Measure:** Hematology
**Time Frame:** up to 57 days
#### Secondary Outcomes
**Description:** Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.
**Measure:** AUC of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the Peak Plasma Concentration after single doses of ASC47.
**Measure:** Cmax of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the Minimum Plasma Concentration after single doses of ASC47.
**Measure:** Cmin of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the Terminal-Phase Half-Life after single doses of ASC47
**Measure:** T1/2 of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the Apparent Systemic Clearance after single doses of ASC47.
**Measure:** CL/F of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the Apparent Volume of Distribution after single doses of ASC47.
**Measure:** Vd/F of ASC47
**Time Frame:** up to 57 days
**Description:** Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.
**Measure:** Lipid parameters
**Time Frame:** up to 57 days
### Eligibility Module
**Eligibility Criteria:** Key inclusion Criteria:
* Subject have provided informed consent before initiation of any study-specific procedures
* Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.
Key exclusion Criteria:
* Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
* Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
* Have a history of febrile illness within 14 days prior to screening.
* Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427577
**Brief Title:** Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites
**Official Title:** Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites
#### Organization Study ID Info
**ID:** 2024-SR-304 ZhenQiFuZheng
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital with Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2028-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Affiliated Hospital with Nanjing Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** ZhenQi FuZheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional Chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. This project intends to establish AR（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of ZhenQiFuZheng granules in AR. We assume that ZhenQi FuZheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in AR patients, thus improving the type 2 inflammation level of allergic rhinitis.
### Conditions Module
**Conditions:**
- Rhinitis, Allergic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** ZhenQi FuZheng granules (ShiDaiYangGuang)
1 bag at a time, twice a day. Oral for 4 weeks.
**Intervention Names:**
- Drug: ZhenQi FuZheng granules (ShiDaiYangGuang)
**Label:** Allergic rhinitis
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Allergic rhinitis
**Description:** 1 bag at a time, twice a day. Oral orally for 4 weeks.
**Name:** ZhenQi FuZheng granules (ShiDaiYangGuang)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
**Measure:** Rhinoconjunctivitis Quality of Life Questionnaire
**Time Frame:** 12 weeks
**Description:** Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
**Measure:** Visual Analog Score for pain
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (18-65 years).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and are diagnosed as allergic rhinitis .
Exclusion Criteria:
* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lei Cheng
**Phone:** +8613776620807
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.
**PMID:** 30473712
**Citation:** Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.
**PMID:** 27434218
**Citation:** Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.
**PMID:** 29949830
**Citation:** Wang XD, Zheng M, Lou HF, Wang CS, Zhang Y, Bo MY, Ge SQ, Zhang N, Zhang L, Bachert C. An increased prevalence of self-reported allergic rhinitis in major Chinese cities from 2005 to 2011. Allergy. 2016 Aug;71(8):1170-80. doi: 10.1111/all.12874. Epub 2016 Apr 13.
**PMID:** 26948849
**Citation:** Li K, Chen Y, Jiang R, Chen D, Wang H, Xiong W, Li D, Liu Z, Li X, Li J, Yuan K. Protective effects of astragaloside IV against ovalbumin-induced allergic rhinitis are mediated by T-box protein expressed in T cells/GATA-3 and forkhead box protein 3/retinoic acid-related orphan nuclear receptor gammat. Mol Med Rep. 2017 Aug;16(2):1207-1215. doi: 10.3892/mmr.2017.6685. Epub 2017 Jun 6.
**PMID:** 28586019
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000009668
- Term: Nose Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15049
- Name: Rhinitis
- Relevance: HIGH
- As Found: Rhinitis
- ID: M30545
- Name: Rhinitis, Allergic
- Relevance: HIGH
- As Found: Rhinitis, Allergic
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12604
- Name: Nose Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012220
- Term: Rhinitis
- ID: D000065631
- Term: Rhinitis, Allergic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427564
**Brief Title:** Vital Signs Collection Via "Comestai" App
**Official Title:** Vital Signs Data Collection Using "Comestai" Application
#### Organization Study ID Info
**ID:** CET 98-2024
#### Organization
**Class:** OTHER
**Full Name:** Buzzi Children's Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Buzzi Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Buzzi Children's Hospital
**Investigator Full Name:** Valeria Calcaterra
**Investigator Title:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the study is to verify and validate the parameters collected from mobile devices via the app named "Comestai" and from reference devices. The assessments considered to define comorbidities are included.. Specifically, collection of vital parameters (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation) through the "Comestai" Application via mobile phones (using photoplethysmographic method) and reference devices such as Withings-Blood Pressure Monitor Connect® (for Blood Pressure), Polar Verity Sense® (for Heart Rate), Masimo-finger sensor® (for Oxygen Saturation, Respiratory Rate), comparing and confirming them. Consent will be sought for the viewing and collection of blood test results that are normally included in evaluations for subjects with overweight and/or obesity and/or diabetes.
Estimated time required for each measurement recording: 10-15 minutes per subject
Total number of subjects: 3000
**Detailed Description:** Early detection of variations in vital parameters allows for the identification of changes in patients' health status and the provision of recommendations for therapeutic adjustments. The application named "Comestai" is a non-invasive and easy-to-use tool that enables the measurement of vital parameters. The app allows users to simultaneously measure vital parameters such as Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (SpO2), and Blood Pressure (BP) using the photoplethysmographic method with the front camera of a mobile device.
The use of simultaneous vital parameter measurement systems like apps can enhance self-monitoring of health status and improve patient care. In this study, vital parameters will be measured using the "Comestai" application and compared and validated with measurements from standard clinical practice devices.
Consent will be sought for the viewing and collection of biochemical evaluation results typically required for individuals with overweight and/or obesity and/or diabetes.
"Comestai" Application: This wellness app allows for non-invasive measurement of vital parameters, enabling users to detect SpO2, HR, RR, and BP by looking at the front camera of a mobile device ("By Face"). The measurement method used is Remote Photoplethysmography (rPPG).
This is a prospective, open-label, study to collect vital parameters using the Comestai application by looking at the front camera of a mobile device ("By Face"). The measurement method of the app is Remote Photoplethysmography (rPPG).
The study plans to enroll up to 3000 subjects
Each subject will be assigned a specific identification number (Subject ID). During the evaluation, the following data will be recorded in the Electronic Case Report Form (eCRF):
Medical history of the subject Current or past therapies Demographic data (date of birth, sex) Smoking habits Physical characteristics (height in meters, weight in kilograms, Body Mass Index in kg/m\^2, and phototype)
During the 'By Face' measurement of vital parameters with the app, subjects will be asked to sit in a comfortable place, looking at the phone screen (about 25 cm away) with their face fully uncovered (no masks, hats, or any facial accessories). During data collection, the subject should remain still and breathe steadily. The subject will be required to look directly at the camera throughout the data collection process. The 'By Face' data collection mode can be performed on both iOS and Android in parallel, with both devices positioned in front of the subject. HR and blood pressure will also be measured immediately before and after the app measurement.
Data Collection Equipment
For vital signs data collection using the "Comestai" application, the study staff will use the following mobile phones for rPPG "By Face" measurements:
* Face: Apple internet(i)Phone 13 Pro (10 bit) \& Samsung Galaxy S21 Ultra
* Two additional phones will be used as remote:
* One Android phone - Recorder Remote to start the measurement from far.
* One Apple iPhone -Masimo-finger sensor App to collect the data from the Masimo finger sensor.
* Other necessary equipment includes phone stands (two per room of measurement). In addition to the equipment for vital signs data collection using the "Comestai" application, reference devices will measure the subject's vital signs as a point of comparison.
rPPG "By Face" vital signs data collection includes videoing the subjects' faces with a mobile device (iOS and Android) front camara for approximately 1.5 minutes.
Vital signs data using the reference devices (i.e., SpO2, RR, BP, PR) will be collected continuously for approximately 1.5 minutes, and simultaneously to the data collected using the "Comestai" application (i.e., "By Face").
Several data collection events (1.5 minutes each) may be performed per subject using the "Comestai" application and reference devices.
BP will be collected using the reference devices prior to data collection using the Comestai application and immediately after completion of data collection using the Comestai application.
During "By Face" data collection, the subjects will be requested to sit in a comfortable place, looking at a screen (distance of \~25cm) with a fully exposed face (not to wear a mask, hat, or any kind of accessory on the face). During data collection, the subject breathing should be stable with minimum movements. The subject will be requested to stare directly towards the camara during the whole data collection process.
"By Face" mode of data collection can be taken for both iOS and Android in parallel when both devices are positioned in front of the subject.
During the "By Face" data collection, SpO2 levels will be monitored continuously using the standard reference device.
Consent will be sought for viewing and collecting the results of pre-scheduled blood tests. Participation is optional, and subjects who do not consent can still proceed with the parameter measurements. In case of acceptance, the following results will be considered:
Complete Blood Count (Hemoglobin, White Blood Cell Count, Neutrophils, Lymphocytes, and Platelets), Hemoglobin Glycosylated (HbA1C), Lipid Profile (Total Cholesterol, Cholesterol-LDL, Cholesterol-HDL, and Triglycerides), Glucose, Alanine transaminase (ALT), Creatinine.
Estimated participation time per subject: approximately 10-15 minutes.
No medical decisions will be based on data obtained through the "Comestai" application, reference devices, or blood sample results.
All data will be recorded in the study's eCRF.
The analysis plan involves verifying and validating the parameters collected from mobile devices via the app and from reference devices, as well as results of pre-scheduled blood tests and patient demographic data. For all parameters, the accuracy of the app measurement compared to the reference device and standard tests will be assessed.
Confidence intervals will be calculated using the bootstrap method. The correlation between measurements using the app and those using reference devices and standard tests will be evaluated using the Pearson correlation coefficient. The agreement between the two measurements (app and reference devices/and standard tests) will be represented using Bland-Altman plots.
### Conditions Module
**Conditions:**
- Vital Signs
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 3000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Collect, verify and validate Pulse rate (beats per minute) in data using the Comestai application and reference devices.
Pulse rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Pulse rate
**Time Frame:** 15 minutes for data collection
**Description:** Collect, verify and validate Oxygen saturation (percentage) in data using the Comestai application and reference devices.
Oxygen saturation data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Oxygen saturation
**Time Frame:** 15 minutes for data collection
**Description:** Collect, verify and validate Respiratory rate (breaths per minute) in data using the Comestai application and reference devices.
Respiratory rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Respiratory rate
**Time Frame:** 15 minutes for data collection
**Description:** Collect, verify and validate Blood pressure (mmHg) in data using the Comestai application and reference devices.
Blood pressure data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Blood pressure
**Time Frame:** 15 minutes for data collection
#### Secondary Outcomes
**Description:** Collect, verify and validate Hemoglobin level (g/dl) in data using the Comestai application and results of pre-scheduled blood tests
Hemoglobin level data obtained using the Comestai application and results of pre-scheduled blood tests will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Hemoglobin
**Time Frame:** 15 minutes for data collection
**Description:** Collect, verify and validate Hemoglobin glycosylated level (mmol/mol) in data using the Comestai application and results of pre-scheduled blood tests
Hemoglobin glycosylated level data obtained using the Comestai application and and results of pre-scheduled blood tests will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team.
The measurement method utilized by the app is Remote Photoplethysmography (rPPG).
No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
**Measure:** Data Collection Storage and Processing-Hemoglobin glycosylated
**Time Frame:** 15 minutes for data collection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Prior to enrollment in this study, subjects must meet all the following inclusion criteria:
1. Subject must have the ability to understand and provide written informed consent.
2. Male or Female subject ≥16 and ≤65 of age.
3. Subject must be willing and able to comply with study procedures.
Exclusion Criteria:
Subjects will be excluded from the study if any of the following conditions are present:
1. Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study.
2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.
3. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.
4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.
5. Subject unfit to participate in the study to the judgment of the investigator.
In addition to the Inclusion/Exclusion criteria, the 70% of target population should include adult subjects with at least one of the following:
* Pre-diabetes or diabetes HbA1C 5.7-13%
* \>30% of subjects with HbA1C 5.7-6.4%
* \>30% of subjects with HbA1C \>6.4%
* Hypertension with systolic measurements above 130 mmHg
* \>40% of subjects with systolic BP \>130 mmHg
* \>20% of subjects with systolic BP \>160 mmHg
* Total cholesterol: \>40% of subjects with \>200 mg/dl and/or LDL above 130 mg/dl
* Atrial fibrillation 1%
* Smokers \~ 20-30% of all subjects in the study
Note: the same subject can have more than one of the above medical conditions. It is preferred that subjects will be treatment- naive for the medical condition they suffer from or are not under treatment at the time of participation (e.g. a subject who suffers from hypertension has not started his treatment to lower his blood pressure).
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 16 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Potential adolescent and adult subjects (male and female ≥16 and ≤65 of age), of any race, physiques and skin pigmentation with awide range of health conditions who provided their consent by signing the informed consent form will be screened into the study and provided with a subject specific identification number used throughout the study (i.e. Subject ID).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gianvincenzo Zuccotti, MD, Prof
**Phone:** +390263631
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Valeria Calcaterra, MD
**Phone:** +390263631
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Buzzi Children's Hospital
**Name:** Gianvincenzo Zuccotti, MD, Prof
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427551
**Acronym:** volupeng
**Brief Title:** Volume Effect in Peng Block for Total Hip Replacement
**Official Title:** Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications
#### Organization Study ID Info
**ID:** VOLUPENG
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliero, Universitaria Pisana
### Status Module
#### Completion Date
**Date:** 2024-01-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Azienda Ospedaliero, Universitaria Pisana
#### Responsible Party
**Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana
**Investigator Full Name:** Serena Ricalzone
**Investigator Title:** principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.
**Detailed Description:** patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery
### Conditions Module
**Conditions:**
- Anesthesia
- Post Operative Pain
**Keywords:**
- postoperative
- orthopedic surgery
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 120
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight
**Intervention Names:**
- Drug: Ropivacaine
**Label:** 15 ml local anesthetic
#### Arm Group 2
**Description:** in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight
**Intervention Names:**
- Drug: Ropivacaine
**Label:** 20 ml local anesthetic
#### Arm Group 3
**Description:** in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight
**Intervention Names:**
- Drug: Ropivacaine
**Label:** 30 ml local anesthetic
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 15 ml local anesthetic
- 20 ml local anesthetic
- 30 ml local anesthetic
**Description:** The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg)
**Name:** Ropivacaine
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours
**Measure:** presence of side effects
**Time Frame:** 24 hours
**Description:** requirement of analgesic to control the pain, assessed every six hours
**Measure:** analgesic requirements
**Time Frame:** 24 hours
#### Primary Outcomes
**Description:** Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.
Success of the block was defined as NRS≤3.
**Measure:** NRS evaluation
**Time Frame:** 24h post-op
#### Secondary Outcomes
**Description:** consider variation of pain, assessed with numeric Pain scale, for each group, every six hours
**Measure:** NRS variation in time
**Time Frame:** 24 h
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA I, ASA II, ASA III
* Age≥18
* Total hip replacement surgery in spinal anesthesia
* Informed consent
Exclusion Criteria:
* ASA IV
* INR\>1.3
* platelet values\<100\*10\^3/ml a
* patients on anticoagulant or antiplatelet therapy
* general anesthesia for total hip replacement surgery
* patients on chronic opioid therapy
* altered sensitivity or motility
* Patients in chronic opioid therapy
* Refuse to sign informed consent form
* Unable to sign informed consent form
* Know allergies to medication used for analgesia
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients underwent total hip replacement in elective surgery
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pisa
**Country:** Italy
**Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
**State:** Toscana
**Zip:** 56124
#### Overall Officials
**Official 1:**
**Affiliation:** aoupisa
**Name:** manuela nicastro, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M1700
- Name: Ropivacaine
- Relevance: HIGH
- As Found: Eye
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077212
- Term: Ropivacaine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427538
**Acronym:** RELIEF
**Brief Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
**Official Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
#### Organization Study ID Info
**ID:** 231367
#### Organization
**Class:** OTHER
**Full Name:** Vanderbilt University Medical Center
### Status Module
#### Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Vanderbilt University Medical Center
#### Responsible Party
**Investigator Affiliation:** Vanderbilt University Medical Center
**Investigator Full Name:** Samira Shojaee
**Investigator Title:** Associate Professor of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.
**Detailed Description:** There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of \<16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.
### Conditions Module
**Conditions:**
- Empyema, Pleural
- Pleural Infection
**Keywords:**
- empyema
- pleural infection
- chest tube
- saline flush
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush.
**Intervention Names:**
- Other: Saline Flush
**Label:** Saline Intervention Arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.
**Label:** No Intervention Arm
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Saline Intervention Arm
**Description:** sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours
**Name:** Saline Flush
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal
**Measure:** Time to chest tube removal
**Time Frame:** up to 3 months
#### Secondary Outcomes
**Measure:** Length of hospitalization
**Time Frame:** up to 365 days
**Measure:** Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal
**Time Frame:** through study completion, an average of 3 months
**Description:** number of additional procedures through study completion
**Measure:** Additional surgical procedures for the management of pleural space infection
**Time Frame:** an average of 3 months
**Measure:** Complications
**Time Frame:** through study completion, an average of 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
* Age \> 18 years old.
Exclusion Criteria:
* Patients who have surgical tubes that can't accommodate a three-way stopcock.
* Study subject has any disease or condition that interferes with the safe completion of the study.
* Inability to provide informed consent.
* Inability to undergo a chest X-ray.
* If the managing clinician believes the chest tube will be placed for less than 24 hours.
* Patients with an indwelling pleural catheter (IPC)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Samira Shojaee, MD, MPH
**Phone:** 615-322-2386
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jennifer Duke, MD
**Phone:** 615-322-2386
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nashville
**Country:** United States
**Facility:** Vanderbilt University Medical Center
**State:** Tennessee
**Zip:** 37203
#### Overall Officials
**Official 1:**
**Affiliation:** Vanderbilt University
**Name:** Jennifer D Duke, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Deidentified data will be shared with other researchers
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000012877
- Term: Skin Manifestations
- ID: D000013492
- Term: Suppuration
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000010995
- Term: Pleural Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7819
- Name: Empyema
- Relevance: HIGH
- As Found: Empyema
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19086
- Name: Empyema, Pleural
- Relevance: HIGH
- As Found: Empyema, Pleural
- ID: M8610
- Name: Flushing
- Relevance: HIGH
- As Found: Flushing
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M16273
- Name: Suppuration
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13885
- Name: Pleural Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004653
- Term: Empyema
- ID: D000016724
- Term: Empyema, Pleural
- ID: D000005483
- Term: Flushing
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M13848
- Name: Plasminogen
- Relevance: LOW
- As Found: Unknown
- ID: M13849
- Name: Tissue Plasminogen Activator
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427525
**Acronym:** obesity
**Brief Title:** The Effect of Mobile Application Supported Health Promotion Program on Obesity of Adolescents
**Official Title:** The Effect of Mobile Application Supported Health Promotion Program on Obesity, Physical Activity and Stress Levels of Adolescents
#### Organization Study ID Info
**ID:** Mobile Application Health
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-14
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-07
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Cumali Yıldızdal
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood.
**Detailed Description:** The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood. The program aims to provide children with positive health behaviors, gain cognitive and behavioral skills that will enable them to increase their knowledge of physical activity, nutrition and stress management.
### Conditions Module
**Conditions:**
- Adolescents
- Mobile Application
- School Health
- Physical Activity
- Nutrition Disorder, Child
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 70
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** mobile application at preventing overweight and obesity in childhood
**Intervention Names:**
- Other: Mobile application-based adolecent obesity education
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** health education
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** Mobile application-based adolecent obesity education
**Name:** Mobile application-based adolecent obesity education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** higher scores mean a better
**Measure:** Healthy Lifestyle Behaviors Scale
**Time Frame:** 4 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Obesity Adolescents
Exclusion Criteria:
non-obese child
**Healthy Volunteers:** True
**Maximum Age:** 16 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** İstanbul
**Country:** Turkey
**Facility:** Florance Nightingale Nursing Faculty
**Zip:** 34000
#### Overall Officials
**Official 1:**
**Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Name:** Cumali Yıldızdal, phd student
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: HIGH
- As Found: Nutrition Disorders
- ID: M18049
- Name: Child Nutrition Disorders
- Relevance: HIGH
- As Found: Nutrition Disorder, Child
### Condition Browse Module - Meshes
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000015362
- Term: Child Nutrition Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427512
**Brief Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID
**Official Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies
#### Organization Study ID Info
**ID:** AAA-TBA
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-01
**Study First Submit QC Date:** 2024-05-20
**Why Stopped:** Funding not available
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** American Heart Association
#### Lead Sponsor
**Class:** OTHER
**Name:** Columbia University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** AIM 1. Characterize cardiovascular phenotypes of long COVID by cardiopulmonary, meta-bolic, and cardiac mechanical/physiological responses to exercise and microvascular vasomotor function.
AIM 2. Identify intercellular signaling between immune cells and cardiac cells associated with microvascular phenotypes of long COVID.
**Detailed Description:** As many as 40-60% of patients who recovered from mild or moderate acute COVID have reported what is now called long COVID - multiple, persistent or recurrent symptoms lasting 6-9 months (or longer) following initial illness.1-4 Fatigue, dyspnea, and chest pain are the most common symptoms. Others include palpitations, lightheadedness, and syncope. All these cardiovascular symptoms can be debilitating, resulting in worse quality of life and morbidity.5, 6 Treatment options are limited.
### Conditions Module
**Conditions:**
- COVID-19
**Keywords:**
- long COVID-19
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with long COVID-19 and experiencing cardiovascular symptoms at 24 weeks post-acute illness or post-COVID without cardiovascular symptoms by 8 weeks after illness.
**Label:** COVID patients
### Outcomes Module
#### Primary Outcomes
**Description:** This is to measure the microvascular dysfunction in patients using Cardiac PET.
**Measure:** Prevalence of Microvascular dysfunction
**Time Frame:** Up to 2.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \> 18, \< 75 yrs
* History of lab-confirmed COVID
* Symptomatic at \>12 wks post-acute COVID (cases)
* Recovered by 8wks post-acute COVID (controls)
Exclusion Criteria:
* Any history of critical illness
* Chronic kidney disease, Stage \>4
* Pre-COVID: HFrEF, CABG, arrhythmia; pulmonary hypertension, pulmonary embolus, interstitial lung disease (ILD), O2 dependence; dementia, stroke, autonomic dysfunction; coagulopathy
* Post-COVID: ILD, O2 dependence
**Maximum Age:** 74 Years
**Minimum Age:** 19 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC).
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New York
**Country:** United States
**Facility:** CUIMC
**State:** New York
**Zip:** 10032
#### Overall Officials
**Official 1:**
**Affiliation:** Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology
**Name:** Emily Tsai, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23.
**PMID:** 34163090
**Citation:** Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.
**PMID:** 33284676
**Citation:** Nehme M, Braillard O, Chappuis F, Courvoisier DS, Guessous I; CoviCare Study Team. Prevalence of Symptoms More Than Seven Months After Diagnosis of Symptomatic COVID-19 in an Outpatient Setting. Ann Intern Med. 2021 Sep;174(9):1252-1260. doi: 10.7326/M21-0878. Epub 2021 Jul 6.
**PMID:** 34224254
**Citation:** Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
**PMID:** 34951953
**Citation:** Huang L, Yao Q, Gu X, Wang Q, Ren L, Wang Y, Hu P, Guo L, Liu M, Xu J, Zhang X, Qu Y, Fan Y, Li X, Li C, Yu T, Xia J, Wei M, Chen L, Li Y, Xiao F, Liu D, Wang J, Wang X, Cao B. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021 Aug 28;398(10302):747-758. doi: 10.1016/S0140-6736(21)01755-4. Erratum In: Lancet. 2022 May 7;399(10337):1778.
**PMID:** 34454673
**Citation:** Sigfrid L, Drake TM, Pauley E, Jesudason EC, Olliaro P, Lim WS, Gillesen A, Berry C, Lowe DJ, McPeake J, Lone N, Munblit D, Cevik M, Casey A, Bannister P, Russell CD, Goodwin L, Ho A, Turtle L, O'Hara ME, Hastie C, Donohue C, Spencer RG, Donegan C, Gummery A, Harrison J, Hardwick HE, Hastie CE, Carson G, Merson L, Baillie JK, Openshaw P, Harrison EM, Docherty AB, Semple MG, Scott JT; ISARIC4C investigators. Long Covid in adults discharged from UK hospitals after Covid-19: A prospective, multicentre cohort study using the ISARIC WHO Clinical Characterisation Protocol. Lancet Reg Health Eur. 2021 Sep;8:100186. doi: 10.1016/j.lanepe.2021.100186. Epub 2021 Aug 6.
**PMID:** 34386785
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000094025
- Term: Post-Infectious Disorders
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3013
- Name: Post-Acute COVID-19 Syndrome
- Relevance: HIGH
- As Found: Long COVID
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3014
- Name: Post-Infectious Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
- ID: D000094024
- Term: Post-Acute COVID-19 Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427499
**Brief Title:** The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.
**Official Title:** The Clinical Investigation of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis: A Three-Month Study in Thailand
#### Organization Study ID Info
**ID:** CRO-2024-04-PGN-BKS-YPZ
#### Organization
**Class:** INDUSTRY
**Full Name:** Colgate Palmolive
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Colgate Palmolive
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.
### Conditions Module
**Conditions:**
- Plaque
- Gingivitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Stannous fluoride toothpaste
**Label:** Stannous Fluoride Toothpaste
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** MFP Fluoride toothpaste
**Intervention Names:**
- Drug: Colgate Cavity Protection Toothpaste
**Label:** Colgate Cavity Protection Toothpaste
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stannous Fluoride Toothpaste
**Description:** brush 2 min morning \& night daily
**Name:** Stannous fluoride toothpaste
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Colgate Cavity Protection Toothpaste
**Description:** brush 2 min morning \& night daily
**Name:** Colgate Cavity Protection Toothpaste
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.
**Measure:** Loe and Silness Gingival Index.
**Time Frame:** baseline, one week, six weeks and three months
**Description:** A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
**Measure:** Quigley and Hein Plaque Index
**Time Frame:** baseline, one week, six weeks and three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects, ages 18-70, inclusive.
* Availability for the three-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form
Exclusion Criteria:
* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Terdphong Triratana
**Phone:** 66-81-311-3986
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** M U International Oral Science Research, Ltd
**Name:** Terdphong Triratana
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9003
- Name: Gingivitis
- Relevance: HIGH
- As Found: Gingivitis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005891
- Term: Gingivitis
### Intervention Browse Module - Ancestors
- ID: D000002327
- Term: Cariostatic Agents
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M8587
- Name: Fluorides
- Relevance: HIGH
- As Found: Genetic
- ID: M140080
- Name: Listerine
- Relevance: LOW
- As Found: Unknown
- ID: M15771
- Name: Sodium Fluoride
- Relevance: LOW
- As Found: Unknown
- ID: M16759
- Name: Tin Fluorides
- Relevance: HIGH
- As Found: Contour
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000005459
- Term: Fluorides
- ID: D000014002
- Term: Tin Fluorides
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427486
**Brief Title:** Telecoaching Intervention for Children With Autism and Their Parents in Palestine
**Official Title:** Investigating the Potential Efficacy, Feasibility, and Acceptability of Parent Telecoaching Intervention on Children With Autism and Their Parents in Palestine: A Mixed-Method Pilot Randomized Controlled Trial
#### Organization Study ID Info
**ID:** Parent Telecoaching and ASD
#### Organization
**Class:** OTHER
**Full Name:** Arab American University (Palestine)
### Status Module
#### Completion Date
**Date:** 2025-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Arab American University (Palestine)
#### Responsible Party
**Investigator Affiliation:** Arab American University (Palestine)
**Investigator Full Name:** Mohammad Salahat
**Investigator Title:** Instructor/ Head of Speech, Language, and Hearing Disorders Department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In Palestine, children with autism spectrum disorder and their parents face difficulties in receiving needed early intervention and rehabilitation services due to a lack of specialized professionals and centers, as well as cultural, political, geographical, and financial barriers. Parents also face difficulties in raising their children with autism in their homes as they lack knowledge about the disorder and the best interventions that can be used to help these children.
Parent telecoaching intervention, or what is called (distance coaching via technology) can help parents and their children with autism. However, no research exists studying the possibility of using this intervention with parents and their children in Palestine and if it can have positive results on both parents and children.
The goal of this trial is to learn if parent telecoaching intervention is feasible and acceptable to parents of children with autism in Palestine. It will also learn if this intervention has the potential to improve children's skills and increase parent's self-competency and quality of life. The main questions it aims to answer are:
* To what extent and in what ways is providing telecoaching intervention for parents of children with Autism in Palestine possible?
* How do parents see telecoaching intervention in terms of suitability, benefits, facilitators, and barriers?
* Does telecoaching intervention for parents have the potential to increase children's participation in daily activities that parents consider important?
* Does telecoaching intervention have the potential to enhance parents' self-competence and family quality of life? Researchers will compare parent telecoaching intervention to a web-based resource designed to provide parents with general information about autism to see if parent telecoaching intervention works to help children with autism and their parents more than the free autism resources provided on the website.
Participants will:
* Take a telecoaching intervention (eight sessions over eight weeks, each session lasts one hour) or use the information provided on the website about autism.
* Apply the planned strategies with their children during the week and record their work using videos or by filling out a form to be reviewed at the beginning of each session.
**Detailed Description:** A purposive sampling technique will be used to recruit children with Autism Spectrum Disorder and their parents/caregivers who live in the West Bank districts. Two recruitment strategies will be used to invite participants from various districts in the West Bank. The first will involve approaching a third party, the Superhero Autism Foundation, to distribute invitation packages to potential eligible participants based on the provided inclusion and exclusion criteria. This foundation has been chosen as it has access to a vast dataset of children with autism across the West Bank. The second strategy will involve advertising flyers on social media and patient organization websites. Those who wish to participate will be asked to send their signed reply slip form to the trial's author using the contact information provided (email or WhatsApp). After that, they will be contacted by phone to screen their eligibility. Parents who meet the eligibility criteria will be informed that an initial meeting with each one of them will be conducted to explain the purpose of the trial further, check their willingness to be randomized, answer any questions they may have, confirm their consent to participate, agree on the first assessment meeting date and time which will be done before randomization, and discuss the schedule of the subsequent telecoaching sessions.
Sample size: A pilot randomized trial typically does not require a sample power calculation. However, as a rule of thumb, at least 30 participants will be needed for a pilot Randomized Controlled Trial. To address a potential attrition rate of 10%, 40 parent-child dyads (20 in each group) will be recruited.
Randomisation: The study will employ a stratified block randomization method to assign parents to either the telecoaching intervention group or the waitlist control group in a 1:1 ratio. Once baseline assessments are completed with eligible participants who have consented to participate, a screening number will be allocated to each parent, and the child's autism symptoms score will be recorded. This score will be categorized as \<60 or ≥60 using the Autism Treatment Evaluation Checklist. The assigned screening number and the child's autism severity score for each participant will then be sent to a non-study member, a lecturer in the Occupational Therapy Department, who will conduct the allocation and randomization process based on predetermined block sizes of four using a computer-generated random sequence. Stratification will be conducted based on autism severity categorized as \<60 or ≥60. This method is chosen to ensure an equal distribution of participants in each group and to minimize the impact of children's autism severity. The trial author responsible for enrolling participants will not have access to the concealed random allocation sequence. However, due to the nature of the intervention, blinding the treatment assigned to participants will not be feasible. All data from randomized participants will be recorded in a Case Report Form (CRF). Participants will be informed of the randomization outcome via phone contact.
Quantitative Data Analysis:
The Statistical Package for the Social Sciences (SPSS) version 26 will be used to conduct all statistical analyses.
Descriptive statistics will be used to analyze the following:
* Feasibility Criterions (1,3, 4, 6): eligibility, retention, provider intervention fidelity, and adverse event (if it occurs).
* Participants' demographic data will be analysed using percentages, mean, and standard deviation).
* The commonalities among family-specified goals on the Canadian Occupational Performance Measure (COPM).
Inferential statistics (Potential efficacy of Parent telecoaching intervention):
A t-test will be used to examine changes in means from pre-to-post-tests (between and within groups).
Qualitative Analysis (Acceptability, benefits, facilitators and barriers):
The recorded interviews will be analyzed using six iterative steps: (1) familiarization, (2) initial coding, (3) theme identification, (4) theme review, (5) theme definition and naming, and (6) report production. The trial author and a colleague will review and create initial codes, revisit the full transcriptions, and search for themes using the codes. They will meet multiple times to ensure theme names accurately describe the reports.
### Conditions Module
**Conditions:**
- Autism Spectrum Disorder
**Keywords:**
- telecoaching
- Telehealth
- Early intervention
- Quality of life
- parent's self-competency
- Activities of daily living
- occupational performance coaching
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a mixed-method pilot randomized waitlist-controlled trial with two parallel groups: the telecoaching intervention group and the waitlist control group, and semi-structured interviews with intervention participants. The utilization of a waitlist control group enables the comparison of the potential effects of the intervention group with those of a control group while ensuring that parents in the wait-listed control group can have access to telecoaching intervention after the completion of the study. After completing telecoaching sessions, participants from the intervention group will be invited to participate in semi-structured interviews to explore their perceptions about the intervention. The reason for using a mixed method is to achieve a comprehensive understanding of telecoaching intervention (its feasibility, acceptability, and potential efficacy) and to explain findings by connecting information obtained from both designs.
##### Masking Info
**Masking:** NONE
**Masking Description:** The trial author responsible for enrolling participants will not have access to the concealed random allocation sequence. However, due to the nature of the intervention, blinding the treatment assigned to participants will not be feasible.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The telecoaching intervention will consist of eight weekly sessions, lasting between 40 minutes to one hour each, conducted through Zoom. Before the sessions begin, an initial assessment meeting will take place with each parent. The sessions will follow the occupational performance coaching (OPC) processes, which aim to enhance parents' problem-solving skills and promote children's participation. These processes include the Connect, Structure, and Share stages, focusing on active listening, goal-setting, and information exchange between the provider and the parent. A Casenote template will be used to organize these sessions.
**Intervention Names:**
- Other: Parents Telecoaching Intervention
**Label:** Parent Telecoaching Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The Waitlist Control Group Intervention will have access to a web-based Autism resources called "Sanad Al-Haya". This resource provides general information and videos on Autism and how to manage specific needs such as sensory issues, social interaction, and activities of daily living. The resources are developed by the trial author in Arabic language. All participants are required to register on the Sanad platform and create an account in their child's name. If they wish, the waitlist control group will have the option to take parent telecoaching sessions after the intervention group has completed all sessions.
**Label:** Access to a web-based (sanadmed).
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Parent Telecoaching Intervention
**Description:** - Synchronous (Zoom platform) and Asynchronous coaching sessions for parents of children with autism.
**Name:** Parents Telecoaching Intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** is used to help parents identify and prioritize the goals they want their child to achieve in the domains of self-care, productivity, and leisure. The tool involves parents rating each identified goal on a scale of 1 to 10, with 1 indicating that the goal is not important and 10 indicating that it is extremely important. From the list of identified goals, parents select the top five that they want to work on during the intervention. Parents then rate their child's performance and their satisfaction with that performance on a scale of 1 to 10, with 1 indicating that they are not satisfied and 10 indicating that they are extremely satisfied. This helps to measure changes in parents' perception of their child's performance and their satisfaction with that change from pre-test to post-test. The COPM has demonstrated sound psychometric properties with parents of children with disabilities, including construct validity and criterion validity.
**Measure:** Canadian Occupational Performance Measure
**Time Frame:** Baseline, pre-intervention
#### Secondary Outcomes
**Description:** is used to evaluate the quality of life of parents using a 36-item Likert-type scale that measures eight domains (general health, physical role limitation, role limitation arising from emotional issues, physical functioning, vitality, mental health, bodily pain, and social function). The SF-36 questionnaire provides scores ranging from 0 to 100, with higher scores indicating better QoL. The questionnaire has been translated into Arabic, culturally validated, and utilized in research aimed at investigating the QoL of parents of children who have autism.
**Measure:** The 36-Item Short Form Health Survey questionnaire (SF-36)
**Time Frame:** Baseline, pre-intervention
**Description:** This is a 29-item Arabic scale that measures parental competence for children with ASD. Each item has a 5-point rating scale. The scale is used to rate statements based on whether parents agree or disagree with them. A score of 5 is given to "Strongly Agree," while a score of 1 is given to "Strongly Disagree" for positive statements. For negative statements, the score is reversed. The minimum score is 29, while the maximum is 145. The validity of the tool was ensured by specialized staff in education psychology, and the reliability of the tool was tested demonstrating acceptable value (Cronbach Alpha 0.89).
**Measure:** Parental Competence Scale for Children with Autism Spectrum Disorder
**Time Frame:** Baseline, pre-intervention
**Description:** This tool is used to identify the severity of autism and assess the effectiveness of interventions and treatments. It comprises of 77 questions that are divided into four categories: speech/language/communication (14 questions), sociability (20 questions), sensory/cognitive awareness (18 questions), and health/physical/behavior (25 questions). Parents or caregivers are responsible for completing the checklist, and lower scores indicate milder symptoms. The ATEC has been translated into Arabic and validated, revealing good internal consistency (a= 0.84), content validity (90% among referees), and construct validity
**Measure:** Autism Treatment Evaluation Checklist (ATEC)
**Time Frame:** Baseline, pre-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Parents are the primary caregivers spending most of the intervention period with their child
* Parents are at least 18 years old and able to provide informed consent
* Parents have access to mobile devices such as phones, tablets or computers with Zoom software and a stable internet connection
* The children are between the ages of 3 and 6 years old and have a confirmed ASD diagnosis from a psychiatrist or pediatrician.
* Children with ASD and other comorbid conditions are also eligible to participate.
Exclusion Criteria:
* Adolescents and older adults with ASD.
**Maximum Age:** 6 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammad Salahat
**Phone:** 0592345678
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hisham A Arabkabeya, Asst. Prof.
**Phone:** 0595637776
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Arab American University (Palestine)
**Name:** Mohammad Salahat, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x.
**PMID:** 36163045
**Citation:** Dahl-Popolizio S, Carpenter H, Coronado M, Popolizio NJ, Swanson C. Telehealth for the Provision of Occupational Therapy: Reflections on Experiences During the COVID-19 Pandemic. Int J Telerehabil. 2020 Dec 8;12(2):77-92. doi: 10.5195/ijt.2020.6328. Erratum In: Int J Telerehabil. 2021 Jun 22;13(1):e6382.
**PMID:** 33520097
**Citation:** Dunn W, Little LM, Pope E, Wallisch A. Establishing Fidelity of Occupational Performance Coaching. OTJR (Thorofare N J). 2018 Apr;38(2):96-104. doi: 10.1177/1539449217724755. Epub 2017 Aug 18.
**PMID:** 28821218
**Citation:** Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.
**PMID:** 21318011
**Citation:** Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
**PMID:** 27965879
**Citation:** Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.
**PMID:** 29426380
**Citation:** Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
**PMID:** 26092476
**Citation:** Yazdani S, Capuano A, Ghaziuddin M, Colombi C. Exclusion Criteria Used in Early Behavioral Intervention Studies for Young Children with Autism Spectrum Disorder. Brain Sci. 2020 Feb 13;10(2):99. doi: 10.3390/brainsci10020099.
**PMID:** 32069875
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002659
- Term: Child Development Disorders, Pervasive
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4623
- Name: Autistic Disorder
- Relevance: HIGH
- As Found: Autism
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: LOW
- As Found: Unknown
- ID: M5902
- Name: Developmental Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001321
- Term: Autistic Disorder
- ID: D000067877
- Term: Autism Spectrum Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427473
**Brief Title:** Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors
**Official Title:** Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** NYCU113018AE
#### Organization
**Class:** OTHER
**Full Name:** National Yang Ming Chiao Tung University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Yang Ming Chiao Tung University
#### Responsible Party
**Investigator Affiliation:** National Yang Ming Chiao Tung University
**Investigator Full Name:** I-Ching Hou
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health.
**Detailed Description:** \[Research Background\] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management.
\[Research Objectives\] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.
\[Research Method\] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.
\[Expected Results\] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health.
### Conditions Module
**Conditions:**
- Breast Cancer
- Weight Loss
**Keywords:**
- weight management
- breast cancer survivors
- mindfulness
- Food Frequency Questionnaire
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** subjects participate diet, exercise and mindfulness programs
**Intervention Names:**
- Behavioral: Dietary program
- Behavioral: Exercise program
- Behavioral: Mindfulness program
**Label:** DEM model
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** subjects participate diet and exercise programs
**Intervention Names:**
- Behavioral: Dietary program
- Behavioral: Exercise program
**Label:** DE model
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DE model
- DEM model
**Description:** Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.
**Name:** Dietary program
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- DE model
- DEM model
**Description:** Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.
**Name:** Exercise program
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- DEM model
**Description:** Participants will attend 8-week online mindfulness course. In addition to weekly classes, participants practiced mindfulness individually for 5 minutes each day and maintained a mindfulness diary.
**Name:** Mindfulness program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** BMI in kg/m2 (weight in kilograms divided by height in meters squared)
**Measure:** Physiological indicator I
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** Waist circumference in centimeter
**Measure:** Physiological indicator II
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** Body fat in percentage
**Measure:** Physiological indicator III
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** Muscle mass in kilograms
**Measure:** Physiological indicator IV
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** Food Frequency Questionnaire
**Measure:** Food Intake Frequency
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.
**Measure:** Mindful Awareness Attention
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
#### Secondary Outcomes
**Description:** The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.
**Measure:** Weight Efficacy Lifestyle Questionnaire
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** 1. Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
2. Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome.
**Measure:** European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
**Description:** The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
**Measure:** Breast Cancer-Specific Quality of Life Questionnaire
**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* stage I-III breast cancer and completed treatment
* Body mass index (BMI) is greater than or equal to 24 kg/m2
* possess a smartphone
Exclusion Criteria:
* Pregnant or planning to become pregnant within six months
* Those who are unable to walk
**Maximum Age:** 65 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** I-Ching Hou
**Phone:** +886-2-28267315
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yi-Fung Lin
**Phone:** +886-958080852
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** I-Ching Hou
- **Phone:** +886-2-28267315
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** National Yang Ming Chiao Tung University
**Zip:** 112
#### Overall Officials
**Official 1:**
**Affiliation:** National Yang Ming Chiao Tung University
**Name:** Associate Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000001836
- Term: Body Weight Changes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M18102
- Name: Weight Loss
- Relevance: HIGH
- As Found: Weight Loss
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Weight
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5115
- Name: Body Weight Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000001835
- Term: Body Weight
- ID: D000015431
- Term: Weight Loss
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427460
**Brief Title:** Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)
**Official Title:** Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk
#### Organization Study ID Info
**ID:** Changhai Hospital NMU
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-12
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhai Hospital
#### Responsible Party
**Investigator Affiliation:** Changhai Hospital
**Investigator Full Name:** Zhang Huo Jun
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.
**Detailed Description:** Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.
In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
**Keywords:**
- pancreatic cancer
- stereotactic body radiation therapy
- inner gross tumor volume
- central boost
- ablative radiation dose
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 67
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Central-boost ablative doses delivered by SBRT.
**Intervention Names:**
- Radiation: Central-boost ablative dose delivered by stereotactic body radiation therapy
**Label:** stereotactic body radiation therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- stereotactic body radiation therapy
**Description:** An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.
**Name:** Central-boost ablative dose delivered by stereotactic body radiation therapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Measure:** One-year local control will be determined.
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** The time from the enrollment to death.
**Measure:** Overall survival will be determined.
**Time Frame:** 2 years
**Description:** The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Measure:** Progression free survival will be determined.
**Time Frame:** 2 years
**Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
**Measure:** Treatment related adverse events
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18-75 years.
* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
* Oligometastasis in the case of metastatic tumor
* the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
* ECOG of 0 to 1 point
* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
Exclusion Criteria:
* History of radiotherapy for the lesion
* History of tumor within 5 years
* ECOG ≥2 points
* Significant abnormality in blood routine test, liver and kidney function test and coagulation test
* Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
* Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
* Infections required antibiotics
* Heart or respiratory insufficiency
* Pregnant or breastfeeding women
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaofei Zhu
**Phone:** 86-021-31162222
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaofei Zhu
- **Phone:** 86-021-31162222
- **Role:** CONTACT
***Contact 2:***
- **Name:** Huojun Zhang, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Huojun Zhang
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200433
#### Overall Officials
**Official 1:**
**Affiliation:** Changhai Hospital
**Name:** Huojun Zhang, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427447
**Acronym:** ADJUPANC
**Brief Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
**Official Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
#### Organization Study ID Info
**ID:** CH hospital
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-12
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhai Hospital
#### Responsible Party
**Investigator Affiliation:** Changhai Hospital
**Investigator Full Name:** Zhang Huo Jun
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.
**Detailed Description:** Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
**Keywords:**
- pancreatic cancer
- adjuvant chemoradiotherapy
- adjuvant chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 770
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 825mg/m2，bid.
**Intervention Names:**
- Combination Product: Adjuvant chemoradiotherapy
**Label:** adjuvant chemoradiotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
**Intervention Names:**
- Drug: Adjuvant chemotherapy
**Label:** adjuvant chemotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- adjuvant chemoradiotherapy
**Description:** Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
**Name:** Adjuvant chemoradiotherapy
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- adjuvant chemotherapy
**Description:** Chemotherapy (gemcitabine plus capecitabine)
**Name:** Adjuvant chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Measure:** Disease progression free survival will be determined.
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** The time from the randomization to death.
**Measure:** Overall survival will be determined.
**Time Frame:** 3 years
**Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
**Measure:** Treatment-related adverse events will be determined.
**Time Frame:** 3 years
**Description:** The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.
**Measure:** Quality of life will be determined.
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18-75 years
* Pathologically confirmed pancreatic ductal adenocarcinoma
* Pathologically confirmed lymph node metastasis, R1 or R2 resection or perineural or lymphovascular invasion (one of the risk factors)
* No history of cancer treatment after surgical resection
* No disease progression confirmed by imaging examinations
* ECOG 0 to1 point
* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
Exclusion Criteria:
* History of cancer treatment after surgical resection
* History of other cancers within 5 years
* Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
* ECOG ≥2 points
* Significant abnormality in blood routine test, liver and kidney function test and coagulation test
* Active inflammatory bowel disease
* Gastrointestinal bleeding or perforation within 6 months
* Infections requiring antibiotics
* Heart or respirotory insufficiency
* Pregnant women or breastfeeding women
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaofei Zhu
**Phone:** 86-021-31162222
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaofei Zhu, M.D.
- **Phone:** 86-021-31162222
- **Role:** CONTACT
***Contact 2:***
- **Name:** Huojun Zhang, M.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Huojun Zhang
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200433
#### Overall Officials
**Official 1:**
**Affiliation:** Changhai Hospital
**Name:** Huojun Zhang, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2985
- Name: Gemcitabine
- Relevance: LOW
- As Found: Unknown
- ID: M377
- Name: Capecitabine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427434
**Brief Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain
**Official Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women
#### Organization Study ID Info
**ID:** P.T.REC/012/004494
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Mina Nageib Soliman
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.
**Detailed Description:** In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth.
A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise.
Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.
### Conditions Module
**Conditions:**
- Low Back Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants will be asked to perform strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks.
**Intervention Names:**
- Other: Strengthening and stretching exercises to the back and abdominal muscles
**Label:** Strengthening and stretching exercises
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The participants will receive Modified Sustained Natural Apophyseal Glide on the affected lumbar level for 30 sec three times per week for 4 weeks. In addition to strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks
**Intervention Names:**
- Other: Strengthening and stretching exercises to the back and abdominal muscles
- Other: Modified Lumbar Sustained Natural Apophyseal Glide
**Label:** Modified Lumbar Sustained Natural Apophyseal Glide
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Modified Lumbar Sustained Natural Apophyseal Glide
- Strengthening and stretching exercises
**Description:** Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.
**Name:** Strengthening and stretching exercises to the back and abdominal muscles
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Modified Lumbar Sustained Natural Apophyseal Glide
**Description:** Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks.
**Name:** Modified Lumbar Sustained Natural Apophyseal Glide
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The visual analogue scale is a 10 cm calibrated line with 0 representing no pain and 10 representing the worst pain; will be used to assess the severity of pain before and after treatment for all participants in both groups.
**Measure:** Pain intenesity
**Time Frame:** within 4 weeks
**Description:** The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).
**Measure:** Lumbar flexion range of motion
**Time Frame:** within 4 weeks
**Description:** The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position.
The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension.
The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1 cm should be considered abnormal).
**Measure:** Lumbar extension range of motion
**Time Frame:** within 4 weeks
**Description:** The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.
**Measure:** Lumbar lateral flexion range of motion
**Time Frame:** within 4 weeks
#### Secondary Outcomes
**Description:** Functional disability will be assessed by the Oswestry Disability Index, it was developed as a clinical valid and reliable assessment tool that would provide an estimate of disability expressed as a percentage score. It is composed of 10 questions and it takes around 5min for a patient to complete. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, bed-bound. A low score = low degree of disability, a high score = high degree of disability.
**Measure:** Functional disability
**Time Frame:** within 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. All participants will be diagnosed as chronic postnatal low back pain.
2. Their ages will be ranged from 20 to 35 years old.
3. Their body mass index (BMI) will not exceed 30 kg/m2.
4. All participants have the same social level.
5. All participants have the same lifestyle.
6. Their number of parity will be ranged from 2-4 children.
Exclusion Criteria:
1. Spinal fracture or any other neurological disorders.
2. Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
3. Women with BMI \> 30 kg/m2.
4. Participants who had pelvic pathology.
5. Skin disease interferes with mobilization application.
6. Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mina soliman, PHD
**Phone:** 01283605551
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Afaf Botla, Assistant professor
**Phone:** 01283126608
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Cairo University
**Name:** Azza Kassab, professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427421
**Acronym:** CARegT1D
**Brief Title:** Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
**Official Title:** Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
#### Organization Study ID Info
**ID:** APHP230664
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** ID-RCB
**ID:** 2024-A00696-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect
**Detailed Description:** During the development of type 1 diabetes (T1DM), regulatory T cells (Treg) are modified and their protective role is no longer optimal, particularly against pathology-specific autoreactive antigens. The hypothesis is that in patients with T1DM, the function and phenotype of Treg cells, as well as their receptor repertoire for the antigen to which they are specific (TCR), no longer allow them to control tolerance. The in-depth study of these cells, at both genetic and molecular levels, will enable a major breakthrough in our understanding of the pathophysiology of T1DM, and in the development of targeted cell therapy.
The investigators expect major/important differences between patient Tregs and those of the control population in this study, at the molecular, phenotypic and functional levels. These differences will highlight the TCRs recognizing the target self-antigens. In this way, investigators expect to be able to select a limited number of Treg TCRs that could ultimately be used in cell therapy to restore the protective role of Tregs in these patients.
Thus, this knowledge will enable to propose in the future a more effective immunotherapy with a long-term effect, in order to improve the management of patients with autoimmune diabetes and potentially cure them.
Accordingly, yhe investigators will study insulin-specific Tregs in T1DM patients and control individuals, as well as conventional T cells directed against the same antigen, which in patients are implicated in the disease. This will include a study of their functional status, their transcriptomic profile, as well as their TCRs and their fine recognition properties of the major diabetes self-antigen, insulin.
### Conditions Module
**Conditions:**
- Type 1 Diabetes
**Keywords:**
- Type 1 Diabetes
- Regulatory T cells
- Pathophysiology of T1DM
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** children aged 6 to under 18 on the day of inclusion, with a recent diagnosis of type 1 diabetes
**Intervention Names:**
- Biological: Frequency of Treg and Teffs
- Biological: Phenotype of Treg and Teffs
- Biological: RNA seq analysis
- Biological: HLA typing
- Biological: beta-cell autoantibody dosage
**Label:** Newly diagnosed T1DM group
**Type:** OTHER
#### Arm Group 2
**Description:** children aged 6 to under 18 on the day of inclusion, with no history of type 1 diabetes
**Intervention Names:**
- Biological: Frequency of Treg and Teffs
- Biological: Phenotype of Treg and Teffs
- Biological: RNA seq analysis
- Biological: HLA typing
- Biological: beta-cell autoantibody dosage
- Biological: Glycated haemoglobin (HbA1C) dosage
- Biological: blood glucose dosage
- Biological: C-peptide dosage
**Label:** Control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Newly diagnosed T1DM group
**Description:** additionnal blood sampling at inclusion
**Name:** Frequency of Treg and Teffs
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Control group
- Newly diagnosed T1DM group
**Description:** additionnal blood sampling at inclusion
**Name:** Phenotype of Treg and Teffs
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- Control group
- Newly diagnosed T1DM group
**Description:** additionnal blood sampling at inclusion
**Name:** RNA seq analysis
**Type:** BIOLOGICAL
#### Intervention 4
**Arm Group Labels:**
- Control group
- Newly diagnosed T1DM group
**Description:** additionnal blood sampling at inclusion
**Name:** HLA typing
**Type:** BIOLOGICAL
#### Intervention 5
**Arm Group Labels:**
- Control group
- Newly diagnosed T1DM group
**Description:** additionnal blood sampling at inclusion
**Name:** beta-cell autoantibody dosage
**Type:** BIOLOGICAL
#### Intervention 6
**Arm Group Labels:**
- Control group
**Description:** additionnal blood sampling at inclusion
**Name:** Glycated haemoglobin (HbA1C) dosage
**Type:** BIOLOGICAL
#### Intervention 7
**Arm Group Labels:**
- Control group
**Description:** additionnal blood sampling at inclusion
**Name:** blood glucose dosage
**Type:** BIOLOGICAL
#### Intervention 8
**Arm Group Labels:**
- Control group
**Description:** additionnal blood sampling at inclusion
**Name:** C-peptide dosage
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** study the frequency and phenotype of insulin-specific autoreactive Tregs lymphocytes among CD4+ T lymphocytes in children with T1DM and compare these values with those of controls. These parameters will be analyzed by flow cytometry using immune cells from blood samples taken from the T1DM and control groups.
**Measure:** Frequency and phenotype of Tregs
**Time Frame:** Within 4 weeks of T1DM diagnosis
#### Secondary Outcomes
**Description:** Description : the HLA of T1DM and controls will be analyzed by qPCR. This will make it possible to associate the results obtained during the analysis of the main criteria with the HLA of each individual.
**Measure:** HLA testing
**Time Frame:** Within 4 weeks of T1DM diagnosis
**Description:** Insulin-specific Tregs and Teffs cells will be isolated by flow cytometry
**Measure:** Isolate insulin-specific Tregs and Teffs cells
**Time Frame:** Within 4 weeks of T1DM diagnosis
**Description:** their transcriptome and TCR will be determined by single-cell transcriptomics analysis (scRNAseq).
**Measure:** Treg and Teffs transcriptome
**Time Frame:** Within 4 weeks of T1DM diagnosis
**Description:** Following flow cytometry, the different repertoires will be compared between the DT1 and control groups.
**Measure:** Full TCR repertoire of Tregs and Teffs
**Time Frame:** Within 4 weeks of T1DM diagnosis
**Description:** Machine learning analysis of the data obtained (TCR, transcriptome, frequency and phenotype of insulin-specific Tregs and Teffs) to predict the relationship between TCR and functional properties of Tregs and Teffs in patients and controls
**Measure:** Machine learning analysis
**Time Frame:** Within 4 weeks of T1DM diagnosis
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Newly diagnosed T1DM group:
* Age ≥ 6 years and \< 18 years on day of inclusion;
* Weight ≥ 12 kg;
* Newly diagnosed T1DM, diagnosis defined according to International Society of Pediatric and Adolescent Diabetes (ISPAD) criteria by: hyperglycemia \> 2g/L and/or ketonemia and/or polyuro-polydipsia and/or weight loss ;
* Absence of other associated inflammatory or autoimmune diseases;
* Affiliation with a health insurance scheme or beneficiary (excluding AME);
* Written consent of parental guardians;
* Ability to understand and read French.
Control group :
* Age ≥ 6 years and \< 18 years on the day of inclusion;
* Weight ≥ 12 kg;
* No personal history of T1DM;
* Affiliation with a health insurance scheme or entitled person (excluding AME);
* Written consent from parental guardians;
* Ability to understand and read French.
Exclusion Criteria:
Newly diagnosed T1DM group:
* Use of corticosteroids in the month prior to blood sampling
* Contraindication to the use of anaesthetic cream for blood sampling.
Control group :
* History of autoimmune or inflammatory disease
* Use of corticosteroids in the month preceding blood sampling
* Contraindication to the use of anaesthetic cream for blood sampling
**Maximum Age:** 18 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jacques BELTRAND, MD, PhD
**Phone:** +33 1 40 61 53 20
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Laure CHOUPEAUX, MSc
**Phone:** + 33 1 44 38 17 11
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jacques BELTRAND, MD, PhD
- **Phone:** +33 1 40 61 53 20
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Laure CHOUPEAUX, MSc
- **Phone:** + 33 1 44 38 17 11
- **Role:** CONTACT
***Contact 3:***
- **Name:** Jacques BELTRAND, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Hôpital Necker Enfants Malades
**Zip:** 75015
#### Overall Officials
**Official 1:**
**Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France
**Name:** Simon FILATREAU, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Patterson CC, Harjutsalo V, Rosenbauer J, Neu A, Cinek O, Skrivarhaug T, Rami-Merhar B, Soltesz G, Svensson J, Parslow RC, Castell C, Schoenle EJ, Bingley PJ, Dahlquist G, Jarosz-Chobot PK, Marciulionyte D, Roche EF, Rothe U, Bratina N, Ionescu-Tirgoviste C, Weets I, Kocova M, Cherubini V, Rojnic Putarek N, deBeaufort CE, Samardzic M, Green A. Trends and cyclical variation in the incidence of childhood type 1 diabetes in 26 European centres in the 25 year period 1989-2013: a multicentre prospective registration study. Diabetologia. 2019 Mar;62(3):408-417. doi: 10.1007/s00125-018-4763-3. Epub 2018 Nov 28.
**PMID:** 30483858
**Citation:** Mobasseri M, Shirmohammadi M, Amiri T, Vahed N, Hosseini Fard H, Ghojazadeh M. Prevalence and incidence of type 1 diabetes in the world: a systematic review and meta-analysis. Health Promot Perspect. 2020 Mar 30;10(2):98-115. doi: 10.34172/hpp.2020.18. eCollection 2020.
**PMID:** 32296622
**Citation:** Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18. Erratum In: Diabetes Technol Ther. 2019 Apr;21(4):230.
**PMID:** 30657336
**Citation:** Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
**PMID:** 25998289
**Citation:** Bougneres PF, Carel JC, Castano L, Boitard C, Gardin JP, Landais P, Hors J, Mihatsch MJ, Paillard M, Chaussain JL, et al. Factors associated with early remission of type I diabetes in children treated with cyclosporine. N Engl J Med. 1988 Mar 17;318(11):663-70. doi: 10.1056/NEJM198803173181103.
**PMID:** 3125434
**Citation:** Parving HH, Tarnow L, Nielsen FS, Rossing P, Mandrup-Poulsen T, Osterby R, Nerup J. Cyclosporine nephrotoxicity in type 1 diabetic patients. A 7-year follow-up study. Diabetes Care. 1999 Mar;22(3):478-83. doi: 10.2337/diacare.22.3.478.
**PMID:** 10097932
**Citation:** Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ; Type 1 Diabetes TrialNet Study Group. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. doi: 10.1056/NEJMoa1902226. Epub 2019 Jun 9. Erratum In: N Engl J Med. 2020 Feb 6;382(6):586.
**PMID:** 31180194
**Citation:** Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980.
**PMID:** 15972866
**Citation:** Vignali DA, Collison LW, Workman CJ. How regulatory T cells work. Nat Rev Immunol. 2008 Jul;8(7):523-32. doi: 10.1038/nri2343.
**PMID:** 18566595
**Citation:** Corthay A. How do regulatory T cells work? Scand J Immunol. 2009 Oct;70(4):326-36. doi: 10.1111/j.1365-3083.2009.02308.x.
**PMID:** 19751267
**Citation:** Visperas A, Vignali DA. Are Regulatory T Cells Defective in Type 1 Diabetes and Can We Fix Them? J Immunol. 2016 Nov 15;197(10):3762-3770. doi: 10.4049/jimmunol.1601118.
**PMID:** 27815439
**Citation:** Bluestone JA, Buckner JH, Fitch M, Gitelman SE, Gupta S, Hellerstein MK, Herold KC, Lares A, Lee MR, Li K, Liu W, Long SA, Masiello LM, Nguyen V, Putnam AL, Rieck M, Sayre PH, Tang Q. Type 1 diabetes immunotherapy using polyclonal regulatory T cells. Sci Transl Med. 2015 Nov 25;7(315):315ra189. doi: 10.1126/scitranslmed.aad4134.
**PMID:** 26606968
**Citation:** Marek-Trzonkowska N, Mysliwiec M, Dobyszuk A, Grabowska M, Techmanska I, Juscinska J, Wujtewicz MA, Witkowski P, Mlynarski W, Balcerska A, Mysliwska J, Trzonkowski P. Administration of CD4+CD25highCD127- regulatory T cells preserves beta-cell function in type 1 diabetes in children. Diabetes Care. 2012 Sep;35(9):1817-20. doi: 10.2337/dc12-0038. Epub 2012 Jun 20.
**PMID:** 22723342
**Citation:** Dong S, Hiam-Galvez KJ, Mowery CT, Herold KC, Gitelman SE, Esensten JH, Liu W, Lares AP, Leinbach AS, Lee M, Nguyen V, Tamaki SJ, Tamaki W, Tamaki CM, Mehdizadeh M, Putnam AL, Spitzer MH, Ye CJ, Tang Q, Bluestone JA. The effect of low-dose IL-2 and Treg adoptive cell therapy in patients with type 1 diabetes. JCI Insight. 2021 Sep 22;6(18):e147474. doi: 10.1172/jci.insight.147474.
**PMID:** 34324441
**Citation:** Kieback E, Hilgenberg E, Stervbo U, Lampropoulou V, Shen P, Bunse M, Jaimes Y, Boudinot P, Radbruch A, Klemm U, Kuhl AA, Liblau R, Hoevelmeyer N, Anderton SM, Uckert W, Fillatreau S. Thymus-Derived Regulatory T Cells Are Positively Selected on Natural Self-Antigen through Cognate Interactions of High Functional Avidity. Immunity. 2016 May 17;44(5):1114-26. doi: 10.1016/j.immuni.2016.04.018.
**PMID:** 27192577
**Citation:** Krischer JP; Type 1 Diabetes TrialNet Study Group. The use of intermediate endpoints in the design of type 1 diabetes prevention trials. Diabetologia. 2013 Sep;56(9):1919-24. doi: 10.1007/s00125-013-2960-7. Epub 2013 Jun 7.
**PMID:** 23744306
**Citation:** Noble JA. Immunogenetics of type 1 diabetes: A comprehensive review. J Autoimmun. 2015 Nov;64:101-12. doi: 10.1016/j.jaut.2015.07.014. Epub 2015 Aug 10.
**PMID:** 26272854
**Citation:** Caillat-Zucman S, Garchon HJ, Timsit J, Assan R, Boitard C, Djilali-Saiah I, Bougneres P, Bach JF. Age-dependent HLA genetic heterogeneity of type 1 insulin-dependent diabetes mellitus. J Clin Invest. 1992 Dec;90(6):2242-50. doi: 10.1172/JCI116110.
**PMID:** 1469084
#### See Also Links
**Label:** Related Info
**URL:** https://diabetesatlas.org/data/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000007155
- Term: Immunologic Factors
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M207501
- Name: Chrysarobin
- Relevance: HIGH
- As Found: Palate
- ID: M4625
- Name: Autoantibodies
- Relevance: HIGH
- As Found: Loncastuximab Tesirine
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000013883
- Term: Chrysarobin
- ID: D000001323
- Term: Autoantibodies
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427408
**Acronym:** VilliRNAseq
**Brief Title:** Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level
**Official Title:** Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy
#### Organization Study ID Info
**ID:** APHP240045
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** France : Ministry of Health
**ID:** 2022-A02452-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)
**Detailed Description:** Chorionic villus biopsies are routinely performed between 11SA and 15SA at the Fetal Medicine Unit́ of the Port-Royal Maternity Hospital (CPDPN Cochin) after the patient has signed an information and consent form for the genetic analysis.
The patient will be asked to participate to the VilliRNAseq project and will sign the consent form of the study. After the cytogeneticist observation, a villi fragment will be snap-frozen in liquid nitrogen and stored at -80°C until use. Each patient sampled in the first trimester is followed until the end of the pregnancy. At delivery, cesarean section or vaginal delivery, a placental sample will be snap-frozen in liquid nitrogen and stored at -80°C until use.
Isolation, sorting and encapsidation of nuclei, RNA libraries preparation and sequencing will be carried out using 10x Genomics technology. State-of-the-art computational analyses to decipher trajectories and cell-to-cell communications.
### Conditions Module
**Conditions:**
- Pregnancy Related
**Keywords:**
- Placenta
- Single nuclei RNA-seq
- Preeclampsia
- Pregnancy outcomes
### Design Module
#### Bio Spec
**Description:** Placental tissue
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach
**Intervention Names:**
- Other: Non applicable
**Label:** Villi RNASeq
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Villi RNASeq
**Description:** Placental transcriptomic analysis
**Name:** Non applicable
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
**Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta
**Time Frame:** Day 0
**Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
**Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta
**Time Frame:** At childbirth
#### Secondary Outcomes
**Measure:** Collection of placental samples
**Time Frame:** Day 0
**Measure:** Collection of placental samples
**Time Frame:** At childbirth
**Description:** Pre-eclampsia, growth retardation in utero, delivery before 37 SA
**Measure:** Identification of early markers of pregnancy complications
**Time Frame:** Until at Childbirth
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 to 50
* Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea
* Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics
* Patient scheduled for delivery at Port-Royal Maternity Hospital
Exclusion Criteria:
* Minor patient
* Multiple pregnancy
* Patient's objection
* Without health insurance
* Patient under guardianship or curatorship
**Gender Based:** True
**Gender Description:** Pregnancy
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vassilis TSATSARIS, MD PHD
**Phone:** 00331 58 41 38 71
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Marie BENHAMMANI-GODARD
**Phone:** 0033158411190
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Hélène COLLINOT, MD
- **Phone:** 0033 1 58 41 38 19
- **Role:** CONTACT
**Country:** France
**Facility:** Maternité Port-Royal, Cochin hospital
**State:** IDF
**Zip:** 75014
#### Overall Officials
**Official 1:**
**Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France
**Name:** Céline MÉHATS, PHD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** APHP
**Name:** Hélène COLLINOT, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427395
**Brief Title:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
**Official Title:** A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)
#### Organization Study ID Info
**ID:** SARO.23.002
#### Organization
**Class:** INDUSTRY
**Full Name:** Zydus Therapeutics Inc.
### Status Module
#### Completion Date
**Date:** 2027-07-18
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-04-18
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Zydus Therapeutics Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
**Detailed Description:** A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)
### Conditions Module
**Conditions:**
- Primary Biliary Cholangitis
**Keywords:**
- Saroglitazar Magnesium
- Primary Biliary Cholangitis
- PBC
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Multicenter, Open-Label, phase III, safety and efficacy study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
**Intervention Names:**
- Drug: Saroglitazar Magnesium 1 mg
**Label:** Saroglitazar Magnesium 1 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Saroglitazar Magnesium 1 mg
**Description:** Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program
**Name:** Saroglitazar Magnesium 1 mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
**Time Frame:** From baseline to 24 Months/EOT
#### Secondary Outcomes
**Description:** ALP \< 1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN relative to baseline in participants with known Gilbert's syndrome
**Measure:** Proportion of participants achieving biochemical response based on the composite endpoints of ALP and total bilirubin
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** complete normalization of ALP. Change and percent change from baseline in ALP
**Measure:** Proportion of participants with biochemical response based on the composite endpoints of ALP and total bilirubin
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Defined as new onset or recurrence of any of the following:
* Hospitalization for new onset or recurrence of variceal bleed
* Hepatic encephalopathy (as defined by a West Haven score ≥2)
* New onset ascites requiring treatment
* Refractory ascites (requiring large volume paracentesis)
* Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
**Measure:** Time to occurrence of the clinical outcome events in study participants with PBC
**Time Frame:** From baseline to 24 Months/EOT
**Description:** Time from enrolment to the first occurrence of Model for End Stage Liver Disease 3.0 score ≥ 15 and 25% increase from baseline as measured on 2 consecutive occasions performed at least two weeks apart with no competing etiologies identified
**Measure:** Time to occurrence of the clinical outcome events based on Model for End Stage Liver Disease 3.0 score
**Time Frame:** From baseline to 24 Months/EOT
**Measure:** Time to first occurrence of Liver transplant or placement on a liver transplant list
**Time Frame:** From baseline to 24 Months/EOT
**Description:** Death (liver and non-liver related)
**Measure:** Time to the occurrence of Death
**Time Frame:** From baseline to 24 Months/EOT
**Description:** Change from baseline in ALT
**Measure:** Effect on liver enzyme parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in AST
**Measure:** Effect on liver enzyme parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in GGT
**Measure:** Effect on liver enzyme parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in total bilirubin
**Measure:** Effect on liver enzyme parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in TG
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in LDL-C
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in HDL-C
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in VLDL-C
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in total cholesterol
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in non-HDL-C
**Measure:** Effect on lipid parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in serum bile acids
**Measure:** Effect on liver enzyme parameters
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in quality of life (PBC 40) questionnaire domains
**Measure:** Effect on disease-related symptoms
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in 5-D itch scale
**Measure:** Effect on disease-related symptoms
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in Worst Itch NRS scores
**Measure:** Effect on disease-related symptoms
**Time Frame:** From baseline to Months 12 and 24/EOT
**Description:** Change from baseline in LSM assessed by Liver elastography/FibroScan
**Measure:** Effect on liver stiffness measurement (LSM) assessed by Liver elastography/FibroScan
**Time Frame:** From baseline to Months 12 and 24/EOT
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Must provide written informed consent and agree to comply with the trial protocol
2. Participated and completed SARO.21.001, the double-blind treatment phase study
Exclusion Criteria:
1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
2. Participants with MELD 3.0 score of 15 or greater
3. History or presence of other concomitant liver diseases at screening:
1. Chronic hepatitis B or C virus (HBV, HCV) infection
2. Primary sclerosing cholangitis (PSC)
3. Alcoholic liver disease
4. Autoimmune hepatitis (AIH)-PBC overlap syndrome
5. Hemochromatosis
6. Non-alcoholic steatohepatitis (NASH) on historical biopsy
4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening.
5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
6. Use of Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)
7. History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT
8. Unstable cardiovascular disease, including:
1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period
2. History/current unstable cardiac dysrhythmias
3. Uncontrolled hypertension at screening
4. Stroke or transient ischemic attack in the 24 weeks before screening
9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
10. An uncontrolled thyroid disorder
1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening
2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening
11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
12. Any of the following laboratory values:
1. Total bilirubin \> 3 x ULN
2. Platelets \< 50 × 103/mL
3. Albumin \< 2.8 g/dL
4. eGFR \< 45 mL/min/1.73 m2
5. ALT or AST \> 250 U/L x ULN
6. ALP \> 10 × ULN
13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening
14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening)
15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients
16. Pregnancy-related exclusions, including:
1. Pregnant/lactating female (including positive pregnancy test at screening)
2. Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance.
17. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)
18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Farheen Shaikh
**Phone:** 609-730-1900
**Phone Ext:** 221
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Deven Parmar
**Phone:** 609-559-0765
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Name:** Haley Sanford
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US007
**State:** Alabama
**Zip:** 35294
**Location 2:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Name:** Nirosha Tilakaratna
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US013
**State:** California
**Zip:** 90048
**Location 3:**
**City:** Pasadena
**Contacts:**
***Contact 1:***
- **Name:** Ariadne Cabrera
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US011
**State:** California
**Zip:** 91105
**Location 4:**
**City:** Sacramento
**Contacts:**
***Contact 1:***
- **Name:** Jerica Golez
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US043
**State:** California
**Zip:** 95817
**Location 5:**
**City:** Aurora
**Contacts:**
***Contact 1:***
- **Name:** Allison Kuehn
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US022
**State:** Colorado
**Zip:** 80045
**Location 6:**
**City:** New Haven
**Contacts:**
***Contact 1:***
- **Name:** Suzie Christopher
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US037
**State:** Connecticut
**Zip:** 06520
**Location 7:**
**City:** Jacksonville
**Contacts:**
***Contact 1:***
- **Name:** Reagan Dukes
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US027
**State:** Florida
**Zip:** 32082
**Location 8:**
**City:** Lakewood Ranch
**Contacts:**
***Contact 1:***
- **Name:** Mandy Burdine
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US006
**State:** Florida
**Zip:** 34211
**Location 9:**
**City:** Miami
**Contacts:**
***Contact 1:***
- **Name:** Kenia Moreno
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US005
**State:** Florida
**Zip:** 33136
**Location 10:**
**City:** Marietta
**Contacts:**
***Contact 1:***
- **Name:** Lynn Bauch
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US020
**State:** Georgia
**Zip:** 30060
**Location 11:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Name:** Mandy Cruz
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US001
**State:** Indiana
**Zip:** 46202
**Location 12:**
**City:** Rochester
**Contacts:**
***Contact 1:***
- **Name:** Mitch Clayton
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US023
**State:** Minnesota
**Zip:** 55905
**Location 13:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Name:** Andrea Riemenschneider
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US030
**State:** Missouri
**Zip:** 63104
**Location 14:**
**City:** Omaha
**Contacts:**
***Contact 1:***
- **Name:** Carol Carney
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US024
**State:** Nebraska
**Zip:** 68198
**Location 15:**
**City:** Rochester
**Contacts:**
***Contact 1:***
- **Name:** Chelsea DiBella
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US035
**State:** New York
**Zip:** 14642
**Location 16:**
**City:** Charlotte
**Contacts:**
***Contact 1:***
- **Name:** Marina Sycheva
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US002
**State:** North Carolina
**Zip:** 28204
**Location 17:**
**City:** Cincinnati
**Contacts:**
***Contact 1:***
- **Name:** Lori Ankney
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US014
**State:** Ohio
**Zip:** 55905
**Location 18:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Name:** Stacey Carmody
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US015
**State:** Pennsylvania
**Zip:** 19141
**Location 19:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Name:** Sali Albarouk
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US004
**State:** Texas
**Zip:** 77030
**Location 20:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Name:** DeShara Emerson
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US042
**State:** Texas
**Zip:** 77030
**Location 21:**
**City:** Murray
**Contacts:**
***Contact 1:***
- **Name:** Anika Unsworth
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US031
**State:** Utah
**Zip:** 84107
**Location 22:**
**City:** Charlottesville
**Contacts:**
***Contact 1:***
- **Name:** Holly McComb
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US016
**State:** Virginia
**Zip:** 22908
**Location 23:**
**City:** Richmond
**Contacts:**
***Contact 1:***
- **Name:** Caitlin Hurst
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US039
**State:** Virginia
**Zip:** 23219
**Location 24:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Name:** Teresa Collins
- **Role:** CONTACT
**Country:** United States
**Facility:** Zydus US033
**State:** Washington
**Zip:** 98105
**Location 25:**
**City:** Ciudad Autónoma de Buenos Aires
**Contacts:**
***Contact 1:***
- **Name:** Ignacio Lucero
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR007
**State:** Buenos Aires
**Zip:** 1199
**Location 26:**
**City:** Ciudad Autónoma de Buenos Aires
**Contacts:**
***Contact 1:***
- **Name:** Karina Barroso
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR006
**State:** Buenos Aires
**Zip:** 1405
**Location 27:**
**City:** Ciudad Autónoma de Buenos Aires
**Contacts:**
***Contact 1:***
- **Name:** Ailén Sparnocchia
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR001
**State:** Buenos Aires
**Zip:** 1640
**Location 28:**
**City:** Ciudad Autónoma de Buenos Aires
**Contacts:**
***Contact 1:***
- **Name:** Verónica Martinez
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR005
**State:** Buenos Aires
**Zip:** 2345
**Location 29:**
**City:** Ciudad Autónoma de Buenos Aires
**Contacts:**
***Contact 1:***
- **Name:** Belen Umina
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR003
**State:** Buenos Aires
**Zip:** 4693
**Location 30:**
**City:** Mar del Plata
**Contacts:**
***Contact 1:***
- **Name:** Ariana Balcarce
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR009
**State:** Buenos Aires
**Zip:** 7600
**Location 31:**
**City:** Pilar
**Contacts:**
***Contact 1:***
- **Name:** Gabriela Marinsalta
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR004
**State:** Buenos Aires
**Zip:** 1500
**Location 32:**
**City:** Rosario
**Contacts:**
***Contact 1:***
- **Name:** Gabriela Juaristi
- **Role:** CONTACT
**Country:** Argentina
**Facility:** Zydus AR010
**State:** Santa Fe
**Zip:** 2000
**Location 33:**
**City:** Adana
**Contacts:**
***Contact 1:***
- **Name:** Asya Cıblakbas
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR014
**Zip:** 236
**Location 34:**
**City:** Altındag
**Contacts:**
***Contact 1:***
- **Name:** Müge Demirsu
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR016
**Location 35:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Name:** Pınar Anul
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR004
**Zip:** 1604
**Location 36:**
**City:** Bursa
**Contacts:**
***Contact 1:***
- **Name:** Merve Karatas
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR005
**Zip:** 16059
**Location 37:**
**City:** Cebeci
**Contacts:**
***Contact 1:***
- **Name:** Melike Zeynep Ciftci
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR017
**Location 38:**
**City:** Gaziantep
**Contacts:**
***Contact 1:***
- **Name:** Selin Büdeyri Sayın
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR008
**Zip:** 27080
**Location 39:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Aybüke Mutaflar Peksert
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR009
**Zip:** 34093
**Location 40:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Sevval Ceren Asi
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR001
**Zip:** 34899
**Location 41:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Kubra Karacaoglu
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR003
**Zip:** 36764
**Location 42:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Aybüke Mutaflar Peksert
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR010
**Location 43:**
**City:** Izmir
**Contacts:**
***Contact 1:***
- **Name:** Gizem Gunyer
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR002
**Zip:** 06230
**Location 44:**
**City:** Izmir
**Contacts:**
***Contact 1:***
- **Name:** Buket Uzun
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR013
**Location 45:**
**City:** Kocaeli
**Contacts:**
***Contact 1:***
- **Name:** Dunya Avcilar
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR011
**Zip:** 41110
**Location 46:**
**City:** Melikgazi
**Contacts:**
***Contact 1:***
- **Name:** Banu Çiçek Yakışan
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR015
**Location 47:**
**City:** Mersin
**Contacts:**
***Contact 1:***
- **Name:** Didem Balci
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Zydus TR006
**Zip:** 33079
#### Overall Officials
**Official 1:**
**Affiliation:** Zydus Therapeutics Inc.
**Name:** Deven Parmar
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000002780
- Term: Cholestasis, Intrahepatic
- ID: D000002779
- Term: Cholestasis
- ID: D000008107
- Term: Liver Diseases
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000005355
- Term: Fibrosis
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6002
- Name: Cholangitis
- Relevance: HIGH
- As Found: Cholangitis
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: LOW
- As Found: Unknown
- ID: M11105
- Name: Liver Cirrhosis, Biliary
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6019
- Name: Cholestasis
- Relevance: LOW
- As Found: Unknown
- ID: M6020
- Name: Cholestasis, Intrahepatic
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: T4683
- Name: Primary Biliary Cholangitis
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
### Condition Browse Module - Meshes
- ID: D000002761
- Term: Cholangitis
- ID: D000008105
- Term: Liver Cirrhosis, Biliary
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427382
**Brief Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
**Official Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
#### Organization Study ID Info
**ID:** perfusion index
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ankara City Hospital Bilkent
#### Responsible Party
**Investigator Affiliation:** Ankara Yildirim Beyazıt University
**Investigator Full Name:** Fatma Kavak Akelma
**Investigator Title:** anesthesiology and reanimation associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** It is aimed to investigate whether perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in young patients.
**Detailed Description:** In orthopedic lower extremity surgeries, spinal anesthesia is a preferred method of anesthesia compared to general anesthesia. Spinal anesthesia may cause severe hypotension and adverse effects in the patient due to pharmacologic sympathectomy. Especially elderly patients and patients with comorbid diseases are at risk. Hypoperfusion and vasopressor drugs to be used in treatment may lead to adverse effects.
Perfusion index is calculated as the ratio non-pulsatile to pulsatile flow in peripheral capillary blood flow. Perfusion index is a non-invasive method that provides insight into the dynamics of vascular tone using pulse oximetry. It can be used to evaluate perfusion dynamics due to changes in peripheral vascular tone and to detect the possibility of developing hypotension following spinal anesthesia. There is insufficient data to evaluate whether PI is a marker of hypotension after spinal anesthesia in older patients compared to younger patients. The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as young patients.
Preoperative demographic data of the patients, preoperative heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressures, and peripheral oxygen saturations will be measured and noted. For the initial perfusion index (PI) value, PI measurements will be taken 3 times at a few minute intervals with a noninvasive probe attached to the finger, and the average will be recorded as the initial PI value. Spinal anesthesia will be applied by injecting an appropriate dose of 0.5% hyperbaric bupivacaine intrathecally, depending on the patient's structure and the type of surgery, to ensure adequate sensory and motor blockade. The patient will be immediately placed in the supine position. After the appropriate period, the level of sensory blockade will be evaluated. Heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressure, peripheral oxygen saturation, and perfusion index will be recorded. Hypotension after spinal anesthesia will be defined as systolic blood pressure less than 90 mmHg, systolic blood pressure decrease by more than 25% from the preoperative baseline value, or average blood pressure less than 60 mmHg. Patients under the age of 60 or over the age of 60 who will undergo lower extremity surgery under spinal anesthesia will be evaluated in two groups. It will be examined whether there are differences between the groups in terms of demographic data (age, gender, comorbidity, etc.) and perfusion index.
The study's primary outcome is to investigate whether PI values have a predictive value in predicting post-spinal hypotension between the two groups and, if so, whether there is a statistically significant difference.
The secondary outcome is to evaluate whether the perfusion index can be used to predict spine-induced hypotension in orthopedic lower extremity surgery.
### Conditions Module
**Conditions:**
- Anesthesia, Spinal
**Keywords:**
- spinal anesthesia
- perfusion index
- orthopedic surgery
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients aged 65 years and older
**Intervention Names:**
- Device: Perfusion index
**Label:** group 1 (age > 65 years)
#### Arm Group 2
**Description:** Patients aged 18 to 65 years
**Intervention Names:**
- Device: Perfusion index
**Label:** group 2 (age < 65 years)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group 1 (age > 65 years)
- group 2 (age < 65 years)
**Description:** Perfusion index determination using non-invasive pulse oximetry
**Name:** Perfusion index
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Determine a threshold for baseline PI value using logistic regression analysis to predict hypotension after spinal anesthesia
**Measure:** Perfusion index age difference
**Time Frame:** 1 hours
#### Secondary Outcomes
**Description:** Determining baseline perfusion index threshold to predict possible hypotension after spinal anesthesia
**Measure:** Perfusion index cut-off point
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** Systolic blood pressure
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** Diastolic blood pressure
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** Mean arterial pressure
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** Hearth Rate
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** perfusion index
**Time Frame:** 1 hours
**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
**Measure:** oxygen saturation(SpO2)
**Time Frame:** 1 hours
**Description:** time to reach the bromage 3 score
**Measure:** bromage score
**Time Frame:** 1 hours
**Description:** time to reach t10 dermatome level
**Measure:** T10 dermatome
**Time Frame:** 1 hours
**Description:** the highest dermatome level achieved with spinal anesthesia
**Measure:** dermatomal level
**Time Frame:** 1 hours
**Description:** ephedrine use
**Measure:** use ephedrine
**Time Frame:** 24 hours
**Description:** To study side effects between 2 groups
**Measure:** side effects
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* American Society of Anesthesiologists (ASA) I-II-III physical status
* patients planned for effective lower extremity surgery in the supine position
* age \>18 years
Exclusion Criteria:
* Known cardiac abnormalities (left ventricular ejection fraction \<50% or decompensated heart failure, heart block, arrhythmia)
* uncontrolled hypertension
* hyperthyroidism
* monoamine oxidase inhibitor use
* chronic beta-blocker or digoxin therapy
* severe arrhythmia
* peripheral arterial disease
* history of glaucoma
* hepatic cell failure
* renal failure
* local anesthetic allergy
* contraindications for spinal anesthesia
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients admitted to ankara city hospital for lower extremity surgery in supine position
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fatma K Akelma
**Phone:** 05327079113
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10072
- Name: Hypotension
- Relevance: HIGH
- As Found: Hypotension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007022
- Term: Hypotension
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427369
**Brief Title:** An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
**Official Title:** Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
#### Organization Study ID Info
**ID:** I -1774023
#### Organization
**Class:** OTHER
**Full Name:** Roswell Park Cancer Institute
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Roswell Park Cancer Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.
SECONDARY OBJECTIVES:
I. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11.
II. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET.
III. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms.
OUTLINE:
Patients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.
After completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.
### Conditions Module
**Conditions:**
- Extensive-stage Small-cell Lung Cancer
- Limited-stage Small-cell Lung Cancer
- Lung Non-Small Cell Carcinoma
- Stage IIIA Lung Cancer
- Stage IV Lung Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive 124I-hJAA-F11 IV on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.
**Intervention Names:**
- Other: Radioconjugate
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan
- Procedure: Biospecimen Collection
**Label:** Diagnostic
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnostic
**Description:** 1241-hJAA-F11 IV administration
**Name:** Radioconjugate
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Diagnostic
**Description:** PET/CT Imaging
**Name:** Positron Emission Tomography
**Other Names:**
- PET
- PET SCAN
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Diagnostic
**Description:** PET/CT Imaging
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Diagnostic
**Description:** FDG PET/CT Imaging
**Name:** FDG-Positron Emission Tomography and Computed Tomography Scan
**Other Names:**
- FDG PET/CT
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Diagnostic
**Description:** Blood sample collection imaging
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
**Measure:** Incidence of grade 3+ I-hJAA-F11 related adverse events
**Time Frame:** Up to 6 months after final PET/CT
**Description:** uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained.
**Measure:** Diagnostic efficacy of I-hJAA-F11
**Time Frame:** Within 30 days of final I/hJAA-f11 PET/CT
#### Secondary Outcomes
**Measure:** Development of anti-drug antibodies
**Time Frame:** Up to approximately 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee \[AJCC\] 8th edition)
* Patients undergoing FDG-PET scan as standard of care testing.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Exclusion Criteria:
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing female participants
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ASK RPCI
**Phone:** 1-877-275-7724
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Roswell Park Comprehensive Cancer Center
**Name:** Grace Dy, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Lung Non-Small Cell Carcinoma
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M28323
- Name: Small Cell Lung Carcinoma
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T5271
- Name: Small Cell Lung Cancer
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000055752
- Term: Small Cell Lung Carcinoma
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427356
**Brief Title:** PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial
**Official Title:** PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic
#### Organization Study ID Info
**ID:** REC 0004
#### Organization
**Class:** FED
**Full Name:** Salem Veterans Affairs Medical Center
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** Durham VA Health Care System
**Class:** UNKNOWN
**Name:** VISN 6 MIRECC
**Class:** UNKNOWN
**Name:** Bedford VA Health Care System
**Class:** OTHER
**Name:** Stanford University
#### Lead Sponsor
**Class:** FED
**Name:** Salem Veterans Affairs Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to \[primary purpose learn if a team that involves five types of pain specialists (interventional pain, psychology, pharmacy, nutrition, physical therapy) can treat chronic pain in Veterans. The main questions it aims to answer are:
* Do patients report less pain after six months in the program?
* Do patients report that pain gets in the way of their life less after six months in the program? The researchers will compare participants who participate in the program to those that wait for six months before participating in the program.
Participants will
* Meet with the team of pain specialists to develop a plan to treat their pain
* Receive calls from a coach once per month
* Return to meet with the team of pain specialists for a six-month follow-up appointment
* Fill out surveys
### Conditions Module
**Conditions:**
- Chronic Pain
**Keywords:**
- Whole health
- rural health
- Interdisciplinary team
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants complete surveys, meet with five pain specialists to develop individualized treatment plans based on whole health, receive monthly coaching calls for five months, then meet with the pain specialists once more for a 6-month follow-up appointment and complete surveys.
**Intervention Names:**
- Behavioral: PREVAIL Interdisciplinary Team
**Label:** Interdisciplinary Team
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants complete surveys but do not engage with the pain specialists for 6 months.
**Label:** Waitlist Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interdisciplinary Team
**Description:** Patient meets simultaneously with an interdisciplinary team (IDT) five pain specialists and develops an individualized treatment plan based on Whole Health. Participants receive five months of coaching calls then return six months later for a follow-up visit with the IDT.
**Name:** PREVAIL Interdisciplinary Team
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** A 9-item scale used to quantify an individual's pain experience (0-10) with higher scores suggesting worse pain severity and pain interference.
**Measure:** Brief Pain Inventory (BPI)
**Time Frame:** Baseline, 6-months
#### Secondary Outcomes
**Description:** A 36-item scale to assess quality of life, including any impact of health problems on completing activities, as well as energy and emotions, with lower scores indicating a higher impact of health problems.
**Measure:** Short Form-36 Item (SF-36)
**Time Frame:** Baseline, 6-months
**Description:** A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty.
**Measure:** Insomnia Severity Index
**Time Frame:** Baseline, 6-months
**Description:** A 10-item scale used to determine how confident an individual is in accomplishing tasks despite the pain (0=not at all confident and 6= completely confident) with higher scores denoting higher levels of pain self-efficacy.
**Measure:** Pain Self-Efficacy Questionnaire
**Time Frame:** Baseline, 6-months
**Description:** A 24-item scale used to assess one's perception of their pain experience (1= never, 5= always), with higher scores indicating higher levels of pain catastrophizing.
**Measure:** University of Washington- Concerns about Pain Scale 24-item
**Time Frame:** Baseline, 6-months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Veteran receiving care at the Salem VA Health Care System (Salem VAHCS) per electronic medical record (EMR)
* Patient participating in PREVAIL Interdisciplinary Team Track per EMR
* Chronic Pain Diagnosis: Defined as pain lasting more than three months per EMR
Exclusion Criteria:
* Diagnosis of Mild Neurocognitive Disorder or Major Neurocognitive Disorder based on Diagnostic Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) per EMR
* Veteran has a current acute physical injury that would artificially elevate pain scores during study period per EMR
* Veteran intends to have a pain-related surgery during the study period per EMR
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rena E Courtney, PhD
**Phone:** 540-982-2463
**Phone Ext:** 4478
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kris Ann Oursler, MD
**Phone:** 540-982-2463
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Salem VA Health Care System
**Name:** Rena E Courtney, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Courtney RE, Schadegg MJ. Chronic, Noncancer Pain Care in the Veterans Administration: Current Trends and Future Directions. Anesthesiol Clin. 2023 Jun;41(2):519-529. doi: 10.1016/j.anclin.2023.02.004. Epub 2023 Mar 15.
**PMID:** 37245954
**Citation:** Darnall BD, Edwards KA, Courtney RE, Ziadni MS, Simons LE, Harrison LE. Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Front Pain Res (Lausanne). 2023 Jul 20;4:1223172. doi: 10.3389/fpain.2023.1223172. eCollection 2023.
**PMID:** 37547824
**Citation:** Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a Whole Health Approach to Build Biopsychosocial-Spiritual Personal Health Plans for Veterans with Chronic Pain. Pain Manag Nurs. 2024 Feb;25(1):69-74. doi: 10.1016/j.pmn.2023.09.010. Epub 2023 Oct 13.
**PMID:** 37839983
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000059350
- Term: Chronic Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427343
**Acronym:** IRONDOSE
**Brief Title:** The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy with Ferric Derisomaltose in Patients with Chronic Heart Failure and Iron Deficiency
**Official Title:** The Effects of Low-dose Versus High-dose Intravenous Iron Therapy with Ferric Derisomaltose in Patients with Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)
#### Organization Study ID Info
**ID:** 2023-ZF-62
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** China-Japan Friendship Hospital
#### Responsible Party
**Investigator Affiliation:** China-Japan Friendship Hospital
**Investigator Full Name:** Jingyi Ren
**Investigator Title:** Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.
**Detailed Description:** Iron deficiency is a common and important comorbidity in heart failure. Randomized controlled trials have consistently demonstrated a beneficial effect of IV iron on exercise capacity and quality of life in iron-deficient patients with HF and reduced ejection fraction. However, these randomized controlled trials exhibit striking heterogeneity in targeting levels for maintenance strategies of IV iron repletion. Some studies (FERRIC-HF, FAIR-HF) withheld intravenous iron in cases of ferritin \>800 ng/mL, hemoglobin \>16.0 g/dL, or transferrin saturation (TSAT) \>50%, while other studies (HEART-FID, IRONMAN) focused on targeting levels that are simply above the definition of iron deficiency. Additionally, the PIVOTAL trial showed that high-dose IV iron decreased recurrent heart failure events in patients undergoing hemodialysis compared to a lower-dose regimen. Whether functional outcomes differ between those on lower versus higher iron repletion targets among patients with heart failure remains unknown. This study will help us address this question.
This is an investigator-initiated, prospective, randomized, open-label blind endpoint study to assess the effects of high-dose IV iron repletion compared to a low-dose IV iron repletion on 12-month change in peak oxygen uptake (VO2) for patients with chronic heart failure and concomitant iron deficiency.
Patients with chronic heart failure and iron deficiency will be enrolled and randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during the follow-up period. In the high dose group, iron dosing will repeat as long as the serum ferritin was not \>700ng/mL, or if TSAT was not \>40%. Patients in the low dose group will receive repeat iron dosing if ferritin \<100 ng/mL, or if ferritin 100-300 ng/mL and TSAT \<20%, in line with criteria for iron deficiency in current guidelines.
### Conditions Module
**Conditions:**
- Heart Failure
- Iron Deficiency
**Keywords:**
- IRONDOSE
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Drug: Ferric Derisomaltose
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 114
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET)
**Measure:** Change in peak VO2
**Time Frame:** Baseline to Week 52
#### Secondary Outcomes
**Description:** Measured by CPET
**Measure:** Change in VO2 at ventilatory threshold
**Time Frame:** Baseline to Week 52
**Description:** Measured by CPET
**Measure:** Change in heart rate at peak exercise
**Time Frame:** Baseline to Week 52
**Description:** Measured by CPET
**Measure:** Change in peak respiratory exchange ratio
**Time Frame:** Baseline to Week 52
**Measure:** Change in 6-minute walking distance
**Time Frame:** Baseline to Week 26 and Week 52
**Description:** Measured by cardiac magnetic resonance imaging
**Measure:** Change in myocardial iron content by cardiac magnetic resonance imaging T2 star
**Time Frame:** Baseline to Week 52
**Description:** Measured by skeletal muscle magnetic resonance imaging
**Measure:** Change in skeletal muscle iron content by magnetic resonance imaging T2 star
**Time Frame:** Baseline to Week 52
**Description:** The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure patients. The clinical summary score, which is derived from the physical limitations and heart failure symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
**Measure:** Change in the clinical summary score by Kansas City Cardiomyopathy Questionnaire (KCCQ)
**Time Frame:** Baseline to Week 52
**Description:** EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration. The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).
**Measure:** Change in the EQ-5D-5L questionnaire indexed value
**Time Frame:** Baseline to Week 52
**Description:** The MMSE is a cognitive test. The score is ranged from 0-30 (units of a scale). 30 points is the better outcome. The investigators will assess the change in the score.
**Measure:** Change in cognitive function score by Mini-Mental State Examination (MMSE)
**Time Frame:** Baseline to Week 52
**Description:** Tested in blood samples
**Measure:** Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP)
**Time Frame:** Baseline to Week 52
**Description:** Assessed by echocardiography
**Measure:** Change in left ventricular systolic function
**Time Frame:** Baseline to Week 52
**Description:** Assessed by echocardiography
**Measure:** Change in left ventricular global longitudinal stress
**Time Frame:** Baseline to Week 52
**Description:** Effects on mortality and HF-related hospitalization rates in patients with heart failure.
**Measure:** Mortality and heart failure-related hospitalization rates
**Time Frame:** Up to 52 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age \>18 years.
2. Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).
3. New York Heart Association (NYHA) class II \~ III.
4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \>300 pg/mL or BNP \>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP \>600 pg/mL or BNP \>200 pg/mL.
5. Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).
6. Serum ferritin \<100 ng / mL or serum ferritin 100-300 ng/mL and TSAT \>20%.
7. Able and willing to perform a CPET at the time of randomization.
8. Able and willing to provide informed consent.
Exclusion Criteria:
1. Hemoglobin \<9.0 g/dL or Hemoglobin \>15.0 g/dL.
2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2.
3. Body weight \<35 kg.
4. Heart failure was secondary to valvular diseases or congenital heart diseases.
5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.
6. Known hypersensitivity to ferric derisomaltose or other IV iron product.
7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.
8. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV/AIDS disease.
9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.
10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.
11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.
12. Use of concurrent immunosuppressive therapy
13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \>100 beats/min at rest), or uncontrolled hypertension with blood pressure \>160/100 mm Hg.
14. Investigator considers a possible alternative diagnosis to account for the patient\'s HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.
15. Pregnancy or breast feeding.
16. Participation in another intervention study involving a drug or device within the past 90 days.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jingyi Ren
**Phone:** 18600195099
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lina Su
**Phone:** 18801230212
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000019189
- Term: Iron Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000000747
- Term: Anemia, Hypochromic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20857
- Name: Anemia, Iron-Deficiency
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M2781
- Name: Iron Deficiencies
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21177
- Name: Iron Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4077
- Name: Anemia, Hypochromic
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000018798
- Term: Anemia, Iron-Deficiency
- ID: D000090463
- Term: Iron Deficiencies
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427330
**Brief Title:** Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
**Official Title:** Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
#### Organization Study ID Info
**ID:** IIT2024022-EC-1
#### Organization
**Class:** OTHER
**Full Name:** Institute of Hematology & Blood Diseases Hospital, China
### Status Module
#### Completion Date
**Date:** 2026-05-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Hematology & Blood Diseases Hospital, China
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.
**Detailed Description:** This is a Phase II study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for ALL and have a high risk of relapse. Participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first Primary Objective
• To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (DFS) at one year.
Secondary Objective(s)
* To evaluate relapse rate, nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
* To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(AE)/severe adverse event(SAEs)
### Conditions Module
**Conditions:**
- Acute Lymphoid Leukemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 21
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Inotuzumab ozogamicin
**Label:** Inotuzumab ozogamicin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Inotuzumab ozogamicin
**Description:** 1. st dose is given after D+60：inotuzumab 0.3mg/m2
2. nd dose is given after 1 month：inotuzumab 0.6mg/m2
**Name:** Inotuzumab ozogamicin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".
**Measure:** DFS
**Time Frame:** at one year after HSCT
#### Secondary Outcomes
**Description:** Defined from time from HSCT to death due to any cause Defined from time from date of HSCT to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
**Measure:** Overall survival
**Time Frame:** at one year after HSCT
**Description:** Defined as time from date of HSCT to the date of first relapse. Reported as Cumulative Incidence
**Measure:** Relapse
**Time Frame:** at one year after HSCT
**Description:** Defined as time from date of first dose to death due to any cause without prior relapse.
**Measure:** NRM
**Time Frame:** at one year after HSCT
**Description:** Number of patients who develop hematological toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia, etc.
**Measure:** Incidence of hematological toxicity
**Time Frame:** at one year after HSCT
**Description:** Number of patients who develop secondary graft failure while on study, defined as: Either cytopenias after initial engraftment (ANC \<500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was \>5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced
**Measure:** Incidence of secondary graft failure(GF)
**Time Frame:** at one year after HSCT
**Description:** safety profile of intervention as measured by percent of participants with any grade AE/SAEs
**Measure:** Percent of participants with AE/SAEs
**Time Frame:** at one year after HSCT
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
* Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
* Patients who are after T+60 after transplantation
* Patients who have/are either:
* High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic
* Leukemia
* Relapsed or refractory to at least 1 line of treatment
* Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test
* Patients who have \> 99% donor chimerism after allogeneic transplantation.
* Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2
* Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
* ≥ 18 years old, including male and female
* Participants must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with evidence of disease progression prior to enrollment
* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
* Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:
* Severe renal deficiency, with creatinine clearance \< 50ml/min
* Severe hepatic deficiency
* Bilirubin, aspartate aminotransferase(AST), and/or ALT(ALT) \> 2X institutional upper limit of normal
* Severe cardiac or pulmonary deficiency
* Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).
* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
* History of veno-occlusive disease(VOD)
* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)
* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tianjin
**Country:** China
**Facility:** Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoid Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphoid Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000000922
- Term: Immunotoxins
- ID: D000018796
- Term: Immunoconjugates
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M2103
- Name: Inotuzumab Ozogamicin
- Relevance: HIGH
- As Found: g/L
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M4241
- Name: Immunotoxins
- Relevance: LOW
- As Found: Unknown
- ID: M20855
- Name: Immunoconjugates
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000080045
- Term: Inotuzumab Ozogamicin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427317
**Acronym:** DATATDM
**Brief Title:** Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
**Official Title:** Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
#### Organization Study ID Info
**ID:** 21HH7287
#### Organization
**Class:** OTHER
**Full Name:** Imperial College London
### Status Module
#### Completion Date
**Date:** 2027-03-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-03-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Imperial College London
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.
**Detailed Description:** To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance.
Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection.
This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies.
Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.
### Conditions Module
**Conditions:**
- Infections, Bacterial
- Pharmacokinetics
- Drug Monitoring
- Drug-Related Side Effects and Adverse Reactions
### Design Module
#### Bio Spec
**Description:** Sera, saliva, urine, nasal mucous, CSF, renal replacement fluid, CSF
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 323
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved
**Measure:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.
**Measure:** Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.
**Time Frame:** 3 years
**Description:** Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.
**Measure:** Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.
**Time Frame:** 3 years
**Description:** Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.
**Measure:** Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.
**Time Frame:** 3 years
**Description:** Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.
**Measure:** Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.
**Time Frame:** 3 years
**Description:** Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies
**Measure:** Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
18 years of age or above.
* Under follow-up for management of infection at Imperial College NHS Trust
* Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).
* Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):
* Delirium which may be caused or exacerbated by having an infection.
* Suspected/confirmed central nervous system infection.
* Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection.
Exclusion Criteria:
* Less than 18 years of age
* Severe anaemia (Hb \< 70g/l)
* Platelets \< 50x10\^9/l, INR \>1.5 or other known blood clotting impairment
* Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.
* Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
* Patients with restricted liberty, prisoners or under legal protection.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** As per inclusion criteria
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Suzy Williams
**Phone:** +44 (0) 20 3313 2732
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Richard Wilson, MPharm
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Suzy Williams
- **Phone:** +44 (0)20 3313 2732
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Imperial College Healthcare NHS Trust
**Status:** RECRUITING
**Zip:** W12 0HS
#### Overall Officials
**Official 1:**
**Affiliation:** Imperial College London
**Name:** Alison Holmes, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000064419
- Term: Chemically-Induced Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: HIGH
- As Found: Drug-Related Side Effects and Adverse Reactions
- ID: M4722
- Name: Bacterial Infections
- Relevance: HIGH
- As Found: Infection, Bacterial
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427304
**Acronym:** ARNOLD
**Brief Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
**Official Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
#### Organization Study ID Info
**ID:** 2023-A01313-42
#### Organization
**Class:** OTHER
**Full Name:** Gérond'if
### Status Module
#### Completion Date
**Date:** 2027-12-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-05-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gérond'if
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography
**Detailed Description:** Patients recruitment will be curry out in 31 geriatric or cardiologic centres.
Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months).
The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data.
Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre.
The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution.
Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death
### Conditions Module
**Conditions:**
- Cardiac Amyloidosis
**Keywords:**
- Cardiac amyloidosis
- Heart failure with left ventricular hypertrophy
- Positive bone scintigraphy
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 637
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy
**Time Frame:** At inclusion
#### Secondary Outcomes
**Description:** The Charlson Comorbidity Index (CCI) assesses the level of comorbidity by considering the level of severity of 19 predefined comorbid disorders and the number of disorders present among them.
**Measure:** Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)
**Time Frame:** At inclusion
**Description:** Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title.
This Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Patients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
**Measure:** Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)
**Time Frame:** At inclusion
**Description:** The Mini-Mental State Examination is an unabbreviated scale title. This scale was developed as a brief screening tool to provide a quantitative evaluation of cognitive impairment and to record cognitive changes over time.
The measure yields a total score of 30. A score of 23 or less is the generally accepted cutoff point indicating the presence of cognitive impairment. Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17)
**Measure:** Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
**Time Frame:** At inclusion
**Description:** This questionnaire is an unabbreviated score title, it was originally developed and validated in French (4 items of neuropathic pain). It was identified as one of the most suitable neuropathic pain screening tools for clinical use:
* Sensitivity: Ranges from 75-98%. Proven high sensitivity for central neuropathic pain and polyneuropathies. Sensitivity is low for tigeminal neuralgia. Moderate sensitivity for detecting a neuropathic component of pain in people with chronic pain.
* Specificity: Ranges from 37-96%.
**Measure:** Estimating the probability of neuropathic pain according "DN4 Questionnaire"
**Time Frame:** At inclusion
**Description:** This is an unabbreviated scale title.
Assessment of 5 dimensions:
* 0, 1 or 2 pathological dimensions = lack of frailty
* 3, 4 or 5 pathological dimensions = presence of frailty
**Measure:** Assessment of physical frailty according Fried scale
**Time Frame:** At inclusion
**Description:** This is an unabbreviated scale title.
* if SEGA score \< ou = 8 : Not very frail
* if it contained in the interval \[9;11\] : Rather frail
* if it \> ou = 12 : Very frail
**Measure:** Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)
**Time Frame:** At inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged ≥ 80 years
* Hospitalised for decompensation of heart failure in the last 12 months
* Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)
* Subjects able to undergo a bone scintigraphy scan
* Subjects willing to participate
Exclusion Criteria:
* Subjects refusing to participate
* Subjects admitted to palliative care unit.
* Subjects under guardianship
* Subjects with a definite diagnosis of cardiac amyloidosis
**Minimum Age:** 80 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isabelle Dufour
**Phone:** +33 (0) 185781011
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Prisca Lucas, MPH PhD
**Phone:** +33 (0)185737323
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olivier Hanon, MD PhD
- **Phone:** +33 (0)144083503
- **Role:** CONTACT
**Country:** France
**Facility:** Geriatric Department, Broca Hospital
**State:** IIe-de-France
**Zip:** 75013
#### Overall Officials
**Official 1:**
**Affiliation:** Geriatric Department, Broca hospital
**Name:** Olivier Hanon, MD PhD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M10035
- Name: Hypertrophy
- Relevance: LOW
- As Found: Unknown
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M4021
- Name: Amyloidosis
- Relevance: HIGH
- As Found: Amyloidosis
- ID: M19658
- Name: Hypertrophy, Left Ventricular
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28747
- Name: Proteostasis Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000000686
- Term: Amyloidosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427291
**Brief Title:** Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients
**Official Title:** A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC)
#### Organization Study ID Info
**ID:** MVR-T3011-ES-EC61-UC
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fudan University
#### Responsible Party
**Investigator Affiliation:** Fudan University
**Investigator Full Name:** Ding-Wei Ye
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC)
### Conditions Module
**Conditions:**
- Bladder Cancer
**Keywords:**
- high-risk non-muscle invasive bladder cancer (NMIBC)
- BCG failure or intolerance
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** T3011 with the dose of 5 x 10\^7 PFU, 5 x 10\^8 PFU or 2 x 10\^9 PFU is administered via intravesical instillation, once a week (QW) for the first 12 weeks and then every 2 weeks (Q2W) until 12 months.
**Intervention Names:**
- Biological: Herpes virus T3011 injection
**Label:** Herpes virus T3011 injection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Herpes virus T3011 injection
**Description:** T3011 will be instilled in the entire solution volume of 50ml, and be will be left in the bladder for at least 1 hour, no more than 2 hours. After competing instillation, the patients should be instructed to drink at lest 1000mL of water
**Name:** Herpes virus T3011 injection
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as the rate of Complete response or relapse-free survival at 3, 6, 9 and 12 months after first study drug administration
**Measure:** CR rate or relapse-free survival rates at 3, 6, 9 and 12 months after the first study dose
**Time Frame:** 3, 6, 9 and 12 months after first study dose
**Description:** Defined as relapse-free survival time
**Measure:** Recurrence-free survival, RFS
**Time Frame:** Up to 2 years
**Description:** Defined as time to progression-free survival
**Measure:** Progression-free survival, PFS
**Time Frame:** Up to 2 years
**Description:** Defined as the rate at which radical cystectomy occurs
**Measure:** Incidence of radical cystectomy
**Time Frame:** Up to 2 years
**Description:** Defined as survival rate at 5 year of administered treatment
**Measure:** 5-year survival rate
**Time Frame:** Up to 5 years
**Description:** Evaluation standard is CTCAE V5.0
**Measure:** Adverse Events, AE
**Time Frame:** up to 30 days after completion of treatment
**Description:** Evaluation standard is CTCAE V5.0
**Measure:** Serious Adverse Event, SAE
**Time Frame:** up to 30 days after completion of treatment
**Description:** Defined as a toxic reaction related to the test drug occurring within the first cycle of treatment, i.e. within 28 days of the first instillation
**Measure:** Dose-limiting toxicity (DLT) events
**Time Frame:** First cycle of treatment, i.e. within 28 days of first instillation
**Description:** Abnormal clinically significant vital signs and their incidence
**Measure:** Abnormal clinically significant vital signs and their incidence
**Time Frame:** Up to 1 years
**Description:** Abnormal clinically significant physical findings and their incidence
**Measure:** Abnormal clinically significant physical findings and their incidence
**Time Frame:** Up to 1 years
**Description:** Abnormal clinically significant laboratory findings and their incidence
**Measure:** Abnormal clinically significant laboratory findings and their incidence
**Time Frame:** Up to 1 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants who understand and voluntarily sign the written ICF, and are willing and able to comply with all trial requirements.
2. Male or female, aged ≥ 18 years at the time of signing the ICF.
3. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Tis).
4. Participants with high risk NMIBC who have been diagnosed by cystoscopy, urine cytology, and histopathology within 8 weeks prior to the first dose administration and have failed or intolerant to BCG treatment after TURBT surgery, and are not suitable or willing to undergo radical cystectomy.
5. BCG-failure include BCG refractory, recurrence or relapsing after BCG treatment, BCG unresponsive and BCG intolerant.
6. All tumors should have no visible tumors after transurethral bladder tumor resection (TURBT). If meeting the requirements for secondary resection, secondary resection need to be done. It is recommended to perform secondary resection if the following conditions are met: the first TURBT is insufficient, there is no muscle tissue in the first resection specimen (excluding low-grade \[Ta G1\] tumors and pure in situ cancers), T1 stage tumors, and high-grade \[G3\] tumors (excluding pure in situ cancers); Secondary resection is recommended to be performed 2-6 weeks after the first resection; Participants undergoing secondary resection must meet the requirement of no visible tumors after surgery.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
8. Expected survival ≥3 months.
9. Sufficient hematology and terminal organ function were met within 4 weeks prior to the first s treatment, for example, having sufficient bone marrow reserves and organ function:
* Hematology (hematopoietic growth factor treatment or blood transfusion should not be given within 2 weeks prior to the treatment of study drug): ANC≥1.5×10\^9/L, PLT count ≥75×10\^9/L, Hemoglobin (HGB) ≥90 g/L.
* Renal function: Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation)
* Hepatic function: Serum total bilirubin (TBIL) ≤1.5×ULN, Aspertate aminotransferase (AST) and alanine transaminase (ALT) ≤3×ULN
* Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated partial thromboplastin time (aPTT) ≤1.5×ULN
10. Women with fertility should agree to use contraceptive measures (such as intrauterine devices (IUDs), contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period. Note: A female subject with fertility is defined as a female subject who has not reached a postmenopausal state after menarche (continuous amenorrhea for at least 12 months, with no other clear cause other than menopause), and has not undergone surgery (i.e. bilateral ovariectomy, fallopian tube resection, and/or hysterectomy) or other causes determined by the researcher (such as underdeveloped Mullerian tubes) leading to permanent infertility.
Exclusion Criteria:
Patients meeting one or more of the following criteria will be excluded:
1. The diagnosis is confirmed as muscle invasive bladder cancer (T2-T4).
2. Patients with concurrent upper and lower urinary tract epithelial carcinoma, lymph node metastasis, or distant metastasis.
3. Pregnant and lactating female patients.
4. Having major surgery within 4 weeks prior to the first dose of the study drug, or anticipate the need for major surgery rather than diagnosis after enrolling the study.
5. In addition to immediate instillation therapy after TURBT surgery, anti-tumor drug treatments such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc. have been received within 4 weeks prior to the first dose of the study drug (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitrso urea or mitomycin C is within 6 weeks prior to the first use of the study drug, and oral fluorouracil and small molecule targeted drugs are within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer). Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of the study drug.
6. Patients who have received systemic corticosteroids (prednisone\>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose of the study drug; Excluding the use of local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment; Short term use of corticosteroids for preventive treatment (such as preventing contrast agent allergies).
7. Taking live attenuated vaccines within 4 weeks prior to the first dose of the study drug, or it is expected that live attenuated vaccines will be vaccinated during the study period.
8. Participants who have previously received oncolytic virus therapy (such as T-vec, T3011, etc.), gene therapy, cell therapy, and tumor vaccines.
9. Participants have a history of splenectomy or organ transplantation.
10. Participants with the malignant tumors other than the disease treated in this study, except for the following:
* Malignant tumors that have undergone treatment with the aim of cure, at least more than 5 years from the drug treatment, have no known active diseases, and have a low potential risk of recurrence;
* Fully treated non-melanoma skin cancer or malignant freckle like nevi with no evidence of disease;
* In situ cancer with sufficient treatment and no evidence of disease.
11. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and gross hematuria.
12. Indwelling ureteral stent or having a history of bladder ureteral reflux disease.
13. Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction within the first three months of enrollment, unstable arrhythmia or unstable angina.
14. Having the history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wagner's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except for patients with hypothyroidism or diabetes who have good control of alternative treatment.
15. Persistent or active infections exist, and drug treatment and control are still not ideal; Including but not limited to: active pulmonary tuberculosis, non negative AIDS virus (HIV) antibody, positive hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA) quantity ≥ the lower limit of the laboratory test in the research center, hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus RNA quantity ≥ the lower limit of the laboratory test in the research center.
16. Participants who require oral or intravenous use of anti herpesvirus drugs during the study period (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foxinkane, cedofovir, etc.) (excluding local use such as topical use).
17. Participants with the history of allergic reactions to HSV-1, IL-12, or anti PD-1 antibodies and similar biological components, or those known to have allergic reactions to any component of T3011.
18. Fever above 38.5 ℃ with no explained reason during the screening period, washout period/baseline period, or on the day of administration (the researcher determines that fever caused by tumors can be included), according to the researcher's judgment, may affect the patient's participation \\in this trial or interfere with the evaluation of efficacy.
19. In the period of recurrent herpes simplex virus infection, there are corresponding clinical manifestations, such as lip herpes, herpetic keratitis, herpetic dermatitis, genital herpes, etc.
20. Participants who have previously developed non infectious pneumonia/interstitial pneumonia or are intolerant to immunotherapy drugs (including but not limited to anti PD-1/PD-L1 antibodies) (including but not limited to developing ≥ grade 3 immune related adverse events \[irAEs\]) (excluding endocrine related irAEs that can be stably controlled through hormone replacement therapy).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dingwei Ye, Doctor
**Phone:** 021-64175590
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dingwei Ye, Doctor
- **Phone:** 021-64175590
- **Role:** CONTACT
**Country:** China
**Facility:** Fudan University Shanghai Cancer Center
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Dingwei Ye, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4793
- Name: BCG Vaccine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427278
**Brief Title:** Implication of Long Non-coding RNA CCDC144NL-AS1/Micro RNA-143-3p Axis Expression Level as Novel Signature in Colorectal Cancer
**Official Title:** CCDC144NL-AS1/Hsa-miR-143-3p/HMGA2 Interaction: In-silico and Clinically Implicated in CRC Progression, Correlated to Tumor Stage and Size in Case-controlled Study; Step Toward ncRNA Precision
#### Organization Study ID Info
**ID:** RHDIRB2020110301/2022
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2023-01-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-10-01
**Type:** ACTUAL
#### Start Date
**Date:** 2019-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Prof. Nadia M. Hamdy, Ph.D.
**Investigator Title:** professor of biochemistry and molecular biology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Elucidate the role of lncRNA CCDC144NL-AS1, hsa-miR-143-3p, and HMGA2 protein as non-invasive epigenetic molecular biomarkers in liquid biopsy of CRC Egyptian patients, individually or as an interaction arm and in comparison, to the conventional protein TMs. In addition, the investigators investigated the potential role of lncRNA CCDC144NL-AS1 as a mediator for development and/or progression of the cancer phenotype as well as CRC metastasis and its relation to both hsa-miR-143-3p and HMGA2, clinically and in silico.
**Detailed Description:** 1. Introduction 1.1. Background Colorectal cancer (CRC) is one of the malicious malignancies worldwide, accounting for nearly 8 % of all annual deaths \[1\]. It is considered Egypt's 7th most prevalent cancer, representing about 3.47 % of male tumors and 3 % of female tumors, respectively \[2\]. By 2030, there will be an estimated 60 % increase in incidence and mortality for CRC globally \[3\]. Early-stage CRC is usually asymptomatic, but when symptoms do manifest, timely detection is essential because any delay in the diagnosis may increase mortality rates \[4\].
1.2. Problem Surgical resection could cure 90 % of CRCs in the early stages. Nevertheless, the majority of patients frequently have poor prognosis since they are detected at an advanced stage \[5\]. Although colonoscopy tissue biopsy is commonly used for CRC diagnosis, yet, it is an invasive high-risk test, not convenient to be implemented in routine medical examination for longitudinal monitoring or prognosis and is considered partially representative of inter-metastatic or tumoral genetic heterogeneity \[6\]. The classical circulating tumor biomarkers (TMs) as carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) \[7\] are used as follow-up or prognosis markers, despite of their limited sensitivity and specificity \[8\]. Therefore, there is an urgent need for more efficient prognostic molecular biomarkers which could be "epi/genetic molecular marker(s)" that have 2 benefits, first, harbor potential therapeutic target(s) and second, augment classical circulating TMs, in order to improve CRC precision. Liquid biopsy has emerged as a minimally invasive diagnostic tool to analyze tumoral genetic and epigenetic molecular markers released into the circulation. Liquid biopsy captures, better, tumor genetic heterogeneity, reflecting the dynamic picture of tumor molecular landscape with lower processing time and lower cost than tissue biopsy \[9\]. Long non-coding RNAs (lncRNAs) are RNA molecules with \>200 nucleotides length, that regulate gene expression at the transcriptional, post-transcriptional, and translational levels, but cannot code for proteins synthesis \[10-12\]. Multiple cancer types exhibit deregulations of lncRNAs, which are involved in all cancer hallmarks, including cancer genesis, progression, and metastasis \[13,14\]. Emerging studies revealed several lncRNAs are implicated in CRC tumorigenesis, metastasis, and progression \[15,16\]. Beyond their potential for diagnosis, lncRNAs would also serve as possible therapeutic targets \[17\]. Coiled-lncRNA Coil Domain Containing 144 N-Terminal-Like antisense 1 (CCDC144NL-AS1) located on the 17p11.2 human chromosome, is a novel oncogenic lncRNA recently reported to be involved in carcinogenesis \[18\]. LncRNA CCDC144NL-AS1 was found to be upregulated in various cancers including gastric cancer (GC) \[18\], hepatocellular carcinoma (HCC) \[19\], non-small cell lung cancer (NSCLC) \[20\], ovarian cancer (OC) \[21\], osteosarcoma \[22\], and CRC \[23\]. However, its clinical role as biomarker for CRC needs to be elucidated. MicroRNAs (miRNAs or miRs) are single-stranded, small RNA molecules that are 18-25 nucleotides length \[24\]. They have a regulatory function in a variety of physiological processes, involving cell differentiation, growth, apoptosis, immunological response, hematopoiesis, and proliferation \[25\]. Several studies have shown miRs have crucial role in both initiation and progression of CRC, besides their potential as molecular biomarkers and possible therapeutic hits \[26-28\]. Hsa-miR-143 located on the human chromosome 5q32 \[29\] is a tumor-suppressor miR reported to be down-regulated via miR-mediated post-transcriptional gene silencing in several human cancers including prostate cancer \[30\], cervical cancer \[31\], OC \[32\], and B-cell lymphoma \[33\]. The 3' arm of the miR precursor product, hsa-miR-143-3p is down regulated in CRC and if it would contribute to CRC initiation \[34\] will be studied currently clinically. LncRNA-miR interaction plays an essential role during various cancer development \[35,36\]. CCDC144NL-AS1 was reported to act as competing endogenous RNA (ceRNA) for hsa-miR-143-3p during GC progression, via competing with the common binding regions of miRs, in order to sequester them and therefore, alter the expression of miRs downstream target genes or proteins \[18\]. Being approved experimentally by Fan et al. \[37\] in GC lncRNA CCDC144NL-AS1 upregulation in GC tissues and sponging hsa-miR-143-3p followed by upregulated expression of its direct endogenous target protein. Similarly, the clinical correlation between lncRNA CCDC144NL-AS1 and hsa-miR-143-3p in CRC patients' peripheral blood samples, that haven't been estimated previously, could further clarify our understanding of CRC molecular pathogenesis and proof the cancer findings documented in silico. High Mobility Group AT-hook 2 (HMGA2) gene encoded by 5 exons and an open reading frame of 330 base pair, is found at human chromosome band 12q13-15 \[38\]. The adult normal cell's HMGA2 protein concentration is minimal or absent under normal physiological conditions, but it is highly expressed during embryogenesis \[38\] and carcinogenesis \[39,40\]. Patients with CRC who have HMGA2 overexpression are experiencing worse prognosis \[41\]. HMGA2 takes part in almost every stage of biological activity of CRC, including cell division, proliferation, apoptosis, senescence, tumor invasion, epithelial-tomesenchymal transition (EMT), DNA repairing mechanism, and stem cell ability of self-renewal \[42\]. HMGA2 in osteosarcoma, was reported to be positively modulated by CCDC144NL-AS1 \[22\].
1.3. Aim The oncogenic lncRNA CCDC144NL-AS1 if being involved in CRC pathogenesis, by acting as a ceRNA/sponging the tumor suppressor hsamiR-143-3p, and further, upregulating the expression of its endogenous target HMGA2 as an interaction arm will be highlighted in the current study.
1.4. Objectives Elucidate the role of lncRNA CCDC144NL-AS1, hsa-miR-143-3p, and HMGA2 protein as non-invasive epigenetic molecular biomarkers in liquid biopsy of CRC Egyptian patients, individually or as an interaction arm and in comparison, to the conventional protein TMs. In addition, we investigated the potential role of lncRNA CCDC144NL-AS1 as a mediator for development and/or progression of the cancer phenotype as well as CRC metastasis and its relation to both hsa-miR-143-3p and HMGA2, clinically and in silico.
2. Subjects 2.1. Sample size and power of the study Based on the previous study by Zhang et al. in 2019 lncRNA CCDC144NL-AS1 was normally distributed with a standard deviation (3.2) and large effect size (0.85) \[43\]. If the true differences between the CRC group and the control group means are 1 and 3.3, respectively, the study group sizes are 34 patients and 34 control subjects. Total sample size was 68 cases, which was increased by 25 % for expected losses, and total sample was finally 90 subjects, 60 CRC subjects and 30 control (2:1). This is to be able to reject the null hypothesis, that the population means of the experimental groups are equal with probability (power) of 0.8. The Type I error probability associated with this test of this null hypothesis is (0.05). Sample size estimation was performed by G power\* sample size online calculator http://www.gpower.hhu.de/en.html, depending on two-sided confidence level 95 %.
2.2. Study design Case-controlled retrospective mono-center study. 2.3. Institutional Review Board (IRB) statement The Research Ethics Committee of the Faculty of Pharmacy, Ain Shams University, granted ethical permission to conduct the study, 2022. All participants (controls or patients) were fully cognizant of the purpose of the study and signed a written, ethically-approved, informed consent (I⋅C) form. This study was conducted in accordance to the Declaration of Helsinki Guidelines approved in 2013 \[44\]. 2.4. Study participants 2.4.1. Patients group A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study.
2.4.1.1. Patients' inclusion criteria. Patients visiting the Colonoscopy Unit for colorectal examination, suffering from variable colonic symptoms, including the CRC alarming symptoms, constipation, abdominal pain, rectal bleeding, and sudden weight loss. CRC diagnosis was clinically confirmed by colonoscopy, abdominal radio-imaging, and histopathologically.
2.4.1.2. Patients' exclusion criteria. Patients suffering from inflammatory disorders, hematological disorders, any cancer other than CRC, or those receiving chemotherapy, radiation, or have undergone surgery, patients with hematological disorders, or any cancer other than CRC. Individuals with inadequate data or missing histopathological diagnosis, as well as those with distant metastases at the time of diagnosis were excluded from the study.
2.4.2. Control group 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation.
2.4.3. Patients demographic, clinical, and pathological data The patients' demographic data including age, gender, smoking status, and the patient full history, retrieved from the hospital medical records. In addition to patients' colorectal surgery history, the complete family history of cancer, as well as history of diabetes mellitus (D.M) and hypertension (HTN) were recorded to determine the non communicable diseases status/impact. From patients' files, the following chemistry lab results were recorded, for statistical correlations, CEA, CA19-9 and routine biochemical testing of liver function profiling of alanine aminotransaminase (ALT), aspartate aminotransaminase (AST), and serum albumin, kidney function tests including serum creatinine and serum urea. Hemoglobin (Hgb) as well as prothrombin time (PT), platelet count, lymphocytes count, lactate dehydrogenase (LDH), and C-reactive protein (CRP) were all measured in blood at the Clinical Biochemistry Lab, Dar Al Shefa Hospital, Cairo, Egypt. Tumor site, tumor size, tumor type if mucinous or not, LN metastasis (LNM), tumor invasion or vascular invasion, tumor differentiation, tumor grade, tumor-node-metastasis (TNM) staging, inflammation status as inflammatory bowel disease (IBD), and CRC locations if colonic or rectal, as well as if transverse, sigmoid, rectosigmoid, and rectal, were collected from the patients' files at the Statistics Unit at Dar Al Shefa Hospital, Cairo.
Pathological records according to the American Joint Committee (AJCC) on Cancer 2010 criteria \[45\] were collected as well. Patients were categorized into three stages from II to IV, Stage I/II is the local cancer with no LN involvement (N0), Stage III where LN involvement (N1-x) is there, and Stage IV with distant metastasis (M1). CRC staging was determined by the colonoscopy results, abdominal radiography, pathological findings, and clinical evaluation, where the early stage T2 indicates invasion of the muscularis propria by the tumor, T3 indicates the tumor penetration to the subserosa and the muscularis propria, while late tumor stage T4 indicates that it has penetrated the rectum or several colon layers.
3. Methods 3.1. In silico database(s) search and analysis (accessed on October 2021 and revised July 2023) 3.1.1. Identification of the investigated ncRNAs by bioinformatics The HUGO Gene Nomenclature Committee (HGNC) https://www. genenames.org/ supported by National Human Genome Research Institute grant, National Center for Biotechnology Information (NCBI) https://www.ncbi.nlm.nih.gov/, NCBI Genome Data Viewer (GDV) \[46\] (USA.gov) and Ensembl Databases https://www.ensembl.org/index.
html for human ncRNAs genes characterization (Ensembl release 109) CCDC144NL-AS1 and MIR-143 are shown in Table 1.
3.1.2. LncRNA disease v2.0 expression The LncRNA and Disease Database (version 2.0) \[47\] http://www.rnanut.net/lncrnadisease/index.php/home to explore lncRNA CCDC144NL-AS1 expression in different cancer types retrieved from validated experimental results in publications or predicted http://www. rnanut.net/lncrnadisease/index.php/home/detail/LDA0044869.
3.1.3. Expression via ENCORI pan-cancer analysis platform \[48\] https://rnasysu.com/encori/panCancer.php of miR, lncRNA or genes across 32 types of Cancers. The expression box-plot values of genes from RNA-seq data were scaled with log2(FPKM +0.01), while the ones from miRNA-seq data were scaled with log2(RPM + 0.01).
3.1.4. Association via miREnvironment database \[49,50\] http://www.cuilab.cn/miren#fragment-1of curated and collected experimentally supported miRNA and various environmental factors (394 factor) interplay and their associated phenotypes (June-28, 2011, the original miREnvironment Database was released, Last update: Sep-9, 2012) for analysis for has-miR-143-3p as prediction of association between environmental factors and human disease.
3.1.5. Interaction via the lncRNASNP2-human \[51\] The lncRNA CCDC144NL-AS1 or HMGA2 as non-conserved targets of miRNA:hsa-miR-143 http://www.noncode.org/gene_trans_search.php search_type=keyword\&keyword=CCDC144NL-AS1\&sbt=Search.
3.1.5.1. Binding targets interaction. Binding targets for hsa-miR-143-3p predicted via database RNAhybrid 2.2 https://mybiosoftware.com/rna 22-v2-microrna-target-detection.html \[52\], http://bibiserv.cebitec.uni -bielefeld.de/rnahybrid \[53\] and RNA22 v2 microRNA target detection https://cm.jefferson.edu/rna22/Interactive/ by Jefferson Computational Medicine Center (CMC) \[54\] to predict hsa-miR-143-3p interaction with either lncRNA CCDC144NL-AS1 or HMGA2 as target, and database RNA22 v2 microRNA target detection.
3.1.6. Functional enrichment analysis, targeted pathways and heatmaps 3.1.6.1. KEGG targeted pathways, clusters/heatmap using DIANA. Reverse Search \[55\] https://dianalab.e-ce.uth.gr/html/universe/index. php?r=mirpath to identify in KEGG pathways-involved miRs using Mirpath, using the DIANA-TarBase v7.0 Heatmap with cluster dendrogram with statistically significant results in red by a posteriori analysis method after an enrichment analysis is performed, p value threshold set at 0.05 and MicroT threshold set at 0.8 (Accessed on July 25th 2023). Functional enrichment analysis using STRING version 11.5 https://string-db.org/ \[56\]. Finally, using the Genome Browser (UCSC) \[57\] Dec. 2013 initial release; June 2022 patch release 14, selected top genes Targets of HMGA2 interactions and pathways from curated databases and textmining https://genome.ucsc.edu/cgi-bin/hgGateway (Accessed on July 25th, 2023). 3.2. Blood samples Five milliliters of peripheral venous blood were withdrawn from controls and CRC patients, under strict sterile conditions, following standard international biosecurity safety procedures, into polymer gel clot activator vacutainers (Greiner Bio-One GmbH, Australia). At room temperature (25 ◦C), completely coagulated samples were centrifuged at 4000 rpm for 10 min. Sera obtained were aliquoted into three DNase/ RNase free Eppendorf tubes and stored at -80 ◦C for molecular analysis.
3.2.1. Total RNA extraction Using the miRNeasy Mini kit (Cat. No.217004; Qiagen, Hilden, Germany) according to the manufacturer's protocol, from serum samples, RNA extraction was done. The isolated RNA was eluted in 40 μL of RNase-free water.
3.2.2. Quantitation of purified RNA including miRNAs Using a NanoDrop® 1000 spectrophotometer (Thermo Scientific, Wilmington, DE, USA) the concentration and purity of all RNA samples were determined. Absorbance at 260 nm was used to measure the conc. of RNA in the sample, whereas 260/280 and 260/230 nm ratios were used to evaluate RNA purity. After quantification, the isolated and eluted RNA was stored at
-80 ◦C in aliquots. 3.2.3. Reverse transcription and measurement of ncRNAs expression 3.2.3.1. cDNA synthesis and measurement of lncRNA CCDC144NL-AS1 expression using qRT-PCR. Total RNA was reverse transcribed into cDNA using the Xpert cDNA Synthesis Kit (Cat. No. GK80.0100; Grisp Research Solutions, Rua Alfredo Allen, Portugal) containing Xpert Reverse Transcriptase (RNase H-), RNA-dependent DNA polymerase appropriate for cDNA synthesis from long RNA templates, following the manufacturer's protocol. The synthesized cDNA was then stored at - 20 ◦C till qRT-PCR. The expression of lncRNA CCDC144NL-AS1 was measured using the Xpert Fast SYBR (Cat. No. GE20.0100; Grisp Research Solutions, Rua Alfredo Allen, Portugal) in accordance with the manufacturer protocol. The primer RT2 lncRNA qPCR Assay for Human CCDC144NL-AS1 (Hs04941765 m1, Cat. No. 4426961) was used to assess the level of expression of the lncRNA CCDC144NL-AS1. The human GAPDH primer (LPH31725A-200, Cat. No. 330701) was used as endogenous control to normalize the expression of lncRNA CCDC144NLAS1.
3.2.3.2. cDNA synthesis and measurement of hsa-miR-143-3p expression using qRT-PCR. The miRCURY LNA RT Kit was used for cDNA synthesis (Cat. No.339340, Qiagen, Hilden, Germany) as proposed by the manufacturer's instructions. The resulting cDNA was kept at - 20 ◦C until quantification. qRT-PCR was used to measure the expression of the hsamiR- 143-3p using the miRCURY LNA miRNA PCR Assay (Cat. No. 339306, Qiagen, Hilden, Germany). The primer SNORD38B (hsa) miRCURY LNA miRNA PCR Assay (YP00203901, Cat. No. 339306) was used as endogenous control to normalize the expression of hsa-miR-143-3p. The reaction was carried out using the PCRmax Eco™48 qRT-PCR system (PCRmax, Staffordshire, USA).
Primers sequences are listed in Table 2. All these primers were designed by Qiagen https://www.qiagen.com/workflow-configurator/ workflows intcmp=CM_QF_WFC_1121_OTHERS_QB_nav_products, except for lncRNA CCDC144NL-AS1 that was obtained from Thermofisher https://www.thermofisher.com/taqman-gene-expression/pr oduct/Hs04941765_m1 (Accessed on October 2021). The RNA relative expression was computed and normalized as fold change using the cycle threshold (Ct) method (2- ΔΔCt) with GAPDH or SNORD38B (hsa) as the internal control for lncRNA CCDC144NL-AS1 and hsa-miR-143-3p, respectively. ΔCt was determined by subtracting the Ct values of GAPDH and SNORD38B (hsa) from those of the lncRNA CCDC144NL-AS1 and hsa-miR-143-3p, respectively; where ΔΔCt = ΔCt cancer samples - ΔCt control samples \[58\].
3.2.4. Quantification of HMGA2 protein concentration by ELISA HMGA2 protein concentration was measured in serum samples by commercially available ELISA kits from Bioassay Technology Laboratory (Cat.No. E7513Hu, Jiaxing, China) according to the manufacturer's instructions. The reaction is based on pre-coating the ELISA plate with Human HMGA2 antibody and HMGA2 present in added samples binds to antibodies coating the wells. Biotinylated human HMGA2 antibody was added to bind HMGA2 in samples. A second detector antibody was then added to bind the biotinylated HMGA2 antibody. A substrate solution was added that reacts with the enzyme-antibody-target complex to produce a measurable signal measured at 450 nm.
3.2.5. Indices and ratios 3.2.5.1. Body mass index (BMI kg/m2) was calculated in kg/m2 for each participant using the website https://www.nhlbi.nih.gov/health /educational/lose wt/BMI/bmicalc.htm. Normal weight individuals have BMI of 18.5-24.9 kg/m2, overweight BMI as 25-29.9 kg/m2, and 30 kg/m2 or more for obesity. 3.2.5.2. Platelets-to-lymphocytes ratio (PLR) was calculated by dividing the patient platelet count (x103 cell/μL) by the lymphocyte count (x103 cell/μL). PLR is an inflammation indicator and immune response-related predictor that has a stronger link with inflammatory diseases severity than the neutrophils-to-lymphocytes ratio (NLR) \[59\] or either individual cells alone.
3.3. Statistical analysis Data were collected and excel tabulated in Microsoft Excel 2019. Statistical package for social studies software SPSS 26.0 (IBM, Armonk, NY) (https://www.ibm.com/products/spss-statistics), and GraphPad Prism® version 8.01 (GraphPad Software, San Diego, USA) (htt ps://www.graphpad.com/scientific-software/prism/) were utilized for figures, while MedCalc Statistical Software version 19.2.6 of (MedCalc Software by Ostend, Belgium) (https://www.medcalc.org) was used for the receiver operating characteristic (ROC) curve analysis. Data were tested for normality using Shapiro-Wilk normality test for both groups and subgroups data. Since the patients' data were not normally distributed, data were expressed as median (interquartile range: IQR (25th percentile-75th percentile). Mann-Whitney (U) or Kruskal-Wallis (H) were conducted to compare between any two or more independent groups, respectively.
The ROC curve was used to find the best cutoff, sensitivities (SNs), specificities (SPs), negative predictive values (NPVs), and positive predictive values (PPVs), with an area under the curve (AUC) calculated ranged from 0 to 1. In medical testing, negative likelihood ratios (LRs) are used to understand the diagnostic or prognostic test utility. Essentially, the LR indicates the likelihood that a patient has a condition or disease. The likelihood that they have the disease or condition increases with the ratio. A low ratio, on the other hand, indicates that they most likely do not. Therefore, a physician can use these ratios to either rule in or rule out an illness. The ratio, which expresses how likely it is for someone to have the disease or condition, supports the SNs and SPs identified by the ROC curve. An alternative definition of the LR is SN and SP, where negative LR = (100 - SN)/SP. Spearman's correlation coefficient r was used to evaluate the correlation between various variables. Additionally, the expression levels of the lncRNA CCDC144NL-AS1, hsamiR- 143-3p, and HMGA2 protein were set to Spearman correlation r, and the link among two variables-one continuous and one dichotomous- was assessed using point-biserial correlation. Significance level was set if the two-tailed statistical analysis test p-value is \<0.05.
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- Colorectal cancer
- lncRNA CCDC144NL-AS1
- Hsa-miR-143-3p
- HMGA2
- Liquid biopsy
- In silico analysis
### Design Module
#### Bio Spec
**Description:** Five milliliters of peripheral venous blood were withdrawn from controls and CRC patients, under strict sterile conditions, following standard international biosecurity safety procedures, into polymer gel clot activator vacutainers (Greiner Bio-One GmbH, Australia). At room temperature (25 ◦C), completely coagulated samples were centrifuged at 4000 rpm for 10 min. Sera obtained were aliquoted into three DNase/ RNase free Eppendorf tubes and stored at -80 ◦C for molecular analysis.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 90
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study.
**Label:** Patient group
#### Arm Group 2
**Description:** 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation.
**Label:** Healthy Control
### Outcomes Module
#### Primary Outcomes
**Measure:** Expression pattern of ncRNAs in CRC patients and controls
**Time Frame:** 9 months
**Measure:** HMGA2 protein concentration in CRC patients and controls
**Time Frame:** 12 months
**Measure:** Association of the investigated ncRNAs and HMGA2 with clinicopathological features of CRC patients
**Time Frame:** 12 months
**Measure:** Correlation between lncRNA CCDC144NL-AS1, hsa-miR-143-3p and HMGA2 and the conventional CRC TMs
**Time Frame:** 10 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* CRC diagnosed patients that is clinically confirmed by colonoscopy, abdominal radio-imaging, and histopathologicaly.
Exclusion Criteria:
* individuals receiving chemotherapy, radiation, or undergone surgery
* patients with blood disorders
* patients with any cancer other than CRC.
* Individuals with inadequate data or missing histopathological diagnoses
* distant metastases
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 30 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** Patients group A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study.
Control group 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab
**Zip:** 11566
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of pharmacy Ain Shams University
**Name:** Nadia Hamdy, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Abd El Fattah YK, Abulsoud AI, AbdelHamid SG, AbdelHalim S, Hamdy NM. CCDC144NL-AS1/hsa-miR-143-3p/HMGA2 interaction: In-silico and clinically implicated in CRC progression, correlated to tumor stage and size in case-controlled study; step toward ncRNA precision. Int J Biol Macromol. 2023 Dec 31;253(Pt 2):126739. doi: 10.1016/j.ijbiomac.2023.126739. Epub 2023 Sep 9.
**PMID:** 37690651
#### See Also Links
**Label:** Related Info
**URL:** https://pubmed.ncbi.nlm.nih.gov/37690651/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9662
- Name: Altretamine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427265
**Brief Title:** Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study
**Official Title:** Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study
#### Organization Study ID Info
**ID:** ZHKYQ202316
#### Organization
**Class:** OTHER
**Full Name:** The Affiliated Hospital Of Guizhou Medical University
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Chinese nursing association
**Class:** UNKNOWN
**Name:** Affiliated Hospital of Guizhou Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** The Affiliated Hospital Of Guizhou Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.
### Conditions Module
**Conditions:**
- Developmental Trajectory of Patients With Post-ICU Syndrome
- Development and Application of Post-ICU Syndrome Prediction Model
**Keywords:**
- Post-icu syndrome
- Prediction model
- Development Trajectory
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 840
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Intensive Care Unit Memory Tool score\\Richards-Campbell Sleep Questionnaire score
**Measure:** Correlation scale score
**Time Frame:** 2024.01-2026.06
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Length of stay in ICU ≥24h; ②Age ≥18 years old; ③ Conscious when leaving ICU, communicating with investigators without barriers; ④ Informed consent.
Exclusion Criteria:
* ① had been admitted to ICU for more than 24h within 3 months prior to this admission; ② Transferred to another ICU; ③ There was cognitive impairment before ICU admission (BDRS \> 4); (4) Serious hearing impairment, dysarthria, etc., can not be followed up; ⑤ Serious illness can not cooperate to complete the questionnaire.
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The inclusion criteria of family members were as follows: 1 family member of each patient aged ≥18 years was selected; (2) Assume the main role of caring for patients and medical decision-making; ③ no history of mental illness or other serious organic diseases; ④ Informed consent, voluntary participation in this study. Exclusion criteria for family members: ① Family members refused to participate in the study due to their own reasons; ② Severe hearing and language impairment could not cooperate with the researchers.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tingrui WANG
**Phone:** 19117899885
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** GuiYang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tingrui WANG
- **Phone:** 19117899885
- **Role:** CONTACT
**Country:** China
**Facility:** Affiliated Hospital of Guizhou Medical University
**State:** Guizhou
**Status:** RECRUITING
**Zip:** 550004
#### Overall Officials
**Official 1:**
**Affiliation:** Affiliated Hospital of Guizhou Medical University
**Name:** Li Yao
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19010
- Name: Critical Illness
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
### Condition Browse Module - Meshes
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427252
**Brief Title:** The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM
**Official Title:** The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of Gastric or Esophagogastric Junctional Cancer With Peritoneal Metastasis: A Prospective, Multicenter Phase II Study
#### Organization Study ID Info
**ID:** GHIST24
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital with Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Affiliated Hospital with Nanjing Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Gastric cancer (GC) with peritoneal metastasis has a poor prognosis and short survival. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC.
**Detailed Description:** Gastric cancer (GC) is the 5th most common malignant tumor worldwide, and it causes the 4th most tumor-related deaths among all malignant tumors. China is a large country with 40% of the total number of GC cases worldwide. Despite the advances in medical detection methods, most of the GC patients in China are in the advanced stage at the time of diagnosis, in which peritoneal metastasis is one of the common metastatic patterns of advanced GC, and the presence of peritoneal metastasis accounts for about 46% of patients with distant metastasis detected at the first diagnosis. The prognosis of GC patients with peritoneal metastasis is extremely poor, and compared with other metastatic organs, patients with stage IV GC with peritoneal metastasis have a worse prognosis and shorter survival.
The treatment of peritoneal metastasis of GC has been based on systemic chemotherapy with reference to advanced GC, but it is difficult for traditional chemotherapeutic agents to reach the peritoneal lesions due to the existence of blood-peritoneal barrier. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC.HIPEC allows chemotherapeutic drugs to act directly on tumor tissues while reducing the impact on other parts of the body; the warming effect is synergistic with the antitumor effects of chemotherapeutic drugs and helps the drugs to act more efficiently on the intraperitoneal tumor cells; moreover, the chemotherapeutic drugs are absorbed through the peritoneum and then enter the liver via the portal vein route, which is beneficial to preventing liver metastasis. HIPEC currently has four applications and indications in the clinic: firstly, palliative application to improve the quality of life for GC abdominal metastasis with a large amount of carcinomatous ascites; secondly, therapeutic application of radical gastric cancer surgery + cytoreductive surgery + HIPEC for the treatment of GC; third, prophylactic application, radical gastric cancer surgery + peritoneal hyperthermia chemotherapy, targeting people with high risk of peritoneal recurrence, especially patients with T3-4 or positive lymph nodes; fourth, neoadjuvant application, neoadjuvant chemotherapy combined with peritoneal hyperthermia chemotherapy before radical gastric cancer treatment, in order to reduce the risk of peritoneal implantation of gastric cancer and to increase the possibility of radical surgery. However, there is a lack of high-level evidence-based medical evidence on the efficacy and safety of HIPEC as a translational treatment for GC with peritoneal metastasis.
The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. The KEYNOTE series of studies evaluated the safety and efficacy of PD-L1 antibody as a first-line treatment for advanced GC, among which the results of KEYNOTE-859 confirmed that the combination of Pembrolizumab and chemotherapy is expected to be a HER-2 negative advanced gastric/esophagogastric junctional cancer first-line treatment option. A recent retrospective study by Chinese scholars demonstrated that patients with stage IV GC who were responded to the immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear.
Therefore, we conducted this prospective multicenter clinical trial trying to combine the specificity of HIPEC for peritoneal metastases with immunotherapy for advanced GC, aiming to evaluate the efficacy and feasibility of multimodal treatment regimens, such as HIPEC in combination with immunotherapy, for the transformative treatment of peritoneal metastases of GC or EJ junctional cancer and to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC.
### Conditions Module
**Conditions:**
- Gastric Cancer, Metastatic
**Keywords:**
- gastric cancer
- peritoneal metastasis
- HIPEC
- immunotherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HIPEC treatment (paclitaxel, at 43°C for 60 min) was performed on the 1st day after the first exploratory laparotomy and on the third day after the radical surgery for a total of 2-3 times (total amount of paclitaxel was 175 mg/m2 ). Systemic therapy was started 3 weeks after HIPEC. Systemic therapy including: Tirilizumab: 200 mg, Q3W; oxaliplatin: 130mg/m2, Q3W; Herceptin: loading dose of 8 mg/kg followed by 6 mg/kg Q3W. Tegeo: Oral administration: 40 mg per dose for BSA \<1.25, 50 mg per dose for BSA 1.25 to 1.5, and 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle Q3W; After 2-6 weeks, laparoscopic exploration was performed, PCI score was calculated, and radical surgery was performed in patients who were eligible for radical surgery. Postoperative HIPEC was performed twice.
**Intervention Names:**
- Drug: HIPEC
- Drug: Systemic therapy
**Label:** HIPEC plus PD-1 plus SOX therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HIPEC plus PD-1 plus SOX therapy
**Description:** In the experimental group, HIPEC treatment (paclitaxel, 3000 ml of physiological saline at 43°C for 60 min) was performed on the first day after the first exploratory laparotomy and on the third day after the radical surgery for a total of 2-3 times (total amount of paclitaxel was 175 mg/m2 ), with an interval of not more than 72 h. Intravenous systemic therapy was started 3 weeks after the completion of HIPEC treatment. systemic therapy.
**Name:** HIPEC
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- HIPEC plus PD-1 plus SOX therapy
**Description:** 1. Tirilizumab: 200 mg, i.v., D1, Q3W;
2. oxaliplatin: 130mg/m2, i.v., D1, Q3W;
3. Herceptin: a tri-weekly dosing regimen with an initial loading dose of 8 mg/kg followed by 6 mg/kg Q3W.
4. Tegeo: Oral administration: 40 mg per dose for BSA \<1.25, 50 mg per dose for BSA 1.25 to 1.5, and 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle D1-D14, Q3W;
**Name:** Systemic therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients still alive at one year from the start of patient enrollment was calculated as a percentage of all patients. Deaths from all causes were included in the calculation of overall survival. The OS of patients who did not reach the one-year loss to follow-up was counted as data censored at the time of last confirmed survival before the loss to follow-up, i.e., only the time point of last known survival was counted in the number of survivors.
**Measure:** Overall Survival
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Percentage of all patients who did not experience disease progression or death within one year from the start of patient enrollment. If disease progression is indicated by imaging, the date of disease progression will be the time of the imaging exam that clearly confirms disease progression. If disease progression was diagnosed by other clinical modalities, the date of diagnosis will be used as the date of disease progression. Patients who discontinued the trial (without follow-up imaging) for reasons other than disease progression and patients who received post-trial therapy will have the time of discontinuation of the trial or the time of initiation of post-trial therapy as the data censored. New onset of other tumors is not considered a disease progression event and is also not censored as data.
**Measure:** Progression-free Survival
**Time Frame:** 1 year
**Description:** CC-0 indicates no residual tumor visible to the naked eye, CC-1 indicates residual tumor with a maximum diameter of \<2.5 mm, CC-2 indicates residual tumor with a diameter of more than 2.5 mm but \<25 mm, and CC-3 indicates residual tumor with a diameter of ≥25 mm. CC-0 and CC-1 are usually classified as complete cytoreduction.
**Measure:** Completeness of cytoreduction score
**Time Frame:** 1 year
**Description:** Refers to the proportion of patients whose tumors shrank to a certain level and remained there for a certain period of time, and includes both CR (Complete Response) and PR (Partial Response) cases. Objective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Patients had to be accompanied by measurable tumor lesions at baseline, and the efficacy assessment criteria were classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressed Disease (PD) according to the RECIST 1.1 criteria. Disease (PD).
**Measure:** Objective Response Rate
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. patients with a pathologically confirmed primary diagnosis of gastric/esophagogastric junctional cancer who have not undergone chemotherapy, radiotherapy, or other antitumor therapy prior to the start of the clinical trial;
2. age 18 to 75 years Eastern Coorperative Oncology Group (ECOG): 0 to 1 points;
3. diagnosis of metastatic adenocarcinoma of the peritoneum \[peritoneal cancer index (PCI) ≤ 20 points\] with or without ascites (beyond the pelvis but not reaching full abdominal ascites) by laparoscopic exploration;
4. Voluntarily sign the informed consent form.
5. good cardiac function for resection with curative intent. If clinically indicated, patients with underlying ischemic, valvular heart disease or other severe heart disease should be evaluated preoperatively by a cardiologist;
6. normal function of major organs and subjects are required to meet the following laboratory criteria: 1) Absolute neutrophil count (ANC) ≥ 1.5x109/L in the last 14 days without granulocyte colony-stimulating factor (GCSF); 2) Platelets ≥ 100 x 109/L in the absence of blood transfusion in the last 14 days; 3) Hemoglobin \> 9 g/dL without transfusion or erythropoietin use in the last 14 days; 4) Total bilirubin ≤ 1.5 x upper limit of normal (ULN); enrollment is also allowed if total bilirubin \> 1.5 x ULN but direct bilirubin ≤ ULN; 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
6) Blood creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; 7) good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN; 8) Normal thyroid function, defined as thyrotropin (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9) Cardiac enzyme profiles within the normal range (enrollment will be allowed if the investigator determines that the laboratory abnormality is not of clinical significance); 7) Thyroid function: thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) in the normal range or mildly abnormal without clinical significance; 8. weight of 40 kg or more (including 40 kg), or BMI \> 18.5; 9. female patients must meet:
* Menopausal (defined as absence of menstruation for at least 1 year with no confirmed cause other than menopause) status, or surgically sterilized (removal of ovaries and/or uterus), or patients of childbearing potential must also meet the following requirements:
* Pregnancy test within 7 days prior to first dose must be negative;
* Agree to use contraception with an annual failure rate of \< 1% or remain abstinent (avoid heterosexual intercourse) (at least 120 days from signing the informed consent form until at least 9 months after the last dose of the test drug and at least 9 months after the procedure (contraceptive methods with an annual failure rate of \< 1% include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that suppress ovulation, hormone-releasing intrauterine contraceptives, and copper-containing intrauterine devices). .;
* No breastfeeding is allowed. 10. The subject reads and fully understands the patient instructions and signs the informed consent form.
Exclusion Criteria:
1. the patient has a previous (within 5 years) or concurrent other malignant tumor;
2. patients who are preparing for or have previously received organ or bone marrow transplantation;
3. have had a blood transfusion within 2 weeks prior to the first dose, or have a history of bleeding, and any bleeding event with a severity rating of 3 or more on the CTCAE 4.0 within 4 weeks prior to screening;
4. abnormal coagulation with bleeding tendency (INR in the absence of anticoagulants at normal values \> 1.5); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; the use of low-dose warfarin (1 mg orally once daily) for prophylactic purposes is permitted, provided the International Normalized Ratio of the prothrombinogen time (INR) is ≤ 1.5, or Small-dose aspirin (no more than 100 mg daily);
5. an actinic/venous thrombotic event within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis due to intravenous cannulation for pre-chemotherapy, which has resolved in the judgment of the investigator), and pulmonary embolism;
6. myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated using the Fridericia formula);
7. the presence of NYHA class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \<50%;
8. urine protein ≥++ and confirmed 24-hour urine protein quantification \>1.0 g;
9. have multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)
10. pleural effusion with clinical symptoms requiring clinical intervention;
11. human immunodeficiency virus (HIV) infection;
12. active tuberculosis;
13. long-standing unhealed wounds or incompletely healed fractures;
14. patients with pre-existing and current interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, and severely impaired lung function that may interfere with the detection and management of suspected drug-associated pulmonary toxicity
15. the presence of a known active or suspected autoimmune disease, except those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppressive therapy);
16. a history of severe chronic autoimmune disease, such as systemic lupus erythematosus; a history of inflammatory bowel disease, such as ulcerative enteritis, Crohn's disease, or chronic diarrheal disease, such as irritable bowel syndrome; a history of tuberculosis or tuberculosis; a history of active hepatitis B, hepatitis C, or HIV; or well-controlled non-severe immune disorders, such as dermatitis, arthritis, or psoriasis, may be eligible. .. Hepatitis B virus titers \< 500copy/ml may be enrolled;
17. patients requiring treatment with systemic corticosteroids (\> 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to the first dose or during the study period. However, enrollment is permitted if patients are allowed to use topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg/day prednisone efficacy dose in the absence of active autoimmune disease;
18. any active infection requiring systemic administration of anti-infective therapy within 14 days prior to the first dose; except for prophylactic antibiotic therapy (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease);
19. treatment with a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza;
20. prior treatment with antibodies/drugs targeting immune checkpoints, e.g., PD-1, PD-L1, CTLA-4 inhibitors, etc;
21. have received treatment with immunologically-affecting related drugs or medical technologies (including but not limited to the following: thymopentin, thymofacine, interferon, CAR-T therapy, etc.) within 6 months prior to the first dose of the drug
22. is receiving treatment in another clinical study or is scheduled to begin treatment in this study less than 1 month from the end of treatment in the previous clinical study;
23. has a known history of allergy or intolerance to any study medication or its components
24. patients with a history of alcoholism, drug abuse, and substance abuse. Patients who have stopped drinking alcohol may be enrolled;
25. patients with non-compliance with medical advice, non-adherence to prescribed medication, or incomplete information that may affect the judgment of efficacy or safety;
26. pregnant or lactating female patients;
27. patients with conditions that may increase the risk of study participation and study medication, or other severe, acute, and chronic conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable.
28. other conditions that, in the judgment of the investigator, make them unsuitable for this clinical trial.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fengyuan Li, PhD
**Phone:** +8617366065271
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yigang Zhang, PhD
**Phone:** +8615996341965
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital with Nanjing Medical University
**Name:** Zekuan Xu, PhD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427239
**Brief Title:** Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
**Official Title:** A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
#### Organization Study ID Info
**ID:** PANC-2nd-IIT-HRS4642-SHR1316
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Jiangsu HengRui Medicine Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Fudan University
#### Responsible Party
**Investigator Affiliation:** Fudan University
**Investigator Full Name:** Xian-Jun Yu
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma.
**Detailed Description:** This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebelimab in the treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of HRS-4642 combined with adelbizumab treatment, and then entered the efficacy exploration phase.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 35
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma.
**Intervention Names:**
- Drug: HRS-4642
- Drug: Adebrelimab
**Label:** Part A: Dose Escalation; Part B: Dose Expansion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A: Dose Escalation; Part B: Dose Expansion
**Description:** HRS-4642 will be administrated per dose level in which the patients are assigned.
**Name:** HRS-4642
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part A: Dose Escalation; Part B: Dose Expansion
**Description:** Adebrelimab will be administrated per dose level in which the patients are assigned
**Name:** Adebrelimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness
**Measure:** Dose Limited Toxicity (DLT)
**Time Frame:** Day 1 to Day 21 after the first combination therapy was administrated
**Description:** RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
**Measure:** Recommended phase II dose (RP2D)
**Time Frame:** Approximately 12 months
**Description:** Evaluated by RECIST v1.1.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to approximately 12 months
#### Secondary Outcomes
**Description:** Evaluated by RECIST v1.1.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** Up to approximately 12 months
**Description:** Evaluated by RECIST v1.1.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to approximately 12 months
**Description:** Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Up to approximately 12 months
**Description:** Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
**Measure:** Overall survival (OS)
**Time Frame:** Up to approximately 12 months
**Description:** AEs are assessed by NCI-CTCAE v5.0
**Measure:** Adverse events (AEs)
**Time Frame:** From the first drug administration to within 90 days for the last adebrelimab dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients volunteered to participate in this study and signed informed consent;
2. Age: ≥18 and ≤75 years old, male or female;
3. Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
4. With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
6. Life expectancy ≥ 12 weeks;
7. Adequate marrow and organ function;
8. AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2;
9. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration;
Exclusion Criteria:
1. Known to be allergic to the investigational drug or any of its components;
2. Have other active malignancies within 5 years;
3. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose;
4. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
5. Accompanied by untreated or active central nervous system (CNS) metastases;
6. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
7. Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
8. Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term;
9. With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
10. Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration;
11. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
12. With any active autoimmune diseases or a history of autoimmune diseases;
13. Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication;
14. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers;
15. Other situations that researchers believe should not be included.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
**State:** Shanghai
**Zip:** 200032
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427226
**Brief Title:** Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity
**Official Title:** Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients
#### Organization Study ID Info
**ID:** Dapagliflozin in breast cancer
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tanta University
#### Responsible Party
**Investigator Affiliation:** Tanta University
**Investigator Full Name:** Sandy Ehab Nabil Rezkallah
**Investigator Title:** Clinical Pharmacist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.
**Detailed Description:** Breast cancer is the most common type of cancer in women and the first cause of cancer death among them. In Egypt, it represents 33%of female cancer cases and more than 22,000 new cases are diagnosed each year. This is expected to rise exponentially over the next years given the enlarging population and changes in the population pyramid.
The Early Breast Cancer "Trialists" Collaborative Group (EBCTCG) reported that the inclusion of anthracyclines as doxorubicin in the management of breast cancer improved absolute survival by approximately 3% at 5 years and 4% at 10 years. Therefore, anthracyclines remain the cornerstone of treatment for breast cancer patients.
Despite its effectiveness, doxorubicin is associated with cumulative, dose-dependent, and potential cardiotoxicity.
Although the main mechanism of doxorubicin-induced cardiotoxicity has not been fully known, there are several mechanisms proposed for cardiac injury including oxidative stress, free radical generation, and apoptosis are most widely reported. Other mechanisms are also involved such as impaired mitochondrial function, perturbation in iron regulatory protein, disruption of Ca2+ homeostasis, autophagy, and the release of nitric oxide and inflammatory mediators.
Dapagliflozin (DAPA), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is a class of glucose-lowering agents and is used to treat patients with type 2 diabetes. Besides reducing glucose reabsorption, DAPA has shown protective effects on cardiovascular diseases. The cardioprotective effects of DAPA have been demonstrated in patients with diabetic cardiomyopathy, heart failure (HF) with preserved ejection fraction (EF), and HF with reduced EF. SGLT2 inhibitors exert their cardioprotective effect by increasing energy metabolism, mitochondrial biogenesis, autophagy, and ketone bodies while decreasing endoplasmic reticulum (ER) stress, ferroptosis, oxidative stress, and inflammation.
In a recent animal study, DAPA protected against doxorubicin-induced cardiotoxicity by reducing ER stress, as evidenced by the decreased expression of the ER-related proteins including glucose-regulated protein 78, protein kinase R-like endoplasmic reticulum kinase and transcription factor 4.
Doxorubicin administration have been shown to increase HF incidence, HF admissions, and the development of cardiomyopathy which is defined by a decline in left ventricle ejection fraction and these outcomes were attenuated by SGLT2 inhibitors.
It is known that doxorubicin increases the circulating level of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) and cardiac Troponin T (cTnT) which DAPA significantly reduced in a recent animal study.
### Conditions Module
**Conditions:**
- Doxorubicin Induced Cardiomyopathy
- Breast Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) only.
**Label:** Control Group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** 23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) plus Dapagliflozin 10 mg once daily.
**Intervention Names:**
- Drug: Dapagliflozin 10mg Tab
**Label:** Dapagliflozin group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dapagliflozin group
**Description:** Dapagliflozin 10 mg tab once daily given during the duration of AC cycles.
**Name:** Dapagliflozin 10mg Tab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Initial evaluation of cardiac function by Echocardiography at baseline and after the end of chemotherapy. The primary outcome is to avoid reduction in patients' ejection fraction during doxorubicin administration.
**Measure:** Assessment of changes in ejection fraction using echocardiography
**Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months).
#### Secondary Outcomes
**Description:** Monitoring the serum biomarker Cardiac Troponin T at baseline and after the end of chemotherapy.
**Measure:** Change in Cardiac Troponin T level
**Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months).
**Description:** Monitoring the serum biomarker NT-pro-BNP at baseline and after the end of chemotherapy.
**Measure:** Change in N-terminal pro-B-type natriuretic peptide level
**Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years old.
* Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients intended to receive at least 4 cycles of doxorubicin or more.
* Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
* Echocardiographic LVEF ≥55%.
* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
* Patients with adequate liver function and adequate renal function.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Age \<18 years old and \>65 years old.
* Patients with prior exposure to anthracyclines within the last 6 months.
* Patients with evidence of metastasis at initial assessment.
* Treatment with any SGLT-2 inhibitors for 6 months prior to the screening.
* Patients taking any other cardioprotective medications.
* Pregnancy and breast feeding.
* Alcohol abuse.
* History of heart failure or LVEF \<50%.
* Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
* Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.
**Gender Based:** True
**Gender Description:** Female breast cancer patients
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sandy Rezkallah, Bachelor
**Phone:** 01221065882
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Osama M Ibrahim, Professor
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Alexandria
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sandy E Rezkallah, Bachelor
- **Phone:** 01221065882
- **Role:** CONTACT
***Contact 2:***
- **Name:** Heba Elsheredy, Professor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Egypt
**Facility:** Medical Research Institute
**State:** Bab Sharqi
**Zip:** 21526
#### Overall Officials
**Official 1:**
**Affiliation:** faculty of pharmacy Tanta University
**Name:** Sandy E Rezkallah, bachelor
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Belen E, Canbolat IP, Yigitturk G, Cetinarslan O, Akdeniz CS, Karaca M, Sonmez M, Erbas O. Cardio-protective effect of dapagliflozin against doxorubicin induced cardiomyopathy in rats. Eur Rev Med Pharmacol Sci. 2022 Jun;26(12):4403-4408. doi: 10.26355/eurrev_202206_29079.
**PMID:** 35776041
**Citation:** Avula V, Sharma G, Kosiborod MN, Vaduganathan M, Neilan TG, Lopez T, Dent S, Baldassarre L, Scherrer-Crosbie M, Barac A, Liu J, Deswal A, Khadke S, Yang EH, Ky B, Lenihan D, Nohria A, Dani SS, Ganatra S. SGLT2 Inhibitor Use and Risk of Clinical Events in Patients With Cancer Therapy-Related Cardiac Dysfunction. JACC Heart Fail. 2024 Jan;12(1):67-78. doi: 10.1016/j.jchf.2023.08.026. Epub 2023 Oct 25.
**PMID:** 37897456
**Citation:** Chang WT, Lin YW, Ho CH, Chen ZC, Liu PY, Shih JY. Dapagliflozin suppresses ER stress and protects doxorubicin-induced cardiotoxicity in breast cancer patients. Arch Toxicol. 2021 Feb;95(2):659-671. doi: 10.1007/s00204-020-02951-8. Epub 2020 Nov 19.
**PMID:** 33211168
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000011832
- Term: Radiation Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M30670
- Name: Cardiotoxicity
- Relevance: HIGH
- As Found: Cardiotoxicity
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14679
- Name: Radiation Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T1930
- Name: Doxorubicin Induced Cardiomyopathy
- Relevance: HIGH
- As Found: Doxorubicin Induced Cardiomyopathy
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000066126
- Term: Cardiotoxicity
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hypo
- Name: Hypoglycemic Agents
### Intervention Browse Module - Browse Leaves
- ID: M7492
- Name: Doxorubicin
- Relevance: LOW
- As Found: Unknown
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: LOW
- As Found: Unknown
- ID: M348449
- Name: Dapagliflozin
- Relevance: HIGH
- As Found: COPD
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000529054
- Term: Dapagliflozin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427213
**Brief Title:** This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
**Official Title:** A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
#### Organization Study ID Info
**ID:** IIT-TN MCL
#### Organization
**Class:** OTHER_GOV
**Full Name:** Henan Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2029-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Henan Cancer Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.
**Detailed Description:** This study is a prospective, multicenter, investigator-initiated clinical trial to evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of newly diagnosed elderly or young patients with high risk MCL, aiming to find a more optimal treatment regimen for elderly or young patients with high risk MCL to improve the efficacy, survival time and quality of life of patients.
In elderly patients arm：patients start with the induction therapy of zanubrutinib combined with obinutuzumab for 1 year and then entered the maintenance therapy of zanubrutinib orally until intolerable toxicity or disease progression
In young patients with high risk arm：patiens \<65 years，and meet one or more of the following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score. patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen, and the patients who achieve CR/PR and meet the transplantation criteria will receive ASCT consolidationand, then received maintenance therapy with zanubrutinib. otherwise, Patients who is ineligible for transplantation，will take zanubrutinib orally until intolerable toxicity or disease progression.
### Conditions Module
**Conditions:**
- Lymphoma, Mantle-Cell
- Lymphoma, Non-Hodgkin
**Keywords:**
- Zanubrutinib
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 41
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Induction: Zanubrutinib and Obinutuzumab 1year
Maintenance: Zanubrutinib continued until progression
**Intervention Names:**
- Drug: Zanubrutinib,Obinutuzumab
**Label:** Elder Patients（≥65）
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Induction: Zanubrutinib and R-BAC 6 cycles
Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment
Maintenance: Zanubrutinib continued until progression
**Intervention Names:**
- Drug: Zanubrutinib and R-BAC
**Label:** Young Patients with High risk （≥18，<65）
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Elder Patients（≥65）
**Description:** Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days.
Maintenance: Zanubrutinib, 160mg PO BID
**Name:** Zanubrutinib,Obinutuzumab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Young Patients with High risk （≥18，<65）
**Description:** Induction: Zanubrutinib and R-BAC 6 cycles
Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment
Maintenance: Zanubrutinib continued until progression
**Name:** Zanubrutinib and R-BAC
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
**Measure:** Objective Response rate after induction
**Time Frame:** 3 yeas
#### Secondary Outcomes
**Description:** Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
**Measure:** Complete remission rate after Interim treatment
**Time Frame:** 3 years
**Description:** MRD negativity rate after induction treatment
**Measure:** MRD negativity rate after induction
**Time Frame:** 3 years
**Description:** The time from start of treatment to progression or death from any cause
**Measure:** Progression free survival (PFS)
**Time Frame:** 5 years
**Description:** The time from start of treatment to death from any cause
**Measure:** Overall survival (OS)
**Time Frame:** 5 years
**Description:** Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
**Measure:** Percentage of Participants With Adverse Events
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps
2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
3. The elderly group ≥65 years old;The young group was ≥18 years old and \< 65 years old.
4. ECOG Performance Status 0-3
5. Life expectancy of at least 3 months
6. At least one evaluable lesion according to 2014 Lugano criteria;
7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g/L;Absolute neutrophil count(ANC)≥0.5×10\^9/L;Platelet count（PLT）≥50×10\^9/L;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml/min（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%
Exclusion Criteria:
1. The presence of other tumors could affect the study medication or interfere with the results;
2. Patients require treatment with strong or moderate CYP3A inhibitors;
3. Pregnant or lactating women;
4. Known to be allergic to the test drug ingredients;
5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;
6. Live vaccination was administered within 28 days prior to treatment
7. Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included;
8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs
9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
10. Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** keshu Zhou
**Phone:** 0371-65587306
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: HIGH
- As Found: Lymphoma, Non-Hodgkin
- ID: M22307
- Name: Lymphoma, Mantle-Cell
- Relevance: HIGH
- As Found: Lymphoma, Mantle-Cell
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T3601
- Name: Mantle Cell Lymphoma
- Relevance: HIGH
- As Found: Mantle Cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000020522
- Term: Lymphoma, Mantle-Cell
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M288906
- Name: Obinutuzumab
- Relevance: HIGH
- As Found: Contraction
- ID: M42199
- Name: Zanubrutinib
- Relevance: HIGH
- As Found: Allowing
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000543332
- Term: Obinutuzumab
- ID: C000629551
- Term: Zanubrutinib
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427200
**Brief Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients
**Official Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients
#### Organization Study ID Info
**ID:** CL(3530)
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
#### Secondary ID Infos
**Domain:** the general organization for teaching hospitals and institutes (GOTHI)
**ID:** IHC00072
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** reham mohamed saied salem
**Investigator Title:** Teaching assistant at Faculty of Pharmacy Cairo University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency.
•Patients will be randomly distributed into the three groups
* All patients will be subjected to baseline data assessment
* Follow up after 12 weeks
### Conditions Module
**Conditions:**
- Heart Failure With Reduced Ejection Fraction
**Keywords:**
- Lactoferrin
- oral iron
- reduced ejection fraction
- iron deficiency
- heart failure
- clinical trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 114
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: oral Iron
**Label:** group "oral iron"
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Lactoferrin
**Label:** group "lactoferrin"
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: lactoferrin and oral iron
**Label:** group "lactoferrin and oral iron"
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group "oral iron"
**Description:** oral iron once daily during or after meals as add-on therapy for 12 weeks.
**Name:** oral Iron
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- group "lactoferrin"
**Description:** lactoferrin twice daily before meals as add-on therapy for 12 weeks.
**Name:** Lactoferrin
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- group "lactoferrin and oral iron"
**Description:** lactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks.
**Name:** lactoferrin and oral iron
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** • Change in health-related quality of life (HR-QoL) as evaluated by Minnesota Living with Heart Failure Questionnaire (MLHFQ) minimum score:0 maximum score:105 minimum score is a better outcome
**Measure:** Change in health-related quality of life (HR-QoL)
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age: 18-65 years old.
2. Chronic heart failure (\> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
3. NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
4. Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and diuretics as needed.
5. No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)
6. No introduction of a new heart failure drug class during the last 4 weeks.
7. Iron deficiency: serum ferritin level of 15 to 100 ng/mL or a serum ferritin level of 101 to 299 ng/mL with transferrin saturation of less than 20%.
Exclusion Criteria:
* 1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min).
2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. Associated chronic medical disorder (chronic kidney disease (creatinine clearance \< 60 ml/min), liver disease (ALT or AST \> 3× upper limit of normal), peptic ulcer or chronic blood loss).
5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) \< 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M20857
- Name: Anemia, Iron-Deficiency
- Relevance: LOW
- As Found: Unknown
- ID: M2781
- Name: Iron Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Intervention Browse Module - Ancestors
- ID: D000014131
- Term: Trace Elements
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M10799
- Name: Lactoferrin
- Relevance: HIGH
- As Found: Peripheral Neuropathy
- ID: M10533
- Name: Iron
- Relevance: HIGH
- As Found: Gastric
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007501
- Term: Iron
- ID: D000007781
- Term: Lactoferrin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427187
**Brief Title:** Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
**Official Title:** Outcomes of Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
#### Organization Study ID Info
**ID:** Mechanical throbectomy
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Mohamed Zayed Saber
**Investigator Title:** assistant lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage
**Detailed Description:** DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor.
### Conditions Module
**Conditions:**
- Acute Ischemic Stroke
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Each presenting Patient subjected to:
* careful history including Age, Sex, comorbid diseases (hypertension, Diabetes, dyslipidemia, cardiac disease...), time from onset to treatment
* examination: Vital signs
* NIHSS at admission
* Lab investigation: basic lab, metabolic profile \& Lipid profile
* The diagnosis was made using a standard CT stroke protocol including CT head Aspect score, arterial CT angiography, and perfusion CT. In some cases, primary stroke MRI was performed including fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI): in order to evaluate location of occluded vessel, size of ischemic core \& penumbra).
All patients received either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each presenting Patient with acute distal vessel occlusion of anterior circulation with (A1-A3)or (M2-M3) either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both.
**Intervention Names:**
- Device: an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems
**Label:** distal vessel occlusion Mechanical thromectomy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- distal vessel occlusion Mechanical thromectomy
**Description:** each patient with distal vessel occlusion subjected to mechanical thrombectomy using aspiration technique or stent retriever
**Name:** an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches:
grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
**Measure:** Thrombolysis in Cerebral Infarction (TICI)
**Time Frame:** 1 day , 10 day
**Description:** grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2 grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory) grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories) grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels this was not part of the original mTICI score, but was added later and has since become widely accepted as being part of the scoring 4 grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
**Measure:** modified Thrombolysis in Cerebral Infarction scale (mTICI)
**Time Frame:** 1 day , 10 day
#### Secondary Outcomes
**Description:** 90 Days modified Rankin scale (mRS) score The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all
1. No significant disability despite symptoms; able to carry out all usual duties and activities
2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
3. Moderate disability; requiring some help, but able to walk without assistance
4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
6. Dead
**Measure:** mRS
**Time Frame:** three months
**Description:** Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).
**Measure:** Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).
**Time Frame:** three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* a. Inclusion criteria:
1. Diagnosis of an acute ischemic stroke due to an occlusion of the anterior cerebral artery (ACA) in the A1-A3 segment 2. Diagnosis of an acute ischemic stroke due to an occlusion of the middle cerebral artery in the distal M2 segment or the M3 segment.
Exclusion Criteria:
1. Posterior circulation small vessel occlusion
2. Tandem lesions with occlusion of the ipsilateral ICA were excluded.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohamed zayed, Master degree
**Phone:** +20109809943
**Role:** CONTACT
### References Module
#### References
**Citation:** Kunz WG, Almekhlafi MA, Goyal M. Distal Vessel Occlusions: When to Consider Endovascular Thrombectomy. Stroke. 2018 Jul;49(7):1581-1583. doi: 10.1161/STROKEAHA.118.021887. Epub 2018 Jun 18. No abstract available.
**PMID:** 29915118
**Citation:** Sepp D, Hernandez Petzsche MR, Zarth T, Wunderlich S, Ikenberg B, Maegerlein C, Zimmer C, Berndt MT, Boeckh-Behrens T, Kirschke JS. Mechanical thrombectomy of distal cerebral vessel occlusions of the anterior circulation. Sci Rep. 2023 Apr 7;13(1):5730. doi: 10.1038/s41598-023-32634-0.
**PMID:** 37029202
**Citation:** Saver JL, Chapot R, Agid R, Hassan A, Jadhav AP, Liebeskind DS, Lobotesis K, Meila D, Meyer L, Raphaeli G, Gupta R; Distal Thrombectomy Summit Group*dagger. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. 2020 Sep;51(9):2872-2884. doi: 10.1161/STROKEAHA.120.028956. Epub 2020 Aug 6. No abstract available. Erratum In: Stroke. 2020 Oct;51(10):e296.
**PMID:** 32757757
**Citation:** Kobeissi H, Bilgin C, Ghozy S, Kadirvel R, Kallmes DF, Brinjikji W. A review of acute ischemic stroke caused by distal, medium vessel occlusions. Interv Neuroradiol. 2023 Aug 29:15910199231197616. doi: 10.1177/15910199231197616. Online ahead of print.
**PMID:** 37644821
**Citation:** Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, Harris GJ, Halpern EF, Koroshetz WJ, Smith WS, Nogueira RG. Prognosis of untreated strokes due to anterior circulation proximal intracranial arterial occlusions detected by use of computed tomography angiography. JAMA Neurol. 2014 Feb;71(2):151-7. doi: 10.1001/jamaneurol.2013.5007.
**PMID:** 24323077
**Citation:** Elhorany M, Rosso C, Shotar E, Baronnet-Chauvet F, Premat K, Lenck S, Crozier S, Corcy C, Bottin L, Mansour OY, Talbi A, El-Din EAT, Fadel WA, Sourour NA, Alamowitch S, Samson Y, Clarencon F. Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: A monocentric retrospective comparative study. J Neuroradiol. 2022 Jun;49(4):311-316. doi: 10.1016/j.neurad.2022.03.008. Epub 2022 Apr 6.
**PMID:** 35397949
**Citation:** Guenego A, Mine B, Bonnet T, Elens S, Vazquez Suarez J, Jodaitis L, Ligot N, Naeije G, Lubicz B. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13). Interv Neuroradiol. 2022 Aug;28(4):444-454. doi: 10.1177/15910199211039926. Epub 2021 Sep 13.
**PMID:** 34516332
**Citation:** Alawieh AM, Chalhoub RM, Al Kasab S, Jabbour P, Psychogios MN, Starke RM, Arthur AS, Fargen KM, De Leacy R, Kan P, Dumont TM, Rai A, Crosa RJ, Maier I, Goyal N, Wolfe SQ, Cawley CM, Mocco J, Tjoumakaris SI, Howard BM, Dimisko L, Saad H, Ogilvy CS, Crowley RW, Mascitelli JR, Fragata I, Levitt MR, Kim JT, Park MS, Gory B, Polifka AJ, Matouk C, Grossberg JA, Spiotta AM; STAR Collaborators. Multicenter investigation of technical and clinical outcomes after thrombectomy for distal vessel occlusion by frontline technique. J Neurointerv Surg. 2023 Sep;15(e1):e93-e101. doi: 10.1136/jnis-2022-019023. Epub 2022 Aug 2.
**PMID:** 35918129
**Citation:** Sweid A, Head J, Tjoumakaris S, Xu V, Shivashankar K, Alexander TD, Dougherty JA, Gooch MR, Herial N, Hasan D, DePrince M, Rosenwasser RH, Jabbour P. Mechanical Thrombectomy in Distal Vessels: Revascularization Rates, Complications, and Functional Outcome. World Neurosurg. 2019 Oct;130:e1098-e1104. doi: 10.1016/j.wneu.2019.07.098. Epub 2019 Jul 16.
**PMID:** 31323418
**Citation:** Atchaneeyasakul K, Malik AM, Yavagal DR, Haussen DC, Jadhav AP, Bouslama M, Kenmuir CL, Desai S, Grossberg JA, Chaturvedi S, Jovin TG, Nogueira RG. Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent Retriever versus Aspiration: A Multicenter Experience. Interv Neurol. 2020 Jan;8(2-6):180-186. doi: 10.1159/000500198. Epub 2019 Jun 18.
**PMID:** 32508900
**Citation:** Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Hussain MS, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke: From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO). J Vasc Interv Radiol. 2018 Apr;29(4):441-453. doi: 10.1016/j.jvir.2017.11.026. Epub 2018 Mar 1. No abstract available.
**PMID:** 29478797
**Citation:** Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
**PMID:** 23920012
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
- ID: D000007238
- Term: Infarction
- ID: D000009336
- Term: Necrosis
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M10282
- Name: Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000002544
- Term: Cerebral Infarction
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427174
**Brief Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries
**Official Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries
#### Organization Study ID Info
**ID:** FB vs CB
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Ahmed Atef Ahmed
**Investigator Title:** Dr
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study is aimed to determine which of the two methods , either the fascia iliaca block or the caudal block is better in managing the post operative pain and by which decreasing the consumption of analgesic drugs post operatively and making the patient more comfortable.
**Detailed Description:** Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site.(1) Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period.4,5 Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.6 Often, the donor site is reported to be more painful than the recipient site,7 affecting early mobilization, sleep, and need for analgesics postoperatively.(1) Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.(2) Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia.(2) Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves(3) American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.(4) Prolongation of analgesia after any surgery is the goal of any phsyician ,and Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in many surgeries, is a nerve block technique with proven efficacy. but which has the superior effect of numbing the pain ..Is it the fascia iliaca erve block or the caudal block .
The objective of this study is to compare post operative analgesic effect and safety of fascia iliaca nerve block versus caudal block in pediatric patient undergoing a graft surgery .
### Conditions Module
**Conditions:**
- Fascia Iliaca Block, Analgesia, Pediatric Surgeries
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Patients and anesthesiologist won't know which group is patients will selected
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position after sterilization of skin over the groin area at the side from which split thickness graft will be taken, high frequency ultrasound probe
**Intervention Names:**
- Drug: Fascia iliaca block
**Label:** Fascia iliaca group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** And the second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.
With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus can be identified .First of all, the posterior superior iliac spines are palpated via anatomical landmarks, the line between both spines (Tuffier's line) representing the base of an equilateral triangle the tip of which indicates the position of the sacral hiatus. The sacrococcygeal ligament can be palpated between the two sacral cornua, which is where the needle should penetrate the skin at an approximate 45° angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle before it can be advanced to the correct final position.
**Intervention Names:**
- Drug: Caudal block
**Label:** Caudal block
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fascia iliaca group
**Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position
**Name:** Fascia iliaca block
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Caudal block
**Description:** second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.
**Name:** Caudal block
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Postoperative analgesia using FLACC score
**Measure:** Postoperative analgesia using FLACC score
**Time Frame:** 1-24 hour postiperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 2- 12 years. ASA I - II Scheduled for split thickness grafting. Availability and suitability of lateral and anterior aspects of the thigh as a donor site.
Exclusion Criteria:
* Patient's gaurdian refusal to participate in the study. Known allergy to local anesthetics Coagulopathy. Patient with motor or sensory deficits in lower extremities. Prior surgery of the inguinal or suprainguinal area . Children who are morbidly obese (BMI≥30) because ultrasound guided regional anesthesia could be too technically difficult.
**Healthy Volunteers:** True
**Maximum Age:** 12 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ahmed Mohamed Atef
**Phone:** 00201003029794
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mohamed Talaat Mohamed
**Phone:** 00201062012031
**Role:** CONTACT
### References Module
#### References
**Citation:** Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.
**PMID:** 30857607
**Citation:** Bromage PR. A comparison of the hydrochloride salts of lignocaine and prilocaine for epidural analgesia. Br J Anaesth. 1965 Oct;37(10):753-61. doi: 10.1093/bja/37.10.753. No abstract available.
**PMID:** 5847259
**Citation:** Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
**PMID:** 12421743
**Citation:** Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
**PMID:** 9220806
**Citation:** Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
**PMID:** 29319604
**Citation:** Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.
**PMID:** 22657583
**Citation:** Shank ES, Martyn JA, Donelan MB, Perrone A, Firth PG, Driscoll DN. Ultrasound-Guided Regional Anesthesia for Pediatric Burn Reconstructive Surgery: A Prospective Study. J Burn Care Res. 2016 May-Jun;37(3):e213-7. doi: 10.1097/BCR.0000000000000174.
**PMID:** 25412051
**Citation:** Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.
**PMID:** 28598907
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427161
**Brief Title:** Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea
**Official Title:** Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome
#### Organization Study ID Info
**ID:** R.23.03.2095-2023/03/07
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2024-04-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-05
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mansoura University
#### Responsible Party
**Investigator Affiliation:** Mansoura University
**Investigator Full Name:** Amira attia
**Investigator Title:** Assistant professor of oral and maxillo-facial surgery Faculty of Dentistry, Mansoura University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study was conducted on 26 patients with obstructive sleep apnea. The patients were divided randomly and equally into two equal groups. In group I, the patients were treated with LLLT, while in group II, the patients were treated with dextrose injection. The patients were evaluated by: Medical history utilizing sleep unit medical sheet, physical examination including: anthropometric measures, epworth sleepiness scale, and Berlin questioner, and Polysomnography
**Detailed Description:** This study was conducted on 26 patients with OSA attending to sleep disorders breathing Unit, Chest Department and oral and maxillofacial department at Mansoura University confirmed by polysomnography. The study was implemented over 2 months. The patients were divided randomly and equally into two therapy groups each compromise 13 patients:
Group I: patients will be treated with LLLT. Group II: patients will be treated with dextrose injection.
Interventions:
The LLLT group received the laser application at 8 points, once a week, over a 2-month period, totaling 8 sessions. Each point was stimulated for 8 seconds in the soft palate, uvula, pharyngeal walls, palatine tonsils, and on the tongue base. LLLT protocol: Diode laser 810nm in continuous contact mode will be used, and the radiant energy will be 2J (250uw X 8 sec) for each point. Total energy will be 16J (2J X 8 points) for each session.
Dextrose injection Protocol: 25% dextrose was injected in the same 8 points; 1/2 ml for each point, total 4ml for each session. The injection was done weekly, up to 4 sessions.
Clinical assessment
* Medical history utilizing sleep unit medical sheet will be taken from all patients: Attention was given to Night symptoms such as snoring, choking, witnessed apnea, bad dreams, and nocturia, and daytime symptoms (morning headache, excessive daytime sleepiness.
* Physical examination including: Anthropometric measures: Height, weight, body-mass index (BMI), teeth imprint, abdominal circumference, Epworth sleepiness scale (Arabic version), and Berlin questioner (Arabic version)
* Polysomnography
### Conditions Module
**Conditions:**
- Obstructive Sleep Apnea
**Keywords:**
- Dextrose
- LLLT
- obstructive sleep apnea
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 26
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients were treated with LLLT.
**Intervention Names:**
- Procedure: LLLT application
- Procedure: dextrose injection
**Label:** Group Ipatients were treated with LLLT.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** patients were treated with dextrose injection.
**Intervention Names:**
- Procedure: LLLT application
- Procedure: dextrose injection
**Label:** Group II
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group II
- Group Ipatients were treated with LLLT.
**Description:** The LLLT group received the laser application at 8 points, once a week, over a 2-month period, totaling 8 sessions. Each point was stimulated for 8 seconds in the soft palate, uvula, pharyngeal walls, palatine tonsils, and on the tongue base. LLLT protocol: Diode laser 810nm in continuous contact mode was used, and the radiant energy was 2J (250uw X 8 sec) for each point. Total energy was 16J (2J X 8 points) for each session.
**Name:** LLLT application
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group II
- Group Ipatients were treated with LLLT.
**Description:** 25% dextrose was injected in the same 8 points; 1/2 ml for each point, total 4ml for each session. The injection was done weekly, up to 4 sessions.
**Name:** dextrose injection
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** No chance of dozing =0, Slight chance of dozing =1, Moderate chance of dozing =2, High chance of dozing =3
**Measure:** Epworth sleepiness scale
**Time Frame:** 1 week after last treatment session.
**Description:** • All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department.
**Measure:** Polysomnography
**Time Frame:** 1 week after last treatment session.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment
Exclusion Criteria:
1. Pregnant patients
2. Active infectious disease (flu like symptoms).
3. Serious co-morbidity such as chronic or decompensated liver disease, and chronic kidney disease with creatinine clearance less than 30%.
4. Patients with neuromuscular disorders.
5. Previous trauma to the head, and neck.
6. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
7. Tonsil size ≥ +3.
8. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
9. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
10. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
11. History of radiation therapy to neck or upper respiratory tract
12. Patients with any cardiac diseases such as heart failure, rheumatic heart diseases, coronary artery disease, and myocardial infarction (MI).
13. Patients take up medications that will alter pain perception.
14. History of dementia or active psychiatric disease that may impact study compliance.
15. Patients who refuse the procedure.
-
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Al Mansoura City
**Country:** Egypt
**Facility:** Mansoura University
**State:** Eldakahlia
**Zip:** 35516
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4361
- Name: Apnea
- Relevance: HIGH
- As Found: Apnea
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Sleep Apnea
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001049
- Term: Apnea
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427148
**Brief Title:** Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
**Official Title:** Golden Breath: Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
#### Organization Study ID Info
**ID:** EU
#### Organization
**Class:** OTHER
**Full Name:** Koç University
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Koç University
#### Responsible Party
**Investigator Affiliation:** Koç University
**Investigator Full Name:** Eysan Hanzade Umac
**Investigator Title:** Research assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The biofeedback-assisted VR game "Golden Breath" that investigators presented in this study was designed to meet children's healthcare needs quickly and efficiently while reducing pain and fear during medical procedures in the pediatric population. "Golden Breath" utilizes biofeedback techniques in a VR environment to ensure the active participation of children. By encouraging the practice of breathing techniques throughout the game, the game aims to reduce negative emotions associated with medical procedures. Through this innovative approach, investigators aim to provide new evidence supporting the effectiveness of VR and biofeedback interventions in pediatric clinical settings and ultimately improve children's overall experience during medical interventions.
**Detailed Description:** Children's increasing interest in phones, tablets, and computer games has led to the integration of technological interventions in pediatric healthcare services. Innovations such as telemedicine, telerehabilitation, mobile health applications, virtual reality (VR), and mobile games provide easy and accessible ways to meet children's health needs. VR, in particular, has gained popularity as a technological intervention, with numerous studies evaluating its effectiveness during children's medical procedures. Research has shown that VR use during procedures like port catheter needle insertion significantly reduces pain and fear. Similarly, VR during venipuncture has been found to positively affect children's pain, fear, and anxiety levels.
In addition to VR, integrating biofeedback technologies into VR experiences has shown positive effects on children's psychosocial outcomes. Studies on biofeedback-based VR games highlight their anxiety-reducing effects. For instance, a biofeedback-based VR game was found to reduce anxiety in children, and a neurofeedback video game, MindLight, significantly lowered anxiety levels. Another study found that a biofeedback-based video game during venipuncture helped distract children from the painful procedure, reducing their pain levels.
Combining VR and biofeedback technologies is believed to enhance intervention outcomes. Biofeedback alone may provide overly abstract or complex visual feedback, while the increased interactivity of VR boosts user engagement. Effective attention capture and active participation are crucial for developing skills and ensuring consistency through these technologies. Biofeedback in VR helps users control their physiological parameters, which is particularly beneficial for children, who can be difficult to engage effectively. These technologies can serve as effective methods for distracting children during medical procedures.
Pediatric medical procedures often cause pain, fear, and anxiety, which can persist long after the procedure and complicate treatment adherence. Therefore, controlling pain, fear, and anxiety is extremely important. Recent analyses highlight the potential of VR and biofeedback-assisted interventions to alleviate emotional distress in children. Moreover, the rise in digital engagement encourages healthcare professionals to develop new approaches to support child health in clinical settings.
### Conditions Module
**Conditions:**
- Pediatric Population
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Feedback was gathered from 10 pediatricians and nurses. Additionally, 5 inpatient children at Koç University Hospital provided their opinions on GoldenBreath, assessing ease of use, clarity, content appropriateness, sound volume, instruction clarity, game duration, and improvement suggestions. Based on feedback from 2 children suggesting more gold coins and longer game duration, options were added to adjust these elements in the game's menu.
Stage 2: Following expert and child evaluations, a preliminary trial was conducted with 13 children at Koç University Hospital's pediatric outpatient clinic. The researcher met with children and parents ten minutes before the procedure. Children tried the game, using VR headsets and earphones during the procedure while receiving routine care.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** To evaluate the feasibility and safety of the GoldenBreath before and after the procedure, the researchers asked the children to report their fears about the procedure. In addition, the children were asked to indicate the pain level they experienced, especially during the needle procedure. Possible missing data, withdrawal from the trial, and intervention fidelity were monitored during this process. Also, the children were monitored for fifteen minutes to see if they experienced any side effects related to the intervention.
**Intervention Names:**
- Other: The biofeedback-assisted VR game "Golden Breath"
**Label:** Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** The biofeedback-assisted VR game "Golden Breath" that we presented in this study was designed to meet children's healthcare needs quickly and efficiently while reducing pain and fear during medical procedures in the pediatric population. "Golden Breath" u
**Name:** The biofeedback-assisted VR game "Golden Breath"
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It is used to evaluate pain in children. The scale consists of six facial expressions. Facial expressions range from 0 points, "no pain-very happy" to 10 points, "unbearable pain-crying." (Wong-Baker Foundation. Home - wong-baker FACES foundation, 9.3.20. https://wongbakerfaces.org/)
**Measure:** Pain-Wong-Baker Pain Assessment Scale
**Time Frame:** immediately after the intervention
**Description:** The scale consists of five facial expressions. In facial expressions, 0 indicates no fear, and 4 indicates severe fear (McKinley et al., 2008). The Turkish validity and reliability of the Child Fear Scale were conducted by Gerçeker and her colleagues (Özalp Gerçeker et al., 2018).
**Measure:** Fear- Child Fear Scale
**Time Frame:** baseline and immediately after the intervention
**Description:** The form created by researchers using the literature to get feedback from children about GoldenBreath consists of eight questions. It includes questions such as: Did you think the game was easy to play? Was the game suitable in terms of content? Was the sound level in the game appropriate? Was it easy for you to follow the instructions in the game? Was the use of the game sufficient in terms of time throughout the process? Is there a feature you would like to add to the game? Have you ever felt uncomfortable while playing the game?
**Measure:** GoldenBreath Evaluation Form
**Time Frame:** During the development phase of the game
**Description:** The scale was created by Hoehle (Hoehle, Aljafari, \& Venkatesh, 2016), and its Turkish adaptation was made by Güler in 2019 (Güler, 2019). This tool provides information about the colors, text styles, font sizes, transitivity, application management, etc., used in the mobile application. It is used to evaluate the properties. The scale is a 7-point Likert-type measurement tool and consists of a total of 40 questions. In our study, it was used to obtain expert opinions.
**Measure:** Mobile Application Usability Scale
**Time Frame:** During the development phase of the game
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged 4-12
* Applied to Koç University Hospital Pediatrics Outpatient Clinic
Exclusion Criteria:
* Children with a pain score \<2 before the procedure
* Participants with previous experience with respiratory biofeedback in VR
**Healthy Volunteers:** True
**Maximum Age:** 12 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eyşan Savaş
**Phone:** 5068418841
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427135
**Brief Title:** A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD
**Official Title:** A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in Inflammatory Bowel Disease: a Single-center, Randomized Controlled Trial
#### Organization Study ID Info
**ID:** WDRY2024-K058
#### Organization
**Class:** OTHER
**Full Name:** Renmin Hospital of Wuhan University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-19
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ping An
#### Responsible Party
**Investigator Affiliation:** Renmin Hospital of Wuhan University
**Investigator Full Name:** Ping An
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.
**Detailed Description:** Inflammatory bowel disease (IBD) is a chronic inflammatory bowel disease that mainly involves the digestive system, including Crohn's disease (CD) and ulcerative colitis (UC).CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation and intestinal obstruction. CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation, and intestinal obstruction; UC is characterized by diarrhea, mucopurulent blood stools, and abdominal pain, and the peak age of onset is between 15 and 40 years old. Notably, many studies have shown that patients with inflammatory bowel disease commonly suffer from malnutrition, low body mass index (BMI), muscle atrophy, decreased bone density, and fatigue and anxiety, and that surgery is not a one-time event, with patients often requiring several surgeries.
Current treatment strategies focus on medication, nutritional support and nursing care, neglecting other possible adjunctive treatments.
Exercise interventions, as an effective adjunctive therapy for inflammatory bowel disease, have been shown to have anti-inflammatory, anti-muscle atrophic, and physical enhancement effects, improve psychological status, and also have beneficial effects on intestinal flora and intestinal absorption. Exercise is also economical, efficient and highly feasible, making it more acceptable to IBD patients. With the integration of physical medicine and the implementation of Healthy China, the role of exercise intervention in the majority of patients will be more important and its application will be more extensive.
Multimodal wearable device is a simple and efficient miniaturized smart device commonly used in the field of exercise, which can monitor the wearer's heart rate, blood oxygen, step count, exercise data in real time, etc. This group proposes to combine the multimodal wearable device as an auxiliary device with the exercise intervention for patients with inflammatory bowel disease (IBD), which is the first of its kind in China.
Most of the current studies are conducted on the conditions of small samples, single period, and single exercise modality, lack of studies on large samples and multi index evaluation, and the field has not yet formed a unified consensus on personalized exercise intervention for different levels of patients. There is still considerable work to be done on the study of exercise interventions for the treatment of inflammatory bowel disease.
Therefore, this group proposes to conduct a randomized controlled trial to investigate the effects of exercise intervention on body composition and disease progression in patients with inflammatory bowel disease.
### Conditions Module
**Conditions:**
- Inflammatory Bowel Diseases
**Keywords:**
- Exercise interventions
- Inflammatory Bowel Diseases
- Wearable Device
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a prospective randomized controlled study divided into intervention and control groups.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 56
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adding exercise intervention therapy to existing medications
**Intervention Names:**
- Behavioral: Exercise interventions
**Label:** Exercise interventions
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No exercise intervention, use of existing medication.
**Label:** Conventional drug therapy
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise interventions
**Description:** Rehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise.
**Name:** Exercise interventions
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P \< 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m\^2.
**Measure:** skeletal muscle mass index
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
#### Secondary Outcomes
**Description:** Changes before and after the intervention were assessed by means of a quality of life questionnaire (Inflammatory Bowel Disease Questionnaire, IBDQ) with a total score of 224, the higher the better.
**Measure:** Quality of life rating
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Changes before and after the intervention were assessed by means of the Anxiety and Depression Scale (Hospital Anxiety and Depression Scale, HADS), with a total HADS score of 42, with higher scores indicating worse indicators.
**Measure:** Psychological assessment
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Changes before and after the intervention were assessed by means of a fatigue scale (Functional Assessment of Chronic Illness Therapy, FACIT), with a total FACIT score of 52, with a higher score indicating a better indicator.
**Measure:** Fatigue status assessment
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Detecting changes in subjects' body fat percentage using a body composition analyzer
**Measure:** body fat percentage
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Changes in muscle strength (kg) in the limbs of the subjects were detected using a plyometer.
**Measure:** muscle power
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Changes in spirometry (mL) before and after the intervention were tested using an electronic spirometry tester.
**Measure:** spirometry
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** Test for changes in fecal calprotectin (FCP) levels in subjects before and after the intervention.The normal range for FCP is less than 100 ng/mL.
**Measure:** Fecal calprotectin level
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
**Description:** To test for changes in subjects' C-reactive protein (CPR) levels before and after the intervention.The normal range for CRP is less than 5.2 mg/l for adult males and less than 4.6 mg/l for adult females.
**Measure:** C-reaction protein level
**Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Commitment to comply with the study procedures and cooperate in the implementation of the full study
* Age ≥ 18 years old, gender is not limited
* Muscle strength examination of all four limbs is greater than or equal to grade 3
* Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission
* Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety
* Voluntarily sign a written informed consent
Exclusion Criteria:
* Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control
* Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc
* Persons with unstable vital signs
* Presence of cognitive, communication disorders
* Patients who have recently undergone gastrointestinal surgery (\<1 month) or who have not fully healed
* Short bowel syndrome
* Presence of extra-intestinal manifestations and complications that interfere with therapy, such as retinopathy, deep vein thrombosis, etc
* Pregnant or lactating women
* Active tuberculosis; if subjects are suspected of having active tuberculosis, chest X-ray, sputum and exclusion by clinical signs and symptoms are required
* Other potential subjects who are not suitable for participation in this study
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ping An
**Phone:** +8618627068700
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Renmin Hospital of Wuhan University
**Name:** Ping An
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005759
- Term: Gastroenteritis
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: HIGH
- As Found: Inflammatory Bowel Disease
- ID: M10444
- Name: Intestinal Diseases
- Relevance: HIGH
- As Found: Bowel Disease
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000015212
- Term: Inflammatory Bowel Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427122
**Acronym:** EMD-U vs CAU
**Brief Title:** Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
**Official Title:** The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
#### Organization Study ID Info
**ID:** 11074
#### Organization
**Class:** OTHER
**Full Name:** Erasmus Medical Center
#### Secondary ID Infos
**Domain:** ToetsingOnline
**ID:** NL84417.078.23
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-07
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tamar Nijsten
#### Responsible Party
**Investigator Affiliation:** Erasmus Medical Center
**Investigator Full Name:** Tamar Nijsten
**Investigator Title:** Prof.
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary objective of this open randomised controlled trial is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.
The main study parameter is the difference in treatment effect between EMD-U and CAU at T2, measured with the Skindex-29 symptoms scale. There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.
Patients are randomly allocated to either the EMD-U or CAU condition.
**Detailed Description:** Rationale: The EMD protocol for urge (EMD-U) is a recently developed treatment that combines elements of Eye Movement Desensitization and Reprocessing (EMDR) therapy, Cognitive Behaviour therapy, and hypnotherapy. EMD-U aims to reduce the urge for scratching behaviour through desensitization techniques, self-registration of behaviour, and homework assignments. The EMD-U treatment has shown promising results in reducing scratching behaviour in patients with atopic dermatitis and is currently being investigated in patients with prurigo nodularis. Yet, the added value of the brief EMD-U intervention in addition to the care as usual (CAU) in improving dermatology-specific quality of life is unknown.
Objective: The primary objective of the study is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.
Study design: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control). There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.
Study population: Patients with atopic dermatitis or prurigo nodularis who suffer from substantial scratching behaviour.
Intervention (if applicable): Patients are randomly allocated to either the EMD-U or CAU condition.
The EMD-U treatment lasts eight weeks, in which two EMD-U sessions and two phone calls take place in the first three weeks. After the first EMD-U session, patients are instructed to apply the learned technique at home until the end of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.
### Conditions Module
**Conditions:**
- Atopic Dermatitis
- Prurigo Nodularis
**Keywords:**
- EMD Protocol for Urge
- Quality of Life
- Itch
- Scratching
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control).
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The EMD-U treatment lasts eight weeks, in which two EMD-U sessions of 60 minutes and two phone calls take place in the first three weeks. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home. An important part of EMD-U consists of homework exercises. These homework exercises comprise to practice/apply the intervention as learned during the sessions with the therapist, in those situations wherein the urge to scratch their skin is present. In the text below, we will explain in more detail what the treatment protocol entails. Patients in this condition receive the EMD-U treatment in addition to the care as usual.
**Intervention Names:**
- Behavioral: EMD Protocol for Urge
- Other: Care as Usual
**Label:** EMD-U
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in the control group receive care as usual (CAU), which is the standard care of the dermatologist. In addition to completing the questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any additional treatment or support aimed at their scratching behaviour.
**Intervention Names:**
- Other: Care as Usual
**Label:** Care as Usual
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EMD-U
**Description:** During the EMD-U sessions, the patient is asked to focus on the spot on his/her skin where the urge to scratch is highest. The patient is asked to rate the level of urge to scratch this spot on a 10-point scale and to imagine that they scratch this spot as they would like. At the same time eye movements are offered for 30 seconds. This procedure is repeated until the level of urge to scratch has become nihil. This procedure is repeated for all other skin parts where the patient experiences an urge to scratch, until there are no skin parts left. As a homework assignment straight after the first session, the patient is instructed and encouraged to practice the same intervention at home. The two EMD-U sessions and two phone calls, take place in the first three weeks of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.
**Name:** EMD Protocol for Urge
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Care as Usual
- EMD-U
**Description:** Patients in the control group receive care as usual (CAU), which is the standard care of the dermatologist. In addition to completing the questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any additional treatment or support aimed at their scratching behaviour.
**Name:** Care as Usual
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** The LEC-5 is a 17-item self-report questionnaire designed to screen for potentially traumatic events in a respondent's lifetime. It identifies whether the person has gone through any of the listed events, and there is no definitive scoring procedure or interpretation involved. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale, and respondents may endorse multiple levels of exposure to the same trauma type. The LEC-5 does not yield a total score or composite score.
**Measure:** Life Events Checklist for DSM-5 (LEC-5)
**Time Frame:** At start of study (T0)
**Description:** The TEX-Q is a 15-item self-report questionnaire assessing patients' expectations of medical and psychological treatments. The scale of the items ranges from 0 to 10. Higher scores indicate higher expectations. The English version of the TEX-Q will be translated into Dutch, using the FACIT translation methodology.
**Measure:** Treatment Expectation Questionnaire (TEX-Q)
**Time Frame:** At start of study (T0)
**Description:** patients are requested to assess their capacity for engaging in visuomotor activities through mental imagery, utilizing a 4-point Likert scale ranging from 0 (totally disagree) to 3 (totally agree). A higher score indicates better imagination capacity.
**Measure:** Mental imagery
**Time Frame:** At start of study (T0)
**Description:** Number of hospital visits and medication
**Measure:** Visits
**Time Frame:** Six months after start study (T4)
#### Primary Outcomes
**Description:** The main study outcome is the dermatology-specific health-related quality of life (HRQOL). It consists of 30 items to be scored on a 5-point response scale. Outcome ranges from 0 (never) to 100 (all the time). The sum of scores is devided by the number of items answered. Higher scores indicate worse quality of life. The instrument has three subscales: symptoms, emotions, and functioning.
**Measure:** Skindex-29
**Time Frame:** measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
#### Secondary Outcomes
**Description:** This is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.
The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores indicate higher disease activity.
**Measure:** Eczema Area and Severity Index (EASI)
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
**Description:** The IGA is a 5-point tool for the objective assessment of chronic prurigo. The IGA for stage of chronic nodular prurigo (CNPG) and signs of activity in chronic prurigo are used. Items range from 0 (clear) to 4 (severe). Higher scores indicate higher disease activity.
**Measure:** Investigator Global Assessment (IGA)
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
**Description:** It is a generic instrument that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale.
Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The visual analogue scale (VAS), on which the patient rates his/her perceived health, ranges from 0 (the worst imaginable health) to 100 (the best imaginable health).
**Measure:** EQ-5D-5L
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
**Description:** The ZCCL is an 11-item self-report questionnaire measuring perceived self-control. There are two subscales: 'positive reward' (of the unwanted behaviour) and 'difficulty resisting'. Each item is scored on a 5-point Likert scale, ranging from 1 (not applicable at all) to 5 (totally applicable). Total score ranges from 11-55. Higher scores indicate less self-control.
**Measure:** The Self-Control Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL)
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
**Description:** The PHQ-4 is a brief self-report screening tool for depression and anxiety, consisting of four items. Two items on depression, and two items on anxiety are scored with a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate more depression and anxiety symptoms.
**Measure:** Patient Health Questionnaire for anxiety and depression (PHQ-4)
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
**Description:** a six-item self-report measure for the assessment of skin picking behaviour. The scale has a total score range of 0-24. Higher scores indicate more skin picking.
**Measure:** Skin Picking Scale (SPS)
**Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 ≥
* A confirmed diagnosis of atopic dermatitis or prurigo nodularis
* Suffering from persistent and frequent scratching behaviour
* IGA-CPG activity score ≥ 3 OR Skindex-29 symptoms subscale score ≥ 42
* Stable course of treatment in the two weeks prior to the study (no medication change, etc.)
* Sufficiently motivated to take part in a new intervention aimed at behaviour change
Exclusion Criteria:
* Insufficient understanding of Dutch language
* Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression
* If medication is changed during the course of the study, the participant will be considered a drop-out from the moment the medication has changed.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rotterdam
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mathijs R de Veer, MSc
- **Phone:** +31631016284
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Erasmus University Medical Center
**Status:** RECRUITING
**Zip:** 3015 GD
#### Overall Officials
**Official 1:**
**Affiliation:** Erasmus University Medical Center, Department of Dermatology
**Name:** Rick Waalboer-Spuij, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology
**Name:** Leonieke W Kranenburg, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No IPD is shared due to privacy issues
**IPD Sharing:** NO
### References Module
#### References
**Citation:** de Veer MR, Waalboer-Spuij R, Hijnen DJ, Doeksen D, Busschbach JJ, Kranenburg LW. Reducing scratching behavior in atopic dermatitis patients using the EMDR treatment protocol for urge: A pilot study. Front Med (Lausanne). 2023 Apr 4;10:1101935. doi: 10.3389/fmed.2023.1101935. eCollection 2023.
**PMID:** 37081840
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: LOW
- As Found: Unknown
- ID: M7655
- Name: Eczema
- Relevance: LOW
- As Found: Unknown
- ID: M14396
- Name: Pruritus
- Relevance: LOW
- As Found: Unknown
- ID: M14395
- Name: Prurigo
- Relevance: HIGH
- As Found: Prurigo
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
- ID: T4769
- Name: Prurigo Nodularis
- Relevance: HIGH
- As Found: Prurigo Nodularis
### Condition Browse Module - Meshes
- ID: D000003872
- Term: Dermatitis
- ID: D000011536
- Term: Prurigo
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427109
**Brief Title:** Omega-3 Fatty Acid and Colorectal Adenoma
**Official Title:** Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma
#### Organization Study ID Info
**ID:** O3FA
#### Organization
**Class:** OTHER
**Full Name:** DongGuk University
### Status Module
#### Completion Date
**Date:** 2024-02-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-30
**Type:** ACTUAL
#### Start Date
**Date:** 2021-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** DongGuk University
#### Responsible Party
**Investigator Affiliation:** Chung-Ang University
**Investigator Full Name:** Sang Hoon Kim
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Patients aged \>40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis.
### Conditions Module
**Conditions:**
- Colorectal Neoplasms
- Adenoma Colon
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 798
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends
**Name:** Dietary intake of omega-3 fatty acid
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** among groups with different omega-3 intake levels
**Measure:** Incidence of Colorectal adenoma
**Time Frame:** at the completion of the colonoscopy procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* all patients aged more than 40 years of age, scheduled for elective colonoscopy.
Exclusion Criteria:
* inflammatory bowel diseases
* history of colorectal neoplasms
* prior gastrointestinal surgery
* substance abuse including alcohol
* an inability to complete the survey due to emergency endoscopy
* cognitive impairments and those undergoing significant dietary modifications
**Minimum Age:** 40 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Multi-center, nationwide cohort in Korea
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Goyang-si
**Country:** Korea, Republic of
**Facility:** Dongguk University Ilsan Hospital
**State:** Gyeonggi Province
**Zip:** 14353
#### Overall Officials
**Official 1:**
**Affiliation:** DongGuk University
**Name:** Yun Jeong Lim
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Neoplasms
- ID: M3591
- Name: Adenoma
- Relevance: HIGH
- As Found: Adenoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000236
- Term: Adenoma
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T415
- Name: Omega 3 Fatty Acid
- Relevance: HIGH
- As Found: Day 3
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427096
**Brief Title:** Effect of Healthy Family Program on Population Blood Pressure
**Official Title:** Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial
#### Organization Study ID Info
**ID:** HFP2024
#### Organization
**Class:** OTHER
**Full Name:** Heart Health Research Center
### Status Module
#### Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Heart Health Research Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a 1:1 parallel design, multi-center, cluster-randomized control trial. A total of 80 villages in Ruyang County, Henan Province, China, will be randomly assigned to the intervention group or control group. At least 100 participants from 30-50 families in each village will be included in this study. The intervention group will engage in a variety of strategies, including adopting a low-sodium diet, managing weight, participating in physical exercise, monitoring blood pressure, and undergoing antihypertensive treatment. These efforts will be led by healthy family instructors from the community. The control group will receive usual care. The primary endpoint of this study is the change of systolic blood pressure from baseline to 6 months, reported as the difference between intervention and control group.
**Detailed Description:** This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family healthy instructors or continue with usual care. Each village will recruit around 100 individuals aged 40-80 years, with or without hypertension. In intervention villages, a blood pressure management team, headed by healthy family instructors and family leaders, will implement various strategies including promoting a low-sodium diet, weight management, physical exercise, blood pressure monitoring, and administering antihypertensive treatment. The intervention will span 6 months, followed by another 6-month follow-up period. The primary hypothesis posits that the mean systolic blood pressure change from baseline to 6 months will be higher in the intervention group compared to the control group. The objective of this "Health Family Program" is to evaluate the efficacy of a non-healthcare provider-led multifaceted intervention in enhancing healthy lifestyles and managing blood pressure among rural residents, regardless of their hypertension status, in China.
### Conditions Module
**Conditions:**
- Blood Pressure
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 8000
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Residents in this group will receive multifaceted intervention including low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment.
**Intervention Names:**
- Behavioral: Multifaceted intervention
**Label:** Multifaceted intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Residents in this group will receive usual lifestyle and health care management.
**Label:** Usual care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Multifaceted intervention
**Description:** The multifaceted interventions is comprised of the following components:
1. To establish a BP management team led by healthy family instructor. The team members also include family leaders and village doctors.
2. To conduct multifaceted intervention, which includes low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment.
**Name:** Multifaceted intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group.
**Measure:** The changes of systolic blood pressure from baseline to 6 months
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group.
**Measure:** The changes of systolic blood pressure from baseline to 12 months
**Time Frame:** 12 months
**Description:** The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group.
**Measure:** The changes of diastolic blood pressure from baseline to 6 months
**Time Frame:** 6 months
**Description:** The percentage of blood pressure ≥130/80mmHg at 6 months, reported as the difference between intervention and control group.
**Measure:** The percentage of blood pressure ≥130/80mmHg
**Time Frame:** 6 months
**Description:** The percentage of hypertensive participants receiving antihypertensive treatment at 6 months, reported as the difference between intervention and control group.
**Measure:** The percentage of hypertensive participants receiving antihypertensive treatment
**Time Frame:** 6 months
**Description:** The percentage of hypertensive participants who achieved blood pressure goal \<130/80mmHg at 6 months, reported as the difference between intervention and control group.
**Measure:** The percentage of hypertensive participants achieving blood pressure goal
**Time Frame:** 6 months
**Description:** The weight changes from baseline to 6 months, reported as the difference between intervention and control group.
**Measure:** The weight changes
**Time Frame:** 6 months
**Description:** The incidence of major cardiovascular events including nonfatal stroke, nonfatal myocardial infarction, hospitalization for heart failure, and cardiovascular death within 6 months, reported as the difference between intervention and control group.
**Measure:** The major cardiovascular events
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** 1. Village screening:
The suitable villages were initially screened according to the statistical information of the number of villages and households in Ruyang County.
2. Inclusion and Exclusion Criteria for the Family
Inclusion Criteria:
1. At least 2 participants between the age of 40-80 years meet the inclusion and exclusion criteria of family members and willing to participate in this study;
2. At least one family member can use the smartphone to upload BP values.
Exclusion Criteria:
1. Any family member participated in the other hypertension-related programs;
2. Inappropriate for the study decided by the healthy family instructor.
3.Inclusion and Exclusion Criteria for the Family Member
Inclusion Criteria:
1. 40-80 years old, regardless of BP level and antihypertensive treatment;
2. No travel plan for more than 1 month during the study period;
3. Written or fingerprinted informed consent form.
Exclusion Criteria:
1. Significant cognitive dysfunction;
2. With advanced tumor, dialysis, or other serious diseases;
3. Lying in bed for a long time or unable to take care of themselves;
4. Diagnosed of secondary hypertension;
5. Having birth plans in the next six months, pregnant or lactating women;
6. Other ineligible circumstances judged by the investigators.
**Maximum Age:** 80 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yanna Song
**Phone:** +86 17839372777
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rong Han
**Phone:** +86 13910669903
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Anzhen Hospital
**Name:** Jun Cai, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Beijing Anzhen Hospital
**Name:** Xin Du, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Institute of Science and Technology for Brain-Inspired Intelligence
**Name:** Craig S Anderson, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Beijing Anzhen Hospital
**Name:** Chao Jiang, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427083
**Brief Title:** Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
**Official Title:** An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
#### Organization Study ID Info
**ID:** DW_ODNENV_DB_02
#### Organization
**Class:** INDUSTRY
**Full Name:** Daewoong Pharmaceutical Co. LTD.
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Daewoong Pharmaceutical Co. LTD.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes, conducted in real primary care settings over a period of 24 weeks.
**Detailed Description:** The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physician's medical judgment, regardless of previous diabetes treatment. However, voluntary consent from patients is required for participation in the study, even if Envlo Tablet or Envlomet SR Tablet are prescribed.
Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation, capturing demographic information, physical measurements, vital signs, and lifestyle factors. Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data, including clinical indicators, safety evaluations, and adverse events. Data will be collected based on routine clinical records, with no mandatory study-specific visits or interventions.
Overall, this observational study aims to collect data on demographics, physical measurements, vital signs, and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings, utilizing information obtained during routine patient care processes.
### Conditions Module
**Conditions:**
- Type 2 Diabetes Mellitus
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patient diagnosed with type2 diabetes mellitus
**Intervention Names:**
- Drug: Envlo Tablet
- Drug: Envolomet SR Tablet
**Label:** patient diagnosed with type2 diabetes mellitus
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patient diagnosed with type2 diabetes mellitus
**Description:** Enavogliflozin 0.3mg
**Name:** Envlo Tablet
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- patient diagnosed with type2 diabetes mellitus
**Description:** Enavogliflozin 0.3mg/Metformin1,000mg
**Name:** Envolomet SR Tablet
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** change in BMI at 24 weeks from baseline
**Measure:** change in BMI
**Time Frame:** 24 weeks
**Description:** change in body weight at 24 weeks from baseline
**Measure:** change in body weight
**Time Frame:** 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults aged 19 to 80 years.
2. Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges:
* Enavogliflozin monotherapy
* Combination therapy of Enavogliflozin with two agents (metformin)
* Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor)
3. Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines:
* Pre-obesity stage: BMI 23\~24.9 kg/m2
* Stage 1 obesity: BMI 25\~29.9 kg/m2
* Stage 2 obesity: BMI 30\~34.9 kg/m2
* Stage 3 obesity: BMI ≥ 35 kg/m2
4. Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
5. Fertile women and men who agree to contraception according to appropriate contraceptive methods during the observational study period or have no plans for pregnancy, adhering to methods such as hormonal contraceptives, intrauterine devices or systems, tubal ligation, vasectomy, dual contraception methods (such as cervical cap and male condom), etc.
6. Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period.
Exclusion Criteria:
1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
2. Individuals contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications:
* Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets
* Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis
* Patients with moderate to severe hepatic impairment (AST or ALT \> 3 times the upper limit of normal, Total Bilirubin \> 2 times the upper limit of normal, hepatitis or hepatic failure)
* Patients classified as NYHA (New York Heart Association) class III or IV
3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.
4. Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.).
5. Individuals with diminished mental capacity.
6. Pregnant and lactating women.
7. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
8. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.
**Maximum Age:** 80 Years
**Minimum Age:** 19 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The mean and standard deviation of the change from baseline to 12 or 24 weeks in weight and body mass index (BMI) from previously conducted Phase 2 and Phase 3 clinical trials were used as references for calculation using G\*Power 3.1.9.7.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** NaRi Kim
**Phone:** 82-10-6611-7051
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001836
- Term: Body Weight Changes
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes Mellitus
- ID: M18102
- Name: Weight Loss
- Relevance: HIGH
- As Found: Weight Loss
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5115
- Name: Body Weight Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
- ID: D000015431
- Term: Weight Loss
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11667
- Name: Metformin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427070
**Brief Title:** Effectiveness of Two Intracanal Irrigation Solutions
**Official Title:** Effectiveness of Two Intracanal Irrigation Solutions Delivered Through Cryotherapy on Post-Endodontic Pain Relieve. A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** CHX 2024
#### Organization
**Class:** OTHER
**Full Name:** Misr University for Science and Technology
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Misr University for Science and Technology
#### Responsible Party
**Investigator Affiliation:** Misr University for Science and Technology
**Investigator Full Name:** Manal Mohamed
**Investigator Title:** Lecturer at Misr university
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the present clinical trial is to investigate and compare the effect of crayotherapy utilizing two intra-canal final irrigating solutions on postoperative pain.
**Detailed Description:** 1. st: Comparison of pain reduction algorism after cryotherapy using the two tested irrigating materials
2. nd. Number and frequency of analgesics taken for pain relief during one week postoperative
### Conditions Module
**Conditions:**
- Irreversible Pulpitis
**Keywords:**
- Pulpitis
- CHX
- Saline
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group 1 sodium hypochlorite Group 2 saline Group 3 chlorohexidine
**Intervention Names:**
- Other: Irrigating solution
**Label:** Irrigating solutions
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Irrigating solutions
**Description:** Saline, sodium hypochlorite, chlorohexidine
**Name:** Irrigating solution
**Other Names:**
- Chlorohexidine
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** pain scale Comparison of the 2 selected irrigating solutions
**Measure:** pain scale
**Time Frame:** 1 week
**Description:** Frequency of analgesics for pain relief
**Measure:** Analgesics Frequency
**Time Frame:** 1 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Case diagnosed as having symptomatic irreversible pulpitis with symptomatic apical periodontitis
* Patients requiring emergency RCT
* Pre-operative pain score 7 on Numerical Rating (NRS) scale
* Middle aged males (25-50)
* Medical profile ASA1
* Willing to sign the consent form
* Willing to answer our call for one week period
Exclusion Criteria:
* Females
* Medical conditions above ASA1
* Multi-rooted teeth
* Patients younger or older than (25-50)
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 25 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Intervention Browse Module - Browse Branches
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M2340
- Name: Acetaminophen
- Relevance: LOW
- As Found: Unknown
- ID: M15775
- Name: Sodium Hypochlorite
- Relevance: LOW
- As Found: Unknown
- ID: M44557
- Name: Eusol
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427057
**Brief Title:** A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors
**Official Title:** A Prospective, Open Label, Dual Cohort Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors
#### Organization Study ID Info
**ID:** TJ-IRB20240519
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tongji Hospital
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Liu Huang
**Investigator Title:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is an open label, dual cohort ,phase II study to explore efficacy and safety of cadonilimab(PD-1/CTLA-4 Bispecific Antibody) combined with standard regimen neoadjuvant treatment in urothelial carcinoma（UC） and renal cell carcinoma（RCC）, with evaluating successful preservation rate of bladder/kidney.
**Detailed Description:** UC and RCC confirmed by histopathology or cytology prior have not received systematic treatment, who had indications for surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. This study enrolled 20 cases in each cohort of UC and RCC，pts received neoadjuvant treatment containing cadonilimab for no more than 6 cycles.
### Conditions Module
**Conditions:**
- Urinary System Tumor
**Keywords:**
- UC，RCC，immunotherapy, neoadjuvant
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （gemcitabine or albumin paclitaxel) neoadjuvant treatment with no more than 6 cycles.
**Intervention Names:**
- Drug: Cadonilimab plus chemotherapy
**Label:** UC
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （TKI，e.g. sunitinib, pezopanib) neoadjuvant treatment with no more than 6 cycles.
**Intervention Names:**
- Drug: Cadonilimab plus TKI
**Label:** RCC
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- UC
**Description:** AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions）
**Name:** Cadonilimab plus chemotherapy
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- RCC
**Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions)
**Name:** Cadonilimab plus TKI
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluating the impact of neoadjuvant therapy on organ preservation function
**Measure:** Bladder/Kidney Preservation rate
**Time Frame:** Up to approximately 18 Weeks (Time of surgery)
#### Secondary Outcomes
**Description:** percentage of participants with a complete response (CR) or partial response (PR)
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to approximately 18 Weeks
**Description:** No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.
**Measure:** Rate of Pathologic Response
**Time Frame:** Up to approximately 18 Weeks (Time of surgery) ]
**Description:** Overall survival is defined as the time from enrollment to death due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to approximately 36 Months
**Description:** Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
**Measure:** Assess Adverse Events
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Histologically confirmed diagnosis of urothelial carcinoma（UC） and renal cell carcinoma（RCC）.
* Prior no antitumor systematic treatment .
* Have clinically non-metastatic high risk urothelial carcinoma (cT2-T4a, N0-3, M0) .
* High risk renal cell carcinoma (≥ T2Nx or TanyN+)，include subjects with only Oligotransfer.
* Willing to undergo surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Exclusion Criteria:
* Has received other antitumor therapy before planned start of trial treatment.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* NYHA Class III heart failure.
* Suffering from active infection requiring systemic treatment.
* Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
* Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Pregnancy or lactation.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Liu Huang, Clinical Professor
**Phone:** 63639656
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Tongji Hospital , Wuhan, Hubei Province, China, 430030
**Name:** Liu Huang, Clinical Professor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Tongji Hospital , Wuhan, Hubei Province, China, 430030
**Name:** Xiao Yu, Clinical Professor
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000014570
- Term: Urologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: HIGH
- As Found: Urinary System Tumors
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014571
- Term: Urologic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2985
- Name: Gemcitabine
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1698
- Name: Sunitinib
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427044
**Brief Title:** Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study
**Official Title:** Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study
#### Organization Study ID Info
**ID:** TJ-IRB202403018
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lu Hua
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Lu Hua
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to investigate the effect and influence of liposome bupivacaine anterior serrat plane block on postoperative chronic pain in breast cancer patients, evaluate the therapeutic effect of liposome bupivacaine in postoperative chronic pain, and provide a new method for patients with postoperative chronic pain.
### Conditions Module
**Conditions:**
- Breast Cancer Patients With Chronic Pain After Surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 143
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block
**Intervention Names:**
- Drug: Anterior serratus block group
**Label:** Anterior serratus block group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Anterior serratus block group
**Description:** Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block
**Name:** Anterior serratus block group
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Pain levels were measured three months after surgery
**Measure:** Incidence of chronic pain 3 months after surgery
**Time Frame:** Three months after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (aged ≥18 years) who are scheduled to undergo unilateral modified radical breast cancer surgery
Exclusion Criteria:
* 1. Patients with coagulation dysfunction 2. There are infected patients at the puncture site 3. For patients allergic to any trial drug 4. Patients who take painkillers within 48 hours before surgery 5. Severe cardiopulmonary insufficiency, such as EF\< 40%, FEVC \< 50% expected; Uncontrolled hypertension; 6. Refuse to perform nerve block puncture 7. Mental disorders, epilepsy history; 8. Unable to give informed consent or are participating in other clinical trials.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** LU HUA, 1
- **Phone:** +8618971287754
- **Role:** CONTACT
**Country:** China
**Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
**State:** Hubei
**Zip:** 430000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000059350
- Term: Chronic Pain
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427031
**Brief Title:** Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
**Official Title:** A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
#### Organization Study ID Info
**ID:** TJO-083-A03
#### Organization
**Class:** INDUSTRY
**Full Name:** Taejoon Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-14
**Type:** ACTUAL
**Status Verified Date:** 2023-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Taejoon Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.
### Conditions Module
**Conditions:**
- Dry Eye
- Dry Eye Syndromes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 288
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** TJO-083 : 1 drop 3 times a day
**Intervention Names:**
- Drug: TJO-083
**Label:** TJO-083
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 1 drop 6 times a day
**Intervention Names:**
- Drug: Diquafosol ophthalmic sodium solution 3%
**Label:** Diquas-s Ophthalmic solution 3% 0.4mL
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TJO-083
**Description:** Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
**Name:** TJO-083
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Diquas-s Ophthalmic solution 3% 0.4mL
**Description:** Diquafosol ophthalmic sodium solution, 1 drop 6 times a day
**Name:** Diquafosol ophthalmic sodium solution 3%
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.
**Measure:** Change From Baseline in Corneal Staining at Week 4
**Time Frame:** Baseline and Week 4
#### Secondary Outcomes
**Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.
**Measure:** Change From Baseline in Corneal Staining at Week 8, 12
**Time Frame:** Baseline and Week 8 and 12
**Description:** Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12
**Measure:** Change From Baseline in Conjunctival Staining at Week 4, 8 and 12
**Time Frame:** Baseline and Week 4, 8 and 12
**Description:** The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
**Measure:** Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12
**Time Frame:** Baseline and Week 4, 8 and 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female, age 20 or over
* Has dry eye symptoms (minimum 3 months)
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial
Exclusion Criteria:
* The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
* The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
* Intraocular pressure(IOP)\> 21 mmHg
* Patients with contact lens
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sukyoung Kwon, MPH., PhD
**Phone:** +82-799-0175
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** HyungKeun Lee, MD
**Phone:** +82-02-2019-3444
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sukyoung Kwon
- **Phone:** 82)-2-799-0175
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Taejoon Pharmaceutical Co., Ltd.
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye
- ID: M8271
- Name: Eye Diseases
- Relevance: HIGH
- As Found: Eye Disease
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
- ID: D000005128
- Term: Eye Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427018
**Brief Title:** Expressions of Ezrin and Pip5k1α Proteins in Airway Smooth Muscle of Asthmatic Patients
**Official Title:** Assessing the Expressions of Ezrin, Phosphorylated Ezrin, and Pip5k1α in the Airway Smooth Muscle of Asthmatic Patient
#### Organization Study ID Info
**ID:** ShanghaiUTCM-0512
#### Organization
**Class:** OTHER
**Full Name:** Shanghai University of Traditional Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
**Class:** OTHER
**Name:** Shanghai 6th People's Hospital
**Class:** OTHER
**Name:** Xiangya Hospital of Central South University
**Class:** UNKNOWN
**Name:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine
#### Lead Sponsor
**Class:** OTHER
**Name:** Lei-Miao Yin
#### Responsible Party
**Investigator Affiliation:** Shanghai University of Traditional Chinese Medicine
**Investigator Full Name:** Lei-Miao Yin
**Investigator Title:** Prof.
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Asthma, a prevalent chronic respiratory affliction, significantly impinges upon the quality of life for affected individuals. Timely and appropriate diagnostic measures, coupled with efficacious therapeutic interventions, are paramount in mitigating exacerbations of symptoms and enhancing the life quality of patients.
Ezrin plays an important role in maintaining cell morphology, cell migration, cell adhesion and polarisation, but Ezrin expression in airway smooth muscle remains unclear.
Pip5k1α is an important kinase involved in intracellular phosphatidylinositol signalling pathways that may be involved in smooth muscle contraction and diastole.
Therefore, further studies are necessary to elucidate the changes of Ezrin and Pip5k1α in patients with asthma to provide a basis for investigating alternative treatments for asthma.
**Detailed Description:** Asthma is a complex and heterogeneous disease with a combination of genetic and environmental multifactors, which is mainly characterised by recurrent episodes of wheezing, shortness of breath, chest tightness and cough. The nature of the pathology manifests itself as a chronic inflammatory disease with abnormal antigen presentation and T-cell activation, and an imbalance of Th1/Th2 cells leading to dysfunction of airway smooth muscle cells. There is a lack of safe and effective medications against asthma for current treatment. For example, although glucocorticosteroids are the first-line drugs for asthma, only 12% of patients are able to use them in accordance with medical advice. β2 agonists are often used in combination with hormones, but up to 55% of asthmatics still fail to get effective control of their symptoms. Therefore, the development of innovative drugs with new targets and mechanisms has become the trend of asthma drug development at home and abroad. The discovery of new asthma targets will help to elucidate the asthma mechanism and solve a series of problems in clinical treatment.
Ezrin is one of the major members of the Ezrin-Radixin-Moesin (ERM) family, which plays an important role in the maintenance of cell morphology, cell migration, cell adhesion and polarisation. Pip5k1α is an important kinase involved in the intracellular phosphatidylinositol signaling pathway, which may be associated with the smooth muscle contraction and diastole related.
In a previous study, single-cell sequencing of lung tissue from asthmatic mice revealed that Ezrin and Pip5k1α were significantly increased in asthmatic airway smooth muscle cells. In vitro cellular experiments suggested that Ezrin and Pip5k1α inhibition could inhibit airway smooth muscle cell contraction, suggesting that inhibitors of both may provide a therapeutic advantage for reducing lung resistance in asthma. Therefore, further studies to elucidate the changes of Ezrin and Pip5k1α in asthma patients are warranted to provide a basis for the use of inhibitors of both as an alternative treatment for asthma.
### Conditions Module
**Conditions:**
- Asthma
- Protein
**Keywords:**
- Asthma
- Ezrin
- Pip5k1α
- Airway smooth muscle
### Design Module
#### Bio Spec
**Description:** Tissue
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** No intervention.
**Intervention Names:**
- Other: No intervention.
**Label:** Asthma group
#### Arm Group 2
**Description:** No intervention.
**Intervention Names:**
- Other: No intervention.
**Label:** Non-asthma group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Asthma group
- Non-asthma group
**Description:** Observational study with no intervention.
**Name:** No intervention.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** IF
**Measure:** Immunofluorescence results
**Time Frame:** 6 months
**Description:** IHC
**Measure:** Immunohistochemistry results
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Lung tissue samples;
* The samples come from patients aged 18-70 years old, regardless of gender, who underwent lung tissue sampling for surgical indications during treatment;
* Paraffin sections of lung tissue from patients diagnosed with bronchial asthma, including tracheal smooth muscle;
* Paraffin sections of lung tissue from non-asthma patients, including tracheal smooth muscle.
Exclusion Criteria:
* Paraffin sections of lung tissue from patients who have been diagnosed with COPD;
* Other situations where the researcher deems it inappropriate to participate in this study.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Referring to previous validation studies of target proteins in the literature, the sample size required for this validation experiment is related to multiple factors: (1) Selection of genes: mRNA differentially expressed genes will have a 50% probability of differential protein expression. (2) Antibody selection: Commercially available antibodies will be used for immunohistochemical detection of formalin-fixed, paraffin-embedded tissues with a success rate of up to 75%.
According to previous validation studies of the target protein, the required samples are 30 in each group, for a total of 60 samples.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lei-Miao Yin, MD
**Phone:** 86 21 54592134
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lei-Miao Yin, MD
- **Phone:** 86-21-54592134
- **Role:** CONTACT
**Country:** China
**Facility:** Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200030
#### Overall Officials
**Official 1:**
**Affiliation:** Yueyang Hospital, Shanghai University of Traditional Chinese medicine
**Name:** Lei-Miao Yin, MD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Shanghai 6th People's Hospital
**Name:** Wei-Wei He, MD
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Xiangya Hospital of Central South University
**Name:** Jun-Tao Feng, MD
**Role:** STUDY_DIRECTOR
**Official 4:**
**Affiliation:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine
**Name:** Li Li, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** It is not yet known if there will be a plan to make IPD available.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06427005
**Brief Title:** Fruquintinib Plus S-1 and Raltitrexed (RSF) for mCRC
**Official Title:** Fruquintinib Combined With S-1 and Raltitrexed for Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies: A Phase II Study
#### Organization Study ID Info
**ID:** 2023-71
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-18
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-02-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** West China Hospital
#### Responsible Party
**Investigator Affiliation:** West China Hospital
**Investigator Full Name:** Meng Qiu
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.
**Detailed Description:** Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and anti-VEGF therapy in the first or second line, including those who had been treated with bevacizumab in two consecutive chemotherapy regimens. Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. The primary endpoint was the ORR, while secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
### Conditions Module
**Conditions:**
- Fruquintinib
- S-1
- Raltitrexed
**Keywords:**
- S-1
- Fruquintinib
- raltitrexed
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks.
**Intervention Names:**
- Drug: Fruquintinib
- Drug: S-1
- Drug: raltitrexed
**Label:** RSF treatment arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- RSF treatment arm
**Description:** Fruquintinib 5 mg daily for 14 days followed by a 7-day break
**Name:** Fruquintinib
**Other Names:**
- Elunate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- RSF treatment arm
**Description:** S-1 80-120 mg daily for 14 days, followed by a 7-day break
**Name:** S-1
**Other Names:**
- Tegafur,Gimeracil and Oteracil Potassium Capsules
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- RSF treatment arm
**Description:** raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg
**Name:** raltitrexed
**Other Names:**
- thymidylate synthase inhibitor
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
**Measure:** ORR
**Time Frame:** about a year
#### Secondary Outcomes
**Description:** Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
**Measure:** DCR
**Time Frame:** about a year
**Description:** OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
**Measure:** OS
**Time Frame:** about a year
**Description:** Version 5.0 and AEs leading to dose interruption or discontinuation.
**Measure:** Safety and tolerability
**Time Frame:** about a year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years, any gender.
2. Patients with metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology.
3. Expected survival time ≥ 12 weeks.
4. ECOG score of 0-2.
5. Previously treated for metastatic colorectal cancer with fluoropyrimidine (allowing intravenous and/or oral fluoropyrimidine formulations, excluding DPD enzyme inhibitors), irinotecan, and oxaliplatin chemotherapy, which failed (treatment failure defined as intolerable adverse reactions, disease progression during treatment, or disease progression within 6 months after completing adjuvant chemotherapy); regardless of prior use of targeted drugs such as cetuximab or bevacizumab.
6. Patients must have an interval of at least 2 weeks since the last chemotherapy (at least 1 week for oral chemotherapy drugs) or more than 4 weeks since the end of radiotherapy, with the study's observable lesions located outside the radiotherapy target area.
7. According to RECIST 1.1 criteria, at least one measurable tumor lesion with a maximum diameter ≥ 1 cm as determined by spiral CT scan.
8. Laboratory test results within 1 week before enrollment must meet the following criteria:
1. Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 75 × 10\^9/L;
2. White blood cells (WBC) ≥ 3.0 × 10\^9/L; Neutrophils (ANC) ≥ 1.5 × 10\^9/L;
3. Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN);
4. Total bilirubin (TBI) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if there is liver metastasis).
9. No prior use of raltitrexed or S-1 (or DPD enzyme inhibitors) in the treatment of colorectal cancer.
10. Signed informed consent.
Exclusion Criteria:
1. Patients unable to take oral medications.
2. Patients who have previously been treated with small molecule TKI drugs.
3. Patients with severe hepatic or renal insufficiency, or a recent history of myocardial infarction (within 3 months).
4. Patients with a history of other malignancies within the past five years, except for cured cervical carcinoma in situ and basal cell carcinoma of the skin.
5. Patients with a history of inflammatory bowel disease or extensive colonic resection, ≥50% or extensive small bowel resection with chronic diarrhea, or intestinal obstruction.
6. Patients with severe uncontrolled internal medical conditions or acute infections (fever \> 38°C due to infection).
7. Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for brain or leptomeningeal metastases \> 6 months, with negative imaging results within 4 weeks before study entry, and has stable clinical symptoms related to brain or leptomeningeal metastases at study entry).
8. Patients with clinically significant, uncontrolled pleural effusion or ascites despite clinical intervention.
9. Pregnant or breastfeeding women, or patients of reproductive potential (males or females not in menopause for less than 1 year) unwilling to use contraception.
10. Patients known to be allergic to raltitrexed, S-1, and Fruquintinib or any of their components.
11. Patients deemed unsuitable for participation in this clinical trial by the investigator.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Meng Qiu, MD.
**Phone:** +8618980921776
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weibing C Leng, PhD.
**Phone:** +8618980921763
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Weibing Leng, Ph.D
- **Phone:** +8618980921763
- **Role:** CONTACT
**Country:** China
**Facility:** Sichuan University West China Hospital
**State:** Sichuan
**Status:** RECRUITING
**Zip:** 610044
**Location 2:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meng Qiu, MD
- **Phone:** 028-85423203
- **Role:** CONTACT
**Country:** China
**Facility:** West China Hospital, Sichuan University
**State:** Sichuan
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Sichuan University
**Name:** Meng Qiu, MD.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M8760
- Name: Tegafur
- Relevance: HIGH
- As Found: Carrier
- ID: M252094
- Name: Raltitrexed
- Relevance: HIGH
- As Found: Ophthalmic suspension
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000005641
- Term: Tegafur
- ID: C000068874
- Term: Raltitrexed
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426992
**Brief Title:** Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
**Official Title:** Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
#### Organization Study ID Info
**ID:** 2402-111-151
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Seoul National University Hospital
#### Responsible Party
**Investigator Affiliation:** Seoul National University Hospital
**Investigator Full Name:** Jeong Min Lee
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.
### Conditions Module
**Conditions:**
- Liver Malignant Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 62
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.
**Intervention Names:**
- Procedure: Microwave ablation
**Label:** Patients with malignant liver tumors
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients with malignant liver tumors
**Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.
**Name:** Microwave ablation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
**Measure:** Technical success
**Time Frame:** Immediately after ablation
**Description:** Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success
**Measure:** Local tumor progression rate
**Time Frame:** 12 months after ablation
#### Secondary Outcomes
**Description:** Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.
**Measure:** Complication after ablation
**Time Frame:** Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
**Description:** Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.
**Measure:** Recurrence-free survival
**Time Frame:** 12 months after ablation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Child-Pugh Class A or B
* Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered
Exclusion Criteria:
* In cases where there are three or more malignant liver tumors
* When the maximum size of the tumor exceeds 4 cm
* Diffuse infiltrative type of cancer with unclear tumor boundaries
* When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
* Severe liver failure (Child-Pugh Class C)
* In cases of vascular invasion by malignant liver tumors
* Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
* In cases of multiple extrahepatic metastases
* Situations where it is highly unlikely to obtain appropriate data for research purposes
**Maximum Age:** 85 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hyun Hee Lee
**Phone:** 82-2-2072-4177
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hyun Hee Lee
- **Phone:** 82-2-2072-4177
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jeong Min Lee, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Seoul National University Hospital
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008107
- Term: Liver Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11113
- Name: Liver Neoplasms
- Relevance: HIGH
- As Found: Liver Malignant Tumors
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008113
- Term: Liver Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426979
**Brief Title:** Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy
**Official Title:** Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy
#### Organization Study ID Info
**ID:** ZU-IRB#254 24/3-2024
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2024-01-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Zagazig University
#### Responsible Party
**Investigator Affiliation:** Zagazig University
**Investigator Full Name:** Walid Mohamed Elnagar
**Investigator Title:** Assistant professor of Gynecology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.
### Conditions Module
**Conditions:**
- Pregnancy Tubal
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Patients were divided into 2 Groups as the group titles were printed into cards that were enclosed in sealed envelopes and patients were asked to choose a closed envelop.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Letrozole and Methotrexate Therapy's Group
**Intervention Names:**
- Drug: Methotrexate
- Drug: Letrozole
**Label:** Group LTZ-MTX
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Methotrexate Therapy's Group
**Intervention Names:**
- Drug: Methotrexate
**Label:** Group MTX
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group LTZ-MTX
- Group MTX
**Description:** Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.
**Name:** Methotrexate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Group LTZ-MTX
**Description:** FEMARA 2.5 mg tablets two tablets daily
**Name:** Letrozole
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.
**Measure:** The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
**Time Frame:** 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
* Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L.
Exclusion Criteria:
* Free of Inclusion Criteria
**Maximum Age:** 60 Years
**Minimum Age:** 22 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Zagazig
**Country:** Egypt
**Facility:** Zagazig university
**State:** Ash Sharqia Governorate
**Zip:** 44519
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14147
- Name: Pregnancy, Ectopic
- Relevance: HIGH
- As Found: Ectopic Pregnancy
- ID: M14150
- Name: Pregnancy, Tubal
- Relevance: HIGH
- As Found: Tubal Ectopic Pregnancy
- ID: M8260
- Name: Cardiac Complexes, Premature
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: T2035
- Name: Ectopic Pregnancy
- Relevance: HIGH
- As Found: Ectopic Pregnancy
### Condition Browse Module - Meshes
- ID: D000011271
- Term: Pregnancy, Ectopic
- ID: D000011274
- Term: Pregnancy, Tubal
### Intervention Browse Module - Ancestors
- ID: D000000020
- Term: Abortifacient Agents, Nonsteroidal
- ID: D000000019
- Term: Abortifacient Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000047072
- Term: Aromatase Inhibitors
- ID: D000065088
- Term: Steroid Synthesis Inhibitors
- ID: D000004965
- Term: Estrogen Antagonists
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M11703
- Name: Methotrexate
- Relevance: HIGH
- As Found: Condition
- ID: M1743
- Name: Letrozole
- Relevance: HIGH
- As Found: Visual
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M25769
- Name: Aromatase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M8116
- Name: Estrogens
- Relevance: LOW
- As Found: Unknown
- ID: M8114
- Name: Estrogen Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M30483
- Name: Estrogen Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008727
- Term: Methotrexate
- ID: D000077289
- Term: Letrozole
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426966
**Acronym:** GS VS BBR A
**Brief Title:** Gymnema Sylvestre vs Berberine in Obesity Gene Expression of Adipokines
**Official Title:** Comparative Efficacy of Gymnema Sylvestre vs Berberine in the Clinical Outcomes and Gene Expression of Adipokines in Patients With Exogenous Obesity
#### Organization Study ID Info
**ID:** ESM.CE-01/7-12-2015
#### Organization
**Class:** OTHER
**Full Name:** National Polytechnic Institute, Mexico
#### Secondary ID Infos
**Domain:** Instituto Politécnico Nacional México
**ID:** 20170253
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2017-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-02-01
**Type:** ACTUAL
#### Start Date
**Date:** 2016-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Instituto Nacional de Pediatria
#### Lead Sponsor
**Class:** OTHER
**Name:** National Polytechnic Institute, Mexico
#### Responsible Party
**Investigator Affiliation:** National Polytechnic Institute, Mexico
**Investigator Full Name:** Cindy Rodríguez Bandala
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Obesity is a disease that affects a large part of the world's population and is a risk factor for the development of metabolic, cardiovascular, oncological, and neurodegenerative diseases. Treatments with Gymnema Sylvestre (GS) and Berberine (BBR) have been studied in metabolic diseases such as obesity and type 2 diabetes mellitus (DM2), and have gained importance in recent years, however, questions remain regarding their comparative effect on biochemical parameters, body composition and gene expression of adipokines. Methodology. We carried out a comparative study in 50 adult Mexican patients with a diagnosis of Obesity. Two groups of patients were formed: A. Treated with GS and B. Treated with BBR. Baseline and final measurements were determined 3 months after treatment. Biochemical and body composition parameters were evaluated and the gene expression of Resistin (Res), Omentin (Om), Visfatin (Vis) and Apelin (Ap) was determined, as well as safety parameters.
**Detailed Description:** Trial oversight A comparative, descriptive, observational, longitudinal, and prospective analysis study was carried out in the Comprehensive Obesity and Overweight Care Program at the Higher School of Medicine. This study was carried out in full accordance with good clinical practice guidelines and the Declaration of Helsinki. The study was registered with the Research and Ethics Committee of the Higher School of Medicine (ESM.CE-01/7-12-2015). All patients signed the informed consent, and the information was protected through a confidentiality letter.
Patients We included 50 Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG(kilogram)/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose \< 126 mg/dL or glycated hemoglobin \< 6.5%). Key exclusion criteria included (i) pregnant patients, (ii) diabetics, and (iii) patients with allergic reaction to any components of the supplements. The first study group, group A (25 patients) was treated with GS at a dose of two 200 mg capsules before breakfast, while in the second group, group B (25 patients) were treated with BBR at dose of one 500 mg tablet three times a day before each meal. In both groups, the treatment lasted 3 months.
Trial procedures and outcomes Anthropometric, physiological, and biochemical parameters were measured in two sessions, before and after treatment. The anthropometric measurements were body weight, height, waist, and hip circumference, in addition to body analysis using the Inbody 770. As a physiological measure, only blood pressure was considered using WelchAllyn brand anomanometers with cuff for obese patients. Regarding biochemical parameters, fasting glucose, lipid profile (total cholesterol, triglycerides, HDL, LDL), basal insulin and HbA1c were measured. Adherence to treatment and the presence of adverse effects was recorded using a log that indicated the time at which the tablets were ingested and whether they had any adverse effects that day.
Additionally, whole blood samples were taken from 50 patients, 25 had received treatment with GS (group A) and 25 received treatment with BBR (group B). The extraction of tRNA(transfer ribonucleic acid) was carried out using the TRIzol®Reagent technique, which consists of a mixture of guanidine isocyanate and phenol-chloroform. Once the total RNA was isolated, it was suspended in RNase-free water to avoid possible degradation of the sample before proceeding with reverse transcription. The extraction and integrity of the tRNA was verified by means of agarose gel electrophoresis. The final purity of the samples was calculated based on the absorbance obtained with a measurement at 260-280. cDNA(complementary DNA) amplification was performed using the "First Strand cDNA transcription" synthesis kit for rtPCR from Roche. A real-time polymerase chain reaction (RT-PCR) procedure was performed to determine the relative expression of the mRNA(messenger ribonucleic acid) of the genes studied, using probes from the human transcriptome library (Human Universal Probe Library), a LightCycler nano thermocycler and a TaqMan type reaction mixture, all from the Roche Diagnostics brand (Roche Diagnostics GmbH(Gesellschaft mit beschränkter Haftung), Mannheim, Germany). The oligo sequences of the primers (sense and antisense) were designed with ProbeFinder software (Apelin, NM_017413.4, F, 5´ gaa agt ggg gga tgg cta ag 3´, R, 5´ ccc acc cac tac cct ctt ct 3´, Omentin, NM_017625.2, F, 5´ tga ggg tca ccg gat gta ac 3´, R, 5´ gga ctg gcc tct gga aag ta 3´, Resistin, NM_001193374.1, F, 5´ cca ccg aga ggg atg aaa g 3´, R, 5´ ttc ttc cat gga gca cag g 3´ and Visfatin, NM_005746.2, F, 5´ aag gga tgg aac tac att ctt gag 3´, R, 5´ ctg tgt ttt cca ccg tga ag 3'. The reaction mix was prepared according to the manufacturer's protocol. Each sample was analyzed in duplicate, and the data obtained were analyzed with the LightCycler nano software.
Statistical analysis The distribution of the quantitative data was performed by Shapiro Wilk. The comparison of frequencies was carried out with X2, while the comparison of basal means between groups was performed with Student's t-test. Final means were compared with Student's t-test when no statistical differences were found in basal comparison, while in the parameters with significant differences in the basal measurement, a covariate adjustment (repeated measures ANOVA) and the Bonferroni test were applied to compare the final means between groups. Self-controlled analysis was performed with paired t test. Analyses were performed with GraphPad Prism software, version 8.0.0 for Windows (GraphPad Software, San Diego, CA, USA), and SPSS software, version 19 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 19.0. Armonk, NY(New York), USA: IBM Corp). A value of p\<0.05 was considered as statistical significance.
### Conditions Module
**Conditions:**
- Diabetes Mellitus
- Obesity
**Keywords:**
- Diabetes
- Gymnema sylvestre
- Berberine
- adipokines
- obesity
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Comparative, quasi-experimental
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who present Obesity administrated with Gymnema sylvestre. At a dose of two 200 mg capsules before breakfast
**Intervention Names:**
- Dietary Supplement: Gymnema sylvestre
**Label:** Gymnema sylvestre
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients who present Obesity administrated with Berberine 500 mg tablet three times a day before each meal
**Intervention Names:**
- Dietary Supplement: Berberine
**Label:** Berberine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Berberine
**Description:** Berberine is an alkaloid derived from plants native to China called Rhizoma coptidis, Cortex phellodendrine and Hydrastis canadensis. These plants are used in the treatment of infectious diarrhea, inflammation, DM2, non-alcoholic fatty liver disease, dyslipidemias, cardiovascular diseases, and obesity. They have been shown to improve insulin sensitivity and stimulate glucose uptake through the activation of AMP-activated protein kinase (AMPK)
**Name:** Berberine
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Gymnema sylvestre
**Description:** Gymnema sylvestre also known as "meshashringi", is a plant from central and southern India. The leaf extract has been used as a laxative, diuretic, and cough suppressant; Likewise, it has antimicrobial, antihypercholesterolemic, and hepatoprotective activities. It is associated with antioxidant properties . Its adjuvant effect has been reported in the therapy of type 2 diabetes, revealing how its active compounds can influence glucose regulation and improve insulin sensitivity.
**Name:** Gymnema sylvestre
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Body weight
**Measure:** Body weight
**Time Frame:** 3 months
**Description:** height
**Measure:** height
**Time Frame:** 3 months
**Description:** waist long
**Measure:** waist
**Time Frame:** 3 months
**Description:** hip circumference
**Measure:** hip circumference
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** blood pressure
**Measure:** blood pressure
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose \< 126 mg/dL or glycated hemoglobin \< 6.5%)
Exclusion Criteria:
* pregnant patients,
* diabetics,
* patients with allergic reaction to any components of the supplements
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**Description:** Publication of the article in a JCR journal
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Zhang X, Ha S, Lau HC, Yu J. Excess body weight: Novel insights into its roles in obesity comorbidities. Semin Cancer Biol. 2023 Jul;92:16-27. doi: 10.1016/j.semcancer.2023.03.008. Epub 2023 Mar 24.
**PMID:** 36965839
**Citation:** Zwick RK, Guerrero-Juarez CF, Horsley V, Plikus MV. Anatomical, Physiological, and Functional Diversity of Adipose Tissue. Cell Metab. 2018 Jan 9;27(1):68-83. doi: 10.1016/j.cmet.2017.12.002.
**PMID:** 29320711
**Citation:** Recinella L, Orlando G, Ferrante C, Chiavaroli A, Brunetti L, Leone S. Adipokines: New Potential Therapeutic Target for Obesity and Metabolic, Rheumatic, and Cardiovascular Diseases. Front Physiol. 2020 Oct 30;11:578966. doi: 10.3389/fphys.2020.578966. eCollection 2020.
**PMID:** 33192583
**Citation:** Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000.
**PMID:** 11201732
**Citation:** Revollo JR, Korner A, Mills KF, Satoh A, Wang T, Garten A, Dasgupta B, Sasaki Y, Wolberger C, Townsend RR, Milbrandt J, Kiess W, Imai S. Nampt/PBEF/Visfatin regulates insulin secretion in beta cells as a systemic NAD biosynthetic enzyme. Cell Metab. 2007 Nov;6(5):363-75. doi: 10.1016/j.cmet.2007.09.003.
**PMID:** 17983582
**Citation:** Dakroub A, A Nasser S, Younis N, Bhagani H, Al-Dhaheri Y, Pintus G, Eid AA, El-Yazbi AF, Eid AH. Visfatin: A Possible Role in Cardiovasculo-Metabolic Disorders. Cells. 2020 Nov 9;9(11):2444. doi: 10.3390/cells9112444.
**PMID:** 33182523
**Citation:** Ugur K, Erman F, Turkoglu S, Aydin Y, Aksoy A, Lale A, Karagoz ZK, Ugur I, Akkoc RF, Yalniz M. Asprosin, visfatin and subfatin as new biomarkers of obesity and metabolic syndrome. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2124-2133. doi: 10.26355/eurrev_202203_28360.
**PMID:** 35363362
**Citation:** Huang J, Kang S, Park SJ, Im DS. Apelin protects against liver X receptor-mediated steatosis through AMPK and PPARalpha in human and mouse hepatocytes. Cell Signal. 2017 Nov;39:84-94. doi: 10.1016/j.cellsig.2017.08.003. Epub 2017 Aug 15.
**PMID:** 28821440
**Citation:** Li C, Cheng H, Adhikari BK, Wang S, Yang N, Liu W, Sun J, Wang Y. The Role of Apelin-APJ System in Diabetes and Obesity. Front Endocrinol (Lausanne). 2022 Mar 9;13:820002. doi: 10.3389/fendo.2022.820002. eCollection 2022.
**PMID:** 35355561
**Citation:** Sperling M, Grzelak T, Pelczynska M, Bogdanski P, Formanowicz D, Czyzewska K. Association of Serum Omentin-1 Concentration with the Content of Adipose Tissue and Glucose Tolerance in Subjects with Central Obesity. Biomedicines. 2023 Jan 24;11(2):331. doi: 10.3390/biomedicines11020331.
**PMID:** 36830868
#### See Also Links
**Label:** World Health Organization: WHO.
**URL:** https://www.who.int/es/news-room/fact-sheets/detail/obesity-and-overweight
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009765
- Term: Obesity
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: AnTuAg
- Name: Antitussive Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7411
- Name: Diuretics
- Relevance: LOW
- As Found: Unknown
- ID: M27664
- Name: Laxatives
- Relevance: LOW
- As Found: Unknown
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M5651
- Name: Cathartics
- Relevance: LOW
- As Found: Unknown
- ID: M4312
- Name: Antitussive Agents
- Relevance: LOW
- As Found: Unknown
- ID: T180
- Name: Gymnema Sylvestre
- Relevance: HIGH
- As Found: Icotinib Hydrochloride
- ID: T171
- Name: Goldenseal
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426953
**Brief Title:** Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD on Diabetes Patients
**Official Title:** Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD on Diabetes Patients
#### Organization Study ID Info
**ID:** IRB-2024-467（IIT）
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xie Kangjie
#### Responsible Party
**Investigator Affiliation:** Zhejiang Cancer Hospital
**Investigator Full Name:** Xie Kangjie
**Investigator Title:** MD
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients
**Detailed Description:** The study was a single-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. We will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA.
### Conditions Module
**Conditions:**
- Diabetes
- Postoperative Delirium
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: No intervention
**Label:** History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%
#### Arm Group 2
**Intervention Names:**
- Other: No intervention
**Label:** No history of diabetes and normal blood glucose
### Interventions
#### Intervention 1
**Arm Group Labels:**
- History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%
- No history of diabetes and normal blood glucose
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The related proteins were detected by ELISA
**Measure:** To investigate the relationship between POD and TGF-β, INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, pgc-1α) in diabetic patients.
**Time Frame:** 2024-05 to 2026-06
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥65 years
2. History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
3. The ASA rating is Class I to III
4. The elderly patients of limited thoracic and abdominal tumor surgery
Exclusion Criteria:
1. Refused to participate
2. Previous history of schizophrenia, epilepsy, Parkinson's disease
3. History of alcohol abuse or drug dependence
4. Patients with ASA grade IV and above
5. Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
6. Participants in other clinical trials within the last two months
7. Patients with severe arrhythmia or cardiac dysfunction(EF\<40%)
8. There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
9. History of cerebrovascular disease or brain surgery or trauma
10. Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Elderly patients with a history of diabetes ≥2 years and a glycated hemoglobin of ≥6.5% or without a history of diabetes and a normal blood glucose level
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** XIE Kangjie, MD
- **Phone:** 13516721870
- **Role:** CONTACT
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejang
**Status:** RECRUITING
**Zip:** 310000
**Location 2:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kangjie Xie, MD
- **Phone:** 008613516721870
- **Role:** CONTACT
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310022
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003693
- Term: Delirium
- ID: D000003221
- Term: Confusion
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M6894
- Name: Delirium
- Relevance: LOW
- As Found: Unknown
- ID: M772
- Name: Emergence Delirium
- Relevance: HIGH
- As Found: Postoperative Delirium
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6446
- Name: Confusion
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: T929
- Name: Camurati-Engelmann Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000071257
- Term: Emergence Delirium
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426940
**Brief Title:** Anesthesia-Related Peroperative Critical Events
**Official Title:** Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
#### Organization Study ID Info
**ID:** SBÜTrabzon
#### Organization
**Class:** OTHER
**Full Name:** Zonguldak Bulent Ecevit University
### Status Module
#### Completion Date
**Date:** 2020-09-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-09-01
**Type:** ACTUAL
#### Start Date
**Date:** 2020-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gamze Küçükosman
#### Responsible Party
**Investigator Affiliation:** Zonguldak Bulent Ecevit University
**Investigator Full Name:** Gamze Küçükosman
**Investigator Title:** associate professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
### Conditions Module
**Conditions:**
- the Frequency of Anesthesia-related Critical Events
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1904
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: anesthesia-related critical events
**Label:** intraoperative anesthesia-related critical events
#### Arm Group 2
**Intervention Names:**
- Other: anesthesia-related critical events
**Label:** postoperative 1 hour (h)anesthesia-related critical events
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intraoperative anesthesia-related critical events
- postoperative 1 hour (h)anesthesia-related critical events
**Description:** anesthesia-related critical events
**Name:** anesthesia-related critical events
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
**Measure:** Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
**Time Frame:** within intraoperative and postoperative 1 hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients
Exclusion Criteria:
* intubated outside the operating room
* taken into operation from the intensive care unit (ICU).
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Age, gender, ASA (the American Society of Anesthesiologists) risk, surgical clinic, anesthesia method (general/regional/local/sedation/local+sedation), anesthesia and surgery duration of the patients, and anesthesia-related CEs occurring within intraoperative and postoperative 1 h were recorded.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Zonguldak
**Country:** Turkey
**Facility:** Gamze Küçükosman
#### Overall Officials
**Official 1:**
**Affiliation:** Zonguldak Bulent Ecevit University
**Name:** gamze küçükosman
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: HIGH
- As Found: Imaging
### Intervention Browse Module - Meshes
- ID: D000000777
- Term: Anesthetics
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426927
**Acronym:** PeLear CCC
**Brief Title:** PeLear CCC: Proyecto Latino Contra Cancer Colorectal
**Official Title:** A Colorectal Cancer Educational Intervention in the Latino Community Assessing the Feasibility of Recruitment & Retention Via a Church-Based Approach: Identification of Novel Barriers to Cancer Clinical Trial Enrollment
#### Organization Study ID Info
**ID:** 22-2980
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**Domain:** NCTraCS Institute
**ID:** CTSC0205
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** North Carolina Translational and Clinical Sciences Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are older than 18 years old and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs.
It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, although Latino individuals are among the largest and fastest growing communities of color in the US, currently comprising 18.7%, their representation in CCTs remains low. This is of concern because: 1) advances arising from trials with limited Latino representation may not be applicable to the Latino population, and 2) decreased Latino participation in CCTs may delay Latino access to novel therapies in a timely fashion. The investigators conducting this study believe that low cancer-specific health knowledge may be impacting Latino representation and willingness to participate in CCTs and can be addressed through culturally and linguistically appropriate community-based educational interventions. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement.
**Detailed Description:** This pilot project aims to address the Clinical and Translational Science (CTS) roadblock of underrepresentation of Latinos in cancer clinical trials (CCTs) through a community-based, culturally, and linguistically appropriate educational intervention aimed at increasing health knowledge on a specific cancer. Colorectal cancer (CRC) will be the "use case" and the church will be the venue for Latino recruitment. This project will lead to the identification of novel Latino-perceived barriers to CCT enrollment, which will be applicable in other fields of medicine aiming to increase Latino CCT enrollment. The investigators believe that one barrier to recruitment for CCTs is low health education, specifically regarding cancers affecting the community, such as CRC, a commonly diagnosed cancer in the US Latino population. Therefore, the hypothesis that an increase in health knowledge in Latinos on a specific cancer mediates a change in their willingness to participate in CCTs will be tested. To do this, three educational CRC videos in Spanish will be created. The first video will review CRC symptoms, the second video will review CRC risk factors while the third video will provide information on CRC screening, treatment and CCTs. In addition, a translated, non-validated questionnaire based on 3 sub-scales from 2 CRC knowledge questionnaires previously validated in English will be developed and pilot tested. Therefore, the Specific Aims of this Pilot Project are to:
1. Identify novel Latino-perceived barriers to participation in CCTs.
2. Assess the association between an educational video and CRC knowledge.
3. Explore the potential relationship between an increase in health knowledge of a specific cancer via an educational video in Spanish and willingness to participate in CCTs.
4. Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos.
5. Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire.
To achieve these aims, recruit 60 Latino, Spanish speaking attendees of the Saint Thomas More (STM) Church in Chapel Hill will be recruited. The study will consist of three Study Days:
1. Study Day 1: Enrolled participants will be asked to attend an educational session at STM Church. During the educational session their baseline knowledge on CRC and their baseline willingness to participate in CCTs will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational CRC videos in Spanish and then their CRC knowledge as well as their willingness to participate in CCTs will be reassessed.
2. Study Day 2: Thirty +/- 7 days after the educational session, participants will be asked to return to STM Church in order to complete a follow-up questionnaire in Spanish. The questionnaire will assess their level of retainment of CRC knowledge, their willingness to participate in CCTs as well as assess in an open-ended fashion their perceived barriers to CCT participation.
3. Study Day 3: Twenty of the 60 enrolled participants will be asked to participate in a qualitative one-on-one interview aimed at identifying Latino perceived barriers to CCT participation.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Rectal Cancer
- Colon Cancer
- Colon Rectal Cancer
- Rectal Neoplasms
- Colon Adenocarcinoma
- Hereditary Nonpolyposis Colon Cancer
**Keywords:**
- Colorectal Cancer
- Latinx
- Barriers
- Cancer Clinical Trials
- Latino
- Spanish
- Familial Colorectal Cancer
- Lynch Syndrome
- Hispanic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Enrolled participants will watch three educational videos in Spanish pertaining to: (1) Colorectal Cancer (CRC) symptoms; (2) CRC risk factors and (3) CRC screening, treatment, and Cancer Clinical Trials (CCT).
**Intervention Names:**
- Other: Colorectal Cancer Educational Videos in Spanish
**Label:** Educational Videos
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Educational Videos
**Description:** Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, screening and treatment will be assessed before and immediately after the educational video and at 30 +/- 7 days. In addition, the association between increase in CRC knowledge and willingness to participate in Cancer Clinical Trials (CCT) will be explored.
**Name:** Colorectal Cancer Educational Videos in Spanish
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes within each section of the interview-attitudes regarding general clinical trials, attitudes regarding cancer clinical trials, and perceptions of the Hispanic/Latino community-and the top 3 higher-level, holistic themes across the sections will be reported in terms of percentage of participants.
**Measure:** Barriers Preventing Latinos from Participating in Cancer Clinical Trials
**Time Frame:** 30 days after participation in Study Day 2
#### Secondary Outcomes
**Description:** Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) symptoms will be assessed using the "Knowledge of Warning Signs" questions from the "Bowel Cancer Awareness Measure". Potential answers include "Yes", "No" and "Don't Know". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.
**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
**Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) risk factors will be assessed using the "Knowledge of Risk Factors" questions from the "Bowel Cancer Awareness Measure". This scale is measured using a Likert 1-5 scale with "1" corresponding to "Strongly Disagree" and "5" corresponding to "Strongly Agree". The overall score will range from 11 to 55 and it is anticipated that the average scores will increase after the intervention. Higher scores imply greater knowledge of risk factors.
**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
**Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (CRC) screening and general facts will be assessed using nine questions from the "Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.
**Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
**Description:** Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size.
**Measure:** Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials
**Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Spanish speaking
* Identifying as Latino
* Older than 18 years old
Exclusion Criteria:
* Non-Spanish speakers
* Not identifying as Latino
* Younger than 18 years old
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** José G. Guillem, MD, MPH, MBA
**Phone:** 919-966-8436
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dimitrios Varvoglis, MD
**Phone:** 919-966-8436
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jose G Guillem, MD, MPH, MBA
- **Phone:** 919-966-8436
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Dimitrios Varvoglis, MD
- **Phone:** 919-966-8436
- **Role:** CONTACT
**Country:** United States
**Facility:** Saint Thomas More Church
**State:** North Carolina
**Zip:** 27514
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** José G. Guillem, MD, MPH, MBA
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Sepucha KR, Feibelmann S, Cosenza C, Levin CA, Pignone M. Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions. BMC Med Inform Decis Mak. 2014 Aug 20;14:72. doi: 10.1186/1472-6947-14-72.
**PMID:** 25138444
**Citation:** American Cancer Society. Cancer Facts & Figures for Hispanic/Latino People 2021-2023. Atlanta: American Cancer Society, Inc. 2021.
**Citation:** Power E, Simon A, Juszczyk D, Hiom S, Wardle J. Assessing awareness of colorectal cancer symptoms: measure development and results from a population survey in the UK. BMC Cancer. 2011 Aug 23;11:366. doi: 10.1186/1471-2407-11-366.
**PMID:** 21859500
#### See Also Links
**Label:** Bowel Cancer Awareness Measure
**URL:** https://www.cancerresearchuk.org/sites/default/files/health_professional_bowel_cam_toolkit_version_2.1_09.02.11.pdf
**Label:** Racial and Ethnic Composition of the United States
**URL:** https://www.census.gov/library/stories/2021/08/improved-race-ethnicity-measures-reveal-united-states-population-much-more-multiracial.html
**Label:** National Cancer Institute Triennial Inclusion of Women and Minorities in Clinical Research Report
**URL:** https://report.nih.gov/sites/report/files/docs/NCITriennialInclusionReportFY2019_FY2021Final.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000009386
- Term: Neoplastic Syndromes, Hereditary
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000049914
- Term: DNA Repair-Deficiency Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: HIGH
- As Found: Rectal Cancer
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colon Cancer
- ID: M6351
- Name: Colorectal Neoplasms, Hereditary Nonpolyposis
- Relevance: HIGH
- As Found: Hereditary Nonpolyposis Colon Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12331
- Name: Neoplastic Syndromes, Hereditary
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M26131
- Name: DNA Repair-Deficiency Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2203
- Name: Familial Colorectal Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000012004
- Term: Rectal Neoplasms
- ID: D000003110
- Term: Colonic Neoplasms
- ID: D000003123
- Term: Colorectal Neoplasms, Hereditary Nonpolyposis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426914
**Brief Title:** Clinical Pilates (CP) Exercises and Kinesiophobia in CABG
**Official Title:** Effect of Clinical Pilates (CP) Exercises on Kinesiophobia and Post-operative Cardiopulmonary Parameters in CABG Patients.
#### Organization Study ID Info
**ID:** Sarosh Gohar
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To determine Effect of Clinical Pilates (CP) exercises on kinesiophobia and post-operative cardiopulmonary parameters in CABG patients. Kinesiophobia may lead to patients\' psychological fear of rehabilitation exercise, thereby refusing rehabilitation exercise, affecting the rehabilitation process of patients, resulting in disuse syndrome, depression, disability and other adverse consequences. Thus, this study is to be conducted to find out the effects Pilates exercises with cardiac rehabilitation for management of Kinesiophobia in post CABG patients.
**Detailed Description:** Clinical Pilates are also evident to be safe and effective in post-surgical patients with different surgical interventions.
A study was conducted in 2021 to evaluate the effects of the Pilates method on pulmonary function and range of motion after coronary artery bypass grafting and concluded that the Pilates method is a safe, viable, and playful option for the patient profile after CABG but they did not evaluate kinesiophobia of patients
### Conditions Module
**Conditions:**
- Post-cardiac Surgery
**Keywords:**
- CABG
- Clinical Pilates
- Kinesiophobia
- Post-operative cardiopulmonary parameters
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pilates Clinical (Introductory program)
**Intervention Names:**
- Other: Clinical Pilates
**Label:** Interventional
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Cardiac Rehabilitation
**Intervention Names:**
- Other: Cardiac Rehabilitation
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional
**Description:** Warmup: 5-10 minutes Pilates Clinical (Introductory program) The Hundred modified The Roll-up modified The roll-over modified Spine twist modified Single-leg circle modified Rolling like a ball Shoulder Bridge modified
For every Step emphasizing:
FOCUS: On muscle involved REPETITIONS: 3-5 VISUALIZATION: Imagination process (Different for each step) Cool down: 5 minutes Total Time: 30 minutes
**Name:** Clinical Pilates
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Chest Physical therapy (Chest percussions and active huffs as per need) Breathing strategies (Diaphragmatic and purse lip 1-3 sets \* 5 Reps/Day)
Functional mobility (walk /cycling as per patient tolerance)
Patient education and Wound care Sternal Precaution guidance
**Name:** Cardiac Rehabilitation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the TSK-SV Heart specifically focuses on assessing Kinesiophobia in the context of cardiac conditions or symptoms. It include questions related to fear of engaging in physical activity due to concerns about cardiac events (such as heart palpitations, chest pain, or shortness of breath) during exercise or daily activities. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible Kinesiophobia, and the higher scores indicate an increasing degree of Kinesiophobia.
**Measure:** Kinesiophobia
**Time Frame:** 2 weeks, 4 weeks
**Description:** Post-operative period and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
**Measure:** Abnormal heart rhythms
**Time Frame:** 2 Weeks, 6 Weeks
#### Secondary Outcomes
**Description:** Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the 10 meter walk test. It is a performance measure test used to assess walking speed in meters per second over a short distance . It can be employed to determine functional mobility.
**Measure:** Functional mobility
**Time Frame:** 2 weeks, 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Hemodynamically stable patient Who underwent elective CABG. Patients diagnosed with Kinesiophobia via Tampa scale for Kinesiophobia Heart (TSK-SV Heart)
Exclusion Criteria:
Neuromuscular conditions which lead to kinesiophobia Diseases that seriously affected the functional capacity or mobility such as liver cirrhosis, chronic renal failure and disabled patients. Prolong intubation Vital instability Patients needing maximum assistance Decline consent
**Maximum Age:** 60 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mehwish Waseem, MSPT-CPPT
**Phone:** 0331-5309015
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Peshawar
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mehwish Waseem, MSPT-CPPT
- **Phone:** 0331-5309015
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sarosh Gohar, MSPT-CPPT*
- **Phone:** 0303-5887220
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Lady Reading Hospital
**State:** KPK
**Status:** RECRUITING
**Zip:** 25000
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Mehwish Waseem, MSPT-CPPT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010698
- Term: Phobic Disorders
- ID: D000001008
- Term: Anxiety Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M2922
- Name: Kinesiophobia
- Relevance: HIGH
- As Found: Kinesiophobia
- ID: M13603
- Name: Phobic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000092442
- Term: Kinesiophobia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426901
**Brief Title:** Effects of Tan Tui Exercises on Strength and Performance of Football Players.
**Official Title:** Effects of Tan Tui Exercises on Strength and Performance of Football Players.
#### Organization Study ID Info
**ID:** REC/01835 Naveed Ullah
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Randomized controlled trial (RCT) to investigate the effects of Tan Tui exercises on the strength and performance of football players. Tan Tui can provide football players with a well-rounded approach to physical and mental development, which can contribute to enhanced performance, injury prevention, and personal improvement both on and off the field there is limited study available on the effectiveness of Tan Tui exercises.
**Detailed Description:** Tan Tui training develops mental fortitude, focus, and discipline. Football players can benefit from better concentration, emotional resilience, and the capacity to remain calm under pressure. While football generally focuses on offensive and defensive strategies, mastering Tan Tui self-defense techniques can teach players with real abilities for personal protection off the field. Tan Tui can help with injury prevention by increasing flexibility and body awareness. Tan Tui practitioners are frequently more equipped to avoid strains and sprains. The meditative aspects of Tan Tui training can help football players manage stress and anxiety, improving their mental well-being and overall quality of life.
### Conditions Module
**Conditions:**
- Football Players
**Keywords:**
- Agility
- Quickness
- Change direction
- Skills
- Strength
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** group1 ,experimental group group 2 control group
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Experimental Group A Springing Leg Forms." var-arranged sequences of movements that incorporate kicks, strikes, and blocks.
Pattern Drills: Pattern drills involve repeating specific combinations of kicks, strikes, and blocks in a repetitive manner.
Basic Kicking Drills: which involve ious types of kicks such as front kicks, sidekicks, roundhouse kicks, and crescent kicks.
Stance Work: Practitioners work on a variety of stances, including horse stance (ma bu), bow stance (gong bu), and cat stance (mao bu).
Forms (Taolu): These forms consist of predrills enhance muscle memory and the ability to execute techniques quickly and accurately.
Conditioning: includes rigorous conditioning exercises to strengthen the legs and develop endurance.
Sparring (San Shou):
bouncing leg exercise intervention cycle lasted 6 weeks, 3 times a week for 30 minutes each. The intervention was split into two parts: motor learning in the first week and motor improvement in the last five weeks.
.
**Intervention Names:**
- Other: Effects of Tan Tui Exercises on Strength and Performance of Football Players.
**Label:** Experimental Group: the group A will be received Tan Tui exercies
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Conventional exercises Squats: Squats are a foundational lower-body exercise that targets the quadriceps, hamstrings, glutes, and lower back.
Bench Press: The bench press is a classic upper-body exercise that targets the chest, shoulders, and triceps.
Power Cleans: Similar to the clean and jerk, power cleans are used to develop explosive power, especially in the legs and hips.
Pull-Ups/Chin-Ups: Pull-ups and chin-ups strengthen the muscles of the upper back, shoulders, and arms.
Push-Ups: Push-ups are a versatile exercise that works the chest, shoulders, triceps, and core.
Lunges: Lunges are excellent for targeting the quadriceps, hamstrings, and glutes while also improving balance and stability.
Core Exercises: Core strength is vital for stability and balance in football. Exercises like planks, Russian twists, and medicine ball throws target the core muscles.
**Label:** Controlled
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group: the group A will be received Tan Tui exercies
**Description:** Tan Tui, Exercises Tan Tui, is a style of traditional Chinese martial art that emphasizes leg techniques, agility, and conditioning. Basic Kicking Drills. Stance Work. Forms (Taolu) Pattern Drills. Conditioning.Sparring (San Shou). This protocol will be implemented by District Physiotherapist who will visit the mentioned Football academies in group session.
**Name:** Effects of Tan Tui Exercises on Strength and Performance of Football Players.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Modified Hand Held Dynamometers (will assess the power of lower limb Muscle)
**Measure:** Hand Held Dynamometer
**Time Frame:** 6 weeks
#### Secondary Outcomes
**Description:** The Agility T-Test is a fitness test that is commonly used in sports and physical fitness training to assess an individual's agility, speed, and quickness. It is especially common in sports requiring quick changes of direction, such as basketball, soccer, football, and tennis. The exam is named after the T-shaped running course that participants must complete in the shortest amount of time.
**Measure:** Agility T-Test
**Time Frame:** 6th week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria Male Player
* Player of academy from last 1 year
* Aged 18-35 years.
* BMI (19-29)
Exclusion Criteria:
* • Surgical History
* Fracture History
* Meniscal pathology
* Knee injury due to trauma
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Riafat Mehmood, PhD*
**Phone:** 03132139115
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dīr
**Country:** Pakistan
**Facility:** Timergara Football club
**State:** KPK
**Zip:** 18300
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Riafat Mehmood
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426888
**Brief Title:** Comparison of Scapular Stabilization and Mobilizations in Sub Acromial Pain Syndrome
**Official Title:** Comparison of Scapular Stabilization Exercises and Scapular Mobilizations in Patients With Sub Acromial Pain Syndrome
#### Organization Study ID Info
**ID:** Riphah IU Gulban Aslam
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this research is to compare the effect Comparison of scapular stabilization exercises and scapular mobilizations on shoulder pain, scapular kinematics, disability and functional limitations in patients with sub acromial pain syndrome Randomized controlled trials done at District Head Quarters Mirpur AJK. The sample size was 36. The subjects were divided in two groups, 18 subjects in scapular mobilization exercise group and 18 in scapular mobilization exercise therapy group. Study duration was of 12 months. Sampling technique applied was non probability convenient sampling technique. Only 25-40 years old patient with unilateral shoulder pain lasting \>6 weeks were included. Tools used in the study are NPRS, SPADI, WORC LSST and SAT.
**Detailed Description:** Sub acromial pain syndrome (SAPS), an up to date terminology (shoulder impingement syndrome ) is a common healthcare problem, especially in adult where the space directly below the acromion process and above the shoulder joint, has narrowed and patients describe pain on lateral and anterior aspect of shoulder . The estimated prevalence in the general population is 7 to 26 percent and it accounts for 44 to 65% of all shoulder problems. Incidence of shoulder impingement in the US military population is 7.77 cases/1000 person-years and in UK 3 out of every 4 patient with shoulder pathologies are seeking medical treatment for SAPS. Risk factors include repetitive activity above the shoulder, decubitus sleeping position, a hook-type acromion, smoking, muscle imbalance, bone and joint abnormalities etc. Common symptoms are persistent pain without any history of trauma, difficulty reaching up behind the back, weakness in shoulder muscles, pain when the arm is raised between 70 and 120 degrees and scapular dyskinesia.
* Research surrounding sub acromial pain syndrome has experienced significant growth recently especially in the area of its management. Physiotherapy management protocol for SAPS includes, postural correction exercises, neuromuscular control exercises, Stretching's, manual therapy techniques of the shoulder, scapular stabilization and Mobility Exercises and myofacial release therapy. Scapular stabilization exercises based on open and closed kinetic chain exercises to increase muscle strength and joint position awareness.
### Conditions Module
**Conditions:**
- Subacromial Impingement Syndrome
**Keywords:**
- Scapular stabilization exercises
- Range of motion
- scapular mobilization
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Ball stabilization exercise, 2.Wall push up 3. Wall push up Patients will be treated 3 times per week for 4 consecutive weeks
**Intervention Names:**
- Other: Experimental interventional group 1(scapular stabilization exercise therapy)
**Label:** Experimental interventional group 1(scapular stabilization exercise therapy)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** scapular mobilization in elevation, depression, protraction and retraction. Patients will be treated 3 times per week for 4 consecutive weeks
**Intervention Names:**
- Other: Experimental :interventional group II (scapular mobilizations)
**Label:** Experimental :interventional group II (scapular mobilizations)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental interventional group 1(scapular stabilization exercise therapy)
**Description:** Ball stabilization exercise: While standing close to the wall, the participant will be asked to position her affected hand on the ball and keep the ball from moving as disturbance will be applied in different directions.
Wall push up: While facing wall patient will be asked to place both hands on wall, shoulder width apart. He will be instruct to breath in, bend his elbows, lean into wall and hold this position for one second then breath out slowly push back until arms are straight again Wall slides
• Patient will be asked to lean his head, upper thorax and butts against the wall, place his hands and arms against the wall in high five position.
**Name:** Experimental interventional group 1(scapular stabilization exercise therapy)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Experimental :interventional group II (scapular mobilizations)
**Description:** Patient lies on unaffected side close to the edge of the treatment bench with hips and knees bent for stability.
Therapist will start by supporting the patient arm on his/her forearm so that shoulder is in maximally loose pack position.
Then he/she will grab on the scapula with both hands. One hand supports the scapula from cranial around the acromion and scapular spine and other hand from the caudal at the inferior angle of scapula.
Then both hands move the scapula cranially over the thorax into elevation and caudally into the depression, upward/downward rotation as well as retraction and protraction.
**Name:** Experimental :interventional group II (scapular mobilizations)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It has 21 items, exploring 5 different domains: Physical symptoms, Sports and recreation, Work, Social function, Emotions. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100.
**Measure:** Western Ontario Rotator Cuff Index (WORC)
**Time Frame:** baseline to 4 weeks
**Description:** this test measures the distance between inferior angle of scapula and nearest vertebral spinous process using tape or goniometer in neutral, 45 and 90 degrees of shoulder abduction with the arms fully internally rotated
**Measure:** Lateral Scapular Slide Test (LSST)
**Time Frame:** baseline to 4 weeks
#### Secondary Outcomes
**Description:** SPADI measures pain and disability related to shoulder pain and It has 13 items with response options ranging from 0(no pain) to 10 (worst pain), the overall score ranges from 0 to 100.
**Measure:** Shoulder Pain and Disability Index (SPADI)
**Time Frame:** baseline to 4 weeks
**Description:** This is an 11 point outcome measure used to measure intensity of pain ranging from 0 (no pain) to 10 (worst imaginable pain)
**Measure:** Numeric pain rating scale
**Time Frame:** baseline to 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ● Unilateral shoulder pain lasting \>6 weeks
* Patients with 3/5 positive special tests (Hawkins-Kennedy test, painful arc test, Neer test, Job test, resisted external rotation test)
* Patients score falling above 3 on NPRS
Exclusion Criteria:
* • History of surgery, fracture, or dislocation in past 6 months
* Traumatic onset of pain.
* received steroid injections and physical therapy during the previous 6 months
* BMI above 30
**Maximum Age:** 40 Years
**Minimum Age:** 25 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Imran Amjad, PHD
**Phone:** 03324390125
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mirpur
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aisha Razzaq, PHD*
- **Phone:** 03015030784
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gulban Aslam, MSPT-OMPT*
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** District Head Quarters
**State:** Azad Jammu Kashmir
**Status:** RECRUITING
**Zip:** 10250
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** aisha Razzaq, PHD*
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000070599
- Term: Shoulder Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M21476
- Name: Shoulder Impingement Syndrome
- Relevance: HIGH
- As Found: Subacromial Impingement Syndrome
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M602
- Name: Shoulder Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019534
- Term: Shoulder Impingement Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426875
**Brief Title:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers
**Official Title:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers
#### Organization Study ID Info
**ID:** REC/01834 Sheeraz Ali Shaikh
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-09-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-19
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Goal of this clinical trial is to determine whether Isometric muscle training decrease pain improve function and enhance performance.
Does Isometric exercise improve pain function and performance in bowlers? Researcher will compare the Isometric muscle training with Traditional therapy to examine that isometric exercise work on pain function and performance.
Participants will receive isometric exercises for three days in week and will be followed up after two weeks total four weeks of trial(experimental group).
Participants will receive traditional physical therapy treatment three days of week and followed up after two weeks total four weeks of trail (contril group)
**Detailed Description:** This research is critical for addressing a common health concern and providing evidence-based recommendations for a potentially effective and accessible intervention that can significantly enhance the quality of life and performance of individuals dealing with shoulder pain. Thesis will benefit the bowlers by increasing their performance by enhancing accuracy, speed and consistency and over all shoulder health. Because shoulder discomfort is so common and has such a detrimental influence on everyday activities and performance, research on how isometric muscle training affects shoulder pain, function, and performance is crucial. In a variety of settings, isometric training has demonstrated promise in enhancing musculoskeletal function and pain management; however, its precise influence on shoulder-related problems is yet unknown.
### Conditions Module
**Conditions:**
- Shoulder Pain
**Keywords:**
- Isometric
- Shoulder Pain
- Bowlers
- Performance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Group 1 Experimental Group 2 Control
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Isometric Exercise Program which comprises targeted exercises for declining pain, improving function and performance, exercises were focused only on shoulder flexion, extension, abduction, adduction, internal rotation and external rotation. Exercises were performed via Thera Bands, free weights and resistance. Each repetition was of 10 to 15 seconds and 10 to 15 number of repetition total of three sets according to FITT formula. Under the supervision of a therapist, these exercises were performed three times each week. Every training session lasts 35 to 40 minutes, with a 5-minute warm-up and a 5-minute cool-down in between. Instruction in the correct form and technique was provided to participants throughout the intervention, and their development was closely evaluated to guarantee safety and effectiveness. Total duration of 35 to 40-minute session three sessions per week total four weeks of intervention, reading will be taken on baseline and after 2nd week and 4th week.
**Intervention Names:**
- Diagnostic Test: Isometric Exercises
**Label:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** (control group) in this group participants will receive Traditional Physical therapy
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers
**Description:** Isometric External Rotation (Perform isometric external rotation exercises with a resistance band to strengthen the rotator cuff.) Hold each contraction for 10-15 seconds. Isometric Internal Rotation (Hold each contraction for 10-15 seconds) Isometric Abduction (Supraspinatus). ( each contraction for 10 -15 sec) 10 repetition 3 sets Isometric Adduction (Subscapularis) Overhead Isometric Holds (Hold each contraction for 15-20 seconds) Isometric Shoulder External Rotation Against Resistance: (Hold each contraction for 15-20 seconds) Isometric Shoulder Press (Hold each contraction for 15-20 seconds) 15 to 20 repetitions 4 sets Total duration of 30 to 35 minute session three sessions per week total four weeks of intervention, reading will be taken on baseline and after 2nd week and 4th week
**Name:** Isometric Exercises
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The DASH questionnaire consists of 30 questions concerning upper limb function and symptoms. Patients figure out their ability to carry out each activity or the degree of their symptoms on a scale from 1 (no difficulty or no symptoms) to 5 (unable to perform the activity or vigorous symptoms). The results are then transformed into a standardized score, ranging from 0 to 100, with higher scores indicating more disabilities
**Measure:** Disability of Arm Hand and Shoulder (DASH)
**Time Frame:** 4th weeks
#### Secondary Outcomes
**Description:** It is used to assess weakness and also useful in identifying actual weakness from imbalance or inadequate endurance. It may be referred to as motor testing, muscular strength grading, manual muscle testing, or any other synonym
**Measure:** Manual Muscle Testing
**Time Frame:** 4th week
**Description:** A VAS consists of a line, usually 10 cm long, with language anchors at each end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right)
**Measure:** Visual Analogue Scale VAS
**Time Frame:** 4th week
**Description:** Bowling speed test: A bowling speed app is a mobile application made to measure and analyze the speed of a thrown cricket ball
**Measure:** Bowling Speed Test
**Time Frame:** 4th week
**Description:** (Cones, Target Set, Wicket to Wicket Bowling, and Video Analysis).
**Measure:** Bowling Accuracy Test
**Time Frame:** 4th week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Active Male Bowlers
* Age 18 - 30
* Pain that affects performance. Any level of pain that significantly affects a bowler's performance, accuracy, or consistency.
* Pain with psychological impact. Pain that causes emotional distress, anxiety, or frustration.
* Rotator Cuff pain.
* Weekly 6 to 8 hour training
Exclusion Criteria:
* Other than bowlers
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Riafat Mehmood, PhD*
**Phone:** 03132139115
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Country:** Pakistan
**Facility:** Elite Cricket Academy Shahbaz sharif sports complex
**State:** Punjab
**Zip:** 44000
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Riafat Mehmood, PhD*
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Not sharing
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018771
- Term: Arthralgia
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M21907
- Name: Shoulder Pain
- Relevance: HIGH
- As Found: Shoulder Pain
- ID: M20833
- Name: Arthralgia
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020069
- Term: Shoulder Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426862
**Brief Title:** Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients
**Official Title:** To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients.
#### Organization Study ID Info
**ID:** REC 01741 Muhammad Baqir
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).
**Detailed Description:** The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- Stroke
- Cardiovascular Attack
- Otago Exercise Program
- Berg Balance Scale
- Time Up & Go Test
- Fugl-Meyer Assessment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly.
**Intervention Names:**
- Other: Otago Exercise Program
- Other: Control Group
**Label:** Interventional Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will receive routine treatment of physiotherapy for strokes like strengthening of upper and lower limb muscles (knee flexor, hip adductor and ankle dorsiflexor), stretching (hip abductors and ankle plantar flexor), postural awareness, gait and balance training like static and dynamic. The participants will be assessed through baseline assessment.
**Intervention Names:**
- Other: Control Group
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional Group
**Description:** Otago exercise program
Strengthening Exercise Knee extensor, Hip adductors, heel and toe raising
Balance exercise Sit to stand, Knee bending, one leg standing, tandem stance, side walk, walk and turn around, tandem walk, backward walk, heel and toe walk, stair climbing
**Name:** Otago Exercise Program
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control group
- Interventional Group
**Description:** Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training.
**Name:** Control Group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.
**Measure:** Berg Balance Scale
**Time Frame:** Baseline
**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.
**Measure:** Berg Balance Scale
**Time Frame:** After 3 weeks
**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.
**Measure:** Berg Balance Scale
**Time Frame:** After 6 weeks
**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.
**Measure:** Time Up & Go Test
**Time Frame:** Baseline
**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.
**Measure:** Time Up & Go Test
**Time Frame:** After 3 weeks
**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.
**Measure:** Time Up & Go Test
**Time Frame:** After 6 weeks
**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.
**Measure:** Fugl-Meyer Assessment
**Time Frame:** Baseline
**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.
**Measure:** Fugl-Meyer Assessment
**Time Frame:** After 3 weeks
**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.
**Measure:** Fugl-Meyer Assessment
**Time Frame:** After 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Ischemic or hemorrhagic stroke
* Medically stable patients with acute to subacute level of stroke recovery (\< 6 month).
* Patients 40 plus age
* Berg balance scale \<45 and \>20 score
* TUG test scoring \>20 sec
Exclusion Criteria:
* Participants having cognition problem or language barrier
* Physical disability (fracture or amputation) other than stroke
* Previous surgery 6 weeks
* Cardiovascular and pulmonary disease
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Muhammad Baqir, MS
**Phone:** +923129008037
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Peshawar
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Imran Amjad, Phd
- **Phone:** +92 332 4390125
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Muhammad Baqir
**State:** KPK
**Status:** RECRUITING
**Zip:** 25000
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** IMRAN AMJAD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426849
**Brief Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Asthma
**Official Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Improving Dyspnea Index and Pulmonary Function in Patients With Asthma
#### Organization Study ID Info
**ID:** Maria Akbar
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Riphah International University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To analyze either Liuzijue exercise or Tai Chi Chuan exercise is effective in improving dyspnea index and pulmonary function in patients with asthma. In the general population, the rate of asthma is increasing day by day because of environmental and occupational risk factors which is becoming a burden. It causes shortness of breath, decreases lung volume, and disturbs quality of life. This study aims to improve dyspnea index, lung volume and quality of life of the patients with asthma.
**Detailed Description:** Liuzijue Exercise is the most popular exercise in ancient Chinese literature which is compiled by the Chinese Qigong Management Centre. Liuzijue exercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, ("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities. It is very helpful to improve pulmonary functions, exercise capacity, and quality of life of patients with pulmonary disease.
Liuzijue exercise takes on the backward abdominal breathing technique joined with physical exercises, which can practice the diaphragm and chest auxiliary respiratory muscles. Hence, the patient's breathing time is extended, and the breathing profundity increments. To accomplish the reason for expanding the gas exchange rate of the lungs and enhancing the lung capacity. Tai Chi Chuan is a traditional Chinese Exercise that is significant in improving the pulmonary functions of asthmatic patients.
Tai Chi (10 forms of yang style ) significantly improves the exercise capacity of patients with lung disease. Tai Chi seems to have physiologic and psychosocial benefits and appears to be protected and viable in advancing balance control, adaptability, and cardiovascular fitness for older adults.
### Conditions Module
**Conditions:**
- Asthma
**Keywords:**
- Liuzijue exercise
- Tai Chi Chuan exercise
- Dyspnea Index
- Pulmonary Function
- Asthma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** LiuzijueExercise will be performed by delivering 6 distinct sounds,("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities.
**Intervention Names:**
- Other: Liuzijue Exercise
**Label:** GROUP A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 10 FORM OF YANG NG STYLE Tai Chi Chuan Exercise that combines deep diaphragmatic breathing and relaxation with many fundamental postures.
**Intervention Names:**
- Other: Tai Chi Chuan Exercise
**Label:** GROUP B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GROUP A
**Description:** LiuzijueExercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, (xū,hē, hū sī, chuī, and xī) through termination along with comparing body activities.
The following are 6-8 vital parts of body movements:
1. Swaying and twisting
2. Hip rotations
3. Arm movements
4. Knee bends
5. Foot pivots
6. Spine elongation
7. Hand gestures
8. Breath synchronization Frequency: 1 session per day for a week Intensity:In first week 1 set of Luizijue exercise will be performed then progressively increase to 4 sets till 6th week .
Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Luizijue Exercise.
**Name:** Liuzijue Exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- GROUP B
**Description:** Tai Chi Chuan Exercise combines deep diaphragmatic breathing and relaxation with many fundamental postures.
Names of the 10 Movements in Sequence
1. Commencing Form
2. Repulsing the Monkey
3. Brush Knee
4. Parting the Horse's Mane
5. Cloud Hands
6. Golden Cockerel Standing on the Left, then the Right
7. Kick Out Right, Kick Out Left
8. Grasping the Bird's Tail
9. Cross Hands or Embrace the Tiger
10. Closing Form Frequency: 3 sessions / week Intensity: Initially each posture will be performed 3 times then progressively leads to 6 or 10 reps according to patient tolorance.
Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Tai Chi Chuan Exercise.
**Name:** Tai Chi Chuan Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** From baseline till 2nd, 4th, and 6th week measured throug Modified Medical Research Council (mMRC) dyspnoea scale. It is a self-rating scale to quantify the level of incapacity that breathlessness presents on everyday activity on a scale from Grade 0 to 4.
Grade 0: No shortness of breath besides on exhausting activity Grade1: Breathlessness while hustling fair and square or strolling along a slight slope Grade 2: Strolls more slow than individuals of same age fair and square in light of shortness of breath or needs to stop to take breath while strolling at their own speed fair and square Grade 3: Stop for breath subsequent to strolling ∼100 m or following couple of moments fair and square.
Grade 4: Excessively breathless to take off from the house, or breathless while dressing or stripping down
**Measure:** Dyspnea index
**Time Frame:** 6 weeks
**Description:** Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze
**Measure:** Forced Expiratory Volume in 1 second (FEV1)
**Time Frame:** 6 weeks
#### Secondary Outcomes
**Description:** From baseline till 6th week measured through Asthma Control Questionnaire that individuals answer in regards to the recurrence of asthma symptoms over 6 weeks.
Each answer has a numeric value. The asthmatic individual adds their score to decide their degree of asthma symptoms control. Score ranges from 5 to 25. A score 20 to 25 indicate well controlled asthma while score ranges between 5 to 6 indicated poor controlled asthma.
**Measure:** Asthma Quality of life
**Time Frame:** 6 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Diagnosed case of Asthma for last 6 months Patients with mild to moderate asthma On spirometry FEV1/FVC ratio less than 70% MRC- Grade 2 and 3
Exclusion Criteria:
Refusal to consent. Unstable vitals. Diagnosed with COPD, pulmonary edema, acute or chronic pneumonia or other lung disease.
Untreated Hypertension. Diagnosed Tumor. Patient with Stroke and other neurological conditions. Patient with active Tuberculosis or other infectious disease. Patients with history of heart failure or any other cardiovascular condition
**Maximum Age:** 40 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mehwish Waseem, MSPT-CPPT
**Phone:** 0331-5309015
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chichawatni
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mehwish Waseem, MSPT-CPPT
- **Phone:** 0331-5309015
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Maria Akbar, MSPT-CPPT*
- **Phone:** 0345-5024803
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Tehsil Headquarter Hospital
**State:** Punjab
**Status:** RECRUITING
**Zip:** 57200
#### Overall Officials
**Official 1:**
**Affiliation:** Riphah International University
**Name:** Mehwish Waseem, MSPT-CPPT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M7591
- Name: Dyspnea
- Relevance: LOW
- As Found: Unknown
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426836
**Acronym:** PADECMO
**Brief Title:** Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
**Official Title:** Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
#### Organization Study ID Info
**ID:** EC 2015/0529
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Ghent
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-08-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Ghent
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
**Detailed Description:** The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.
### Conditions Module
**Conditions:**
- Pharmacokinetics
- Amoxicillin-clavulanate
- Piperacillin-tazobactam
- Meropenem
- Cefazolin
- Teicoplanin
- Vancomycin
- Ciprofloxacin
- Amikacin
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Amoxicillin-clavulanate
**Label:** Amoxicillin-clavulanate
**Type:** OTHER
#### Arm Group 2
**Description:** Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Piperacillin-tazobactam
**Label:** Piperacillin-tazobactam
**Type:** OTHER
#### Arm Group 3
**Description:** Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Meropenem
**Label:** Meropenem
**Type:** OTHER
#### Arm Group 4
**Description:** Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Cefazolin
**Label:** Cefazolin
**Type:** OTHER
#### Arm Group 5
**Description:** Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Vancomycin
**Label:** Vancomycin
**Type:** OTHER
#### Arm Group 6
**Description:** Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Teicoplanin
**Label:** Teicoplanin
**Type:** OTHER
#### Arm Group 7
**Description:** Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Ciprofloxacin
**Label:** Ciprofloxacin
**Type:** OTHER
#### Arm Group 8
**Description:** Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling
**Intervention Names:**
- Other: Amikacin
**Label:** Amikacin
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Amoxicillin-clavulanate
**Description:** blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
**Name:** Amoxicillin-clavulanate
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Piperacillin-tazobactam
**Description:** blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
**Name:** Piperacillin-tazobactam
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Meropenem
**Description:** blood sampling in patients receiving meropenem as part of routine clinical care.
**Name:** Meropenem
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Cefazolin
**Description:** blood sampling in patients receiving cefazolin as part of routine clinical care.
**Name:** Cefazolin
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Vancomycin
**Description:** blood sampling in patients receiving vancomycin as part of routine clinical care.
**Name:** Vancomycin
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Teicoplanin
**Description:** blood sampling in patients receiving teicoplanin as part of routine clinical care.
**Name:** Teicoplanin
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Ciprofloxacin
**Description:** blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
**Name:** Ciprofloxacin
**Other Names:**
- Blood sampling
**Type:** OTHER
#### Intervention 8
**Arm Group Labels:**
- Amikacin
**Description:** blood sampling in patients receiving amikacin as part of routine clinical care.
**Name:** Amikacin
**Other Names:**
- Blood sampling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
**Time Frame:** up to 1 month
**Description:** % of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
**Time Frame:** up to 1 month
**Description:** % of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
**Time Frame:** up to 1 month
**Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
**Time Frame:** up to 1 month
**Description:** % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
**Time Frame:** July 2026
**Description:** % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
**Measure:** Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
**Time Frame:** July 2026
#### Secondary Outcomes
**Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a percentage of time during which the unbound concentration remains above the Minimal Inhibitory Concentration (MIC) of the micro-organism of at least 50% and a maximum concentration of 10 x MIC
**Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics
**Time Frame:** up to 1 month
**Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of ciprofloxacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 86
**Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin
**Time Frame:** up to 1 month
**Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of vancomycin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 200 to 300
**Measure:** Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin
**Time Frame:** up to 1 month
**Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of teicoplanin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is an Area-under the concentration-Time Curve of 900
**Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin
**Time Frame:** up to 1 month
**Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of amikacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a peak over Minimal Inhibitory Concentration Ratio of 8 to 10, trough concentration below 5 mg/L and Area under the Concentration Time Curve/MIC\>399
**Measure:** Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin
**Time Frame:** up to 1 month
**Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in first dose conditions
**Measure:** Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC)
**Time Frame:** up to 1 month
**Description:** % of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
**Measure:** Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
**Measure:** Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
**Measure:** Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
**Time Frame:** up to 1 month
**Description:** % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
**Measure:** Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
**Time Frame:** up to 1 month
**Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
**Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
**Time Frame:** up to 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients admitted to the pediatric intensive care unit or cardiac intensive care unit
* patient age : 1,8 kg-15 years
* patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)
* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
* extracorporeal membrane oxygenation circuit
Exclusion Criteria:
* no catheter in place for blood sampling
* absence of parental/patient consent
* known hypersensitivity to beta-lactam antibiotics and ciprofloxacin
**Maximum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pieter De Cock, PharmD
**Phone:** +32 9 332 29 69
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brussel
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Biarent Dominique
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Vens Daphne
- **Role:** CONTACT
**Country:** Belgium
**Facility:** Queen Fabiola Children's University Hospital
**Status:** RECRUITING
**Zip:** 1020
**Location 2:**
**City:** Ghent
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pieter De Cock
- **Role:** CONTACT
**Country:** Belgium
**Facility:** University Hospital
**Status:** RECRUITING
**Zip:** 9000
**Location 3:**
**City:** Leuven
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Debaveye Yves
- **Role:** CONTACT
**Country:** Belgium
**Facility:** Universitair hospital
**Status:** RECRUITING
**Zip:** 3000
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Ghent
**Name:** Annick de Jaeger, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000065609
- Term: Cytochrome P-450 CYP1A2 Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
- ID: D000065093
- Term: beta-Lactamase Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3995
- Name: Amoxicillin
- Relevance: HIGH
- As Found: Colorectal
- ID: M17388
- Name: Vancomycin
- Relevance: HIGH
- As Found: Place
- ID: M6176
- Name: Ciprofloxacin
- Relevance: HIGH
- As Found: Endothelial
- ID: M1889
- Name: Meropenem
- Relevance: HIGH
- As Found: Expiratory
- ID: M5687
- Name: Cefazolin
- Relevance: HIGH
- As Found: Immune Response
- ID: M1938
- Name: Tazobactam
- Relevance: HIGH
- As Found: Ancillary studies
- ID: M13772
- Name: Piperacillin
- Relevance: HIGH
- As Found: Wide
- ID: M21710
- Name: Clavulanic Acid
- Relevance: HIGH
- As Found: Chemoembolization
- ID: M3924
- Name: Amikacin
- Relevance: HIGH
- As Found: Total Body Irradiation
- ID: M1885
- Name: Piperacillin, Tazobactam Drug Combination
- Relevance: HIGH
- As Found: Paroxysmal Atrial Fibrillation
- ID: M21845
- Name: Amoxicillin-Potassium Clavulanate Combination
- Relevance: HIGH
- As Found: Treatment failure
- ID: M19621
- Name: Teicoplanin
- Relevance: HIGH
- As Found: Soda
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M6204
- Name: Clavulanic Acids
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M30537
- Name: Cytochrome P-450 Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M30450
- Name: beta-Lactamase Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000658
- Term: Amoxicillin
- ID: D000014640
- Term: Vancomycin
- ID: D000002939
- Term: Ciprofloxacin
- ID: D000077731
- Term: Meropenem
- ID: D000002437
- Term: Cefazolin
- ID: D000078142
- Term: Tazobactam
- ID: D000010878
- Term: Piperacillin
- ID: D000019818
- Term: Clavulanic Acid
- ID: D000000583
- Term: Amikacin
- ID: D000077725
- Term: Piperacillin, Tazobactam Drug Combination
- ID: D000019980
- Term: Amoxicillin-Potassium Clavulanate Combination
- ID: D000017334
- Term: Teicoplanin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426823
**Acronym:** GA-17b
**Brief Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes
**Official Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes
#### Organization Study ID Info
**ID:** GA-17b
#### Organization
**Class:** OTHER
**Full Name:** University of Copenhagen
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Rigshospitalet, Denmark
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Copenhagen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.
**Detailed Description:** Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).
MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.
### Conditions Module
**Conditions:**
- Blood Flow
**Keywords:**
- Gut hormones
- GIP
- Physiology
- Type 2 diabetes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Single blind, placebo controlled, randomized, crossover study
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Saline infusion, oral water ingestion
**Intervention Names:**
- Other: Saline / placebo
**Label:** Saline and oral water (SAL-WAT)
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Saline infusion, oral glucose ingestion
**Intervention Names:**
- Other: Saline / placebo
**Label:** Saline infusion and oral glucose ingestion (SAL-GLU)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** GIPR antagonist infusion, oral water ingestion
**Intervention Names:**
- Other: GIPR antagonist / study tool
**Label:** GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** GIPR antagonist infusion, oral glucose ingestion
**Intervention Names:**
- Other: GIPR antagonist / study tool
**Label:** GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Saline and oral water (SAL-WAT)
- Saline infusion and oral glucose ingestion (SAL-GLU)
**Description:** NaCl (9 mg/ml)
**Name:** Saline / placebo
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)
- GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)
**Description:** GIP(3-30)NH2
**Name:** GIPR antagonist / study tool
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measued with phase-contrast MRI in ml/min
**Measure:** Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)
**Time Frame:** 80 minutes
#### Secondary Outcomes
**Description:** Radioimmuno assay on plasma blood sample (pmol/L)
**Measure:** GIP levels
**Time Frame:** 80 minutes
**Description:** Radioimmuno assay on plasma blood sample (nmol/L)
**Measure:** GIP(3-30)NH2 levels
**Time Frame:** 80 minutes
**Description:** Bedside measurement of whole blood sample (mmol/L)
**Measure:** Glucose
**Time Frame:** 80 minutes
**Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)
**Measure:** C-peptide
**Time Frame:** 80 minutes
**Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)
**Measure:** Insulin
**Time Frame:** 80 minutes
**Description:** Radioimmuno assay on plasma blood samples (pmol/L)
**Measure:** Glucagon
**Time Frame:** 80 minutes
**Description:** Measued with phase-contrast MRI in ml/min
**Measure:** Blood flow in portal vein
**Time Frame:** 80 minutes
**Description:** Measued with phase-contrast MRI in ml/min
**Measure:** Blood flow in coeliac trunc
**Time Frame:** 80 minutes
**Description:** Measued with phase-contrast MRI in ml/min
**Measure:** Blood flow in hepatic artery
**Time Frame:** 80 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Type 2 diabetes
* BMI 20-35 kg/m\^2
* Age 20-80
Exclusion Criteria:
* Not MRI-compatible implants
* Claustrophobia
* Abnormal kidney or liver function
* Anemia
* Planned weight loss or change in diet
* Hypertension
* Other conditions that could be expected to affect the primary or secondary outcomes
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lærke S Gasbjerg, MD PhD
**Phone:** 25346894
**Phone Ext:** +45
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rasmus S Rasmussen, Cand.scient.
**Phone:** 50534173
**Phone Ext:** +45
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Copenhagen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lærke S Gasbjerg
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Rigshospitalet
**Status:** RECRUITING
**Zip:** 2200
### IPD Sharing Statement Module
**Description:** Will share upon requests
**IPD Sharing:** YES
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-17
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 1602889
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-17T06:14
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M11449
- Name: Mechlorethamine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426810
**Brief Title:** Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
**Official Title:** A Prospective Randomized Study Comparing Electrosurgical Bipolar Systems Versus Conventional Electrocautery After Sentinel Lymph Node Biopsy in Obese or Preoperative Chemotherapy Treated Breast Cancer Patients
#### Organization Study ID Info
**ID:** 10-2024-18
#### Organization
**Class:** OTHER
**Full Name:** SMG-SNU Boramae Medical Center
### Status Module
#### Completion Date
**Date:** 2027-04-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-04-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** SMG-SNU Boramae Medical Center
#### Responsible Party
**Investigator Affiliation:** SMG-SNU Boramae Medical Center
**Investigator Full Name:** Jong-Ho Cheun
**Investigator Title:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The efficacy of electrosurgical bipolar systems in axillary lymph node dissection for breast cancer surgery is well known. In this study, the investigators aim to determine whether using electrosurgical bipolar systems helps reduce seroma formation in high-risk patients undergoing sentinel lymph node biopsy (SLNB) for breast cancer surgery. The investigators will focus on patients who are expected to experience high drainage output after SLNB, especially those who are obese (BMI\>25) or have undergone preoperative chemotherapy.
**Detailed Description:** The most common complications of breast cancer surgery are lymphorrhea and seroma. Seroma increases the length of hospital stay, the duration of outpatient treatment, and patient discomfort. Persistent seroma can lead to re-hospitalization due to wound infection caused by repeated aspirations. Seroma generally occurs in 10% to 85% of cases after breast cancer surgery. Risk factors associated with seroma or lymphorrhea identified in previous studies include age over 60, high BMI, tumor size, preoperative chemotherapy, extent of breast tissue resection, number of lymph nodes removed, and number of lymph node metastases.
Efforts to reduce seroma after breast cancer surgery include meticulous techniques such as sharp dissection, the use of monopolar energy devices, and ligation of blood vessels and lymphatics. Recently, the bipolar energy sealing system has been increasingly used. LigaSure, which uses electric energy and pressure to denature collagen and elastin in tissue, has been shown to reduce surgical time and medical costs compared to traditional clamp-and-tie methods and advanced sealing systems in various surgeries, including breast cancer.
In breast cancer surgery, using a electrosurgical bipolar systems for ligating blood vessels and lymph nodes has several potential advantages. Traditional ligation using sutures or monopolar energy devices can be influenced by surgical technique and has drawbacks such as thermal injury to surrounding tissue. In contrast, the bipolar energy sealer applies both electric energy and pressure simultaneously, minimizing thermal injury to surrounding tissue while ensuring permanent vessel and lymphatic ligation.
A 2008 prospective study showed that using bipolar energy sealers in axillary dissection allowed for earlier removal of drains compared to conventional methods. Other studies have shown less blood loss, lower drainage output, and shorter hospital stays during surgery. Recent research has also reported new applications of bipolar energy sealers in skin-sparing mastectomy, indicating active use in breast surgery overseas. A study conducted at Severance Hospital in South Korea found that using bipolar energy sealers reduced drainage.
However, most of these studies were conducted abroad with a small number of reported cases, and the results mainly concern axillary lymph node dissection (ALND), which is where seroma is most often formed. With the decreasing trend of ALND due to advances in preoperative chemotherapy and radiotherapy, there is a lack of studies on whether using electrosurgical bipolar systems helps reduce seroma formation after sentinel lymph node biopsy.
### Conditions Module
**Conditions:**
- Breast Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.
**Intervention Names:**
- Device: Electrosurgical bipolar system (LigaSure)
**Label:** Electrosurgical bipolar systems group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery.
**Label:** Conventional electrocautery group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Electrosurgical bipolar systems group
**Description:** Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.
**Name:** Electrosurgical bipolar system (LigaSure)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Total drainage amount from axilla after surgery (ml)
**Measure:** Drainage amount
**Time Frame:** Up to four weeks
#### Secondary Outcomes
**Description:** Total drainage amount from axilla before discharge (ml)
**Measure:** Drainage amount during admission
**Time Frame:** Up to one week
**Description:** Operation time during axillar surgery (min)
**Measure:** Operation time
**Time Frame:** Up to 2 hours
**Description:** Complications of axilla
**Measure:** Complication
**Time Frame:** At one month of surgery
**Description:** Days before drain removal (days)
**Measure:** Draine removal days
**Time Frame:** Up to two weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women aged 20-80
* Candidates for breast-conserving surgery and axillary sentinel lymph node biopsy
* BMI over 25 or those who have received preoperative chemotherapy
* Overall performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
* Participants who understand the study contents and can provide written consent
* Participants without evidence of distant metastasis
Exclusion Criteria:
* Those with suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound)
* Among patients who had confirmed lymph node metastasis before neoadjuvant chemotherapy, whose preopreative image showed residual disease at axillary lymph node
* Those planning for mastectomy
* Those planning for axillary lymph node dissection without SLNBx
* Male breast cancer patients
* Patients with bilateral breast cancer
* Illiterate individuals, foreigners, or others who cannot read or understand the consent form
* Individuals who voluntarily decide not to participate in the study or do not sign the consent form
* Those judged by the researcher to be inappropriate for participation in this study
* Study participants who did not have a drain inserted in the surgical area
* If the randomized device is not used due to surgical room conditions (e.g., unavailability due to other emergency surgeries, device malfunction) and another device is substituted
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jong-Ho Cheun, M.S.
**Phone:** +82-10-8754-3054
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jong-Ho Cheun, M.S.
- **Phone:** +82-10-8754-3054
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** SMG-SNU Boramae medical center
**State:** Dongjak-gu
**Status:** RECRUITING
**Zip:** 07061
#### Overall Officials
**Official 1:**
**Affiliation:** SMG-SNU Boramae Medical Center
**Name:** Jong-Ho Cheun, M.S.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
**PMID:** 21849243
**Citation:** Manouras A, Markogiannakis H, Genetzakis M, Filippakis GM, Lagoudianakis EE, Kafiri G, Filis K, Zografos GC. Modified radical mastectomy with axillary dissection using the electrothermal bipolar vessel sealing system. Arch Surg. 2008 Jun;143(6):575-80; discussion 581. doi: 10.1001/archsurg.143.6.575.
**PMID:** 18559751
**Citation:** Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.
**PMID:** 22959311
**Citation:** Cortadellas T, Cordoba O, Espinosa-Bravo M, Mendoza-Santin C, Rodriguez-Fernandez J, Esgueva A, Alvarez-Vinuesa M, Rubio IT, Xercavins J. Electrothermal bipolar vessel sealing system in axillary dissection: a prospective randomized clinical study. Int J Surg. 2011;9(8):636-40. doi: 10.1016/j.ijsu.2011.08.002. Epub 2011 Sep 10.
**PMID:** 21925293
**Citation:** Miyagi K, Rossi SH, Malata CM, Forouhi P. Novel use of LigaSure Impact electrosurgical bipolar vessel sealing system in skin-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Jun;68(6):e126-8. doi: 10.1016/j.bjps.2015.01.005. Epub 2015 Jan 26. No abstract available.
**PMID:** 25682592
**Citation:** Park HS, Lee J, Kim JY, Park JM, Kwon Y. A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery. J Breast Cancer. 2022 Aug;25(4):307-317. doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27.
**PMID:** 35914746
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-19
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 153614
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-17T07:38
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426797
**Brief Title:** Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
**Official Title:** Safety and Efficacy of Cadonilimab Combined With Anlotinib in Neoadjuvant Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Single Arm, Phase II Study
#### Organization Study ID Info
**ID:** AK104-IIT-C-N1-0104
#### Organization
**Class:** OTHER
**Full Name:** Peking University People's Hospital
### Status Module
#### Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Akeso Pharmaceuticals, Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University People's Hospital
#### Responsible Party
**Investigator Affiliation:** Peking University People's Hospital
**Investigator Full Name:** Yang Fan, MD
**Investigator Title:** Professor of Thoracic Surgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are:
What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity?
Participants will:
Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles.
Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication.
Accept an follow-up for 2 years after surgery.
**Detailed Description:** Esophageal cancer has a high incidence in China, among which esophageal squamous cell carcinoma is the most common. Neoadjuvant chemoradiotherapy combined with surgery is currently the recommended treatment modality for locally advanced esophageal cancer, but the side effects of chemoradiotherapy are serious, which increases the risk of surgery.
Immune checkpoint inhibitors have made significant progress in the field of cancer treatment in recent years, and have now become an important treatment method for advanced and metastatic esophageal cancer. Several trials on neoadjuvant immuno-chemotherapy demonstrated better outcomes with acceptable toxicity compared to traditional chemoradiotherapy. Cadonilimab is a dual immune antibody drug comprised of PD-1 antibody and CTLA-4 antibody, which has the anti-tumor effect of two immune checkpoint pathways at the same time.
On the other hand, angiogenesis plays a vital role in the growth and metastasis of tumors, and anti-angiogenic drugs have become an important part of cancer treatment. Anlotinib is an oral, small molecule anti-angiogenic targeted agent that has been approved for use in a variety of cancer treatments.
This study plans to conduct a prospective study of cadonilimab combined with anlotinib in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma, and aims to explore the efficacy and safety of this neoadjuvant regimen that avoids chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma.
### Conditions Module
**Conditions:**
- Locally Advanced Esophageal Squamous Cell Carcinoma
**Keywords:**
- esophageal squamous cell carcinoma
- neoadjuvant immunotherapy
- pathological complete response
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Patients with locally advanced resectable esophageal squamous cell carcinoma
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with locally advanced esophageal squamous cell carcinoma
**Intervention Names:**
- Drug: Cadonilimab plus anlotinib
**Label:** locally advanced ESCC
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- locally advanced ESCC
**Description:** cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles
**Name:** Cadonilimab plus anlotinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Pathological complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR).
**Measure:** Pathological Complete Response (pCR) Rate
**Time Frame:** Within 1 week after surgery
#### Secondary Outcomes
**Description:** Major pathological response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
**Measure:** Major Pathological Response (MPR) Rate
**Time Frame:** Within 1 week after surgery
**Description:** Objective response rate (ORR) is defined as the Percentage of participants achieving complete response (CR) or partial response (PR) in all patients with measurable disease at baseline, as assessed by the investigator according to RECIST version 1.1.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Within 1 week before surgery
**Description:** The incidence and severity of treatment emergent adverse events (including adverse events, serious adverse events and immune-related adverse events) among all participants.
**Measure:** Treatment Emergent Adverse Events (TEAE)
**Time Frame:** Up to 24 months after participation
**Description:** EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST version 1.1.
**Measure:** Event-free Survival (EFS)
**Time Frame:** Up to 24 months after participation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able to provide written informed consent and understand and agree to comply with the requirements of this study as well as the assessment schedule.
2. Be at least 18 years of age on the date of signing the ICF.
3. Histopathologically confirmed esophageal squamous cell carcinoma: the clinical stage is T1-2N1-3M0, T2 (diameter≥3 cm) N0M0 or T3-4aN0-3M0 (stage II-IVA), and the staging should be based on the AJCC 8th edition esophageal cancer staging system.
4. Patients are asked to provide an archival tumor tissue sample (FFPE tissue block or approximately 15 \[≥6\] freshly cut unstained FFPE sections) and a pathology report of this baseline sample. If no archival sample is available or the sample is not available, a biopsy sample is requested at baseline.
5. Prior to study enrollment, patients are evaluated by thoracic surgeon in charge of surgery to verify that they meet the study requirements for R0 resection with radical curative intent.
6. Cardiac and pulmonary function is good, and surgical resection for curative purposes is confirmed, and cardiopulmonary function tests and respiratory or cardiology consultation can be completed if necessary.
7. Measurable disease as assessed by the investigator according to RECIST version 1.1.
8. Eligible for anlotinib treatment.
9. ECOG performance status ≤ 2 points.
10. ≤ 14 days prior to enrollment, the following laboratory test values during the screening period suggest that the patient has good organ function:
* Patient has not had a blood transfusion or use of growth factor supportive therapy within ≤14 days prior to blood draw, when the following items are tested prior to enrollment:
* Absolute neutrophil count ≥ 1.5 x 109/L
* Platelet ≥ 75×109/L
* Hemoglobin ≥ 90 g/L
* Glomerular filtration rate (GFR) estimated by the Cooperative Equation for Epidemiology of Chronic Kidney Disease ≥45mL/min/1.73 m2.
* Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin must be \<3 ×ULN in patients with Gilbert's syndrome).
* AST and ALT≤2.5 ×ULN.
* Patients not receiving anticoagulant therapy: International normalized ratio or activated partial prothrombin time ≤ 1.5× ULN.
11. Females of childbearing potential must be willing to practice highly effective contraception for the duration of the study, and for ≥120 days after the last dose of cadonilimab or anlotinib, whichever occurs later, and have a negative urine or serum pregnancy test result within ≤7 days prior to enrollment.
Exclusion Criteria:
1. Previous treatment for current esophageal cancer, including chemotherapy or radiotherapy.
2. Prior receipt of antibodies or drugs targeting immune checkpoint pathways, including but not limited to anti-cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1, and anti-PD-L1 therapeutic antibodies.
3. Patients with non-squamous cell carcinoma.
4. Presence of locally advanced, unresectable disease, regardless of disease stage and presence or absence of metastases (stage IV).
5. Active autoimmune disease or history of autoimmune disease that may recur.
Note: Patients with the following conditions do not need to be excluded and can proceed for further enrollment screening:
* Well-controlled type I diabetes
* Hypothyroidism (as long as it is treated with hormone replacement therapy alone)
* Well-controlled celiac disease
* Skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia)
* Any other illness that is not expected to recur in the absence of an external trigger
6. Any active malignancy in the ≤ 2 years prior to enrollment, with the exception of the specific cancers studied in this study and cancers that have recured locally after radical therapy (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ).
7. Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent\> 10 mg/day) or other immunosuppressive medications within ≤14 days prior to enrollment.
Note: Patients with current or prior use of any of the following steroid regimens do not need to be excluded:
* Adrenal replacement steroids (prednisone or equivalent\> 10 mg/day)
* Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with very low systemic absorption
* Short-term (≤7 days) prophylactic use of corticosteroids (e.g., contrast allergy) or for the treatment of non-autoimmune diseases (e.g., delayed-type hypersensitivity reactions caused by contact allergens)
8. Poorly controlled diabetes mellitus ≤ 14 days prior to enrollment, or abnormal laboratory test results of potassium, sodium, or corrected calcium \> grade 1 (regardless of standard medical management) or ≥ grade 3 hypoalbuminemia.
9. Has a history of interstitial lung disease, non-infectious pneumonitis, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.
10. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
11. Known history of HIV virus infection.
12. Patients with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded.
Note: Patients with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \< 500 IU/mL), and cured hepatitis C patients can be enrolled.
13. Any major surgical procedure requiring general anesthesia ≤ 28 days prior to enrollment.
14. Previous allogeneic stem cell transplantation or organ transplantation.
15. Any of the following cardiovascular risk factors:
* Cardiogenic chest pain within 28 days prior to enrollment, defined as moderate pain with instrumental limitation of activities of daily living.
* Symptomatic pulmonary embolism within 28 days prior to enrollment.
* Any history of acute myocardial infarction within 6 months prior to enrollment.
* Any history of heart failure consistent with New York Heart Association Classification Class III or IV≤ 6 months prior to enrollment.
* Any ≥ grade 2 ventricular arrhythmic event within 6 months prior to enrollment (inclusive).
* Any history of cerebrovascular accident within 6 months prior to enrollment.
* Hypertension that remains uncontrolled with standard antihypertensive medication within 28 days prior to enrollment.
* Syncope or seizures ≤ 28 days prior to enrollment.
16. History of severe allergic reaction to chimeric or humanized antibodies or fusion proteins.
17. Received any other chemotherapy, immunotherapy (e.g., interleukin, interferon, thymosin), or any investigational therapy during the study period.
18. Patients who have not returned to baseline or stable levels of toxic side effects (due to prior antineoplastic therapy) unless the AE is not considered to pose a safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities).
19. Received a live vaccine ≤ 4 weeks prior to enrollment. Note: Seasonal influenza vaccines are usually inactivated and are therefore permitted. Intranasal vaccination is a live vaccine, so it is not allowed.
20. Has an underlying medical condition (including laboratory abnormalities) or alcohol/drug abuse or dependence that, in the opinion of the investigator, is detrimental to study drug administration or affects the interpretation of drug toxicity or adverse events, or in the judgment of the investigator that the patient's adherence during the study is not adequate that could affect compliance.
21. Participating in another therapeutic clinical study at the same time.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fan Yang, M.D.
**Phone:** +86-010-88326657
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xiang Yan, M.D.
**Phone:** +86-13581786750
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University People's Hospital
**Name:** Fan Yang, M.D.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000018307
- Term: Neoplasms, Squamous Cell
- ID: D000004938
- Term: Esophageal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M1733
- Name: Esophageal Squamous Cell Carcinoma
- Relevance: HIGH
- As Found: Esophageal Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000077277
- Term: Esophageal Squamous Cell Carcinoma
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426784
**Brief Title:** Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
**Official Title:** Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
#### Organization Study ID Info
**ID:** F-5-2/2024(ERRB)/PIMS
#### Organization
**Class:** OTHER_GOV
**Full Name:** Pakistan Institute of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Pakistan Institute of Medical Sciences
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Muhammad Haroon Anwar
#### Responsible Party
**Investigator Affiliation:** Pakistan Institute of Medical Sciences
**Investigator Full Name:** Muhammad Haroon Anwar
**Investigator Title:** Principal Investigator, Department of Anaesthesia and Critical Care Medicine
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** C-section is one of the commonly performed surgical procedures. During this surgical procedure the surgeon cuts into uterine cavity through abdominal wall and takes out the baby. This is done by by making the lower half body of the patient numb by injecting local anesthesia drugs into the space surrounding the spinal cord. This allows the mother to remain awake and immediately bond with the baby once it gets delivered. Also this technique provides effective pain relief both during and after the surgery. However like any other technique or drug it is associated with a number of side effects. The most important being fall in blood pressure. There are numerous ways to treat it. However if one is able to predict fall in blood pressure before administration of anesthetic technique one can easily prevent it. One of the recently discovered novel way to predict fall in blood pressure is Perfusion index which is calculated by Pulse oximeter. It is a device use to check amount of oxygen in blood and heart rate. Perfusion index refers to the total amount of blood present in the limbs of the person. Once we administer drug in the space surrounding the spinal cord the amount of blood in the limbs increases while the amount returning to heart decreases which ultimately results in less amount of blood being pumped out by heart resulting in fall in blood pressure. Therefore theoretically those individuals who have a high baseline Perfusion index will more likely to develop low blood pressure. This study aims to identify the cut off value of perfusion index to predict fall in blood pressure.
**Detailed Description:** Spinal anesthesia is employed to provide excellent surgical conditions in case of C-Section. It is the anesthetic technique of choice among obstetric patients. However it is associated with sympathectomy which reduces the venous return and ultimately causes hypotension. This hypotension is mainly due to redistribution of blood volume to the peripheral compartment. Perfusion index which is measured by Pulse Oximetery is a ratio of pulsatile to non-pulsatile blood in the peripheral compartment of the body. As spinal anesthesia causes sympathectomy, peripheral blood volume increases. As a result perfusion index value should rise. This will then co-relate with hypotension. In simple terms those individuals who have a high baseline Perfusion index value will more likely to develop hypotension. This study aims to identify the baseline perfusion index value which co-relates with development of hypotension following sub-arachnoid block for C-section.
### Conditions Module
**Conditions:**
- Hypotension
- Hypotension on Induction
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pregnant patients having baseline perfusion index less than 3.5 will be enrolled into this group.
**Label:** Low Perfusion index
#### Arm Group 2
**Description:** Pregnant patients having baseline perfusion index ≥ 3.5 will be enrolled into this group.
**Label:** High Perfusion index
### Outcomes Module
#### Primary Outcomes
**Description:** Number of episodes of hypotension among both groups will be compared.
**Measure:** Incidence of hypotension
**Time Frame:** Intra-operative peroid
#### Secondary Outcomes
**Description:** Sensitivity and specificity of baseline perfusion index to predict intra-operative hypotension following sub-arachnoid block
**Measure:** Baseline perfusion index as a predictor of hypotension
**Time Frame:** Intra operative peroid
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA class II and III
* Elective LSCS under sub-arachnoid block
* Age 18-35 years
Exclusion Criteria:
* Hypertensive disorders of pregnancy
* Autonomic neuropathy
* Fetal distress
* NPO \>8h
* Lack of maintenance fluid or oral clear fluid intake during NPO period.
* BMI \> 35 kg/m2
* Patients requiring Vasopressor and Ionotropic support.
**Gender Based:** True
**Gender Description:** Pregnant females undergoing elective Lower segment caesarean section
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Pregnant females undergoing elective lower segment caesarean section under spinal anesthesia at Pakistan Institute of Medical sciences will be enrolled in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Muhammad Haroon Anwar, MBBS
**Phone:** +92-333-5236956
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Naheed Fatima, MBBS,FCPS
**Phone:** +92-300-5236655
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Islamabad
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Muhammad Haroon Anwar, MBBS
- **Phone:** +92-333-5236956
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Naheed Fatima, MBBS,FCPS
- **Phone:** +92-300-5236655
- **Role:** CONTACT
***Contact 3:***
- **Name:** Muhammad Haroon Anwar, MBBS
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Pakistan
**Facility:** Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
**State:** Federal
**Status:** RECRUITING
**Zip:** 44000
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
**Name:** Muhammad Haroon Anwar, MBBS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Lal J, Bansal T, Bhardwaj S, Jain M, Singh AK. A study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia for caesarean section. J Anaesthesiol Clin Pharmacol. 2022 Apr-Jun;38(2):294-299. doi: 10.4103/joacp.JOACP_385_20. Epub 2022 Jun 16.
**PMID:** 36171921
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10072
- Name: Hypotension
- Relevance: HIGH
- As Found: Hypotension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007022
- Term: Hypotension
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426771
**Acronym:** AMH
**Brief Title:** Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density
**Official Title:** Investigation of Dietary Inflammatory Index, Dietary Phytochemical Index and NRF Nutrient Density in Patients With High and Low Antimullerian Hormone Levels
#### Organization Study ID Info
**ID:** 02/10 28.02.2024
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
**Investigator Full Name:** Mujde Can Ibanoglu
**Investigator Title:** Assoc. Prof
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of the study was to calculate the dietary inflammatory index, dietary phytochemical index and NRF nutrient density of the dietary pattern routinely consumed by women and to assess whether there is a difference between PCOS patients with high AMH levels and the group with low AMH levels.
**Detailed Description:** There is currently growing interest in the relationship between lifestyle, reproductive health and fertility. Recent research emphasizes the influence of environmental and lifestyle factors such as stress, diet and nutritional status on reproductive health. Ovarian reserve refers to the number and quality of eggs and is an indicator of reproductive potential. Ovarian reserve is inversely proportional to the chronological age of the mother, which is the most important determinant of reproductive capacity and reproductive success. It has been shown that reproductive aging accelerates after the age of 35. Therefore, the assessment of ovarian reserve is an important step in both the evaluation and treatment of infertility. Markers of ovarian reserve include antral follicle count (AFC), which is determined by transvaginal ultrasound, and serum levels of various biomarkers such as anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol. Studies show that certain dietary patterns and the intake of certain nutrients are associated with endometriosis, ovarian reserve and egg quality, ovarian infertility and fertility. In addition, there is evidence that modifiable lifestyle factors, such as adherence to certain dietary habits and avoidance of environmental toxins, may also have positive effects on ovarian reserve. Recent studies have shown that women's nutritional status, body mass index and eating habits influence ovarian reserve.
The Dietary Inflammatory Index (DII) is an index developed to assess the impact of general dietary habits on inflammation. It is known that the dietary inflammatory index is high in chronic diseases associated with inflammation. The Phytochemical Index is a calculation based on the consumption of fruits high in phytochemicals, all vegetables except potatoes, legumes, whole grains and whole grain-containing foods, and oilseeds that provides information about the level of phytochemicals in the diet. The NRF Nutrient Density Index is a continuous function and represents an arithmetic combination of weighted variables. In this continuous function algorithm, the negative part (foods that should be restricted) is subtracted from the positive part (foods that should be consumed). In the calculation phase of this model, foods were scored according to their nutrient content per 100 kcal and per serving size. By calculating the nutrient density of the food consumed, the quality of the person's diet can be determined.
Based on this information, it was planned to compare these 3 nutritional indices in patients diagnosed with PCOS with an AMH level above 3.32 ng/ml, in the low ovarian reserve group without a PCOS diagnosis with an AMH level below 1.2 ng/ml and in normo-responder patients with an AMH level between these two values.
### Conditions Module
**Conditions:**
- AMH
- Diet Habit
- Ovarian Failure
- Polycystic Ovary Syndrome
**Keywords:**
- NRF Nutrient Density Index
- Dietary Inflammatory Index
- Phytochemical Index
- anti-Müllerian hormone
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** AMH levels: those with low AMH levels (\<1.2 ng/ml): 30 participants
**Intervention Names:**
- Behavioral: Dietary Inflammatory Index
- Diagnostic Test: hormone profile
**Label:** Low AMH Levels-
#### Arm Group 2
**Description:** normal AMH levels (1.2-3.32 ng/ml): 30 participants
**Intervention Names:**
- Behavioral: Dietary Inflammatory Index
- Diagnostic Test: hormone profile
**Label:** Normal AMH levels-
#### Arm Group 3
**Description:** high AMH levels (\>3.32 ng/ml): 30 Participants
**Intervention Names:**
- Behavioral: Dietary Inflammatory Index
- Diagnostic Test: hormone profile
**Label:** High AMH levels-
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High AMH levels-
- Low AMH Levels-
- Normal AMH levels-
**Description:** The aim of this study was to compare the dietary habits of patients with PCOS and an AMH value of \>3.32 ng/ml, of patients with low ovarian reserve without PCOS and an AMH value of less than 1.2 ng/ml and of patients with normal AMH values (between 1.2-3.32 ng/ml) according to Dietary Nutrient Density according to Dietary Inflammatory Index, Dietary Phytochemical Index and Nutrient Rich Food Index.
**Name:** Dietary Inflammatory Index
**Other Names:**
- Dietary Phytochemical Index
- Nutrient Rich Food Index
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- High AMH levels-
- Low AMH Levels-
- Normal AMH levels-
**Description:** In the routine practice of the PCOS clinic, about 7 ml of blood is taken in a vacuum gel tube for hormonal and biochemical analysis by medical staff. The blood samples are centrifuged by the researchers at 1000xg for 20 minutes. In the next step, the supernatant part is separated and transferred to 3 mL Ependorfs. These samples are used to determine the levels of anti-Müllerian hormone (AMH), oestradiol, LH and FSH, which are routinely determined at the PCOS clinic.
**Name:** hormone profile
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Patients with low, normal and high AMH values are examined for differences in the indices calculated according to nutrient density.
**Measure:** AMH levels according to dietary indexes
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Between the ages of 18 and 40,
* No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
* Female patients with AMH levels in our hospital,
* Participants attending the PCOS clinic and under the care of our hospital dietitian will be enrolled in the study.
Exclusion Criteria:
1. Age \< 18 and \> 40 years;
2. Menopause, pregnancy or breastfeeding in the last 6 months;
3. Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary causes, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction, and adrenal disease),
4. Pre-existing systemic or psychiatric illnesses
5. Taking medication that affects carbohydrate or fat metabolism (contraceptive pills, metformin, antiepileptic drugs, antipsychotics, statins and fish oil);
6. Certain nutritional therapies or hypocaloric diet in the last three months; supplementation with antioxidants, vitamins or minerals;
7. Taking medications that can affect fluid balance, such as non-steroidal anti-inflammatory drugs, diuretics, etc.
8. Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of impaired device activity.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** This study was designed as a cross-sectional cohort study including individuals who were followed up in the PCOS Clinic and dietetic department of Etlik Zübeyde Hanım Gynaecology Training and Research Hospital. Patients will be divided into 3 groups according to AMH value as those with low AMH value, those with normal AMH value and those with high AMH value (11).
The study will include 90 individuals who agreed to be included in the study and accepted the consent form verbally and in writing.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mujde Can Ibanoglu
**Phone:** 05323089488
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yaprak Engin-Ustun
**Phone:** 05323089488
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
**Name:** Mujde Can Ibanoglu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Lakoma K, Kukharuk O, Sliz D. The Influence of Metabolic Factors and Diet on Fertility. Nutrients. 2023 Feb 27;15(5):1180. doi: 10.3390/nu15051180.
**PMID:** 36904180
**Citation:** Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
**PMID:** 31547562
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010048
- Term: Ovarian Cysts
- ID: D000003560
- Term: Cysts
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13970
- Name: Polycystic Ovary Syndrome
- Relevance: HIGH
- As Found: Polycystic Ovary Syndrome
- ID: M6765
- Name: Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12971
- Name: Ovarian Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011085
- Term: Polycystic Ovary Syndrome
### Intervention Browse Module - Ancestors
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Repr
- Name: Reproductive Control Agents
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: HIGH
- As Found: Loss
- ID: M266279
- Name: Estradiol 17 beta-cypionate
- Relevance: LOW
- As Found: Unknown
- ID: M266280
- Name: Estradiol 3-benzoate
- Relevance: LOW
- As Found: Unknown
- ID: M8108
- Name: Estradiol
- Relevance: LOW
- As Found: Unknown
- ID: M234941
- Name: Polyestradiol phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006728
- Term: Hormones
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426758
**Brief Title:** Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation
**Official Title:** The Morbidity of Graves' Disease and Recurrence Rate of Hyperthyroidism Due to Epstein-Barr Virus Lytic Reactivation
#### Organization Study ID Info
**ID:** NanjingMU2
#### Organization
**Class:** OTHER
**Full Name:** Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Natural Science Foundation of China
#### Lead Sponsor
**Class:** OTHER
**Name:** Xiao-Ming Mao
#### Responsible Party
**Investigator Affiliation:** Nanjing Medical University
**Investigator Full Name:** Xiao-Ming Mao
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Previous studies have proved that the lytic reactivation of latent Epstein-Barr virus (EBV) was significantly associated with the onset of Graves'disease (GD), however, the morbidity of GD and recurrence rate of hyperthyroidism after antithyroid drugs treatment due to lytic reactivation of EBV is not understood. We will recruit patients with newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment. In order to confirm lytic reactivation of EBV, the number of EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic EBV genes，EBV +TRAb+cells will be tested. The proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism was evaluated.
**Detailed Description:** The lytic reactivation of latent EBV play importment roles in development of GD and recurrence rate of hyperthyroidism. The aim of this study is to evaluate the proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism.
All patients satisfied the diagnostic criteria for GD. The diagnotic remission of hyperthyroidism was included of clinical symptoms and elevated FT3 and FT4, the patients who have been received antithyroid drugs (methimazole or propylthiouracil) titration treatment for 18 or more months and of antithyroid drugs titration treatment and withdrawal antithyroid drugs at least 3 months.
The evaluation of lytic reactivation of latent EBV including EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic genes，and EBV +TRAb+cells. The EBV DNA copies was tested with PCR, mRNA and protein expression of immediate-early, early and late lytic EBV genes were analysed with RT-qPCR or Western blot and EBV +TRAb+cells were evaluated with flow cytometry.
All statistical tests were performed using GraphPad Prism V8.0.
### Conditions Module
**Conditions:**
- Graves Disease
- Graves' Disease in Remission
- Epstein-Barr Virus
**Keywords:**
- Graves Disease
- Relapse of hyperthyroidism
- Epstein-Barr virus
- Lytic reactivation
- Morbidity
### Design Module
#### Bio Spec
**Description:** Following DNA isolation with a QIAamp DNA Blood Mini Kit, the number of EBV copies in PBMCs was detected using real-time PCR assay by means of the ISEX variant of the EBV PCR kit. The results are expressed in units of EBV DNA copies/µg of DNA, EBV DNA copies/mL of PBMCs suspension, and EBV DNAcopies/100,000 cells.
Peripheral blood samples were collected from patients with GD and recurrence of hyperthyroidism.Total RNA was extracted from blood using the conventional TRIzol method. Reverse transcription was performed using PrimeScript RT Reagent Kit with cDNA Eraser for two-step reverse transcription polymerase chain reaction.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The GD patients with high number of EBV DNA copies, EBV +TRAb+cells and overexpression lytic genes are considered as lytic reactivation of EBV
**Measure:** The incidence rate of GD and and recurrence of hyperthyroidism due to lytic reactivation of EBV
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The clinical evaluation included patient history, physical examination, and thyroid ultrasonography. Laboratory and diagnostic testing included determination of serum levels of free thyroxine (FT4), T3 ( FT3), thyrotropin (TSH), TPOAb, TGAb, and serum levels of thyrotropin receptor antibody (TRAb).
Exclusion Criteria:
* Patients with subacute thyroiditis, hyperfunctioning thyroid nodules, iodine hyperthyroidism, drug-induced hyperthyroidism, or other causes of hyperthyroidism were also excluded. The exclusion criteria for both patients with GD included diabetes, infectious diseases, other chronic diseases, and cancer.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiao-Ming Mao, MD.
**Phone:** +86-18951670295
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Guo-Qing Li, PhD.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiao-Ming Mao, MD.
- **Phone:** +86-18951670295
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Guo-Qing Li, PhD.
- **Phone:** +86-15895915500
- **Role:** CONTACT
**Country:** China
**Facility:** Nanjing First Hospital, Nanjing Medical University
**State:** Jiangsu
**Zip:** 210006
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014412
- Term: Tumor Virus Infections
- ID: D000005094
- Term: Exophthalmos
- ID: D000009916
- Term: Orbital Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000006042
- Term: Goiter
- ID: D000013959
- Term: Thyroid Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M21881
- Name: Epstein-Barr Virus Infections
- Relevance: HIGH
- As Found: Epstein-Barr Virus
- ID: M9214
- Name: Graves Disease
- Relevance: HIGH
- As Found: Graves' Disease
- ID: M10031
- Name: Hyperthyroidism
- Relevance: HIGH
- As Found: Hyperthyroidism
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17162
- Name: Tumor Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M8237
- Name: Exophthalmos
- Relevance: LOW
- As Found: Unknown
- ID: M12845
- Name: Orbital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9147
- Name: Goiter
- Relevance: LOW
- As Found: Unknown
- ID: M16718
- Name: Thyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020031
- Term: Epstein-Barr Virus Infections
- ID: D000006111
- Term: Graves Disease
- ID: D000006980
- Term: Hyperthyroidism
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06426745
**Brief Title:** Split-dose Versus Single-dose Bowel Preparation for Colonoscopy
**Official Title:** Split-dose Versus Single-dose Bowel Preparation for Colonoscopy
#### Organization Study ID Info
**ID:** PEG solution
#### Organization
**Class:** INDUSTRY
**Full Name:** Egymedicalpedia
### Status Module
#### Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-25
**Type:** ACTUAL
#### Start Date
**Date:** 2022-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Egymedicalpedia
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions.
**Detailed Description:** Colonic cancers are a major concern in the Middle East and the world in general, and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development. From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies, 693 were incomplete (7.8%), and for 25% of failure was because of inadequate bowel preparation.
An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients. The polyethylene glycol (PEG) solution, an isosmotic non-absorbable polymer, is generally used for bowel preparation, because of its safety, effectiveness, and good tolerability. Quality of bowel cleansing depends not only on the formula used, but the preparation regimen also plays a role. Split dosing of the laxative offers, in general, better cleansing than a single dose preparation.
A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation.
Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose, in terms of adequate bowel preparation and polyp detection.
On the other hand , a large randomized trial of PEG regimens show, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose. Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated, and acceptable bowel preparation for colonoscopy.
A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose: the fasting time is shorter and there is no sleep disturbance, which can be associated with split-dose or previous-day regimen.
### Conditions Module
**Conditions:**
- Colonic Cancer
- Colonic Polyp
- IBS - Irritable Bowel Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 180
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** About 90 participants underwent Split-dose bowel preparation for colonoscopy
**Intervention Names:**
- Procedure: Bowel preparation
**Label:** Split-dose bowel preparation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** About 90 participants underwent single-dose bowel preparation for colonoscopy
**Intervention Names:**
- Procedure: Bowel preparation
**Label:** single-dose bowel preparation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Split-dose bowel preparation
- single-dose bowel preparation
**Description:** to compare bowel cleanliness, compliance, tolerability, and patient satisfaction of a single regimen versus a split regimen for colonoscopy.
**Name:** Bowel preparation
**Other Names:**
- colonoscopy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** to compare the efficacy of split-dose versus single morning administration of PEG solution for colon cleansing in patient undergoing colonoscopy using Boston Bowel Preparation Scale , and to assess the optimal preparation- to-colonoscopy (PC) interval .
**Measure:** colon cleansing
**Time Frame:** 2 hours before Bowel Preparation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- All patients undergoing elective colonoscopy
Exclusion Criteria:
* Presence of sever renal impairment. (Creatinine clearance \< 30 ml/min or patient on hemodialysis).
* Sever congestive heart failure (NHYA III or IV).
* Pregnant woman.
* History of bowel obstruction or resection.
* Known allergies to polyethylene glycol.
* Refusal of consent for the study.
* Signs of liver cell failure as ascites and hepatic encephalopathy.
* Electrolytes disturbances
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mansoura
**Country:** Egypt
**Facility:** Mansoura university Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Internal Medicine Hepatology and Gastroenterology Faculty of Medicine - Mansoura University
**Name:** Seham Mohammad Abd-AlAdl Seif, Professor
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Hepatology and Gastroenterology Faculty of Medicine - Mansoura University
**Name:** Hany Shabana, M.D
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003109
- Term: Colonic Diseases, Functional
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007417
- Term: Intestinal Polyps
- ID: D000011127
- Term: Polyps
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M25118
- Name: Irritable Bowel Syndrome
- Relevance: HIGH
- As Found: Irritable Bowel Syndrome
- ID: M6339
- Name: Colonic Polyps
- Relevance: HIGH
- As Found: Colonic Polyps
- ID: M14011
- Name: Polyps
- Relevance: LOW
- As Found: Unknown
- ID: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colonic Cancer
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6337
- Name: Colonic Diseases, Functional
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10451
- Name: Intestinal Polyps
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003110
- Term: Colonic Neoplasms
- ID: D000043183
- Term: Irritable Bowel Syndrome
- ID: D000003111
- Term: Colonic Polyps
### Misc Info Module
- Version Holder: 2024-05-31
|
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.