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## Protocol Section
### Identification Module
**NCT ID:** NCT06430632
**Acronym:** ERA Stroke
**Brief Title:** Early Robotic Gait Training After Stroke
**Official Title:** Early Robotic Gait Training After Stroke
#### Organization Study ID Info
**ID:** 023-471
#### Organization
**Class:** OTHER
**Full Name:** Baylor Research Institute
#### Secondary ID Infos
**Domain:** National Institute on Disability, Independent Living, and Rehabilitation Research
**ID:** 90IFRE0074
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** National Institute on Disability, Independent Living, and Rehabilitation Research
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR).
**Detailed Description:** Importance: Stroke is estimated to affect 6.6 million Americans, and around 795,000 new cases are reported each year. By 2030, annual stroke-related healthcare costs are expected to eclipse $240 billion, a staggering 445% increase from the current annual cost of $53.9 billion. Specialized stroke rehabilitation reduces long-term disability and stroke-related costs, making cost-efficient efforts to minimize functional deficits faced by people with stroke (e.g., gait impairment) a high priority. This project will provision preliminary evidence regarding the clinical use and efficacy of robotic gait training (RGT) during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. Its results will help with developing safe, tolerable, and cost-effective training protocols to improve walking function after stroke. Additionally, follow-up assessments after discharge will investigate any carryover effect of RGT, providing foundational data to evaluate the dose-response relationship for delivering RGT during inpatient rehabilitation after stroke. Altogether, this evidence will help stroke rehabilitation programs to assess their planning and budgeting needs prior to adopting RGT technology, improving outcomes and lowering lifetime care costs for patients with stroke.
Aims: (1) Evaluate the safety, tolerability, and feasibility of delivering an RGT intervention that meets the unique needs of people after stroke during inpatient rehabilitation informed by an Advisory Board comprised of stakeholders living with stroke. (2) Examine the efficacy of RGT compared to usual care (UC) gait training during inpatient rehabilitation for people with stroke. (3) Conduct a cost analysis of delivering RGT during inpatient rehabilitation compared to UC.
Methods: This randomized controlled trial will enroll 54 patients admitted to the Baylor Scott and White Institute for Rehabilitation following stroke. Participants will be randomized to either the experimental group receiving RGT or the control group receiving UC.
Addition to State-of-the-Art: Expected products include a manualized, stakeholder-informed RGT intervention and cost-analysis template that can be replicated across early rehabilitation settings nationally for people with stroke.
Sustained Approach: This project builds upon our earlier findings to achieve optimal walking recovery post-stroke during inpatient rehabilitation. The proposed work will generate preliminary efficacy, safety, tolerability, feasibility, and cost-analysis data concerning delivering an RGT intervention during the subacute phase for people with stroke.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- Exoskeleton
- Gait training
- Inpatient rehabilitation
- Physical therapy
- Physical rehabilitation and medicine
- Randomized controlled trial
- Robotic gait training
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 54
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.
**Intervention Names:**
- Device: Robotic Gait Training
**Label:** Robotic Gait Training
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.
**Intervention Names:**
- Other: Usual Care Gait Training
**Label:** Usual Care Gait Training
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Robotic Gait Training
**Description:** Participants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function.
**Name:** Robotic Gait Training
**Other Names:**
- EksoNR Robotic Exoskeleton
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Usual Care Gait Training
**Description:** Participants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function.
**Name:** Usual Care Gait Training
**Other Names:**
- Standard of Care Gait Training
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** To supplement the study's measurements of RGT efficacy (10-meter walk test \[gait speed\], 6-minute walk test \[gait endurance\], and Functional Ambulation Category \[gait independence\]), the investigators will additionally measure gait quality. Improvements in quality of gait after a stroke are associated with gains in balance and functional mobility. Further, return to participation in life roles is largely associated with a patients' perspective on their recovery. Therefore, the most impactful way to capture gait quality for each participant will be to use a measure of self-report. Specifically, gait quality will be measured weekly on a visual analog scale from 1 ("my walking is the worst it has ever been") to 10 ("my walking is just like before my stroke").
**Measure:** Gait quality
**Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
**Description:** Pain after stroke is common and can result in reduced participation in activity. This change will allow the investigators to monitor the impact of pain on gait outcomes. Pain will be assessed following each RGT and UC session using a pain visual analog scale, as per standard of care in the investigators' inpatient rehabilitation hospital.
**Measure:** Pain following each gait training session
**Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
**Description:** Number of adverse events occurring at baseline through study completion.
**Measure:** Adverse event rate
**Time Frame:** through study completion (up to 3.5 months)
**Description:** Subjects will provide feedback on their tolerance of treatment sessions via a questionnaire that measures tolerability on a scale 0 (not tolerable at all) to 10 (maximally tolerable). A higher score means greater tolerability in robotic gait training.
**Measure:** Treatment tolerability (RGT only)
**Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
**Description:** The number of sessions attended divided by the number of scheduled sessions.
**Measure:** Treatment completion rate
**Time Frame:** through study completion (up to 3.5 months)
#### Primary Outcomes
**Description:** The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (\<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (\>0.8 m/s). Score changes \>0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is \>1.27 m/s.
**Measure:** Gait speed via 10-Meter Walk Test (10MWT)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
#### Secondary Outcomes
**Description:** The FAC assesses functional ambulation in patients undergoing rehabilitation and has excellent reliability, good predictive validity, and good responsiveness in patients with stroke. Scores range from 0 (unable to walk) to 5 (independent walking anywhere). After 4 weeks of rehabilitation, FAC scores ≥4 predict community ambulation at 6 months with 100% sensitivity and 78% specificity.
**Measure:** Functional Ambulation Category (FAC)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The Section GG CARE is utilized in post-acute care settings for tracking progress across the continuum of care and is conducted at admission and discharge. The CARE addresses self-care (GG0130, 8 items) and functional mobility (GG0170, 17 items). Scores for each item range from 1 (dependent) to 6 (independent). Total scores for the CARE have strong positive correlations with total scores for the Functional Independence Measure.
**Measure:** Continuity Assessment Record and Evaluation (CARE)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of walking capacity. Endurance (captured as walking capacity) is essential to participate in community-based activities. With excellent test-retest reliability (ICC = 0.99) for people with stroke, the established MCID is 34.4 meters.
**Measure:** 6-Minute Walk Test (6MWT)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The mRS measures the degree of disability or dependence in the daily activities of people who have had a stroke. The mRS is an ordinal scale with 6 categories ranging from 0 (no symptoms) to 5 (complete physical dependence).
**Measure:** Modified Rankin Scale (mRS)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The STREAM assesses upper and lower limb motor function along with basic mobility in people with stroke and has a very high inter-rater reliability (ICC = 0.96). MCID values have been established for the upper extremity (2.2 points), lower extremity (1.9 points), and mobility (4.8 points) subscales.
**Measure:** Stroke Rehabilitation Assessment of Movement (STREAM)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The 5TSST assesses lower extremity strength and is an indicator of postural control. People with stroke who score \>15 seconds are considered at risk for falls. Normal scores for individuals aged 60-80 years range from 11.4 to 12.7 seconds. The 5TSST has demonstrated excellent test-retest reliability (ICC = 0.95) with an established MDC95 of 2.3 seconds.
**Measure:** 5 Times Sit-to-Stand Test (5TSST)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The BBS is a 14-item objective measure that assesses static balance and fall risk in adults. With excellent reliability (ICC = 0.95), the BBS has a large responsiveness for acute stroke (effect size = 0.85) and a minimal detectable change of 6.9 points. Scores \<45/56 indicate a risk of falling.
**Measure:** Berg Balance Scale (BBS)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The SIS-16 assesses 4 dimensions of health-related QOLs specific to people who have had a stroke. It includes subscales that assess strength, hand function, mobility, and activities of daily living via 5-point Likert scales.
**Measure:** Stroke Impact Scale - 16 (SIS-16)
**Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
**Description:** The Borg RPE is a 15-point scale with verbal descriptors to standardize perceived exertion across tasks and individuals. Participants will be asked to provide a self-reported intensity level on the Borg Rating of Perceived Exertion Scale during RGT and UC gait training sessions. A self-report of 12 to 14 on the RPE indicates moderate intensity.
**Measure:** Rating of Perceived Exertion (RPE)
**Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
**Description:** The Ekso device records several data points for each session including number of steps, "Up" time (the amount of time spent standing in the device), "Walk" time (the amount of time spent walking in the device), and device assistance scores. While all of these data values will be recorded to describe each RGT session and tracked to monitor progression of the RGT intervention, the number of steps per session will be utilized as an indicator of RGT session intensity.
**Measure:** Number of steps (RGT only)
**Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
**Description:** Distance walked will be recorded to describe each UC session, tracked to monitor progression of the UC intervention, and utilized as an indicator of UC session intensity.
**Measure:** Distance walked (UC only)
**Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-85 years of age
* All types of stroke
* Acute/subacute phase of recovery
* Medically stable as deemed by a physician
* Undergoing medical care and rehabilitation at BSWIR
* All genders, races, and ethnicities
* Meets Ekso robotic exoskeleton frame limitations
* Continence or on a program for bladder and bowel management
* Capacity and goal for walking recovery
Exclusion Criteria:
* Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm)
* Profound cognitive impairment
* Pregnancy
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sara Baltz, MS
**Phone:** (214) 820-5022
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Faith Meza, MPH
**Phone:** (214) 820-9409
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Name:** Baylor Scott & White Institute for Rehabilitation
- **Role:** CONTACT
***Contact 2:***
- **Name:** Chad Swank, PT, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Baylor Scott & White Institute for Rehabilitation
**State:** Texas
**Status:** RECRUITING
**Zip:** 75246
### 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:** NCT06430619
**Brief Title:** Can Novel Oxygenation Indices Guide the Diagnosis of Acute Respiratory Distress Syndrome
**Official Title:** New Criteria for Classifying Acute Respiratory Distress Syndrome Severity Using a Machine Learning Approach: Novel Oxygenation and Saturation Indices
#### Organization Study ID Info
**ID:** 2024-40
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-01
**Type:** ACTUAL
#### Start Date
**Date:** 2012-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Furkan Tontu
**Investigator Title:** Doctor of Anesthesiology and Reanimation
**Type:** PRINCIPAL_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 determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.
**Detailed Description:** Recent studies have shown that mechanical power (MP) values below 17 J/min and driving pressure (DP) values below 15 cmH2O reduce intensive care unit (ICU) mortality. Asar et al. have introduced six new oxygenation indices utilizing MP and DP instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn). They compared the predictive abilities of these new indices for ICU mortality in Covid-ARDS (C-ARDS) patients with conventional oxygenation indices (P/F, SpO2/FiO2, OI, OSI, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices exhibited the highest predictive power for ICU mortality. However, cut-off values for the diagnosis and severity determination (mild, moderate, and severe) of ARDS patients have not been investigated.
In this study, our objective is to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.
### Conditions Module
**Conditions:**
- Respiratory Distress Syndrome, Adult
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The oxygenation indexes of the patients will be measured and the effectiveness of these indexes in diagnosing ARDS will be compared.
**Label:** Patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria
### Outcomes Module
#### Primary Outcomes
**Description:** It was aimed to compare the oxygenation indexes of the patients. It will be examined which of these indices is more effective in diagnosing ARDS.
**Measure:** Oxygenation indices
**Time Frame:** During 28 days in the intensive care unit
#### Secondary Outcomes
**Description:** It was aimed to compare the sequential organ failure assessment scores of the patients.
Score ranges from 0 (best outcome) to 24 (worst outcome) points.
**Measure:** Other parameters
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the acute physiology and chronic health evaluation-II scores of the patients.
Score ranges from 0 (best outcome) to 71 (worst outcome) points.
**Measure:** acute physiology and chronic health evaluation-II
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the Charlson comorbidity index scores of the patients. Based on the Charlson comorbidity index score, the severity of comorbidity was categorized into three grades: mild, with Charlson comorbidity index scores of 1-2; moderate, with Charlson comorbidity index scores of 3-4; and severe, with Charlson comorbidity index scores ≥5.
**Measure:** Charlson comorbidity index scores
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the Charlson comorbidity index of the patients.
**Measure:** Other parameters
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the pH of the patients.
**Measure:** arterial blood gas parameters
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the base excess of the patients.
**Measure:** arterial blood gas parameters
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the lactate of the patients.
**Measure:** arterial blood gas parameters
**Time Frame:** During 28 days in the intensive care unit
**Description:** It was aimed to compare the partial oxygen pressure of the patients.
**Measure:** arterial blood gas parameters
**Time Frame:** During 28 days in the intensive care unit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients admitted to intensive care units diagnosed with ARDS / C-ARDS according to the Berlin criteria.
2. Adult patients aged between 18 and 80 years
Exclusion Criteria:
1. Patients under the age of 18
2. Pregnant patients
3. Patients without ARDS
4. Patients with missing data
5. Patients transferred to another hospital
6. Patients discharged from the ICU within 72 hours
7. Patients receiving extracorporeal membrane oxygenation (ECMO) support.
8. Patients were on mechanical ventilation for less than 24 hours
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients admitted to the intensive care unit of Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital with a preliminary diagnosis of ARDS/C-ARDS between June 01, 2012, and February 01, 2024
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Basaksehir Cam Sakura City Hospital
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** DesPrez K, McNeil JB, Wang C, Bastarache JA, Shaver CM, Ware LB. Oxygenation Saturation Index Predicts Clinical Outcomes in ARDS. Chest. 2017 Dec;152(6):1151-1158. doi: 10.1016/j.chest.2017.08.002. Epub 2017 Aug 16. Erratum In: Chest. 2018 Mar;153(3):768.
**PMID:** 28823812
**Citation:** Chen WL, Lin WT, Kung SC, Lai CC, Chao CM. The Value of Oxygenation Saturation Index in Predicting the Outcomes of Patients with Acute Respiratory Distress Syndrome. J Clin Med. 2018 Aug 8;7(8):205. doi: 10.3390/jcm7080205.
**PMID:** 30096809
**Citation:** Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
**PMID:** 25693014
**Citation:** ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
**PMID:** 22797452
**Citation:** Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
**PMID:** 26903337
**Citation:** Sayed M, Riano D, Villar J. Novel criteria to classify ARDS severity using a machine learning approach. Crit Care. 2021 Apr 20;25(1):150. doi: 10.1186/s13054-021-03566-w.
**PMID:** 33879214
**Citation:** Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
**PMID:** 30291378
**Citation:** Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jan 5:8850666231223498. doi: 10.1177/08850666231223498. Online ahead of print.
**PMID:** 38179691
**Citation:** Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
**PMID:** 27620287
**Citation:** Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.
**PMID:** 31931417
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
- ID: D000055370
- Term: Lung Injury
### 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: 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M28144
- Name: Acute Lung Injury
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome, Adult
- ID: M28143
- Name: 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: M14957
- Name: Respiration Disorders
- 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: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
- ID: D000055371
- Term: Acute Lung Injury
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430606
**Brief Title:** Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries
**Official Title:** How Do Novel Oxygenation Indices Change With Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries?
#### Organization Study ID Info
**ID:** 2024-05-
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Furkan Tontu
**Investigator Title:** Doctor of Anesthesiology and Reanimation
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study, changes in new oxygenation indices investigated by Asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and Trendelenburg position.
**Detailed Description:** During the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. The PaO2/FiO2 and SpO2/FiO2 ratios have been traditionally used to assess this condition. Subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (OI = (FiO2 × Pmean) / PaO2) and oxygenation saturation index (OSI = (FiO2 × Pmean) / SpO2). More recently, Asar et al. have defined 8 novel oxygenation indices using mean power (MP) and driving pressure (DP) instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). They compared the predictive power of these new indices for intensive care unit (ICU) mortality in COVID-ARDS (C-ARDS) patients with conventional oxygenation indices (PaO2/FiO2, SpO2/FiO2, OI, OSI). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices were found to have the highest predictive power for ICU mortality. However, there is currently no study investigating the changes of these new indices during the intraoperative period.
### Conditions Module
**Conditions:**
- Ventilator-Induced Lung Injury
**Keywords:**
- trendelenburg
- robot-assisted laparoscopic surgery
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery.
**Intervention Names:**
- Procedure: Tint Time
- Procedure: T0 Time
- Procedure: T1
**Label:** Patients undergoing robotic-assisted laparoscopic surgery
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients undergoing robotic-assisted laparoscopic surgery
**Description:** Arterial blood gas was obtained immediately after intubation(Tint) in supine position. Ventilator parameters and hemodynamic parameters were recorded.
**Name:** Tint Time
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Patients undergoing robotic-assisted laparoscopic surgery
**Description:** Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.
**Name:** T0 Time
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Patients undergoing robotic-assisted laparoscopic surgery
**Description:** Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.
**Name:** T1
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum OSI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on PaO2/(FiO2xPEEP) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2xPEEP in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2 in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI (oxygenation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI (oxygenation saturation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
**Measure:** Oxygenation indices
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
#### Secondary Outcomes
**Description:** Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum
**Measure:** Mechanical ventilator parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in compliance (mL/cmH2O) with Trendelenburg position and pneumoperitoneum
**Measure:** Mechanical ventilator parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in peak pressure (cmH2O) with Trendelenburg position and pneumoperitoneum
**Measure:** Mechanical ventilator parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the pH with Trendelenburg position and pneumoperitoneum
**Measure:** Arterial blood gas parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the base excess(mmol/lt) with Trendelenburg position and pneumoperitoneum
**Measure:** Arterial blood gas parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the partial oxgyen(mmHg) with Trendelenburg position and pneumoperitoneum
**Measure:** Arterial blood gas parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the partial carbon dioxide(mmHg) with Trendelenburg position and pneumoperitoneum
**Measure:** Arterial blood gas parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the lactate(mmol/lt) with Trendelenburg position and pneumoperitoneum
**Measure:** Arterial blood gas parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the heart rate with Trendelenburg position and pneumoperitoneum
**Measure:** Hemodynamic parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
**Description:** Change in the mean arterial blood pressure with Trendelenburg position and pneumoperitoneum
**Measure:** Hemodynamic parameters
**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA (American Society of Anesthesiologists) class I-III
* Age between 18-75 years
* Signed informed consent form
Exclusion Criteria:
* Diagnosis of COPD (Chronic Obstructive Pulmonary Disease) and asthma
* History of thoracic surgery
* Body mass index (BMI) \> 35
* Development of hemodynamic instability or desaturation (SpO2 \< 92) during the operation
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Study Population The study will include 42 volunteer patients, aged over 18, classified under the American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk groups, who are scheduled to undergo robot-assisted laparoscopic surgery at the Health Sciences University Basaksehir Cam and Sakura City Hospital operating room.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Basaksehir Cam Sakura City Hospital
### IPD Sharing Statement Module
**Description:** Not decided yet
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
**PMID:** 24283226
**Citation:** Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
**PMID:** 20167583
**Citation:** Queiroz VNF, da Costa LGV, Barbosa RP, Takaoka F, De Baerdemaeker L, Cesar DS, D'Orto UC, Galdi JR, Gottumukkala V, Cata JP, Hemmes SNT, Hollman MW, Kalmar A, Moura LAB, Mariano RM, Matot I, Mazzinari G, Mills GH, Posso IP, Teruya A, Vidal Melo MF, Sprung J, Weingarten TN, Treschan TA, Koopman S, Eidelman L, Chen LL, Lee JW, Arino Irujo JJ, Tena B, Groeben H, Pelosi P, de Abreu MG, Schultz MJ, Serpa Neto A; AVATaR and PROVE Network investigators. International multicenter observational study on assessment of ventilatory management during general anaesthesia for robotic surgery and its effects on postoperative pulmonary complication (AVATaR): study protocol and statistical analysis plan. BMJ Open. 2018 Aug 23;8(8):e021643. doi: 10.1136/bmjopen-2018-021643.
**PMID:** 30139899
**Citation:** Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.
**PMID:** 25978326
**Citation:** O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.
**PMID:** 30201797
**Citation:** Tartler TM, Ahrens E, Munoz-Acuna R, Azizi BA, Chen G, Suleiman A, Wachtendorf LJ, Costa ELV, Talmor DS, Amato MBP, Baedorf-Kassis EN, Schaefer MS. High Mechanical Power and Driving Pressures are Associated With Postoperative Respiratory Failure Independent From Patients' Respiratory System Mechanics. Crit Care Med. 2024 Jan 1;52(1):68-79. doi: 10.1097/CCM.0000000000006038. Epub 2023 Sep 11.
**PMID:** 37695139
**Citation:** Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jan 5:8850666231223498. doi: 10.1177/08850666231223498. Online ahead of print.
**PMID:** 38179691
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000013898
- Term: Thoracic Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M28143
- Name: Lung Injury
- Relevance: HIGH
- As Found: Lung Injury
- ID: M28152
- Name: Ventilator-Induced Lung Injury
- Relevance: HIGH
- As Found: Ventilator-Induced Lung Injury
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16657
- Name: Thoracic Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055370
- Term: Lung Injury
- ID: D000055397
- Term: Ventilator-Induced Lung Injury
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430593
**Brief Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries
**Official Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries
#### Organization Study ID Info
**ID:** 2024- 183
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Hilal AKCA
**Investigator Title:** Anesthesiologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In our clinic, we routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
**Detailed Description:** Robotic surgery is the performance of laparoscopic surgery using a robotic interface. The robotic surgery system used today is called Da Vinci S. In surgeries performed with the help of a robot, the surgeon can work more precisely and with greater maneuverability. Therefore, an operation can be performed that is less traumatic for the patient than other methods.Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In these applications, fresh gas flow in anesthesia systems can be made with traditional high, normal or low flow strategies, depending on the preference of the clinicians.Low-flow anesthesia creates a breathing air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow amounts does not pose a safety risk for patients, and that the use of low-flow anesthesia methods should be more widespread due to the advantages it provides. In our clinic, investigators routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
### Conditions Module
**Conditions:**
- Oncology
**Keywords:**
- low-flow anesthesia
- robotic-assisted surgery
- general anesthesia
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 68
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** 0,5 lt/min
**Intervention Names:**
- Procedure: low-flow anesthesia
**Label:** low-flow anesthesia
#### Arm Group 2
**Description:** \>1 lt/min
**Intervention Names:**
- Procedure: low-flow anesthesia
**Label:** normal flow anesthesia
### Interventions
#### Intervention 1
**Arm Group Labels:**
- low-flow anesthesia
- normal flow anesthesia
**Description:** 0,5 l/min \>1 l/min
**Name:** low-flow anesthesia
**Other Names:**
- normal flow anesthesia
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** It was aimed to compare heart rates in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
**Measure:** Hemodynamic Parameters
**Time Frame:** Perioperative period(approximately 3-6 hours)
**Description:** It was aimed to compare blood pressure in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
**Measure:** Hemodynamic Parameters
**Time Frame:** Perioperative period(approximately 3-6 hours)
**Description:** It was aimed to compare oxygen saturation in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
**Measure:** Respiratory parameters
**Time Frame:** Perioperative period(approximately 3-6 hours)
**Description:** It was aimed to compare endtidal carbon dioxide in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
**Measure:** Respiratory parameters
**Time Frame:** Perioperative period(approximately 3-6 hours)
**Description:** It was aimed to compare inhalation agent (sevoflurane) consumption (lt) in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
**Measure:** Inhalation agent (sevoflurane) consumption
**Time Frame:** Perioperative period(approximately 3-6 hours)
**Description:** It was aimed to compare soda lime consumption in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.
Soda lime consumption refers to the number of changes of the soda lime canister.
**Measure:** Soda lime consumption
**Time Frame:** Perioperative period(approximately 3-6 hours)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Ages 18-75
* ASA I,II
* Patients undergoing robotic-assisted laparoscopic surgery
Exclusion Criteria:
* ASA III,IV,V
* Those with serious cardiac, respiratory, hepatic, renal disease
* People with mental status disorders, psychiatric illnesses
* Patients with hearing problems and glaucoma
* Desire to be out of work
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Ages 18-75, ASA I,II, Patients undergoing robotic-assisted laparoscopic surgery
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### 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:** NCT06430580
**Acronym:** COBRAS
**Brief Title:** Cannabinoids and Biological Reactivity to Stress
**Official Title:** Cannabinoids and Biological Reactivity to Stress
#### Organization Study ID Info
**ID:** 20241368
#### Organization
**Class:** OTHER
**Full Name:** Auburn University
#### Secondary ID Infos
**ID:** R21DA058780-01A1
**Link:** https://reporter.nih.gov/quickSearch/R21DA058780-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-03-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Wayne State University
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Auburn University
#### Responsible Party
**Investigator Affiliation:** Auburn University
**Investigator Full Name:** Richard Macatee
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to test the impact of two drugs that produce temporary stress-like symptoms, both in isolation and together, on cannabis use motivation in individuals with Cannabis Use Disorder. The main questions it will answer are:
1. How do different forms of stress affect cannabis use motivation?
2. How do different forms of stress affect the body's natural cannabinoids?
Researchers will compare a placebo to both drugs in isolation, as well as together, across four separate lab visits.
Participants will:
1) Complete a clinical screening interview (by phone or in-person) and visit the lab for a medical screening, and if eligible:
a) Visit the lab four times where they will: i). Take one of four drug combinations ii). Complete an interview, questionnaires, and computerized tasks iii). Have their brain activity recorded with an EEG cap iv). Provide three blood samples
**Detailed Description:** The prevalence of daily cannabis use and cannabis use disorder (CUD) has increased in the United States over the past two decades. Unfortunately, psychosocial treatments produce minimal long-term abstinence rates and no FDA-approved medications for CUD exist. Thus, identifying novel CUD treatment targets is an increasingly urgent public health need.
Stress-elicited cannabis use motivation has been implicated in worse CUD outcomes, but a mechanistic understanding of how acute stress increases cannabis use motivation in CUD is limited. Prior work has demonstrated that acute psychosocial stress enhancement of subsequent cannabis cue incentive salience, as indexed by the late positive potential (neural measure of approach-motivated attention recorded using electroencephalography \[EEG\]), was associated with worse CUD severity and intervention response, independent of subjective craving. Moreover, hypothalamic pituitary adrenal \[HPA\]-axis, rather than noradrenergic or subjective reactivity to the psychosocial stressor was associated with subsequent potentiation of the cannabis cue-elicited late positive potential. These studies suggest that non-genomic, rapid glucocorticoid effects may be a contributing mechanism in stress amplification of neural drug-cue reactivity, but their correlational designs preclude causal inference. Further, psychosocial stressors are unable to isolate HPA-axis vs. noradrenergic components of stress reactivity.
To isolate HPA-axis activation and test causality, pharmacological manipulations, common in animal models but rare in human studies, will be used to produce separate and co-operative glucocorticoid (20mg hydrocortisone) and noradrenergic (54mg yohimbine) activation. The investigators will employ a 2x2 randomized, placebo-controlled double-blind crossover design in 36 participants with severe CUD. The primary aim is to test the causal potentiating effect of glucocorticoids on drug-cue reactivity and drug use motivation, and further determine if the effect depends on co-occurring noradrenergic stimulation. Preclinical work indicates that glucocorticoids can potentiate reward motivation via mobilization of endocannabinoid activity (primary target of cannabis). Thus, as an exploratory aim, the investigators will obtain plasma samples to test the impact of pharmacological stress on circulating endocannabinoids (2-AG, AEA) and their mediating role in glucocorticoid potentiation of drug-cue reactivity and drug use motivation. This project represents a highly novel integration of a rigorous pharmacological challenge design with biological markers of drug-cue incentive salience and endocannabinoid system activity. If hypotheses are confirmed, one causal mechanism through which stress increases neural cannabis cue reactivity will be known, which has immediate implications for testing experimental therapeutics. The long-term goal is to understand how a stress-related mechanism predictive of worse CUD phenotype is generated and can be blocked in CUD. Development of this model will provide a valid, efficient and (relative to other neuroimaging methods) low-cost approach to screen candidate medications and optimize psychosocial drug cue exposure therapies.
### Conditions Module
**Conditions:**
- Cannabis Use Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** 2x2 randomized double-blind within-subject crossover
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Double-blind
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 20mg hydrocortisone, single oral dose 54mg yohimbine hcl, single oral dose
**Intervention Names:**
- Drug: Hydrocortisone Oral
- Drug: Yohimbine Hydrochloride
**Label:** 20mg hydrocortisone + 54mg yohimbine hcl
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 20mg hydrocortisone, single oral dose 54mg cornstarch placebo, single oral dose
**Intervention Names:**
- Drug: Hydrocortisone Oral
- Drug: Cornstarch Placebo 54mg
**Label:** 20mg hydrocortisone + 54mg placebo
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 20mg cornstarch placebo, single oral dose 54mg yohimbine hcl, single oral dose
**Intervention Names:**
- Drug: Yohimbine Hydrochloride
- Drug: Cornstarch Placebo 20mg
**Label:** 20mg placebo + 54mg yohimbine hcl
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** 20mg cornstarch placebo, single oral dose 54mg cornstarch placebo, single oral dose
**Intervention Names:**
- Drug: Cornstarch Placebo 20mg
- Drug: Cornstarch Placebo 54mg
**Label:** 20mg placebo + 54mg placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 20mg hydrocortisone + 54mg placebo
- 20mg hydrocortisone + 54mg yohimbine hcl
**Description:** 20mg hydrocortisone, single oral dose
**Name:** Hydrocortisone Oral
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 20mg hydrocortisone + 54mg yohimbine hcl
- 20mg placebo + 54mg yohimbine hcl
**Description:** 54mg yohimbine hcl, single oral dose
**Name:** Yohimbine Hydrochloride
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- 20mg placebo + 54mg placebo
- 20mg placebo + 54mg yohimbine hcl
**Description:** 20mg cornstarch placebo, single oral dose
**Name:** Cornstarch Placebo 20mg
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- 20mg hydrocortisone + 54mg placebo
- 20mg placebo + 54mg placebo
**Description:** 54mg cornstarch placebo, single oral dose
**Name:** Cornstarch Placebo 54mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change in electroencephalography-recorded (EEG) late positive potential amplitude to cannabis cue images after hydrocortisone (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo conditions (higher amplitudes indicate worse outcome)
**Measure:** Amplitude of neurophysiological response to cannabis cues (μV)
**Time Frame:** Late positive potential amplitude outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Marijuana purchase task-derived Intensity after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased Intensity indicates worse outcome)
**Measure:** Amplitude of Demand Intensity for Cannabis (# of hits at $0)
**Time Frame:** Intensity is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Marijuana purchase task-derived OMax after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased OMax indicates worse outcome)
**Measure:** Peak Total Monetary Expenditure for Cannabis (total amount of money spent on hits)
**Time Frame:** OMax is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Marijuana purchase task-derived Breakpoint after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased Breakpoint indicates worse outcome)
**Measure:** Breakpoint of Monetary Expenditure for Cannabis (price at which no hits are purchased)
**Time Frame:** Breakpoint is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Marijuana purchase task-derived Elasticity after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (decreased Elasticity indicates worse outcome)
**Measure:** Sensitivity of Cannabis Hit Purchasing Behavior to Price Increases
**Time Frame:** Elasticity is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Change in cannabis image selections on the Implicit Image Choice Task (computerized behavioral task; range 0-30; higher scores indicate worse outcome) after hydrocortisone administration (with and without yohimbine) compared to placebo+placebo and yohimbine+placebo
**Measure:** Frequency of implicit cannabis image choice
**Time Frame:** Implicit choice task # of cannabis image selections outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days)
**Description:** Change in cannabis image selections on the Explicit Image Choice Task (computerized behavioral task; range 0-30; higher scores indicate worse outcome) after hydrocortisone administration (with and without yohimbine) compared to placebo+placebo and yohimbine+placebo
**Measure:** Frequency of explicit cannabis image choice
**Time Frame:** Explicit choice task # of cannabis image selections outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meets criteria for current, severe Cannabis Use Disorder (CUD) as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview.
* Reports engagement in daily cannabis use.
* Provide a urine sample positive for THC.
* Must be adequately informed of the nature and risks of the study and given written informed consent prior to screening.
* Able to read and write in English.
Exclusion Criteria:
* Has a history of serious psychiatric problems (i.e., psychosis, Bipolar Disorder I), as assessed by the SCID-V-RV.
* Reports current active suicidal ideation.
* Meets DSM-5 criteria for any other current substance use disorder (other than CUD or Tobacco Use Disorder)
* Has a positive result urine drug screen for all other drugs aside from THC (i.e., amphetamine, methamphetamine, benzodiazepine, cocaine, MDMA, morphine, oxycodone, methadone, buprenorphine) at screening or at any lab visit.
* Has structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, a history of other neurological diseases, or a history of head trauma resulting in unconsciousness.
* Has a history of cardiovascular disease, myocardial infarction, chest pain, or palpitations on exertion or drug use, edema, hypertension, resting heart rate \<50 BPM or \>90 BPM. Cardiovascular diseases include:
. a. Benign prostatic hyperplasia (BPH) b. Post-myocardial infarction
* Demonstrates systolic BP outside of acceptable range (80-160mmHG), or diastolic BP outside of acceptable range (50-90 mmHG)
* Has a history of obstructive pulmonary disease, cor pulmonale, dyspnea, orthopnea, tachypnea (\>24 breaths per minute), or asthma.
* Currently taking any daily psychotropic medication
* Currently taking any of the following medications:
1. Angiotensin-Converting Enzyme (ACE) inhibitors including Lisinopril, Enalapril, Benazepril, and Bamipril
2. Angiotensin II Receptor Blockers (ARB) including Losartan, Valsartan, and Olmesartan
3. Thiazide Diuretics including Hydrochlorothiazide (HCTZ), Chlorthalidone
4. Calcium Channel Blockers including Amlodipine, Diltiazem, and Verapamil
5. Beta-blockers including Carvedilol, Metoprolol, Atenolol, Propranolol
6. Anti-Arrythmic Medication including Disopyramide, Flecainide, and Mexiletine
7. Edema (Diuretics)
8. Thiazide Diuretics (as above)
9. Loop Diuretics including Furosemide and Torsemide
10. Potassium Sparing Diuretics: Spironolactone and Eplerenone
11. Anti-Platelet Medications such as Clopidogrel, Prasugrel, and Ticagrelor
* Reproductively capable candidates who are pregnant (based on urine test at screening or at any lab visit) or are heterosexually active and not using medically approved birth control measures (oral contraceptives, IUD, condom, sterilization).
* Self-reports currently seeking or engaging in CUD treatment or any other alcohol or drug treatment.
* Self-reports intent to imminently quit cannabis use.
* Has a Blood-Injection-Injury Phobia, as determined by scores greater than 15 on the Injection and Blood Draw subscale of the Medical Fear Survey
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Julia Gorday, MS
**Phone:** (334)-844-6642
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Auburn University
**Name:** Richard J Macatee, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5449
- Name: Marijuana Abuse
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000009184
- Term: Mydriatics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000058669
- Term: Adrenergic alpha-2 Receptor Antagonists
- ID: D000000317
- Term: Adrenergic alpha-Antagonists
- ID: D000018674
- Term: Adrenergic Antagonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000064804
- Term: Urological Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Urol
- Name: Urological Agents
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M9912
- Name: Hydrocortisone
- Relevance: HIGH
- As Found: Group A
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M17752
- Name: Yohimbine
- Relevance: HIGH
- As Found: Blood pressure measured
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12139
- Name: Mydriatics
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M29195
- Name: Adrenergic alpha-2 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M3669
- Name: Adrenergic alpha-Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20755
- Name: Adrenergic Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: T332
- Name: Yohimbe
- Relevance: HIGH
- As Found: Blood pressure measured
### Intervention Browse Module - Meshes
- ID: D000006854
- Term: Hydrocortisone
- ID: D000015016
- Term: Yohimbine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430567
**Acronym:** BFR
**Brief Title:** Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure
**Official Title:** Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure
#### Organization Study ID Info
**ID:** EHC Morges BFR
#### Organization
**Class:** OTHER
**Full Name:** Ensemble Hospitalier de la Côte
### Status Module
#### Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** Ensemble Hospitalier de la Côte
#### Responsible Party
**Investigator Affiliation:** Ensemble Hospitalier de la Côte
**Investigator Full Name:** Arnaud Meylan
**Investigator Title:** Doctor
**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:** The goal of this clinical trial is to evaluate the effects of Blood Flow Restriction (BFR) training on post-surgery rehabilitation following the Latarjet procedure in athletes aged 18-35.
The main questions it aims to answer are:
Does BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation?
Researchers will compare three groups:
BFR Group with 50% AOP \[arterial occlusion pressure\] compression BFR Placebo Group with 10% AOP compression Control Group
Participants will:
Perform the same four strengthening exercises twice a week Complete 16 semi-autonomous strength training sessions over 8 weeks Undergo isokinetic and isometric strength tests, shoulder mobility assessments, and complete self-assessment questionnaires.
### Conditions Module
**Conditions:**
- Shoulder Dislocation
**Keywords:**
- Blood flow restriction
- Latarjet surgery
- Rehabilitation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Participants between placebo and intervention group will be blinded
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient will not use BFR
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Patient will use BFR sub optimally as described in the literature
**Intervention Names:**
- Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
**Label:** Placebo 10% of pressure for arterial occlusion
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature
**Intervention Names:**
- Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
**Label:** Interventional 50% of pressure for arterial occlusion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional 50% of pressure for arterial occlusion
**Description:** Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:
Group 1) BFR Group with 50% AOP compression
Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30-15-15-15 at 40% 1RM (repetition maximum)
Exercise :
External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band
BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.
**Name:** Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Placebo 10% of pressure for arterial occlusion
**Description:** Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:
Group 2) BFR Group with 10% AOP compression
Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15-15-15-15 at 70% 1RM
Exercise :
External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band
BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.
**Name:** Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Concentric peak torque (Nm) IR-ER at 60°/sec
**Measure:** Isokinetic strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Concentric peak torque (Nm) IR-ER at 240°/sec
**Measure:** Isokinetic strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Eccentric peak torque (Nm) IR-ER at 60°/sec
**Measure:** Isokinetic strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Concentric ratio (ER conc 60°/ IR conc 60°)
**Measure:** Isokinetic strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Cocking gesture ratio (IR exc 60° /ER conc 240°)
**Measure:** Isokinetic strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Flexion in the scapular plane (Nm)
**Measure:** Isometric strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Athletic shoulder test (positions I, Y, T) (Nm)
**Measure:** Isometric strength
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Grip test (Nm)
**Measure:** Isometric strength
**Time Frame:** Preoperative and at 14 weeks postoperative
#### Secondary Outcomes
**Description:** Flexion
**Measure:** Shoulder mobility
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Abduction
**Measure:** Shoulder mobility
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Internal rotation at 90° abduction
**Measure:** Shoulder mobility
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** External rotation at 90° abduction
**Measure:** Shoulder mobility
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Scapular dyskinesis test (SDT)
**Measure:** Shoulder mobility
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Modified closed kinetic upper extremity stability test
**Measure:** Scapular girdle stability
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Shoulder Instability Return to Sport Index (SIRSI)
**Measure:** Scapular girdle stability
**Time Frame:** Preoperative and at 14 weeks postoperative
**Description:** Western Ontario Shoulder Instability Index (WOSI)
**Measure:** Scapular girdle stability
**Time Frame:** Preoperative and at 14 weeks postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: 18-35 years
* Indication for shoulder stabilization surgery using the Latarjet procedure (documented anterior dislocations with proof of emergency reduction, with or without hypermobility and confirmation of traumatic capsulo-ligamentous injury by MRI).
* Regular exercise (min. 1x / week)
* Signed the informed consent form for the study.
Exclusion Criteria:
* Pregnant or breast-feeding women
* Active oncological disease under treatment. (Patient with stable oncological disease eligible)
* Adverse events during the 6-week post-operative period such as:-Fracture/displacement of the reconstructed bone-Luxation of the operated shoulder-Requirement for emergency hospitalization
* History of deep vein thrombosis/pulmonary embolism
* Inability to follow study procedures, due to language problems, psychological disorders, dementia.
* Need for skin grafting following shoulder stabilization surgery
* Coronary heart disease
* Unstable hypertension
* Peripheral vascular disease
* Hypercoagulable states (blood coagulation disorders)
* Left ventricular dysfunction
* Hemophilia
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bauer Stefan, MD
**Phone:** 0787105993
**Phone Ext:** +41
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Arnaud Meylan, MD
**Phone:** 0792092956
**Phone Ext:** +41
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** EHC Morges
**Name:** Bauer Stefan, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004204
- Term: Joint Dislocations
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000070599
- Term: Shoulder Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15591
- Name: Shoulder Dislocation
- Relevance: HIGH
- As Found: Shoulder Dislocation
- ID: M7385
- Name: Joint Dislocations
- 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: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M602
- Name: Shoulder Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012783
- Term: Shoulder Dislocation
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430554
**Brief Title:** Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability
**Official Title:** Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients
#### Organization Study ID Info
**ID:** 2024ZDSYLL044-P01
#### Organization
**Class:** OTHER
**Full Name:** Zhongda Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhongda Hospital
#### Responsible Party
**Investigator Affiliation:** Zhongda Hospital
**Investigator Full Name:** Fengmei Guo
**Investigator Title:** Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.
**Detailed Description:** Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability.
Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows:
Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team.
To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters.
EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).
### Conditions Module
**Conditions:**
- Respiratory Distress Syndrome
- Positive-Pressure Respiration
- Mechanical Ventilation
**Keywords:**
- Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused
**Measure:** Ventilation-perfusion matching (V/Q match%)
**Time Frame:** Through study completion (within 24 hours)
#### Secondary Outcomes
**Description:** corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused
**Measure:** percentage of dead space
**Time Frame:** Through study completion (within 24 hours)
**Description:** corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused
**Measure:** percentage of shunt
**Time Frame:** Through study completion (within 24 hours)
**Description:** The compliance of respiratory system
**Measure:** Respiratory system compliance
**Time Frame:** Through study completion (within 24 hours)
**Description:** PaO2/FiO2 ratio
**Measure:** PaO2/FiO2 ratio
**Time Frame:** Through study completion (within 24 hours)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age ≥18 years
2. Moderate-to-severe ARDS as per the 2023 ESICM definition
3. Undergoing invasive mechanical ventilation
4. Planned prone position based on the attending physicians' decisions
5. Signed informed consent
Exclusion Criteria:
1. age ≥85 years
2. Pregnancy
3. Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
4. Clinically suspected elevated intracranial pressure (\>18 mm Hg)
5. Bronchopleural fistula
6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
7. Severe hypernatremia (\>170mmol/L)
8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Intubated mechanically ventilated ARDS patients.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fengmei Guo, PhD, MD
**Phone:** +8613813841261
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Zhiqian Zha, MM
**Phone:** +8615505083904
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Fengmei Guo, Ph.D
- **Phone:** +8613813841261
- **Role:** CONTACT
**Country:** China
**Facility:** Zhongda Hospital, Southeast University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210009
#### Overall Officials
**Official 1:**
**Affiliation:** Nanjing Zhongda Hospital, Southeast University
**Name:** Fengmei Guo, PhD, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, 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: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M28144
- Name: Acute 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: M14957
- Name: Respiration Disorders
- 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: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430541
**Brief Title:** A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
**Official Title:** A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission
#### Organization Study ID Info
**ID:** 23-1455.cc
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2028-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-12
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Usona Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Denver
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]:
Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life?
Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
### Conditions Module
**Conditions:**
- Breast Cancer
- Ovarian Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 25mg cGMP Psilocybin in combination with manualized therapy
**Intervention Names:**
- Drug: Psilocybin
**Label:** Psilocybin Assisted Psychotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Psilocybin Assisted Psychotherapy
**Description:** A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.
**Name:** Psilocybin
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Symptoms of depression as measured by HADS-D
**Measure:** Depression
**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
**Description:** Symptoms of anxiety as measured by HADS-A
**Measure:** Anxiety
**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
**Description:** Demoralization Syndrome will be measured with the Demoralization Scale Version II (DS-II)
**Measure:** Cancer-related Existential Distress
**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
**Description:** Quality of life as measured by FACT-G
**Measure:** Quality of Life-FACT-G
**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
**Description:** Spirituality as measured by FACT-Sp
**Measure:** Spirituality
**Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks
#### Primary Outcomes
**Description:** Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline.
**Measure:** Change in Fear of Cancer Recurrence Inventory
**Time Frame:** 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
#### Secondary Outcomes
**Description:** Assess Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events
**Measure:** Safety as measured by adverse events
**Time Frame:** for the duration of study participation -6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1, Aged ≥ 21 2. Diagnosis of:
* early-stage breast cancer at low risk of recurrence
* defined as clinical stage 1 or 2
* completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago
* oncologist reported risk of recurrence at 10 years \< 20%
* late-stage ovarian cancer at high risk of recurrence
* defined as Clinical stage 3 or 4
* currently in remission
* oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as:
* Eastern Cooperative Oncology Group (ECOG) ≤1
* Palliative Performance Scale (PPS) ≥60%
* Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person
* Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
Exclusion Criteria:
1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:
* Congestive heart failure
* Valvular heart disease
* Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450)
* Recent acute myocardial infarction or evidence of ischemia
* Malignant hypertension
* Congenital long QT syndrome
* Acute renal failure
* Severe hepatic impairment
* Respiratory failure
* eGFR \< 50 mL/min/1.73m2
* LFTs \> 1.5 x ULN
* WBC \< 5 x 10\*9/L
* Hemoglobin \< 8.0 g/dL
* Platelets \< 150 x 10\*9/L
2. Risk for hypertensive crisis defined as:
Screening, Baseline, Medication session (predose) blood pressure \>140/90 mmHg
3. Significant central nervous system (CNS) pathology
Examples include:
* Primary or secondary cerebral neoplasm
* Epilepsy
* History of stroke
* Cerebral aneurysm
* Dementia
* Delirium
4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:
* Schizophrenia spectrum disorders
* Schizoaffective disorder
* Bipolar I or bipolar II disorder
* Major Depressive Disorder with psychotic features
* Prior history of psychosis due to medical condition or substance use
5. Family history of psychotic or serious bipolar spectrum illnesses.
Examples include first-degree relative with:
* Schizophrenia spectrum disorders
* Schizoaffective disorder
* Bipolar I disorder with psychotic features
6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:
* Agitation
* Violent behavior
7. Active substance use disorders (SUDs) defined as:
* DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
* DAST-10 score of 3 or higher
* Two or more "yes" responses to CAGE screening questionnaire
8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:
* Any use in the last 12 months
* \>25 lifetime uses
9. Clinically significant suicidality or high risk of completed suicide defined as:
* 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
* Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
* Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
10. History of hallucinogen persisting perception disorder (HPPD)
11. Pregnancy/lactation
12. Cognitive impairment as defined by:
• Montreal Cognitive Assessment Test (MoCA) \< 23
13. Concurrent Medications
* Antidepressants
* Centrally-acting serotonergic agents (e.g., MAO inhibitors)
* Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
* Antipsychotics (e.g., first and second generation)
* Mood stabilizers (e.g., lithium, valproic acid)
* Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
* Significant inhibitors of UGT 1A0 or UGT
1A10
* Efavirenz
14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), and Phencyclidine (PCP).
15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
17. Have an allergy or intolerance to any of the materials contained in the drug product
18. Non-English speaking individual
19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)
**Gender Based:** True
**Minimum Age:** 21 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mary Mancuso
**Phone:** 303-724-5729
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aurora
**Contacts:**
***Contact 1:***
- **Name:** Stacy Fischer, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Outpatient CTRC
**State:** Colorado
**Zip:** 80045
**Location 2:**
**City:** Aurora
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Stacy Fischer, MD
- **Phone:** 303-724-6353
- **Role:** CONTACT
***Contact 2:***
- **Name:** Stacy Fischer, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Colorado Cancer Center
**State:** Colorado
**Zip:** 80045
#### Overall Officials
**Official 1:**
**Affiliation:** University of Colorado, Denver
**Name:** Stacy Fischer, MD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: D000004701
- Term: Endocrine Gland 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: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M5534
- Name: Carcinoma
- 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: M7863
- Name: Endocrine Gland Neoplasms
- 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: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000006213
- Term: Hallucinogens
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000011619
- Term: Psychotropic Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14419
- Name: Psilocybin
- Relevance: HIGH
- As Found: Cover
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011562
- Term: Psilocybin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430528
**Brief Title:** A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
**Official Title:** A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
#### Organization Study ID Info
**ID:** HUM00246263
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Recordati Rare Diseases
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Michigan
#### Responsible Party
**Investigator Affiliation:** University of Michigan
**Investigator Full Name:** Richard J. Auchus, MD PhD
**Investigator Title:** Professor of Translational Medicine, Professor of Internal Medicine and Professor of Pharmacology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach).
The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.
**Detailed Description:** Phase 1 (Titration):
Participants will provide written informed consent and receive the first dose of osilodrostat (1-2 mg) in the evening. The following morning, participants will add treatment with at least a physiologic replacement dose of methylprednisolone (4-6 mg/d based on body size in not more than 2 divided doses) and concurrently continue 1-2 mg BID of osilodrostat. Frequent communication is maintained with each participant, at least twice weekly for the first 3 months and weekly thereafter until target osilodrostat dose is reached. Study personnel will ask targeted questions related to the primary endpoint with parameters to notify the study physicians for early signs of adrenal insufficiency. Participants are instructed to double their methylprednisolone dose for intercurrent illness and for symptoms of cortisol deficiency or withdrawal that do not resolve with pausing osilodrostat dosing. Every 4-12 weeks, an AM cortisol, as well as a research sample for steroid profiling (including 11OHA4), is obtained prior to the first doses of methylprednisolone and osilodrostat. The osilodrostat dose is up-titrated as necessary to achieve an AM cortisol goal of \<5 µg/dL. Once the AM cortisol is at goal, a late-night saliva cortisol (LNSC) and 24 h urine free cortisol (UFC) is obtained per standard of care. Osilodrostat titration is continued if necessary until the UFC is also at goal of \<10 µg/24h. Once the AM cortisol and UFC are at goals (\<5 µg/dL and \<10 µg/24h, respectively), the primary endpoint measures are completed, and the participant enters Phase 2.
Phase 2 (Maintenance):
Once the participant reaches what the investigator considers the maintenance doses of osilodrostat and methylprednisolone, participants are followed for a total of 48 weeks from the first osilodrostat dose before being considered at the end of study. The AM serum cortisol, UFC, and LNSC are repeated at the end of the 48-week period and as clinically indicated throughout Phase 2, generally every 3-6 months.
### Conditions Module
**Conditions:**
- Endogenous Cushing Syndrome
- Adrenal Insufficiency
- Hypercortisolism
**Keywords:**
- Osilodrostat
- Glucocorticoid
- Methylprednisolone
- Medrol
### Design Module
#### Bio Spec
**Description:** Serum samples for steroid measurements.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy.
**Intervention Names:**
- Drug: Osilodrostat
**Label:** Observational cohort
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Observational cohort
**Description:** Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.
**Name:** Osilodrostat
**Other Names:**
- Isturisa
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy
**Measure:** Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase)
**Time Frame:** Through phase 1, approximately 24 weeks
#### Secondary Outcomes
**Description:** compare biomarkers measured by mass spectrometry. This may be calculated Upon 12 participants completing phase 1 or at the end of the study, whichever comes first.
**Measure:** Correlation between AM cortisol and 11OHA4 measurements
**Time Frame:** Up to end of study, approximately 48 weeks
**Description:** based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy
**Measure:** Adrenal insufficiency episodes during Phase 2 (maintenance)
**Time Frame:** Up to end of phase 2 (approximately 48 weeks)
**Description:** Based on patient-reported outcomes
**Measure:** Frequency of cortisol withdrawal symptoms
**Time Frame:** Up to end of phase 2 (approximately 48 weeks)
**Description:** Based on clinic measurements
**Measure:** Change in weight
**Time Frame:** Baseline, end of phase 2 (approximately 48 weeks)
**Description:** Based on clinic measurements
**Measure:** Change in diastolic blood pressure
**Time Frame:** Baseline, end of phase 2 (approximately 48 weeks)
**Description:** Based on clinic measurements
**Measure:** Change in systolic blood pressure
**Time Frame:** Baseline, end of phase 2 (approximately 48 weeks)
**Description:** Based on clinical laboratory measurements
**Measure:** Change in HgbA1c
**Time Frame:** Baseline, end of phase 2 (approximately 48 weeks)
**Description:** Based on clinic notes, total number of medications used to treat Cushing syndrome comorbidities
**Measure:** Change in number of concomitant medications
**Time Frame:** Baseline, end of phase 2 (approximately 48 weeks)
**Description:** Custom questionnaire for adrenal insufficiency- 4 Likert questions with scores ranging from 4-20. Higher scores indicate worse symptoms.
**Measure:** Adrenal Insufficiency Assessment Questionnaire scores
**Time Frame:** Up to end of study, approximately 48 weeks
**Description:** The 36-Item Short Form Health Survey (SF-36) is standard RAND form used clinically. It is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 with higher scores indicating a better Health-related Quality of Life.
**Measure:** RAND Short Form (SF)-36 scores
**Time Frame:** Up to end of study, approximately 48 weeks
**Description:** Investigators' judgment (1-5 scale)
**Measure:** Ease of titration
**Time Frame:** Up to end of phase 1 (approximately 48 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Endogenous Cushing syndrome, either following surgery or not candidates for surgery
* Under consideration to receive osilodrostat as part of their clinical care
* Able to provide informed consent.
Exclusion Criteria:
* Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
* A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients receiving care at the University of Michigan.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eyad Alsafadi
**Phone:** 734-647-5661
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ann Arbor
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Eyad Alsafadi
- **Phone:** 734-647-5661
- **Role:** CONTACT
***Contact 2:***
- **Name:** Richard Auchus, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Michigan
**State:** Michigan
**Status:** RECRUITING
**Zip:** 48109
#### Overall Officials
**Official 1:**
**Affiliation:** University of Michigan
**Name:** Richard Auchus, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000307
- Term: Adrenal Gland Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3661
- Name: Adrenal Insufficiency
- Relevance: HIGH
- As Found: Adrenal Insufficiency
- ID: M6689
- Name: Cushing Syndrome
- Relevance: HIGH
- As Found: Cushing's Syndrome
- ID: M3660
- Name: Adrenocortical Hyperfunction
- Relevance: HIGH
- As Found: Hypercortisolism
- ID: M3659
- Name: Adrenal Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1679
- Name: Cushing's Syndrome
- Relevance: HIGH
- As Found: Cushing's Syndrome
- ID: T2879
- Name: Hyperadrenalism
- Relevance: HIGH
- As Found: Hypercortisolism
### Condition Browse Module - Meshes
- ID: D000000309
- Term: Adrenal Insufficiency
- ID: D000003480
- Term: Cushing Syndrome
- ID: D000000308
- Term: Adrenocortical Hyperfunction
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M14120
- Name: Prednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- Relevance: LOW
- As Found: Unknown
- ID: M11749
- Name: Methylprednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M1833
- Name: Methylprednisolone Acetate
- Relevance: LOW
- As Found: Unknown
- ID: M11750
- Name: Methylprednisolone Hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M229449
- Name: Prednisolone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M211887
- Name: Prednisolone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M248881
- Name: Prednisolone phosphate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430515
**Brief Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors
**Official Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors Through Fine Needle Puncture
#### Organization Study ID Info
**ID:** KY23197
#### Organization
**Class:** OTHER
**Full Name:** Wuxi People's Hospital
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wuxi People's 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:** This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.
**Detailed Description:** Malignant solid tumours including lung and liver cancers are the most common malignant tumours worldwide and have a very high mortality rate. Currently,the clinical practice mainly relies on systemic administration of chemotherapeutic agents usually by intravenous infusion for patients with solid cancer with multiple metastases,but the overall efficiency is not high.Single or multiple chemotherapeutic agents are infused intratumourally to increase the local drug concentration in the tumour, improve efficacy and reduce drug resistance and systemic adverse effects. This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.
### Conditions Module
**Conditions:**
- Intratumoral Injection
- Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Fine-needle puncture guided by CT or ultrasound and infusion of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.) via the tumour increases the local drug concentration in the tumour, improves therapeutic efficacy and reduces drug resistance and systemic adverse effects.
**Intervention Names:**
- Procedure: Intratumoral Injection of Chemotherapy
**Label:** Intratumoral Injection of Chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intratumoral Injection of Chemotherapy
**Description:** This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.
**Name:** Intratumoral Injection of Chemotherapy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
**Measure:** Relief degree of tumors
**Time Frame:** through study completion, an average of 5 year
#### Secondary Outcomes
**Description:** The duration from the beginning of treatment to cancer recurrence or progression
**Measure:** Progress free survival（PFS）
**Time Frame:** 3 years, year 3
**Description:** The duration from the beginning of treatment to patient death
**Measure:** Overall survival（OS）
**Time Frame:** 5 years, year 5
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
10. Subjects in other conditions that are considered unsuitable for this study by the investigator.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Peihua Lu
**Phone:** 13621500031
**Phone Ext:** +86
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuxi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Peihua Lu, MD
- **Phone:** 13621500031
- **Role:** CONTACT
**Country:** China
**Facility:** Wuxi People's Hospital
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 214043
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6182
- Name: Cisplatin
- 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:** NCT06430502
**Brief Title:** Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours
**Official Title:** Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours
#### Organization Study ID Info
**ID:** KY23189
#### Organization
**Class:** OTHER
**Full Name:** Wuxi People's Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wuxi People's Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective.
**Detailed Description:** The innovative invention of Tumour Treatment Vaccine (TTV) has been verified in previous studies that the TTV vaccine can play a good role in enhancing the anti-tumour effect of immune checkpoint inhibitor therapy, and the tumour suppression rate of combined anti-PD-1 inhibitor reaches 75.96%. Therefore, this study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective.
### Conditions Module
**Conditions:**
- Cancer
- PD-L1 Gene Mutation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor. Use PD-1/L1 inhibitors in accordance with the drug indication.
**Intervention Names:**
- Biological: Tumor Treatment Vaccine; PD-1/L1 inhibitors
**Label:** Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors
**Description:** Before and after the patient's treatment period using PD-1 inhibitors，patients will receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm or near the tumor.The initial dose is 1ml each time, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml each time.The interval between injections can be shortened or extended depending on the patient's condition and response.
**Name:** Tumor Treatment Vaccine; PD-1/L1 inhibitors
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
**Measure:** Relief degree of tumors
**Time Frame:** immediately after the last treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
10. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
11. Subjects in other conditions that are considered unsuitable for this study by the investigator.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Peihua Lu
**Phone:** 0510-85350495
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuxi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Peihua Lu, MD
- **Phone:** 13621500031
- **Role:** CONTACT
**Country:** China
**Facility:** Wuxi People's Hospital
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 214043
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430489
**Acronym:** PROTORISC
**Brief Title:** Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide
**Official Title:** Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
#### Organization Study ID Info
**ID:** DR230123
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Tours
### Status Module
#### Completion Date
**Date:** 2026-01
**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:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Tours
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Suicide prevention is a major public health concern, with nearly 9,000 suicides and over 200,000 suicide attempts reported each year in France. Suicide attempts and suicidal ideation are among the most frequent reasons for emergency room visits and psychiatric hospitalizations. Although there is no approved pharmacological treatment for suicidal crises, some psychiatric treatments appear promising. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promising results in reducing suicidal ideation. However, its use is limited due to its side effects. Nitrous oxide, another NMDA receptor inhibitor commonly used in anesthesia and pain management, has demonstrated rapid antidepressant effects and few side effects. Given its rapid and lasting effects, nitrous oxide could swiftly alleviate suicidal ideation.
### Conditions Module
**Conditions:**
- Suicidal Ideation
- Emergency Psychiatric
- Nitrous Oxide
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Medical air
**Label:** Control
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: Nitrous oxide
**Label:** Experimental
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** inhaled nitrous oxide (1 hour at 50% concentration)
**Name:** Nitrous oxide
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** inhaled medical air (1 hour)
**Name:** Medical air
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Suicidal ideation severity decrease (SSI)
**Measure:** suicidal ideation severity
**Time Frame:** At Hour 4
#### Secondary Outcomes
**Description:** Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation
**Measure:** suicidal ideation severity
**Time Frame:** At Hour 24, at Hour 48, at Day 7 and at Month 1
**Measure:** Suicidal ideation assessed by the SSI scale.
**Time Frame:** At Hour 24, at Hour 48, at Day 7 and at Month 1
**Measure:** Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).
**Time Frame:** At Day 0 et Day 7
**Description:** The higher the total score, the greater the severity of depression
**Measure:** Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).
**Time Frame:** At Day 0 et Day 7
**Description:** The higher the total score, the greater the severity of depression
**Measure:** Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire.
**Time Frame:** At Day 0, At Hour 4, at Hour 24, at Hour 48 et at Day 7
**Description:** The higher the total score, the greater the severity of anxiety
**Measure:** Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale.
**Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7
**Description:** The higher the score, the more the clinical condition has worsened
**Measure:** Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score.
**Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7
**Description:** Number of suicide attempts and methods in the month following the intervention
**Measure:** Commitment to suicidal action in the month following inclusion
**Time Frame:** in the month following Day 0
**Measure:** Consumption of psychotropic medication for anxiolytic or sedative purposes.
**Time Frame:** At Hour 0 up to Hour 4
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Active suicidal ideations
* Beck Scale for Suicidal Ideation score greater than or equal to 8
* French speaking
* Patient admitted to psychiatric emergency department
* Capable of wearing a facial mask
* Having signed an informed consent
* Affiliated with social security
Exclusion Criteria:
* Psychotic disorder, neurodegenerative disease, known substance use disorder (excluding caffeine or tobacco), substance intoxication, unstable somatic pathology
* Pregnancy or breastfeeding
* Contraindication to the use of nitrous oxide
* Legal incapacity
* Participation in another drug clinical trial
* Patient subject to compulsory care measures
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ANAIS VANDEVELDE, MD, PHD
**Phone:** +33247474747
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Stellina AUGIS
**Phone:** 02.47.47.46.38
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tours
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ANAÏS VANDEVELDE, MD PhD
- **Phone:** 02.47.47.95.08
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Psychiatric Emergencies
**Zip:** 37044
#### Overall Officials
**Official 1:**
**Affiliation:** CHRU de Tours
**Name:** ANAIS VANDEVELDE, MD, PHD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000013405
- Term: Suicide
- ID: D000016728
- Term: Self-Injurious Behavior
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M29364
- Name: Suicidal Ideation
- Relevance: HIGH
- As Found: Suicidal Ideation
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M16191
- Name: Suicide
- Relevance: LOW
- As Found: Unknown
- ID: M19089
- Name: Self-Injurious Behavior
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004630
- Term: Emergencies
- ID: D000059020
- Term: Suicidal Ideation
### Intervention Browse Module - Ancestors
- ID: D000018685
- Term: Anesthetics, Inhalation
- ID: D000018681
- Term: Anesthetics, General
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12546
- Name: Nitrous Oxide
- Relevance: HIGH
- As Found: Liver Transplantation
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M20765
- Name: Anesthetics, Inhalation
- Relevance: LOW
- As Found: Unknown
- ID: M20761
- Name: Anesthetics, General
- 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
### Intervention Browse Module - Meshes
- ID: D000009609
- Term: Nitrous Oxide
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430476
**Brief Title:** EMI Therapy for Depression in Hong Kong
**Official Title:** Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong
#### Organization Study ID Info
**ID:** EMI_depression
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Hong Kong
#### 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 if a two-week ecological momentary intervention (two EMA + one EMI daily) as augmentation to treatment as usual would reduce depressive symptoms, rumination levels, and functioning in subjects with mild to moderate depression, as compared to active controls receiving three EMA prompts daily.
**Detailed Description:** Background:
Major Depressive Disorder (MDD) is the leading contributors to disability-adjusted life years, with a burden comparable to that of cardiovascular disease. Among the core symptoms of MDD, rumination stands out as a particularly pernicious factor. Rumination is dysfunctional disturbing thinking; a maladaptive pattern of regulating thoughts and emotions characterized by a repetitive focus on negative thoughts, such as dwelling on negative memories and analyzing events without taking actions. Rumination amplifies negative cognitions and attenuates the effect of adapting problem-solving strategy, decreasing the motivation of patients to cope with stressful encounters and become more vulnerable to momentary low mood. Interventional strategies (such as Cognitive Bias Modification) targeting rumination involves increases one's ability to become aware of their own rumination and supporting them to adapt alternative thinking habits. Complementary techniques such as mindfulness and relaxation do not involve the reframing of negative thoughts but rather promote the acceptance of these thoughts, in this way, it allows one become more aware of distractions and repetitive past or future thinking events. The ESM, a structured self-report diary technique several times a day over a number of days using mobile devices zooming in on the micro-level of experience and behavior, presents a novel and promising approach to accurately track symptoms and experience by minimizing recall bias and capturing the natural fluctuations of symptom on a more immediate, granular level. The ESM-derived intervention (ESM-I), uses personalized mobile feedback to effectively treat depressive symptoms. Importantly, increasing evidence from randomised controlled trials (RCTs) have shown ESM-I as effective means to augment interventions in depression. While improving rumination is key the core depression symptom, ESM-I has yet to specifically target rumination, and the mechanisms by which ESM-I exert therapeutic effects warrant further investigation.
Objectives:
Our study aims to investigate the efficacy of a newly developed smartphone based 2-week Ecological Momentary Intervention (EMI) in comparison with an active control group receiving only ESM, as an innovative, online-based, accessible, and augmentative treatment for depression. This intervention is designed to be both timely and adaptive, targeting the core symptom of anhedonia in a clinical sample within Hong Kong.
Design:
This is a single-center, randomized, double-blind, sham-controlled trial with three assessment time points: Baseline (T0), post-intervention (T1) and 1-month post-intervention (T2).
Ecological Momentary Assessment (EMA): After providing informed consent, participants will install the "m-path" smartphone-based application, which is an open-source ESM program developed by KU Leuven. Following a briefing and practise run, participants will be randomly prompted within designated 3-hour blocks three times daily to complete a 5-minute questionnaire assessing their momentary affect, rumination levels, and suicidality, using visual analogue scales ranging from 0 (lowest) to 100 (highest). There will be 14 EMA questions covering affect (8 questions), suicidality (2 questions), and rumination (4 questions).
Ecological Momentary Intervention (EMI): Embedded within the last EMA survey, the EMI arm will include interactive tasks when a participant's computed rumination score (i.e., mean score of the four EMA rumination questions) reaches above the 80th percentile of their own cumulative score, or if the raw rumination score reach above 70 out of 100 (15). The intervention comprises of short exercises (most can be completed within 1-3 minutes) rooted in cognitive bias modification (CBM) techniques. Participants will interact with instructions and multimedia formats based on CBM module framework based on reflection / brooding. Participants will continue treatment with their psychiatrists who will be blinded to group allocation.
Variables:
* Hamilton Depression Rating Scale (HDRS)
* Montgomery-Åsberg Depression Rating Scale (MADRS)
* Social and Occupational Functioning Assessment scale (SOFAS) (Morosini et al., 2000)
* Role Functioning Scale (RFS)
* Global Functioning: Social Scale and Role Scale
* Short Form Health Survey (SF-12)
* General Self Efficacy Scale
* Rumination Response Scale (RRS)
* System Usability Scale - Chinese version
* Beck Scale for Suicidal Ideation
### Conditions Module
**Conditions:**
- Mild to Moderate Depression
**Keywords:**
- Depression
- Ecological momentary intervention
- Rumination
- Hong Kong
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** EMA arm: participants will receive three ecological momentary assessment (EMA) prompts daily with the prompts spread out throughout the day. Within each prompt, participants will answer 14 questions regarding affect, suicidality, and rumination. Afterwards, they will be shown a video clip extracted from a popular and longstanding soap opera in Chinese that lasts between three to four minutes. Each prompt would take around 8 minutes to complete. In total, participants will complete 70 EMA prompts during the intervention period.
EMI arm: participants will receive two EMA prompts and one EMI prompt daily. The EMA prompts would be identical to the ones in the EMA arm without the video clip at the end. The EMI prompt would contain an interactive task designed to counter ruminative thoughts.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** masking: Participants will be notified that they would engage in a diary recording activity for two weeks, but would be blinded to whether they were receiving the intervention or active control version. Trained research assistents would assess outcomes and the principal investigator would randomise participants to the two conditions based on anonymised IDs. Treatment provided to participants as usual by their usual care providers (e.g., doctors) would not be notified about the randomisation conditions.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ecological momentary assessment (EMA) arm: participants will receive three ecological momentary assessment (EMA) prompts daily within three time blocks spread out throughout the day. Within each prompt, participants will answer 14 questions regarding affect, suicidality, and rumination. Afterwards, they will be shown a video clip extracted from a popular and longstanding soap opera in Chinese that lasts between three to four minutes. Each prompt would take around 8 minutes to complete. In total, participants will complete 70 EMA prompts during the intervention period.
**Intervention Names:**
- Other: EMI
**Label:** EMA
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** EMI arm: participants in this arm will receive two ecological momentary assessment (EMA) prompts and one econological momentary intervention (EMI) prompt daily. The EMA prompts would be identical to the ones in the EMA arm without the video clip at the end. The EMI prompt would contain an interactive task designed to counter ruminative thoughts. Examples of the interactive tasks include: mindfulness exercises (mindful walking), cognitive reappriasal, strengths recognition, etc. Each EMI prompt would last around 3-5 minutes.
**Intervention Names:**
- Other: EMI
**Label:** EMI
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EMA
- EMI
**Description:** A phone-based intervention carried out on an experience sampling platform m-Path
**Name:** EMI
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Gold standard for measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.
**Measure:** Hamilton Depression Rating Scale (HDRS) - 17 items
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms.
**Measure:** Montgomery-Åsberg Depression Rating Scale (MADRS)
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
#### Secondary Outcomes
**Description:** Reference (Morosini et al., 2000); measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability.
**Measure:** Social and Occupational Functioning Assessment scale (SOFAS)
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning
**Measure:** Role Functioning Scale (RFS)
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning
**Measure:** Global Functioning: Social Scale and Role Scale
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures impacts of overall physical and emotional health on individuals' day to day living; score ranges from 0 (minimum) to 100 (maximum), higher score indicates better physical and mental health functioning
**Measure:** Short Form Health Survey (SF-12)
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures self-reported self-efficacy; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating more self-efficacy
**Measure:** General Self Efficacy Scale
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures self-reported rumination responses; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating higher levels of ruminative responses styles.
**Measure:** Rumination Response Scale (RRS)
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide.
**Measure:** Beck Scale for Suicidal Ideation
**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Reference: (Wang et al., 2019); to assess acceptability and feedback regarding conducting EMA and EMI on mPath platform; scores ranges from 10 (minimum) to 50 (maximum), with higher scores indicating higher perceived usability of the systems involved.
**Measure:** System Usability Scale - Chinese version
**Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up)
**Description:** Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome.
**Measure:** Clinical Global Impression Scale
**Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 16-65 years
* Cantonese-speaking ethnic Chinese
* Diagnosis of major depressive episode (MDE) established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder 5th Edition (DSM-V)
* 17-item Hamilton Depression Rating Scale (HDRS) ≥ 14 at screening and at baseline (i.e. moderate to severe depression)
* Having a smartphone with Internet access and iOS or Android operating system.
Exclusion Criteria:
* Patients who could not read Chinese, are unable to provide informed consents
* Comorbid with other Axis I diagnoses (especially schizoaffective disorder)
* With an unstable medical condition or current substance abuse
* Have a score of ≥4 on any one of the three items on Positive and Negative Syndrome Scale (P1 Delusion, P2 Conceptual disorganization, P3 Hallucination)
* Marked risk of self-harm or suicide that could not be safely managed in an outpatient clinic setting
* Currently receiving any other weekly psychosocial therapy
* Unable to use a smartphone-based application due to cognitive impairment or learning disability or inadequate vision.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hong Kong
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ka Ying Heidi Lo
- **Phone:** 2255 4486
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone:** 2255 4486
- **Role:** CONTACT
**Country:** Hong Kong
**Facility:** University of Hong Kong
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M2062
- Name: Rumination Syndrome
- Relevance: LOW
- As Found: Unknown
- 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: T5077
- Name: Rumination Disorder
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430463
**Brief Title:** Impact of Interscalenous Block Anesthesia on Hearing
**Official Title:** Effect of Interscalenous Block Anesthesia on Hearing Levels
#### Organization Study ID Info
**ID:** 02-2024/11
#### Organization
**Class:** OTHER
**Full Name:** Karaman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-11-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karaman Training and Research 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:** Interscalene brachial plexus block (ISBPB) is used frequently in shoulder, clavicle and upper arm surgeries to obtain analgesia in the postoperative period. Our primary aim in this study is to evaluate if interscalene block anesthesia has an effect on hearing levels of patients undergoing orthopedic shoulder surgeries.
**Detailed Description:** Interscalene brachial plexus block (ISBPB) is used for both anesthesia and analgesia purposes in shoulder, clavicle and upper arm surgeries. It is also frequently used to obtain analgesia in the postoperative period especially in patients undergoing shoulder surgeries. Thus, it provides decrease in opioid need and opioid related side effects in the perioperative period. The effect of IBPB on hearing is probably not caused by an effect on the vestibulocochlear nerve because of its central location. The innervation area of the greater auricular nerve, a derivative of the cervical plexus, is often involved in an IBPB. However, this nerve is not known to affect hearing. The nerves supplying the outer ear canal and the tympanic membrane (branches of the mandibular, facial and vagal nerves) are located far enough from the IBPB injection site to make their involvement unlikely. However, sound conduction through the middle ear to the inner ear, and functioning of the spiral organ of the cochlea may be indirectly affected by regional sympathetic block that is most likely seen after IBPB. Sympathetic block may cause vasodilatation and swelling of the mucosal membranes of the middle ear and the eustachian tube with deterioration of hearing.
The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. Ultrasaoun guided Interscalene block anesthesia will be applied to all patients. Each patient will be treated with the same multimodal analgesia method at the postoperative period.
### Conditions Module
**Conditions:**
- Hearing Loss
**Keywords:**
- hearing level, interscalene block anesthesia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ultrasound-guided Interscalene block will be applied to all patientsand also every patients will be treated with the same multimodal analgesia for postoperative pain control. The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up.
**Intervention Names:**
- Diagnostic Test: pure tone audiometry levels
**Label:** patients undergoing shoulder surgery with interscalene block
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patients undergoing shoulder surgery with interscalene block
**Description:** The patient will be examined by ENT physician on the morning of the operation, otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up.
**Name:** pure tone audiometry levels
**Other Names:**
- speech audiometry
- tympanometry
- otoscopic examnation
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** pure tone audiometry measurements at all frequencies measured via MADSEN Astera2 device
**Measure:** Number of Participants with a Difference of 10 dB or more between Pre- and Post-surgery pure tone audiometry measurements at any Frequency
**Time Frame:** pre-surgery, a day after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* participants are undergoing a shoulder surgery.
* ASA I and II patients without uncontrolled diabetes and hypertension
* participants have normal or near-normal hearing thresholds in the un-operated ear
Exclusion Criteria:
* participants have hearing loss (PTA \> 35 dB HL) in pure tone audiometry testing before surgery in any side
* participants have medical conditions after the surgery which prevents having hearing tests
* participants have abnormal tympanometric results
* participants with chronic otitis media or a history of ear surgery
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants undergoing shoulder surgery with ultrasoun-guided interscalene brachial plexus block.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arife Sezgin
**Phone:** +905304069461
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karaman
**Country:** Turkey
**Facility:** Karaman training and research hospital
**State:** Merkez
**Zip:** 70200
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M24420
- Name: Hearing Loss
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M6840
- Name: Deafness
- Relevance: LOW
- As Found: Unknown
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000034381
- Term: Hearing Loss
### 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:** NCT06430450
**Brief Title:** Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease
**Official Title:** Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease
#### Organization Study ID Info
**ID:** ISMAILKMU
#### Organization
**Class:** OTHER
**Full Name:** Karamanoğlu Mehmetbey University
### Status Module
#### Completion Date
**Date:** 2025-01-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karamanoğlu Mehmetbey University
#### Responsible Party
**Investigator Affiliation:** Karamanoğlu Mehmetbey University
**Investigator Full Name:** İsmail Taşdemir
**Investigator Title:** Assistant 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 aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze correlations with clinical parameters. In our study, saliva samples will be taken from a total of 80 systemically healthy volunteers, 20 of patients are periodontal healthy, 20 of patients have degree A periodontitis, 20 of patients have degree B periodontitis and 20 of patients have degree C periodontitis, along with the measurement of whole mouth clinical parameters. Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in the samples taken will be subjected to enzyme-related immunoassay ( It will be determined by ELISA). Cytokine levels between different groups will then be interpreted as a result of statistical analysis. Possible significant differences shed light on future studies with Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α. These cytokines may help develop different diagnostic methods or treatment strategies in future periodontal treatments.
**Detailed Description:** The study included patients between the ages of 18 and 70 who applied to Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry Department of Periodontology, were non-smokers, had no systemic problems, had not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 3 months, were not pregnant, had not received periodontal treatment in the last 6 months, and having at least 20 teeth in its mouth; for grade A periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio \<0.25 in the tooth with the most bone loss; for grade B periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss; for grade C periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio \>1.0 in the tooth with the most bone loss; For the healthy group; According to the evaluation made in 6 regions of each tooth, including 20 individuals who show bleeding on probing in less than 20% of the area, have a probing depth of less than 4 mm, and have no attachment loss. The healthy and periodontal disease group will consist of 80 patients in total.Anamnesis will be taken from individuals at the beginning of the interview, and individuals who meet the specified criteria after the anamnesis will be included in the study. After being informed about the study, an informed consent form will be obtained from the individuals.
After the anamnesis is taken, clinical periodontal evaluations will be performed on individuals who are deemed to meet the inclusion criteria. Clinically, plaque index (Sillness and Löe 1964), gingival index (Löe and Sillness 1963), pocket depth and bleeding on probing index(Ainamo\&Bay, 1975) will be recorded.
Saliva samples will be taken from individuals divided into groups for biochemical examinations. Saliva samples will be taken from each patient, first frozen at -20ºC and than stored at -28ºC until the day of analysis. Cytokine levels in the samples collected from the patients will be determined by the enzyme-related immune test "Enzyme Linked-Immuno-Sorbent Assay" (ELISA).
### Conditions Module
**Conditions:**
- Periodontitis
- Periodontal Diseases
**Keywords:**
- Periodontitis
- Saliva
- Cytokine
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 5 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Individuals who have no clinical signs of inflammation in the periodontal tissues and the number of areas showing bleeding on probing does not exceed 20%.
**Intervention Names:**
- Diagnostic Test: Clinical measurements and saliva samples collection
**Label:** Healty
#### Arm Group 2
**Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio in the tooth with the most bone loss \<0.25
**Intervention Names:**
- Diagnostic Test: Clinical measurements and saliva samples collection
**Label:** Grade A
#### Arm Group 3
**Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss.
**Intervention Names:**
- Diagnostic Test: Clinical measurements and saliva samples collection
**Label:** Grade B
#### Arm Group 4
**Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and a radiological bone loss percentage/age ratio \>1.0 in the tooth with the most bone loss.
**Intervention Names:**
- Diagnostic Test: Clinical measurements and saliva samples collection
**Label:** Grade C
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Grade A
- Grade B
- Grade C
- Healty
**Description:** Clinical measurements will be taken from all patients and saliva samples will be collected for biochemical analysis.
**Name:** Clinical measurements and saliva samples collection
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees. To examine and determine the correlation of these cytokines with clinical measurements.
**Measure:** Outcome 1
**Time Frame:** First 5 months
#### Secondary Outcomes
**Description:** By investigating the changes in these cytokine levels in the presence of periodontal disease, they can be used in disease diagnosis in the future or to provide preliminary information on possible treatments that can be performed through these cytokine pathways.
**Measure:** Outcome 2
**Time Frame:** Two months after the study was completed
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with a varying degree of periodontal status (periodontally healthy, gingivitis, and chronic periodontitis).
* Have no systemic disease.
* No smoking/ not using any tobacco products or alcohol.
* No periodontal therapy in last 6 months.
* Not using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
* Not to be pregnant or in lactation period.
* Having ≥20 permanent teeth.
Exclusion Criteria:
* Having any systemic disease.
* Smokers, other tobacco product, and alcohol consumers.
* Having any periodontal therapy in last 6 months.
* Using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
* Being pregnant or in lactation period.
* Having ˂20 permanent teeth.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** * 20 healty patients
* 20 Grade A periodontitis
* 20 Grade B periodontitis
* 20 Grade C periodontitis
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ismail taşdemir, assistant professor
**Phone:** +905455694573
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### 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: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13419
- Name: Periodontal Diseases
- Relevance: HIGH
- As Found: Periodontal Diseases
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxia
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000000860
- Term: Hypoxia
### 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430437
**Brief Title:** A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
**Official Title:** A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
#### Organization Study ID Info
**ID:** SHR-A1811-310
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu HengRui Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Jiangsu HengRui Medicine Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
### Conditions Module
**Conditions:**
- Non-Small Cell Lung Cancer With HER2- Mutations
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR-A1811
**Label:** SHR-A1811
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
**Label:** Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SHR-A1811
**Description:** Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
**Name:** SHR-A1811
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
**Description:** Drug: Camrelizumab administered intravenously every 3 weeks (Q3W)
Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
**Name:** Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
**Measure:** Progression-free survival (PFS) based on blinded independent central review (BICR)
**Time Frame:** Until progression, assessed up to approximately 2 years
#### Secondary Outcomes
**Description:** Defined as time from randomization until the date of death due to any cause
**Measure:** Overall Survival (OS)
**Time Frame:** Until death, assessed up to approximately 3 years
**Description:** Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator
**Measure:** Progression Free Survival (PFS) by investigator assessment
**Time Frame:** Until progression, assessed up to approximately 2 years
**Description:** Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
**Measure:** Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
**Time Frame:** until to 90 days after the last dose，assessed up to approximately 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. 18-75 years old (inclusive of both ends)
3. ECOG score of 0 or 1.
4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
5. Subjects with central laboratory- confirmed functional HER2 mutations
6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
8. Protocol-defined adequate organ function including cardiac, renal, hepatic function
Exclusion Criteria:
1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
4. With poorly controlled tumor-related pain.
5. previous or current with other malignancies.
6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
7. Subjects with active or previous autoimmune diseases.
8. Subjects with uncontrolled or severe cardiovascular diseases.
9. Subjects with active hepatitis B or hepatitis C.
**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:** You Li
**Phone:** 0518-81220121
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Shun Lu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shanghai Chest Hospital
**State:** Shanghai
**Zip:** 200030
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M5534
- Name: Carcinoma
- 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
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000019384
- Term: Nucleic Acid Synthesis 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: M19537
- Name: Paclitaxel
- Relevance: HIGH
- As Found: Surgery
- ID: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
- ID: M264
- Name: Pemetrexed
- Relevance: HIGH
- As Found: Strategies
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic 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: 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: D000017239
- Term: Paclitaxel
- ID: D000016190
- Term: Carboplatin
- ID: D000068437
- Term: Pemetrexed
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430424
**Acronym:** GBrecurr
**Brief Title:** Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma
**Official Title:** Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
#### Organization Study ID Info
**ID:** CHUBX 2023/79
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2026-04
**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:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Bordeaux
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.
**Detailed Description:** Glioblastomas are the most frequent and aggressive malignant Central Nervous System (CNS) tumors in adults, with a median survival of only 14 months.
Current treatment is based on surgery followed by radiochemotherapy (STUPP protocol), unchanged since 2005. Clinical trials evaluating immune checkpoint inhibitors and targeted therapies have largely failed to demonstrate efficacy in these tumors. In order to better understand the oncogenesis of glioblastoma and identify potential new therapeutic targets, the study of the characteristics of relapsed tumors compared with the initial tumor seems relevant.
The aim of this retrospective study is to investigate the transcriptomic, proteomic and metabolic characteristics of relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available. These analyses will be correlated with relapse-free and overall survival of the patients.
### Conditions Module
**Conditions:**
- Relapsed Cancer
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
**Keywords:**
- Recurrent glioblastoma
- Prognostic
- Metabolism
- Proteomic
- Transcriptomic
- Microbiota
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
**Intervention Names:**
- Biological: Relapsed glioblastoma
**Label:** Patients operated for primary and recurrent glioblastoma
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients operated for primary and recurrent glioblastoma
**Description:** Paired tumor samples diagnosis/relapse
**Name:** Relapsed glioblastoma
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample
**Measure:** Evaluation of metabolic changes involved in glioblastoma relapse
**Time Frame:** Up to 2 years after the start of the study
#### Secondary Outcomes
**Description:** Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion
**Measure:** Progression-free survival
**Time Frame:** From date of the second surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
**Description:** Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse
**Measure:** Overall survival
**Time Frame:** From date of the second surgery until the date of death from any cause, assessed up to 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age \> 18 years
* surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux
Exclusion Criteria:
* systemic therapy received for non-glioblastoma tumor
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mathieu LARROQUETTE
**Phone:** +33 5 56 79 58 08
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Julien ENGELHARDT
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bordeaux
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mathieu LARROQUETTE
- **Role:** CONTACT
**Country:** France
**Facility:** CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale
**Zip:** 33000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001254
- Term: Astrocytoma
- ID: D000005910
- Term: Glioma
- ID: D000018302
- Term: Neoplasms, Neuroepithelial
- 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: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M9019
- Name: Glioblastoma
- Relevance: HIGH
- As Found: Glioblastoma
- ID: M4561
- Name: Astrocytoma
- Relevance: LOW
- As Found: Unknown
- ID: M9020
- Name: Glioma
- Relevance: LOW
- As Found: Unknown
- ID: M20446
- Name: Neoplasms, Neuroepithelial
- Relevance: LOW
- As Found: Unknown
- 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: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: T2518
- Name: Glioblastoma
- Relevance: HIGH
- As Found: Glioblastoma
- ID: T2519
- Name: Glioma
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005909
- Term: Glioblastoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430411
**Acronym:** OLIGOMET
**Brief Title:** Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
**Official Title:** Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
#### Organization Study ID Info
**ID:** 1336/2022
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2031-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** IRCCS Ospedale San Raffaele
**Class:** OTHER
**Name:** University Hospital of Cologne
**Class:** OTHER
**Name:** St. Antonius Hospital
**Class:** OTHER
**Name:** Istituto Europeo di Oncologia
**Class:** OTHER
**Name:** University Hospital, Udine, Italy
**Class:** OTHER
**Name:** Azienda Ospedaliera San Giovanni Battista
**Class:** OTHER
**Name:** Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
**Class:** OTHER
**Name:** Lund University
**Class:** OTHER
**Name:** Medical University of Warsaw
**Class:** OTHER
**Name:** Ziekenhuis Netwerk Antwerpen (ZNA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Dr. Pawel G. Rajwa
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** PSMA-PET/CT or PSMA-PET/MRI are more accurate imaging modalities compared to CT/BS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET.
Currently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.
**Detailed Description:** The Emerging Role of PSMA-PET in Prostate Cancer Imaging
PSMA-PET, in conjunction with CT or MRI, has significantly enhanced the precision of prostate cancer staging. Traditional imaging modalities, such as CT or BS, often fail to accurately determine the disease's extent. In contrast, PSMA-PET offers a more precise diagnostic alternative, especially in identifying oligometastatic cases among high-risk prostate cancer patients. Remarkably, 10-20% of patients with unfavorable prostate cancer initially classified as non-metastatic through conventional imaging are reclassified as oligometastatic when reassessed with PSMA-PET. This reclassification is pivotal, possibly influencing treatment decisions and prognostic outcomes.
The Need for a Focused Study
Oligometastatic prostate cancer represents an intermediate stage between localized and systemic disease, reflecting an early phase in metastatic progression. These tumors not only exhibit unique biological characteristics but also constitute a distinct clinical entity, offering possibilities for long-term control or even cure. Numerous studies demonstrated benefits from combining local and metastasis-directed therapies with systemic treatment in oligometastatic prostate cancer patients diagnosed with conventional imaging. However, despite diagnostic advancements and the evolving uptake of PSMA-PET, substantial gaps persist in the understanding of optimal management for oligometastatic prostate cancer identified with next-generation imaging.
Due to the diagnostics advancements and dynamically changing treatment landscape with various local, systemic, and metastasis-directed therapies, this topic requires a prospective multicenter registry. To address this, the investigators have initiated this prospective cohort study focusing on the efficacy and safety of local therapies in oligometastatic prostate cancer patients diagnosed with PSMA-PET, performed under the umbrella of EAU Young Academic Urologists (YAU) Prostate Cancer Working Group.
Study Design and Objectives
This multicenter, prospective observational cohort study aims primarily to evaluate time to castration-resistance, clinical and radiological progression-free survival in patients with oligometastatic prostate cancer identified using PSMA-PET. Secondary objectives include assessing complications of local therapies, pathological, functional, and oncologic outcomes among others.
Eligible patients are those diagnosed with primary oligometastatic prostate cancer with PSMA-PET and treated with local therapies such as radical prostatectomy or radiation. The oligometastatic state is defined as cM1a and/or cM1b with ≤5 bone metastases and/or M1c with ≤3 lung lesions, with or without cN positivity. Key exclusion criteria include the presence of visceral metastases (other than lungs) or neoadjuvant therapy before initial PSMA-PET assessment.
The study aims to answer pivotal questions about oncological, functional, and safety outcomes after local treatment in oligometastatic prostate cancer patients on PSMA-PET. Furthermore, the goal is to report treatment strategies for this disease state in this dynamically changing field, and to identify factors predicting improved outcomes.
Data Collection and Management
Data will be meticulously collected and managed using the Castor electronic case report form platform, provided by the European Association of Urology Foundation for Urological Research, ensuring pseudonymization and security. With the study starting in 2024, the investigators aim to collect data until end of 2030.
Estimated Impact of the Study
This study is anticipated to substantially contribute to the understanding of oligometastatic prostate cancer and the role of PSMA-PET in its diagnosis and management. In a recent multicenter EAU-YAU study closely related to OLIGOMET project, the investigators have shown that patients with oligometastatic prostate cancer diagnosed with PSMA-PET and treated with radical prostatectomy have overall favorable oncologic outcomes. Nevertheless, a portion of these patients still faced a risk of early progression, emphasizing the need for multimodal therapy. The study illustrated the lack of evidence and precise clinical guidance in this distinct disease stage; there existed significant heterogeneity in the treatment approach among participating tertiary referral centers, with the majority of patients receiving multimodal therapy.
While the combination of radiation and systemic therapy can be considered the current standard of care in oligometastatic patients on conventional imaging, the preferred management of patients with a small metastatic burden on PSMA-PET remains unknown. Therefore, the investigators believe that evaluating the effectiveness of local therapies in patients diagnosed with next-generation imaging can pave the way for personalized, and effective treatment strategies of oligometastatic disease in the future. Moreover, the use of PSMA-PET may allow for early identification and intervention, potentially altering the natural history of the disease and improving oncologic control. Finally, the investigators expect that by understanding the role of combination therapies and identifying predictive factors to guide treatment selection, could lead to extended survival and improved quality of life of patients.
### Conditions Module
**Conditions:**
- Prostate Cancer Metastatic
- Prostate Cancer Metastatic to Bone
- Prostate Cancer
- Prostate Neoplasm
- Oligometastatic Disease
- Oligometastasis
**Keywords:**
- prostate
- oligometastatic
- oligometastasis
- oligomet
- prostatectomy
- irradiation
- abiraterone
- enzalutamide
- darolutamide
- apalutamide
- androgen deprivation therapy
- ADT
- docetaxel
- PSMA PET
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 5 Years
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Removal of the prostate and seminal vesicles.
**Name:** Radical prostatectomy
**Type:** PROCEDURE
#### Intervention 2
**Description:** Radiation therapy of the prostate.
**Name:** Prostate irradiation
**Type:** RADIATION
#### Intervention 3
**Description:** Surgical removal of metastases.
**Name:** Surgical metastasectomy
**Type:** PROCEDURE
#### Intervention 4
**Description:** Radiation therapy of metastases.
**Name:** Irradiation of metastases
**Type:** RADIATION
#### Intervention 5
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Abiraterone acetate
**Type:** DRUG
#### Intervention 6
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Enzalutamide
**Type:** DRUG
#### Intervention 7
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Darolutamide
**Type:** DRUG
#### Intervention 8
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Apalutamide
**Type:** DRUG
#### Intervention 9
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Docetaxel
**Type:** DRUG
#### Intervention 10
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Lutetium-PSMA
**Type:** DRUG
#### Intervention 11
**Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer
**Name:** Androgen deprivation treatment
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as increase in size of existing lesion or appearance of new lesion (on any subsequent follow-up imaging modality used for baseline assessment), or death.
**Measure:** Radiographic progression-free survival (rPFS)
**Time Frame:** From date of diagnosis until the date of first documented radiographic progression or date of death from any cause, whichever came first, assessed up to 100 months
**Description:** Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death.
**Measure:** Clinical progression-free survival (cPFS)
**Time Frame:** From date of diagnosis until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 100 months
**Description:** Castration resistance is defined as: castrate serum testosterone \<50ng/dL or 1.7nmol/L, plus either biochemical progression (three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \> 2ng/mL) or radiographic progression (\> 2 new bone lesions or a new soft tissue lesion).
**Measure:** Castration resistance-free survival (CRPC-FS)
**Time Frame:** From date of diagnosis until the date of castration resistance or date of death from any cause, whichever came first, assessed up to 100 months
#### Secondary Outcomes
**Description:** Local therapy complications are assessed using Clavien-Dindo classification for radical prostatectomy and RTOG/EORTC Radiation Toxicity Grading for radiation therapy.
**Measure:** Local therapy complications
**Time Frame:** From the time of local therapy to 30 days after treatment.
**Description:** Change of pathological stage
**Measure:** Pathological response to systemic therapy
**Time Frame:** Measured immediately after the surgery
**Description:** Defined as prostate cancer downstaging and/or decrease in number of metastasis lesions due to the effect of systemic therapy.
Time Frame:
Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months
**Measure:** Imaging response to systemic therapy
**Time Frame:** Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months
**Description:** Defined as continence rate (no incontinence 0 pads/24h, mild 1 pads/24h, moderate 2-3 pads/24h, severe \>3 pads/24h).
**Measure:** Functional outcomes - continence
**Time Frame:** 6 months, 1, 2, and 3 years after local therapy.
**Description:** Defined as potency (potent ( IIEF-EF=\>22), inpotent (IIEF-EF \<22)
**Measure:** Functional outcomes - potency
**Time Frame:** 6 months, 1, 2, and 3 years after local therapy.
**Description:** Time from oligometastasis diagnosis to death from prostate cancer.
**Measure:** Cancer-specific survival
**Time Frame:** From date of diagnosis until the date of death from prostate cancer, assessed up to 100 months
**Description:** Time from oligometastasis diagnosis to death of any cause.
**Measure:** Overall survival
**Time Frame:** From date of diagnosis until the date of death from any cause, assessed up to 100 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and/or cM1b with ≤5 osseous metastases and/or M1c with ≤3 lung lesions, with or without cN positivity.
* Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.
* Any Gleason Score, any cT stage, any PSA
Exclusion Criteria:
* Visceral metastases (apart from lungs).
* Neoadjuvant therapy prior to first PSMA PET.
* Non-metastatic prostate cancer.
* Patients who did not undergo imaging before local treatment.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Oligometastatic prostate cancer patients treated with local therapy across Europe.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tamás Fazekas, MD
**Phone:** +36-70-611-8524
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pawel G Rajwa, MD PhD
**Phone:** +48-604-090-416
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of Vienna
**Name:** Shahrokh F Shariat, MD PhD DDsc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Medical University of Vienna
**Name:** Pawel G Rajwa, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic 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: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000065088
- Term: Steroid Synthesis Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
- ID: D000006728
- Term: Hormones
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4059
- Name: Androgens
- Relevance: HIGH
- As Found: Assistance
- ID: M1668
- Name: Docetaxel
- Relevance: HIGH
- As Found: Physical
- ID: M451
- Name: Abiraterone Acetate
- Relevance: HIGH
- As Found: Website
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- 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: M30537
- Name: Cytochrome P-450 Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077143
- Term: Docetaxel
- ID: D000069501
- Term: Abiraterone Acetate
- ID: D000000728
- Term: Androgens
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430398
**Acronym:** PREMEM
**Brief Title:** A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy
**Official Title:** Ruolo Del Microbiota Materno Sulla Risposta Immunitaria e Sul Metabolismo Nei Disordini Ipertensivi
#### Organization Study ID Info
**ID:** 0011882
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Clinico Humanitas
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Preeclampsia (PE) is a leading cause of maternal-fetal morbidity and mortality, affecting 3-8% of pregnancies and causing over 76,000 maternal deaths annually. PE is characterized by high blood pressure and proteinuria or organ damage/intrauterine growth restriction (IUGR). There are two phenotypes: placental PE, caused by abnormal trophoblast invasion, often leading to early pregnancy complications and IUGR, and metabolic PE, associated with maternal metabolic issues like visceral obesity and metabolic syndrome, leading to low-grade inflammation and insulin resistance.
Recent research highlights the role of maternal gut microbiota in these conditions, suggesting that gut dysbiosis-altered microbial balance-can influence systemic immune responses and contribute to PE. This study aims to characterize the maternal gut microbiota in the two PE phenotypes to better understand their distinct etiologies and improve prediction and prevention strategies.
**Detailed Description:** Preeclampsia (PE) is one of the leading causes of maternal-fetal morbidity and mortality. It is defined as systolic blood pressure (SBP) ≥ 140 and diastolic blood pressure (DBP) ≥ 90 in two consecutive measurements taken 6 hours apart, associated with proteinuria \>300 mg/24 h or 2++ detected by a urine dipstick, or the presence of organ damage or intrauterine growth restriction (IUGR). Preeclampsia complicates 3-8% of pregnancies and is responsible for over 76,000 maternal deaths each year.
Scientific evidence suggests the existence of two distinct phenotypes of the condition: placental preeclampsia and metabolic preeclampsia. The first phenotype is caused by abnormal invasion of the maternal endometrium by the trophoblast, leading to preeclampsia often associated with early presentation in pregnancy, intrauterine growth restriction, and the need for delivery at early gestational ages. Fetal growth restriction due to likely placental insufficiency is defined by the Delphi criteria: estimated fetal weight (EFW) \< 3rd percentile, or at least two of the following criteria: EFW \< 10th percentile, a decrease in EFW by at least 40 percentiles even if above the 10th percentile, cerebro-placental ratio (CPR) ≤ 1 (5th percentile) or umbilical artery pulsatility index (PI) ≥ 95th percentile, uterine arteries with PI ≥ 95th percentile.
Beyond the hypothesis of abnormal placentation at the beginning of pregnancy, it is now recognized that maternal metabolic risk factors may cause placental malfunction later in pregnancy. The second phenotype is rooted in a metabolic basis, representing about 4% of hypertensive disorders of pregnancy (HDP), and depends on a maternal predisposition in patients with visceral obesity and metabolic syndrome. Visceral obesity is associated with a state of chronic low-grade inflammation, which contributes to insulin resistance, altered glucose homeostasis, and cardiovascular complications.
Metabolic preeclampsia occurs in patients with a pre-existing state of low-grade inflammation related to trunk obesity and metabolic syndrome, compounded by the inflammation and insulin resistance typical of pregnancy. Scientific evidence has shown that in the placentas of these patients, there is a higher density of tertiary villi compared to physiological pregnancies, with reduced intervillous spaces, resulting in hypoperfusion and oxidative stress. Differentiation between these clinical phenotypes can be identified during pregnancy by studying fetal growth as an index of placental function, as well as maternal cardiovascular adaptation to pregnancy in terms of hemodynamic parameters and body water, and finally by studying placental histology after delivery. Hypertensive disorders of pregnancy associated with intrauterine growth restriction (HDP-IUGR) and hypertensive disorders of pregnancy with appropriate-for-gestational-age fetuses (HDP-AGA) are distinguished.
Currently, starting from the first trimester of pregnancy, maternal cardiovascular and hemodynamic function can be assessed with a non-invasive and harmless method for both mother and fetus using the USCOM (Ultra Sonic Cardiac Output Monitor) system. This provides real-time data on numerous central and peripheral hemodynamic parameters such as cardiac output and stroke volume beat-to-beat. It allows measurement of cardiac output from both the right and left heart, systolic stroke volume (SV), systemic vascular resistance, and inotropic index. Its use in pregnancy has already been validated and will significantly enhance the quality of care provided to women with high-risk or pathological pregnancies.
However, there is still discordance among scientific societies regarding the classification of preeclampsia and its potential different clinical phenotypes, making a personalized clinical approach to this condition challenging. While diagnostic criteria have been codified by major national and international scientific societies, it is increasingly important to identify high-risk groups early on, not only to plan a close diagnostic follow-up but also to define appropriate therapeutic strategies based on the etiology.
Recently, a screening method at 11-13 weeks of gestation has been developed, capable of predicting 75% of pregnancies that will develop preterm preeclampsia (\<37 weeks of gestation). This is based on a risk calculation algorithm that combines measurements of weight and height, mean arterial pressure measured with automated devices, blood sampling for PLGF levels, and Doppler ultrasound measurement of the mean pulsatility index (PI) of the uterine arteries. However, this screening can only predict a subset of patients who will develop preeclampsia \<37 weeks and who may benefit from aspirin administration if taken at doses \>100mg and before 16 weeks.
To date, it is still not possible to effectively predict and prevent preeclampsia manifesting \>37 weeks, and the etiology of this serious obstetric condition remains a topic of debate and scientific research. Among emerging etiological hypotheses, numerous scientific publications support that an alteration in maternal immunity and immune tolerance underlies hypertensive disorders in pregnancy. Studies on animal models have shown that the activation and expansion of aberrant B cells can trigger inflammatory events leading to preeclampsia. IFN-γ produced by NK cells plays an essential role in spiral arterial remodeling in murine pregnancy. Studies on NK cell-deficient mice have shown defective placental vascular remodeling, characterized by narrow vascular lumens, thick vascular walls, and retention of vascular smooth muscle actin.
Recent discoveries suggest that changes in the maternal gut microbiota, a commensal microbial community capable of modulating the host's immune responses, underlie these immunological alterations. It has been widely described how changes in the diversity and composition of the host gut microbiota-a phenomenon called "dysbiosis," commonly induced by dietary changes or antibiotic treatment-affect systemic immune responses and can disrupt the balance between pro-inflammatory and anti-inflammatory activation. Gut dysbiosis can be associated with excessive weight gain during pregnancy and promote metabolic disorders such as gestational diabetes and preeclampsia, with risks of metabolic alterations in the newborn.
Based on these premises, this study aims to define the characteristics of the maternal gut microbiota in the two different clinical phenotypes of preeclampsia: placental preeclampsia, where the hypertensive disorder is associated with growth restriction, and metabolic preeclampsia, where the hypertensive disorder is associated with a fetus of appropriate weight for gestational age.
### Conditions Module
**Conditions:**
- Preeclampsia
### Design Module
#### Bio Spec
**Description:** The protocol involves the analysis of maternal microbiota and metabolome from saliva and fecal samples, as well as blood samples collected from consenting women during scheduled obstetric visits conducted by the study's responsible physicians until delivery. At each visit, as per protocol, saliva and fecal samples will be collected and frozen at -80°C, and a 7 ml whole peripheral blood sample in EDTA will be collected and kept at room temperature. The blood will be centrifuged to separate plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Age \> 18 years
Singleton pregnancy Live fetus at 11-13 weeks of pregnancy Women identified as high-risk during first-trimester screening for preeclampsia and fetal growth restriction
**Label:** Case
#### Arm Group 2
**Description:** Low-risk pregnancies at first-trimester screening for preeclampsia and fetal growth restriction, which will undergo physiological monitoring in subsequent follow-up visits until delivery (homogeneous control sample).
**Label:** Control
### Outcomes Module
#### Primary Outcomes
**Description:** Identifying biomarkers useful for predicting different clinical phenotypes of preeclampsia that could assist in innovative preventive strategies and/or future therapeutic targets.
**Measure:** Identification of Biomarkers for Predicting Clinical Phenotypes of Preeclampsia: Implications for Innovative Preventive Strategies and Future Therapeutic Targets
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** Evaluation of microbiota changes in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction
**Measure:** Assessment of first trimester microbiota characteristics
**Time Frame:** through study completion, an average of 1 year
**Description:** Evaluation of metabolites in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction
**Measure:** Assessment of first trimester metaboloma characteristics
**Time Frame:** through study completion, an average of 1 year
**Description:** Evaluation of maternal immune cells in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction
**Measure:** Assessment of first trimester immune system characteristics
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \> 18 years
* Singleton pregnancy
* Live fetus at 11-13 weeks of gestation
* Women identified as high-risk during first-trimester screening for preeclampsia and subsequent low risk
* Written Informed Consent
Exclusion Criteria:
* Multiple pregnancy
* Pregnancy complicated by major fetal anomalies identified during the evaluation at 11-13 weeks gestation,
* Unconscious or severely ill women, women with learning difficulties, and severe psychiatric disorders,
* Age \<18 years
* - Women who will not have signed the informed consent for the study Women with HIV, HBV, HCV infection
* Women with a history of leukemia and lymphoma
* Women with immunodeficiency
* Women who have used corticosteroids or other immunosuppressants in the past 3 months
**Gender Based:** True
**Gender Description:** Pregnancy
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Women identified as high risk for developing preeclampsia from the first trimester of pregnancy will be offered the opportunity to participate in the study. To obtain a control sample, an equal number (1:1 ratio) of pregnant women identified as low risk during the first-trimester screening for preeclampsia and fetal growth restriction, and who will present physiological check-ups in subsequent follow-up visits until delivery, will also be invited to participate. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk.
Patients will be followed up according to a defined schedule, varying depending on the underlying condition, while high-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pieve Emanuele
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Silvia Giugliano, PhD
- **Phone:** +390282243190
- **Role:** CONTACT
***Contact 2:***
- **Name:** Silvia Giugliano, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Hunanitas University
**State:** Milan
**Status:** RECRUITING
**Zip:** 20072
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000046110
- Term: Hypertension, Pregnancy-Induced
- 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: HIGH
- As Found: Preeclampsia
- ID: M7633
- Name: Eclampsia
- Relevance: LOW
- As Found: Unknown
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M25635
- Name: Hypertension, Pregnancy-Induced
- 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: T2019
- Name: Eclampsia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011225
- Term: Pre-Eclampsia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430385
**Brief Title:** ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)
**Official Title:** A Phase 1-2, Double-Blind, Sham-Controlled Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Patients With MECP2 Duplication Syndrome
#### Organization Study ID Info
**ID:** ION440-CS1
#### Organization
**Class:** INDUSTRY
**Full Name:** Ionis Pharmaceuticals, Inc.
#### Secondary ID Infos
**ID:** 2023-507192-22
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2030-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ionis Pharmaceuticals, 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:** The primary purpose of this study is to evaluate the safety and tolerability of ION440.
**Detailed Description:** This is a phase 1-2 randomized, double-blind, sham-controlled, multiple-ascending dose (MAD) study to evaluate ION440 in pediatric and adult participants with MECP2 Duplication Syndrome (MDS) and will be conducted in two parts. During Part 1 (MAD) (36 weeks), participants will be randomized in a 3:1 ratio to receive ION440 or sham. Individuals who complete Part 1 may enter Part 2, an open label long-term extension study (LTE), where they will receive ION440 for up to approximately 156 weeks. Multiple dose cohorts (Dose A, Dose B, and Dose C) will be evaluated in the study.
All dosing cohorts will be further subdivided by age. Sub cohort A will include participants 8 years of age and older and sub cohort B will include participants 2 through 7 years of age. Dosing cohorts will be enrolled sequentially with sub cohort A initiating prior to sub cohort B.
### Conditions Module
**Conditions:**
- Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive ION440 intrathecally at Dose A during Part 1/MAD, followed by ION440 Dose A during Part 2/LTE.
**Intervention Names:**
- Drug: ION440
**Label:** Cohort 1: ION440 Dose A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive ION440 intrathecally at Dose B during Part 1/MAD, followed by ION440 Dose B during Part 2/LTE.
**Intervention Names:**
- Drug: ION440
**Label:** Cohort 2: ION440 Dose B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive ION440 intrathecally at Dose C during Part 1/MAD, followed by ION440 Dose C during Part 2/LTE.
**Intervention Names:**
- Drug: ION440
**Label:** Cohort 3: ION440 Dose C
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** During the Part 1/MAD period, a lumbar procedure (LP) will be performed at the same frequency as ION440 administration. Participants will not receive ITB injections during this period. It will be followed by the open-label Part 2/LTE period, where participants will receive ION440 at the same dose as their enrolled cohort (e.g. Dose A, Dose B or Dose C).
**Intervention Names:**
- Procedure: Sham procedure
**Label:** Sham Procedure
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1: ION440 Dose A
- Cohort 2: ION440 Dose B
- Cohort 3: ION440 Dose C
**Description:** ION440 will be administered by intrathecal bolus (ITB) injection.
**Name:** ION440
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Sham Procedure
**Description:** An LP will be performed with CSF collection but will not be followed by the administration of study treatment by ITB injection.
**Name:** Sham procedure
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
**Time Frame:** Up to approximately 36 weeks
**Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
**Time Frame:** Baseline up to approximately 36 weeks
**Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings
**Time Frame:** Baseline up to approximately 36 weeks
**Measure:** Part 1: Number of Participants With Clinically Significant Change from Baseline in Laboratory Assessments
**Time Frame:** Baseline up to approximately 36 weeks
**Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
**Time Frame:** Baseline up to approximately 36 weeks
**Measure:** Part 2: Number of Participants With TEAEs
**Time Frame:** Up to approximately 192 weeks
**Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
**Time Frame:** Baseline up to approximately 192 weeks
**Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings
**Time Frame:** Baseline up to approximately 192 weeks
**Measure:** Part 2: Number of Participants With Clinically Significant Change from Baseline in Laboratory Assessments
**Time Frame:** Baseline up to approximately 192 weeks
**Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in ECG
**Time Frame:** Baseline up to approximately 192 weeks
#### Secondary Outcomes
**Measure:** Part 1: Maximum Observed Concentration (Cmax) of ION440 in Plasma
**Time Frame:** Pre-dose and at multiple points post-dose up to Week 36
**Measure:** Part 1: Area Under the Concentration-time Curve (AUC) of ION440 in Plasma
**Time Frame:** Pre-dose and at multiple points post-dose up to Week 36
**Measure:** Part 1: Plasma Terminal Elimination Half-life (t½) of ION440
**Time Frame:** Pre-dose and at multiple points post-dose up to Week 36
**Measure:** Part 1: Trough Concentration (Ctrough) of ION440 in Plasma and CSF
**Time Frame:** Pre-dose and at multiple points post-dose up to Week 36
**Measure:** Part 1: Plasma Concentration of ION440
**Time Frame:** Pre-dose and at multiple points post-dose up to Week 36
**Measure:** Part 2: Trough Concentration (Ctrough) of ION440 in Plasma and CSF
**Time Frame:** Up to approximately 192 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria for Part 1:
1. Males age ≥ 2 years to ≤ 65 years old, depending on specific cohort and group, at the time of informed consent.
1. Group A: ≥ 8 to ≤ 65 years old
2. Group B: 2 to 7 years old, inclusive
2. Participant has at least one parent or caregiver ≥ 18 years old capable of providing informed consent (signed and dated), and able to attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol, and able to comply with all study requirements and activities,
3. Participant has a documented diagnosis of MDS, with genetic confirmation of MECP2 duplication
4. Is currently receiving stable doses of concomitant medications for at least 3 months prior to baseline. If recent changes (\< 3 months stable) in medications, the participant may be allowed per Investigator judgment in consult with Sponsor Medical Monitor.
5. Able to complete all study procedures, measurements and visits and caregiver/participant has adequately supportive psychosocial circumstances, in the opinion of the Investigator.
Exclusion criteria for Part 1:
1. Documented diagnosis of complex MECP2 duplications including terminal duplication and/or translocation or MECP2 triplication OR clinical features associated with complex variant structure including (a) onset of seizures prior to age 5 (for those age 5 and above at signing of ICF), (b) oxygen dependence, (c) microcephaly, IF MECP2 genetic structure information is unavailable.
2. Clinically significant vital sign or ECG abnormality at Screening \[including heart rate (HR) \< 45 beats per minute; systolic blood pressure \< 90 millimeters of mercury (mmHg); confirmed blood pressure readings \> 170/105 mmHg\]
3. Known brain or spinal disease that would interfere with the LP procedure, or CSF circulation or presence of other factors would affect the safety of the LP procedure.
4. Has any concomitant disease or condition or circumstance, or any finding at Screening that, in the opinion of the Investigator, makes the participant unsuitable for enrollment or that could interfere with the conduct of the study or that would pose an unacceptable risk to the participant in this study.
5. Treatment with an investigational drug, biological agent, or device within 30 days of Screening, or 5 half-lives of investigational agent, whichever is longer.
6. Previous treatment with an oligonucleotide (including siRNA) within 4 months of Screening if single dose received, or within 12 months of Screening if multiple doses received (this exclusion does not apply to vaccines - both mRNA and viral vector vaccines are allowed including COVID-19). For centrally administered ASOs, a minimum of 12 months washout is required irrespective of the number of doses received.
7. Currently enrolled in a clinical trial of an investigational agent or device or has used any investigational agent or device within 5 half-lives of investigational agent, whichever is longer.
8. Has a history of gene therapy or cell transplantation or any other experimental brain surgery.
9. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Baseline (Day 1).
10. Has experienced Status Epilepticus in the past 6 months.
Inclusion criteria for Part 2:
1. Completed ION440-CS1, Part 1/MAD. Completers are defined as participants who received at least one dose of Study Drug and attended all study visits through Follow Up.
2. All inclusion criteria in Part 1/MAD apply (participants will not be required to undergo new Screening bloodwork).
Exclusion criteria for Part 2:
1. Has developed any concomitant disease (e.g., gastrointestinal, renal, hepatic, endocrine, respiratory, or cardiovascular system disease) or condition or circumstance, or any finding during Part 1/MAD that, in the opinion of the Investigator, makes the participant unsuitable for continued treatment (e.g. could interfere with the conduct of the study or that would pose an unacceptable risk to the participant in this study).
**Gender Based:** True
**Gender Description:** Only males are included for this disease condition.
**Maximum Age:** 65 Years
**Minimum Age:** 2 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ionis Pharmaceuticals
**Phone:** (844) 779-1497
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000038901
- Term: Mental Retardation, X-Linked
- ID: D000008607
- Term: Intellectual Disability
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000040181
- Term: Genetic Diseases, X-Linked
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000020271
- Term: Heredodegenerative Disorders, Nervous System
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M18163
- Name: Rett Syndrome
- Relevance: HIGH
- As Found: Methyl CpG Binding Protein 2
- ID: M11589
- Name: Intellectual Disability
- Relevance: LOW
- As Found: Unknown
- ID: M24774
- Name: Mental Retardation, X-Linked
- 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: M24877
- Name: Genetic Diseases, X-Linked
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M22092
- Name: Heredodegenerative Disorders, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: T4987
- Name: Rett Syndrome
- Relevance: HIGH
- As Found: Methyl CpG Binding Protein 2
- ID: T3658
- Name: MECP2 Duplication Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015518
- Term: Rett Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430372
**Brief Title:** Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract
**Official Title:** Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
#### Organization Study ID Info
**ID:** NIR-II-ENDO
#### Organization
**Class:** OTHER
**Full Name:** Institute of Automation, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2026-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Automation, Chinese Academy of Sciences
#### Responsible Party
**Investigator Affiliation:** Institute of Automation, Chinese Academy of Sciences
**Investigator Full Name:** Zhenhua Hu
**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 study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. We are using a VEGF-A targeting fluorescent probe and a NIR-II fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye.
The main purposes of this study include:
1. To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
2. To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
3. To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.
### Conditions Module
**Conditions:**
- Gastrointestinal Carcinoma
- Dysplasia
- Gastrointestinal Polyp
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.
**Intervention Names:**
- Drug: Bev-ICG
- Device: NIR-II fluorescence endoscopy platform
**Label:** Bev-ICG NIR-II Endoscopy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bev-ICG NIR-II Endoscopy
**Description:** Probe targeting VEGF-A that is topically administrated during the endoscopy
**Name:** Bev-ICG
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Bev-ICG NIR-II Endoscopy
**Description:** An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy
**Name:** NIR-II fluorescence endoscopy platform
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Demonstrate the feasibility of using the NIR-II endoscope and VEGF-A targeting fluorescent probe to image abnormal tissues of the gastrointestinal tract.
**Measure:** Validation of NIR-II endoscope and probe targeting VEGF-A
**Time Frame:** During endoscopy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Known or suspected gastrointestinal lesions.
* Scheduled for a clinically-indicated endoscopy.
* Mentally competent person, 18 years or older.
* Approved to sign the informed consent.
* Adequate potential for follow-up.
Exclusion Criteria:
* Subjects with known allergy or negative reaction to ICG or derivatives.
* Undesirable function of heart, lung, kidney, or any other organs.
* Enrolled in other trials in the past 3 months.
* Pregnant or trying to conceive.
* Unable to tolerate an endoscopy.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* The researchers considered inappropriate to be included.
**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:** Lidan Fu
**Phone:** 17754927702
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lidan Fu
- **Phone:** 17754927702
- **Role:** CONTACT
**Country:** China
**Facility:** Lidan Fu
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100190
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M14011
- Name: Polyps
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M18681
- Name: Endothelial Growth Factors
- Relevance: LOW
- As Found: Unknown
- ID: M11900
- Name: Mitogens
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430359
**Acronym:** VARCUWIC
**Brief Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
**Official Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
#### Organization Study ID Info
**ID:** 69HCL23_1227
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations.
Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts.
Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency.
Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine.
There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine.
According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon.
The study would aim to find the period of the day best correlated with 24h urinary copper excretion
### Conditions Module
**Conditions:**
- Wilson Disease
**Keywords:**
- Wilson disease
- urinary copper
- chelator
### Design Module
#### Bio Spec
**Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine
**Intervention Names:**
- Diagnostic Test: urine and blood test
**Label:** Group 1 - DP
#### Arm Group 2
**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine
**Intervention Names:**
- Diagnostic Test: urine and blood test
**Label:** Group 2 - Trientine
#### Arm Group 3
**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc.
**Intervention Names:**
- Diagnostic Test: urine and blood test
**Label:** Group 3 - ZINC
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1 - DP
- Group 2 - Trientine
- Group 3 - ZINC
**Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment
**Name:** urine and blood test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).
**Measure:** Correlation factor
**Time Frame:** Two 24-hour urine recollection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
* Age ≥ 6 years and ≤70 years.
* Patient able to perform 24h urine.
* Current treatment with D-Pencillamine, Trientine or Zinc.
* Non-opposition of patient and/or legal representatives for minor patients.
Exclusion Criteria:
* Patients who had a change in treatment within the last 6 months before the inclusion
* Patients who have undergone liver transplantation
* Patients with known chronic renal failure (GFR \< 30 ml/min)
* Patients on long-term diuretic or corticosteroid therapy
* Persons deprived of liberty by a judicial or administrative decision
* Patient under judicial protection, unable to express consent
**Maximum Age:** 70 Years
**Minimum Age:** 6 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** - Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eduardo COUCHONNAL, Dr
**Phone:** 04 27 35 70 50
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Abdelouahed BELMALIH, PhD
**Phone:** 04 27 85 62 67
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bron
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Eduardo Couchonnal, Dr
- **Phone:** 04 27 35 70 50
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Abdelouahed BELMALIH, PhD
- **Phone:** 04 27 85 62 67
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
**State:** Rhone
**Zip:** 69500
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020739
- Term: Brain Diseases, Metabolic, Inborn
- ID: D000001928
- Term: Brain Diseases, Metabolic
- ID: D000009069
- Term: Movement Disorders
- ID: D000020271
- Term: Heredodegenerative Disorders, Nervous System
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000008664
- Term: Metal Metabolism, Inborn Errors
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9612
- Name: Hepatolenticular Degeneration
- Relevance: HIGH
- As Found: Wilson Disease
- ID: M11107
- Name: Liver 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: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- 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: M5205
- Name: Brain Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M22498
- Name: Brain Diseases, Metabolic, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M22092
- Name: Heredodegenerative Disorders, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M11644
- Name: Metal Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5933
- Name: Wilson Disease
- Relevance: HIGH
- As Found: Wilson Disease
### Condition Browse Module - Meshes
- ID: D000006527
- Term: Hepatolenticular Degeneration
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Mi
- Name: Mineral
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M5860
- Name: Chelating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M6523
- Name: Copper
- Relevance: LOW
- As Found: Unknown
- ID: M17018
- Name: Trientine
- Relevance: LOW
- As Found: Unknown
- ID: T338
- Name: Copper Supplement
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430346
**Brief Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer
**Official Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study
#### Organization Study ID Info
**ID:** MCC-23121
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2027-05
**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:** 2027-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** H. Lee Moffitt Cancer Center and Research Institute
#### 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 purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).
### Conditions Module
**Conditions:**
- Esophageal Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.
**Intervention Names:**
- Behavioral: Exercise
**Label:** Exercise prehabilitation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise prehabilitation
**Description:** Physical activity and resistance training
**Name:** Exercise
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The number of participants who complete T0 and T1 measures.
**Measure:** Retention
**Time Frame:** Up to 11 weeks
#### Secondary Outcomes
**Description:** The number of participants who demonstrate improvements in exploratory outcome measures.
**Measure:** Exploratory outcomes and changes
**Time Frame:** Up to 17 weeks
**Description:** Chi-square testing will be used to determine if there's a difference in perioperative outcomes between groups.
**Measure:** Clinical and treatment outcomes
**Time Frame:** Up to 17 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Biopsy-proven locoregional esophageal cancer (LEC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
* Ability to read and speak English
Exclusion Criteria:
* Regular engagement in resistance training (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely
* Numeric pain rating scale of 7 or more out of 10
* Myopathic or rheumatologic disease that impacts physical function
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nathan Parker, PhD
**Phone:** 813-745-6849
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nathan Parker, PhD
- **Phone:** 813-745-0527
- **Role:** CONTACT
***Contact 2:***
- **Name:** Nathan Parker, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Jose Pimiento, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Moffitt Cancer Center
**State:** Florida
**Zip:** 33612
#### Overall Officials
**Official 1:**
**Affiliation:** Moffitt Cancer Center
**Name:** Nathan Parker, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: 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: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- 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: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430333
**Acronym:** STRIDE P
**Brief Title:** Sleep to Reduce Incident Depression Effectively in Peripartum
**Official Title:** Sleep to Reduce Incident Depression Effectively in Peripartum
#### Organization Study ID Info
**ID:** STRIDE P
#### Organization
**Class:** OTHER
**Full Name:** Henry Ford Health System
### Status Module
#### Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-10-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Henry Ford Health System
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.
**Detailed Description:** Perinatal depression (PND) affects nearly 20% of pregnant and postpartum women, with estimates soaring above 30% during the COVID-19 pandemic. Prospective data show insomnia often precedes PND incidence and relapse cases by more than doubling risk for major depression. This is highly relevant to a large segment of the pregnant population as \~20% of women meet diagnostic criteria for insomnia disorder by the end of pregnancy. Fortunately, insomnia is a modifiable risk factor for PND, and insomnia may serve as an entry point to prevent PND incidence and relapse. Our team has identified cognitive arousal as a promising candidate factor for alleviating insomnia and preventing depression via insomnia therapy. Indeed, undertreatment of cognitive arousal in pregnancy is associated with insomnia non-remission and continued depression after therapy. Moreover, patient stakeholders identify 'calming a busy mind at night' as a critical target for improving sleep during pregnancy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, we developed Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). PUMAS places behavioral sleep strategies within a mindfulness intervention framework to develop an insomnia therapy specifically for pregnant women: RCT data show that PUMAS yields large effects on insomnia, depression, and cognitive arousal.
This study is a hybrid effectiveness-implementation RCT of 500 women with DSM-5 insomnia disorder (without PND) who are randomized to PUMAS or treatment-as-usual. We will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. We will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context.
### Conditions Module
**Conditions:**
- Insomnia
- Depression
**Keywords:**
- pregnancy
- postpartum
- sleep
- worry
- rumination
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** PUMAS is a clinician-administered psychotherapy intervention for prenatal insomnia that includes six weekly 60-minute sessions in an individual format. PUMAS combines behavioral sleep strategies with mindfulness exercises and tailors all components to pregnancy to improve sleep quality. PUMAS will be delivered via telemedicine video.
**Intervention Names:**
- Behavioral: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
**Label:** Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** TAU reflects real-world care where patients and their providers make their own treatment decisions for treating prenatal insomnia. Common TAU options include over-the-counter sleep aids, sleep hygiene education, melatonin, and cognitive-behavioral therapy for insomnia. The TAU group will be well-characterized (i.e., we will monitor interventions administered by the usual care providers and collect information on dosage, frequency, duration, adherence) to best describe treatment options sought and completed in the real world.
**Intervention Names:**
- Other: Treatment-as-usual (TAU)
**Label:** Treatment-as-usual (TAU)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
**Description:** Mindfulness-based sleep program for pregnant women.
**Name:** Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Treatment-as-usual (TAU)
**Description:** Usual practices from real-world care experiences.
**Name:** Treatment-as-usual (TAU)
**Other Names:**
- Usual care practice
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Insomnia Severity Index is a commonly used self-report measure of insomnia symptoms that has been validated in peripartum. ISI scores range from 0 to 28 with higher scores indicating greater insomnia severity.
**Measure:** Insomnia effectiveness
**Time Frame:** We will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly across the first postpartum year.
**Description:** The Edinburgh Postnatal Depression Scale (EDPS) is the most widely use depression measure in pregnancy and postpartum. EPDS scores range from 0 to 30 with higher scores indicating greater depression severity.
**Measure:** Depression prevention
**Time Frame:** We will examine onset of major depression (EPDS scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly across the first postpartum year.
#### Secondary Outcomes
**Description:** The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in peripartum. PSASC scores range 8 to 40 with higHEr scores indicating greater pre-sleep cognitive arousal.
**Measure:** Pre-sleep cognitive arousal
**Time Frame:** We will examine change in PSASC from pretreatment to posttreatment (8 weeks later).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Singleton pregnancy, gestational week 14-31 at screening.
2. DSM-5 Insomnia Disorder (≥1 month duration).
3. Insomnia Severity Index (ISI) score ≥ 11.
4. Edinburgh Postnatal Depression Scale score\<13 at screening.
5. No current DSM-5 Major Depression.
6. Reliable internet access for treatment and assessments.
7. Not currently engaged in therapy for major depression or insomnia disorder.
Exclusion Criteria:
1. High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).
2. Active suicidal intent.
3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
4. Untreated RLS (treated RLS is OK).
5. Excessive daytime sleepiness; Epworth Sleepiness Scale\>15.
6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David A Kalmbach, PhD
**Phone:** 248-325-3938
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christopher L Drake, PhD
**Phone:** 248-344-6672
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Novi
**Country:** United States
**Facility:** Henry Ford Medical Center
**State:** Michigan
**Zip:** 48377
#### Overall Officials
**Official 1:**
**Affiliation:** Henry Ford Health
**Name:** David A Kalmbach, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** N/A - We do not plan to share individual participant data to other researchers.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M2062
- Name: Rumination Syndrome
- Relevance: LOW
- As Found: Unknown
- 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: T5077
- Name: Rumination Disorder
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AAll
- Name: Anti-Allergic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M11533
- Name: Melatonin
- Relevance: LOW
- As Found: Unknown
- ID: M7338
- Name: Diphenhydramine
- Relevance: LOW
- As Found: Unknown
- ID: M14268
- Name: Promethazine
- Relevance: LOW
- As Found: Unknown
- ID: T410
- Name: Melatonin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430320
**Acronym:** ALOFT
**Brief Title:** Ascertaining Longterm Outcomes of Fibroid Treatments
**Official Title:** Long Term Effectiveness of Uterine Sparing Fibroid Treatments
#### Organization Study ID Info
**ID:** R9NXPE2GTCN9
#### Organization
**Class:** OTHER
**Full Name:** Henry Ford Health System
### Status Module
#### Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Mayo Clinic
**Class:** OTHER
**Name:** University of California, San Francisco
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Lead Sponsor
**Class:** OTHER
**Name:** Henry Ford Health System
#### 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 the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).
The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.
Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.
The study's analyses will focus on comparisons of primary and secondary outcomes among women.
### Conditions Module
**Conditions:**
- Uterine Fibroid
**Keywords:**
- Uterine fibroid treatment
- Multi-center, prospective, observational cohort study
- Uterine-sparing treatment procedures
- Patient-reported outcomes
- Quality of life
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 700
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** NA- no intervention
**Name:** NA- no intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The need for another uterine fibroid treatment procedure
**Measure:** Time to treatment failure
**Time Frame:** Up to 12 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
* Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Exclusion Criteria:
* Individuals who were not consented into the original COMPARE-UF or ULTRA study
* Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
**Gender Based:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants who were previously enrolled in either the COMPARE-UF or ULTRA study
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Francisco
**Country:** United States
**Facility:** University of California San Francisco
**State:** California
**Zip:** 94143
**Location 2:**
**City:** Detroit
**Country:** United States
**Facility:** Henry Ford Health
**State:** Michigan
**Zip:** 48202
**Location 3:**
**City:** Rochester
**Country:** United States
**Facility:** Mayo Clinic
**State:** Minnesota
**Zip:** 55905
**Location 4:**
**City:** Chapel Hill
**Country:** United States
**Facility:** The University of North Carolina at Chapel Hill
**State:** North Carolina
**Zip:** 27514
#### Overall Officials
**Official 1:**
**Affiliation:** Henry Ford Health
**Name:** Ganesa Wegienka, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** ALOFT study landing page
**URL:** https://www.henryford.com/hcp/research/aloft-study
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009379
- Term: Neoplasms, Muscle Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009372
- Term: Neoplasms, Connective Tissue
- ID: D000003240
- Term: Connective Tissue Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Fibroids
- ID: M25846
- Name: Myofibroma
- Relevance: HIGH
- As Found: Fibroids
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12317
- Name: Neoplasms, Connective Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007889
- Term: Leiomyoma
- ID: D000047708
- Term: Myofibroma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430307
**Brief Title:** Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism
**Official Title:** A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism
#### Organization Study ID Info
**ID:** 2022014P7A01
#### Organization
**Class:** OTHER
**Full Name:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Quan Jiang
#### Responsible Party
**Investigator Affiliation:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences
**Investigator Full Name:** Quan Jiang
**Investigator Title:** chief physician
**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 is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism.
### Conditions Module
**Conditions:**
- Postpartum Rheumatism
**Keywords:**
- Saussurea Involucrata Liquid Tonic
- Traditional Chinese Medicine
- Postpartum Rheumatism
### 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:** 128
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.
**Intervention Names:**
- Drug: Saussurea Involucrata Liquid Tonic
**Label:** Saussurea Involucrata Liquid Tonic
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** placebo of Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.
**Intervention Names:**
- Drug: Saussurea Involucrata Liquid Tonic
**Label:** placebo of Saussurea Involucrata Liquid Tonic
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Saussurea Involucrata Liquid Tonic
- placebo of Saussurea Involucrata Liquid Tonic
**Description:** This product is a single preparation of Saussurea Involucrata Liquid Tonic. It is used for rheumatoid arthritis, rheumatoid arthritis and dysmenorrhea caused by insufficient kidney yang and cold-damp stasis.
**Name:** Saussurea Involucrata Liquid Tonic
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.
**Measure:** VAS (visual analog scale)
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** the MOS item short from health survey, SF-36
**Measure:** SF-36
**Time Frame:** 8 weeks
**Description:** Hospital Anxiety and Depression Scale
**Measure:** HADS
**Time Frame:** 8 weeks
**Description:** Stanford Health Assessment Questionnaire
**Measure:** HAQ
**Time Frame:** 8 weeks
**Description:** Visual Analogue Score
**Measure:** VAS
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations
* Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome.
* Age 18-50
* Pain VAS score ≥4cm
Exclusion Criteria:
* Those in the puerperium (within 42 days after delivery).
* Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy.
* Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count \< 3.0×109/L, or hemoglobin \< 90 g/L, or platelet count \< 100.0×109/L in routine blood examination
* Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc.
* Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks.
* Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution.
* Existing or past history of cancer.
* Those who have participated in other clinical drug studies in the past 2 months.
* Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: HIGH
- As Found: Rheumatism
- ID: M6323
- Name: Collagen Diseases
- Relevance: HIGH
- As Found: Rheumatism
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000003095
- Term: Collagen Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430294
**Brief Title:** Caracteristics of Pediatric Spinal Mobilizations
**Official Title:** Force-time Characteristics of Spinal Mobilizations Delivered on Pediatric Manikins
#### Organization Study ID Info
**ID:** UQTR_IP_SIMULATIONS_2024
#### Organization
**Class:** OTHER
**Full Name:** Université du Québec à Trois-Rivières
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Université du Québec à Trois-Rivières
#### Responsible Party
**Investigator Affiliation:** Université du Québec à Trois-Rivières
**Investigator Full Name:** Isabelle Pagé
**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:** This observational study aims to create simulations using pediatric manikins to teach pediatric spinal mobilizations. We'll measure the force and duration of spinal mobilizations applied by chiropractors on pediatric manikins. Another objective is to gather feedback from both students and teachers on the effectiveness of using manikins for teaching.
The main questions it aims to answer are:
1. How much force and for how long do chiropractors apply spinal mobilizations on pediatric manikins?
**Detailed Description:** This project aims to initiate the development of low-fidelity simulations to enhance the learning of skills associated with performing pediatric spinal mobilizations. This will be achieved by gathering target values for the force and duration of spinal mobilizations performed by chiropractors on pediatric manikins.
### Conditions Module
**Conditions:**
- Spinal Mobilization
**Keywords:**
- Chiropractic
- Pediatric
- Simulations
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Chiropractors will perform spinal mobilizations on three different pediatric-sized manikins while a sensor will measure the force and time parameters used.
**Intervention Names:**
- Other: Spinal mobilisation
**Label:** Participants
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants
**Description:** Application of a force on pediatric manikins.
**Name:** Spinal mobilisation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The spinal mobilization will be delivered on a force sensor (Loadpad(R)) that will measured the force-time characteristics. The peak force reached during the therapy will be extracted.
**Measure:** Peak force (N) reached during the spinal mobilization measured by a force sensor
**Time Frame:** During the spinal mobilization
**Description:** The spinal mobilization will be delivered on a force sensor (Loadpad(R)) that will measured the force-time characteristics. The duration of the therapy will be extracted.
**Measure:** Duration (s) of spinal mobilization measured by a force sensor
**Time Frame:** During the spinal mobilization
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being a chiropractor in private practice and a member of the Ordre des chiropraticiens du Québec
Exclusion Criteria:
* Not been able to perform pediatric spinal mobilizations
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Licensed chiropractors
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isabelle Pagé, DC, PhD
**Phone:** 819-376-5011
**Phone Ext:** 3885
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Trois-Rivières
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Isabelle Pagé, DC, PhD
- **Phone:** 819-376-5011
- **Phone Ext:** 3885
- **Role:** CONTACT
**Country:** Canada
**Facility:** Université Québec à Trois-Rivières
**State:** Quebec
**Status:** RECRUITING
**Zip:** G8Z4M3
#### Overall Officials
**Official 1:**
**Affiliation:** Université du Québec à Trois-Rivières
**Name:** Isabelle Pagé, DC, 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:** NCT06430281
**Brief Title:** Manual Therapy Force Perception Scale
**Official Title:** Development and Pre-testing of a Manual Therapy Force Perception Scale
#### Organization Study ID Info
**ID:** UQTR_IP_EchelleTM_2024
#### Organization
**Class:** OTHER
**Full Name:** Université du Québec à Trois-Rivières
### Status Module
#### Completion Date
**Date:** 2024-07-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Université du Québec à Trois-Rivières
#### Responsible Party
**Investigator Affiliation:** Université du Québec à Trois-Rivières
**Investigator Full Name:** Isabelle Pagé
**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 objective of this observational study is to pilot a scale designed to assist clinicians in evaluating the force they perceive during manual therapy.
The main question it aims to answer is:
- Are clinicians able to evaluate the force they use when delivering manual therapies to their patients using a scale?
For the pilot test, licensed chiropractors administer manual therapies on a manikin.
**Detailed Description:** The aim of this observational study is to pilot test an ordinal scale (the Manual Therapy Force Perception \[MTFP\] scale) intended to enable clinicians to assign ordinal rankings to their patients based on their perception of the force they applied during manual therapy . This involved evaluating the agreement between the force applied by clinicians during spinal manipulations and mobilizations delivered on a manikin and their subjective perception of force, as determined using the MTFP scale. Additionally, the pilot study aimed to seek feedback on the MTFP scale from clinicians who are its potential users.
### Conditions Module
**Conditions:**
- Manual Therapy
**Keywords:**
- Chiropractic
- Spinal mobilization
- Spinal manipulation
- force sensor
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Chiropractors will administer manual therapies on a manikin utilizing three distinct levels of force (typical force, low force, high force), determined by the trial label on the scale. A sensor will gauge the magnitude of force applied.
**Intervention Names:**
- Other: Manual therapy
**Label:** Participants
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants
**Description:** A manual force will be applied to a manikin positioned on a chiropractic treatment table. The force exerted during the manual therapy must align with the trial label indicated on the Manual Therapy Force Perception \[MTFP\] scale.
**Name:** Manual therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The therapy will be delivered on a force sensor (Loadpad(R)) which will measured the force applied. The peak force reached during the therapy will be extracted.
**Measure:** Peak force measured by a force sensor during the manual therapy
**Time Frame:** During the manual therapy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Licensed chiropractors with a private practice within the province of Quebec, Canada.
Exclusion Criteria:
* Having a condition that prevents the execution of approximately 50 manual therapies over a 1-hour period.
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Licensed chiropractors
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isabelle Pagé, DC, PhD
**Phone:** 819-376-5011
**Phone Ext:** 3885
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Trois-Rivières
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Isabelle Pagé, DC, PhD
- **Phone:** 819-376-5011
- **Phone Ext:** 3885
- **Role:** CONTACT
***Contact 2:***
- **Name:** Isabelle Pagé, DC, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** Université du Québec à Trois-Rivières
**State:** Quebec
**Status:** RECRUITING
**Zip:** G8Z 4M3
#### Overall Officials
**Official 1:**
**Affiliation:** Université du Québec à Trois-Rivières
**Name:** Isabelle Pagé, DC, 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:** NCT06430268
**Brief Title:** Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants
**Official Title:** Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants: A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** STUDY23100029
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Association for Dental Infection Control
#### Lead Sponsor
**Class:** OTHER
**Name:** Andrea Ravida
#### Responsible Party
**Investigator Affiliation:** University of Pittsburgh
**Investigator Full Name:** Andrea Ravida
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used in the non-surgical and surgical setting, followed by implant removal. Then, in-vitro analysis to assess the efficacy of surface decontamination will be performed.
**Detailed Description:** A screening visit will be performed to determine the elegibility of the individuals to participate in the study. Information related to the target implant (e.g., brand, material, surface, dimensions, time of function, history of treatment of peri-implantitis) and reconstruction (e.g., cemented or screwed prosthesis, single, multi-unit or full-arch) will be collected. Intra-oral radiographs will be obtained or exported from patients' dental records, and the marginal bone level (MBL) will be measured at the mesial and distal aspects of the implants by one calibrated investigator using an image analysis software (Image J; National Institutes of Health, Bethesda, MD, USA). The anatomy of the bone defect will be determined.
Randomization will be performed in a stratified manner, in sets of 10 implants, by a computer software, to obtain equally balanced groups based on implant characteristics (site, brand, design). A researcher not involved in the clinical interventions will be responsible for randomization.
At the day of implant removal, a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe: (1) Plaque accumulation, using the modified plaque index \[mPI\]; (2) Probing depth (mm); (3) Bleeding on probing, using the modified gingival index \[mGI\] ; (4) Suppuration; (5) Recession (mm). The width of keratinized mucosa (KM) will be obtained in the mid-buccal and mid-lingal aspect of the implants (mm). A standard tessellation language (STL) file of the arch of interest using an intraoral optical scanner (Trios 3, 3Shape, Denmark) will be obtained.
Surface decontamination protocols:
All cleaning procedures will be performed without the suprastructures. A notch will be performed on the buccal side of all implant shoulders with the aid of a bur, in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases.
Following local anesthesia, implants will be randomly assigned to the following study groups:
1. Non-surgical decontamination with titanium curettes prior to implant removal (n = 20);
2. Non-surgical decontamination with erythritol powder prior to implant removal (n = 20);
3. Surgical decontamination with titanium curettes prior to implant removal (n = 20);
4. Surgical decontamination with erythritol powder prior to implant removal (n = 20);
5. No decontamination prior to implant removal (n=10).
In the surgical groups, intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.
All giant (visible) calculus will be removed with an ultrasonic tip in advance, without touching the implant surface directly. Copious irrigation with saline will be performed in both groups prior to implant decontamination. All implants will be cleaned by the same operator with the aid of dental surgical loupes. The time needed for the operator to consider the implant surface clean will be recorded.
* Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants.
* Air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) will be carried out with AIR-FLOW powder PLUS (EMS) containing erythritol (sugar alcohol, 14 μm), amorphous silica and 0.3% chlorhexidine. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water.
* Non-surgical group: The supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant.
* Surgical group: The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned.
Implant removal:
Once the decontamination procedure has been completed, all the implants will be explanted with the aid of a reverse torque device (Implant Removal Kit; Zimmer Biomet); no trephines will be used. During the procedure, care will be taken to avoid damage to the implant and its surface. The retrieved implants will be immersed in a transport medium (Dulbecco's Modified Eagle Medium) and stored in sterile plastic vials at 4°C until further analysis.
In all study groups, the explanted sites will be again curetted and the soft tissues will be sutured with interrupted or crossed sutures. Subjects will receive detailed verbal and written postoperative instructions, as well as a prescription for anti-inflammatory medication (ibuprofen \[600mg\], for 3-5 days, as needed for pain control). Patients will be instructed to rinse gently with 0.12% chlorhexidine twice daily for 1 week. Sutures will be removed after 2 weeks.
Subsequently, a second randomization will take place to direct each implant (n = 10 in each decontamination group) for microbiological/elementary composition analysis and biocompatibility analysis. In-vitro analysis post surface decontamination includes assessing the cleaning efficacy, microbiological analysis, biocompatibility analysis including cultivation of cells, RNA extraction, Reverse Transcription (RT) and Real-Time RT-Polymerase Chain Reaction (Real-Time RT-PCR) , and elementary composition analysis including implant surface degradation, corrosion performance and atomic composition.
### Conditions Module
**Conditions:**
- Peri-Implantitis
- Dental Implant Failed
**Keywords:**
- Peri-implantitis
- Decontamination
- Implant Surface
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation.
**Intervention Names:**
- Procedure: implant decontamination with titanium curette
**Label:** Non-surgical decontamination with titanium curettes followed by explantation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Without any flap elevation, the supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant.
**Intervention Names:**
- Device: implant decontamination with Air-Flow device
**Label:** : Non-surgical decontamination with erythritol powder prior to implant removal
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants
**Intervention Names:**
- Procedure: implant decontamination with titanium curette
**Label:** Surgical decontamination with titanium curettes prior to implant removal
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned.
**Intervention Names:**
- Device: implant decontamination with Air-Flow device
**Label:** Surgical decontamination with erythritol powder prior to implant removal
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** No decontamination will be performed on implants in this group.
**Label:** No decontamination prior to implant removal
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Non-surgical decontamination with titanium curettes followed by explantation
- Surgical decontamination with titanium curettes prior to implant removal
**Description:** Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation.
**Name:** implant decontamination with titanium curette
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- : Non-surgical decontamination with erythritol powder prior to implant removal
- Surgical decontamination with erythritol powder prior to implant removal
**Description:** Air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) will be carried out with AIR-FLOW powder PLUS (EMS) containing erythritol (sugar alcohol, 14 μm), amorphous silica and 0.3% chlorhexidine to decontaminate implants with and without flap elevation. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water.
**Name:** implant decontamination with Air-Flow device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The cleaned surface area will be planimetrically recorded, and the percentage presence/absence of mineralized deposits as well as scratches on the decontaminated implant surfaces will be determined with the aid of a stereomicroscope.
**Measure:** Percentage of clean implant surface area following implant decontamination approaches
**Time Frame:** Right after decontamination and implant removal (T0)
#### Secondary Outcomes
**Description:** Shotgun metagenomic sequencing will be used to identify the bacterial composition in the residual biofilms.
**Measure:** Bacterial composition of the implants
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** Cultivation of osteoblastic cells will be performed and assessed on the implants.
**Measure:** Biocompatibility analysis of the implant
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** SEM images of the surfaces of negative control implants (brand new) and treated implants for each decontamination method will be exemplarily taken after instrumentation and cell culture.
**Measure:** Scanning electron microscopy analysis of the cells and residual bacterial deposits
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** Patients will be asked to fill out a questionnaire.
**Measure:** Patient satisfaction with the decontamination devices
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** Incidence of complications will be recorded by the clinician performing the intervention.
**Measure:** Incidence of complications
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** Three-dimensional images and roughness line profiles will be acquired by laser scanning confocal microscopy.
**Measure:** Implant surface degradation
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** In vitro electrochemical tests will be conducted to determine the corrosion performance.
**Measure:** Corrosion performance
**Time Frame:** Right after decontamination and implant removal (T0)
**Description:** The atomic composition of the surface of the decontaminated implants will be examined using energy-dispersive x-ray spectroscopy (EDS).
**Measure:** Atomic composition of the implants after removal
**Time Frame:** Right after decontamination and implant removal (T0)
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria: (1) Adult individuals between 18 and 80 years of age who require the explantation of at least one titanium or titanium alloy implant due to severe peri-implantitis (\> 50% bone loss and signs of inflammation); (2) Individuals who did not undergo surgical or non-surgical peri-implant therapy in the previous 6 months.
Exclusion criteria: (1) Acute infection associated with adjacent teeth; (2) Any technical complication that does not allow implant removal using a reverse torque device; (3) Active infectious diseases of any kind; (4) Medical conditions which requires premedication prior to dental treatments/visits; (5) Pregnant women or planning to become pregnant (self-reported); (6) History of radiotherapy in the head and neck or chemotherapy in the last 3 years; (7) Any other diseases or medications that may contraindicate the surgical procedure or compromise wound healing.
**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:** Andrea Ravida, DDS MS PhD
**Phone:** (734) 730-9678
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Carla Sanchez, MS
**Phone:** (412) 624-1179
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pittsburgh
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Andrea Ravida, DDS,MSc, PhD
- **Phone:** 734-730-9678
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Pittsburgh, School of Dental Medicine
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 15213
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pittsburgh
**Name:** Andrea Ravida, DDS MS PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M28893
- Name: Peri-Implantitis
- Relevance: HIGH
- As Found: Peri-implantitis
- 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: D000057873
- Term: Peri-Implantitis
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M5953
- Name: Chlorhexidine
- Relevance: LOW
- As Found: Unknown
- ID: M344731
- Name: Chlorhexidine gluconate
- Relevance: LOW
- As Found: Unknown
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M8050
- Name: Erythritol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430255
**Brief Title:** Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain
**Official Title:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** 24-1243
#### Organization
**Class:** OTHER
**Full Name:** Taif University
### Status Module
#### Completion Date
**Date:** 2024-06-25
**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:** 2024-06-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Taif University
#### Responsible Party
**Investigator Affiliation:** Taif University
**Investigator Full Name:** Alaa Saleh Baboor
**Investigator Title:** Physical Therapist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain
**Detailed Description:** The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program. The primary outcomes will be pain intensity, disability, and fingertip to floor test. The secondary outcomes will be pain catastrophizing, kinesiophobia and depression.
### Conditions Module
**Conditions:**
- Pain, Back
### 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:** is a physical therapy method developed in France by Philippe-Emmanuel Souchard. This therapy method is founded on an integrated concept of the muscular system, which is composed of muscle chains. These muscle chains are susceptible to shortening as a result of constitutional, behavioral, and psychological factors, Patients allocated to this group will be having a GPR method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of 3 therapeutic postures, lying, sitting, or standing, to be held for 15-20 minutes each. The postures used are considered the most effective in lengthening the posterior chain, which is usually shortened in patients with LBP.
**Intervention Names:**
- Other: Global Postural Re-education
**Label:** Global Postural Re-education
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients allocated to this group will be having a LGSE method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of lumbar movement control exercises. The physiotherapist responsible for the intervention corrected each participant individually as required when performing the movement control exercises to ensure the correct technique. The exercises is progress from the supine position through to standing, 4-point kneeling. The program consists of 8 exercises first starting with abdominal-diaphragmatic breathing and isolated contraction of the transversus abdominis contractions of 10 seconds' duration 5 repetition, Abdominal preparation, Pelvic elevation with previous transversus abdominis contraction and neutral pelvis,
**Intervention Names:**
- Other: Laser-guided Supervised Exercise
**Label:** Laser-guided Supervised Exercise
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Global Postural Re-education
**Description:** Program for treatment
**Name:** Global Postural Re-education
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Laser-guided Supervised Exercise
**Description:** Program for treatment
**Name:** Laser-guided Supervised Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain")
**Measure:** Pain intensity
**Time Frame:** One month
**Description:** modified Oswestry Low Back Pain Disability (ODI) questionnaire Each part has six statements rated from 0 (least difficult to accomplish action) to 5 (most difficult) The overall score goes from 0 to 50 (the greatest impairment) In individuals with LBP
**Measure:** Disability
**Time Frame:** 7 weeks
**Description:** excellent metric properties for LBP
**Measure:** Fingertip-to-floor test
**Time Frame:** 7 weeks
#### Secondary Outcomes
**Description:** will be used to measure pain catastrophizing. Scores range from 0 (never) to 4 (always) for each item (total score = 0-52). Higher ratings reflect more catastrophizing of pain
**Measure:** Pain catastrophizing
**Time Frame:** One month
**Description:** will be assessed using the 11 items that make up the TSK-11. The overall score is between 11 and 44 points. A higher score indicates a greater fear of discomfort, movement, and harm.
**Measure:** Kinesiophobia
**Time Frame:** One month
**Description:** Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-administered 9-item questionnaire with four statements ranging from 0 (not at all) to 3 (nearly every day) for each item. A higher total score (20-27) suggests that the patient is suffering from severe depression.
**Measure:** Depression
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 18 and 45 years.
* Diagnosed with NSLBP.
* Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS).
Exclusion Criteria:
* Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems).
* Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders).
* Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome)
* Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program.
* With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum).
* Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alaa Baboor
**Phone:** 966596628155
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ibrahim Alkayshan
**Phone:** 966501272615
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Taif University
**Name:** Hosam Alzahrani, Dr
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Pain, Back
- 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
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- 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:** NCT06430242
**Brief Title:** Tele-rehabilitation in Knee Osteo Arthritis
**Official Title:** Role of Tele-rehabilitation in Elderly Women With Locomotor Disabilities Due to Knee Osteo Arthritis
#### Organization Study ID Info
**ID:** RHPT-01
#### Organization
**Class:** OTHER
**Full Name:** Prince Sattam Bin Abdulaziz University
### Status Module
#### Completion Date
**Date:** 2024-04-20
**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:** 2024-04-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-28
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Prince Sattam Bin Abdulaziz University
#### Responsible Party
**Investigator Affiliation:** Prince Sattam Bin Abdulaziz University
**Investigator Full Name:** Gopal Nambi
**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:** Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength. OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients.
**Detailed Description:** Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage, progresses with disruption of chondrocyte responses and results in tissue destruction. In OA, primary involvement is seen in the articular cartilage, and progressive damage occurs. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength.
OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The lack of professional supervision and feedback will result in reduced participation in continuing OA medical or rehabilitative services, which in turn will reduce the effectiveness of OA treatments.
With the development of telemedicine, it has been determined that patients living in remote areas have the chance to communicate with professional physicians simultaneously. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients. Internet- based rehabilitation is one of the effective strategies in telerehabilitation. The use of the internet to provide health-related interventions has the potential to reduce the cost of treatment and improve user satisfaction.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
**Keywords:**
- Knee
- Osteoarthritis
- Locomotor
- Disability
- Female
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 56
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months and the treatment will be monitored.
**Intervention Names:**
- Device: Tele rehabilitation
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week.
**Intervention Names:**
- Other: Exercise
**Label:** Group B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** In the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months.
**Name:** Tele rehabilitation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Group B
**Description:** Participants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week.
**Name:** Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Which was measured by 10 cm visual analogue scale
**Measure:** Pain intensity
**Time Frame:** Baseline
**Description:** Which was measured by 10 cm visual analogue scale
**Measure:** Pain intensity
**Time Frame:** 2 months
**Description:** Which was measured by 10 cm visual analogue scale
**Measure:** Pain intensity
**Time Frame:** After 6 months
#### Secondary Outcomes
**Description:** Which was measured by WOMAC questionnaire
**Measure:** Functional disability
**Time Frame:** Baseline
**Description:** Which was measured by WOMAC questionnaire
**Measure:** Functional disability
**Time Frame:** 2 months
**Description:** Which was measured by WOMAC questionnaire
**Measure:** Functional disability
**Time Frame:** 6 months
**Description:** Which was measured in meters/ second
**Measure:** Gait velocity
**Time Frame:** Baseline
**Description:** Which was measured in meters/ second
**Measure:** Gait velocity
**Time Frame:** 2 months
**Description:** Which was measured in meters/ second
**Measure:** Gait velocity
**Time Frame:** 6 months
**Description:** Which was measured in meters
**Measure:** Step length
**Time Frame:** Baseline
**Description:** Which was measured in meters
**Measure:** Step length
**Time Frame:** 2 months
**Description:** Which was measured in meters
**Measure:** Step length
**Time Frame:** 6 months
**Description:** Which was measured in number of steps per minute
**Measure:** Cadence
**Time Frame:** Baseline
**Description:** Which was measured in number of steps per minute
**Measure:** Cadence
**Time Frame:** 2 months
**Description:** Which was measured in number of steps per minute
**Measure:** Cadence
**Time Frame:** 6 months
**Description:** Which was measured with KOOS questionnaire
**Measure:** Quality
**Time Frame:** Baseline
**Description:** Which was measured with KOOS questionnaire
**Measure:** Quality
**Time Frame:** 2 months
**Description:** Which was measured with KOOS questionnaire
**Measure:** Quality
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients diagnosed with mild to moderate OA by their physicians.
* Female in the age range of 45 - 65 years.
* Volunteer to participate in the study.
* Living independently.
* Being able to walk without using an assistive device.
* Owning a mobile phone, tablet, or computer with an internet connection.
* Being able to use the device without assistance.
Exclusion Criteria:
* Having been diagnosed with any other systemic rheumatic diseases.
* Having been involved in a physiotherapy and rehabilitation program in any health institution in the last 6 months,
* Having knee-related surgery,
* Having meniscal or ligament-associated tears occurred in the past 6 months,
* Having a history of falling more than 2 times in the last 6 months,
* Having a history of knee injection in the last 4 weeks or scheduled in the next 8 week,
* Being illiterate, having cognitive problems, having blurred vision problem, and having hearing loss.
**Gender Based:** True
**Gender Description:** Female participants in the age range of 45 - 65 years.
**Maximum Age:** 65 Years
**Minimum Age:** 45 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Al Kharj
**Country:** Saudi Arabia
**Facility:** Gopal Nambi
**State:** Riyadh
**Zip:** 11942
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteo Arthritis
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteo Arthritis
- ID: M4476
- Name: Arthritis
- 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: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430229
**Brief Title:** Atelectasis Frequency in Different Ventilation Modes
**Official Title:** Evaluation of Atelectasis Frequency in Different Ventilation Modes Used in General Anesthesia in Children With Lung Ultrasonography
#### Organization Study ID Info
**ID:** AEŞH-BADEK-2024-152
#### Organization
**Class:** OTHER_GOV
**Full Name:** Ankara Etlik City Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Ankara Etlik City Hospital
#### Responsible Party
**Investigator Affiliation:** Ankara Etlik City Hospital
**Investigator Full Name:** Ahmet Aras
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** General anesthesia is characterized by temporary loss of consciousness and decreased reflex activity without any change in vital functions. It can be performed with intravenous and/or inhalation agents. During general anesthesia, breathing is stopped and respiratory support is provided to patients with various respiratory equipment and ventilation modes on the anesthesia device. The most commonly used ventilation modes during anesthesia are volume controlled (VCV) and pressure controlled (PCV). In pressure-controlled ventilation, ventilation is provided with the airway pressure determined by the anesthesiologist throughout inspiration. While the pressure is constant during inspiration, the tidal volume is variable. In volume controlled ventilation, ventilation executed at the volume is set by the anesthesiologist. In other words, the determined volume is constant, but airway pressures vary.
In pediatric anesthesia practice modes have not been shown to have a clear advantage over each other. Both modes have advantages and disadvantages. With the development of modern anesthesia devices in recent years, safe ventilation can be provided even in very young children with volume controlled mode (VCV).
Atelectasis is the restriction of gas exchange due to complete or partial collapse of the lung. Atelectasis can be seen in 90 percent of patients receiving general anesthesia. This incidence is reported to be 68-100 percent in children.
Lung ultrasonography is an imaging method with many advantages for imaging lung-related diseases, such as not containing ionizing radiation, being inexpensive, and being performed at the bedside. Recently, its use by anesthesiologists has become widespread in many lung pathologies, including atelectasis. Traditional and modified lung ultrasonography scoring systems can be used to evaluate atelectasis in lung parenchyma with ultrasonography. In addition to the traditional system, modified scoring system also enables to evaluate small subpleural consolidations
In this study, it was aimed to compare the effects of volume controlled and pressure controlled ventilation modes used in general anesthesia in children on atelectasis with lung ultrasonography.
**Detailed Description:** Traditional and modified lung ultrasonography scoring systems can be used to evaluate atelectasis in the lung parenchyma by ultrasonography. The modified scoring system also provides the opportunity to evaluate small subpleural consolidations in addition to the traditional system.
Lung tissue is evaluated between the intercostal spaces. On ultrasound, the pleural line can usually be seen as bright white due to the acoustic impedance difference between the aerated lung tissue and the surrounding tissues. Most of the ultrasound waves are reflected from this line. Due to the constantly reflected ultrasound waves between the pleural line and the transducer, hyperechoic lines parallel to the pleural line, called A lines, can be observed in the parenchyma. Vertical hyperechoic lines emerging from the pleural line in the lung ultrasound image are defined as B lines. B lines follow perpendicular to A lines. B lines accompany the sliding movement of the lungs along with the respiratory movement.
The patient is usually evaluated while lying in the supine position. The thorax is divided into 12 quadrants when evaluated with ultrasound for atelectasis. Midsternal line, anterior axillary line, posterior axillary line form the vertical boundaries of the quadrants. Each area is divided into two parts, upper and lower, by a line passing through its midpoint. Left hemithorax anterior upper, lateral upper, posterior upper, anterior lower, lateral lower, posterior lateral; The right hemithorax consists of 12 quadrants: anterior upper, lateral upper, posterior upper, anterior lower, lateral lower, and posterior lateral. The ultrasound probe is advanced transversely and each quadrant is examined. The patient may be asked to turn slightly to the side to evaluate the posterior quadrants. The ultrasound probe is placed vertically on the ribs and the lung parenchyma seen between the intercostal spaces is evaluated. Loss of ventilation is evaluated according to the modified lung ultrasonography scoring system for each quadrant. The score is collected by evaluating 12 quadrants from 0 to 3 and a value between 0-36 is obtained. For each quadrant, 0 represents the region with no ventilation loss and 3 indicates the region with severe ventilation loss. 0 indicates normal tissue with no loss of ventilation and 2 or fewer B lines are observed. 1 indicates little loss of ventilation, 3 or more B lines or one or more subpleural consolidations separated by a normal pleural line are observed. 2 indicates moderate loss of ventilation, observed as multiple fused B lines or multiple small subpleural consolidations separated by thickened or irregular pleural lines. 3 indicates severe loss of ventilation and is observed as consolidation or subpleural consolidation larger than 1x2 cm.
Each patient underwent transthoracic lung ultrasonography a total of 4 times: before laryngeal mask airway (LMA), at the 10th minute after LMA, before extubation and at the 10th minute after extubation. In addition, data on respiratory mechanics and hemodynamic parameters were recorded twice, at the 10th minute after LMA and before extubation.
### Conditions Module
**Conditions:**
- Pulmonary Atelectasis
- Mechanical Ventilation Complication
- General Anesthesia
- Lung Ultrasound
**Keywords:**
- Pulmonary Atelectasis
- Mechanic Ventilation
- General anesthesia
- Lung Ultrasound
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 110
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients to be ventilated with VCV mode were placed on respiratory support (Dräger Primus) with a breathing rate that would provide 8 ml/kg tidal volume, 5 cmH2O positive end expiratory pressure (PEEP), and 30-35 mmHg end-tidal carbon dioxide concentration (etCO2) level.
**Intervention Names:**
- Procedure: Volume controlled ventilation (VCV) mode
**Label:** Patients ventilated with volume controlled ventilation (VCV) mode
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Appropriate peak inspiratory pressure was set to create a tidal volume of 8 ml/kg in patients who would be ventilated with PCV mode. The number of breaths (Dräger Primus) was adjusted to provide an end-tidal carbon dioxide concentration (etCO2) level of 30-35 mmHg. PEEP was set to 5 cmH2O.
**Intervention Names:**
- Procedure: Pressure controlled ventilation (PCV) mode
**Label:** Patients ventilated with pressure controlled ventilation (PCV) mode
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients ventilated with volume controlled ventilation (VCV) mode
**Description:** Patients to be ventilated with VCV mode were placed on respiratory support (Dräger Primus) with a breathing rate that would provide 8 ml/kg tidal volume, 5 cmH2O PEEP, and 30-35 mmHg end-tidal carbon dioxide concentration (etCO2) level.
Lung ultrasonography was performed at 4 different time periods. Modified lung ultrasonography scores of 12 quadrants were recorded.
**Name:** Volume controlled ventilation (VCV) mode
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Patients ventilated with pressure controlled ventilation (PCV) mode
**Description:** Appropriate peak inspiratory pressure was set to create a tidal volume of 8 ml/kg in patients who would be ventilated with PCV mode. The number of breaths (Dräger Primus) was adjusted to provide an end-tidal carbon dioxide concentration (etCO2) level of 30-35 mmHg. PEEP was set to 5 cmH2O.
Lung ultrasonography was performed at 4 different time periods. Modified lung ultrasonography scores of 12 quadrants were recorded.
**Name:** Pressure controlled ventilation (PCV) mode
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Comparison of the total lung ultrasonography score of 12 quadrants before extubation between groups in terms of atelectasis.
**Measure:** Volume-controlled (VCV ) and pressure-controlled (PCV) respiratory ventilation modes modified lung ultrasonography scores before extubation
**Time Frame:** Before extubation
#### Secondary Outcomes
**Description:** Determining the frequency of atelectasis in all quadrants before laryngeal mask airway (LMA) (preoperative period) and comparing it between the two groups
**Measure:** Volume-controlled (VCV ) and pressure-controlled (PCV) respiratory ventilation modes
**Time Frame:** Before LMA (preoperative period)
**Description:** Determining the frequency of atelectasis in all quadrants in the 10th minute after LMA and comparing it between the two groups
**Measure:** Volume-controlled (VCV ) and pressure-controlled (PCV) respiratory ventilation modes
**Time Frame:** 10th minute after LMA
**Description:** Determining the frequency of atelectasis in all quadrants in the 10th minute after extubation and comparing it between the two groups
**Measure:** Volume-controlled (VCV ) and pressure-controlled (PCV) respiratory ventilation modes
**Time Frame:** 10th minute after extubation
**Description:** The frequency of atelectasis in all lung quadrants in the pre-LMA period, at the 10th minute after LMA, in the pre-extubation period, and at the 10th minute after extubation will be determined and compared.
**Measure:** Comparison of atelectasis incidence and modified Lung ultrasonography (USG) scores in 12 different lung regions of patients followed in VCV/PCV ventilation modes under general anesthesia
**Time Frame:** pre-LMA period (preoperative period), 10th minute after LMA, pre-extubation period, 10th minute after extubation
**Description:** Effect of different ventilation modes on lung pressures (peak pressure cmH2O, plat pressure cmH2O, and mean pressure cmH2O parameters.
**Measure:** The effects of these ventilation modes on lung pressures parameters.
**Time Frame:** 10th minute after LMA, pre-extubation period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 2 and 10
* American Society of Anesthesiologists (ASA) Scoring I-II
* Elective surgery planned
* Cases that will undergo general anesthesia
* Surgical time is expected to be \>30 minutes
Exclusion Criteria:
* Patients who are allergic to ultrasonography (USG) gel
* Known obstructive and restrictive lung disease
* Pulmonary infection in the last 3 months
* Having a history of surgery in the last 3 months
* A history of multiple trauma in the last 3 months
* Body Mass Index ≥30
* With diaphragmatic hernia
* Having undergone laparoscopic abdominal surgery
**Maximum Age:** 120 Months
**Minimum Age:** 24 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ahmet Aras, MD
**Phone:** 00905373222505
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Aslı Dönmez, Full Prof
**Phone:** 00905322256473
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Yenimahalle
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ahmet Aras, MD
- **Phone:** 00905373222505
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Asli Dönmez, Full Prof
- **Phone:** 00905322256473
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Ahmet Aras
**State:** Ankara
**Status:** RECRUITING
**Zip:** 06170
#### Overall Officials
**Official 1:**
**Affiliation:** Republic of Türkiye Ministry of Health Ankara Etlik City Hospital
**Name:** Ahmet Aras, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4567
- Name: Pulmonary Atelectasis
- Relevance: HIGH
- As Found: Atelectasis
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001261
- Term: Pulmonary Atelectasis
### 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:** NCT06430216
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** 129-1346-01
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430203
**Brief Title:** Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program
**Official Title:** Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program
#### Organization Study ID Info
**ID:** 2025-10728
#### Organization
**Class:** OTHER
**Full Name:** McGill University Health Centre/Research Institute of the McGill University Health Centre
### Status Module
#### Completion Date
**Date:** 2028-09-01
**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:** 2028-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** McGill University Health Centre/Research Institute of the McGill University Health Centre
#### Responsible Party
**Investigator Affiliation:** McGill University Health Centre/Research Institute of the McGill University Health Centre
**Investigator Full Name:** Romina Pace
**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:** The goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes.
* Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?
* What is it like for Indigenous youth and young adults to be live with diabetes?
* Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?
* Can a peer-mentoring program lead to changes in lifestyle (diet, physical activity, substance use) and diabetes related clinical outcomes among Indigenous youth and young adults with diabetes.
Researchers will compare distress, resilience, lifestyles, and diabetes related clinical outcomes before participating in the peer-mentoring program and at 6 and 12 months into the program. Additionally, participants will be asked to share their journey with diabetes through photos throughout the program
Participants will:
* Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes
* Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors
* Complete questionnaires on distress, resilience, and lifestyle every 6 months.
* Participate in Photovoice workshops to share their stories through pictures.
**Detailed Description:** The rates of diabetes are increasing among youth and young adults. This rise is particularly steep among Indigenous peoples who also face high rates of depression and emotional distress due to the ongoing legacy of colonization resulting in systemic racism and intergenerational trauma. Diabetes care includes many aspects of self-care (checking sugar, taking medication, following exercise and diet advice), which is negatively impacted by emotional distress. The emotional distress specific to living with diabetes, known as diabetes distress (DD), is due to feeling overwhelmed by the demands of self-care, fears of complications, and guilt or shame over lifestyle choices. DD is known to be related to decreased wellbeing and poor diabetes control. The rate of DD has not been studied among Indigenous youth, nor have interventions aimed at reducing it to improve diabetes management.
Peer support has been shown to help empower youth and young adults by normalizing their experiences and providing a safe space to express themselves. In the Eeyou Istchee Cree community in Quebec, Jonathan Linton, an Indigenous young adult with diabetes, developed a program for youth with diabetes on management and self-care for diabetes that incorporates traditional elements. As he helps participants be more active and eat healthier, he supports them in their journey with diabetes and creates a safe space for them to voice concerns, easing their distress.
This research study will build on the initiative developed by Mr. Linton to create a community of peer-mentors to provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. To evaluate the program, a combination of questionnaires to assess changes in DD and other emotional factors, measures of diabetes outcomes (glycemia, blood pressure, weight), and Photovoice, a research tool that allows participants to use images to explain their experience with diabetes, will be used.
### Conditions Module
**Conditions:**
- Diabetes Mellitus
- Distress, Emotional
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Peer-mentoring which will include land based activities, nutrition and physical activity teaching.
**Intervention Names:**
- Behavioral: Peer mentoring
**Label:** Peer-mentoring
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Peer-mentoring
**Description:** Indigenous young adult peer mentors who will develop and deliver the program based on needs and wants of our participants. The program will be built on their experience and ideas. They will be empowered to guide the program in the direction they see best for their communities.
**Name:** Peer mentoring
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress
**Measure:** Diabetes Distress
**Time Frame:** 0,6 and 12 months
#### Secondary Outcomes
**Description:** 0 item Kessler Psychological Distress scale (K10), from 10-50, the higher the score the greater the global distress.
**Measure:** Global Distress
**Time Frame:** 0,6 and 12 months
**Description:** Child and Youth Resilience Measure-Revised (CYRM-R), for 10-18 years old. Scale from 17-85, the higher the score the greater the resilience
**Measure:** Resilience-Children
**Time Frame:** 0,6 and 12 months
**Description:** Adult Resilience Measure-Revised (ARM-R), for those \> 18 years. Scale from 17-85, the higher the score the greater the resilience
**Measure:** Resilience-Adults
**Time Frame:** 0,6 and 12 months
**Description:** Weight (kg)/\[Height(m)\]\^2
**Measure:** Body Mass Index
**Time Frame:** 0 and 12 months
**Description:** Percent HbA1c
**Measure:** Hemoglobin A1c
**Time Frame:** 0 and 12 months
**Description:** mg/mmol
**Measure:** urine albumin to creatine ratio
**Time Frame:** 0 and 12 months
**Description:** mmol/L
**Measure:** low density lipoprotein
**Time Frame:** 0 and 12 months
**Description:** mmHg
**Measure:** Blood pressure
**Time Frame:** 0 and 12 months
**Description:** Developed by Cree Board of health to assess diet and physical activity. Not a scale
**Measure:** Lifestyle questionnaire
**Time Frame:** 0 and 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Age 10-29 years old Clinical diagnosis of diabetes or gestational diabetes
Exclusion Criteria:
Age \> 29 years old Not at risk of diabetes
**Healthy Volunteers:** True
**Maximum Age:** 29 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sahar Fazeli
**Phone:** (438) 860-6079
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** MUHC-RI
**Name:** Romina Pace
**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
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: 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: D000003920
- Term: Diabetes Mellitus
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430190
**Brief Title:** Peginterferon α-2b Combined CO2 Laser in Condylomata Acuminata
**Official Title:** A Prospective, Exploratory Study to Evaluate the Efficacy of Peginterferon α-2b Injection Combined With Carbon Dioxide(CO2) Laser in the Treatment of Condylomata Acuminata
#### Organization Study ID Info
**ID:** Peg IFN α- 2b treatment for CA
#### Organization
**Class:** OTHER
**Full Name:** First People's Hospital of Hangzhou
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhangyu Bu
#### Responsible Party
**Investigator Affiliation:** First People's Hospital of Hangzhou
**Investigator Full Name:** Zhangyu Bu
**Investigator Title:** Attending Physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a prospective, randomized, open-label, controlled study, aiming to enroll 30 patients with Condylomata Acuminata. The study consists of two phases: a treatment phase (Weeks W1-W12) and an observation phase (Weeks W13-W24). Eligible patients will be randomly allocated into three groups at a ratio of 1:1:1: Test Group 1, Test Group 2, or the Control Group. And clinical cure, recurrence rates, adverse events, vital signs, laboratory tests, drug exposure doses, premature withdrawals will be analyzed.
### Conditions Module
**Conditions:**
- Condylomata Acuminata
**Keywords:**
- Condyloma Acuminatum, Genital Warts, Peginterferon α-2b, Interferon, CO2 Laser
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Peginterferon α-2b injection
- Other: CO2 laser
**Label:** Lesional group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Peginterferon α-2b injection
- Other: CO2 laser
**Label:** Systemic group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Other: CO2 laser
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lesional group
**Description:** Participants receive CO2 laser treatment followed by local injection of 36mcg of Peginterferon α-2b directly into the base of each treated wart, repeated weekly for 12 weeks, and then followed for another 12 weeks.
**Name:** Peginterferon α-2b injection
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Systemic group
**Description:** Participants undergo CO2 laser treatment and then receive a weekly subcutaneous injection of 180mcg of Peginterferon α-2b for 12 weeks, and then followed for another 12 weeks.
**Name:** Peginterferon α-2b injection
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Control group
- Lesional group
- Systemic group
**Description:** On the day (baseline), CO2 laser treatment was performed to remove all warts, and the treatment range was 0.2cm around the lesion and the depth was up to the dermis. Wound disinfection after laser. Participants are treated with CO2 laser therapy only and are observed for 12 weeks, followed by another 12-week observation period without any additional adjuvant therapy.
**Name:** CO2 laser
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Measure:** Adverse events
**Time Frame:** from baseline to 24 weeks.
#### Primary Outcomes
**Measure:** Clinical cure rate
**Time Frame:** Week 12
#### Secondary Outcomes
**Measure:** Recurrence rate
**Time Frame:** Week 24
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients must be between 18 and 65 years old.
* Patients with positive of human papillomavirus(HPV) nucleic acid test and acetowhite test, were diagnosed as condyloma acuminatum according to clinical manifestations and epidemiological history.
* Patients' lesions are located on non-cavity areas such as the foreskin, glans penis, labia majora, labia minora, with a number ranging from 1 to 5 individual lesions, and each individual lesion having a diameter less than 1 centimeter.
* For female participants with reproductive capability, a negative pregnancy test result is mandatory at the screening stage.
* Participants must volunteer to enroll in the study and be able to understand and sign a written informed consent form.
Exclusion Criteria:
* Pregnant women, breastfeeding mothers, or individuals planning to conceive during the study period.
* Patients who received treatment for genital warts within two weeks prior to screening.
* Patients with concurrent skin conditions in the affected area that might significantly impact the evaluation of treatment efficacy.
* Individuals with known severe immunodeficiency or those requiring long-term use of corticosteroids and immunosuppressive agents.
* Active carriers of hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or Treponema pallidum (syphilis).
* Patients with a history of severe cardiovascular, hepatic, renal, endocrine, digestive, immune, respiratory, or nervous system diseases.
* Patients with severe retinal disorders or other serious ophthalmologic conditions.
* Patients allergic to interferons or excipients in the medication formulation, or those deemed unsuitable for CO2 laser treatment.
* Individuals meeting any contraindications listed in the investigational drug's package insert.
* Patients who participated in another interventional clinical trial within three months before screening, or those planning to participate in another clinical trial during the study period.
* Other cases deemed inappropriate for enrollment by the investigator due to various reasons.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhangyu Bu
- **Phone:** 0571-56005600
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Kune Lu
- **Phone:** 0571-56005600
- **Role:** CONTACT
**Country:** China
**Facility:** Hangzhou First People's Hospital
**State:** Zhejiang
**Zip:** 310006
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000014860
- Term: Warts
- ID: D000030361
- Term: Papillomavirus Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000017193
- Term: Skin Diseases, Viral
- ID: D000014412
- Term: Tumor Virus Infections
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000012874
- Term: Skin Diseases, Infectious
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- 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: M6443
- Name: Condylomata Acuminata
- Relevance: HIGH
- As Found: Condylomata
- ID: M17603
- Name: Warts
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17933
- Name: Sexually Transmitted Diseases, 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: M23687
- Name: Papillomavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19501
- Name: Skin Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M17162
- Name: Tumor Virus Infections
- 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: M15677
- Name: Skin Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003218
- Term: Condylomata Acuminata
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10407
- Name: Interferons
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430177
**Brief Title:** The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement
**Official Title:** The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement: A Randomized, Placebo and Controlled Study
#### Organization Study ID Info
**ID:** 2024/07-28
#### Organization
**Class:** OTHER
**Full Name:** Firat University
### Status Module
#### Completion Date
**Date:** 2024-12-01
**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:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Firat University
#### Responsible Party
**Investigator Affiliation:** Firat University
**Investigator Full Name:** Gülcan Bahçecioğlu Turan
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cancer is a fatal disease characterized by uncontrolled growth and proliferation of tissues and organs in the human body. Among cancer treatments, chemotherapy is the most commonly used treatment method. The drugs used in chemotherapy cause vascular toxic effects during administration, frequent blood samples taken from the patient, antibiotic treatments applied, parenteral nutrition treatments. Subcutaneous venous port catheter (SCVPK), which is a permanent and long-term vascular access route that can be used for medical purposes and in emergency situations, is a frequently preferred and safe intravenous access route because it is not visible outside the body, is well tolerated by the patient, and has a low risk of infection. However, invasive procedures such as port needle insertion and replacement can also cause pain, anxiety and changes in vital signs in patients. Nowadays, the use of non-pharmacological approaches as well as pharmacological methods is increasing in the management of symptoms such as anxiety before the invasive procedure and pain during application in patients receiving chemotherapy treatment. These approaches improve the quality of life of patients and have a positive physiological effect. One of these approaches is sujok therapy. In Su Jok application; The reflection points of the organs are on the hands and feet. These points reflect to the body organ in that area and healing occurs. By finding the right point, energy flow is provided by massaging with appropriate applicators. This research will be conducted to examine the effect of Sujok therapy on pain intensity and anxiety level in cancer patients who have undergone port catheter placement.
The research will be conducted as a randomized experimental and placebo study with a pretest-posttest control group in the oncology service of Fethi Sekin City Hospital. 90 (30 experimental, 30 control, 30 placebo) cancer patients who accept the research and meet the sample criteria of the study will be subjected to port catheter application. Application areas for pain, anxiety and stress before the port catheter to the patients in the experimental group will be determined with the help of a probe (diagnostic stick), and seeds will be added to these points approximately 45 minutes before the application and fixed with a patch. For cancer patients in the placebo group, the same procedure will be performed with seeds that have a neutral effect on the body. No procedure will be applied to the patients in the control group. Patient Information Form, General Comfort Scale (GAS), Visual Analog Scale -Pain (VAS-P), Visual Analog Scale -Anxiety (VAS-A) and State-Trait Anxiety Scale were used as data collection tools. (DSKÖ) scale will be used. SPPS 21.0 (Statistical Programme for Social Sciences) package program will be used to evaluate the data obtained from the research. It is thought that if the objectives of the study are achieved, it will help reduce the level of pain and anxiety that may occur during and after port catheter application. In addition, it will contribute to the professional advancement of the project manager, which is a career development project. The positive results in this study will guide other interventions to increase the comfort level of cancer patients who will undergo port catheterization and reduce the level of pain and anxiety.
### Conditions Module
**Conditions:**
- Cancer
- Chemotherapy Effect
**Keywords:**
- Su Jok
- Pain
- Anxiety
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Su Jok will be done
**Intervention Names:**
- Behavioral: Su Jok
**Label:** Experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Su Jok will be done
**Intervention Names:**
- Behavioral: Su Jok
**Label:** Placebo
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
- Placebo
**Description:** Su Jok will be done
**Name:** Su Jok
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** It is a four-point Likert type consisting of 48 items to measure the expected comfort result of the patient in order to test the taxonomic structure created after completing the conceptual studies of comfort. In this research, the scale adapted to Turkish by Kuğuoğlu and Karabacak was used. The scale is a four/six point Likert type and contains a total of 48 items. A four-point Likert type was preferred in the study due to its ease of use. Scale sub-dimensions; relief (16 items), relaxation (17 items) and overcoming problems (15 items). The response patterns of the scale, which consists of positive and negative items, are given in mixed order. Accordingly, in positive statements, a high score (4p) indicates high comfort, a low score (1p) indicates low comfort, in negative items, a low score (1p) indicates high comfort, and a high score (4p) indicates low comfort. In the evaluation of the scale; The negative scores obtained are reverse coded and added to the positive items.
**Measure:** General Comfort Scale
**Time Frame:** two hours later
**Description:** The patients were asked to measure their anxiety level during rest or activity on a 10 cm long horizontal line.
is requested to show. The value 0 is at the beginning of the line and 10 is at the end. 10 indicates extreme anxiety, 0 indicates not at all.
It shows that there is no concern. VAS scale is used quite frequently during the evaluation of anxiety severity.
is used
**Measure:** Visual Analog Scale - Anxiety
**Time Frame:** two hours later
**Description:** It is used to convert some values that cannot be measured numerically into numerical values. Two extreme definitions of the parameter to be evaluated are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her situation is appropriate on this line by drawing a line, placing a dot, or pointing.
**Measure:** Visual Analog Scale -Agrı
**Time Frame:** two hours later
**Description:** It is a scale developed to measure individuals' state and trait anxiety levels. It is a self-assessment scale whose Turkish validity and reliability studies have been conducted. In this study, the section of the scale measuring state anxiety was used to determine the state anxiety levels of the patients. State Anxiety Scale is a 4-point Likert type with 20 items and is scored according to the severity of the feelings, thoughts or behaviors expressed by the items as "not at all": 1, "somewhat": 2, "a lot": 3, "completely": 4. . The scale includes directly or reverse scored expressions.
**Measure:** State-Trait Anxiety Scale
**Time Frame:** two hours later
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being over 18 years of age
* Ability to communicate adequately
* Being diagnosed with cancer
* Will receive chemotherapy treatment
* Port catheter placement will be performed
* Suitable for Implantable Port Catheter Placement
Exclusion Criteria:
* Loss of sensation in the hands, amputation, injury, etc. that would prevent practice. to be
* Patients with chronic pain or anxiety disorders, using any analgesics or anxiolytics
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gülcan Bahçecioğlu Turan
**Phone:** 05065576086
**Role:** CONTACT
**Contact 2:**
**Name:** Necla Yıldırım
**Phone:** 0551 553 28 58
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Elazığ
**Country:** Turkey
**Facility:** Fırat university
**State:** Center
**Zip:** 25240
### IPD Sharing Statement Module
**Description:** It will be shared after it is finished
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: HIGH
- As Found: Pain Intensity
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010146
- Term: Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430164
**Brief Title:** AB Gait Estim Neurophysiology
**Official Title:** Effects of Gait Training Strategies and Noninvasive Stimulation on Neurophysiology and Walking Performance in Able-Bodied Adults- A Preliminary Study
#### Organization Study ID Info
**ID:** STUDY00007235
#### Organization
**Class:** OTHER
**Full Name:** Emory University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Emory University
#### Responsible Party
**Investigator Affiliation:** Emory University
**Investigator Full Name:** Trisha Kesar
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors.
The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals.
The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance.
The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.
**Detailed Description:** This study is being done to determine the effects of electrical stimulation and walking practice on connections between the brain and muscles.
This study consists of 1-5 study visits lasting up to 5 hours each. Participants will complete stepping training with or without electrical stimulation delivered to their leg muscles; noninvasive stimulation will be delivered to the participants' brain or nerves in the leg to measure the strength of connections within their brain and between their brain / spinal cord and their muscles.
### Conditions Module
**Conditions:**
- Gait
**Keywords:**
- Corticospinal excitability
- Non-invasive stimulation
- Functional electrical stimulation (FES)
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill with functional electrical stimulation, and non-invasive measurement of neural circuit excitability.
Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).
**Intervention Names:**
- Other: Gait Training
- Device: Functional electrical stimulation (FES)
**Label:** Gait with functional electrical stimulation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill without functional electrical stimulation, and non-invasive measurement of neural circuit excitability.
Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).
**Intervention Names:**
- Other: Gait Training
**Label:** Gait without functional electrical stimulation
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will participate in a single session of peripheral electrical stimulation paired with cortical stimulation pulses (i.e. paired associative stimulation(PAS)) on somatosensory, spinal-reflex, and corticospinal neurophysiology.
**Intervention Names:**
- Other: Gait Training
- Device: Peripheral electrical stimulation paired with cortical stimulation pulses
**Label:** Paired stimulation of the cortex and peripheral nervous system
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gait with functional electrical stimulation
- Gait without functional electrical stimulation
- Paired stimulation of the cortex and peripheral nervous system
**Description:** Gait training: One or multiple short bouts of stepping practice on a treadmill at self-selected or fast speeds will be delivered without FES.
**Name:** Gait Training
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Gait with functional electrical stimulation
**Description:** Electrical stimulation involving the parameters and settings proposed here is commonly used in clinical practice and research for pain relief and other applications also referred to as neuromuscular or transcutaneous electrical nerve stimulation. The FES will be delivered using the UDel Stimulator, a custom-designed FES system from the University of Delaware FES lab.
Researchers will use a customized, real-time system to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains will be delivered during gait.
**Name:** Functional electrical stimulation (FES)
**Other Names:**
- FES
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Paired stimulation of the cortex and peripheral nervous system
**Description:** Paired associative stimulation (PAS) on somatosensory, spinal-reflex, and corticospinal neurophysiology delivered with different stimulation parameters. The PAS sessions will be conducted in a static posture (seated or standing).
**Name:** Peripheral electrical stimulation paired with cortical stimulation pulses
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** To record muscle activity, small electromyography (EMG) sensors may be attached to various muscles. The EMG sensors will be attached using hypo-allergenic adhesive. EMG signals will be recorded from the following muscles: tibialis anterior, soleus, gastrocnemius, quadriceps femoris, hamstrings, gluteus medius, and erector spinae
**Measure:** Muscle activity during gait
**Time Frame:** Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
**Description:** Somatosensory transmission and excitability may be assessed using electroencephalography (EEG) responses to peripheral nerve stimulation (PNS) stimuli delivered to the lower limb.
**Measure:** Somatosensory excitability
**Time Frame:** Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
#### Primary Outcomes
**Description:** Marker data will be collected using a 7-camera motion analysis system at 120 Hz (Vicon, Oxford, UK). During treadmill walking, ground reaction forces during treadmill walking will be collected using a treadmill instrumented with two 6-component force platforms under each belt (Bertec, USA). Ground reaction forces will be collected using a force plate embedded within the lab floor (AMTI, USA).
**Measure:** Gait Performance
**Time Frame:** Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
**Description:** Corticospinal excitability will be assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). TMS will be delivered using MagStim Stimulators with a double circular coil, custom-built double-cone, or batwing coil (Magstim Ltd, Wales, UK). Electrical activity from muscles in response to the TMS will be collected using surface EMG electrodes attached to muscles that play critical roles during walking (e.g., quadriceps femoris, tibialis anterior, soleus, gastrocnemius, hamstrings, etc.). In addition, EMG signals may be recorded from a couple of upper extremity muscles (e.g., first dorsal interosseus, flexor digitorum indicis) to be used as a control.
**Measure:** Corticospinal excitability
**Time Frame:** Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
**Description:** Spinal excitability may be assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. The methods for electrical stimulation are similar to those used for delivering functional electrical stimulation except that the subjects are seated and the stimulation is used to obtain outcome measures assessing spinal excitability. Muscles of interest are the soleus and medial gastrocnemius (calf muscles), and tibialis anterior (front of lower leg).
EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity from 1mA - 80 mA), 7-10 seconds apart, are delivered to the muscle. Researchers may also deliver 5-20 electrical stimulus pulses at intensities that elicit a percentage of the maximum reflex response.
**Measure:** Spinal circuit excitability
**Time Frame:** Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-65 years
* Able-bodied (healthy without any physical disability, neurological, orthopedic, or other medical disorder affecting walking or study protocol participation)
* Ability to walk \>10m overground and for 1 minute on a treadmill
* Ability to follow 3-stage commands and provide informed consent.
Exclusion Criteria:
* Self-reported history or evidence of orthopedic or physical disability
* History or evidence of neurological pathology
* Pregnancy (female)
* Uncontrolled hypertension
* Cardiac pacemaker or other implanted electronic system
* Presence of skin conditions preventing electrical stimulation setup
* Impaired sensation in the left upper limb.
* Bruises or cuts at the stimulation electrode placement site
* Concurrent enrollment in rehabilitation or another investigational study.
* History or evidence of orthopedic or physical disability interfering with study procedures
* History or evidence of neurological pathology or disorder
* Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
* Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months
**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:** Trisha Kesar, PT, PhD
**Phone:** 404-712-5803
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Atlanta
**Country:** United States
**Facility:** Emory University
**State:** Georgia
**Status:** RECRUITING
**Zip:** 30329
#### Overall Officials
**Official 1:**
**Affiliation:** Emory University
**Name:** Trisha Kesar, PT, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Requests sent to PI with supporting documentation.
**Description:** Researchers will share group deidentified data.
**IPD Sharing:** YES
**Time Frame:** Within two years after study completion and in conjunction with peer-reviewed publication
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430151
**Brief Title:** Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
**Official Title:** Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
#### Organization Study ID Info
**ID:** A096551
#### Organization
**Class:** OTHER
**Full Name:** Cambridge University Hospitals NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2024-12-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** Dr Alistair Mackett
#### Responsible Party
**Investigator Affiliation:** Cambridge University Hospitals NHS Foundation Trust
**Investigator Full Name:** Dr Alistair Mackett
**Investigator Title:** Consultant Geriatrician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The CUE1 device is a non-invasive wearable device for people with Parkinson's Disease (PD) approved for sale in the UK. The CUE1 device utilises two established methods to improve motor symptoms in PD, namely pulsed cueing and vibrotactile stimulation. Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom.
Study design and eligibility: This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD. 20-25 participants aged \>60 years with PD will be recruited from a movement disorder service to the study.
Methodology: Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home. Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes. The participants will complete a daily diary of useability and acceptability for 4 weeks. A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed.
### Conditions Module
**Conditions:**
- Parkinson Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Useability and acceptability study of a vibrotactile stimulation device
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: CUE1
**Label:** CUE1 users
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CUE1 users
**Description:** Sternal worn focused vibrotactile stimulation and cueing device
**Name:** CUE1
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Participants' completion of a patient diary which will collect safety, tolerability, useability, and efficacy reports of the device over the study period. Participants will also complete a Patient Global Impression of Change (PGI-C) questionnaire at the end of the study.
**Measure:** Useability and acceptability of the CUE1 device in older people with Parkinson's disease
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** Completion of validated motor scores during the study period to evaluate feasibility of the data collection method for motor symptom change. Any signals of improvement in motor scores would potentially justify larger randomised controlled studies to evaluate this systematically.
**Measure:** To undertake standardized, validated measurements of motor function with use of the CUE1 device
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Individuals under the care of a Cambridge University Hospitals Foundation Trust movement disorder service with an established clinical diagnosis of Parkinson's disease based on the UK Brain bank criteria
Exclusion Criteria:
1. Co-existing significant neurological disorder (disabling stroke, multiple sclerosis, dementia, motor neurone disease),
2. Atypical parkinsonian disorder diagnosis (e.g. multiple systems atrophy, progressive supranuclear palsy or cortical basal degeneration syndrome)
3. co-existing physical impairment or disability causing significant mobility impairment (severe lower limb osteoarthritis)
4. trauma or pain to the sternum
5. use of other medical device e.g. pacemaker, deep brain stimulator, TENS machine etc
6. lacking capacity to consent to the study
7. Sensitivity to medical adhesives
8. Existing participant in intervention research trial
**Maximum Age:** 100 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alistair J Mackett, MBBS
**Phone:** 01223 217483
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cambridge
**Contacts:**
***Contact 1:***
- **Name:** Alistair J Mackett, MBBS
- **Phone:** 01223 217483
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Cambridge University Hospitals Foundation Trust
**Status:** RECRUITING
### IPD Sharing Statement Module
**Description:** No plans to make IPD available to other researchers
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- 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: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430138
**Acronym:** ORANGUT
**Brief Title:** Bioavailability and Bioactivity of Orange Polyphenols
**Official Title:** Bioavailability and Bioactivity of Orange Polyphenols on Gut Health
#### Organization Study ID Info
**ID:** REC/24/0002
#### Organization
**Class:** OTHER
**Full Name:** University of Ulster
### Status Module
#### Completion Date
**Date:** 2024-12-13
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-26
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Andalusian Institute of Agricultural and Fisheries Research and Training (IFAPA)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Ulster
#### 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 study will provide a greater insight into the relationship between orange consumption and health (particularly gut health) and could be used to help with the development of novel food products. Oranges are a rich source of (poly)phenols, and although the advantages of a (poly)phenol-rich diet are well-established, the bioavailability and bioactivity of orange (poly)phenols in the context of human digestion are poorly understood. This study will address this gap in research.
**Detailed Description:** This study will provide a greater insight into the relationship between orange consumption and health (particularly gut health) and could be used to help with the development of novel food products. Oranges are a rich source of (poly)phenols, and although the advantages of a (poly)phenol-rich diet are well-established, the bioavailability and bioactivity of orange (poly)phenols in the context of human digestion are poorly understood.
Until recently, analysis of biofluids with HPLC-MS revealed relatively simple phenolic profiles. However, with current high resolution (HR)-MS instrumentation detection limits and selectivity have improved greatly and HPLC-HR-MS methodology is now the analytical method of choice. Consequently, the number of phenolics that can be monitored has increased markedly in recent years. A previous study, using validated methodology, identified 65 phenolic compounds in urine collected after ingestion of orange juice.
In the proposed project it is planned to use such analytical methodology for targeted and untargeted metabolomics of flavanone metabolites and colonic catabolites in biofluids collected after consumption of orange juice by ileostomists and subjects with a functioning colon. Metabolomics refers to the measurement of metabolites present within a cell, tissue, or organism resulting from physiological stimulus - in the context of the current study, the stimulus is orange juice consumption. Untargeted metabolomics involves a comprehensive analysis of all measurable substances in a sample of unknown metabolites, and targeted metabolomics denotes the quantification of defined group(s) of metabolites. The particular value of including ileostomists in the study is that analysis of their ileal fluid and urine will provide valuable information on compounds derived from the ingested OJ flavanones, prior to digestion and absorption by the large intestine.
Acute bioavailability feeding study in two groups; ileostomists and healthy adults. The study will take place in the Human Intervention Studies Unit (HISU), at Ulster University, Coleraine Campus. Prior to attending the HISU, participants will be asked to follow a restriction diet for 72 hours before the study and the 24 hours of the study day, which will involve the intake of food containing low levels of (poly)phenols. The participants will be provided with a restriction (low (poly)phenol) meal, which they will consume the evening before the study (at approximately 6 - 7.00pm) and fast until attending the HISU the following morning. This means no food will be taken overnight and no breakfast taken prior to attending the HISU.
Low (poly)phenol foods will be provided to participants on the day of the study, and they will be asked to continue this restriction diet until all samples have been collected. Healthy participants and Ileostomists (N=20) will provide 10 blood samples and 3 urine samples over the study period.
Blood samples:
Upon arrival at the HISU, a qualified phlebotomist will fit a cannula, and collect a blood sample (0hr) (\~8ml). The participant will then be given the intervention; 300 ml of orange juice. A further 8 blood samples will be collected at 1hr intervals (1hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr). After the 8hr blood draw the cannula will be removed by the phlebotomist and the participant will be free to go home. They will return to the HISU the following morning to provide a final blood sample (24hr). Ten blood samples will be collected in total.
Urine samples:
Participants will start a 24-hour urine collection the day before the study day. They will be provided with a 2L urine container in advance of commencing the urine collection; participants will use this to deposit urine samples over the 24-hr period. Upon arrival at the HISU on the morning of the study, participants will return the urine container holding the -24 to 0 hr urine sample. Participants will complete two additional urine collections (0-8hr and 8-24hr samples), a fresh urine container will be provided at each time point. The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample.
Ileostomist participants (n=10) will also provide three ileal samples over the study period.
Ileal samples:
Participants will be asked to refrain from emptying their stoma bag upon waking on the morning of the study. Upon arrival at the HISU, an ileal sample will be collected; the overnight stoma bag will be removed and replaced with a new stoma bag by the participant. Two additional ileal samples will be collected at 0-8 hr and 8-24 hrs, the stoma bag will be removed and replaced with a new stoma bag by the participant at each sampling point. The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample. Multiple stoma bags may be used by the participant as required.
Height and weight measurements will also be taken for all participants (N=20), during their visit to the HISU.
### Conditions Module
**Conditions:**
- Healthy Nutrition
**Keywords:**
- Orange,
- polyphenols
- ileostomy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** FACTORIAL
**Intervention Model Description:** Acute intervention in populations with and without colon
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single Blind(with masked participant)
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participant will be given Orange Juice 300ml to drink
**Intervention Names:**
- Dietary Supplement: 300ml Orange Juice
**Label:** Healthy participants
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participant will be given orange Juice 300ml to drink
**Intervention Names:**
- Dietary Supplement: 300ml Orange Juice
**Label:** Ileostomy participants
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy participants
- Ileostomy participants
**Description:** Acute intervention in populations with and without colon
**Name:** 300ml Orange Juice
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Quantification of polyphenols via LC-MS/MS
**Measure:** Quantification of circulating (blood) (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).
**Time Frame:** Change over 24 hours compared
**Description:** Quantification of polyphenols via LC-MS/MS
**Measure:** Quantification of urinary (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).
**Time Frame:** Change over 24 hours ]
#### Secondary Outcomes
**Description:** Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)
**Measure:** ileal fluid polyphenolic metabolites.
**Time Frame:** Change over 24 hours
**Description:** Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)
**Measure:** Ileal fluid microbial mediated metabolites
**Time Frame:** Change over 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: (ileostomates)
* Adult with an ileostomy, ≥1.5-years post-operative
* Aged 18-75 years at recruitment
* Not pregnant / lactating
* No learning or other disabilities
* Not currently taking antibiotics
* Not currently taking plant-based dietary supplements
* Not currently taking any prescribed medications that would prevent overnight fasting
Inclusion Criteria Healthy adults; no pre-existing chronic disease (GI related)
* Aged 18-75 years at recruitment
* Not pregnant / lactating
* No learning or other disabilities
* Not currently taking antibiotics
* Not currently taking plant-based dietary supplements
* Not currently taking any prescribed medications that would prevent overnight fasting
Exclusion criteria (Ileostomates):
* Adults \<18 or \>75 years at recruitment
* Ileostomy, \<1.5 years post-operative
* Pregnant/lactating females
* Adults with learning or other disabilities
* Citrus fruit (orange) allergy or sensitivity
* Currently taking antibiotics
* Currently taking plant-based dietary supplements
* Currently taking any prescribed medications that would prevent overnight fasting
Exclusion criteria (Healthy adults):
* Adults \<18 or \>70 years at recruitment
* Pregnant/lactating females
* Adults with learning or other disabilities
* Citrus fruit (orange) allergy or sensitivity
* Currently taking antibiotics
* Currently taking plant-based dietary supplements
* Currently taking any prescribed medications that would prevent overnight fasting
**Healthy Volunteers:** True
**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:** Prof Gill, PhD
**Phone:** +44 28 7012 3181
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ruth Price, PhD
**Phone:** +442870123878
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Coleraine
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ruth Price, PhD
- **Phone:** 00442870123878
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Geraldine Horigan, PhD
- **Phone:** +44 2870 123043
- **Phone Ext:** 23043
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Ulster University,Human Intervention Studies Unit,
**State:** Co. Londonderry
**Status:** RECRUITING
**Zip:** BT521SA
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T244
- Name: Orange
- Relevance: HIGH
- As Found: Hard
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430125
**Brief Title:** Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus
**Official Title:** Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
#### Organization Study ID Info
**ID:** Nicorandil Nephroprotective
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-02-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tanta University
#### Responsible Party
**Investigator Affiliation:** Tanta University
**Investigator Full Name:** Mohammed Atta Ali El-Hazzab
**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 aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
### Conditions Module
**Conditions:**
- Type2 Diabetes Mellitus
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
**Intervention Names:**
- Drug: Nicorandil 10 MG Oral Tablet
**Label:** Nicorandil group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nicorandil group
**Description:** Nicorandil 10 MG oral tablet twice daily
**Name:** Nicorandil 10 MG Oral Tablet
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks
**Measure:** prevention of progression of kidney disease as measured by KDIGO.
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Venous blood will be collected before treatment and after 12 week .
**Measure:** change in the serum concentrations of Kidney injury molecule 1(Kim-1).
**Time Frame:** 12 weeks
**Description:** Venous blood will be collected before treatment and after 12 week .
**Measure:** change in the serum concentrations of Interleukin 18 (IL-18).
**Time Frame:** 12 weeks
**Description:** Venous blood will be collected before treatment and after 12 week .
**Measure:** change in the serum concentrations of Nitric oxide (NO).
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C\< 7 )
* Age range between 18 and 60 years old.
* Both sexes.
* Stage 1and Stage 2 CKD according to KDIGO .
* Controlled HTN .
Exclusion Criteria:
* Pregnant and lactating females.
* Patients with hypersensitivity to nicorandil.
* Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
* Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
* Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammed A El-hazzab
**Phone:** 201151998914
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mohammed A El-hazzab
- **Phone:** 201151998914
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Tanta University
**State:** EL Gharbia
**Status:** RECRUITING
## 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
### 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: 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: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Intervention Browse Module - Ancestors
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000014803
- Term: Vitamin B Complex
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M21946
- Name: Nicorandil
- Relevance: HIGH
- As Found: Enabling
- ID: M11667
- Name: Metformin
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- 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: D000020108
- Term: Nicorandil
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430112
**Brief Title:** Liposomal Bupivacaine vs Ropivacaine for TAPBs
**Official Title:** Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial
#### Organization Study ID Info
**ID:** B2023-485-01
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Ping Yu
**Investigator Title:** Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.
**Detailed Description:** This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.
### Conditions Module
**Conditions:**
- Abdominal Tumor
- Postoperative Analgesia
- Liposomal Bupivacaine
- Ropivacaine
**Keywords:**
- liposomal bupivacaine
- ropivacaine
- transversus abdominis plane block
- laparoscopic lower abdominal tumor resection
- opioid consumption
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Liposomal Bupivacaine was used in the group
**Intervention Names:**
- Drug: Liposomal Bupivacaine
**Label:** Liposomal Bupivacaine group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Ropivacaine was used in this group
**Intervention Names:**
- Drug: Ropivacaine
**Label:** Ropivacaine group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Liposomal Bupivacaine group
**Description:** After induction of anesthesia, bilateral TAPB was performed under ultrasound guidance. The patients in the bupivacaine liposome group were injected with bupivacaine liposome 133mg(10ml+ 10ml 0.9% normal saline mixed into 20ml)/ point (two points in total).
**Name:** Liposomal Bupivacaine
**Other Names:**
- Bupivacaine liposome
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Ropivacaine group
**Description:** Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total).
**Name:** Ropivacaine
**Other Names:**
- Ropivacaine Hydrochloride Injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The amount of drug used in the postoperative analgesia pump
**Measure:** Postoperative opioid use
**Time Frame:** 3 days postoperatively
#### Secondary Outcomes
**Description:** Postoperative VAS score
**Measure:** Postoperative pain score
**Time Frame:** 3 days postoperatively
**Description:** Postoperative adverse reactions were followed up
**Measure:** Postoperative adverse reactions
**Time Frame:** 3 days postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients undergoing laparoscopic resection of lower abdominal tumors
2. ASA grade II-III
3. Age: 18-70 years.
Exclusion Criteria:
1. (1) The patient does not agree to participate in the clinical study
2. (2) The patient has a clear history of opioid tolerance or allergy
3. (3) The patient has a history of local anesthetic allergy
4. (4) Previous history of dementia, mental illness or other central nervous system diseases
5. (5) Have a history of chronic pain or are taking opioids and other analgesics
6. (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
7. (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
8. (8) Pregnant women
9. (9) Unable to cooperate with follow-up or poor compliance
10. (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
11. (11) ASA score above grade III.
**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:** Ping Yu
**Phone:** 00-86-13631373286
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jingdun Xie
**Phone:** 00-86-13560380116
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jingdun Xie
- **Phone:** +8613560380116
- **Role:** CONTACT
**Country:** China
**Facility:** Jingdun Xie
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510060
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Anesthesiology,Sun Yat-Sen University Cancer Center
**Name:** Jingdun Xie
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** The persons who were willing to study.
**Description:** https://www.medicalresearch.org.cn/,Time: After completing the academic paper for publication
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** After completing the academic paper for publication
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7
- Name: Abdominal Neoplasms
- Relevance: HIGH
- As Found: Abdominal Tumors
### Condition Browse Module - Meshes
- ID: D000000008
- Term: Abdominal Neoplasms
### 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
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M1700
- Name: Ropivacaine
- Relevance: HIGH
- As Found: Eye
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002045
- Term: Bupivacaine
- ID: D000077212
- Term: Ropivacaine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430099
**Brief Title:** Rate of Blood Pressure Control Among Hypertensive Patients With Hemodialysis in Sohag University Hospital
**Official Title:** Rate of Blood Pressure Control Among Hypertensive Patients With Hemodialysis in Sohag University Hospital
#### Organization Study ID Info
**ID:** Sohagu.
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2024-12-20
**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:** 2024-12-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hager Abdo Mohamed
#### Responsible Party
**Investigator Affiliation:** Sohag University
**Investigator Full Name:** Hager Abdo Mohamed
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this Cross-sectional study is to detect hypertensive patients with hemodialysis in Sohag University Hospital and controlled patients and noncontrolled patients. The main questions it aims to answer are:
1. What is the pattern of blood pressure control among patients receiving hemodialysis?
2. What are factors associated with successful blood pressure control?
3. What is the level of patient knowledge and awareness regarding blood pressure management?
4. What are the challenges and barriers faced by patients in achieving optimal blood pressure control? Participants Blood pressure calculated by taking the average of three consecutive days measurement.
**Detailed Description:** 1. Survey Type: Cross-sectional study.
2. Target Population: Patients undergoing hemodialysis.
3. Sample Size: The target sample size are all hypertensive patients in Sohag university hospital dialysis unit
4. Survey Method: person to person interview in dialysis units will be used for data collection.
Blood pressure calculated by taking the average of three consecutive days
* 1st day (Dialysis Day): - Blood pressure will be measured (pre dialysis, inter dialysis, post dialysis).
* 2nd day (Inter Dialytic Day): - Blood pressure will be measured two times (AM, PM).
* 3rd day (Dialysis Day): - Blood pressure will be measured (pre dialysis, inter dialysis, post dialysis).
### Conditions Module
**Conditions:**
- Hemodialysis
- Hypertension
**Keywords:**
- hypertension hemodialysis
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Days
### Outcomes Module
#### Primary Outcomes
**Measure:** Rate of blood pressure control among hypertensive patients with hemodialysis in Sohag University Hospital with hemodialysis in Sohag University Hospital
**Time Frame:** 3 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- Participants must be
* 18 years or older.
* currently receiving hemodialysis.
* Hypertensive patients.
Exclusion Criteria:
* patients under 18 years old.
* Patients stopped hemodialysis.
* Patients with ESRD not receiving hemodialysis.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** hypertensive patients with hemodialysis in Sohag University Hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hager A Mohamed, M.B.B.CH
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sohag
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hager A Mohamed, M.B.B.CH
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hager A Mohamed, M.B.B.CH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Egypt
**Facility:** Faculty of Medicine Sohag University
**Zip:** 82524
#### Overall Officials
**Official 1:**
**Affiliation:** Sohag University
**Name:** Hassan A Hassanien, professor
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Sohag University
**Name:** Alaa A Ghaleb, professor
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Sohag University
**Name:** Ahmed N Nour Eldin, Lecturer
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Susel J, Batycka-Baran A, Reich A, Szepietowski JC. Uraemic pruritus markedly affects the quality of life and depressive symptoms in haemodialysis patients with end-stage renal disease. Acta Derm Venereol. 2014 May;94(3):276-81. doi: 10.2340/00015555-1749.
**PMID:** 24217858
**Citation:** Lopes AA, Bragg J, Young E, Goodkin D, Mapes D, Combe C, Piera L, Held P, Gillespie B, Port FK; Dialysis Outcomes and Practice Patterns Study (DOPPS). Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney Int. 2002 Jul;62(1):199-207. doi: 10.1046/j.1523-1755.2002.00411.x.
**PMID:** 12081579
**Citation:** Joshi VD. Quality of life in end stage renal disease patients. World J Nephrol. 2014 Nov 6;3(4):308-16. doi: 10.5527/wjn.v3.i4.308.
**PMID:** 25374827
**Citation:** Garcia-Llana H, Remor E, Selgas R. Adherence to treatment, emotional state and quality of life in patients with end-stage renal disease undergoing dialysis. Psicothema. 2013 Feb;25(1):79-86. doi: 10.7334/psicothema2012.96.
**PMID:** 23336548
## 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: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430086
**Brief Title:** Mechanistic Effect of Walnut Consumption on Sleep Quality
**Official Title:** Mechanistic Effect of Walnut Consumption on Sleep Quality
#### Organization Study ID Info
**ID:** AAAV1362
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
#### Secondary ID Infos
**Domain:** USDA/NIFA
**ID:** GRANT13949102
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** United States Department of Agriculture (USDA)
**Class:** OTHER
**Name:** California Walnut Commission
#### Lead Sponsor
**Class:** OTHER
**Name:** Columbia University
#### Responsible Party
**Investigator Affiliation:** Columbia University
**Investigator Full Name:** Marie-Pierre St-Onge
**Investigator Title:** Associate Professor of Nutritional Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.
**Detailed Description:** Walnuts are a nutrient-rich food which provides melatonin and polyphenols. While there is evidence that dietary intakes of foods high in melatonin and polyphenols positively influence sleep quality, the effect of walnuts has not been investigated. The investigators propose to fill this knowledge gap by testing the effects of walnut consumption on serum melatonin and resulting sleep and circadian biology. The study hypotheses are that walnut consumption for 4 days will increase melatonin levels, suggestive of more robust circadian rhythms, and lead to better sleep quality compared to a high-carbohydrate high-sugar (HCHS) equivalent. Using a randomized controlled crossover trial, the study aims to: 1) determine the effect of walnut vs HCHS consumption on melatonin levels; and 2) determine the effect of walnut vs HCHS consumption on sleep and circadian physiology. Adult males and females with poor sleep quality will consume three servings/day of walnuts or an equicaloric HCHS food for 4 days. Sleep quality will be measured nightly using the Karolinska Sleep Diary and wrist actigraphy; sleep architecture from polysomnography will be measured on night 3. Circadian physiology will be assessed on day 4 using body temperature and hourly serum melatonin and on the morning of day 5 from overnight urinary 6-sulfatoxymelatonin. Given the extent of poor sleep, our findings may open new avenues to improve sleep health from increased walnut consumption.
### Conditions Module
**Conditions:**
- Poor Sleep Quality
**Keywords:**
- Randomized crossover study
- Controlled feeding
- Dietary intervention
- Inpatient visit
- Outpatient monitoring
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Randomized crossover design
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Statistician will be masked to study condition. Participants cannot be masked. Other personnel involved in the study cannot be masked.
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will consume 3 servings/day of walnuts (3 oz/d) over 4 days and have a washout for 2-3 weeks then crossover to consume 3 equicaloric servings of a HCHS food over 4 days.
Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.
**Intervention Names:**
- Other: Walnut consumption
- Other: HCHS consumption
**Label:** Walnut - washout - HCHS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will consume 3 equicaloric servings of a HCHS food over 4 days and have a washout for 2-3 weeks then crossover to consume 3 servings/day of walnuts (3 oz/d) for 4 days.
Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.
**Intervention Names:**
- Other: Walnut consumption
- Other: HCHS consumption
**Label:** HCHS - washout - Walnut
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HCHS - washout - Walnut
- Walnut - washout - HCHS
**Description:** Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.
**Name:** Walnut consumption
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- HCHS - washout - Walnut
- Walnut - washout - HCHS
**Description:** Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.
An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.
**Name:** HCHS consumption
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** This is to measure Endothelial cell inflammation in endothelial cells collected from a forearm vein. Repeated for each phase. Fasted sample.
**Measure:** NFkB level
**Time Frame:** Day 4 (or Day 5)
#### Primary Outcomes
**Description:** Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.
**Measure:** Serum melatonin
**Time Frame:** Baseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)
**Description:** Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.
**Measure:** Sleep quality index
**Time Frame:** Night 1, Night 2, Night 3, Night 4
**Description:** Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.
**Measure:** Slow wave sleep index
**Time Frame:** Night 3
#### Secondary Outcomes
**Description:** This is to measure Melatonin production in urine samples. Repeated for each phase.
**Measure:** 6-sulfatoxymelatonin level
**Time Frame:** Night 4 to morning of Day 5 (Approximately up to 12 hours)
**Description:** Proximal to distal body temperature gradient measured using thermochron devices (iButtons). Repeated for each phase. In patient. Over 24 hours.
**Measure:** Body temperature
**Time Frame:** Day 4
**Description:** Self-reported sleep quality assessed using the Karolinska Sleep Diary. Repeated for each phase.
**Measure:** Sleep quality score
**Time Frame:** Days 2, 3, 4, 5
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Equal numbers of men and women (12 male and 12 post-menopausal female)
* Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2)
* Participants will self-report poor sleep quality, reflected by a global score \>5 on Pittsburgh Sleep Quality Index
Exclusion Criteria:
* Diagnosed sleep disorder
* Participants with conditions that could affect sleep will be excluded:
* smoking, excessive caffeine intake (\>300 mg/day)
* shift work
* chronic pain
* diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease),
* autoimmune diseases
* cardiovascular event or cancer in the past 24 months
* psychiatric/neurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)
* use of medications that influence CYP1A2 enzymes
* Allergy/intolerance to nuts, tree nuts, or unwilling to eat study foods
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lena Navarro, BS
**Phone:** 347-963-8845
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Claudia Dreyer, BS
**Phone:** 347-881-6008
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lena Navarro, BS
- **Phone:** 347-963-8845
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Claudia Dreyer, BS
- **Phone:** 347-881-6008
- **Role:** CONTACT
***Contact 3:***
- **Name:** Marie-Pierre St-Onge, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Columbia University Irving Medical Center
**State:** New York
**Zip:** 10032
#### Overall Officials
**Official 1:**
**Affiliation:** Associate Professor of Nutritional Medicine
**Name:** Marie-Pierre St-Onge, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. We will submit metadata associated with the datasets to Zenodo. The repository will provide metadata, persistent identifiers, and long-term access for open and controlled access. Each study created in Zenodo is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication. To request access of the data, researchers will use the standard processes at Zenodo. Given that we seek the widest possible availability, in most cases all that is necessary is obtaining a Zenodo account from the repository web site.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Within 12 months of final study completion.
**URL:** https://about.zenodo.org/policies/
## Derived Section
### 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
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M11533
- Name: Melatonin
- Relevance: LOW
- As Found: Unknown
- ID: T410
- Name: Melatonin
- Relevance: LOW
- As Found: Unknown
- ID: T143
- Name: English Walnut
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430073
**Acronym:** INFRAGEN
**Brief Title:** Effect of Infections and Global DNA Methylation on Frailty Trajectories in Hospitalized Older Patients (INFRAGEN)
**Official Title:** Effect of Infections and Global DNA Methylation on Frailty Trajectories in Hospitalized Older Patients: a Multicenter Observational Study (INFRAGEN)
#### Organization Study ID Info
**ID:** 83/2023/Oss/AOUFe
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Ferrara
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-26
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Azienda Ospedaliera di Padova
**Class:** OTHER
**Name:** Fondazione IRCCS San Gerardo dei Tintori
**Class:** OTHER
**Name:** Azienda Ospedaliera Universitaria Policlinico
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital of Ferrara
#### 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 prospective multicenter study aims at exploring the impact of infections on intra-hospital and 3-month changes in the frailty profile of older inpatients.
To understand the complex pathways under the relationship between infections and frailty, this study will evaluate infection-related clinical and biochemical markers of systemic inflammation and genetics/epigenetics markers at ward admission.
The interplay between clinical, functional, and genetics/epigenetics factors will be evaluated in a subgroup of patients by testing whether 3-month changes in frailty concur with changes in the genomic DNA markers. This study will help characterize the pathophysiological mechanisms of frailty and identify at-risk conditions that may accelerate its course.
**Detailed Description:** Infectious diseases are among the most common causes of hospitalization in older adults. Indeed, recent data report that more than 15% of hospital admissions in adults 65 years or older are due to infections, mainly in the urinary and respiratory tracts. Frailty is a well-known geriatric syndrome characterized by reduced individual resilience and increased vulnerability to external stressors. The prevalence of frailty ranges from around 10% in the community setting to almost 50% among institutionalized individuals.
Although both infectious diseases and frailty are associated with negative outcomes for the health of older adults and the healthcare system, their interplay has not been largely explored. In particular, it is not clear whether and to which extent acute infectious diseases might affect frailty, fastening its development or hampering its reversion.
The overall goal of the proposed project is to evaluate the impact of acute infections on frailty trajectories in older hospitalized patients from the pre-admission status to 3 months after hospital discharge. Moreover, a comprehensive set of sociodemographic, clinical, functional, and genetic/epigenetic factors will be assessed as possible effect modifiers in the association between infections and frailty trajectories.
This multicenter prospective observational study includes four geriatric wards (Ferrara, Padova, Milano, and Napoli) and involves individuals with no or mild-to-moderate frailty. A novel and interesting aspect will be represented by the analysis of genetic and epigenetic factors, i.e. global DNA methylation and telomere length. This point will make possible exploring the complex pathophysiologic mechanisms of frailty development using a translational approach involving both basic science and clinical researchers.
Overall, this study will help better identify at-risk conditions that may accelerate the course of frailty. Therefore, the project findings may promote the importance of interventions that could counteract frailty development during the hospital stay and should be addressed primarily to the categories of patients at highest risk.
### Conditions Module
**Conditions:**
- Aging
- Frailty
- Telomere Shortening
- Inflammation
- Hospital Infection
### Design Module
#### Bio Spec
**Description:** Blood sample
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 340
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study cohort will be composed of 340 older patients hospitalized in a Geriatric Unit with no or mild frailty in the pre-admission period, and who will present acute infections at admission or during the hospital stay.
**Label:** Total sample
### Outcomes Module
#### Primary Outcomes
**Description:** Frailty will be valuated through the Frailty Index (i.e. score from 0 to 1, with higher values corresponding to higher frailty), considering clinical and functional data. Pre-admission frailty will be retrospectively assessed to reflect the participant's status in the two weeks prior to the hospital admission. Frailty assessment will be repeated within 48h before the hospital discharge.
**Measure:** Change in frailty index from pre-admission to hospital discharge
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
#### Secondary Outcomes
**Description:** Frailty will be evaluated through the Clinical Frailty Scale (i.e. score from 1 to 9, with higher values corresponding to higher frailty). Pre-admission frailty will be retrospectively assessed to reflect the participant's status in the two weeks prior to the hospital admission. Frailty assessment will be repeated within 48h before the hospital discharge.
**Measure:** Change in Clinical Frailty Scale from pre-admission to hospital discharge
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
**Description:** All-cause mortality will be computed for participants with vs without infections associated with a systemic inflammatory response.
**Measure:** Difference in in-hospital mortality between inpatients with vs without infections with systemic inflammation
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
**Description:** The length of hospital stay (number of days from hospital admission to hospital discharge) will be computed for participants with vs without infections associated with a systemic inflammatory response.
**Measure:** Difference in the length of hospital stay between inpatients with vs without infections with systemic inflammation
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
**Description:** DNA extraction from whole blood will be performed by Automated Genomic DNA Purification EZ1 XL machine (QIAGEN). Global DNA methylation assessment will be performed by "highly quantitative pyrosequencing" technique as genome-wide DNA methylation levels and as gene promoter associated CpG islands utilizing selected age-related methylation marker loci and at LINE-1 repetitive elements (as a surrogate for genome-wide methylation). The patterns of global DNA methylation will be assessed in duplicate for each sample and expressed in percentage as the mean obtained by the two evaluations and considered valuable with a discrepancy \<2%. Methylation percentages can be stratified into quartiles, and the middle two quartiles combined will be used as the reference category. The frequencies of individuals belonging to the highest and lowest DNA methylation quartiles will be compared between individuals reporting worsening in FI or CFS during the hospitalization vs those stable in frailty levels.
**Measure:** Difference in the global DNA methylation between individuals with stable vs worsened frailty during the hospital stay.
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
**Description:** Telomere length will be compared between individuals with stable vs worsened frailty during the hospital stay. DNA extraction from whole blood will be performed by Automated Genomic DNA Purification EZ1 XL machine (QIAGEN). Leukocyte Telomere Length (LTL) will be assessed by quantitative PCR as previously described as predictors of biological age in frailty and mortality association studies. As a measure of the relative Telomere length, the ratio of the telomere repeat copy number to the number of single-copy gene ratio (T/S ratio) will be determined by quantitative PCR using the single-copy gene 36B4 for reference and a standard curve. Quality controls and assay validation tests will be assessed by official commercial recognized standards (Qiagen, LifeTechnology).
**Measure:** Difference in telomere length between individuals with stable vs worsened frailty during the hospital stay
**Time Frame:** From 14 days before admission to hospital discharge (up to 60 days)
**Description:** Frailty will be valuated through the Frailty Index (i.e. score from 0 to 1, with higher values corresponding to higher frailty), considering clinical and functional data. Frailty assessment will be performed within 48h before the hospital discharge and after 3-month from the hospital discharge.
**Measure:** Change in frailty index from hospital discharge to 3-month follow-up
**Time Frame:** From hospital discharge until 3 months after hospital discharge (time frame: 3 months)
**Description:** Frailty will be evaluated through the Clinical Frailty Scale (i.e. score from 1 to 9, with higher values corresponding to higher frailty). Frailty assessment will be performed within 48h before the hospital discharge and after 3-month from the hospital discharge.
**Measure:** Change in Clinical Frailty Scale from hospital discharge to 3-month follow-up
**Time Frame:** From hospital discharge until 3 months after hospital discharge (time frame: 3 months)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* confirmed diagnosis of acute infection diseases at hospital admission or during the hospital stay, according to specific ICD-9 codes with or without systemic inflammatory reaction;
* pre-admission non-frailty or mild frailty assessed using the Clinical Frailty Scale (CFS \< 6).
Exclusion Criteria:
* terminally ill patients with an estimated life expectancy less than 3 months;
* presence of pre-admission frailty (CFS ≥ 6);
* unwillingness to participate in the study or to complete the follow-up assessments
**Minimum Age:** 70 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** The project will involve older patients hospitalized in the Geriatric Units of the University Hospital of Ferrara, Padua, Monza, and Napoli. All patients non-frail or with mild frailty in the pre-admission period, and who will present a confirmed diagnosis of acute infection diseases at hospital admission or during the hospital stay, will be enrolled in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Caterina Trevisan, PhD
**Phone:** +393896743650
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Università degli Studi di Ferrara
**Name:** Stefano Volpato, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Franceschi C, Campisi J. Chronic inflammation (inflammaging) and its potential contribution to age-associated diseases. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9. doi: 10.1093/gerona/glu057.
**PMID:** 24833586
**Citation:** Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
**PMID:** 11253156
**Citation:** Greco GI, Noale M, Trevisan C, Zatti G, Dalla Pozza M, Lazzarin M, Haxhiaj L, Ramon R, Imoscopi A, Bellon S, Maggi S, Sergi G. Increase in Frailty in Nursing Home Survivors of Coronavirus Disease 2019: Comparison With Noninfected Residents. J Am Med Dir Assoc. 2021 May;22(5):943-947.e3. doi: 10.1016/j.jamda.2021.02.019. Epub 2021 Feb 22.
**PMID:** 33757725
**Citation:** Huoman J, Sayyab S, Apostolou E, Karlsson L, Porcile L, Rizwan M, Sharma S, Das J, Rosen A, Lerm M. Epigenetic rewiring of pathways related to odour perception in immune cells exposed to SARS-CoV-2 in vivo and in vitro. Epigenetics. 2022 Dec;17(13):1875-1891. doi: 10.1080/15592294.2022.2089471. Epub 2022 Jun 26.
**PMID:** 35758003
**Citation:** Iwai-Saito K, Shobugawa Y, Aida J, Kondo K. Frailty is associated with susceptibility and severity of pneumonia in older adults (A JAGES multilevel cross-sectional study). Sci Rep. 2021 Apr 12;11(1):7966. doi: 10.1038/s41598-021-86854-3.
**PMID:** 33846416
**Citation:** Lapham K, Kvale MN, Lin J, Connell S, Croen LA, Dispensa BP, Fang L, Hesselson S, Hoffmann TJ, Iribarren C, Jorgenson E, Kushi LH, Ludwig D, Matsuguchi T, McGuire WB, Miles S, Quesenberry CP Jr, Rowell S, Sadler M, Sakoda LC, Smethurst D, Somkin CP, Van Den Eeden SK, Walter L, Whitmer RA, Kwok PY, Risch N, Schaefer C, Blackburn EH. Automated Assay of Telomere Length Measurement and Informatics for 100,000 Subjects in the Genetic Epidemiology Research on Adult Health and Aging (GERA) Cohort. Genetics. 2015 Aug;200(4):1061-72. doi: 10.1534/genetics.115.178624. Epub 2015 Jun 19.
**PMID:** 26092717
**Citation:** Park CM, Kim W, Rhim HC, Lee ES, Kim JH, Cho KH, Kim DH. Frailty and hospitalization-associated disability after pneumonia: A prospective cohort study. BMC Geriatr. 2021 Feb 5;21(1):111. doi: 10.1186/s12877-021-02049-5.
**PMID:** 33546614
**Citation:** Prampart S, Le Gentil S, Bureau ML, Macchi C, Leroux C, Chapelet G, de Decker L, Rouaud A, Boureau AS. Functional decline, long term symptoms and course of frailty at 3-months follow-up in COVID-19 older survivors, a prospective observational cohort study. BMC Geriatr. 2022 Jun 30;22(1):542. doi: 10.1186/s12877-022-03197-y.
**PMID:** 35768781
**Citation:** Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.
**PMID:** 17634318
**Citation:** Schneider CV, Schneider KM, Teumer A, Rudolph KL, Hartmann D, Rader DJ, Strnad P. Association of Telomere Length With Risk of Disease and Mortality. JAMA Intern Med. 2022 Mar 1;182(3):291-300. doi: 10.1001/jamainternmed.2021.7804.
**PMID:** 35040871
**Citation:** Schork NJ, Beaulieu-Jones B, Liang W, Smalley S, Goetz LH. Does Modulation of an Epigenetic Clock Define a Geroprotector? Adv Geriatr Med Res. 2022;4(1):e220002. doi: 10.20900/agmr20220002. Epub 2022 Mar 29.
**PMID:** 35466328
**Citation:** Seligman BJ, Berry SD, Lipsitz LA, Travison TG, Kiel DP. Epigenetic Age Acceleration and Change in Frailty in MOBILIZE Boston. J Gerontol A Biol Sci Med Sci. 2022 Sep 1;77(9):1760-1765. doi: 10.1093/gerona/glac019.
**PMID:** 35037036
**Citation:** Vetter VM, Kalies CH, Sommerer Y, Spira D, Drewelies J, Regitz-Zagrosek V, Bertram L, Gerstorf D, Demuth I. Relationship Between 5 Epigenetic Clocks, Telomere Length, and Functional Capacity Assessed in Older Adults: Cross-Sectional and Longitudinal Analyses. J Gerontol A Biol Sci Med Sci. 2022 Sep 1;77(9):1724-1733. doi: 10.1093/gerona/glab381.
**PMID:** 35032170
**Citation:** Vlachogiannis NI, Baker KF, Georgiopoulos G, Lazaridis C, van der Loeff IS, Hanrath AT, Sopova K, Tual-Chalot S, Gatsiou A, Spyridopoulos I, Stamatelopoulos K, Duncan CJA, Stellos K. Clinical frailty, and not features of acute infection, is associated with late mortality in COVID-19: a retrospective cohort study. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1502-1513. doi: 10.1002/jcsm.12966. Epub 2022 Mar 7.
**PMID:** 35257497
**Citation:** Wang J, Maxwell CA, Yu F. Biological Processes and Biomarkers Related to Frailty in Older Adults: A State-of-the-Science Literature Review. Biol Res Nurs. 2019 Jan;21(1):80-106. doi: 10.1177/1099800418798047. Epub 2018 Sep 9.
**PMID:** 30198309
**Citation:** Yoshikawa TT, Norman DC. Geriatric Infectious Diseases: Current Concepts on Diagnosis and Management. J Am Geriatr Soc. 2017 Mar;65(3):631-641. doi: 10.1111/jgs.14731. Epub 2017 Jan 31.
**PMID:** 28140454
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007049
- Term: Iatrogenic Disease
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- 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: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Frailty
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M6642
- Name: Cross Infection
- Relevance: HIGH
- As Found: Hospital Infection
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M10099
- Name: Iatrogenic Disease
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000003428
- Term: Cross Infection
- ID: D000007249
- Term: Inflammation
- ID: D000073496
- Term: Frailty
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430060
**Brief Title:** The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis
**Official Title:** The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Threemonth Clinical Study)
#### Organization Study ID Info
**ID:** CRO-2024-03-GIN-DZN-CN-YPZ
#### Organization
**Class:** INDUSTRY
**Full Name:** Colgate Palmolive
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### 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:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.
### Conditions Module
**Conditions:**
- Plaque, Dental
- 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:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** toothpaste
**Intervention Names:**
- Drug: zinc containing toothpaste
**Label:** Colgate Dual Zinc Toothpaste
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** toothpaste
**Intervention Names:**
- Drug: MFP Fluoride toothpaste
**Label:** Colgate Cavity Protection Toothpaste
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Colgate Dual Zinc Toothpaste
**Description:** Toothpaste
**Name:** zinc containing toothpaste
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Colgate Cavity Protection Toothpaste
**Description:** toothpaste
**Name:** MFP Fluoride 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-Silness Gingival Index score
**Time Frame:** baseline, 2 week, 6 week, 3 month
**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-Hein Plaque Index score
**Time Frame:** baseline, 2 week, 6 week, 3 month
### 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).
* 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 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 which 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:** Deyu Hu, DDS, MS
**Phone:** 86-1390-803-4990
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chengdu
**Country:** China
**Facility:** West China Dental Institute of Chengdu
**State:** Sichuan
**Zip:** 610041
#### Overall Officials
**Official 1:**
**Affiliation:** West China Dental Institute of Chengdu
**Name:** Deyu Hu, DDS, MS
**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
- ID: D000003741
- Term: Dental Deposits
- ID: D000014076
- Term: Tooth 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: M6970
- Name: Dental Plaque
- Relevance: HIGH
- As Found: Plaque, Dental
- 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
- ID: M6938
- Name: Dental Deposits
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005891
- Term: Gingivitis
- ID: D000003773
- Term: Dental Plaque
### 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
- Abbrev: Micro
- Name: Micronutrients
### 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: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000005459
- Term: Fluorides
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430047
**Brief Title:** Efficacy and Safety of EsoDuo®
**Official Title:** The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
#### Organization Study ID Info
**ID:** B73_02GERD2107
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-11-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chong Kun Dang Pharmaceutical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid
**Detailed Description:** The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study \[RACER Study\]
### Conditions Module
**Conditions:**
- Gastro Esophageal Reflux
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: EsoDuo® Tablet
**Label:** Experimental Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group
**Description:** QD, PO
**Name:** EsoDuo® Tablet
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the symptoms of GERD : heartburn or acid reflux
**Measure:** The time taken to control the symptoms of GERD
**Time Frame:** 2 weeks after the clinical trial participation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or Female aged ≥ 19 years
2. Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
3. Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)
Exclusion Criteria:
1. Surgery history on stomach or esophagus
2. Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
3. Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
4. Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
5. Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
6. Clinically significant Abnormal Lab test
7. Pregnant woman, Breastfeeding woman.
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hwoon-Yong Jung, M.D, PhD
**Phone:** 82+2-3010-3197
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Hwoon-Yong Jung, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone:** 82+2-3010-3197
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Asan Medical Center
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Asan Medical Cental of Korea
**Name:** Hwoon-Yong Jung, M.D, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015154
- Term: Esophageal Motility Disorders
- ID: D000003680
- Term: Deglutition Disorders
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M8880
- Name: Gastroesophageal Reflux
- Relevance: HIGH
- As Found: Gastro Esophageal Reflux
- ID: M17874
- Name: Esophageal Motility Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17875
- Name: Esophageal Spasm, Diffuse
- Relevance: LOW
- As Found: Unknown
- ID: M6882
- Name: Deglutition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal 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
### Condition Browse Module - Meshes
- ID: D000005764
- Term: Gastroesophageal Reflux
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430034
**Brief Title:** Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization by Botulinum Toxin Injections. Study of Facial Symmetry Before and After Botulinum Toxin Injections on the Face of Patients Suffering From Sequellar Peripheral Facial Paralysis
**Official Title:** Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization Through Botulinum Toxin Injections, in Patients With Peripheral Facial Palsy
#### Organization Study ID Info
**ID:** 24IUFC01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2025-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Nice
#### 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 is a prospective, single-center study. The main objective of our study will be to objectively evaluate the improvement of facial symmetry after botulinum toxin injection on the face in patients suffering from sequelae of peripheral facial paralysis. A secondary objective will be to assess the utility of 3D photography and stereophotogrammetry to detect and quantify facial changes relevant to this type of treatment. The number of patients included in the study is expected to be 15 at minimum. Our study will rely on 3D photographs taken with the Vectra H2 Imaging System camera device (Canfield Scientific, Inc., Fairfield, New Jersey), which will be captured before and 3 weeks to 1 month after botulinum toxin injection into the facial muscles. Various analyses of static and dynamic symmetry will be performed using the Vectra software: bi-pupillary line angle / bi-commissural line angle, superposition of healthy and pathological sides followed by RMS (root mean square) calculation, analysis of pre- and post-injection skin displacement vectors.
The results of these analyses will allow conclusions to be drawn regarding the objective efficacy of botulinum toxin injections for facial symmetrization in patients with peripheral facial paralysis, as well as to adapt injection patterns based on the severity of facial paralysis."
### Conditions Module
**Conditions:**
- Peripheral Facial Palsy
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of static and dynamic symmetry: bi-pupillary line / bi-commissural line angle - measure in degrees
**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection - line
**Time Frame:** Day of injection and 3-4 weeks after.
**Description:** Assessment of static and dynamic symmetry:
superposition of healthy and pathological sides and calculation of RMS (root mean square)
**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection
**Time Frame:** Day of injection and 3-4 weeks after.
**Description:** Assessment of static and dynamic symmetry:
analysis of pre- and post-injection skin displacement vectors, Before and after botulinum toxin injection.
**Measure:** Objective assessment of facial symmetrization after botulinum toxin injection
**Time Frame:** Day of injection and 3-4 weeks after.
#### Secondary Outcomes
**Description:** Measure of symmetrization : degrees of facial palsy.
**Measure:** Evaluation of the importance of symmetrization based on injection patterns, types, and degrees of facial palsy.
**Time Frame:** Day of injection and 3-4 weeks after.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The inclusion criteria were patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France at Head and Neck Institute, Nice, France. The exclusion criteria were history of corrective surgery for facial palsy, significant facial surgery, neurodegenerative diseases, the presence of skin imperfections or facial tumors that would impede a rigorous analysis of wrinkles and facial movements.
Exclusion Criteria: None
-
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at Head and Neck Institute, Nice, France
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Robin PRADEL
**Phone:** 0673398497
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Charles SAVOLDELLI, MD
**Phone:** 0648275014
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Robin PRADEL
- **Phone:** 0673398497
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Charles SAVOLDELLI, MD
- **Phone:** 0648275014
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** CHU NICE
**State:** Alpes Maritimes
**Status:** RECRUITING
**Zip:** 0600
#### Overall Officials
**Official 1:**
**Affiliation:** Centre Hospitalier Universitaire de Nice
**Name:** Charles SAVOLDELLI
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010243
- Term: Paralysis
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000005155
- Term: Facial Nerve Diseases
- ID: D000003389
- Term: Cranial Nerve Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC10
- Name: Nervous 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: M22138
- Name: Bell Palsy
- Relevance: HIGH
- As Found: Facial Palsy
- ID: M8301
- Name: Facial Paralysis
- Relevance: HIGH
- As Found: Facial Palsy
- ID: M21089
- Name: Facies
- Relevance: HIGH
- As Found: Facial
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- 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
- ID: M12404
- Name: Neurologic Manifestations
- 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: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M8298
- Name: Facial Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6605
- Name: Cranial Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T707
- Name: Bell's Palsy
- Relevance: HIGH
- As Found: Facial Palsy
### Condition Browse Module - Meshes
- ID: D000020330
- Term: Bell Palsy
- ID: D000005158
- Term: Facial Paralysis
- ID: D000019066
- Term: Facies
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5183
- Name: Botulinum Toxins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430021
**Acronym:** PRO-NEM1
**Brief Title:** Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an MEN1 Mutation
**Official Title:** Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation: the Progastrin-NEM1 Study
#### Organization Study ID Info
**ID:** GOUDET BIODENA 2023
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire Dijon
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**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:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire Dijon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Multiple Endocrine Neoplasia type 1 (MEN1) is an autosomal dominant disease with a high degree of penetrance (\>80% of patients). It is caused by the presence of the MEN1 mutation located on chromosome 11q13. The prevalence of this mutation is estimated at approximately 1/30,000. This hereditary syndrome is characterized by the presence of tumours of the endocrine system (adenoma of the parathyroid, pituitary and adrenal glands, neuroendocrine tumors - NETs - of the endocrine pancreas, duodenum, lung or thymus), which threaten the health of these patients. Other malignant tumors such as breast cancer are also more common in patients with MEN1.
The clinical manifestations of MEN1 are linked to the location of the adenomas and NETs and their secretory products. Indeed, most NETs produce and secrete numerous peptide hormones (in the case of Insulinomas, Gastrinomas, VIPomas, Glucagonomas or PPomas for example). This causes a specific clinical syndrome, which can be detected in the blood serum. However, most NETs are "non-functional" tumors, which do not have specific secretions.
Among general tumor markers, chromogranin A (CgA) is widely used as a biomarker for monitoring NETs. CgA is a secretory protein released into the blood by neuroendocrine cells. However, the performance of CgA as a diagnostic biomarker is too limited to be used for the early identification of NETs, particularly in patients with MEN1.
This is why patients with MEN1 undergo regular biological and morphological examinations, at least once a year, to screen for the development of adenomas and NETs. However, CgA or hormone secretions assays, and imaging examinations (MRI, CT scan, or duodenopancratic endoscopic ultrasound (EUS)) are tedious and stressful for patients; in addition, they all have their limitations (poor performance for biological tests; irradiation for CT scan; need for anesthesia for endoscopic ultrasound, etc.). Consequently, there is a need for new markers to identify NETs in this population as early as possible.
Progastrin is a pro-hormone that, under physiological conditions, is matured into gastrin in the G cells of the antrum of the stomach. The role of gastrin is to stimulate gastric acid secretion during digestion. It also plays an important role in regulating cell growth in the gastric mucosa. In pathological situations, it has been shown that the GAST gene, which codes for progastrin, is over-expressed in human tumor cells of different origins, leading to the accumulation of progastrin within them. Tumor cells that are unable to mature progastrin into gastrin, either because the maturation enzymes are not expressed or are inhibited, will secrete it. This circulating progastrin is then called hPG80 (to differentiate it from intracellular progastrin) and is detectable in patient blood. hPG80 is a new biomarker for the detection of different types of cancer. It appears to be elevated in the early stages of the disease, potentially more so than other biomarkers such as circulating tumor DNA (ctDNA) or NETest. In addition, hPG80 is easily measured in plasma using the DxPG80.Lab ELISA (Progastrin Manufacturing). The analytical characteristics of this CE-marked in vitro diagnostic test have been published in the Analytical Methods journal. It has been validated in numerous studies of various cancers, including NET patients. In addition, a study conducted by the team at Progastrin Manufacturing (formerly ECS-Progastrin) showed that hPG80 was unequivocally present in the peripheral blood of patients with 11 different types of cancer, with a concentration significantly higher than that found in blood donors considered to be healthy. We therefore hypothesize that hPG80 could also be a biomarker for NETs in MEN1.
### Conditions Module
**Conditions:**
- Neuroendocrine Tumors
- MEN1 Mutation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 297
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients with proven MEN1, symptomatic or not
**Intervention Names:**
- Biological: blood sample
**Label:** patient
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patient
**Description:** 8 mL blood sample in EDTA tube
**Name:** blood sample
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Significant NET = metastatic or progressive morphologically or supracentimetric NET of the pancreas, duodenum, lung/bronchus or thymus absence of significant NET = patient with sub-centimetric, stable and asymptomatic NET / with or without adenoma
**Measure:** Presence of at least one significant NET vs. absence of significant NET or resected NET without relapse confirmed by thoracic-abdominal imaging
**Time Frame:** Within 3 months before or after inclusion.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with proven MEN1, symptomatic or not, confirmed on the basis of the following international criteria (Thakker et al.):
* patients with an MEN1 mutation;
* patients belonging to an identified MEN1 family in which at least one first-degree relative has been affected and has at least one MEN1-related lesion;
* patients without a positive genetic test or a family history of the disease, but with at least two of the three main MEN1 lesions (parathyroid adenomas, duodenopancreatic NETs and pituitary tumours).
* Patients aged between 18 and 60 years,
* Patients who have undergone thoracoabdominal imaging (MRI, and/or CT and/or somatostatin receptor imaging (PET or octreotide scan)) within 3 months prior to inclusion or are due to undergo imaging within 3 months of inclusion to document the presence of NETs,
* Regardless of the treatment they are receiving (treatment naïve or treated patient),
* Regardless of the type of disease associated with MEN1 (presence or absence of NET, adenoma....),
* Patients who did not object to taking part in the study.
Exclusion Criteria:
* Person not affiliated to national health insurance
* Person subject to a measure legal protection (curatorship, guardianship) or a court order
* Pregnant, parturient or breastfeeding mothers
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** Patients will be seen for follow-up consultations
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Côme LEPAGE
**Phone:** 0380293750
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dijon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Côme LEPAGE
- **Phone:** 0380293750
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Chu Dijon Bourgogne
**Zip:** 21000
## 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- 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: T4091
- Name: Neuroendocrine Tumor
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018358
- Term: Neuroendocrine Tumors
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06430008
**Brief Title:** The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
**Official Title:** A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
#### Organization Study ID Info
**ID:** 2024-KY-144
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hu Yinan
#### Responsible Party
**Investigator Affiliation:** China-Japan Friendship Hospital
**Investigator Full Name:** Hu Yinan
**Investigator Title:** China-Japan Friendship Hospital
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is:
Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia?
Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.
### Conditions Module
**Conditions:**
- Lipid Pneumonia
- Superoxide Dismutase
- Sialic Acid
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 160
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** lipid pneumonia
#### Arm Group 2
**Label:** cough
#### Arm Group 3
**Label:** cryptogenic organizing pneumonia
#### Arm Group 4
**Label:** pulmonary alveolar proteinosis
#### Arm Group 5
**Label:** bacterial pneumonia
#### Arm Group 6
**Label:** fungal pneumonia
#### Arm Group 7
**Label:** pulmonary edema
#### Arm Group 8
**Label:** mucinous adenocarcinoma of the lung
### Outcomes Module
#### Primary Outcomes
**Measure:** superoxide dismutase
**Time Frame:** At the time of admission
#### Secondary Outcomes
**Measure:** sialic acid
**Time Frame:** At the time of admission
**Measure:** death or not
**Time Frame:** Within 10 years after discharge
**Measure:** neutrophil-to-lymphocyte ratio
**Time Frame:** At the time of admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age≥ 18 years old;
2. The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
3. Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
4. Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
5. Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
6. Lung imaging of patients with pulmonary edema must show paving stone signs;
Exclusion Criteria:
1. Age\< 18 years old;
2. The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
3. Co-infection with the corona virus disease 2019 at the onset of illness;
4. Pregnant
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This study includes the lipoid pneumonia patients, patients with cough in the upper respiratory tract only, patients with bacterial and fungal pneumonia, patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis, patients with lung mucinous adenocarcinoma and patients with pulmonary edema.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** China-Japan Friendship Hospital
**State:** Beijing
**Zip:** 100000
#### Overall Officials
**Official 1:**
**Affiliation:** China-Japan Friendship Hospital
**Name:** Yinan Hu
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** All IPD collected throughout the trial, only IPD used in the results publication
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**URL:** http://www.medresman.org.cn
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000011015
- Term: Pneumonia, Aspiration
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M13904
- Name: Pneumonia
- Relevance: HIGH
- As Found: Pneumonia
- ID: M13907
- Name: Pneumonia, Lipid
- Relevance: HIGH
- As Found: Lipoid Pneumonia
- 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: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13905
- Name: Pneumonia, Aspiration
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011014
- Term: Pneumonia
- ID: D000011017
- Term: Pneumonia, Lipid
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16264
- Name: Superoxide Dismutase
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429995
**Acronym:** SFPMAMMA
**Brief Title:** Standard Follow-up Program (SFP) for Breast Cancer Patients
**Official Title:** Standard Follow-up Program (SFP) for Breast Cancer Patients
#### Organization Study ID Info
**ID:** SFP MAMMA
#### Organization
**Class:** OTHER
**Full Name:** University Medical Center Groningen
### Status Module
#### Completion Date
**Date:** 2030-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2030-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2008-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Medical Center Groningen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.
Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
### Conditions Module
**Conditions:**
- Breast Cancer
**Keywords:**
- Acute toxicity
- Late toxicity
- Prediction models
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 30 Years
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Radiotherapy
**Other Names:**
- chemoradiation
**Type:** RADIATION
### Outcomes Module
#### Other Outcomes
**Description:** Hb level (mmol/l) measured in blood
**Measure:** Hemoglobin (Hb)
**Time Frame:** Before start of radiation therapy
**Description:** Ht levels (L/L) measured in blood
**Measure:** Hematocrit (Ht)
**Time Frame:** Before start of radiation therapy
**Description:** Leukocytes + differential count (10E9/l) measured in blood
**Measure:** Leukocytes
**Time Frame:** Before start of radiation therapy
**Description:** Creatinine levels (mmol/l) measured in blood
**Measure:** Creatinine
**Time Frame:** Before start of radiation therapy
**Description:** eGFR calculated from creatinine levels (ml/min)
**Measure:** Estimated Glomerular filtration rate (eGFR)
**Time Frame:** Before start of radiation therapy
**Description:** Urea levels (mmol/l) measured in blood
**Measure:** Urea
**Time Frame:** Before start of radiation therapy
**Description:** HbA1c levels (mmol/mol) measured in blood
**Measure:** Hemoglobin A1c (HbA1c)
**Time Frame:** Before start of radiation therapy
**Description:** Cholesterol levels (mmol/L) measured in blood
**Measure:** Cholesterol
**Time Frame:** Before start of radiation therapy
**Description:** HDL cholesterol levels (mmol/L) measured in blood
**Measure:** High-densitiy-lipoprotein cholesterol (HDL cholesterol)
**Time Frame:** Before start of radiation therapy
**Description:** LDL cholesterol levels (mmol/L) measured in blood
**Measure:** Low-density-lipoprotein cholesterol (LDL cholesterol)
**Time Frame:** Before start of radiation therapy
**Description:** Triglycerides levels (mmol/L) measured in blood
**Measure:** Triglycerides
**Time Frame:** Before start of radiation therapy
**Description:** HsCRP levels (mg/L) measured in blood
**Measure:** High sensitive C-reactive protein (hsCRP)
**Time Frame:** Before start of radiation therapy
**Description:** TSH levels (mU/L) measured in blood
**Measure:** Thyroid stimulating hormone (TSH)
**Time Frame:** Before start of radiation therapy, 1 and 2 years after radiation therapy
**Description:** FT4 levels (pmol/L) measured in blood
**Measure:** Free Thyroxine-4 (FT4)
**Time Frame:** Before start of radiation therapy, 1 and 2 years after radiation therapy
**Description:** Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)
**Measure:** Patient-rated Demographics measured with the baseline questionnaire on Demographics
**Time Frame:** Before start of radiation therapy
**Description:** Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)
**Measure:** Patient-rated symptoms measured with the EORTC QLQ-BR23
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated symptoms are measured with the Breast Cancer Questionnaire (BCSCQ: Based on the BCTOS (1) and the questionnaire on Patients' satisfaction with the cosmetic outcome by Sneeuw at al.(2))
**Measure:** Patient-rated symptoms measured with the BCSCQ
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years.
**Description:** Patient-rated symptoms are measured with the baseline questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases before start of radiation therapy (unvalidated questionnaire)
**Measure:** Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)
**Time Frame:** Before start of radiation therapy
**Description:** Patient-rated symptoms are measured with the follow up questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (semi)annually after last day of radiation therapy (unvalidated questionnaire)
**Measure:** Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)
**Time Frame:** 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)
**Measure:** Patient-rated symptoms measured with the questionnaire on Performance Status
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)
**Measure:** : Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor
**Time Frame:** 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)
**Measure:** Patient-rated Quality of Life measured with the EORTC QLQ-C30
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D_5L)
**Measure:** Patient-rated Quality of Life measured with the EuroQoL-5D_5L
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
**Description:** Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).
**Measure:** Patient-rated Quality of Life measured with EORTC QLQ-BR23
**Time Frame:** Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
#### Primary Outcomes
**Description:** Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
**Measure:** Score of Acute toxicity
**Time Frame:** Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
**Description:** Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
**Measure:** Score of Late toxicity
**Time Frame:** At one and two years after last day of radiation therapy.
#### Secondary Outcomes
**Description:** Overall survival
**Measure:** Overall survival
**Time Frame:** At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
**Description:** Loco-regional tumor control
**Measure:** Loco-regional tumor control
**Time Frame:** At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with breast cancer Patients receiving a radiotherapy dose
Exclusion Criteria:
* Failure to comply with any of the inclusion criteria
**Gender Based:** True
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with breast cancer receiving radiotherapy
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Groningen
**Country:** Netherlands
**Facility:** University Medical Center Groningen
**Zip:** 9700RB
#### Overall Officials
**Official 1:**
**Affiliation:** UMCG
**Name:** Anne Crijns, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.
**PMID:** 11413515
**Citation:** Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.
**PMID:** 1470691
## 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
- Abbrev: Rare
- Name: Rare Diseases
### 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
- ID: T170
- Name: Acute Graft Versus Host Disease
- 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:** NCT06429982
**Brief Title:** Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
**Official Title:** A Clinical Trial to Assess Whether Dexamethasone Addition to Standard Protocols for Non-Traumatic Rhabdomyolysis of Unknown or Genetic Etiologies Improves Patient Outcomes
#### Organization Study ID Info
**ID:** STUDY00000710
#### Organization
**Class:** OTHER
**Full Name:** Children's National Research Institute
### Status Module
#### Completion Date
**Date:** 2026-12-31
**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:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-31
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Children's National Research Institute
#### Responsible Party
**Investigator Affiliation:** Children's National Research Institute
**Investigator Full Name:** Natasha Shur
**Investigator Title:** MD, Principal Investigator, Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** There is a significant unmet need for optimized treatment in rhabdomyolysis. There are few prospective interventional studies on treatment for rhabdomyolysis, a condition which affects diverse and underrepresented populations at a higher rate. While steroids are often used off-label, a systematic study has not yet been initiated, and steroids have not been yet considered in as a consideration to standard care guidelines.
The hypothesis is that patients who receive dexamethasone in addition to standard care versus placebo and standard care will have improvement in pain, length of hospital stay, and decrease in kidney complications.
**Detailed Description:** Study Objective:
This is a single center, 2-year, blinded prospective randomized study for those diagnosed with rhabdomyolysis age six months-25 years using dexamethasone versus placebo treatment in addition to standard care in up to 50 patients.
Study Design:
Patients will be enrolled with a 2:1 ratio of treatment of dexamethasone for 5 days versus placebo treatment for 5 days in addition to receiving standard care. The treatment period for each subject will be five days treatment with oral treatment once per day with study drug (dexamethasone versus placebo). All patients will also receive standard care. Patients and their parent/ caregiver will have the option to complete surveys before and after treatment in order to assess pain level and treatment improvement. Chart review will be performed on all patients throughout and after the five-day study treatment period. There will be no additional interventions.
### Conditions Module
**Conditions:**
- Rhabdomyolysis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** There will be a 2: 1 treatment ratio of dexamethasone treated group versus placebo.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** This study will be double-blinded. The pharmacy will determine which patients are in the study group.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dexamethasone five days with 0.6 mg/ kg dose per day max 16 mg dose. Standard care will also be provided.
**Intervention Names:**
- Drug: Dexamethasone
**Label:** Dexamethasone group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Placebo for five days with one dose per day placebo oral dosing. Standard care will also be provided.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dexamethasone group
**Description:** Steroid five day treatment
**Name:** Dexamethasone
**Other Names:**
- DexPak
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** Placebo control group
**Name:** Placebo
**Other Names:**
- Sugar Pill
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of days Length of Stay in Each Group
**Measure:** Length of Stay
**Time Frame:** Primarily 5 days - 1 year
**Description:** Creatinine Kinase trend comparison between groups
**Measure:** Muscle breakdown
**Time Frame:** Primarily 5 days - 1 year
**Description:** Bun/ Creatinine
**Measure:** Renal complications
**Time Frame:** Primarily 5 days - 1 year
#### Secondary Outcomes
**Description:** EHR pain scores
**Measure:** Quantitative Pain Outcomes
**Time Frame:** 14 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
1. Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded
2. Ability of parents/patients to understand and the willingness to sign a written informed consent document.
3. Patients ages 12 and older will sign written assent
Exclusion Criteria:
* Already taking systemic steroids.
* Inability to comply with study instructions.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.
o A urine pregnancy test will be performed for women of child-bearing potential.
* Below gestational age of 40 weeks
* Allergy to fluconazole, clotrimazole or nystatin.
* Cannot tolerate PO medications
**Maximum Age:** 25 Years
**Minimum Age:** 6 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Natasha Shur
- **Phone:** 202-545-2515
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Seth Berger
- **Phone:** 202 476-6156
- **Role:** CONTACT
**Country:** United States
**Facility:** Childrens National
**State:** District of Columbia
**Zip:** 20010
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Chavez LO, Leon M, Einav S, Varon J. Beyond muscle destruction: a systematic review of rhabdomyolysis for clinical practice. Crit Care. 2016 Jun 15;20(1):135. doi: 10.1186/s13054-016-1314-5.
**PMID:** 27301374
**Citation:** Summerlin ML, Regier DS, Fraser JL, Chapman KA, Kafashzadeh D, Billington C Jr, Kisling M, Grochowsky A, Ah Mew N, Shur N. Use of dexamethasone in idiopathic, acute pediatric rhabdomyolysis. Am J Med Genet A. 2021 Feb;185(2):500-507. doi: 10.1002/ajmg.a.62000. Epub 2020 Dec 10.
**PMID:** 33300687
**Citation:** Szugye HS. Pediatric Rhabdomyolysis. Pediatr Rev. 2020 Jun;41(6):265-275. doi: 10.1542/pir.2018-0300.
**PMID:** 32482689
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M15035
- Name: Rhabdomyolysis
- Relevance: HIGH
- As Found: Rhabdomyolysis
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012206
- Term: Rhabdomyolysis
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- 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: D000005938
- Term: Glucocorticoids
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7102
- Name: Dexamethasone
- Relevance: HIGH
- As Found: Children
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M199152
- Name: BB 1101
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- 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: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003907
- Term: Dexamethasone
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429969
**Acronym:** NMR
**Brief Title:** Metabolomic Profile of Vitreoretinal Diseases: an NMR-Based Approach Using Vitreous.
**Official Title:** Nuclear Magnetic Resonance (NMR)-Based Metabolomic Characterisation of Vitreoretinal Diseases Using Vitreous Fluid
#### Organization Study ID Info
**ID:** WDRY2022-K222
#### Organization
**Class:** OTHER
**Full Name:** Renmin Hospital of Wuhan University
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-04-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-17
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Renmin Hospital of Wuhan University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study was to learn about metabolomics profiles in vitreoretinal diseases by nuclear magnetic resonance (NMR)using vitreous fluid. The main question it aimed to answer was abnormal biomarkers for common retinal diseases such as idiopathic macular hole(IMH), diabetic retinopathy(DR) and retinal detachment(RD). Participants would not be subjected to any intervention and the investigators would only collect preoperative information and remaining vitreous samples. The investigators divided the participants into groups with appropriate disease names based on the disease diagnosis, such as IMH group, DR group, and RD group. The MH group was used as a control group, investigators compared other groups to see the metabolomic abnormalities.
**Detailed Description:** This study aimed to analyze vitreous fluid using NMR to discover potential biomarkers for the prevention, early diagnosis, and treatment of vitreoretinal diseases and to reveal the mechanisms of disease progression. Patients suffering from IMH, DR, RD, idiopathic macular epiretinal membrane (IMM), and retinal vein occlusion (RVO) quiring for pars plana vitrectomy (PPV), who visited Renmin Hospital of Wuhan University, were chosen to participate in this study. Participants were not subjected to any intervention and the investigator only collected preoperative information and remaining vitreous samples. Participants provided preoperative examination information and medical history, and the investigators divided the participants into five groups with corresponding disease names based on the disease diagnosis, including five groups for five diseases: IMH group, DR group, RD group, IMM group, and RVO group. The control group for the diseases was the IMH group, and metabolomic differences were observed. These patients are usually treated with PPV, during PPV typically performed on these patients, vitreous fluid is usually disposed of as waste, and investigators collected 100-250 ul of the fluid for NMR analysis to see metabolomic characterization of these diseases.
### Conditions Module
**Conditions:**
- Vitreoretinal Disease
### Design Module
#### Bio Spec
**Description:** The vitreous body is a transparent gel composed mainly of fibrous collagen and hydrophilic hyaluronic acid, with a volume of approximately 4.5 ml, constituting the largest volume in the eye. When patients suffer from vitreoretinal diseases such as IMH, DR, RD, IMM, RVO, PPV is usually required so that it can constitute a passageway to allow instruments to enter the retina for manipulation, at which point the vitreous is disposed of as waste.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 450
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants diagnosed with idiopathic macular hole(IMH) requiring PPV were enrolled in the IMH group, and this group was a control group because the vitreous of IMH may be closest to normal and normal people do not undergo PPV. 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
**Label:** IMH group
#### Arm Group 2
**Description:** In patients with a confirmed diagnosis of diabetic retinopathy (DR) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
**Label:** DR group
#### Arm Group 3
**Description:** In patients with a confirmed diagnosis of retinal detachment (RD) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
**Label:** RD group
#### Arm Group 4
**Description:** In patients with a confirmed diagnosis of idiopathic macular epiretinal membrane (IMM) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
**Label:** IMM group
#### Arm Group 5
**Description:** In patients with a confirmed diagnosis of retinal vein occlusion (RVO) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
**Label:** RVO group
### Outcomes Module
#### Primary Outcomes
**Description:** NMR provides spectral data to show the relative concentration of various amino acids, and the use of NMR to measure vitreous humor and compare changes in amino acid content across disease species leads to speculation about biological markers of disease progression.
**Measure:** Relative amino acid concentration(Unite: %)
**Time Frame:** intraoperative
#### Secondary Outcomes
**Description:** Macromolecules such as glucose and lipids also play a role in the metabolism of vitreoretinal diseases, so NMR spectroscopy will be used to show the relative concentration of macromolecules.
**Measure:** Relative concentrations of macromolecules such as glucose and lipids(Unite: %)
**Time Frame:** intraoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Confirmation of IMH diagnosis with concomitant need for PPV surgery;
2. Confirmation of DR diagnosis with concomitant need for PPV surgery;
3. Confirmation of RD diagnosis with concomitant need for PPV surgery;
4. Confirmation of IMM diagnosis with concomitant need for PPV surgery;
5. Confirmation of RVO diagnosis with concomitant need for PPV surgery.
Exclusion Criteria:
1. Diagnosed vitreoretinal disease with no need for PPV surgery;
2. Previous history of PPV surgery;
3. Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;
4. Combination of serious systemic diseases such as hypertension and diabetes mellitus.
**Maximum Age:** 90 Years
**Minimum Age:** 40 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The enrolled participants were patients who attended Renmin Hospital of Wuhan University with a confirmed diagnosis of vitreoretinal disease. As a result, most of the participants were residents of Hubei Province, China. It is expected that vitreous fluid samples collected from patients with IMH, DR, RD, IMM, and RVO were 50, 100, 100, 50, and 50, respectively, for a total of 450, with about a mean age of 56 years.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Liwei Cheng
**Phone:** 027-88041911
**Phone Ext:** 86346
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Liwei Cheng
- **Phone:** 02788041911
- **Phone Ext:** 86346
- **Role:** CONTACT
**Country:** China
**Facility:** Eye, Center, Renmin Hospital of Wuhan University
**State:** Hubei
**Status:** RECRUITING
**Zip:** 430060
#### Overall Officials
**Official 1:**
**Affiliation:** Renmin Hospital of Wuhan University
**Name:** Lei Du
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** This is not considered for the time being, as further processing of the samples are required subsequently and there may be culling data.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429956
**Brief Title:** Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression
**Official Title:** Combining Treatment Components in Transdiagnostic Therapy for Anxiety and Depression: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** Combinatory effects in CBT 24
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**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:** 2024-05-28
**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 Aarhus
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The present study is a randomized controlled trial that will evaluate the effect of combining two treatment components (i.e., cognitive restructuring and detached mindfulness) drawn from cognitive behavioral therapies (CBTs) that are often combined in clinical practice. However, knowledge about the effect of combining these treatment components is lacking. Therefore, this study aims to explore single, combined, and sequencing effects of these two treatment components in patients with depression and/or anxiety disorders. Furthermore, the study aims to explore possible demographic and clinical moderators of the effects to address the question of what works for whom.
**Detailed Description:** A relatively large proportion of psychotherapists endorse practicing eclectic or integrative therapy, drawing from different schools of therapy (Norcross \& Alexander, 2019). This tendency towards integrative therapy has been expressed by former president of the Association of Cognitive and Behavioral Therapies, J. B. Persons, who writes: "We \[clinicians\] rarely proceed through a single protocol from beginning to end. Instead, we use what might be called a mix-and-match strategy, in which we select interventions or modules from one or even two or more protocols that we believe will be helpful to the patient" (Persons, 2005, p. 107). Indeed, there has been a growing research and clinical interest in personalized therapy where treatment components from different therapies are combined with the aim of targeting the symptomatology and theorized maintenance processes of the individual patient (Cohen et al., 2021; DeRubeis et al., 2014; Fisher et al., 2019; Fisher \& Boswell, 2016; Hayes et al., 2022; Huibers et al., 2021; Sauer-Zavala et al., 2022). In addition to this, an increasing number of therapies are designed by combining components from different treatment models (e.g., modular and process-based therapies; Barlow et al., 2018; Hofmann \& Hayes, 2019; Hofmann et al., 2021). As a result, patients are likely to be the recipients of several different techniques or strategies, based on different theoretical models, emphasizing different change principles. However, the extent to which compatibility exists between different treatment components remains an underexplored scientific question. The present study aims to fill this gap.
Combining cognitive behavioral therapies
Cognitive behavioral therapies (CBTs) are among the most well-researched psychological treatments for anxiety and depressive disorders (Cuijpers, 2017; Cuijpers et al., 2014). While CBT is often viewed as one of the major schools of psychotherapy, specific CBTs differ in their rationale and understanding of the key maintaining processes in psychopathology (Hayes, 2004). A core tenet of traditional CBT, also known as second-wave CBT, is that psychopathology is maintained by maladaptive or irrational thoughts (Beck, 1976). Thus, a commonly used therapeutic component derived from second-wave CBT is cognitive restructuring, where the patient is taught to think more realistically about emotion-evoking situations (Beck et al., 1979; Clark \& Beck, 2010). Thus, cognitive restructuring can be said to target the content of thoughts.
In contrast, newer contemporary or so-called third-wave CBTs such as metacognitive therapy (MCT), acceptance and commitment therapy (ACT), and mindfulness-based cognitive therapy (MBCT) target thought processes (Hayes, 2004). A commonly used therapeutic component across third-wave CBTs involves teaching the patient to meet their experiences with mindfulness and acceptance rather than attempting to change their form (termed detached mindfulness in MCT, defusion in ACT, and decentering in MCT; Hayes et al., 2012; Segal et al., 2002; Wells, 2009). Thus, it can be argued that second- and third-wave CBTs reflect very different ways of approaching one's inner life.
Despite the differences between second- and third-wave CBTs, treatment components from each wave are often combined. One example of this is the widely employed Unified Protocol (UP) which is a transdiagnostic modular cognitive-behavioral treatment for emotional disorders (e.g., anxiety and depression) (Barlow et al., 2018). In UP, patients are asked to engage in cognitive restructuring (within the treatment module of cognitive flexibility) in one module and to practice detached mindfulness (within the treatment module of mindful emotion awareness) in another (Barlow et al., 2018). Several studies have documented that UP is an effective treatment for anxiety and depression (Longley \& Gleiser, 2023). However, since the treatment modules in UP are rooted in different therapeutic traditions with different rationales, an intriguing question remains whether the treatment modules are in fact compatible. If not, then it is possible that UP is effective not because but rather despite the combination of the treatment modules (O'Toole et al., 2024).
Compatibility of components
Regarding the combination of mindful emotion awareness and cognitive flexibility, it is theoretically plausible that these modules might be incompatible since the technique of noticing and accepting one's thoughts/emotions (in the module mindful emotion awareness) could be argued to be in opposition to the technique of actively changing one's thoughts (in the module cognitive flexibility). This notion is supported by a small study (N=12) by Gkika and Wells (2015) which investigated the effect of cognitive restructuring and detached mindfulness in an anxiety-provoking situation in patients with elevated symptoms of social anxiety. They found that each technique alone reduced symptoms of social anxiety. However, when combined, a sequencing effect emerged where detached mindfulness followed by cognitive restructuring, but not the reverse, led to increased anxiety (Gkika \& Wells, 2015). Borlimi et al. (2019) similarly demonstrated a sequencing effect. They asked non-clinical participants (N=35) to recall an unpleasant experience and apply either cognitive restructuring or an acceptance technique. Acceptance reduced sympathetic reactivity (i.e., galvanic skin response) more than cognitive restructuring, and importantly, the effect was significantly larger when acceptance followed cognitive restructuring than vice versa (Borlimi et al., 2019).
The studies by Gkika and Wells (2015) and Borlimi et al. (2019) are both laboratory experimental studies. The question thus remains whether and how their findings can be generalized to a clinical context with longer duration of each treatment component. Only one larger intervention study exploring combinatory and sequencing effects exists. In this study, Brose et al. (2023) investigated the effect of internet-based cognitive restructuring and behavioral activation on symptoms of depression delivered over 6 weeks. Individuals with mild to moderate depressive symptoms (N=2,304) were randomized to one of two treatment arms, one receiving behavioral activation followed by cognitive restructuring, the other vice versa. The groups had similar dropout rates and showed similar improvements over time, indicating no incongruency between those two components. Besides differences in size and setting (experimental vs. actual treatment), the study by Brose et al. (2023) also differs from the other clinical studies by testing a "cognitive" component against a "behavioral" component instead of comparing different "cognitive" components (e.g., cognitive restructuring and detached mindfulness) against each other. In this case, the rationales may be more consistent with each other.
Taken together, the research findings described above, coupled with results from the few other available studies of combinatory effects (Dibbets et al., 2012; Woelk et al., 2022), testify that combining otherwise effective stand-alone treatment components 1) does not necessarily yield an additive effect, 2) may even sometimes detract from a positive outcome, and 3) that the combined effect may depend on the order of the components. Thus, to be able to combine different treatment components for anxiety and depression effectively, there is a need for intervention studies examining single, combined, and sequencing effects for treatment components from different therapies that are often combined. Currently, such research is sparse, thereby motivating the present study. Moreover, understanding for whom these effects are likely to occur is important for the appropriate adaptations of therapeutic interventions to fit the needs of the individual patients (i.e., personalized therapy; Cohen et al., 2021).
Aims and hypotheses
The primary aim of the present study is to explore the effect of combining treatment components drawn from different CBTs. Thus, we will explore single, combined, and sequencing effects of two treatment modules (i.e., mindful emotion awareness and cognitive flexibility). These modules are routinely delivered together in UP for patients with anxiety disorders or MDD. It is hypothesized that both mindful emotion awareness and cognitive flexibility, when delivered individually, will be effective in reducing symptoms of anxiety and depression. The study will take an exploratory stance regarding combined and sequencing effects and will explore if combined effects are best understood as non-additive, additive, synergistic or antagonistic (cf. O'Toole et al., 2024).
A secondary aim of the study is to explore possible demographic and clinical moderators of the effects (e.g., primary diagnosis, baseline cognitive function and symptomatology) to address the question of what works for whom.
### Conditions Module
**Conditions:**
- Depression
- Anxiety
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomized to receive either 1) the mindful emotion awareness module followed by the cognitive flexibility module or 2) the cognitive flexibility module followed by the mindful emotion awareness module. All participants will undergo a three-week waiting period before starting treatment.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** It will not be known to participants that we are testing combinatory and sequencing effects and that participants are randomly allocated to receive the treatment modules in a specific order.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 93
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive 6 therapy sessions starting with 3 sessions of mindful emotion awareness followed by 3 sessions of cognitive flexibility. Each session will have a duration of approximately 1 hour. Treatment will follow the UP manual by Barlow et al. (2018).
**Intervention Names:**
- Behavioral: Mindful emotion awareness
- Behavioral: Cognitive flexibility
**Label:** Order 1 (mindful emotion awareness + cognitive flexibility)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive 6 therapy sessions starting with 3 sessions of cognitive flexibility followed by 3 sessions of mindful emotion awareness. Each session will have a duration of approximately 1 hour. Treatment will follow the UP manual by Barlow et al. (2018).
**Intervention Names:**
- Behavioral: Mindful emotion awareness
- Behavioral: Cognitive flexibility
**Label:** Order 2 (cognitive flexibility + mindful emotion awareness)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Order 1 (mindful emotion awareness + cognitive flexibility)
- Order 2 (cognitive flexibility + mindful emotion awareness)
**Description:** The mindful emotion awareness module will follow the manual by Barlow et al. (2018). In session 1, the participant will receive psychoeducation about the purpose of mindful emotion awareness (i.e., to cultivate present-focused, non-judgmental attention to one's emotional experiences) and will complete an in-session guided meditation exercise which they will be asked to practice daily using an audio file. In session 2 and 3, two additional exercises are introduced. With "mindful mood induction", the participant is instructed to induce emotions and then practice mindful emotion awareness in this context. With "anchoring in the present", the participant is taught four steps to help them use mindful emotion awareness to pull themself back to the present whenever they feel an emotional response start to build in their everyday life. For homework, the participant will practice mindful emotion using these exercises and the audio file.
**Name:** Mindful emotion awareness
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Order 1 (mindful emotion awareness + cognitive flexibility)
- Order 2 (cognitive flexibility + mindful emotion awareness)
**Description:** The cognitive flexibility module will follow the manual by Barlow et al. (2018) which is based on the principles by Beck (1976). In session 1, the participant will be psychoeducated about the purpose of cognitive flexibility (i.e., to encourage flexible thinking through reappraisal of one's automatic thinking), and how their thoughts influence their emotional reactions. For homework, the participant will be asked to monitor their automatic thoughts. In session 2, the participant will be introduced to the technique of cognitive flexibility (i.e., generating other possible interpretations), and this technique will be practiced throughout session 2 and 3. For homework, the participant will continue to monitor their automatic thoughts and generate and record other possible interpretations.
**Name:** Cognitive flexibility
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** The Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5; Brown \& Barlow, 2014) will be used to confirm a diagnosis of an anxiety disorder or MDD and establish the number of episodes, onset age, and potential comorbid disorders. The interview will also be used to confirm that none of the above listed reasons for exclusion are present (e.g., bipolar disorder, current or past psychosis).
**Measure:** Clinical diagnosis (ADIS-5)
**Time Frame:** Baseline only
**Description:** Trail Making Test part A (TMT-A; Reitan, 1958).
**Measure:** Objective cognitive function - processing speed (TMT-A)
**Time Frame:** Baseline only
**Description:** Wechsler Adult Intelligence Scale - Fourth Edition, Coding (WAIS-IV coding; Wechsler, 2008).
**Measure:** Objective cognitive function - processing speed (WAIS-IV coding)
**Time Frame:** Baseline only
**Description:** Wechsler Adult Intelligence Scale - Fourth Edition, Digit span (WAIS-IV Digit span; Wechsler, 2008).
**Measure:** Objective cognitive function - attention and working memory (WAIS-IV Digit span)
**Time Frame:** Baseline only
**Description:** Controlled Oral Word Association Test (COWAT; Harrison et al., 2000).
**Measure:** Objective cognitive function - executive function (COWAT)
**Time Frame:** Baseline only
**Description:** Trail Making Test part B (TMT-B; Reitan, 1958).
**Measure:** Objective cognitive function - executive function (TMT-B)
**Time Frame:** Baseline only
**Description:** The Stroop Color and Word Test (STROOP; Stroop, 1935).
**Measure:** Objective cognitive function - executive function (STROOP)
**Time Frame:** Baseline only
**Description:** Wechsler Adult Intelligence Scale - Fourth Edition, Information (WAIS-IV Information; Wechsler, 2008) will be included to control for premorbid intellectual abilities.
**Measure:** Objective cognitive function - premorbid intellectual abilities (WAIS-IV Information)
**Time Frame:** Baseline only
#### Primary Outcomes
**Description:** Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000).
**Measure:** Depressive symptoms (PHQ-9)
**Time Frame:** Development from pre-treatment to post-treatment (6 weeks)
**Description:** Beck's Anxiety Inventory (BAI; Beck et al., 1988; Beck \& Steer, 1991).
**Measure:** Anxiety symptoms (BAI)
**Time Frame:** Development from pre-treatment to post-treatment (6 weeks)
**Description:** The General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006).
**Measure:** Symptoms of generalized anxiety disorder (GAD-7)
**Time Frame:** Development from pre-treatment to post-treatment (6 weeks)
**Description:** The Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998).
**Measure:** Symptoms of social anxiety disorder (SIAS)
**Time Frame:** Development from pre-treatment to post-treatment (6 weeks)
**Description:** The Panic Disorder Severity Scale - Self-Report Version (PDSS-SR; Houck et al., 2002).
**Measure:** Symptoms of panic disorder (PDSS-SR)
**Time Frame:** Development from pre-treatment to post-treatment (6 weeks)
#### Secondary Outcomes
**Description:** Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; Spitzer et al., 1999; Spitzer et al., 2000).
**Measure:** Depressive symptoms (PHQ-9)
**Time Frame:** Development from pre-treatment through 3-month follow-up
**Description:** Beck's Anxiety Inventory (BAI; Beck et al., 1988; Beck \& Steer, 1991).
**Measure:** Anxiety symptoms (BAI)
**Time Frame:** Development from pre-treatment through 3-month follow-up
**Description:** The General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006).
**Measure:** Symptoms of generalized anxiety disorder (GAD-7)
**Time Frame:** Development from pre-treatment through 3-month follow-up
**Description:** The Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998).
**Measure:** Symptoms of social anxiety disorder (SIAS)
**Time Frame:** Development from pre-treatment through 3-month follow-up
**Description:** The Panic Disorder Severity Scale - Self-Report Version (PDSS-SR; Houck et al., 2002).
**Measure:** Symptoms of panic disorder (PDSS-SR)
**Time Frame:** Development from pre-treatment through 3-month follow-up
**Description:** The World Health Organization (WHO)-5 questionnaire (Bech, 1999; Topp et al., 2015).
**Measure:** Quality of life (WHO-5)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** The Ruminative Response Scale (RRS) brooding subscale (Treynor et al., 2003).
**Measure:** Rumination (RRS brooding subscale)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990).
**Measure:** Worry (PSWQ)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** For in-session questionnaires, the Ambulatory Worry Scale (AWS; Kramer et al., 2021) will be used because it has been specially developed to evaluate state variations in worry.
**Measure:** Worry (AWS)
**Time Frame:** Session by session development during the 6 weeks of active treatment
**Description:** The Experiences Questionnaire (EQ) decentering subscale (Fresco et al., 2007).
**Measure:** Decentering (EQ decentering subscale)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** Emotion Regulation Questionnaire (ERQ) reappraisal subscale (Gross \& John, 2003).
**Measure:** Reappraisal (ERQ)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** Five Facet Mindfulness Questionnaire - 15 (FFMQ-15; Baer et al., 2006).
**Measure:** Mindfulness (FFMQ-15)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** Perceived Deficits Questionnaire - Depression (PDQ-D; Fehnel et al., 2016)
**Measure:** Subjective cognitive function (PDQ-D)
**Time Frame:** Development from pre-treatment to post-treatment and development from pre-treatment through 3-month follow-up
**Description:** Five questions concerning the participants' experience or expectations concerning the components have been developed by the project group due to a lack of such assessment in the field.
**Measure:** Experience of therapy
**Time Frame:** Session by session development during the 6 weeks of active treatment and through 3-month follow-up
**Description:** Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010).
**Measure:** Working alliance (WAI-SR)
**Time Frame:** Session 3 and 5 only
**Description:** The Information Overload (IO) scale, consisting of 8 items. This is our own adaptation of the Cancer Information Overload scale (Jensen et al., 2014) to assess perceived information overload related to the received treatment. This is included in all session questionnaires.
**Measure:** Information overload (IO)
**Time Frame:** Session by session development during the 6 weeks of active treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years.
2. A diagnosis of an anxiety disorder (generalized anxiety disorder, social anxiety disorder, or panic disorder with or without agoraphobia) and/or mild to moderate major depressive disorder (MDD) according to DSM-5 (American Psychiatric Association, 2022).
3. Danish language proficiency.
4. Ability and willingness to give informed consent.
5. No or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 8 weeks).
6. Access to either a smartphone, tablet, or computer with video camera.
Exclusion Criteria:
1. Severe depression deemed to require more intense psychotherapy or medication.
2. Persistent depressive disorder (i.e., depressive symptoms have persisted for 2 years or more).
3. Non-stabilized medication (see above).
4. Currently receiving other psychotherapy or counseling.
5. Not capable of participating online.
6. Lack of Danish proficiency.
7. A history of bipolar disorder.
8. Current or past psychosis.
9. Substance abuse or dependence judged to require treatment.
10. Suicide risk requiring immediate hospitalization.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Caroline Nørskov, MSc
**Phone:** +4587150193
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mia O'Toole, PhD
**Phone:** +4587165289
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Aarhus
**Name:** Caroline Nørskov, MSc
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-13
- Filename: SAP_000.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 207843
- Type Abbrev: SAP
- Upload Date: 2024-05-13T05:33
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood 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: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- 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
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429943
**Brief Title:** Cerebrolysin in SAH (Subarachnoidal Haemorrhage) - Observational Study
**Official Title:** Cerebrolysin in Patients Diagnosed With SAH - an Observational Cohort Study (PILOT)
#### Organization Study ID Info
**ID:** SAH/2020/2023
#### Organization
**Class:** OTHER
**Full Name:** Pomeranian Medical University Szczecin
### Status Module
#### Completion Date
**Date:** 2023-01-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-10-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-01-15
**Type:** ACTUAL
**Status Verified Date:** 2023-12
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pomeranian Medical University Szczecin
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Subarachnoid haemorrhage often affects people in middle age and is associated with high mortality or neurological damage. In recent years, advances in surgical techniques have im-proved the mortality rate. However, there is still need for the research for the optimal possible final effect of treatment. In our study, we've decided to examine the effect of a multimodal approach including Cerebrolysin in the supportive treatment of patients. We've examined the supply of neuroprotective drugs and neuromonitoring.
### Conditions Module
**Conditions:**
- SAH (Subarachnoid Hemorrhage)
**Keywords:**
- SAH
- Cerebrolysin
- neuromonitoring
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 47
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Month
### Arms Interventions Module
#### Arm Group 1
**Description:** Cerebrolysin administration
**Label:** A
#### Arm Group 2
**Description:** without Cerebrolysin administration
**Label:** B
### Outcomes Module
#### Primary Outcomes
**Description:** Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits
**Measure:** GOS Glasgow Outcome Scale
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** length of stay in days, that patient spent in hospital/ intensive care unit
**Measure:** LOS Length of Stay
**Time Frame:** hospitalisation time
**Description:** mortality
**Measure:** mortality
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age \>18 years old, diagnosis of SAH, treatment in ICU conditions
Exclusion Criteria:
* age \<18 years, medical history of allergy to Cerebrolysin, acute renal failure, pregnancy, multi organ trauma, death within 48 hours after admission
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population is the population of patients diagnosed with SAH, treated in University Hospital no.1 in Szczecin, Poland. Mainly the patients come from the population of westerpomeranian county, but as SAH is an acute disease also patients from the whole region of Poland, treated in the Hospital were included in the study.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Szczecin
**Country:** Poland
**Facility:** Pomeranian Medical University, University Hospital no.1
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- 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: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### 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
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M16135
- Name: Subarachnoid Hemorrhage
- Relevance: HIGH
- As Found: Subarachnoid Hemorrhage
- ID: M22113
- Name: Intracranial Hemorrhages
- 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: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013345
- Term: Subarachnoid Hemorrhage
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Browse Branches
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
- Abbrev: NootAg
- Name: Nootropic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M352392
- Name: Cerebrolysin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429930
**Brief Title:** Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
**Official Title:** A Phase 1, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Participants
#### Organization Study ID Info
**ID:** PBI-L608-B12
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharmosa Biopharm Inc.
### Status Module
#### Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Novotech (New Zealand) Limited
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pharmosa Biopharm Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with higher dose levels, starting from 20 μg and escalating up to a planned maximum dose of 110 μg.
**Detailed Description:** L608 inhalation Solution (L608) is developed by Pharmosa Biopharm Inc. (PBI) as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with WHO Group 1 PAH. As a liposomal formulation of iloprost, L608 is intended to reduce the dosing frequency, as well as provide sustained and selective release along with achieving therapeutically relevant iloprost level. Meanwhile, L608 is expected to mitigate burst release related local irritation and systemic side effects (e.g., hypotension due to plasma peak) in clinical practice.
This Phase I, randomized, double-blinded, placebo-controlled study will be conducted in healthy participants in New Zealand to evaluate the safety, tolerability, and pharmacokinetic of L608. The dose escalation design is applied in this study. The sentinel dosing design will be applied for all cohorts.
### Conditions Module
**Conditions:**
- Pulmonary Arterial Hypertension
**Keywords:**
- Pulmonary Arterial Hypertension
- Hypertension, Pulmonary
- Lung Diseases
- Respiratory Tract Diseases
- Pharmaceutical Solutions
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Randomized, Placebo-controlled, double-blinded, single ascending dose escalation
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** This is a double-blinded, single ascending dose escalation design. After confirmation of eligibility, subjects will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for rest of the cohorts to receive the assigned dose of L608 or placebo.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 56
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2).
**Intervention Names:**
- Drug: L608 Liposomal inhalation solution
**Label:** L608 Liposomal inhalation solution
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Eight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2).
**Intervention Names:**
- Drug: Placebo Solution
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- L608 Liposomal inhalation solution
**Description:** Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo.
**Name:** L608 Liposomal inhalation solution
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo.
**Name:** Placebo Solution
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** DLT: Dose-limiting toxicity
**Measure:** Percentage of participants with DLT
**Time Frame:** 7 days after administration
**Description:** TEAEs: treatment emergent adverse events; SAEs: serious adverse events
**Measure:** Percentage of participants with TEAEs and SAEs
**Time Frame:** 2 weeks after administration
**Description:** TEAEs: treatment emergent adverse events; SAEs: serious adverse events
**Measure:** Frequency and severity of TEAEs and SAEs
**Time Frame:** 2 weeks after administration
#### Secondary Outcomes
**Description:** Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration
**Measure:** AUC0-t
**Time Frame:** 24 hours after administration
**Description:** Area under the plasma concentration-time curve from time 0 to infinity
**Measure:** AUC0-inf
**Time Frame:** 24 hours after administration
**Description:** AUC extrapolated from the last measurable concentration to infinity as a percentage of total AUC
**Measure:** %AUCextrap
**Time Frame:** 24 hours after administration
**Description:** Maximum observed plasma concentration
**Measure:** Cmax
**Time Frame:** 24 hours after administration
**Description:** Time to reach the maximum observed plasma concentration
**Measure:** Tmax
**Time Frame:** 24 hours after administration
**Description:** Apparent plasma terminal elimination half-life
**Measure:** T1/2
**Time Frame:** 24 hours after administration
**Description:** Apparent total plasma clearance
**Measure:** CL/F
**Time Frame:** 24 hours after administration
**Description:** Apparent volume of distribution during the terminal phase
**Measure:** Vz/F
**Time Frame:** 24 hours after administration
**Description:** Terminal elimination rate constant
**Measure:** λz
**Time Frame:** 24 hours after administration
**Description:** Dose-normalized Cmax.
**Measure:** Cmax/D
**Time Frame:** 24 hours after administration
**Description:** Dose-normalized AUC0-t.
**Measure:** AUC0-t/D
**Time Frame:** 24 hours after administration
**Description:** Dose-normalized AUC0-inf.
**Measure:** AUC0-inf/D
**Time Frame:** 24 hours after administration
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
2. Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
3. Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening.
4. Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last dose of the Investigational product.
Key Exclusion Criteria:
1. Participants with contraindications or sensitivity to any components of the study treatment.
2. Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
3. Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway. Subjects who have had childhood asthma which have resolved as deemed by the PI can be considered.
4. Participants with histories or active conditions of myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery disease (CAD), unstable angina, heart failure, significant cardiac arrhythmias, congenital or acquired valvular heart disease with clinically insignificant symptom, suspected lung congestion, and/or pulmonary arterial hypertension (PAH) causing by venous thromboembolism.
5. Participants with systolic blood pressure \< 90 mmHg or \> 140 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at Screening or check-in visit.
6. Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit.
7. Participants with histories of drug or alcohol abuse within 1 year prior to subject check-in (Day -1). Regular alcohol consumption defined as \> 14 standard drinks per week for female and \> 21 standard drinks per week for male.
8. Consumption of products containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 \[CYP\] 3A4 activity) within 10 days prior to drug administration, and/or participants unwilling to refrain from consumption of alcohol from 48 hours before dosing to Day 14.
9. Receipt of blood products within 2 months prior to dosing.
10. Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and pregnancy test.
11. Blood donation or significant blood loss (\>480 ml) within 3 months prior to Screening.
12. Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing until the EOS visit.
13. Participants planning to receive a tattoo, body piercing, or undergo any invasive procedure during the study period.
**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:** Pei Kan, PhD
**Phone:** +886-2-2782-7561
**Phone Ext:** 102
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sydney Chuang
**Phone:** +886-2-2782-7561
**Phone Ext:** 110
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Christchurch
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christopher John Wynne
- **Phone:** +64 3 372-9477
- **Role:** CONTACT
**Country:** New Zealand
**Facility:** NZCR Ltd (New Zealand Clinical Research)
**Zip:** 8011
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M2261
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Arterial Hypertension
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4807
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Arterial Hypertension
### Condition Browse Module - Meshes
- ID: D000081029
- Term: Pulmonary Arterial Hypertension
- ID: D000006973
- Term: Hypertension
### 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: HIGH
- As Found: Procedure
### Intervention Browse Module - Meshes
- ID: D000019999
- Term: Pharmaceutical Solutions
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429917
**Brief Title:** Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis
**Official Title:** Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis- An Interventional Study
#### Organization Study ID Info
**ID:** PGIDS/BHRC/24/37
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### 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 study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .
**Detailed Description:** Patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. Applying masticatory pressure provides relief in these symptoms. However, this practice may lead to the development of bruxism habits in patients over time.
A deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively.
Till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients.
. This study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients with periodontitis
### Conditions Module
**Conditions:**
- Periodontitis
- Bruxism
**Keywords:**
- Inflammation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.
**Intervention Names:**
- Other: Subgingival instrumentation
**Label:** Periodontitis with bruxism
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Periodontitis with bruxism
**Description:** All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.
**Name:** Subgingival instrumentation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.
**Measure:** Jaw symptoms
**Time Frame:** baseline , 2 months , 3 months and 6 months
#### Secondary Outcomes
**Description:** BOP recorded as 1 if bleeding occurs within 15 seconds of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100
**Measure:** Bleeding on probing
**Time Frame:** baseline , 2 months , 3 months and 6 months
**Description:** Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation.
**Measure:** Gingival index
**Time Frame:** baseline , 2 months , 3 months and 6 months
**Description:** Probing Pocket Depth (PPD): Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe. The probe will be inserted in the bottom of pocket and maintained parallel to vertical axis of the tooth. Measurements will be noted at 6sites of a tooth (mesio-buccal, mid-buccal, disto- buccal, mesio-lingual, mid-lingual and disto- lingual). Measurements will be rounded to the nearest whole millimeter.
**Measure:** Probing pocket depth
**Time Frame:** baseline , 2 months , 3 months and 6 months
**Description:** Tooth mobility is assessed using Miller Mobility Index
**Measure:** tooth mobility
**Time Frame:** baseline , 2 months , 3 months and 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity
Exclusion Criteria:
1. History of systemic disease such as diabetes or autoimmune disease
2. History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
3. Pregnant or lactating females.
4. Post-menopausal women.
5. Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
6. Patients receiving interventions for bruxism.
7. History of Psychological disorders
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** RAJINDER KR SHARMA, MDS
**Phone:** 9416358222
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** VARSHA KAPOOR, BDS
**Phone:** 9991802339
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Country:** India
**Facility:** Post Graduate Institute of Dental Sciences
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, ROHTAK
**Name:** VARSHA KAPOOR, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000014076
- Term: Tooth Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M5286
- Name: Bruxism
- Relevance: HIGH
- As Found: Bruxism
- 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
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000002012
- Term: Bruxism
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429904
**Brief Title:** Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
**Official Title:** A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
#### Organization Study ID Info
**ID:** IST-Nim-PC-29
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College 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:** This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).
**Detailed Description:** This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Patients will receive Nimotuzumab plus NALIRIFOX as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is overall survival (OS). Additional end points included resection rates, progression-free survival (PFS), objective response rate (ORR), safety, etc.
### Conditions Module
**Conditions:**
- Locally Advanced Pancreatic Cancer
**Keywords:**
- Nimotuzumab
- locally advanced pancreatic cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 31
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer
**Intervention Names:**
- Drug: Nimotuzumab+ NALIRIFOX
**Label:** Nimotuzumab combined with NALIRIFOX
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nimotuzumab combined with NALIRIFOX
**Description:** Drug: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg, 600mg, 400mg on Day 1, 8, 15, respectively, 28 days as a cycle, up to 6 cycles.
Other Names: h-R3
Drug: NALIRIFOX Patients will receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle, up to 6 cycles.
Other Names: NALIRIFOX
**Name:** Nimotuzumab+ NALIRIFOX
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The time from the beginning of treatment to death due to any cause.
**Measure:** overall survival (OS)
**Time Frame:** Up to 24 months
#### Secondary Outcomes
**Description:** The proportion of patients who underwent surgery.
**Measure:** resection rate
**Time Frame:** Up to 24 months
**Description:** PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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 (PFS)
**Time Frame:** Up to 24 months
**Description:** Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
**Measure:** Objective response rate (ORR)
**Time Frame:** Up to 12 months
**Description:** To explore the influence of tumor-related markers such as CA199 and EGFR on prognosis.
**Measure:** tumor-related markers
**Time Frame:** Up to 24 months
**Description:** Frequency and severity of adverse events.
**Measure:** adverse events
**Time Frame:** Up to 30 days after last administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
3. Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging;
4. Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation;
5. No prior tumor systemic therapy.
6. Measurable disease according to RECIST criteria v1.1;
7. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Postoperative survival was expected to be ≥3 months;
10. Fertile subjects are willing to take contraceptive measures during the study period.
11. Good compliance and signed informed consent voluntarily.
Exclusion Criteria:
1. Refuse chemotherapy or surgery;
2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
4. Undergone major surgery within 30 days;
5. Use of EGFR-mab or EGFR-TKI within 30 days;
6. Known allergy to prescription or any component of the prescription used in this study;
7. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
8. Other reasons that are not suitable to participate in this study according to the researcher's judgment
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Peking Union Medical College Hospital
### 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 - 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
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M1671
- Name: Irinotecan
- Relevance: LOW
- As Found: Unknown
- ID: M288889
- Name: Nimotuzumab
- Relevance: HIGH
- As Found: Details
- ID: M6191
- Name: Leucovorin
- Relevance: LOW
- As Found: Unknown
- ID: M8600
- Name: Fluorouracil
- Relevance: LOW
- As Found: Unknown
- ID: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000501466
- Term: Nimotuzumab
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429891
**Brief Title:** Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization
**Official Title:** Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization
#### Organization Study ID Info
**ID:** 2024KT68
#### Organization
**Class:** OTHER
**Full Name:** Peking University Cancer Hospital & Institute
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hua Zhu
#### Responsible Party
**Investigator Affiliation:** Peking University Cancer Hospital & Institute
**Investigator Full Name:** Hua Zhu
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. Starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research object. Based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC gene sequencing and other technologies, and screen key MUC family proteins. Based on the discovery of differential recognition of COSMC deficient cells by antibodies, MUC1-targeted specific monoclonal antibody was developed. Further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry (DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (RDC) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.
### Conditions Module
**Conditions:**
- Solid Tumor
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All study participants will be allocated to this arm (single-arm study). Study participants will undergo 89Zr-16A PET/CT scans.
**Intervention Names:**
- Drug: 18F-FDG
**Label:** 89Zr-16A
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 89Zr-16A
**Description:** All study participants will undergo one 18F-FDG PET/CT scan.
**Name:** 18F-FDG
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The uptake of the tracer (89Zr-16A) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
**Measure:** Standardized uptake value (SUV)
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged ≥18 years old; ECOG 0 or 1;
2. Patients with solid tumor confirmed by histopathology;
3. Patients with imaging confirmed measurable lesions;
4. life expectancy \>=12 weeks.
Exclusion Criteria:
1. Significant hepatic or renal dysfunction;
2. ls pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases；
6. Any other situation that researchers think it is not suitable to participate in the experiment.
**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:** Hua Zhu
**Phone:** +861088196495
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hua Zhu, Dr.
- **Phone:** +861088196495
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Zip:** 100142
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University Cancer Hospital & Institute
**Name:** Hua Zhu
**Role:** PRINCIPAL_INVESTIGATOR
## 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: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- 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 - Ancestors
- ID: D000019275
- Term: Radiopharmaceuticals
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21686
- Name: Fluorodeoxyglucose F18
- Relevance: HIGH
- As Found: Valsartan
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000019788
- Term: Fluorodeoxyglucose F18
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429878
**Brief Title:** The Long Term Effect of MRI Before Radical Prostatectomy.
**Official Title:** The Long Term Effect of MRI Before Radical Prostatectomy.
#### Organization Study ID Info
**ID:** 248365
#### Organization
**Class:** OTHER
**Full Name:** Oslo University Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2012-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2009-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Oslo University Hospital
#### Responsible Party
**Investigator Affiliation:** Oslo University Hospital
**Investigator Full Name:** Erik Rud
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A randomized clinical trial conducted by Oslo University Hospital between 2010 and 2012 included 438 patients with prostate cancer to the non-MRI group (216) or the MRI group (222) before robot-assisted radical prostatectomy (RALP). The primary endpoint was to compare the nerve-sparing surgery types and the proportion of positive surgical margins (PSM) in each group. The MRI group underwent more non-nerve sparing surgery, whereas the proportion of PSM was similar in both groups (p=0.4) \[1\]. Since the long-term effects of preoperative MRI are unknown, we aimed to assess the variations in the long-term functional and oncological outcomes between the groups.
**Detailed Description:** The aim of this study was to evaluate the oncological and functional outcomes in a 12-year follow-up after RALP in patients preoperatively randomized to no-MRI or MRI.
Material: a total of 438 consecutive patients were referred to RALP. Of these, 222 were randomized to preoperative MRI (intervention group), and 216 were randomized to no MRI (control group). All underwent radical prostatectomy between 2010 and 2012.
Study design: An experimental interventional study with 12-years follow-up
Endpoints: PSA recurrence (PSA ≥0.2ng/ml) Predictors for PSA recurrence (PSM, DÁmico risk group, Gleason score, T-stage) Overall survival (OS) Predictors for OS (PSM, DÁmico risk group, Gleason score, T-stage) MRI predictors for PSM, PSA recurrence and OS
Erectile function (IEEF-5) and urinary continence (IPSS-10) Urinary incontinence rates (≥1daily pads)
Statistics: Before RALP, included patients were randomized to the i) non-MRI group and ii) MRI-group. Kaplan Meier curves express the RFS and OS in the two groups, and the Log-rank test assesses any difference. Cox regression analyses is used to calculate the effect of MRI (Hazard ratios with 95% CIs). Chi-square test is used to assess the difference in incontinence rates, and the Mann-Whitney U test for assessing the difference in median IIEF-5 and IPSS-10 scores. Binary and Cox regression analysis is used to assess the predictive value of a positive surgical margin on PSA recurrence, and the effect of MRI variables in predicting RFS and OS (ADC, tumor volume, and radiological T-classification).
Data collection and handling of data: All patients were included in the study "Clinical impact of MRI in patients with prostate cancer." The urological and/or oncological clinic have followed these patients as part of routine clinical practice. Relevant clinical data are recorded in the "Radical prostatectomy registry ." All patients have already answered appropriate questionnaires during their regular follow-up.
PhD project: The study is a PhD project for radiologist Daniyal Noor at Oslo University Hospital
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- disease-free survival
- overall survival
- functional outcomes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients were randomized to either MRI or no-MRI before radical prostactomy
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 438
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** received no MRI before prostatectomy
**Intervention Names:**
- Diagnostic Test: Biparametric prostatic MRI
**Label:** no-MRI
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** received MRI before prostatectomy
**Intervention Names:**
- Diagnostic Test: Biparametric prostatic MRI
**Label:** MRI
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MRI
- no-MRI
**Name:** Biparametric prostatic MRI
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The difference between patients randomized to MRI or no-MRI
**Measure:** Disease-free survival (DFS)
**Time Frame:** 12-years after surgery
#### Secondary Outcomes
**Description:** The difference between patients randomized to MRI or no-MRI
**Measure:** Overall survival (OS)
**Time Frame:** 12-years after surgery
**Description:** The difference between patients randomized to MRI or no-MRI
**Measure:** Erectile dysfunction
**Time Frame:** After 12 years
**Description:** Predictors for recurrence
**Measure:** The impact of the length of positive surgical margin and Gleason score upon DFS.
**Time Frame:** After 12 years
**Description:** MRI predictors for recurrence
**Measure:** The impact of MRI variables for predicting PSM, PSA recurrence and OS
**Time Frame:** After 12 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Prostate cancer scheduled for prostatectomy. All participated in the previous RCT
Exclusion Criteria:
Patients who did not sign the consent paper for any reason or did not accept the study premises.
Patients who underwent MRI prior to randomization. Patents who withdrew their consent for any reason during the study.
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Oslo University Hospital
**Name:** Erik Rud, MD,PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Rud E, Baco E, Klotz D, Rennesund K, Svindland A, Berge V, Lundeby E, Wessel N, Hoff JR, Berg RE, Diep L, Eggesbo HB, Eri LM. Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial? Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.
**PMID:** 25813692
#### See Also Links
**Label:** A link to the original study
**URL:** http://clinicaltrials.gov/study/NCT01347320
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic 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: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429865
**Brief Title:** Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma
**Official Title:** Safety and Effectiveness of Cytosponge in Surveillance After Endoscopic Submucosal Dissection for Esophageal Squamous Cell Carcinoma
#### Organization Study ID Info
**ID:** CTSESD-20220509
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Tongliao City Hospital
**Class:** OTHER
**Name:** Ankang Central Hospital
**Class:** OTHER
**Name:** Yancheng First People's Hospital
**Class:** UNKNOWN
**Name:** Lianshui County People's Hospital
**Class:** OTHER_GOV
**Name:** Nanchong Central Hospital
**Class:** OTHER
**Name:** Henan Provincial People's Hospital
**Class:** OTHER
**Name:** The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
**Class:** OTHER
**Name:** Zhongda Hospital
**Class:** UNKNOWN
**Name:** Affiliated hospital of nanjing university hospital of Chinese medicine
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhai Hospital
#### Responsible Party
**Investigator Affiliation:** Changhai Hospital
**Investigator Full Name:** Wangluowei
**Investigator Title:** PhD; MD； Chief Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** cytosponge has good diagnostic efficacy in the diagnosis of esophageal cancer, and is more safe, economic and comfortable. It is expected to replace gastroscope in the surveillance after endoscopic submucosal dissection to a certain extent. At present, there is no relevant research at home and abroad. This study plans to establish a large sample cohort based on the collaborative research network established earlier, prospectively include 1000 patients who received endoscopic submucosal dissection for esophageal squamous cell carcinoma and compare the effectiveness and safety of cytosponge and gastroscope in surveillance after endoscopic submucosal dissection for esophageal squamous cell carcinoma through self -comparison.
**Detailed Description:** Esophageal cancer is one of the common malignant tumors in the world. In 2020, the number of new cases of esophageal cancer in the world will reach 604000, and the number of deaths will reach 544000. As a high incidence area of esophageal cancer in China, esophageal squamous cell carcinoma (ESCC) is the most common, with about 324000 cases of morbidity and 301000 deaths each year, posing a serious threat to people's lives and health. With the continuous development of digestive endoscopy technology, endoscopic submucosal dissection (ESD) and other minimally invasive endoscopic techniques have become the first line of treatment for early esophageal cancer. However, studies have shown that there is a risk of local recurrence within one year after ESD for early esophageal cancer, with a recurrence rate of 0-17%. Therefore, surveillance detection after ESD has become an important link in the diagnosis and treatment of esophageal cancer.
At present, there is no uniform standard at home and abroad for surveillance after ESD for esophageal squamous cell carcinoma, no matter the frequency or method of surveillance. For example, the guidelines issued by Japan suggest that the surveillance should be conducted every 6 to 12 months after ESD, at least once a year. In the guidelines issued by the European Society of Gastroenterology, it is recommended to review endoscopy 3 to 6 months after ESD. If there is no recurrence, it can be changed to review endoscopy once a year. The Guidelines for the Diagnosis and Treatment of Esophageal Cancer issued by the National Health Commission in April 2022 suggests that patients should be rechecked 3 months, 6 months and 12 months after ESD, and if there is no recurrence, they should be rechecked once a year. Recheck once every three months within two years after surgery, once every six months within two to five years, and once every year after five years. Although the above guidelines and specific strategies for surveillance after esophageal cancer surgery have not yet been unified, the use of upper gastrointestinal endoscopy (hereinafter referred to as "gastroscope") as the main means of review and close surveillance are more consistent.
However, due to the invasiveness, cost and availability of gastroscope, frequent endoscopic surveillance of patients with esophageal cancer after ESD may bring significant economic and health burden to patients, and lead to a decline in patients' subjective surveillance enthusiasm. Therefore, it is of great significance to find a more safe, economical and comfortable surveillance method that is equivalent to the diagnostic performance of gastroscope for standardizing the surveillance after ESD for esophageal cancer.
cytosponge is a new non-invasive examination method, which can diagnose esophageal lesions by collecting esophageal cells and carrying out cytological examination and p53 staining. Its diagnostic efficacy for esophageal cancer has been confirmed in various studies at home and abroad. Esophageal cytology has been proved to have a good application prospect in the identification and screening of high-risk groups of esophageal cancer. In the 20th century, our country widely carried out esophageal mesh cytology for screening esophageal cancer in high incidence areas, but this method has low sensitivity (39%\~47%), is easy to miss diagnosis, and has poor inspection comfort, and has been eliminated at present. The improved new esophageal cell collectors (such as CytospongeTM, EsophaCapTM, Shikang No. 1 TM, etc.) adopt the expanded sponge capsule design, which increases the contact area with esophageal mucosa, and has a higher success rate than the original dragnet cytology sampling. Cytological examination is relatively simple. Combining with the high-risk factor scoring scale can improve the screening effect and improve the positive rate and screening efficiency of surveillance endoscopic intensive examination. Foreign studies on Barrett's esophagus showed that the sensitivity of cytology combined with different biomarkers of the new cell collector of the esophagus was 73.3% - 93.1%, and the specificity was 92.4-95.7%; It can play a good risk stratification role in Barrett's esophageal related dysplasia and early esophageal adenocarcinoma (0% in low-risk group, 14% in medium risk group, and 87% in high-risk group). The diagnostic and management guidelines for Barrett's esophagus formulated by the British Gastroenterological Association and the American Gastroenterological Society both point out that: Cytosponge can be used as a screening method for Barrett's esophagus, and it is more in line with the principles of health economics. As early as 2010, a prospective cohort study in the UK showed that the sensitivity and specificity of cytosponges in diagnosing Barrett's esophagus with a circumference of 1cm or more were 73.3% and 93.8%, respectively. Similarly, a multicenter randomized controlled trial in the UK in recent years also confirmed the diagnostic efficacy of cellular sponge capsule in Barrett's esophagus. In addition, for areas with high incidence of ESCC, a study based on the Golestan cohort in Iran pointed out that the accuracy of cytological examination combined with p53 staining in detecting high-grade esophageal squamous hyperplasia could reach 100%. In a previous study conducted by our team, 1844 subjects from high-risk areas of ESCC were recruited, and the effectiveness, safety and comfort of the two in esophageal cancer screening were compared through cytosponge examination and gastroscopy. The results showed that the sensitivity and specificity of cellular sponge capsule in the diagnosis of high-grade esophageal lesions (including esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia) were 90% and 93.7% respectively. However, no serious adverse events were recorded during cell collection, which fully demonstrates the feasibility and safety of AI helper cytosponge in community screening of ESCC.
To sum up, the cellular sponge capsule has good diagnostic efficacy in the diagnosis of esophageal cancer, and is more safe, economical and comfortable. It is expected to replace gastroscope in the surveillance after ESD to a certain extent. At present, there is no relevant research at home and abroad. This study plans to establish a large sample cohort based on the collaborative research network established earlier, prospectively include 1000 patients who received ESD resection treatment for early esophageal cancer and compare the effectiveness and safety of cytosponge and gastroscope in the surveillance of early esophageal cancer after ESD through self-comparison.
### Conditions Module
**Conditions:**
- Esophageal Squamous Cell Carcinoma
**Keywords:**
- Esophageal Squamous Cell Carcinoma
- Cytosponge
- Surveillance
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants were instructed to place the capsule near the root of the tongue and fold the string in their mouths, leaving approximately 20 cm of string outside, with a blue mark on the string right at the lips. The capsule was then swallowed with water, and the end of the string was held out of the mouth. Participants were then asked to slowly drink 150-200 mL of 50°C water in approximately 2 minutes to allow the capsule to dissolve so that the sponge mesh inside was released. The device was then slowly withdrawn up the esophagus by pulling the string. The retrieved and expanded cell collection material was put in preservative fluid (Froeasy Technology, Nanjing, China) and transferred to the cytology laboratory at room temperature.
**Intervention Names:**
- Diagnostic Test: cytosponge
**Label:** esophageal squamous cell carcinoma group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- esophageal squamous cell carcinoma group
**Description:** Use of cytosponge as a tool to patients who need surveillance after endoscopic submucosal dissection for esophageal squamous cell carcinoma
**Name:** cytosponge
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Sensitivity and Specificity
**Measure:** Diagnostic accuracy
**Time Frame:** 60 minute
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* (1) Sex unlimited, age 18-85; (2) The indication of ESD for early (superficial) esophageal squamous cell carcinoma conforms to the domestic and foreign guidelines; (3) The pathological stage of ESD was pT1a/pT1b.
Exclusion Criteria:
* (1) The pathological findings after ESD were HGIN; (2) Dysphagia (Stooler grade 2-4), inability to swallow cell sponge capsule successfully; (3) Postoperative pathological data were incomplete; (4) Have a history of cancer, early cancer, adenoma and other benign and malignant tumors of stomach and duodenum, combined with malignant tumors of other parts; (5) Previous esophageal or gastric surgery; (6) Esophagectomy, segmented endoscopic mucosal resection (EMR), multi ring mucosal resection (MBM) and other endoscopic non block resection techniques were used; (7) Those who have coagulation dysfunction or need to take anticoagulant and antiplatelet drugs continuously; (8) There are contraindications to gastroscopy and mucosal biopsy; (9) People with other serious diseases whose life expectancy is less than 5 years; (10) I refuse to cooperate with the research scheme and refuse to sign the informed consent form.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Changhai Hospital
**State:** Shanghai
**Zip:** 200433
#### Overall Officials
**Official 1:**
**Affiliation:** Changhai Hospital
**Name:** Luowei Wang, MD
**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: 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429852
**Brief Title:** The Impact, Feasibility, and Acceptability of the DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program
**Official Title:** Examining the Impact, Feasibility, and Acceptability of the DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Exposed Individuals
#### Organization Study ID Info
**ID:** CSV202403
#### Organization
**Class:** OTHER
**Full Name:** CanSagligi Foundation
### Status Module
#### Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**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:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** CanSagligi Foundation
#### Responsible Party
**Investigator Affiliation:** CanSagligi Foundation
**Investigator Full Name:** Sevinc Ulusoy
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to develop a post-earthquake trauma-focused Acceptance and Commitment Therapy (ACT)-based psychosocial intervention program (DeST-ACT) and to examine the effectiveness, feasibility, and acceptability of this program on enhancing life satisfaction and psychological flexibility in individuals exposed to earthquake trauma.
In this regard, the main hypothesis is that the DeST-ACT psychosocial intervention program is effective, feasible, and acceptable among individuals exposed to earthquake trauma, including both primary and secondary outcomes of the program.
**Detailed Description:** This quantitative, randomized controlled trial involves two groups and includes a pre-test and repeated post-tests. The study aims to assess the effectiveness, feasibility, and acceptability of the developed DeST-ACT program in addressing post-traumatic stress disorder, psychological flexibility, life satisfaction, values-based living, and depression-anxiety-stress levels in individuals affected by the February 6, 2023 earthquake. In this study, participants will be randomly assigned to experimental and control groups in a 1:1 ratio using an internet-based block randomization program.
The DeST-ACT psychosocial intervention program consists of a 4 session online intervention supported by self-help materials. In the 4-week program, each session is one day a week for 50 minutes.
The main hypotheses are:
* The intervention group will demonstrate a significant decrease in Post Traumatic Stress Disorder (PTSD) and depression-anxiety-stress levels compared to the control group.
* The intervention group will experience a greater increase in values-based living, life satisfaction and psychological flexibility over time compared to the control group.
* The intervention group will demonstrate a significant decrease in PTSD and depression-anxiety-stress levels compared to baseline measures.
* The intervention group will experience a greater increase in values-based living, life satisfaction and psychological flexibility over time compared to baseline measures.
### Conditions Module
**Conditions:**
- Trauma and Stressor Related Disorders
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study will be a quantitative, randomized controlled trial consisting of two groups with a pre-test and repeated post-tests.
##### Masking Info
**Masking:** NONE
**Masking Description:** Randomization will be conducted by a research assistant using an internet-based program following the pre-test. The pre-test and post-tests will be administered by a different researcher who will be blinded to the study. The therapy program will be conducted by independent therapists who will also be blinded to the study.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the intervention group will undergo the DeST-ACT psychosocial intervention. This program includes a 4-session online intervention supplemented with self-help materials. These materials comprise concise texts designed to reinforce the skills covered in each session.
**Intervention Names:**
- Behavioral: The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program
**Label:** DeST-ACT Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The other group will consist of participants on the wait-list. Similar to those in the intervention group, participants in the waitlist group will undergo research assessments at baseline, post-therapy, and 1 month after therapy. Subsequently, they will be included in the 4-session intervention program administered in the study. No measurements will be taken after the intervention.
**Label:** Waitlist Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DeST-ACT Intervention Group
**Description:** Trauma-focused psychosocial intervention program consists of a 4 sessions online therapy.
**Name:** The DeST-ACT Trauma-Focused Acceptance and Commitment Therapy Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Caps-5 is a structured clinical interview form developed to assess PTSD symptoms and symptom severity. The CAPS-5 consists of questions that assess the frequency and severity of each symptom, the impact of the symptoms on the patient's social and occupational functioning, and the total severity of symptoms. Turkish validity and reliability study was conducted and Cronbach's Alpha values were higher than 0.87 for all symptom dimensions.
**Measure:** Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
**Time Frame:** The scale will be used to assess the inclusion criterion before the randomization.
#### Primary Outcomes
**Description:** PCL-5 was developed by considering the diagnostic criteria in DSM-5, and its aim is to evaluate PTSD symptoms. The scale consists of 20 items with a 5-point Likert type. Scores above 47 are indicative of PTSD.
**Measure:** PTSD Checklist for DSM-5 (PCL-5)
**Time Frame:** At baseline, after 4 weeks, after 8 weeks
**Description:** DASS-21 measures the dimensions of depression, stress, and anxiety. The scale consists of 21 items with a 4-point Likert type ranging from 0 = Never to 4 = Always (minimum:0; maxiumum:84). The Cronbach's alpha value of the scale, for which Turkish validity and reliability studies have been conducted, is 0.80 for anxiety, 0.82 for depression and 0.75 for stress.
**Measure:** Depression Anxiety and Stress Scale 21 (DASS-21)
**Time Frame:** At baseline, after 4 weeks, after 8 weeks
**Description:** Engaged Living Scale is a measure aiming to evaluate values-based living. The scale consists of 16 items with a 5-point Likert type as 1= Totally Agree and 4 = Totally Disagree (minimum:16; maxiumum:64). The scale, for which Turkish validity and reliability studies have been conducted, has two sub-dimensions: "valued living " and "life fulfillment". The Cronbach's alpha value of the Turkish version of the scale was found to be .91; as for the valued living sub-dimension was .87 and for the life fulfillment sub-dimension was .86.
**Measure:** Engaged Living Scale
**Time Frame:** At baseline, after 4 weeks, after 8 weeks
#### Secondary Outcomes
**Description:** AAQ-2 is a measure aiming to evaluate experiential avoidance. The scale consists of 7-point Likert type (minimum:7 to maxiumum 49). Higher points indicate higher experiential avoidance.
**Measure:** Acceptance and Action Questionnaire-2
**Time Frame:** At baseline, after 4 weeks, after 8 weeks
**Description:** It is a semi-structured form designed by the researchers to assess acceptability and perceived effectiveness. It is a 10-question form scored between 0 (not at all) and 4 (completely).
**Measure:** Therapy Satisfaction Questionnaire
**Time Frame:** after 4 week
**Description:** To evaluate acceptability, participants attendance rate to the program will be recorded.
**Measure:** Drop Rate
**Time Frame:** after 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteering to participate in the research
* During the earthquake of 6 February, being present in cities such as Kahramanmaraş, Gaziantep, Hatay, Adıyaman, Malatya where destruction occurred
* Being literate
* Able to have an online interview with the therapist
* Having sub-threshold PTSD or PTSD
Exclusion Criteria:
* Being in other cities at the time of the earthquake and not being exposed to the earthquake
* Having visual and/or hearing problems
* Having any psychotic disorder, experiencing an active mood episode, or having conditions such as intellectual disability or dementia that would prevent participation in therapy
* Starting a new psychiatric treatment during the research period or having a change in medication or dosage within the last 3 months.
**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:** Aleyna Güleryüz, BA
**Phone:** 02122696611
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sevinç Ulusoy, MD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Eda Aksoy
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sevinç Ulusoy, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Aleyna Güleryüz, BA
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** Cansagligi Foundation Center for Contextual Behavioral Science
**State:** Uskudar
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Trauma
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: HIGH
- As Found: Trauma and Stressor Related Disorders
- 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: D000014947
- Term: Wounds and Injuries
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429839
**Brief Title:** Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
**Official Title:** Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study
#### Organization Study ID Info
**ID:** NCC4571
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
**Investigator Full Name:** XIN WANG
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.
Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.
The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.
### Conditions Module
**Conditions:**
- Esophageal Cancer
- Nimotuzumab
- Chemoradiotherapy
- Chemotherapy
- Immunotherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 55
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Combination Product: Nimotuzumab with chemoradiotherapy
**Label:** Nimotuzumab concurrent with chemordiotherapy followed by surgery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nimotuzumab concurrent with chemordiotherapy followed by surgery
**Description:** Radiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days.
**Name:** Nimotuzumab with chemoradiotherapy
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.
**Measure:** R0 resection rate
**Time Frame:** 4 months after initiation of induction chemoimmunotherapy
#### Secondary Outcomes
**Description:** the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes
**Measure:** Pathological complete response
**Time Frame:** 4 months after initiation of induction chemoimmunotherapy
**Description:** the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
**Measure:** Event-free survival
**Time Frame:** 1 month after chemoradiotherapy
**Measure:** Postoperative complications
**Time Frame:** 1 month after surgery
**Description:** the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up
**Measure:** Overall survival
**Time Frame:** 1 year after all treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically confirmed esophageal squamous cell carcinoma.
* No previous treatment for the esophageal carcinoma.
* KPS score ≥70.
* NRS-2002 score≥2.
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;
Exclusion Criteria:
* Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy.
* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* There are active infections, such as active tuberculosis and hepatitis
* There are contraindications to targeted therapy.
**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:** Xin Wang, Doctor
**Phone:** 13311583220
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Guojie Feng, B.M
**Phone:** 16601212285
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xin Wang, Doctor
- **Phone:** 13311583220
- **Role:** CONTACT
**Country:** China
**Facility:** National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
**Status:** RECRUITING
## 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: 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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M25306
- Name: Malnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M1733
- Name: Esophageal Squamous Cell Carcinoma
- 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: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
### 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: M288889
- Name: Nimotuzumab
- Relevance: HIGH
- As Found: Details
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000501466
- Term: Nimotuzumab
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429826
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** ATTN201-P3-01
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429813
**Brief Title:** Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)
**Official Title:** A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/Muscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification
#### Organization Study ID Info
**ID:** HSR230542
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2025-11
**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:** 2025-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Paul Viscuse
#### Responsible Party
**Investigator Affiliation:** University of Virginia
**Investigator Full Name:** Paul Viscuse
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.
**Detailed Description:** The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment.
Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs:
* Arm A: A high intensity interval (HIIT) stationary bike program
* Arm B: A walking program
Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team.
Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.
### Conditions Module
**Conditions:**
- Castrate Sensitive Prostate Cancer
- Metastatic Prostate Cancer
**Keywords:**
- prostate
- metastatic prostate cancer
- metastatic castrate-sensitive prostate cancer
- prostate cancer
- exercise
- ADT
- ARSI
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HIIT Cycling Intervention
**Intervention Names:**
- Behavioral: Home-Based Exercise Intervention - HIIT Cycling
**Label:** Arm A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Walking Intervention
**Intervention Names:**
- Behavioral: Home-Based Exercise Intervention - Walking
**Label:** Arm B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm B
**Description:** 30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks
**Name:** Home-Based Exercise Intervention - Walking
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Arm A
**Description:** Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks
**Name:** Home-Based Exercise Intervention - HIIT Cycling
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants who complete the post-intervention follow-up assessment
**Measure:** Number of participants who complete the post-intervention follow-up assessment
**Time Frame:** 14 weeks from the start of the intervention
#### Secondary Outcomes
**Description:** Frequency, intensity and duration of exercise as measured by the activity monitors.
**Measure:** Treatment engagement with intervention
**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
**Description:** The Physical Activity Enjoyment Scale (PACES) is an 18 question, 7 point scale that includes questions regarding enjoyment of physical activity in the study.
**Measure:** Acceptability of exercise
**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
**Description:** Exit interviews include open and closed ended questions about the participant's experience in the study.
**Measure:** Patient-reported outcomes on exercise
**Time Frame:** From the beginning of the intervention to the Post-intervention visit (about 12 weeks)
**Description:** Number of individuals screened and randomized
**Measure:** Rate of recruitment per month
**Time Frame:** Each month for 12 months (estimated duration of accrual of participants)
**Description:** As measured by VO2 peak
**Measure:** Physical fitness (Cardiorespiratory)
**Time Frame:** Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later)
**Description:** Isometric and isokinetic torque in multiple positions (e.g. 60-120 degrees)
**Measure:** Muscular strength (quadriceps)
**Time Frame:** Measured at the baseline visit before the start of the intervention and post-intervention visit (about 16 weeks later
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, aged ≥18 years old
4. Diagnosis of mCSPC (defined as either biopsy-proven metastatic prostate cancer or elevated PSA (Prostate Specific Antigen) in the setting of imaging findings typical of prostate cancer spread; patients can either have de novo metastatic disease or recurrent metastatic disease after prior definitive therapy to the primary tumor with either surgery or radiation)
5. Planned treatment with ADT (LHRH \[Luteinizing hormone-releasing hormone\] agonist such as leuprolide or LHRH antagonist such as degarelix), and intensification with ARSI (abiraterone/prednisone, enzalutamide, apalutamide, or darolutamide)
6. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.
7. Ability to take oral medication and willing to adhere to the study intervention regimen
8. Ability to read, speak, and understand English.
Exclusion Criteria:
1. Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of disease on imaging PSA progression with PSA increase of \> 25% and 2 ng/mL above nadir, confirmed at 2 time points at least 3 weeks apart, in the setting of testosterone level \< 50)
2. Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA \[Prostate-Specific Antigen\] rise) but radiographic imaging is negative for metastatic disease
3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician
4. Medical/orthopedic comorbidities that preclude stationary cycling or walking
5. Significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training
6. Unstable angina or myocardial infarction within 4-weeks prior to treatment
7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms
8. Symptomatic severe aortic stenosis
9. Acute pulmonary embolus
10. Acute myocarditis
11. Untreated high-risk proliferative retinopathy
12. Recent retinal hemorrhage
13. Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg)
14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator
15. Uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema)
16. Symptomatic peripheral vascular disease
17. Prior treatment with taxane- or platinum- based chemotherapy
18. Prior treatment with PARP \[Poly (ADP-ribose) polymerase\] inhibitors
19. Prior treatment with radium-223 or lutetium-177
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Steven Goff
**Phone:** 434-806-1357
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christine Martin
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charlottesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Steven Goff
- **Phone:** 434-806-1357
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Virginia
**State:** Virginia
**Zip:** 22908
#### Overall Officials
**Official 1:**
**Affiliation:** University of Virginia
**Name:** Paul Viscuse, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000007154
- Term: Immune System 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
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Sensitive
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
- ID: D000006967
- Term: Hypersensitivity
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4059
- Name: Androgens
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429800
**Brief Title:** A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis
**Official Title:** A Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of ATA3219, Allogeneic Anti-CD19 Chimeric Antigen Receptor T-cell (CAR T) Therapy, in Subjects With Lupus Nephritis
#### Organization Study ID Info
**ID:** ATA3219-AEC-104
#### Organization
**Class:** INDUSTRY
**Full Name:** Atara Biotherapeutics
### Status Module
#### Completion Date
**Date:** 2029-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Atara Biotherapeutics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of the study is to evaluate the safety and preliminary efficacy of ATA3219 (following lymphodepletion) for treatment of participants with lupus nephritis (LN).
**Detailed Description:** This is a Phase 1, multi-centered, open-labeled, dose escalation study to evaluate the safety and preliminary efficacy of ATA3219 (as monotherapy) in participants with LN. Up to 3 dose levels (DLs) will be explored in the dose escalation portion of the study and if needed a lower dose may be explored. Prior to undergoing any screening procedure, prospective participants must undergo the ATA3219 inventory check assessments to ensure availability of an appropriate partially human leukocyte antigen (HLA)-matched ATA3219 lot. Before administration of ATA3219, participants will receive conditioning chemotherapy. For all enrolled participants, hospitalization during and following ATA3219 dosing is mandatory. Participants will receive a single dose intravenous (IV) infusion of ATA3219 (monotherapy) on Day 1. Participants will remain inpatient for a minimum of 1 week post ATA3219 dosing, where they will be frequently monitored. Lupus nephritis activity will be assessed by the investigator on Day 28 (+ 5 days) following each dose of ATA3219. During dose escalation, up to 3 dose levels of ATA3219 are planned to be evaluated sequentially and a lower dose may be added. At least 3 and up to 6 dose-limiting toxicity (DLT)-evaluable participants, those who complete the 28-day DLT observation period, will be assessed at each dose level. Within each dose level, treatment will be staggered to allow appropriate safety monitoring by an independent Data Safety Monitoring Committee (DSMC).
Participants who do not receive ATA3219 for any cause may be replaced. Participants who experience an adverse event (AE) prior to completion of the 28-day DLT observation period will not be replaced. If a participant is treated with ATA3219 and discontinues for any reason other than a DLT prior to completing the 28-day DLT observation period, an additional participant may be enrolled at the dose level to ensure that the recommended phase 2 dose (RP2D) can be determined. In rare situations, retreatment of participants with inadequate renal response may be considered.
After treatment is completed or discontinued, participants will be followed for safety and renal response for up to 24 months from the last dose of ATA3219. A separate long-term follow-up study will be conducted to follow participants for up to a total of 15 years after their last dose of ATA3219.
### Conditions Module
**Conditions:**
- Lupus Nephritis
- Systemic Lupus Erythematosus
**Keywords:**
- Lupus Nephritis (LN)
- Systemic Lupus Erythematosus (SLE)
- Anti CD19 Chimeric Antigen Receptor T cell (CAR T) Therapy
- Human leukocyte antigen (HLA)
- Epstein-Barr virus (EBV) T cells
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a single IV infusion of ATA3219 Dose Level -1 (if required) on Day 1 of a 28-day dose limiting toxicity (DLT) observation period.
**Intervention Names:**
- Drug: ATA3219
**Label:** ATA3219 Dose Level -1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive a single IV infusion of ATA3219 Dose Level 1 on Day 1 of a 28-day DLT observation period.
**Intervention Names:**
- Drug: ATA3219
**Label:** ATA3219 Dose Level 1
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive a single IV infusion of ATA3219 Dose Level 2 on Day 1 of a 28-day DLT observation period.
**Intervention Names:**
- Drug: ATA3219
**Label:** ATA3219 Dose Level 2
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants will receive a single IV infusion of ATA3219 Dose Level 3 on Day 1 of a 28-day DLT observation period.
**Intervention Names:**
- Drug: ATA3219
**Label:** ATA3219 Dose Level 3
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ATA3219 Dose Level -1
- ATA3219 Dose Level 1
- ATA3219 Dose Level 2
- ATA3219 Dose Level 3
**Description:** ATA3219 is an allogeneic chimeric antigen receptor (CAR) T-cell therapy containing a second generation CD19 CAR construct in Epstein Barr virus (EBV) T cells, administered intravenously on Day 1.
**Name:** ATA3219
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence and severity of treatment-emergent adverse events, including adverse events of special interest
**Time Frame:** From administration of conditioning treatment through 90 days after administration of study drug
**Measure:** Incidence of Dose-limiting Toxicities
**Time Frame:** Day 1 through Day 28 of first dose of study drug
**Measure:** Maximum Tolerated dose
**Time Frame:** Day 1 through Day 28 of first dose of study drug
**Measure:** Recommended Phase 2 dose of ATA3219
**Time Frame:** Day 1 through Day 28 of first dose of study drug
#### Secondary Outcomes
**Measure:** Maximum Observed Plasma Concentration (Cmax) of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Time to Reach Cmax (Tmax) of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Partial Area Under the Curve (pAUC) of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Last Observed Plasma Concentration (Clast) of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Time of Clast of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Terminal Half-life (t1/2) of ATA3219
**Time Frame:** Pre-dose on Day 1 through 24 months after the last dose on a defined schedule
**Measure:** Complete Renal Response
**Time Frame:** Weeks 24 and 52
**Measure:** Partial Renal Response
**Time Frame:** Weeks 24 and 52
**Measure:** Renal Objective Response Rate
**Time Frame:** Weeks 24 and 52
**Measure:** Change From Baseline in Urine protein to Creatinine Ratio
**Time Frame:** Baseline (Day -5) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in Estimated Glomerular Filtration Rate
**Time Frame:** Baseline (Day -5) through 24 months after the last dose on a defined schedule
**Measure:** Duration of Urine Protein to Creatinine ratio ≤ 0.5
**Time Frame:** Baseline (Day -5) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in Lupus Low Disease Activity State (LLDAS)
**Time Frame:** Baseline (Day 28) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in Definition of Remission in Systemic Lupus Nephritis (DORIS)
**Time Frame:** Baseline (Day 28) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in the Modified Version of the Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Nephritis Disease Activity (Hybrid SELENA-SLEDAI) Index
**Time Frame:** Baseline (Day 28) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in British Isles Lupus Assessment Group (BILAG) Index
**Time Frame:** Baseline (Day 28) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in Antibodies to Double Stranded Deoxyribonucleic Acid
**Time Frame:** Baseline (Day 1) through 24 months after the last dose on a defined schedule
**Measure:** Change From Baseline in Complement Component 3 (C3) and Complement Component 4 (C4) Levels
**Time Frame:** Baseline (Day 1) through 24 months after the last dose on a defined schedule
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Diagnosed with SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology classification for SLE or the Systemic Lupus International Collaborating Clinics Classification criteria \[Petri 2012\].
2. Meets one or more of the following immunologic criteria during screening:
1. Anti double stranded DNA above laboratory reference range, except enzyme linked immunosorbent assay (2 × above laboratory reference range), OR
2. Presence of anti-Smith antibody, OR
3. Low complement as demonstrated by low complement component 3, low complement component 4, or low complement CH50.
3. History of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy either within 6 months prior to screening or as performed during screening. Biopsy should demonstrate evidence of active nephritis.
4. Proteinuria level between ≥ 1.0 to 6.0 g/day via urine protein creatinine ratio during screening.
5. Has refractory LN defined as having received 1 or more standard therapies for LN (which must have included mycophenolate mofetil, mycophenolic acid, or cyclophosphamide), and:
1. Has worsening LN (per criteria listed in \[Gordon 2009\]) while on treatment, OR
2. Has not achieved a complete renal response (CRR) after 2 or more lines of therapy, OR
3. Has not achieved a CRR after first-line therapy after a minimum of 12 months.
6. Is using a stable, optimized dose of a renin angiotensin system inhibitor for at least 4 weeks prior to enrollment, unless deemed inappropriate by the investigator.
7. Participants must have been previously vaccinated for pneumococcus within 5 years prior to screening (and no later than 4 weeks prior to enrollment) or be willing to receive prophylaxis against infections with encapsulated bacteria via vaccination in accordance with local standards of practice and/or guidelines.
8. Is current per national or local health authority or institutional guidelines for immunocompromised individuals on the following vaccinations, unless refused or medically contraindicated: varicella zoster (Shingrix), pneumococcal, influenza, and Corona virus disease 2019 (COVID-19).
Exclusion Criteria:
1. Severe kidney disease as assessed locally, defined as history of ISN/RPS Class VI or isolated Class V glomerulonephritis (without co existent/predominant Class III or IV glomerulonephritis) on renal biopsy.
2. Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus.
3. Has any unstable or progressive manifestation of SLE that is likely to warrant an intensification of lupus-directed therapy
4. Has a history of confirmed or suspected drug-induced lupus.
5. Has a history of catastrophic antiphospholipid syndrome, or any history of prior thrombosis due to antiphospholipid syndrome resulting in hospitalization due to myocardial infarction, pulmonary embolism, or stroke.
6. Has a history of bleeding disorder requiring hospitalization or systemic therapeutic intervention within the previous 3 months, or for participants without a prior kidney biopsy meeting eligibility criterion within the past 6 months who will require a biopsy during screening, any contraindication to kidney biopsy.
7. Severe B cell immunodeficiency as evidenced by clinically significant refractory/recurrent infection.
8. Any prior cellular therapies, obinutuzumab, anti-cluster of differentiation 19 (CD19) antibody, or B-cell targeting bispecific antibody, unless B-cells have recovered to baseline as assessed by the investigator. Investigational therapies or initiation of new SLE-directed therapies within 4 weeks.
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Study Director
**Phone:** 650-278-8930
**Phone Ext:** 1
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Atara Biotherapeutics
**Name:** Justin Walstrom, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
**PMID:** 22553077
**Citation:** Gordon C, Jayne D, Pusey C, Adu D, Amoura Z, Aringer M, Ballerin J, Cervera R, Calvo-Alen J, Chizzolini C, Dayer J, Doria A, Ferrario F, Floege J, Guillevin L, Haubitz M, Hiepe F, Houssiau F, Lesavre P, Lightstone L, Meroni P, Meyer O, Moulin B, O'Reilly K, Praga M, Schulze-Koops H, Sinico R, Smith K, Tincani A, Vasconcelos C, Hughes G. European consensus statement on the terminology used in the management of lupus glomerulonephritis. Lupus. 2009 Mar;18(3):257-63. doi: 10.1177/0961203308100481.
**PMID:** 19213865
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- 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: D000005921
- Term: Glomerulonephritis
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12338
- Name: Nephritis
- Relevance: HIGH
- As Found: Nephritis
- ID: M11178
- Name: Lupus Nephritis
- Relevance: HIGH
- As Found: Lupus Nephritis
- ID: M11177
- Name: Lupus Erythematosus, Systemic
- Relevance: HIGH
- As Found: Systemic Lupus Erythematosus
- ID: M21881
- Name: Epstein-Barr Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue 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
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9031
- Name: Glomerulonephritis
- Relevance: LOW
- As Found: Unknown
- ID: T3523
- Name: Lupus Nephritis
- Relevance: HIGH
- As Found: Lupus Nephritis
- ID: T2525
- Name: Glomerulonephritis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009393
- Term: Nephritis
- ID: D000008181
- Term: Lupus Nephritis
- ID: D000008180
- Term: Lupus Erythematosus, Systemic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429787
**Brief Title:** Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
**Official Title:** Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.
#### Organization Study ID Info
**ID:** LEX-212
#### Organization
**Class:** INDUSTRY
**Full Name:** Octapharma
### Status Module
#### Completion Date
**Date:** 2032-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Octapharma
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
### Conditions Module
**Conditions:**
- Vitamin K-Dependent Coagulation Defect
- Significant Bleeding Risk
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 3574
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight
**Intervention Names:**
- Drug: Balfaxar
**Label:** BALFAXAR® (500 IU)
#### Arm Group 2
**Description:** KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (\~3 units/kg/min) up to a maximum rate of 8.4 mL/min (\~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.
**Intervention Names:**
- Drug: Kcentra
**Label:** Kcentra® (500 IU)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BALFAXAR® (500 IU)
**Description:** BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure
**Name:** Balfaxar
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Kcentra® (500 IU)
**Description:** KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:
* acute major bleeding or
* need for an urgent surgery/invasive procedure
**Name:** Kcentra
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.
**Measure:** TEEs within 45 days following VKA reversal treatment
**Time Frame:** 45 days
#### Secondary Outcomes
**Description:** Proportion of subjects diagnosed with TEEs within 7 and 14 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.
**Measure:** TEEs within 7 and 14 days following VKA reversal treatment
**Time Frame:** 14 days
**Description:** Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra
**Measure:** Median Time to TEEs
**Time Frame:** 45 days
**Description:** Proportion of subjects who die from any reason within 7, 14 and 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects who die from any reason within the same time period following treatment with Kcentra.
**Measure:** All Cause Mortality
**Time Frame:** 45 days
**Description:** Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra
**Measure:** Median Time to All Cause Mortality
**Time Frame:** 45 days
**Description:** Rate of fatal TEEs following treatment with BALFAXAR compared to rate of fatal TEEs following treatment with Kcentra within 7, 14 and 45 days following VKA reversal treatment
**Measure:** Rate of Fatal TEEs
**Time Frame:** 45 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subjects at least 18 years of age.
2. Subjects on VKA treatment.
3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.
Exclusion Criteria:
1. History of TEE within 90 days before receipt of VKA reversal therapy.
2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Patrick Murphy
**Phone:** 8663371868
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006474
- Term: Hemorrhagic Disorders
### 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: BC15
- Name: Blood and Lymph Conditions
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: HIGH
- As Found: Coagulation Defect
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: HIGH
- As Found: Coagulation Defect
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020141
- Term: Hemostatic Disorders
- ID: D000001778
- Term: Blood Coagulation Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Coag
- Name: Coagulants
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17602
- Name: Warfarin
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M16676
- Name: Thrombin
- Relevance: LOW
- As Found: Unknown
- ID: M17555
- Name: Vitamin K
- Relevance: LOW
- As Found: Unknown
- ID: T481
- Name: Vitamin K
- Relevance: LOW
- As Found: Unknown
- ID: T449
- Name: Menadione
- Relevance: LOW
- As Found: Unknown
- ID: T450
- Name: Menaquinone
- Relevance: LOW
- As Found: Unknown
- ID: T452
- Name: Naphthoquinone
- Relevance: LOW
- As Found: Unknown
- ID: T458
- Name: Phylloquinone
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429774
**Brief Title:** Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)
**Official Title:** Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study
#### Organization Study ID Info
**ID:** SF 2024-1-2042
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**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:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**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, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes.
**Detailed Description:** Traumatic brain injury (TBI) is associated with significant morbidity, mortality, and disability, profoundly impacting public health. This study aims to establish a database for acute craniocerebral trauma within the Beijing-Tianjin-Hebei region, and compiles indicators of hospital treatment capabilities and patient data, including neuroimaging, clinical progression, and rehabilitation prognoses.The study is bifurcated into two segments: the initial phase surveys the current status of acute treatment outcomes for TBI inpatients across hospitals in the Beijing-Tianjin-Hebei region and conducts a comparative effectiveness analysis to identify the clinical interventions to optimize. Subsequent phases build on the former by applying optimized treatment strategies to improve efficacy and establish collaborative optimized treatment protocols.
This is a prospective, multicenter, observational study designed to enroll 2,000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imaging.The primary outcome is the Extended Glasgow Outcome Score within 12 months. Secondary outcomes include the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener (SIS) and 12-Item Short-Form Health Survey version 2(SF-12v2).
The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region.
### Conditions Module
**Conditions:**
- Traumatic Brain Injury
**Keywords:**
- Traumatic Brain Injury
- Beijing-Tianjin-Hebei region
- Database
- Comparative effectiveness of intervention
- Clinical Treatment Guideline
### Design Module
#### Bio Spec
**Description:** * vein blood
* hematoma fluid
* dura mater
* hematoma outer membrane
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Year
### Arms Interventions Module
#### Arm Group 1
**Description:** TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.
The exclusion criteria are those who fulfill one of the following conditions:
1. patients ≥90 years of age;
2. patients who did not accept follow-up visits or were unable to complete follow-up assessments;
3. patients with incomplete information;
4. patients who did not obtain written informed consent;
5. patients with concomitant cancer or other serious illnesses.
**Intervention Names:**
- Other: Neurological function
- Other: Mental State, cognitive function, and life quality assessment
- Other: Peripheral blood test
- Other: Hematoma test
**Label:** TBI Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TBI Group
**Description:** Neurological function will be examined using Glasgow Coma Scale (GCS) and Extended Glasgow Outcome Scale (GOSE).The GOSE was created as an advancement from the original GOS. The GOSE score categorizes the prognosis of patients with traumatic brain injury into eight categories.The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.
**Name:** Neurological function
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- TBI Group
**Description:** Mental State, cognitive function, and life quality will be examined using the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener（SIS） and 12-Item Short-Form Health Survey version 2(SF-12v2).
**Name:** Mental State, cognitive function, and life quality assessment
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- TBI Group
**Description:** Collect peripheral blood samples from patients.
**Name:** Peripheral blood test
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- TBI Group
**Description:** Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
**Name:** Hematoma test
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Extended Glasgow Outcome Scores(GOSE) range from 1 to 8, with higher scores indicating a better outcome. The summary of the scale is below:1.Dead;2. Vegetative State;3. Lower Severe Disability;4. Upper Severe Disability;5. Lower Moderate Disability;6. Upper Moderate Disability;7. Lower Good Recovery;8.Upper Good Recovery.Therefore, a score of 1 represents the worst outcome (death), and a score of 8 represents the best outcome (upper good recovery).
The rates of death or severe disability (GOSE scores 1-3) due to traumatic brain injury in the short term (at discharge) and in the long term (3, 6, and 12 months post-discharge) give an indication of the extent to which a patient recovers from different treatments.
**Measure:** Difference in the Extended Glasgow Outcome Score
**Time Frame:** From discharge up to 12 months postoperatively
#### Secondary Outcomes
**Description:** Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Generalized Anxiety Disorder-7 Scale(GAD-7).
The GAD-7 scale consists of seven items, each describing a symptom of Generalized Anxiety Disorder(GAD), and respondents rate how often they've been bothered by each symptom over the past two weeks.The GAD-7 score of 10 suggests moderate anxiety, on a scale ranging from 0 (minimal anxiety) to 21 (severe anxiety), with higher scores indicating worse outcomes.
**Measure:** Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Patient Health Questionnaire-9 Scale(PHQ-9).
The PHQ-9 scale consists of nine items, each describing a symptom of depression, and respondents rate how often they've been bothered by each symptom over the past two weeks. The PHQ-9 scores between 10-14 suggest moderate depression, on a scale ranging from 0 (minimal depression) to 27 (severe depression), with higher scores indicating worse outcomes.
**Measure:** Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Rivermead Post-Concussive Symptoms Questionnaire(RPQ).
The RPQ score ranges from 0 (no symptoms) to 64 (severe symptoms). Higher scores on the RPQ indicate a greater severity of post-concussive symptoms and a worse outcome. This information helps healthcare providers assess the impact of the concussion on the patient's daily life and track their recovery progress.
**Measure:** Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Post-Traumatic Stress Disorder Checklist-5 (PCL-5). Each of the 20 items on the PCL-5 is rated on a scale from 0 ("Not at all") to 4 ("Extremely"). The PCL-5 score ranges from 0 to 80, with higher scores indicating worse Post-traumatic stress disorder(PTSD) symptoms.
**Measure:** Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Patients were scored on their subsequent level of quality of life at 3, 6, and 12 months after discharge based on different scores on the 12-item Short-Form Health Survey 2 (SF-12v2).
The SF-12v2 provides two summary scores: the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. For both the PCS and MCS scores range from 0(the lowest level of health) to 100(the highest level of health). Higher scores on the PCS and MCS indicate better physical and mental health, respectively.
**Measure:** Difference in life quality assessment
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Patients were scored on their subsequent level of cognitive function at 3, 6, and 12 months after discharge based on different scores on the Six-Item Screener (SIS).
The SIS is a brief cognitive assessment tool used primarily to screen for cognitive impairment. The SIS assesses orientation and recall, two critical components often affected in cognitive disorders such as dementia.It ranges from 0 to 6, with higher scores mean a better outcome in terms of cognitive function.
**Measure:** Difference in cognitive function
**Time Frame:** From discharge up to 12 months postoperatively
**Description:** Rates of complications and adverse events during hospitalization and 12 months after discharge.
**Measure:** Rate of complications and adverse events
**Time Frame:** From discharge up to 12 months postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient (1 years to 89 years) presenting with clinical symptoms of traumatic brain injury
* Traumatic brain injury verified on cranial computed tomography or magnetic resonance imaging
* Written informed consent from patients or their next of kin according to the patient's cognitive status
Exclusion Criteria:
* patients ≥90 years of age
* patients who did not accept follow-up visits or were unable to complete follow-up assessments
* patients with incomplete information
* patients who did not obtain written informed consent
* patients with concomitant cancer or other serious illnesses
**Maximum Age:** 89 Years
**Minimum Age:** 1 Year
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Weiming Liu, M.D.
**Phone:** 13701182770
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yu Shi, M.D.
**Phone:** 13611533819
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Fengtai You'anmen Hospital
**State:** Beijing
**Zip:** 100000
**Location 2:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Huairou Hospital
**State:** Beijing
**Zip:** 100000
**Location 3:**
**City:** Beijing
**Country:** China
**Facility:** Beijing HuaSheng Rehabilitation Hospital
**State:** Beijing
**Zip:** 100000
**Location 4:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Luhe Hospital,Capital Medical University
**State:** Beijing
**Zip:** 100000
**Location 5:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Tsinghua Changgung Hospital
**State:** Beijing
**Zip:** 100000
**Location 6:**
**City:** Beijing
**Country:** China
**Facility:** Peking University People's Hospital
**State:** Beijing
**Zip:** 100000
**Location 7:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Chaoyang Hospital, Capital Medical University
**State:** Beijing
**Zip:** 100020
**Location 8:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital
**State:** Beijing
**Zip:** 100020
**Location 9:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Daxing District People's Hospital
**State:** Beijing
**Zip:** 100020
**Location 10:**
**City:** Beijing
**Country:** China
**Facility:** Peking University International Hospital
**State:** Beijing
**Zip:** 100020
**Location 11:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Weiming Liu, MD
- **Phone:** 13701182770
- **Phone Ext:** +86
- **Role:** CONTACT
***Contact 2:***
- **Name:** Weiming Liu, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Guoyi Gao, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Dongling Sun, MD
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Beijing Tiantan Hospital, Capital Medical University
**State:** Beijing
**Zip:** 100070
**Location 12:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Pinggu Hospital
**State:** Beijing
**Zip:** 101200
**Location 13:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Changping Hospital
**State:** Beijing
**Zip:** 102200
**Location 14:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Mentougou District Hospital
**State:** Beijing
**Zip:** 102300
**Location 15:**
**City:** Beijing
**Country:** China
**Facility:** Liangxiang Hospital
**State:** Beijing
**Zip:** 102400
**Location 16:**
**City:** Beijing
**Country:** China
**Facility:** The First Hospital of Fangshan District, Bejing
**State:** Beijing
**Zip:** 102400
**Location 17:**
**City:** Baoding
**Country:** China
**Facility:** Affiliated Hospital Of Hebei University
**State:** Hebei
**Zip:** 071000
**Location 18:**
**City:** Baoding
**Country:** China
**Facility:** Bao Ding No.1 Central Hospital
**State:** Hebei
**Zip:** 071000
**Location 19:**
**City:** Baoding
**Country:** China
**Facility:** The No.2 Hospital of Baoding
**State:** Hebei
**Zip:** 071000
**Location 20:**
**City:** Baoding
**Country:** China
**Facility:** Anguo Hospital
**State:** Hebei
**Zip:** 071200
**Location 21:**
**City:** Baoding
**Country:** China
**Facility:** Xiongxian Hospital
**State:** Hebei
**Zip:** 071800
**Location 22:**
**City:** Baoding
**Country:** China
**Facility:** The Fourth Central Hospital of Baoding City
**State:** Hebei
**Zip:** 072350
**Location 23:**
**City:** Baoding
**Country:** China
**Facility:** Gaobeidian Hospital
**State:** Hebei
**Zip:** 074099
**Location 24:**
**City:** Cangzhou
**Country:** China
**Facility:** Suning Hospital
**State:** Hebei
**Zip:** 062350
**Location 25:**
**City:** Chengde
**Country:** China
**Facility:** Affiliated Hospital Of Chengde Medical University
**State:** Hebei
**Zip:** 067000
**Location 26:**
**City:** Chengde
**Country:** China
**Facility:** Luanping Hospital
**State:** Hebei
**Zip:** 068250
**Location 27:**
**City:** Handan
**Country:** China
**Facility:** Handan Central Hospital
**State:** Hebei
**Zip:** 056000
**Location 28:**
**City:** Handan
**Country:** China
**Facility:** Hangang Hospital
**State:** Hebei
**Zip:** 056000
**Location 29:**
**City:** Handan
**Country:** China
**Facility:** Weixian Chinese Traditional Medicine Hospital
**State:** Hebei
**Zip:** 056800
**Location 30:**
**City:** Handan
**Country:** China
**Facility:** The No.1 Hospital Of Yongnian District Handan City
**State:** Hebei
**Zip:** 057150
**Location 31:**
**City:** Hengyang
**Country:** China
**Facility:** Raoyang People's Hospital
**State:** Hebei
**Zip:** 053900
**Location 32:**
**City:** Langfang
**Country:** China
**Facility:** Langfang People's Hospital
**State:** Hebei
**Zip:** 065000
**Location 33:**
**City:** Langfang
**Country:** China
**Facility:** Yanjiao Fuhe No.1 Hospital
**State:** Hebei
**Zip:** 065201
**Location 34:**
**City:** Langfang
**Country:** China
**Facility:** Dachang Hui Autonomous County People's Hospital
**State:** Hebei
**Zip:** 065300
**Location 35:**
**City:** Langfang
**Country:** China
**Facility:** Xianghe Hospital
**State:** Hebei
**Zip:** 065400
**Location 36:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Hebei Medical University Third Hospital
**State:** Hebei
**Zip:** 050000
**Location 37:**
**City:** Shijiazhuang
**Country:** China
**Facility:** The Fourth Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 050000
**Location 38:**
**City:** Shijiazhuang
**Country:** China
**Facility:** The Third Hospital Of Shijiazhuang
**State:** Hebei
**Zip:** 050000
**Location 39:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Hebei Chest Hospital
**State:** Hebei
**Zip:** 050041
**Location 40:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Jingxing Hospital
**State:** Hebei
**Zip:** 050300
**Location 41:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Xibaipo Rescue Center
**State:** Hebei
**Zip:** 050411
**Location 42:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Xinle Chinese Traditional Medicine Hospital
**State:** Hebei
**Zip:** 050700
**Location 43:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Yuanshi Chinese Traditional Medicine Hospital
**State:** Hebei
**Zip:** 051130
**Location 44:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Gaoyi Hospital
**State:** Hebei
**Zip:** 051330
**Location 45:**
**City:** Tangshan
**Country:** China
**Facility:** Tangshan Fengrun People's Hospital
**State:** Hebei
**Zip:** 063000
**Location 46:**
**City:** Tangshan
**Country:** China
**Facility:** Tangshan Workers' Hospital
**State:** Hebei
**Zip:** 063000
**Location 47:**
**City:** Tangshan
**Country:** China
**Facility:** People's Hospital Of Zunhua
**State:** Hebei
**Zip:** 064200
**Location 48:**
**City:** Xingtai
**Country:** China
**Facility:** Xingtai Central Hospital
**State:** Hebei
**Zip:** 054000
**Location 49:**
**City:** Xingtai
**Country:** China
**Facility:** LinCheng People's Hospital
**State:** Hebei
**Zip:** 054300
**Location 50:**
**City:** Xingtai
**Country:** China
**Facility:** Qinghe Central Hospital
**State:** Hebei
**Zip:** 054800
**Location 51:**
**City:** Tianjin
**Country:** China
**Facility:** Tianjin Hospital
**State:** Tianjin
**Zip:** 300000
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Tiantan Hospital
**Name:** Weiming Liu, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020 Mar;104(2):213-238. doi: 10.1016/j.mcna.2019.11.001.
**PMID:** 32035565
**Citation:** Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant. 2017 Jul;26(7):1118-1130. doi: 10.1177/0963689717714102.
**PMID:** 28933211
**Citation:** Jiang JY, Gao GY, Feng JF, Mao Q, Chen LG, Yang XF, Liu JF, Wang YH, Qiu BH, Huang XJ. Traumatic brain injury in China. Lancet Neurol. 2019 Mar;18(3):286-295. doi: 10.1016/S1474-4422(18)30469-1. Epub 2019 Feb 12.
**PMID:** 30784557
**Citation:** Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
**PMID:** 28504109
**Citation:** Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbuchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.
**PMID:** 31526754
**Citation:** Silverberg ND, Duhaime AC, Iaccarino MA. Mild Traumatic Brain Injury in 2019-2020. JAMA. 2020 Jan 14;323(2):177-178. doi: 10.1001/jama.2019.18134. No abstract available.
**PMID:** 31816030
**Citation:** Sun D, Jiang B, Ru X, Sun H, Fu J, Wu S, Wang L, Wang L, Zhang M, Liu B, Wang W; for the NESS-China investigators. Prevalence and Altered Causes of Traumatic Brain Injury in China: A Nationwide Survey in 2013. Neuroepidemiology. 2020;54(2):106-113. doi: 10.1159/000501911. Epub 2019 Dec 18.
**PMID:** 31851999
## Derived Section
### Condition Browse Module - Ancestors
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5207
- Name: Brain Injuries
- Relevance: HIGH
- As Found: Brain Injury
- ID: M628
- Name: Brain Injuries, Traumatic
- Relevance: HIGH
- As Found: Traumatic Brain Injury
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001930
- Term: Brain Injuries
- ID: D000070642
- Term: Brain Injuries, Traumatic
- ID: D000014947
- Term: Wounds and Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11767
- Name: Metronidazole
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429761
**Acronym:** STRIDE
**Brief Title:** A PROSPECTIVE, MULTI-CENTER, PHASE 4 STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
**Official Title:** A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
#### Organization Study ID Info
**ID:** D9673L00012
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
**Detailed Description:** As per recommendation from DCGI, the current phase-IV study is planned with an aim to assess the safety of Trastuzumab deruxtecan in Indian subjects receiving the drug as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. The data obtained from the present study will help to understand the safety profile of Trastuzumab deruxtecan among Indian patients.
### Conditions Module
**Conditions:**
- BREAST CANCER
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Trastuzumab deruxtecan
**Intervention Names:**
- Drug: Trastuzumab deruxtecan
**Label:** Single Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single Arm
**Description:** IV infusion
**Name:** Trastuzumab deruxtecan
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of adverse events
**Measure:** To assess the safety of trastuzumab deruxtecan in adult Indian patients
**Time Frame:** 6 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent.
2 Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
3 Participants with pathologically documented breast cancer that:
* is unresectable or metastatic
* HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment.
* was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as:
a. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony-stimulating factor administration is not allowed within 1 wk prior to Screening assessment); b. Platelet count ≥ 100 × 109/L (Platelet transfusion is not allowed within 1 wk prior to Screening assessment); c. Hemoglobin level ≥ 9.0 g/dL (Red blood cell transfusion is not allowed within 1 wk prior to Screening assessment).
5 Adequate renal function within 14 d before enrolment, defined as:
* Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation (CLcr (mL/min) = \[140 - age (years)\] × weight (kg) {× 0.85 for females}; 72 × serum creatinine (mg/dL) 6 Adequate hepatic function within 14 d before enrolment, defined as:
* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \< 3
× ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline, and
* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × ULN
7 Adequate blood clotting function within 14 d before enrolment, defined as:
* International normalized ratio/prothrombin time ≤ 1.5 × ULN and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN 8 Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of trastuzumab deruxtecan. Male subjects must agree to inform all potential female partners that they are participating in a clinical trial of a drug that may cause birth defects. Male subjects must also agree to either avoid intercourse or that they and/or any female partners of reproductive/childbearing potential will use a highly effective form of contraception during and upon completion of the study and for at least 4.5 mo after the last dose of trastuzumab deruxtecan. Methods considered as highly effective methods of contraception include:
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
o Oral
o Intravaginal
o Transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation:
o Oral
o Injectable
o Implantable
* Intrauterine device
* Intrauterine hormone-releasing system
* Bilateral tubal occlusion
* Vasectomized partner
* Complete sexual abstinence defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 7 mo for female subjects (4.5 mo for male subjects) after the last dose of trastuzumab deruxtecan. True abstinence must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, postovulation methods) is not an acceptable method of contraception.
Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 mo of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \> 40 mIU/mL and estradiol \< 40 pg/mL \[\< 147 pmol/L\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 wk will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method.
9 Male subjects must not freeze or donate sperm throughout the study period beginning at Cycle 1 Day 1 and for at least 4.5 mo after the last dose of trastuzumab deruxtecan or Preservation of sperm should be considered prior to enrollment in this study.
10 Female subjects must not donate ova or retrieve them for their own use from the time of Screening and throughout the study treatment period, and for at least 7 mo after the last dose of trastuzumab deruxtecan
Exclusion Criteria:
1. Prior treatment with T-DXd
2. Uncontrolled or significant cardiovascular disease, including any of the following:
1. History of myocardial infarction within 6 months before enrolment
2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
3. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male);
4. LVEF \< 50% within 28 d prior to treatment initiation.
3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
4. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
* Subjects with clinically inactive brain metastases may be included in the study.
* Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment.
5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product or to other mAbs.
6. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
7. Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection.
8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade 2 chemotherapy-induced neuropathy).
9. Therapeutic radiation therapy or major surgery within 4 wk before enrolment or palliative stereotactic radiation therapy within 2 wk before enrolment.
10. Systemic treatment with anticancer therapy (immunotherapy \[non-antibody-based therapy\], retinoid therapy, or hormonal therapy) within 3 wk before enrolment; antibody-based-anticancer-therapy within 4 wk before enrolment; or treatment with nitrosoureas or mitomycin C within 6 wk before randomization; or treatment with small-molecule targeted agents within 2 wk or 5 half-lives before enrolment, whichever is longer.
11. Participation in a therapeutic clinical study within 3 wk before enrolment (for small-molecule targeted agents, this non-participation period is 2 wk or 5 half-lives, whichever is longer), or current participation in other investigational procedures.
12. Pregnant, breastfeeding, or planning to become pregnant.
13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion etc), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjögren's, sarcoidosis etc), or prior pneumonectomy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-9479
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal
Vivli.org. All requests 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 approved.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
**URL:** https://vivli.org/
## 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 - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000018796
- Term: Immunoconjugates
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M325
- Name: Trastuzumab
- Relevance: HIGH
- As Found: Medication
- ID: M233243
- Name: Trastuzumab deruxtecan
- Relevance: HIGH
- As Found: Aspirate
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- 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: D000068878
- Term: Trastuzumab
- ID: C000614160
- Term: Trastuzumab deruxtecan
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429748
**Acronym:** SET
**Brief Title:** Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation
**Official Title:** A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)
#### Organization Study ID Info
**ID:** 44-50019-000
#### Organization
**Class:** OTHER
**Full Name:** Neuronetics
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Neuronetics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.
**Detailed Description:** Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.
### Conditions Module
**Conditions:**
- Neurologic Symptoms
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### 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:** Single Group
**Intervention Names:**
- Device: rTMS
**Label:** Open Label
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Open Label
**Description:** repetitive Transcranial Magnetic Stimultion
**Name:** rTMS
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Treatment related Adverse Events
**Measure:** Safety Outcome
**Time Frame:** 16 weeks
#### Primary Outcomes
**Description:** Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.
**Measure:** Changes in multiple symptoms after rTMS treatment.
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to final follow-up visit.
**Measure:** Durability of changes in symptoms
**Time Frame:** 16 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults, 22 to 70 years of age
2. Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
3. Score \> or = 8 on ISI scale
4. If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
5. If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
6. Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.
Exclusion Criteria:
1. Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. History of head trauma associated with loss of consciousness or diagnosed as concussion.
3. History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
4. Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
5. Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
6. Has medication infusion device.
7. Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
8. PHQ-9 total score \> or = 10 or QIDS total score \> or = 11.
9. Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
10. Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
11. Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
12. Has a clinically significant abnormality on the screening examination.
13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
**Maximum Age:** 70 Years
**Minimum Age:** 22 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Neha Goyal
**Phone:** 7635281599
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charlotte
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Robyn Allen, RN
- **Phone:** 704-333-9113
- **Role:** CONTACT
***Contact 2:***
- **Name:** Elizabeth Rostan, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Charlotte Skin and Laser
**State:** North Carolina
**Status:** RECRUITING
**Zip:** 28207
#### Overall Officials
**Official 1:**
**Affiliation:** Neuronetics
**Name:** Steve Erickson
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: HIGH
- As Found: Neurologic Symptoms
### Condition Browse Module - Meshes
- ID: D000009461
- Term: Neurologic Manifestations
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429735
**Acronym:** PRIME
**Brief Title:** Precise Robotically Implanted Brain-Computer Interface
**Official Title:** PRIME: An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices
#### Organization Study ID Info
**ID:** N1-EFS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Neuralink Corp
### Status Module
#### Completion Date
**Date:** 2031-01
**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:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-09
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Neuralink Corp
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
### Conditions Module
**Conditions:**
- Tetraplegia/Tetraparesis
- Quadriplegia
- Cervical Spinal Cord Injury
- Amyotrophic Lateral Sclerosis
- Quadriplegia/Tetraplegia
- Tetraplegic; Paralysis
**Keywords:**
- spinal cord injury, ALS, brain computer interface, BCI
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DEVICE_FEASIBILITY
#### Enrollment Info
**Count:** 3
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Implantation of the N1 Implant by the R1 Robot.
**Intervention Names:**
- Device: N1 Implant
- Device: R1 Robot
**Label:** Neuralink N1 Implant and R1 Robot
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neuralink N1 Implant and R1 Robot
**Description:** The N1 Implant is a type of implantable brain-computer interface
**Name:** N1 Implant
**Other Names:**
- Neuralink N1 Implant, N1, Telepathy, Link
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Neuralink N1 Implant and R1 Robot
**Description:** The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
**Name:** R1 Robot
**Other Names:**
- R1, Neuralink R1 Robot
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** Device-Related Adverse Events (AE)
**Time Frame:** 12 months post-implant
**Measure:** Procedure-Related Adverse Events (AE)
**Time Frame:** 12 months post-implant
#### Secondary Outcomes
**Measure:** Device-Related Adverse Events (AE)
**Time Frame:** Up to 72 months post-implant
**Measure:** Procedure-Related Adverse Events (AE)
**Time Frame:** Up to 72 months post-implant
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver
Exclusion Criteria
* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
**Maximum Age:** 75 Years
**Minimum Age:** 22 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Head of Clinical
**Phone:** 818-527-2710
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Phoenix
**Contacts:**
***Contact 1:***
- **Name:** Francisco Ponce, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Barrow Neurological Institute
**State:** Arizona
**Status:** RECRUITING
**Zip:** 85013
#### Overall Officials
**Official 1:**
**Affiliation:** Barrow Neurological Institute
**Name:** Francisco Ponce, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** https://neuralink.com/
**URL:** https://neuralink.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000057177
- Term: TDP-43 Proteinopathies
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M14632
- Name: Quadriplegia
- Relevance: HIGH
- As Found: Quadriplegia
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M18879
- Name: Motor Neuron Disease
- Relevance: HIGH
- As Found: Lateral Sclerosis
- ID: M4024
- Name: Amyotrophic Lateral Sclerosis
- Relevance: HIGH
- As Found: Amyotrophic Lateral Sclerosis
- ID: M13157
- Name: Paralysis
- Relevance: HIGH
- As Found: Paralysis
- ID: M15915
- Name: Spinal Cord 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: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28759
- Name: TDP-43 Proteinopathies
- 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
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T349
- Name: Amyotrophic Lateral Sclerosis
- Relevance: HIGH
- As Found: Amyotrophic Lateral Sclerosis
- ID: T4699
- Name: Primary Lateral Sclerosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000016472
- Term: Motor Neuron Disease
- ID: D000000690
- Term: Amyotrophic Lateral Sclerosis
- ID: D000010243
- Term: Paralysis
- ID: D000011782
- Term: Quadriplegia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429722
**Brief Title:** To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
**Official Title:** A Phase 2a, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With a Major Depressive Episode Associated With Bipolar II Disorder
#### Organization Study ID Info
**ID:** NMRA-335140-202
#### Organization
**Class:** INDUSTRY
**Full Name:** Neumora Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Neumora 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:** This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.
### Conditions Module
**Conditions:**
- Major Depressive Episode Associated With Bipolar II Disorder
**Keywords:**
- NMRA-335140
- Navacaprant
- BTRX-335140
- CYM-53093
- Bipolar II Disorder
- Major Depressive Episode
- Placebo-controlled
- Double-blind
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Sponsor will also be blinded
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD.
**Intervention Names:**
- Drug: NMRA-335140 80 mg
**Label:** NMRA-335140 80 milligrams (mg) once daily (QD)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo participants will receive matching placebo tablet once daily.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NMRA-335140 80 milligrams (mg) once daily (QD)
**Description:** Participants will receive NMRA-335140 at a dose of 80 mg QD, orally.
**Name:** NMRA-335140 80 mg
**Other Names:**
- BTRX-335140
- CYM-53093
- Navacaprant
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo will be administered orally
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7- point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
**Measure:** Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
**Time Frame:** Baseline and up to Week 6
#### Secondary Outcomes
**Description:** The SHAPS is a 14-item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability, and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the response items; where those answered with "strongly agree" will be coded as a 1, while a "strongly disagree" response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
**Measure:** Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
**Time Frame:** Baseline and up to Week 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of BP II disorder with a current major depressive episode (MDE), without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID-5-CT) at screening (this may be a first or recurrent episode).
2. Participant's current MDE and lifetime history of hypomanic episodes must be confirmed by independent assessment.
3. The symptoms of the current MDE have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
4. Have a MADRS total score of 25 or higher at Screening and Baseline.
5. A change in MADRS total score between Screening and Baseline of ≤20%.
Exclusion Criteria:
1. Have failed 2 or more courses of antidepressant (adequate dose and duration, i.e., minimum 6 weeks) or mood stabilizer/antipsychotic treatment (each or in combination) for treatment of depressive symptoms in the current MDE.
2. Have currently or in the past year any of the following DSM-5-TR disorders: bipolar episodes with mixed features (including the current MDE), bipolar II with rapid cycling pattern (4 or more distinct mood episodes during a 12-month period). Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, panic disorder, for whom bipolar II MDE is considered the primary diagnosis are not excluded.
3. Have a lifetime diagnosis of bipolar I disorder (manic episode schizophrenia, schizoaffective disorder, schizophreniform disorder, anorexia nervosa, bulimia nervosa, cluster B personality disorder, post-traumatic stress disorder (PTSD), or obsessive- compulsive disorder.
4. Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
5. Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
**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:** Study Contact
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lauderhill
**Country:** United States
**Facility:** Neumora Investigator Site
**State:** Florida
**Status:** RECRUITING
**Zip:** 33161
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood 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: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Episode
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depressive Episode
- ID: M7060
- Name: Depressive Disorder, Major
- Relevance: HIGH
- As Found: Major Depressive Episode
- 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
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
- ID: D000003865
- Term: Depressive Disorder, Major
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429709
**Brief Title:** Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM
**Official Title:** Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media
#### Organization Study ID Info
**ID:** H-50018
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** OtoNexus Medical Technologies, Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor College of Medicine
#### Responsible Party
**Investigator Affiliation:** Baylor College of Medicine
**Investigator Full Name:** Yi-Chun Carol Liu
**Investigator Title:** 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 objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children scheduled for tympanostomy tube surgery for the purpose of algorithm development.
**Detailed Description:** The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children scheduled for tympanostomy tube surgery for the purpose of algorithm development.
After informed consent from a parent or guardian is obtained, ultrasound and visual data will be collected for each of the child's ears. The images will be taken with the Advanced Ultrasound Otoscope device. The ear laterality will be noted as well as any infection present in the fluid, non-infected fluid, or normal findings in the middle ear as reported by the surgeon. No identifiable data will be recorded. Each study participant will be given a unique study number that will be linked to the images and middle ear findings. No additional information is gathered including age, sex, name or other PHI. The images and corresponding study data will be stored on a password protected smartphone or tablet as well as on a password protected external hard drive. Other characteristics that will be collected include surgical and lab findings regarding effusion, presence or absence (i.e. effusion). The middle ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this collected fluid will be sent to the microbiology laboratory for analysis
Investigators will be collecting ultrasound and visual data from the tympanic membrane. The images the investigators are collecting are optical images of the surface of the tympanic membrane. The waveforms do not traverse the body tissue, the tympanic membrane is a strong reflector, and the signal is returned to the ultrasound transducer for processing the waveform from an analog to a digital signal. The power of the ultrasound signal is 1/1000th of the ultrasound power used for fetal imaging which is considered safe.
### Conditions Module
**Conditions:**
- Otitis Media Recurrent
- Middle Ear Infection
- Ear Infection
**Keywords:**
- Otoscope
- Tympanogram
- Effusion
- Ultrasound
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ultrasound and signal information and visual otoscopic images will be collected with an engineering prototype otoscope device for children scheduled for tympanostomy tube surgery. Images of each of the child's ears will be taken by the advanced ultrasound otoscope device. Data collected will include ear laterality, surgical and lab findings of the effusion (present or absent) and characteristics as reported by the surgeon. The middle ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this collected fluid will be send for analysis to microbiology. The pathology results will be recorded to correlate ultrasound signals to surgical findings
**Intervention Names:**
- Device: Advanced Ultrasound Otoscope
**Label:** Algorithm Development
#### Arm Group 2
**Description:** The clinical validation phase includes the same procedures as the algorithm development phase only, the clinical validation phase is a double blind study where ultrasound score is compared to surgical findings and lab analysis.
**Intervention Names:**
- Device: Advanced Ultrasound Otoscope
**Label:** Clinical Validation
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Algorithm Development
- Clinical Validation
**Description:** The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type
**Name:** Advanced Ultrasound Otoscope
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Correlation of device measurements to the gold standard of surgeon's findings at myringotomy. Gather ultrasound data for the four disease states of middle ear effusion (normal, viral infection, bacterial infection, and Adhesive Otitis Media) and correlate the ultrasound waveforms with the surgeon's findings and lab analysis obtained at tympanostomy tube insertion. For estimation of fluid character, the middle ear fluid will be correlated with the surgeon's semiquantitative grading of middle ear fluid. For the analysis of microbiota, the middle ear effusion fluid will be sent to microbiology.
**Measure:** Device Performance
**Time Frame:** 2 years and 6 months
#### Secondary Outcomes
**Description:** Evaluate the usability of the Advanced Ultrasound Otoscope device in pediatric patients as measured by the ability of the device to fit in subjects' external auditory canals and obtain a tympanic mobility measurement(s).
**Measure:** Device Usability
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Newborn to 12 years of age
* Receiving first set of pressure equalization (PE) tubes, even if coordinated with other procedures such as adenoidectomy
* Indication for surgery includes recurrent acute otitis media, chronic otitis media with effusion, Eustachian tube dysfunction, and/or hearing loss.
Exclusion Criteria:
* Cholesteatoma, tympanic membrane perforation, myringitis
* History of PE tube placement or PE tubes currently in place.
**Maximum Age:** 12 Years
**Minimum Age:** 0 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** We will be recruiting patients between 0 months and 12 years of age who meet the listed inclusion criteria and do not meet any of the listed exclusion criteria. We are not selecting patients based on race/ethnicity or gender/sex. Parents must be fluent in either English or Spanish.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rachel Arp
**Phone:** 936-267-7707
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Justine Kasay
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rachel Arp
- **Phone:** 936-267-7707
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Justine Kasay
- **Role:** CONTACT
***Contact 3:***
- **Name:** Yi-Chun Liu, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Texas Children's Hospital
**State:** Texas
**Status:** RECRUITING
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** Baylor College of Medicine
**Name:** Tiffany Raynor, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Baylor College of Medicine
**Name:** Yi-Chun Liu, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Baylor College of Medicine
**Name:** Shraddha Mukerji, MD
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Baylor College of Medicine
**Name:** Jennifer Yan, MD
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Baylor College of Medicine
**Name:** Sonal Saraiya, MD
**Role:** STUDY_CHAIR
**Official 6:**
**Affiliation:** Baylor College of Medicine
**Name:** Mary E Williamson, MD
**Role:** STUDY_CHAIR
**Official 7:**
**Affiliation:** Baylor College of Medicine
**Name:** Henri Traboulsi, MD
**Role:** STUDY_CHAIR
**Official 8:**
**Affiliation:** Baylor College of Medicine
**Name:** Anna Messner, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M12954
- Name: Otitis
- Relevance: HIGH
- As Found: Ear Infection
- ID: M12956
- Name: Otitis Media
- Relevance: HIGH
- As Found: Otitis Media
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000010031
- Term: Otitis
- ID: D000010033
- Term: Otitis Media
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429696
**Brief Title:** PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
**Official Title:** Single-arm, Prospective Clinical Study of PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
#### Organization Study ID Info
**ID:** NFEC-2024-220
#### Organization
**Class:** OTHER
**Full Name:** Nanfang Hospital, Southern Medical University
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nanfang Hospital, Southern Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of a PD-L1 inhibitor combined with apatinib as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The study plans to recruit 40 patients. After receiving 4-6 cycles of induction therapy, patients whose efficacy is evaluated as CR, PR or SD (according to RECIST 1.1) will enter maintenance therapy with PD-L1 inhibitor + apatinib 250 mg po qd. , the selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase. Efficacy was assessed using RECISIT 1.1, with imaging evaluations every 6 weeks (±7 days) for 48 weeks after the first dose and every 9 weeks (±7 days) after week 48, regardless of treatment delays or interruptions, until Disease progression or study termination, whichever occurs first. The primary efficacy endpoint of this study is 6-month PFS rate, and secondary efficacy endpoints include median PFS, median OS and safety.
### Conditions Module
**Conditions:**
- Small Cell Lung Cancer Extensive Stage
**Keywords:**
- first-line maintenance treatment
- PD-L1 inhibitor
- apatinib
- ES-SCLC
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### 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:** Six-month progression-free survival rate (6-month PFS rate) of PD-L1 inhibitor combined with apatinib in first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC)
**Intervention Names:**
- Drug: PD-L1 inhibitor combined with apatinib
**Label:** PD-L1 inhibitor combined with apatinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PD-L1 inhibitor combined with apatinib
**Description:** Every 3 weeks (21 days) is a treatment cycle. After 4-6 cycles of induction therapy, patients whose efficacy is evaluated as CR, PR or SD (according to RECIST 1.1) will enter maintenance therapy until the disease progresses and becomes intolerable. Toxic and side effects, death, withdrawal of information or the investigator's decision to withdraw the subject from the study, non-compliance with study treatment or other reasons specified in the study procedures or protocol, or treatment for up to 2 years. Maintenance treatment: PD-L1 inhibitor + apatinib 250 mg po qd, maintained for up to 2 years. Note: The specific PD-L1 inhibitor is selected by the researcher, such as adebelimab 1200mg iv, q3w; or atezolizumab 1200mg iv d1, q3w; or durvalumab 1500mg iv d1, q3w . The selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase.
**Name:** PD-L1 inhibitor combined with apatinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as the time between the onset of PD when the patient first received study drug and death, whichever occurred first.
**Measure:** 6-month progression-free survival (PFS)
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** Defined as the time between the onset of PD when the patient first received study drug and death, whichever occurred first.
**Measure:** Median progression-free survival (PFS)
**Time Frame:** 3 years
**Description:** Defined as the time between the patient's first receipt of study drug and death
**Measure:** Median overall survival (OS)
**Time Frame:** 3 years
**Description:** Defined as the proportion of patients achieving complete response (CR) or partial response (PR).
**Measure:** Objective response rate (ORR)
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 18-75 years old, both men and women are welcome;
2. Extensive-stage small cell lung cancer confirmed by histology or cytology (staging according to the American Veterans Lung Cancer Association, VALG);
3. Patients whose induction therapy must receive the first-line standard treatment regimen of PD-L1 monoclonal antibody combined with chemotherapy, and whose efficacy evaluation is CR, PR or SD (according to RECIST 1.1); patients who have previously undergone surgical treatment and receive curative adjuvant therapy such as radiotherapy , chemotherapy patients, there is a treatment-free interval of at least 6 months from the last chemotherapy, radiotherapy or chemoradiotherapy to the diagnosis of extensive-stage SCLC;
4. Expected survival time ≥12 weeks;
5. ECOG physical status score 0\~1 points;
6. Before the first dose of study drug, laboratory test values must meet the following conditions:
1. Blood routine (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): WBC ≥3.0 × 109/L; ANC ≥1.5 × 109/L; PLT ≥100 × 109/L; HGB ≥90 g/L;
2. Liver function: AST ≤2.5 × ULN in subjects without liver metastasis; ALT ≤2.5 × ULN; ALT and AST in subjects with liver metastasis ≤5 × ULN; TBIL ≤1.5 × ULN;
3. Renal function: serum Cr ≤1.5 × ULN or CrCl ≥50 mL/min (using Cockcroft/Gault formula);
4. Coagulation function: INR ≤1.5 × ULN, APTT ≤1.5 × ULN (only applicable to patients who are not currently receiving anticoagulation therapy);
7. Women of childbearing age must have a serum pregnancy test within 7 days before taking the drug for the first time, and the result is negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use contraception within 24 weeks from signing the informed consent form to the last administration of the study drug;
8. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. Patients transformed from non-small cell carcinoma (NSCLC) to SCLC or SCLC with mixed histology;
2. Meningeal metastasis or symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or stable symptoms for ≥ 2 weeks after treatment of brain metastasis, they can participate in this study as long as they meet all the following criteria: Outside the central nervous system Have measurable lesions, no metastasis to the meninges, midbrain, pons, cerebellum, medulla oblongata or spinal cord, no previous history of intracranial hemorrhage, and stop hormone therapy 14 days before the first dose of study drug;
3. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that cannot be controlled by pumping or other treatments;
4. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, infectious pneumonia, radiation pneumonitis requiring steroid treatment, active tuberculosis, or other serious effects on the lungs Functional moderate to severe lung disease;
5. There is an active autoimmune disease and corticosteroids (\>10 mg/day prednisone or equivalent dose) or other immunosuppressants are used within 14 days before the first medication;
6. Have serious cardiovascular diseases, such as New York Heart Association (NYHA) grade 2 or above heart failure, unstable angina, unstable arrhythmia, and myocardial infarction occurring within 3 months before enrollment or cerebrovascular accident;
7. Other malignant tumors ≤5 years before the first dose of medication (fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery can be admitted) group and allows hormone therapy for non-metastatic prostate or breast cancer);
8. Hypertension that cannot be controlled by oral antihypertensive drugs (systolic blood pressure ≧140mmHg or diastolic blood pressure ≧90mmHg);
9. Urine routine shows urine protein ≥++ and confirms that the 24-hour urine protein quantification is \>1.0 g;
10. Risk of bleeding: Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, etc.; suffer from hereditary or acquired bleeding diseases or coagulation Functional disorders, such as aplastic anemia, etc.; taking anticoagulant or antiplatelet drugs (such as warfarin, phenprocoumon);
11. Those who have recently experienced intestinal obstruction or gastrointestinal perforation (within 3 months); or those who are unable to swallow tablets normally, which may affect drug absorption as judged by the researcher;
12. People with the following infectious diseases are not allowed to join the group:
1. HBsAg is positive and the HBV DNA copy number is greater than the upper limit of normal value (1000 copies/ml or 500IU/ml) in the laboratory of the research center;
2. HCV positive (HCV RNA or HCV Ab detection indicates acute or chronic infection);
3. Known history of HIV positivity or known acquired immunodeficiency syndrome;
13. Have undergone major surgery within 28 days before the screening period, or plan to undergo major surgery during the study period;
14. Have received systemic immunosuppressive drug treatment (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor \[anti-tumor necrosis factor\] within 1 week before the first medication) TNF\] drugs). Patients receiving short-term, systemic immunosuppressive therapy, such as glucocorticoids for nausea, vomiting, or allergic reaction management or prophylaxis, may be enrolled in the study after approval by the investigator;
15. Live attenuated vaccines are used within 28 days before the first dose, or live attenuated vaccines are expected to be needed during the study;
16. Known to be allergic to study drugs or excipients, known to have severe allergic reactions to any monoclonal antibody drug;
17. Have received any other experimental drug treatment or participated in another interventional clinical study within 4 weeks before the first use of the drug;
18. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
19. According to the researcher's judgment, the subject has other factors that may lead to the forced termination of this study, such as non-compliance with the protocol, other serious diseases (including mental illness) that require combined treatment, and family or social factors that may affect the study. to the safety of subjects or the collection of information and samples
**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:** Wangjun Liao, MD, PhD
**Phone:** 86-20-62787731
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Nanfang Hospital, Southern Medical University
**Name:** Wangjun Liao, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: 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: M5534
- Name: Carcinoma
- 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: 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
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M288166
- Name: Apatinib
- Relevance: HIGH
- As Found: Immunogenicity
- ID: M272500
- Name: Durvalumab
- Relevance: LOW
- As Found: Unknown
- ID: M349417
- Name: Atezolizumab
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: HIGH
- As Found: Glucose sensor
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000553458
- Term: Apatinib
- ID: D000082082
- Term: Immune Checkpoint Inhibitors
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429683
**Brief Title:** Effectıveness of The Sexually Transmıtted Dıseases Educatıon Program for Adolescents
**Official Title:** Effectıveness of The Sexually Transmıtted Dıseases Educatıon Program for Adolescents
#### Organization Study ID Info
**ID:** IstanbulGelisimuniversity
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Gelisim University
### Status Module
#### Completion Date
**Date:** 2023-06-01
**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:** 2023-02-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bahar Nur Kanbur
#### Responsible Party
**Investigator Affiliation:** Istanbul Gelisim University
**Investigator Full Name:** Bahar Nur Kanbur
**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:** The World Health Organization has defined the period between the ages of 10-19 as adolescence, 15-24 years as youth and 10-24 years as youth period. Adolescence is divided into 3 periods: early adolescence (10-13 years), middle adolescence (14-16 years) and late adolescence (17-21 years). HIV virus and AIDS, which have become a problem among sexually transmitted diseases all over the world, have increased the importance of controlling sexually transmitted diseases. There is a strong correlation between the spread of STDs through traditional means and the transmission of HIV; and sexually transmitted diseases have been found to increase the risk of sexual transmission of HIV. According to WHO data, 340 million treatable STDs, millions of incurable STDs and 5 million HIV cases occur worldwide each year.
**Detailed Description:** People in the 15-49 age group who are sexually active are the most likely to contract sexually transmitted diseases. The prevalence of STDs is higher in developing countries than in developed countries. These diseases are among the top 5 etiologic factors that cause loss of years of "healthy productive life" in developing countries. As in other countries, sexually transmitted diseases are of great importance in terms of complications and sequelae in Turkey
One out of 20 young people is infected with STDs every year. In our country, the age of sexual maturation has shifted earlier. In addition, the age of sexual experience of young people has also shifted earlier. Young people's understanding of freedom and their inability to access FP methods whenever they want negatively affect their sexual health behaviors. Impact on Society STDs cause a lot of economic and social damage to society. STDs may disrupt the normal functioning of family, community and health institutions and leave these institutions under a heavy economic burden. STDs reduce the productivity of men and women at the most productive ages of their lives. In addition, when outbreaks of these infections are not controlled, the costs to society will increase.
Translated with DeepL.com (free version)
### Conditions Module
**Conditions:**
- Sexually Transmitted Diseases
**Keywords:**
- adolescent
- sexually transmitted diseases
- education
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 250
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** To evaluate the effectiveness of sexually transmitted diseases education given to young adolescents aged 17-21 years
**Intervention Names:**
- Other: Sexually transmitted diseases training for young adolescents aged 17-21
**Label:** Sexually transmitted diseases training for young adolescents aged 17-21
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sexually transmitted diseases training for young adolescents aged 17-21
**Description:** Education
**Name:** Sexually transmitted diseases training for young adolescents aged 17-21
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Sexually Transmitted Diseases Knowledge Test includes 36 questions that assess students' level of knowledge about sexually transmitted diseases. The questions are answered as "True", "False", and "I don't know". Students will be administered the STD knowledge test before the training. The test will be administered again after the training. In the post-training test, the student is expected to give more correct answers to the questions compared to the previous test.
**Measure:** Students' Knowledge Test on Sexually Transmitted Diseases
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At a Foundation University located within the borders of Istanbul Province 1.2.3. and 4th grade students
Exclusion Criteria:
-
**Healthy Volunteers:** True
**Maximum Age:** 21 Years
**Minimum Age:** 17 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul Gelisim University
**State:** Avcılar
#### Overall Officials
**Official 1:**
**Affiliation:** Trakya University
**Name:** Canan Örüklü
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: HIGH
- As Found: Sexually Transmitted Diseases
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012749
- Term: Sexually Transmitted Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429670
**Acronym:** VENAURA
**Brief Title:** Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory
**Official Title:** Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group
#### Organization Study ID Info
**ID:** 69HCL24_0521
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2023-09-01
**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:** 2023-07-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.
### Conditions Module
**Conditions:**
- Acute Myeloid Leukemia
**Keywords:**
- acute myeloid leukemia
- azacitdine
- venetoclax
- MRD
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adult patients with acute myeloid leukemia treated by AZACYTIDINE and VENETOCLAX in frontline and relapse/refractory settings
**Label:** Azacytidine and venetoclax treated patients
### Outcomes Module
#### Primary Outcomes
**Description:** Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.
**Measure:** Overall survival
**Time Frame:** up to 5 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \>18 years old
* Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
* receiving AZA/VEN combination regimen
Exclusion Criteria:
* Another VEN combination chemotherapy
* AZA/VEN initiation prior January 2019 and after December 2023
* Opposition to the study
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Every adult patients ( \>18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bourgoin-Jallieu
**Country:** France
**Facility:** Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord
**Zip:** 38300
**Location 2:**
**City:** Chambéry
**Country:** France
**Facility:** METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
**Zip:** 73000
**Location 3:**
**City:** Clermont-Ferrand
**Country:** France
**Facility:** CHU Clermont-Ferrand Site Estaing
**Zip:** 63100
**Location 4:**
**City:** La Tronche
**Country:** France
**Facility:** CHU Grenoble Alpes
**Location 5:**
**City:** Lyon
**Country:** France
**Facility:** Centre Léon Bérard
**Zip:** 69003
**Location 6:**
**City:** Lyon
**Country:** France
**Facility:** Hospices Civils de Lyon
**Zip:** 69229
**Location 7:**
**City:** Roanne
**Country:** France
**Facility:** Centre Hospitalier de Roanne
**Zip:** 42300
**Location 8:**
**City:** Saint-Priest-en-Jarez
**Country:** France
**Facility:** CHU de Saint-Étienne Hôpital Nord
**Zip:** 42270
**Location 9:**
**City:** Valence
**Country:** France
**Facility:** Centre Hospitalier de Valence
**Zip:** 26000
**Location 10:**
**City:** Valence
**Country:** France
**Facility:** Ch de Valence
**Location 11:**
**City:** Vichy
**Country:** France
**Facility:** Hopital Vichy
**Zip:** 03200
**Location 12:**
**City:** Épagny
**Country:** France
**Facility:** Centre Hospitalier Annecy Genevois
**Zip:** 74370
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- 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: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M249656
- Name: Venetoclax
- Relevance: LOW
- As Found: Unknown
- ID: M4673
- Name: Azacitidine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429657
**Acronym:** Ketamine
**Brief Title:** Ketamine for Sedation in Severe Traumatic Brain Injury
**Official Title:** Ketamine for Sedation in Severe Traumatic Brain Injury
#### Organization Study ID Info
**ID:** C.2024.025
#### Organization
**Class:** OTHER
**Full Name:** Henry M. Jackson Foundation for the Advancement of Military Medicine
### Status Module
#### Completion Date
**Date:** 2027-06-30
**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:** 2027-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** Uniformed Services University of the Health Sciences
**Class:** FED
**Name:** Brooke Army Medical Center
#### Lead Sponsor
**Class:** OTHER
**Name:** Henry M. Jackson Foundation for the Advancement of Military Medicine
#### 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 protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.
**Detailed Description:** Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm.
Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes (coughing etc.). In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will be continued until removal of intracranial pressure monitoring.
This study will take place during the participant's hospital care. The clinical team will administer treatment using standard practices, including all safety precautions available. Side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk.
The research team will performed one outpatient follow-up after study intervention ends.
### Conditions Module
**Conditions:**
- Severe Traumatic Brain Injury
- Intracranial Hypertension
- Intracranial Hemorrhage, Hypertensive
**Keywords:**
- TBI
- Severe TBI
- Traumatic Brain Injury
- Sedation
- Ketamine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine
**Intervention Names:**
- Drug: Ketamine with propofol
**Label:** Ketamine with propofol
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam.
**Intervention Names:**
- Other: Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
**Label:** SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ketamine with propofol
**Description:** Propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine
**Name:** Ketamine with propofol
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
**Description:** Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam administered according to the institutional SOC guidelines.
**Name:** Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** ICP elevations \> 22 mmHg for greater than 5 minutes.
**Measure:** Number of ICP elevations greater than 22 mmHg for greater than 5 minutes
**Time Frame:** During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting
**Description:** Mean ICP
**Measure:** Mean ICP
**Time Frame:** During the maximum 5-day course of study intervention.
#### Secondary Outcomes
**Description:** Total time spent with ICP \>22 mmHg (in minutes).
**Measure:** Total time spent with intracranial pressure (ICP) >22 mmHg
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Mean CPP (in minutes).
**Measure:** Mean Cerebral Perfusion Pressure (CPP)
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Total time spent with CPP \<60 mmHg (in minutes).
**Measure:** Total time spent with CPP <60 mmHg
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Total number of events where CPP \<60 mmHg (in minutes) for greater than 5 minutes.
**Measure:** Total number of events where CPP <60 mmHg for greater than 5 minutes
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Relationship between vasopressor infusion dose and mean arterial blood pressure. VDI= (dobutamine dose × 1) + (dopamine dose × 1) + (norepinephrine dose × 100) + (vasopressin × 100) + (epinephrine × 100))/MAP indicating the relationship of high VDI and poor outcome.
**Measure:** Vasopressor dependency index (VDI)
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Incidence of seizures (as documented by EEG).
**Measure:** Incidence of seizures
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Incidence of cardiac arrhythmias (other than sinus tachycardia).
**Measure:** Incidence of cardiac arrhythmias
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Mean heart rate (HR).
**Measure:** Mean heart rate
**Time Frame:** During the maximum 5-day course of study intervention.
**Description:** Incidence of PTSD at 6-month outpatient follow-up.
**Measure:** Incidence of post-traumatic stress disorder (PTSD) in outpatient setting
**Time Frame:** Outpatient follow-up six months after intervention.
**Description:** GOSE-TBI assessment resulting in subjective measure of 0-8 regarding recovery after injury with higher score indicating greatest recovery to pre-injury life, will be conducted at 6-month outpatient follow-up.
**Measure:** Glasgow Coma Outcome Scale extended (GOSE-TBI) scores
**Time Frame:** Outpatient follow-up six months after intervention.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults 18-65 years of age
* Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
* Placement of intracranial pressure monitor
* Receiving treatment in an intensive care unit (ICU)
Exclusion Criteria:
* Significant cardiovascular disease with recent coronary intervention
* Pregnancy
* Prisoners
* Known allergy to ketamine or propofol
**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:** Marisa F Rodriguez
**Phone:** 210-851-5779
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Martin R Cota, MPH
**Phone:** 301-295-9685
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Iaccarino C, Carretta A, Nicolosi F, Morselli C. Epidemiology of severe traumatic brain injury. J Neurosurg Sci. 2018 Oct;62(5):535-541. doi: 10.23736/S0390-5616.18.04532-0.
**PMID:** 30182649
**Citation:** Agrawal D, Raghavendran K, Schaubel DE, Mishra MC, Rajajee V. A Propensity Score Analysis of the Impact of Invasive Intracranial Pressure Monitoring on Outcomes after Severe Traumatic Brain Injury. J Neurotrauma. 2016 May 1;33(9):853-8. doi: 10.1089/neu.2015.4015. Epub 2015 Oct 8.
**PMID:** 26414629
**Citation:** Butcher I, Maas AI, Lu J, Marmarou A, Murray GD, Mushkudiani NA, McHugh GS, Steyerberg EW. Prognostic value of admission blood pressure in traumatic brain injury: results from the IMPACT study. J Neurotrauma. 2007 Feb;24(2):294-302. doi: 10.1089/neu.2006.0032.
**PMID:** 17375994
**Citation:** McHugh GS, Engel DC, Butcher I, Steyerberg EW, Lu J, Mushkudiani N, Hernandez AV, Marmarou A, Maas AI, Murray GD. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. 2007 Feb;24(2):287-93. doi: 10.1089/neu.2006.0031.
**PMID:** 17375993
**Citation:** Murray GD, Butcher I, McHugh GS, Lu J, Mushkudiani NA, Maas AI, Marmarou A, Steyerberg EW. Multivariable prognostic analysis in traumatic brain injury: results from the IMPACT study. J Neurotrauma. 2007 Feb;24(2):329-37. doi: 10.1089/neu.2006.0035.
**PMID:** 17375997
**Citation:** Petkus V, Preiksaitis A, Chaleckas E, Chomskis R, Zubaviciute E, Vosylius S, Rocka S, Rastenyte D, Aries MJ, Ragauskas A, Neumann JO. Optimal Cerebral Perfusion Pressure: Targeted Treatment for Severe Traumatic Brain Injury. J Neurotrauma. 2020 Jan 15;37(2):389-396. doi: 10.1089/neu.2019.6551. Epub 2019 Nov 13.
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**Citation:** Bebarta VS, Mora AG, Bebarta EK, Reeves LK, Maddry JK, Schauer SG, Lairet JR. Prehospital Use of Ketamine in the Combat Setting: A Sub-Analysis of Patients With Head Injuries Evaluated in the Prospective Life Saving Intervention Study. Mil Med. 2020 Jan 7;185(Suppl 1):136-142. doi: 10.1093/milmed/usz302.
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**PMID:** 33482641
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**Citation:** Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, Servadei F, Walters BC, Wilberger JE; Surgical Management of Traumatic Brain Injury Author Group. Surgical management of acute subdural hematomas. Neurosurgery. 2006 Mar;58(3 Suppl):S16-24; discussion Si-iv.
**PMID:** 16710968
**Citation:** Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, Servadei F, Walters BC, Wilberger J; Surgical Management of Traumatic Brain Injury Author Group. Surgical management of traumatic parenchymal lesions. Neurosurgery. 2006 Mar;58(3 Suppl):S25-46; discussion Si-iv. doi: 10.1227/01.NEU.0000210365.36914.E3.
**PMID:** 16540746
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## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- 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: D000010335
- Term: Pathologic Processes
- ID: D000002561
- Term: Cerebrovascular Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M21521
- Name: Intracranial Hypertension
- Relevance: HIGH
- As Found: Intracranial Hypertension
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: HIGH
- As Found: Intracranial Hemorrhage
- ID: M5207
- Name: Brain Injuries
- Relevance: HIGH
- As Found: Brain Injury
- ID: M628
- Name: Brain Injuries, Traumatic
- Relevance: HIGH
- As Found: Traumatic Brain Injury
- ID: M22112
- Name: Intracranial Hemorrhage, Hypertensive
- Relevance: HIGH
- As Found: Intracranial Hemorrhage, Hypertensive
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M17400
- Name: Vascular Diseases
- 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: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001930
- Term: Brain Injuries
- ID: D000070642
- Term: Brain Injuries, Traumatic
- ID: D000020300
- Term: Intracranial Hemorrhages
- ID: D000019586
- Term: Intracranial Hypertension
- ID: D000020299
- Term: Intracranial Hemorrhage, Hypertensive
- ID: D000006470
- Term: Hemorrhage
- ID: D000014947
- Term: Wounds and Injuries
### Intervention Browse Module - Ancestors
- ID: D000006993
- Term: Hypnotics and Sedatives
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- 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: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018686
- Term: Anesthetics, Intravenous
- ID: D000018681
- Term: Anesthetics, General
- ID: D000000777
- Term: Anesthetics
- ID: D000000778
- Term: Anesthetics, Dissociative
- ID: D000018691
- Term: Excitatory Amino Acid Antagonists
- ID: D000018683
- Term: Excitatory Amino Acid Agents
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000000759
- Term: Adjuvants, Anesthesia
- ID: D000014151
- Term: Anti-Anxiety Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018757
- Term: GABA Modulators
- ID: D000018682
- Term: GABA Agents
- ID: D000000927
- Term: Anticonvulsants
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M8418
- Name: Fentanyl
- Relevance: HIGH
- As Found: Scan
- ID: M22662
- Name: Dexmedetomidine
- Relevance: HIGH
- As Found: Twice daily
- ID: M11845
- Name: Midazolam
- Relevance: HIGH
- As Found: Induction
- ID: M10674
- Name: Ketamine
- Relevance: HIGH
- As Found: Provided
- ID: M11982
- Name: Morphine
- Relevance: HIGH
- As Found: Site
- ID: M7275
- Name: Hydromorphone
- Relevance: HIGH
- As Found: Phase 2 Study
- ID: M11140
- Name: Lorazepam
- Relevance: HIGH
- As Found: Zoledronic Acid
- ID: M18307
- Name: Propofol
- Relevance: HIGH
- As Found: Symptoms
- 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: M4107
- Name: Anesthetics
- 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: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M4089
- Name: Adjuvants, Anesthesia
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M20827
- Name: GABA Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008874
- Term: Midazolam
- ID: D000005283
- Term: Fentanyl
- ID: D000020927
- Term: Dexmedetomidine
- ID: D000007649
- Term: Ketamine
- ID: D000009020
- Term: Morphine
- ID: D000004091
- Term: Hydromorphone
- ID: D000008140
- Term: Lorazepam
- ID: D000015742
- Term: Propofol
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429644
**Brief Title:** Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
**Official Title:** Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
#### Organization Study ID Info
**ID:** 2022-04-039
#### Organization
**Class:** OTHER
**Full Name:** Hanyang University Seoul Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-08
**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:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-07-07
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Korean Surgical Society
**Class:** UNKNOWN
**Name:** Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
#### Lead Sponsor
**Class:** OTHER
**Name:** Hanyang University Seoul 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:** The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients in breast cancer patients with BRCA 1/2 mutations.
**Detailed Description:** The purpose of study is to assess the oncologic safety of BCS in patients carrying BRCA1/2 mutations by comparing long-term outcomes with mastectomy. The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients. By providing insights into the feasibility of BCS for patients with BRCA1/2 mutations, the investigators aim to present evidence to aid in surgical decision-making for the care of these patients.
### Conditions Module
**Conditions:**
- BRCA1/2 Mutation
- Breast-conserving Surgery
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 4010
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University, Dongtan, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Dongtan Sacred Heart Hospital
#### Arm Group 2
**Description:** Division of Breast Surgery, Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Samsung Medical Center
#### Arm Group 3
**Description:** Breast Care Center, Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Seoul National University Hospital
#### Arm Group 4
**Description:** Department of Surgery, Severance hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Severance hospital
#### Arm Group 5
**Description:** Department of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Kyungpook National University Chilgok Hospital
#### Arm Group 6
**Description:** Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Gangnam Severance Hospital
#### Arm Group 7
**Description:** Department of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Hanyang University Medical Center
#### Arm Group 8
**Description:** Department of Breast \& Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Hallym University Sacred Heart Hospital
#### Arm Group 9
**Description:** Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Kangbuk Samsung Hospital
#### Arm Group 10
**Description:** Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Incheon St. Mary's Hospital
#### Arm Group 11
**Description:** Department of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Kyung Hee University Hospital
#### Arm Group 12
**Description:** Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Keimyung University School of Medicine
#### Arm Group 13
**Description:** Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
**Intervention Names:**
- Procedure: Breast-conserving surgery
**Label:** Asan Medical Center
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Asan Medical Center
- Dongtan Sacred Heart Hospital
- Gangnam Severance Hospital
- Hallym University Sacred Heart Hospital
- Hanyang University Medical Center
- Incheon St. Mary's Hospital
- Kangbuk Samsung Hospital
- Keimyung University School of Medicine
- Kyung Hee University Hospital
- Kyungpook National University Chilgok Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance hospital
**Description:** Breast-conserving surgery, also known as breast-conserving therapy or lumpectomy, is a surgical procedure used to treat breast cancer while preserving as much of the breast tissue as possible. During this procedure, the surgeon removes the cancerous tumor along with a surrounding margin of normal tissue. The goal is to remove the cancerous cells while maintaining the appearance and function of the breast as much as possible.
**Name:** Breast-conserving surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Recurrence in breast or chest wall and/or regional lymph nodes
**Measure:** Locoregional recurrence-free survival
**Time Frame:** Duration from diagnosis until the development of recurrence up to 10year
**Description:** Recurrence in a distant organ
**Measure:** Distant recurrence-free survival
**Time Frame:** Duration from diagnosis until the development of recurrence up to 10year
**Description:** Any form of disease recurrence
**Measure:** Recurrence-free survival
**Time Frame:** Duration from diagnosis until the development of recurrence up to 10year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary invasive breast cancer who underwent BCS or mastectomy
* Received a BRCA1/2 mutation test
Exclusion Criteria:
* Patients with de novo metastasis
* Pregnancy-associated breast cancer
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The ON-BRCAII is multi-institution cohort study being conducted by the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Patients with primary breast cancer who underwent BCS or mastectomy and received a BRCA1/2 mutation test between January 2008 and December 2015 were retrospectively identified from 13 institutions in South Korea. The inclusion criteria comprised patients aged 20 to 80 years with invasive breast cancer (pT1-3, N0-3). The exclusion criteria consisted of patients with de novo metastasis and those with pregnancy-associated breast cancer.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Hanyang university hospital
## Derived Section
### 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: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429631
**Brief Title:** The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury.
**Official Title:** The Effect of CIC Education on Quality of Life and Compliance With Mobile Application After Discharge in Individuals With Spinal Cord Injury (CIC: Clean Intermittent Catheterization)
#### Organization Study ID Info
**ID:** 77082166-302.08.01-424987
#### Organization
**Class:** OTHER
**Full Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Gazi University
#### Lead Sponsor
**Class:** OTHER
**Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
**Investigator Full Name:** Nilgün Aras
**Investigator Title:** Nurse, MSN
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and causes urination disorders. Nowadays, in individuals diagnosed with neurogenic bladder, Clean Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder. Clean Intermittent Catheterization(CIC) is a simple, safe and effective method in which the catheter is placed through the meatus. In this application, the catheter is removed without waiting after urine drainage is achieved. This process is usually performed on its own. Since IC(Intermittent Catheterization) is a procedure performed on the bladder, it may cause some complications. IC application must be performed successfully to prevent or reduce complications. The success of the technique largely depends on patient education and follow-up. Sometimes patients may not be able to come to the hospital for follow-up and feedback after IC training.
Innovations are needed to ensure the continuation of distance education so that the education of patients who cannot come to the hospital is not incomplete. The literature includes brochures, videos, websites and some mobile applications for IC training. However, no application has been found that monitors patients' urine amounts.
This research was planned to examine the effect of clean intermittent catheterization training given via mobile application to individuals with spinal cord injury on their quality of life and compliance.
**Detailed Description:** scales:
1. Information form: Authors will ask to patients age, weight, height, gender, marital status, education level, diagnosis, time of injury, cause of injury, independence level, working or not working, presence of spasticity, presence of complications
2. WHOQOL-BREF(World Health Organization Quality of Life Scale):The WHO Quality of Life Assessment (WHOQOL) is a generic quality of life instrument that was designed to be applicable to people living under different circumstances, conditions, and cultures. The short version known as WHOQOL-BREF with 26 items. It is based on a Likert-type scale and is scored from 1 to 5, with higher scores indicating a better quality of life.
3. Intermittent Self-Catheterization Questionnaire (ISC-Q): This is a 24-item self-administered questionnaire. Each item is scored on a 5-point Likert-type scale ranging from 0 (strongly disagree) to 4 (strongly agree), and after the conversion of the 14 reverse-coded items to give a common range of 0-100, the scores are calculated by multiplying the mean value of all items within each domain by 25. The total ISC-Q score is then calculated from the simple average from across the four domains (0-100), with higher scores indicating a higher quality of life.
4. Intermittent Catheterization Adherence Scale (ICAS): ICAS (IntermittentCatheterization Adherence Scale) is used to assess long-term patient adherence to prescribed ISC treatment. Binary answers were used for the first seven questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's score is empirically classified into three intervals: strong adherence = 0; average adherence = 1-2; low adherence = 3-8.
5. Mobile Application Usability Scale (MAUS): The scale measures mobile application usability which is formed with 10 constructs/factors which includes four items each (40 items at total). The scale measures using a 7-point Likert-type scale (1=strongly disagree...7=strongly agree)
### Conditions Module
**Conditions:**
- Neurogenic Bladder
- Spinal Cord Injury
- Intermittent Catheterization
- Mobile Application
**Keywords:**
- neurogenic bladder
- education
- mobil application
- compliance
- quality of life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** parallel group single-blind randomized control trial
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The person doing the statistical analysis will not know which is the experiment and which is the control group.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group has routine CIC education. They fill the scales before discharge and 12. week after discharge.
**Label:** control group(routine CIC education)
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** This group has routine CIC education. Also mobile application uploaded their telephone before discharge.
They fill the scales before discharge and 12. week after discharge.
**Intervention Names:**
- Device: mobile application on telephone
**Label:** experimental group(routine CIC education+mobile application on telephone)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- experimental group(routine CIC education+mobile application on telephone)
**Description:** when patient discharge from the hospital, mobile application downloaded their telephone. then researcher give feedback about patients CIC outputs.
also mobile application include 2 animations, videos, "frequently asked questions" and "ask the expert" section.
**Name:** mobile application on telephone
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** The scale measures mobile application usability which is formed with 10 constructs/factors which includes four items each (40 items at total). The scale measures using a 7-point Likert-type scale (1=strongly disagree...7=strongly agree)
**Measure:** Mobile Application Usability Scale (MAUS)
**Time Frame:** Only the experimental group completes this scale 12 weeks after discharge.
#### Primary Outcomes
**Description:** This study want to evaluate quality of life with 2 scales. WHOQOL-BREF(World Health Organization Quality of Life Scale):The WHO Quality of Life Assessment (WHOQOL) is a generic quality of life instrument that was designed to be applicable to people living under different circumstances, conditions, and cultures. The short version known as WHOQOL-BREF with 26 items. Turkish version is 27 items. It is based on a Likert-type scale and is scored from 1 to 5, with higher scores indicating a better quality of life.
**Measure:** 1. WHOQOL-BREF(World Health Organization Quality of Life questionnaire),
**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.
**Description:** This is a 24-item self-administered questionnaire. Each item is scored on a 5-point Likert-type scale ranging from 0 (strongly disagree) to 4 (strongly agree), and after the conversion of the 14 reverse-coded items to give a common range of 0-100, the scores are calculated by multiplying the mean value of all items within each domain by 25. The total ISC-Q score is then calculated from the simple average from across the four domains (0-100), with higher scores indicating a higher quality of life.
**Measure:** 2. Intermittent Self-Catheterization Questionnaire (ISC-Q)
**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.
#### Secondary Outcomes
**Description:** This study want to evaluate compliance with one scale. ICAS (IntermittentCatheterization Adherence Scale) is used to assess long-term patient adherence to prescribed ISC treatment. Binary answers were used for the first seven questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's score is empirically classified in to three intervals: strong adherence = 0; average adherence = 1-2; low adherence = 3-8.
**Measure:** Intermittent Catheterization Adherence Scale (ICAS)
**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* spinal cord injury patients,
* The doctor has decided that the patient should undergo intermittent catheterization
* Having received CIC training within the last month,
* Having a phone with IOS/Android features,
* Sending the surveys in the 12th week, the participants must be using the WhatsApp application to send the surveys.
* being able to communicate,
* sufficient manual dexterity,
* having a body mass index below 30,
* no vision problems,
* turkish speech,
* using single-use catheter
Exclusion Criteria:
* Having received IC training more than 1 month ago,
* Individuals in the experimental group did not use the mobile application,
* incompletely filled out forms,
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
**State:** Çankaya
**Zip:** 0000000
**Location 2:**
**City:** Ankara
**Country:** Turkey
**Facility:** Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
**State:** Çankaya
**Zip:** 680000
#### Overall Officials
**Official 1:**
**Affiliation:** Gazi University
**Name:** NURCAN ÇALIŞKAN, Prof. Dr
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
**Name:** BİLGE YILMAZ, Prof. Dr.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
**Name:** Nilgün Aras, Phd student
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** Since the study is still not finished, it was decided not to share it.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M5031
- Name: Urinary Bladder, Neurogenic
- Relevance: HIGH
- As Found: Neurogenic Bladder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: 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: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000001750
- Term: Urinary Bladder, Neurogenic
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429618
**Acronym:** PCOS
**Brief Title:** Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet
**Official Title:** Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
#### Organization Study ID Info
**ID:** 01/07 22.01.2024
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-01
**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:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** 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 investigate the changes in the clinical and biochemical parameters of adolescents on a low-carbohydrate diet in relation to their PCOS phenotype in the 3rd trimester.
**Detailed Description:** Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries, and metabolic abnormalities. In addition, some clinical and laboratory phenotypic features have been defined that were not previously included in the PCOS definition criteria, but which complement the clinical picture and influence the severity and morbidity of the clinical picture. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM.For adult patients, internationally recognized diagnostic criteria have been developed based on combinations of otherwise unexplained hyperandrogenism, anovulation and polycystic ovary and are covered by the Rotterdam Consensus Criteria. However, in the adolescent age group, the frequency of anovulatory cycles and associated menstrual irregularities, the frequent symptoms of hyperandrogenism and acne vulgaris in the developmental phase, the problems with testosterone measurement and the prevalence of polycystic ovarian morphology in normal adolescents complicate the diagnosis.
PCOS is a serious clinical and psychological problem for adolescent girls. Key interventions include lifestyle modification, including diet, physical activity and weight loss. These measures have been shown to alter the course of the disease in overweight and obese girls. In particular, it is known that high glycemic index carbohydrate intake and glycemic load lead to a rapid rise in blood glucose levels and increased insulin production.
It is therefore thought that reducing the amount of insulin could have a more positive effect on PCOS than the usual carbohydrates. A low-carbohydrate diet is an effective, weight-independent approach in the treatment of metabolic disorders in PCOS patients. With this in mind, this study aimed to evaluate the clinical and biochemical outcomes at month 3 after application of the low-carbohydrate diet in adolescents according to their PCOS phenotype.
### Conditions Module
**Conditions:**
- Polycystic Ovary Syndrome
- Adolescent Behavior
- Diet Habit
**Keywords:**
- phenotype
- polycystic ovary syndrome
- adolescents
- low carbonhydrate diet
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM
**Intervention Names:**
- Dietary Supplement: Low carbonhydrate diet
**Label:** Phenotype A
#### Arm Group 2
**Description:** PHENOTYPE B: HA+OD
**Intervention Names:**
- Dietary Supplement: Low carbonhydrate diet
**Label:** Phenotype B
#### Arm Group 3
**Description:** PHENOTYPE C: HA+PCOM
**Intervention Names:**
- Dietary Supplement: Low carbonhydrate diet
**Label:** Phenotype C
#### Arm Group 4
**Description:** PHENOTYPE D: OD+PCOM
**Intervention Names:**
- Dietary Supplement: Low carbonhydrate diet
**Label:** Phenotype D
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Phenotype A
- Phenotype B
- Phenotype C
- Phenotype D
**Description:** Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.
**Name:** Low carbonhydrate diet
**Other Names:**
- 0.
- 3.month
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Age, smoking, physical activity status, weight, height, body mass index (weight (kilogram)/height\*2 (meter2)), waist circumference(centimeters), degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24) were obtained from hospital records. Calculation of BMI: Height and body weight of the patients were measured using professionally calibrated devices. BMI was calculated using the formula BMI = weight (kg)/height (m)2.
**Measure:** Evaluation of clinical outcomes at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
**Time Frame:** 3 months
**Description:** Collection of serum samples: C-reactive protein (CRP) (mg/dL), complete blood analysis, sex hormone-binding globulin (SHBG), free and total testosterone (ng/mL), 17-OH progesterone (mIU/mL), prolactin (ng/mL), thyroid stimulating hormone (TSH) (mIU/mL), androstenedione (mosm/kg), dehydroepiandrosterone sulfate (DHEA-S) (μg/dL), Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL), fasting blood glucose, 50 g screening test values were analyzed in the biochemistry laboratory. Serum levels of DHEA-S, 17-OH-progesterone and testosterone were measured using the radiometric method. The blood count was measured using the Sysmex/XN-1000 (2016) blood analyzer. Serum levels of DHEA-S, 17-OH-progesterone and free testosterone were measured using a radiomonassay. Serum lipid and glucose levels were analyzed using the AU680 Chemistry System (Beckman Coulter, Fullerton, CA, USA).
**Measure:** Evaluation of biochemical outcomes at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
**Time Frame:** 3 months
**Description:** Calculation of insulin resistance: A fasting blood glucose level between 100-125 mg/dl was considered as 'impaired fasting glucose'. A Homeostatic Model Assessment Insulin Resistance (HOMA-IR) value of ≥2.5 was defined as insulin resistance. Insulin resistance was calculated using the formula of the homeostatic model. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].
**Measure:** Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* at least 1 year has passed since menarche
* under 24 years old
* patients who have not received an oral contraceptive method and have given verbal and written informed consent will be included.
Exclusion Criteria:
* over 24 years old
* hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid diseases
* neuromuscular, liver, pancreatic or gastrointestinal diseases
* hormonal medication such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers or lipid regulators
**Healthy Volunteers:** True
**Maximum Age:** 24 Years
**Minimum Age:** 12 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** The study will be conducted based on the 2018 ESHRE/ASRM guideline:
1. Oligo and/or anovulation\*
2. Clinical and/or biochemical hyperandrogenism \*Oligo and/or anovulation are defined as follows:
* It is considered normal in the first year after menarche as part of the pubertal transition
* Between 1-3 years after menarche: \< 21 or \> 45 days
* 3 years after menarche - perimenopause: \< 21 or \> 35 days or \< 8 cycles per year
* 1 year after menarche: \>90 days for each menstrual cycle
* Absence of menstruation at the age of 15 years or 3 years after menarche.
Identification of phenotype groups:
PHENOTYPE A: HA+ OD + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PCOM.
### 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
**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:** NO
### References Module
#### References
**Citation:** Joham AE, Pena AS. Polycystic Ovary Syndrome in Adolescence. Semin Reprod Med. 2022 Mar;40(1-02):e1-e8. doi: 10.1055/s-0042-1757138. Epub 2022 Sep 12.
**PMID:** 36096151
**Citation:** Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.
**PMID:** 27664216
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- 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: HIGH
- As Found: Syndrome
- 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
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429605
**Brief Title:** Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Vaginal Hysterectomy.
**Official Title:** Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Vaginal Hysterectomy.
#### Organization Study ID Info
**ID:** Muğla-77
#### Organization
**Class:** OTHER
**Full Name:** Erzincan Military Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-15
**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:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** Erzincan Military Hospital
#### Responsible Party
**Investigator Affiliation:** Erzincan Military Hospital
**Investigator Full Name:** Kemal GUNGORDUK
**Investigator Title:** MD.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Vaginal hysterectomy is the preferred route of choice for women desiring hysterectomy to treat uterine pathology, including premalignant conditions and fibroids. Compared with an abdominal or a laparoscopic approach, VH has been associated with a shorter recovery time and faster return to daily activities. However, management of postoperative pain still remains challenging for patients undergoing VH.
Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain In contrast, studies examining its use to ameliorate acute postoperative pain are limited to a single trial.12 More importantly, it remains to be determined whether perioperative duloxetine can improve the global quality of recovery after surgery. The study included the hypothesis that perioperative duloxetine would ease postoperative recovery in patients undergoing VH, and the Quality of Recovery-15 questionnaire (QoR-15) was to be used for evaluation
### Conditions Module
**Conditions:**
- Vaginal Hysterectomy
- Postoperative Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Only our clinic's standard preoperative and postoperative care were used (Güngördük K, Selimoğlu B, Gülseren V, Yasar E, Comba C, Özdemir İA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116)
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery
**Intervention Names:**
- Drug: duloxetine
**Label:** Duloxetine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Duloxetine
**Description:** In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery
**Name:** duloxetine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the level of abdominal pain during ambulation (according to VAS score) Since the visual analog scale (VAS) has been used in prior studies for evaluating similar outcomes \[10\], a 100-mm VAS was used to grade the level of pain. For assessing pain at rest, patients were asked to grade their level of pain from 0 (no pain) to 10 (worst pain ever experienced) at the abdomen and at the vagina while lying in bed. For assessing pain during ambulation, patients were asked to stand up, walk a few steps, and sit in a chair. Then, they were asked to grade their pain, using the same scale, during ambulation.
**Measure:** The primary outcome
**Time Frame:** 8 hours after surgery
#### Secondary Outcomes
**Description:** The QoR-15 is a 15-item questionnaire that measures the patient's QoR. Each item is answered on an 11-point numerical rating scale. The score ranges from 0 to 150 with a higher score indicating a better QoR. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state
**Measure:** total QoR-15 score.
**Time Frame:** on postoperative day 2
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients undergoing VH with or without bilateral salpingo-oophorectomy to gynecologic conditions and uterine size ≤12 weeks
* American Society of Anesthesiologists grade 1-3
Exclusion Criteria:
* patients with chronic non-gynecologic conditions (liver or renal or pulmonary disease or diabetes) -those using psychiatric drugs (antidepressants, neuroleptics, lithium) in the last 1 year, ---
* those with duloxetine allergy
* those using opioids for gynecologic or non-gynecologic conditions
* additional concurrent abdominal/ laparoscopic procedures
* Total vaginal prolapsus
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kemal Güngördük
**Phone:** 05057465266
**Role:** CONTACT
## 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: Postoperative Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- 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: D000068760
- Term: Serotonin and Noradrenaline Reuptake Inhibitors
- ID: D000014179
- Term: Neurotransmitter Uptake Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000015259
- Term: Dopamine Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M299
- Name: Duloxetine Hydrochloride
- Relevance: HIGH
- As Found: American
- ID: M12575
- Name: Norepinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M305
- Name: Serotonin and Noradrenaline Reuptake Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068736
- Term: Duloxetine Hydrochloride
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429592
**Brief Title:** Stress and Satisfaction Levels of Mothers According to Neuman's Systems Model on Stress and Satisfaction Levels of Mothers With Children in the Intensive Care Unit and Effective Decision Making
**Official Title:** The Effect of the Empowerment Program Constructed According to Neuman's Systems Model on Stress and Satisfaction Levels of Mothers With Children in the Intensive Care Unit and Effective Decision Making
#### Organization Study ID Info
**ID:** gulsahogulerciyes4023640013
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2024-10-15
**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:** 2024-09-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Gulsah Ogul
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Research; It will be carried out to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
**Detailed Description:** For pediatric nurses, supporting families, especially mothers, who take a primary role in care, increasing their ability to cope with the stress they experience, helping them access the information and resources they need, and supporting family functionality are vital parts of nursing care.
In order to strengthen the family, the relationship between the nurse and the family must be based on respect and trust. In the nurse's communication with the family; The family should discuss the expectations of the family, discuss their views, and care about how much the family wants to be involved in care and what they want to do. Communication provided through these foundations helps to establish a trusting relationship between the family and the nurse and to determine boundaries with the parents. In this way, role confusion between the nurse and parent can be prevented and bidirectional satisfaction can be achieved.
Another issue required to strengthen the family is to establish a close physical and emotional bond between the nurse and the family. This bond is related to the family feeling close enough to the nurse to open up to them not only in the presence of the problem, but also outside the problems. Thus, the family's trust in the nurse increases, removing the nurse from the position of healthcare personnel only caring for the child. Thanks to this special bond the nurse establishes with the family, it makes it easier for family members to express themselves and can even help them discover their weaknesses that they are not aware of. In addition, the nurse evaluates the family's coping methods, helps reveal their strengths, and can ensure more effective planning of care. Studies have shown that as a result of the empowerment programs applied by nurses to families, parents' depression and stress levels decrease, family function, self-efficacy, autonomy, problem-solving skills and family members' support for each other increases.
In order to strengthen the family, it is of great importance to reduce the effects of internal and external stressors, holistic approach, increase the patient's perceptions and motivation, interact with the environment, reach, protect and maintain optimal health. In line with this purpose, the conceptual framework of nursing theories and models forms the basis and directs nursing education, management, practice and nursing research. These components are also included in the philosophical basis of the Neuman Systems Model. Neuman Systems Model is a model that focuses on human needs and emphasizes human uniqueness. It focuses on the multidimensional evaluation of the individual from a holistic perspective in achieving optimal health/well-being. However, accepting that the human being is a biopsychosocial being, it attaches importance to environmental stress and the health of the patient system that reacts to this stress. In Neuman's Systems Model, it is stated that when an individual is exposed to various stressors, his defense system is affected and the individual needs help to protect his basic structure.
It is thought that nursing care structured in line with the Neuman Systems Model facilitates family and child-centered care practice. This study will be conducted to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
### Conditions Module
**Conditions:**
- Nurse-Patient Relations
**Keywords:**
- Mother
- Pediatric intensive care
- Effective decision making
- Satisfaction
- Stres
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 5 Days
### Arms Interventions Module
#### Arm Group 1
**Description:** Data collection tools for mothers in the experimental group after acceptance of admission to the intensive care unit \[Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the mothers are being treated, no other treatment will be done in the unit.
Different time slots will be scheduled for each experiment. After the 5th day of the application was completed, data collection tools were used.
**Intervention Names:**
- Other: education
**Label:** experimental group
#### Arm Group 2
**Description:** Data collection tools from mothers in the control group after admission to the intensive care unit \[Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The routine operation of the intensive care unit will continue and data will be collected again after 5 days of hospitalization.
**Intervention Names:**
- Other: education
**Label:** control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- control group
- experimental group
**Description:** nursing care practice
**Name:** education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** For mothers in the experimental group, data will be collected with data collection tools after acceptance of admission to the intensive care unit. The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the treatments are being carried out to the mothers, no other treatments will be performed in the unit.
Different time slots will be scheduled for each experiment. After the 5th day of the application is completed, data will be collected with data collection tools and mothers' stress levels and satisfaction levels will be evaluated.
**Measure:** Mothers' stress levels and satisfaction levels will be evaluated.
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Research Inclusion Criteria;
1. Communicable,
2. Mothers whose children are admitted to the intensive care unit,
3. Mother must be over 18 years old
4. The child has a biological mother
5. Mothers who agreed to participate in the study and signed written consent forms,
6. The child's intensive care stay must be at least 5 days.
Exclusion Criteria:
* Criteria for Exclusion from the Study
1. Wanting to leave the study,
2. The child must have left the intensive care unit less than 5 days ago,
3. The mother is under 18 years of age.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Mothers who want to voluntarily participate in the research
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** GULSAH OGUL
**Phone:** 6177507711
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** erciyes universitesi
**Name:** oznur basdas, professor
**Role:** STUDY_DIRECTOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429579
**Brief Title:** Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
**Official Title:** Multicenter, Prospective, and Exploratory Study of Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
#### Organization Study ID Info
**ID:** NCRC2024001
#### Organization
**Class:** OTHER_GOV
**Full Name:** China National Center for Cardiovascular Diseases
### Status Module
#### Completion Date
**Date:** 2029-04-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-04-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-23
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** China National Center for Cardiovascular Diseases
#### 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 multi-center, perspective, and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension (PAH). The included criteria are as followed: 1)6 months \< age ≤ 18 years; 2) ESC 2022 Group I PAH; 3) Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4) Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5) Informed consent form signed by the patient and their guardian. The excluded criteria are as followed: 1) ESC 2022 Group II-V PAH; 2) Poor right ventricular function: RVEF \< 25% or RVFAC \< 20%; 3) Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4) Pulmonary artery pressure/main arterial pressure ratio \< 0.7; 5) Six-minute walk distance \< 150 meters (only applicable to patients aged 8 and above); 6) No significant improvement in RVEF under triple drug therapy. All of the pediatric patients with severe PAH who attend to pediatric cardiac outpatient clinic and meet the designed included criteria and excluded criteria will be enrolled in this study. All of the participants will be divided into two groups (Potts-shunt combined with conventional drug therapy group and only conventional drug therapy group) according to their individual health status (i.e., some contraindications of surgery) and their (or their parents') aspiration for Potts-shunts procedure. Follow-up is designed (eight-times follow-up) at the time of Potts-shunt procedure, post-operative ICU period, one month, three months, six months, one year, two years, and three years after Potts-shunt procedure or the rejection of Potts-shunt procedure. The items of follow-up include state of survival, whether or not have the lung transplantation (LTx), clinical manifestation, laboratory examination, function of right ventricle (detected by echocardiogram and cardiac magnetic resonance imaging), and the pulmonary circulation pressure (detected by right heart catheterization or Swan-Ganz catheterization). Primary outcome is the incidence rates of death or LTx three-years after Potts-shunt. Secondary outcomes are as followed: 1) Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure; 2) Three-year WHO cardiac functional and 6-minute walk distance after Potts-shunt procedure; 3) the NT-ProBNP levels three-years after Potts-shunt procedure; 4) Right ventricular function on echocardiography three years after Potts-shunt procedure; 5) Right ventricular function on cardiac magnetic resonance imaging three years after Potts-shunt procedure; 6) Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization three years after Potts-shunt procedure; 7) Three-year mortality or LTx incidence rates after only conventional drug therapy.
### Conditions Module
**Conditions:**
- Pulmonary Artery Hypertension
### Design Module
#### Design Info
**Allocation:** NON_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:** The comprehensive therapy included Potts-shunt procedure and conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists)
**Intervention Names:**
- Procedure: Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
**Label:** Potts-shunt combined with conventional drug therapy group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Only admitted with conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists)
**Intervention Names:**
- Drug: Only conventional drug therapy
**Label:** Only conventional drug therapy group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Potts-shunt combined with conventional drug therapy group
**Description:** Potts-shunt procedure is the surgery that connect the descending aorta and the left/main pulmonary artery by direct anastomosis, a Gore-tex tube or a Gore-tex tube with flap.
**Name:** Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Only conventional drug therapy group
**Description:** Only conventional drug therapy (i.e., Prostacyclin analogues, PDE-5 inhibitors, and Endothelin receptor antagonists)
**Name:** Only conventional drug therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The incidence rates of death or lung transplantation 3 years after Potts-shunt, accessed by in-patient, out-patient, or telephone follow-up
**Measure:** Mortality or Lung transplantation
**Time Frame:** From the date of enrollment until the date of dear from any cause or lung transplantation, which ever came first, accessed up to 3 years
#### Secondary Outcomes
**Description:** Postoperative complications include hemoptysis, syncope, pulmonary hypertension crisis, low blood oxygen in the lower extremities etc. accessed by pediatric ICU doctors.
**Measure:** Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of any postoperative complications, whichever came first, accessed up to 3 years
**Description:** WHO-FC was designed to measure the severity of pulmonary hypertension based on symptoms of dyspnea, fatigue, chest pain, and related syncope, accessed by the pediatric doctors.
**Measure:** World Health Organization functional class (WHO-FC) after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
**Description:** NT-ProBNP (pg/ml) accessed by laboratory test
**Measure:** NT-ProBNP levels after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
**Description:** The RVEF (%) accessed by cardiac MRI
**Measure:** Right ventricular function on cardiac magnetic resonance imaging after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
**Description:** The RVFAC (%) accessed by echocardiography
**Measure:** Right ventricular function on echocardiography after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
**Description:** SPAP, DPAP, MPAP (mmHg) etc. accessed by right heart catheterization or Swan-Ganz catheterization
**Measure:** Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
**Description:** The incidence rates of death or lung transplantation 3 years after enrollment
**Measure:** Mortality or lung transplantation incidence rates after only conventional drug therapy
**Time Frame:** From the date of enrollment until the date of dear from any cause or lung transplantation, which ever came first, accessed up to 3 years
**Description:** The 6-minutes distance (meter) was designed to measure activity tolerance, accessed by pediatric doctors or parents of participants.
**Measure:** The 6-minutes distance after Potts-shunt procedure
**Time Frame:** From the date of enrollment to the date of every view-point, assessed up to 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 6 months \< age ≤ 18 years;
2. ESC 2022 Group I PAH;
3. Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022;
4. Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc);
5. Informed consent form signed by the patient and their guardian.
Exclusion Criteria:
1. ESC 2022 Group II-V PAH;
2. Poor right ventricular function: RVEF \< 25% or RVFAC \< 20%;
3. Deteriorated general condition: requiring ICU resuscitation or ECMO assistance;
4. Pulmonary artery pressure/main arterial pressure ratio \< 0.7;
5. Six-minute walk distance \< 150 meters (only applicable to patients aged 8 and above);
6. No significant improvement in RVEF under triple drug therapy.
**Maximum Age:** 18 Years
**Minimum Age:** 6 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shoujun Li, MD
**Phone:** +8613501071589
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shoujun Li, MD
- **Phone:** +8613501071589
- **Role:** CONTACT
**Country:** China
**Facility:** Pediatric cardic surgical center, Fuwai Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100037
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M2261
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Artery Hypertension
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: HIGH
- As Found: Pulmonary Hypertension
- ID: M17400
- Name: Vascular Diseases
- 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: T4807
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Artery Hypertension
### Condition Browse Module - Meshes
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000081029
- Term: Pulmonary Arterial Hypertension
- ID: D000006973
- Term: Hypertension
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M30466
- Name: Endothelin Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M29332
- Name: Phosphodiesterase 5 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14328
- Name: Epoprostenol
- Relevance: LOW
- As Found: Unknown
- ID: M262431
- Name: Tezosentan
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429566
**Brief Title:** Clinical Study of GB001 Recombinant Polypeptide Spray IIa Patients
**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Oral Local Use of GB001 Recombinant Peptide Spray for the Treatment of Mild Recurrent Aphthous Ulcer
#### Organization Study ID Info
**ID:** YK2019L01P-IIa
#### Organization
**Class:** INDUSTRY
**Full Name:** Zhejiang Echon Biopharm Limited
### Status Module
#### Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-12-06
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-18
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Zhejiang Echon Biopharm Limited
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This trial is conducted in China. The purpose is to evaluate the efficacy, Pharmacokinetics (PK) profile, immunogenicity and safety of GB001 recombinant peptide spray in adults with mild recurrent aphthous ulcer.
### Conditions Module
**Conditions:**
- Healthy
### 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:** 120
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, no more than 29 times，The dosage of the group is 0.108mg/spray.
**Intervention Names:**
- Drug: GB001 recombinant peptide spray low dose group、high dose group
**Label:** GB001 recombinant peptide spray low dose group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, no more than 29 times，The dosage of the group is 0.216mg/spray.
**Intervention Names:**
- Drug: GB001 recombinant peptide spray low dose group、high dose group
**Label:** GB001 recombinant peptide spray high dose group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days.
**Intervention Names:**
- Drug: GB001 recombinant peptide spray placebo
**Label:** Placebo group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GB001 recombinant peptide spray high dose group
- GB001 recombinant peptide spray low dose group
**Description:** Administrated oral spray. Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, no more than 29 times，The dosage of the group is 0.108mg/spray for low dose group and 0.216mg/spray for high dose group.
**Name:** GB001 recombinant peptide spray low dose group、high dose group
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** Administrated oral spray.Each subject will take oral GB001 recombinant peptide spray placebo 4 times a day, 4 sprays each time, no more than 29 times
**Name:** GB001 recombinant peptide spray placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Ulcer healing was defined as disappearance of pain and zeroing of ulcer size. At the screening visit the ulcer area and pain severity of patient to clinical examination will be rated at baseline. The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined in day 6 to assess the ulcer area by periodontal probe.
**Measure:** Target ulcer healing rate for patients in day 6
**Time Frame:** Day 6
**Measure:** Subjects self-rated the time it took for irritation pain to disappear
**Time Frame:** Day 8
#### Secondary Outcomes
**Description:** Ulcer healing was defined as disappearance of pain and zeroing of ulcer size.The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined to assess the ulcer area by periodontal probe.
**Measure:** Time for target ulcer to heal
**Time Frame:** Day 8
**Description:** Ulcer healing was defined as disappearance of pain and zeroing of ulcer size. At the screening visit the ulcer area and pain severity of patient to clinical examination will be rated at baseline. The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined in day 4 and day 8 to assess the ulcer area by periodontal probe.
**Measure:** Targeted ulcer healing rate for patients in day 4 and day 8
**Time Frame:** Day 4,Day 8
**Description:** At the screening visit the ulcer area of patient to clinical examination will be rated at baseline. And the patients will be re-examined in day 4、day 6 and day 8 to assess the ulcer area by periodontal probe.
**Measure:** Changes in target ulcer area relative to baseline
**Time Frame:** Day 4,Day 6,Day 8
**Measure:** Self evaluation of pain disappearance rate and relief rate
**Time Frame:** Day 4,Day 6,Day 8
**Description:** Apparent terminal phase half-life
**Measure:** Pharmacokinetics Characteristics， t½ of GB001 Recombinant Peptide
**Time Frame:** Day 1,Day 4
**Description:** Area under the plasma concentration versus time curve
**Measure:** Pharmacokinetics Characteristics，AUC of GB001 Recombinant Peptide
**Time Frame:** Day 1,Day 4
**Description:** Maximum plasma concentration
**Measure:** Pharmacokinetics Characteristics， Cmax of GB001 Recombinant Peptide
**Time Frame:** Day 1,Day 4
**Description:** Time of maximum plasma concentration
**Measure:** Pharmacokinetics Characteristics， Tmax of GB001 Recombinant Peptide
**Time Frame:** Day 1,Day 4
**Measure:** Immunogenicity(drug resistant antibody (ADA))
**Time Frame:** Day 1,Day 14,Day 28
**Measure:** Incidence of Adverse Events
**Time Frame:** First dose to last visit,an average of 1 month.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. It meets the diagnostic criteria for mild recurrent Aphthous ulcer in the fifth edition of Oral Mucosa published by People's Medical Publishing House in 2020.
2. 18≤ age ≤65 years old, gender is not limited.
3. Patients with untreated target ulcer onset ≤48 hours at the time of screening.
4. VAS score of target ulcer irritation pain ≥3 points, 2mm≤ length diameter of target ulcer ≤10mm.
5. Subjects and their sexual partners agree to use effective contraception during the study period and for at least 30 days after the study ends.
6. Sign a written informed consent, and be able to comply with the visit and related procedures stipulated in the program.
Exclusion criteria:
1. The diagnosis was severe aphthous ulcer, herpetic aphthous ulcer, acute herpetic gingivitis stomatitis, traumatic ulcer, cancerous ulcer, tuberculous ulcer, syphilitic ulcer, necrotic salivate metaplasia, Behcet disease and other diseases or drug induced ulcers.
2. Patients with suppurative tonsillitis or other painful lesions in the mouth, such as pericoronitis, pulpitis, periapical inflammation, etc., affecting the pain score of target ulcer.
3. Target ulcer is affected by residual root, residual crown, denture, prosthesis, orthodontic device and other stimulating factors in the corresponding parts of the target ulcer.
4. The ulcer is located in the lingual frenulum, the back wall of the pharynx and other parts, and its size is not easy to measure.
5. Those who plan to perform other oral treatments during the trial that affect the determination of drug effectiveness and safety.
6. Smokers \> 20 cigarettes/day or betel nut lovers in the past 3 months.
7. People who have used painkillers or drugs that may affect the efficacy of pain observation within 24 hours before the first administration, such as sedatives, anti-allergy drugs, non-steroidal anti-inflammatory drugs, etc.
8. Patients who have used antibiotics or antiviral drugs locally or systematically within 1 week before screening.
9. Patients who had used immunosuppressive agents locally within 1 week before screening or systemic immunosuppressive agents within 2 weeks before screening.
10. Patients with oral local or systemic use of glucocorticosteroids within 4 weeks prior to screening.
11. Patients who have taken anticholinergic drugs to reduce salivary secretion within 2 weeks prior to screening.
12. Complicated with severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT and AST≥ 1.5 times the upper limit of normal, SCr \> the upper limit of normal).
13. Patients with severe anemia (Hb \< 60g/L).
14. Complicated with severe heart and lung disease, uncontrolled diabetes (fasting blood glucose \> 7.0mmol/L or random blood glucose ≥11.1mmol/L), advanced tumors, diseases of the blood and hematopoietic system, or other serious or progressive diseases of the system.
15. Known or suspected allergic history or serious adverse reactions to the experimental drug and its excipients.
16. Pregnant or lactating women and those with recent pregnancy plans.
17. Participants who had participated in other interventional clinical trials within 3 months prior to screening.
18. Other conditions deemed inappropriate by the investigator for participation in the study.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Changsha
**Country:** China
**Facility:** The First Hospital of Hunan University of Chinese Medicine
**State:** Hunan
**Zip:** 410000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M16071
- Name: Stomatitis, Aphthous
- Relevance: LOW
- As Found: Unknown
- ID: T455
- Name: Aphthous Stomatitis
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429553
**Brief Title:** Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage
**Official Title:** A Multicenter Randomized Controlled Clinical Study of Minimally Invasive Intracranial Hematoma Aspiration and Drainage Combined With Urokinase Injection and Drug Therapy for Spontaneous Intracerebral Hemorrhage
#### Organization Study ID Info
**ID:** 2023KY135
#### Organization
**Class:** OTHER_GOV
**Full Name:** Anhui Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Anhui Provincial 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:** To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage.
**Detailed Description:** Intracerebral hemorrhage (ICH) refers to the spontaneous rupture of large and small arteries, veins, and capillaries in the brain caused by various reasons under non-traumatic conditions. Hypertension is the most common predisposing factor for intracerebral hematoma, and the risk increases with age. The challenge in surgical hematoma evacuation lies in the potential for surgical complications to negate the benefits of hematoma removal. Surgical treatment is generally considered only when the supratentorial hematoma causes a life-threatening space-occupying effect. Therefore, the size of the intracerebral hematoma is a key factor in determining whether surgery can bring benefits to patients. Specifically, intracerebral hematomas with a volume less than 30 ml are considered small and medium-sized.
Previously, drug-based conservative treatment was often the first choice for small and medium-sized intracerebral hematomas. However, with the accumulation of clinical data, it has been found that while these patients have low blood loss and mortality, their neurological function impairment is significant, and the recovery of neurological function under conservative treatment is often suboptimal. Therefore, some scholars have suggested the use of adjunctive surgical options for small and medium-sized intracerebral hematomas, such as small craniotomy, craniotomy, endoscopic surgery, fibrinolytic therapy combined with hematoma aspiration, and CT-guided stereotactic aspiration (i.e., minimally invasive surgery).
### Conditions Module
**Conditions:**
- Spontaneous Cerebral Hemorrhage
**Keywords:**
- Spontaneous cerebral hemorrhage
- intracranial hematoma aspiration
- urokinase
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Minimally invasive hematoma aspiration drainage combined with urokinase injection
**Intervention Names:**
- Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection
**Label:** Hematoma puncture group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Drug conserved group
**Intervention Names:**
- Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection
**Label:** Drug conserved group
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Drug conserved group
- Hematoma puncture group
**Description:** Minimally invasive hematoma aspiration drainage combined with urokinase injection
**Name:** Minimally invasive hematoma aspiration drainage combined with urokinase injection
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
**Measure:** Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** volume of hematoma
**Measure:** volume of hematoma
**Time Frame:** 2 weeks
**Description:** National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）
**Measure:** National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）
**Time Frame:** 6 months
**Description:** Muscle strength classification change（0-5）（ higher scores mean a better outcome.）
**Measure:** Muscle strength classification change（0-5）（ higher scores mean a better outcome.）
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 18-80 years;
2. ICH in the basal ganglia was diagnosed by CT examination of the head (bleeding mainly from the caudate nucleus, lentiform nucleus, clavate nucleus or amygdala);
3. Based on CT examination of the head, the volume of hematoma was calculated to be 20-40 mL, and the midline structure was shifted horizontally in the pineal gland \< 3 mm; The calculation formula of hematoma volume V (cm3) = A\*B\*C\*1/2, where A is the longest diameter (cm) of the largest level of hematoma in the horizontal CT scan, B is the widest diameter (cm) of the hematoma in the plane perpendicular to A, and C is the thickness (cm) of the hematoma in the CT film;
4. The time from onset to randomization is within 48 hours;
5. GCS score 4-14 points during randomization;
6. NIHSS score \>= 6 points during randomization;
7. Muscle strength of unilateral limbs on the symptomatic side is grade 0-3;
8. mRS0-1 score before onset;
9. Systolic blood pressure was controlled below 180mmHg before randomization;
10. Written informed consent signed by the patient and his legal representative.
Exclusion Criteria:
1. Bleeding in other areas (such as the thalamus, brain stem, or cerebellum);
2. Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage transformation of massive cerebral infarction, hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, severe coagulation disorder;
3. Recent history of cerebral hemorrhage (\< 1 year);
4. Multiple intracranial hemorrhage;
5. The CTA source map indicated early signs of expanded intracerebral hemorrhage hematoma (point sign), and the possibility of progressive hemorrhage was largely ruled out;
6. Patients with ventricular hemorrhage or ICH intrusion into the ventricle should be considered for external ventricular drainage;
7. Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history within the last 30 days;
8. Patients with coagulation dysfunction such as hereditary or acquired bleeding constitution and lack of coagulation factor;
9. Hemoglobin \< 100 g/L, hematocrit \< 25%, platelet count \< 100\*10\^9/L;
10. Were receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within one week before enrollment, with INR \> 1.4;
11. Long-term anticoagulant and antiplatelet therapy is expected;
12. There is a history of internal bleeding, such as digestive tract bleeding, urogenital system bleeding, respiratory tract bleeding is not completely controlled;
13. Myocardial infarction within the last 30 days;
14. Known high risk of embolism, including patients with mechanical heart valve implantation, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is suitable;
15. Severe liver function damage, ALT \> 3 times the upper limit of normal, or AST \> 3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate \< 30 ml/min/1.73m2;
16. Hypertension that could not be effectively controlled by active antihypertensive therapy before randomization (systolic blood pressure was still greater than 180 mmHg);
17. Patients with Alzheimer's disease or mental illness are unable to complete the follow-up plan as required;
18. Combined with any serious diseases that may be assessed to interfere with the test results: including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system and blood system;
19. Those who currently have drug or alcohol abuse or dependence and are expected to have poor compliance and difficulty in completing follow-up;
20. Allergic to urokinase or surgery-related drugs and instruments;
21. Pregnant or lactating women, or those planning to become pregnant within one year;
22. Life expectancy of \< 12 months due to advanced stage of any disease;
23. Are participating in other clinical trials or have been included in this trial in the previous stage;
24. The patient or his legal guardian is not willing to sign a written informed consent (YNMT).
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hao Xu, PhD
- **Phone:** +8618019576586
- **Role:** CONTACT
**Country:** China
**Facility:** Hao Xu
**State:** Anhui
**Status:** RECRUITING
**Zip:** 230001
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- 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: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### 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
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M5792
- Name: Cerebral Hemorrhage
- Relevance: HIGH
- As Found: Cerebral Hemorrhage
- ID: M9493
- Name: Hematoma
- Relevance: HIGH
- As Found: Hematoma
- ID: M22113
- Name: Intracranial Hemorrhages
- 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: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002543
- Term: Cerebral Hemorrhage
- ID: D000006470
- Term: Hemorrhage
- ID: D000006406
- Term: Hematoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429540
**Brief Title:** Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft
**Official Title:** Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft in the Esthetic Zone: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** 12224PER6-3-1
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Danah Tayseer Al Ghothani
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to clinically and radiographically evaluate the dimensional changes of hard tissue after using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone.
The main question: In patients with unrestorable teeth, will the use of partially demineralized Dentin Block be more effective than Xenograft in preserving vertical and horizontal ridge dimensions?
After enrollment, a thorough preoperative assessment, including history taking, clinical, and radiographic examinations, will be conducted.
Initial therapy includes periodontal treatment (phase 1 therapy) followed by random assignment to one of two treatment groups: ridge preservation using Partially Demineralized Dentin Block or Xenograft.
Both groups will undergo atraumatic extraction.
For the test group, an autogenous partially demineralized dentin graft will be prepared, involving tooth cleaning, grinding, and partial demineralization with the Tooth Transformer device, followed by Leukocyte-Platelet Rich Fibrin (L-PRF) membrane and liquid fibrinogen preparation. The L-PRF membranes will be cut, mixed with dentin particles, and combined with liquid fibrinogen to form a compact graft. The block will be placed inside the socket and covered by an L-PRF membrane and secured with a cross-suture.
In the control group, Xenograft will be used, and the socket filled with deproteinized bovine bone mineral, covered with a collagen membrane, and secured with a cross-suture.
After a healing period of 6 months, at the time of implant placement, a biopsy will be taken using a trephine bur.
**Detailed Description:** Objective of the study: The aim of this study is to evaluate post extraction hard tissue changes following ridge preservation using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone.
Research Procedure: Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University.
General operative procedures: Patients who fulfill the inclusion criteria will be enrolled. The nature of the study will be explained to each patient, as well as the importance of compliance with pre- and post-operative instructions and follow-up visits.
Preoperative preparation: A thorough preoperative assessment of all patients will be carried out, including history taking, clinical examination, and radiographic examination.
History: Each patient will be interviewed to obtain a comprehensive history.
Clinical examination: Proper intraoral examination will be done to evaluate the following parameters for the tooth of interest: 1) Restorability of the tooth. 2) Periodontal condition of the tooth to be extracted and the adjacent teeth.
Radiographic examination:
1. Periapical radiographs will be done to rule out the presence of any periapical infection and evaluate the presence of caries or periodontal disease in the adjacent teeth.
2. In cases that meet the inclusion criteria, cone beam computed tomography (CBCT) will be taken at three time points: before the surgery, immediately after socket preservation, and after 6 months. The CBCT before the surgery will be used to assess the type of socket, while the baseline CBCT immediately after socket preservation will be used to evaluate the horizontal ridge width at 1, 3, and 5 mm below the most coronal aspect of the crest, and buccal and palatal ridge height. The CBCT taken after 6 months will serve to superimpose the two scans and assess long-term changes.
Initial Therapy: The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restorations, and polishing. Mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
Patients will be randomly assigned to one of the treatment groups:
* Test Group: Ridge preservation using Partially Demineralized Dentin Block in the esthetic zone.
* Control Group: Ridge preservation using Xenograft in the esthetic zone.
Surgical Procedure:
Atraumatic extraction:
* The patient will rinse with 0.12% Chlorhexidine (Hexitol, ADCO Pharma Co, Egypt).
* The operator will administer 4% articaine hydrochloride with 1:100,000 epinephrine (Septodent Co. for Pharmaceuticals, France).
* Flapless and atraumatic tooth extraction will be initiated by making an intrasulcular incision using a 15c blade.
* Next, a periotome will be used to sever the periodontal ligament (PDL) fibers, followed by the use of a straight elevator and extraction forceps for the extraction process.
In the test group, the autogenous partially demineralized dentin graft will be prepared as follows: A high-speed fine finishing stone and saline irrigation will be used to clean the tooth and remove any decay, restoration, or foreign materials. The tooth will be rinsed twice in phosphate buffered saline. The tooth will be dried using air, then ground and partially demineralized with the Tooth Transformer device following the manufacturer's protocol. Dentin particles will be obtained with dimensions of 400 - 800 μm.
Dentin block preparation: During the preparation of partially demineralized dentin, Leukocyte-Platelet Rich Fibrin (L-PRF) membranes will also be prepared. Vacutainer tubes without anticoagulant (red cap, glass coating) will be used to collect four 10-cc blood samples, which will then be immediately centrifuged at 2700 rpm for 12 minutes using the IntraSpin centrifuge (IntraLock, Florida, USA). Additionally, two extra blood samples will be collected in 9-cc non-coated vacutainer tubes without anticoagulants (white cap). These samples will be centrifuged at 2700 rpm for 3 minutes. The resulting yellow fluid (liquid fibrinogen) at the top of the white cap tubes will be carefully aspirated using a sterile syringe, while avoiding red blood cells.
The L-PRF clots obtained after 12 minutes of centrifugation will be placed in the Xpression box (IntraSpin, Intra-Lock, Florida, USA) for 5 minutes to allow gentle compression (by gravity) into membranes.
To prepare the L-PRF block, the L-PRF membranes will be cut into small pieces and mixed with the dentin particles at a ratio of 2 membranes to 0.5 g of dentin, providing a 1:1 volume ratio. The liquid fibrinogen will be added to the homogeneous mixture, and while shaping the mixture into the desired form, it will be gently stirred for approximately 10 seconds. Within a few minutes, the fibrinogen will convert into fibrin primarily from the activated blood platelets in the chopped L-PRF membranes. This process will effectively trap the biomaterial and the L-PRF pieces, forming a sturdy block known as the "dentin block," which serves as a convenient and compact graft.
Alveolar ridge preservation: Following a thorough cleaning procedure, the sockets will be carefully packed with customized "dentin blocks" that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with two layers of L-PRF membranes, which will extend approximately 2 mm along the entire envelope formed between the periosteum and the bony boundaries of the sockets (in a 360° fashion). To ensure stability and prevent displacement, the wounds will be secured using non-resorbable sutures. It's important to note that the purpose of the sutures is to maintain the position of the grafts and membranes rather than closing the wounds entirely.
In the control group: The same extraction and socket debridement procedure will be performed. Following that, the extraction socket will be thoroughly filled with deproteinized bovine bone mineral, and a collagen membrane will be employed to cover the socket. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.
The sutures will be removed two weeks after the surgery.
Biopsy collection: After a healing period of 6 months, at the time of implant placement, a biopsy will be taken from the central area of the grafted site using a 3-mm trephine bur. The biopsy will be promptly fixed in 10% neutral buffered formalin, followed by dehydration through a series of alcohol baths with increasing concentrations (ranging from 50% to 100%). Subsequently, the specimen will be embedded in paraffin. Finally, a tissue section with a thickness of 4 μm will be prepared and subjected to hematoxylin-eosin staining for subsequent histological analysis.
Outcomes: Radiographic vertical buccal bone changes, vertical palatal bone changes, horizontal bone changes, percentage of new vital bone formation, percentage of residual bone graft, and implant primary stability
### Conditions Module
**Conditions:**
- Socket Preservation
**Keywords:**
- L-PRF
- Xenograft
- Collagen membrane
- Dentin block
- Partially demineralized dentin block
- Socket preservation
- Liquid fibrinogen
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A Randomized Controlled Clinical Trial
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Partially Demineralized Dentin Block will be prepared using the Tooth Transformer device to grind the extracted tooth and partially demineralize it. Leukocyte-Platelet Rich Fibrin (L-PRF) and liquid fibrinogen will then be added to create a block graft.
**Intervention Names:**
- Biological: Partially Demineralized Dentin Block
**Label:** Partially Demineralized Dentin Block
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The Xenograft procedure will involve filling the socket with deproteinized bovine bone mineral, followed by the placement of a collagen membrane to cover the socket
**Intervention Names:**
- Biological: Xenograft
**Label:** Xenograft
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Partially Demineralized Dentin Block
**Description:** The extracted tooth will be dried using air, then ground and partially demineralized with the Tooth Transformer device following the manufacturer's protocol. Dentin particles will be obtained with dimensions of 400-800 μm. The partially demineralized dentin will then be prepared by cutting the Leukocyte-Platelet Rich Fibrin (L-PRF) membranes into small pieces and mixing them with the dentin particles. Liquid fibrinogen will be added to the homogeneous mixture. Within a few minutes, the fibrinogen will convert into fibrin primarily from the activated blood platelets in the chopped L-PRF membranes. This process will effectively trap the biomaterial and the L-PRF pieces, forming the "dentin block". After that, the sockets will be carefully packed with the dentin block and it will be covered with L-PRF membrane. To ensure stability and prevent displacement, the wounds will be secured using non-resorbable sutures.
**Name:** Partially Demineralized Dentin Block
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Xenograft
**Description:** In the control group using the Xenograft, the same extraction and socket debridement procedure will be performed. Following that, the extraction socket will be thoroughly filled with deproteinized bovine bone mineral, and a collagen membrane will be employed to cover the socket. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.
**Name:** Xenograft
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point.
The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.
**Measure:** Change in radiographic horizontal ridge width
**Time Frame:** at baseline and 6 months postoperatively
#### Secondary Outcomes
**Description:** CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point.
The height of the alveolus will be measured at the midbuccal aspect (BH) and midlingual aspect (LH).
**Measure:** Change in radiographic buccal and palatal ridge height
**Time Frame:** at baseline and 6 months postoperatively
**Description:** The biopsies will be stored in a 10% formalin solution for preservation. Afterward, they will undergo decalcification in EDTA for a duration of four weeks. Following decalcification, the specimens will be processed and embedded in paraffin to create tissue blocks. Longitudinal sections of 5μm thickness will be cut from the paraffin blocks. These sections will be stained using hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains for histological evaluation and histomorphometric analysis.
**Measure:** Percentage of new vital bone formation and residual graft
**Time Frame:** after 6 months postoperatively
**Description:** The primary stability of the implant fixture will be assessed using the Osstell Mentor Resonance Frequency Analyzer (Osstell AB, Goteborg, Sweden). Two measurements will be taken in the buccolingual and mesiodistal directions for each implant. The average of these two measurements will be recorded as the representative implant stability quotient (ISQ) for each individual implant.
**Measure:** Implant Primary Stability
**Time Frame:** after 6 months postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with non-restorable teeth and Type II extraction socket in the esthetic zone
* Healthy patients with adequate oral hygiene (bleeding on probing ≤20%; Plaque index ≤20%).
* Systemically healthy.
Exclusion Criteria:
* Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
* Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
* Patients with poor oral hygiene (bleeding on probing \>20%; Plaque index \>20%)
* The presence of acute periapical infection.
* The presence of severe periodontal destruction.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Danah Al Ghothani, Bachelor
**Phone:** 1026826826
**Phone Ext:** +20
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weam Elbattawy, Ass. Prof
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of dentistry Cairo University
**State:** Elmanil
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Cairo University
**Name:** Manal Hosny, Professor
**Role:** STUDY_DIRECTOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429527
**Brief Title:** Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: A Multi-Center Randomized Controlled Trial
**Official Title:** Evaluating App-Based Vision Testing (WHOeyes) Combined With the Questionnaire as a Substitute for One-Week Postoperative In-Clinic Follow-Up in Age-Related Cataract Patients: A Multi-center Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2024KYPJ037
#### Organization
**Class:** OTHER
**Full Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**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:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** West China Hospital
**Class:** OTHER
**Name:** People's Hospital of Guangxi
**Class:** OTHER
**Name:** Beijing Tongren Hospital
**Class:** OTHER
**Name:** Eye & ENT Hospital of Fudan University
**Class:** OTHER
**Name:** Shanxi Eye Hospital
**Class:** OTHER
**Name:** Shenzhen Eye Hospital
**Class:** OTHER
**Name:** The Eye Hospital of Wenzhou Medical University
**Class:** OTHER
**Name:** The First Affiliated Hospital of Zhengzhou University
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Zhongshan Ophthalmic Center, Sun Yat-sen University
**Investigator Full Name:** Lixia Luo
**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 goal of this clinical trial is to learn if an app-based vision testing (WHOeyes) combined with a questionnaire can recognize those who have to go back to the hospital, and thus replace the in-clinic 1-week review after an uncomplicated cataract surgery in people with senile cataract. It will also learn about the cost-effectiveness and environmental benefits of such remote follow-up pattern. Besides, the safety and user's satisfaction will also be evaluated. The main questions it aims to answer are:
For people with uncomplicated senile cataract, does 1-week clinical follow-up replaced with remote follow-up (using a vision test app and a questionnaire) not adversely affect patients' prognosis? Can this alternative approach bring greater cost-effectiveness and environmental friendliness compared to the traditional follow-up method? Researchers will compare one-week remote follow-up to a routine clinical follow-up to see if one-week remote follow-up is feasible.
Participants will:
Visit the clinic to finish routine follow-up 1 day and 1 month after cataract surgery.
Using app (WHOeyes) and a questionnaire at home or visit the clinic 1 week after cataract surgery.
### Conditions Module
**Conditions:**
- Cataract Senile
**Keywords:**
- cataract
- telemedicine
- health economics
- carbon emission
- follow-up postoperatively
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 334
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One week postoperatively, the participants use the WHOeyes app to test their uncorrected visual acuity and fill in a self-made discomfort identification questionnaire.
Visit the clinics for review 1 day and 1 month post-cataract surgery.
**Intervention Names:**
- Behavioral: WHOeyes combined with a questionnaire.
**Label:** Remote follow-up
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants routinely returned to the hospital for review 1 day, 1 week and 1 month post-cataract surgery
**Label:** Usual care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Remote follow-up
**Description:** The WHOeyes app (a self-administered visual acuity testing app) plus a questionnaire (to ask the patients to go to the hospital if they ever experience ocular discomfort including eye redness, discharge, etc.) will be used for 1-week follow-up after cataract surgery, and only those with significant vision loss based on WHOeye test or with ocular discomfort are advised to return to the hospital for follow-up.
**Name:** WHOeyes combined with a questionnaire.
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Using the ETDRS chart to test the BCVA of the operative eye.
**Measure:** The best corrected distant visual acuity (BCVA) of the operative eye
**Time Frame:** 1 month after cataract surgery
#### Secondary Outcomes
**Description:** Mean difference in costs divided by mean difference in quality adjusted life years (QALYs).
**Measure:** Incremental cost-effectiveness ratios (ICERs)
**Time Frame:** 1 month postoperatively
**Description:** Collect the carbon emission related activity data generated in the process of postoperative follow-up of patients and hospital through enquiry and questionnaire.
**Measure:** Carbon emission
**Time Frame:** 1 week and 1 month postoperatively
**Description:** Using the ETDRS chart to test the UDVA of the operative eye.
**Measure:** Uncorrected distant visual acuity (UDVA)of the operative eye
**Time Frame:** 1 month postoperatively
**Description:** The proportion of postoperative complications of cataract in the two groups 1 week after surgery was calculated, and the postoperative complications were diagnosed by professional doctors.
**Measure:** Incidence and severity of postoperative complications
**Time Frame:** Until 1 month postoperatively
**Description:** Collected by self-reported outcomes and past medical records (if any) of subjects.
**Measure:** Incidence and severity of self-reported ocular discomfort
**Time Frame:** Until 1 month postoperatively
**Description:** Collected by self-reported outcomes and past medical records (if any) of subjects.
**Measure:** Number of unplanned visits
**Time Frame:** Until 1 month after cataract surgery
**Description:** Vision-specific quality of life is measured by the Chinese version of 9-item short-form of Catquest questionnaire (Catquest-9SF). There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". The minimum score is 9 and maximum score is 36, and lower scores mean a better outcome.
**Measure:** Patient reported outcome measures (PROMs): Catquest-9SF
**Time Frame:** 1 month after cataract surgery
**Description:** Vision-specific quality of life as measured by the Chinese version of National Eye Institute Visual Function Questionnaire (NEI-VFQ-25). The minimum score is 0 and maximum score is 100, and higher scores mean a better outcome.
**Measure:** Patient reported outcome measures (PROMs): NEI-VFQ-25
**Time Frame:** 1 month after cataract surgery
**Description:** Health-related quality of life as measured by the Chinese version of five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). The overall answer for the five dimensions can be combined into a five-digit number that describes the patient's health state. The raw scores are also converted to an EQ-5D index value (Chinese value set) ranging from -0.391 (worst perceived health state) to 1 (best perceived health state).
**Measure:** Patient reported outcome measures (PROMs): EQ-5D-5L
**Time Frame:** 1 month after cataract surgery
**Description:** Assessed by a self-made questionnaire, the answer of it can converted into a 5-point scale. The minimum value is 1 and the maximum value is 5. The higher the scores are, the greater the satisfaction the users have.
**Measure:** Users' satisfaction with the WHOeyes app
**Time Frame:** 1 month after cataract surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Senile cataract patients undergoing Phaco + IOL implantation for the first time under local anesthesia.
2. Aged between 50 and 80 years old (inclusive), regardless of gender.
3. Possession of a smartphone and capable of understanding and correctly installing and using WHOeyes for visual acuity examination after physician's guidance, .
4. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
Exclusion Criteria:
1. Complicated with other serious eye diseases except cataract.
1. History of chronic or recurrent diseases during screening (e.g., keratitis or corneal malnutrition, iritis, scleritis, uveitis, iridocyclitis, excluding refractive errors, dry eye, and chronic conjunctivitis).
2. Presence of ocular infection or active inflammation in either eye during screening.
3. History of acute uveitis within the past 6 months during screening.
4. Intraocular pressure \>21mmHg or a history of glaucoma in the study eye during screening.
5. Presence of unstable active lesions or other ocular diseases judged by the investigator to potentially affect the evaluation of this trial or subject safety, such as moderate to severe diabetic retinopathy, wet age-related macular degeneration, retinal detachment, etc.
6. Congenital abnormalities in the study eye (e.g., congenital cataracts, aniridia).
7. Best corrected visual acuity in the non-operative eye \<0.1.
2. History of ocular trauma in the study eye.
3. History of ocular surgery in the study eye, such as glaucoma surgery, vitrectomy, corneal refractive surgery, corneal transplantation.
4. Planned ocular surgery in either eye during the trial period, such as trabeculectomy, corneal transplantation.
5. Occurrence of complications (e.g., elevated intraocular pressure, corneal edema) within 1 day after cataract surgery.
6. Implantation of a functional intraocular lens (Toric or multifocal intraocular lens).
7. Best corrected visual acuity of the operative eye less than 0.5 within 1 day after surgery.
8. People with severe chronic systemic diseases or who are susceptible to infection.
1. Poorly controlled diabetes (fasting blood sugar \>10 mmol/L) during screening.
2. Poorly controlled hypertension (systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg) during screening.
3. Require systemic treatment for infectious diseases during screening;
4. With cachexia or bone marrow suppression.
5. History of acquired immunodeficiency syndrome or positive human immunodeficiency virus antibodies during screening.
6. Presence of other severe cardiovascular, pulmonary, hepatic, renal, endocrine, immune, dermatological, musculoskeletal, neurological, or psychiatric diseases, hearing impairment, or mobility impairment, as deemed unsuitable for participation in this trial by the investigator.
9. Participation in other clinical trials within the past month (excluding those who only participated in clinical trial screening without using trial drugs or devices).
10. Pregnant or lactating women.
11. Patients deemed unsuitable for participation in this trial for other reasons by the investigator.
**Maximum Age:** 80 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007905
- Term: Lens Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5638
- Name: Cataract
- Relevance: HIGH
- As Found: Cataract
- ID: M10917
- Name: Lens Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002386
- Term: Cataract
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429514
**Brief Title:** Study on the Mechanism of Ganoderma Lucidum Spore Powder in the Treatment of Depression
**Official Title:** Based on the Theory of Gut-brain Axis, the Intervention Effect and Related Mechanism of Ganoderma Lucidum Spore Powder on Depressive Symptoms in Patients With Thyroid Cancer Were Investigated
#### Organization Study ID Info
**ID:** IRB-2023-307
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-03
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Ling Zhiqiang
#### Responsible Party
**Investigator Affiliation:** Zhejiang Cancer Hospital
**Investigator Full Name:** Ling Zhiqiang
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To clarify the clinical effect of Ganoderma lucidum spore powder intervention on postoperative depressive symptoms of papillary thyroid carcinoma ; to elucidate the antidepressant mechanism of Ganoderma lucidum spore powder.
**Detailed Description:** After being informed of the study and potential risks, all patients who gave written informed consent were enrolled. A total of 300 eligible patients were randomly assigned in a double-blind manner and divided into experimental group and control group at a ratio of 2 : 1. The subjects were given oral test drugs ( Ganoderma lucidum spore powder or placebo ) 4g per day for 90 days from the first day after enrollment.
### Conditions Module
**Conditions:**
- Depression
- Thyroid Cancer
**Keywords:**
- Depression
- Thyroid Cancer
- the gut-brain axis
- ganoderma lucidum
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients with depressive symptoms after papillary thyroid carcinoma surgery 300 cases ; there were 200 cases in the experimental group and 100 cases in the control group. From the first day after enrollment, the subjects were given 4 g of the test drug ( Ganoderma lucidum spore powder or placebo ) every day for 90 days.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 298
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days
**Intervention Names:**
- Dietary Supplement: Ganoderma lucidum spore powder
**Label:** Ganoderma lucidum spore powder
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Oral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days.
**Intervention Names:**
- Other: placebo
**Label:** placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ganoderma lucidum spore powder
**Description:** One bag at a time, 2 times a day, 2g / bag
**Name:** Ganoderma lucidum spore powder
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- placebo
**Description:** One bag at a time, 2 times a day, 2g / bag
**Name:** placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** hamilton depression rating scale relieved from 8-20 to ≤8
**Measure:** Depression symptoms relieved
**Time Frame:** Day0,Month3
#### Secondary Outcomes
**Description:** The increase of intestinal microbial diversity and abundance
**Measure:** Changes of intestinal microbial diversity in patients
**Time Frame:** Day0,Month3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* patients with depressive symptoms after surgery for papillary thyroid carcinoma in the outpatient department of Zhejiang Cancer Hospital
* Han nationality
* No previous depression and other mental diseases
* 18-80 years old
* Women
* BMI 19 \~ 24
Exclusion Criteria
* suffering from other diseases of the intestinal system
* Gastrointestinal surgery was performed before intervention
* Including patients with other malignant tumors, who need chemotherapy, radiotherapy, biological therapy or traditional Chinese medicine treatment received antibiotics or microecological modulators within 3 months before the intervention
* Acute intestinal obstruction
* Patients with severe depressive symptoms who must receive antidepressant treatment organic diseases such as heart and brain diseases, brain trauma history of mental illness, use of psychoactive drugs such as drugs
* Severe liver and kidney dysfunction
* Pregnancy, lactation
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hangzhou
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejiang
**Zip:** 310022
#### Overall Officials
**Official 1:**
**Affiliation:** Zhejiang Cancer Hospital
**Name:** Jinbiao Shang
**Role:** STUDY_DIRECTOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-03-28
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 350832
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-15T03:08
- Date: 2023-03-28
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 194352
- Type Abbrev: ICF
- Upload Date: 2024-05-15T03:09
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: HIGH
- As Found: Thyroid Cancer
- 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: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013964
- Term: Thyroid Neoplasms
- ID: D000013959
- Term: Thyroid Diseases
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T274
- Name: Reishi
- Relevance: HIGH
- As Found: Northwestern
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429501
**Acronym:** LAFF
**Brief Title:** Local Anesthesia for Facial Fractures
**Official Title:** The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 202401085
#### Organization
**Class:** OTHER
**Full Name:** Washington University School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Washington University School of Medicine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.
**Detailed Description:** Effective pain management is critical to successful postoperative care and is known to decrease patient morbidity, incurred patient and hospital costs, and length of hospital stay. Pain and nausea after surgery for traumatic facial fractures can limit patients' early morbidity, oral intake, and ability to communicate.
The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative mandibular or midface fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence. The primary outcome measure is the amount of opioid that patients receive in PACU in morphine milligram equivalent (MMEs).
The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and antiemetics that patients receive in PACU after CMF trauma surgery.
### Conditions Module
**Conditions:**
- Pain Management
**Keywords:**
- otolaryngology
- surgery
- facial plastic
- trauma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-blinded, placebo-controlled randomized clinical trial
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** All study team members and the participants will be blinded to the assignment of participants in the study groups. Only the pharmacist will prepare the study syringes and the unblinded statistician will have access to the study group assignments.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The surgeon will be provided with a 10 mL syringe, and he/she will be blinded to the contents of the syringe. The appropriate landmarks will be identified, and a 21, 25, or 27- gauge needle will be used to perform the nerve block with 0.25% bupivacaine.
**Intervention Names:**
- Drug: Bupivacaine/Epinephrine
**Label:** Bupivacaine injection
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The placebo sham injection will be performed in an identical fashion as the nerve block with the exception of using 10 mL of 0.9% saline injection instead of bupivacaine.
**Intervention Names:**
- Drug: Saline
**Label:** Saline injection
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bupivacaine injection
**Description:** injection
**Name:** Bupivacaine/Epinephrine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Saline injection
**Description:** injection
**Name:** Saline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the impact of a perioperative bupivacaine nerve block on PACU opioid use in patients undergoing operative fixation of facial fractures compared to placebo nerve block assessment of the amount of opioids that patients receive in PACU in morphine milligram equivalents (MMEs) will be calculated.
**Measure:** Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs).
**Time Frame:** day 1 or the day of surgery
#### Secondary Outcomes
**Description:** To evaluate the impact of a perioperative bupivacaine nerve block on PACU antiemetic use in patients undergoing operative fixation of facial fractures compared to placebo nerve block. Additional variables that will be collected perioperatively include the medications used for induction/maintenance of anesthesia as well as intraoperative analgesia (I.e. fentanyl, hydromorphone, morphine, acetaminophen, ketorolac, etc.), operative time, estimated blood loss, and intraoperative complications.
**Measure:** Impact of a perioperative bupivacaine nerve block on antiemetic use as assessed by the numbers who receive opioids and antiemetics, amount of antiemetics, pain score, frequency of emesis, and time until discharge.
**Time Frame:** within 1 month post surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults age 18 and over
2. Isolated facial fracture to the mandible and/or midface undergoing surgical repair
3. No allergy to local anesthetic
4. Ability to read, write, and understand English
Exclusion Criteria:
1. Patients under the age of 18
2. Isolated nasal bone fracture
3. Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
4. Allergy to local anesthetic
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amrita Hari-Raj, MD
**Phone:** 314-518-6410
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sara Kukuljan
**Phone:** 314-362-7563
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sara Kukuljan
- **Phone:** 314-362-7563
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Amrita Hari-Raj, MD
- **Phone:** 314-518-6410
- **Role:** CONTACT
**Country:** United States
**Facility:** Washington University
**State:** Missouri
**Status:** RECRUITING
**Zip:** 63110
#### Overall Officials
**Official 1:**
**Affiliation:** Washington University School of Medicine
**Name:** Amrita Hari_Raj, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Washington University School of Medicine
**Name:** Jay Piccirillo, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Hedegaard H, Minino AM, Spencer MR, Warner M. Drug Overdose Deaths in the United States, 1999-2020. NCHS Data Brief. 2021 Dec;(426):1-8.
**PMID:** 34978529
**Citation:** Abraham AJ, Rieckmann T, Gu Y, Lind BK. Inappropriate Opioid Prescribing in Oregon's Coordinated Care Organizations. J Addict Med. 2020 Jul/Aug;14(4):293-299. doi: 10.1097/ADM.0000000000000569.
**PMID:** 31609864
**Citation:** BJC Healthcare. Level I Trauma Center. Barnes-Jewish Hospital. https://www.barnesjewish.org/Medical-Services/Trauma-Acute-CareSurgery/Level-I-Trauma-Center
**Citation:** Lapidus JB, Santosa KB, Skolnick GB, Som A, Cho GJ, Waljee JF, AuBuchon JD, Patel KB. Opioid Prescribing and Use Patterns in Postsurgical Facial Trauma Patients. Plast Reconstr Surg. 2020 Mar;145(3):780-789. doi: 10.1097/PRS.0000000000006588.
**PMID:** 32097326
**Citation:** Perloff MD, Chung JS. Urgent care peripheral nerve blocks for refractory trigeminal neuralgia. Am J Emerg Med. 2018 Nov;36(11):2058-2060. doi: 10.1016/j.ajem.2018.08.019. Epub 2018 Aug 8.
**PMID:** 30119988
**Citation:** Staity G, Saadi RA, Pool C, Lighthall JG. The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty. Facial Plast Surg Aesthet Med. 2022 May-Jun;24(3):202-206. doi: 10.1089/fpsam.2020.0544. Epub 2021 Feb 22.
**PMID:** 33617355
**Citation:** Schumacher JK, Cristel RT, Talugula S, Shah AR. The Use of Adjunctive Perioperative Nerve Blocks in Rhinoplasty in the Immediate Postoperative Period. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):361-362. doi: 10.1089/fpsam.2022.0125. Epub 2022 Sep 14. No abstract available.
**PMID:** 36106969
**Citation:** The University of Iowa Otolaryngology Protocols. https://medicine.uiowa.edu/iowaprotocols/maximum-recommended-doses-andduration-local-anesthetics
**Citation:** Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
**PMID:** 17695343
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M26370
- Name: Fractures, Bone
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M21089
- Name: Facies
- Relevance: LOW
- As Found: Unknown
### 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: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000009184
- Term: Mydriatics
- ID: D000013566
- Term: Sympathomimetics
- ID: D000014662
- Term: Vasoconstrictor Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M7992
- Name: Epinephrine
- Relevance: HIGH
- As Found: Growth
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M30371
- Name: Racepinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M211043
- Name: Epinephryl borate
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- 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: M3670
- Name: Adrenergic beta-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12139
- Name: Mydriatics
- Relevance: LOW
- As Found: Unknown
- ID: M16345
- Name: Sympathomimetics
- Relevance: LOW
- As Found: Unknown
- ID: M17409
- Name: Vasoconstrictor Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004837
- Term: Epinephrine
- ID: D000002045
- Term: Bupivacaine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429488
**Brief Title:** Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease
**Official Title:** Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease
#### Organization Study ID Info
**ID:** 233/2022
#### Organization
**Class:** OTHER
**Full Name:** University of Jordan
### Status Module
#### Completion Date
**Date:** 2023-09-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Jordan
#### Responsible Party
**Investigator Affiliation:** University of Jordan
**Investigator Full Name:** Mohammad Sami El Muhtaseb
**Investigator Title:** 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:** Introduction: Crohn's disease (CD) and obsessive-compulsive disorder (OCD) are two distinct medical conditions that affect millions of people worldwide. While numerous studies have explored anxiety and depression in CD, there is a notable lack of research about the link between OCD and CD. The aim of the study is to look for a relation between these seemingly unrelated conditions.
Methods: Patients with a diagnosis of Crohn's disease were given four different questionnaires in order to assess for the presence of obsessive-compulsive disorder, depression, and anxiety symptoms using the OCI-R score, DASS-21, PHQ-9, and GAD-7. The same questionnaires were used to assess healthy controls for similar symptoms.
**Detailed Description:** This is an observational case-control study conducted at Jordan University Hospital. Using hospital medical records, patients with Crohn's disease who had been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness were invited to fill in the same questionnaire. The controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
The following psychological assessment tools were used:
The Obsessive-Compulsive Inventory-Revised (OCI-R) for obsessive-compulsive symptoms. It is composed of an 18-item self-report validated questionnaire that measures symptoms across 6 subscales including washing, checking, neutralizing, obsessing, ordering, and hoarding. The possible range of scores is 0-72.
The Depression Anxiety Stress Scales-21 (DASS-21) for overall emotional well-being. It is a set of three self-report scales to understand the degree of stress and distress, depressive and anxiety symptoms. The shortened version was used, which consists of 21 items and has been widely used for research and clinical purposes and is easy to administer.
The Patient Health Questionnaire-9 (PHQ-9), a nine-item depression scale of the patient health questionnaire, to assess depressive symptoms. The individual responses are interpreted as a score, with depression divided from no depression to severe depression.
The Generalized Anxiety Disorder-7 (GAD-7), a seven-item tool used to measure or assess anxiety symptoms and the severity of generalized anxiety disorder (GAD).
Data analysis:
The data was collected using Microsoft Forms and downloaded into Excel for coding and deidentification before being imported into the Statistical Package for Social Science (IBM SPSS Statistics for Windows, version 25, IBM Corp., Armonk, N.Y., USA) for analysis. The chi-square test was used to compare different categorical variables. The Mann-Whitney U test was used to compare non-categorical variables. The Kruskal-Wallis test was applied to test for significant differences between the scales.
Ethical consideration:
This study adhered to the principles of the Declaration of Helsinki 1975 and was approved by the Institutional Review Board at Jordan University Hospital.
### Conditions Module
**Conditions:**
- Inflammatory Bowel Diseases
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 293
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients diagnosed with CD at the department of Gastroenterology were collected from hospital records, and all patients were contacted and accepted to be part of this study
**Intervention Names:**
- Other: no intervention, questionnaires were used
**Label:** chron's disease patients
#### Arm Group 2
**Description:** Healthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry
**Intervention Names:**
- Other: no intervention, questionnaires were used
**Label:** Healthy controls
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy controls
- chron's disease patients
**Description:** The following psychological assessment tools were used:
Obsessive-Compulsive Inventory-Revised (OCI-R): An 18-item self-report questionnaire measuring symptoms across six subscales: washing, checking, neutralizing, obsessing, ordering, and hoarding. A score of 21 or higher indicates likely OCD.
Depression Anxiety Stress Scales-21 (DASS-21): A set of three self-report scales assessing stress, depression, and anxiety over 21 items. This shortened version is widely used for research and clinical purposes and is easy to administer.
Patient Health Questionnaire-9 (PHQ-9): A nine-item scale for assessing depressive symptoms. Scores are categorized as: 1-4 (no/minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression).
Generalized Anxiety Disorder-7 (GAD-7): A seven-item tool measuring anxiety symptoms and the severity of generalized anxiety disorder (GAD).
**Name:** no intervention, questionnaires were used
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Depression Anxiety Stress Scales-21 (DASS-21)
**Measure:** This study aims to determine the prevalence of obsessive-compulsive disorder in patients with CD and compare it with people without CD (controls)
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** The Patient Health Questionnaire-9 (PHQ-9)
**Measure:** This study aims to determine the Patient Health Questionnaire-9 (PHQ-9) in patients with CD and compare it with people without CD (controls)
**Time Frame:** 6 months
**Description:** The Generalized Anxiety Disorder-7 (GAD-7)
**Measure:** This study aims to determine the Generalized Anxiety Disorder-7 (GAD-7) in patients with CD and compare it with people without CD (controls)
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients diagnosed with Crohn's disease who have been treated and followed up at the gastro-enterology and colorectal clinics of Jordan University Hospital.
* Patients who have provided informed consent to participate in the research after being informed about the study's goals and the nature of the questionnaires used.
* Healthy controls with no prior history of medical or mental illness.
* Controls who are relatives of patients attending non-gastroenterology and non-psychiatry clinics at Jordan University Hospital.
* Participants (both patients and healthy controls) who agree to fill in the online questionnaire.
Exclusion Criteria:
- Patients and controls with documented psychiatric illnesses.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This is an observational case-control study was conducted at Jordan University Hospital, Using hospital medical records, patients with Crohn's disease who been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain their consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls where relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Amman
**Country:** Jordan
**Facility:** the Jordan University Hospital
**Zip:** 11942
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000010554
- Term: Personality Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001008
- Term: Anxiety Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: HIGH
- As Found: Inflammatory Bowel Disease
- ID: M6419
- Name: Compulsive Personality Disorder
- Relevance: HIGH
- As Found: Compulsive Disorder
- ID: M12706
- Name: Obsessive-Compulsive Disorder
- Relevance: HIGH
- As Found: Obsessive-Compulsive Disorder
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13462
- Name: Personality Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- 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: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003424
- Term: Crohn Disease
- ID: D000015212
- Term: Inflammatory Bowel Diseases
- ID: D000003193
- Term: Compulsive Personality Disorder
- ID: D000009771
- Term: Obsessive-Compulsive Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429475
**Acronym:** AIRSA001
**Brief Title:** Anti-Inflammatory Reliever South Africa
**Official Title:** Anti-Inflammatory Reliever Therapy for Asthma Using Inhaled Budesonide/Formoterol As-needed With or Without Maintenance in South African Children: A Pragmatic Open Label Phase 3 Randomised Controlled Trial
#### Organization Study ID Info
**ID:** BREC/00005663/2023
#### Organization
**Class:** OTHER
**Full Name:** University of KwaZulu
### Status Module
#### Completion Date
**Date:** 2026-05-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of KwaZulu
#### Responsible Party
**Type:** SPONSOR
### 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 is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide/formoterol 80/4.5 (6-11 years) and 160/4.5 (12-18 years) compared to the standard of care in reducing asthma exacerbations over 52 weeks.
Children and adolescents with a diagnosis of asthma or newly diagnosed with asthma will be screened for eligibility for enrolment. Those who had an asthma exacerbation in the previous year will be randomised 1:1, to either receive budesonide/formoterol inhaler for both symptom relief and for chronic anti- inflammatory maintenance therapy or the standard of care which is separate inhalers for symptom relief (short acting bronchodilator salbutamol) and chronic maintenance therapy with inhaled corticosteroids (beclomethasone or budesonide) and/or long-acting beta agonists or montelukast as determined by treating physicians. All asthma exacerbations and clinic/hospital admissions will be recorded for the duration of the 52-week follow-up. Participants will be followed up at 13, 26, 39 and 52 weeks. The 13- and 39-week visit will be telephonic visits to capture the primary end-point i.e. asthma exacerbations. Adverse events and medication changes data will also be collected.
An independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in asthma and asthma clinical trials. The purpose of the DSMB will be to monitor the study for safety and operational futility with pre-defined stopping criteria. In addition, a Trial Steering Committee (TSC) will also provide overall supervision of the trial and ensure the trial is delivered in accordance with ICH-GCP. The TSC has been established with an independent Chair and include additional independent members including an observer early career researcher. Representatives of the Trial Funder (NIHR) and Sponsor (AHRI) will be invited to all TSC meetings.
**Detailed Description:** Over the last two decades non-communicable diseases (NCDs) have been rising in sub-Saharan Africa, and NCDs are set to overtake communicable, maternal, neonatal, and nutritional diseases combined as the leading cause of mortality in sub-Saharan Africa by 2030. Many NCDs have their roots in childhood with lifestyle changes in combination with an increasing median population age in Africa making a further dramatic rise in NCDs in Africa's near future highly likely. The World Health Organization (WHO) now considers the prevention and control of NCDs as an urgent development issue and essential to the achievement of the Sustainable Development Goals (SDG) and this can only be achieved with childhood interventions. The 2018 WHO report on NCDs, reported 3.8 million deaths annually from non-communicable respiratory diseases (asthma and chronic obstructive pulmonary disease), with 78% of deaths in low-income and middle-income countries (LMICs). Asthma morbidity and mortality are preventable with inhaled therapies-however, there is lack of evidence on how to deliver these in an affordable and effective way.
The WHO highlights asthma as an under-appreciated cause of poverty in LMICs that retards economic and social development, erodes the health and well-being of those affected and has a negative impact on families and societies. Asthma aggravates poverty and poverty aggravates asthma. Children miss out on education, adults lose days at work and the costs of drugs, emergency visits, and hospitalization are major financial burdens, not only for individuals/families but also for struggling health systems.
In South Africa, asthma is the most common NCD in childhood affecting 1 in 5 children with a prevalence of asthma symptoms at 21% in adolescence. Despite the availability of asthma medicines in the Essential Medicines List, asthmatic children report having severe asthma symptoms in over 50% of those with asthma. South Africa still reports the fourth highest mortality rate globally. The core to asthma management includes use of chronic use of anti-inflammatory inhaled corticosteroids to address the inflammatory process in the airways (maintenance) and bronchodilators (relievers) for relief of the bronchospasm. Many studies have shown that asthma mortality is linked to poor use of anti-inflammatory inhaler treatment and over-reliance on short- acting β2 bronchodilator reliever therapy to treat asthma exacerbations. In many LMICs including South Africa, the use of controller treatment use of anti-inflammatory inhalers is limited, with only 40% of people with severe asthma symptoms using regular ICS for chronic asthma treatment, but with over 89% using their short-acting β2 agonists. There is a large body of evidence showing that overuse of SABAs is linked with asthma mortality and poorer outcomes.
The combination treatment with budesonide/formoterol for the management of asthma has transformed asthma treatment in high-income countries (HIC), where it is recommended in the very first step of asthma treatment as both an anti-inflammatory and reliever therapy. With the "as needed" use of budesonide/formoterol, asthmatics benefit from the additional dose of a maintenance anti-inflammatory dose, which improves symptom control and reduces exacerbations. This approach has not been adopted in many LMICs related to access to budesonide/formoterol and its cost and therefore, people in LMICs are relegated to use of Track 2 of Global Initiative of Asthma (GINA) treatment which still suggests the use of separate anti-inflammatory and reliever inhalers.
To address this gap, a large body of randomized controlled clinical trial evidence (SYGMA, Novel START, PRACTICAL, and several trials of SMART), have shown that use of budesonide/formoterol as needed (for exacerbations) and for long-term controller treatment compared to separate inhaled corticosteroid and short-acting bronchodilators, reduces the number of asthma exacerbations and improves quality of life. The trials have though been limited in that there is no data on the cost-effectiveness of this approach in lower resourced settings and limited data from small studies participant numbers (\<100) of this approach in children 6-11 years of age. Based on this, the approach of using budesonide/formoterol has not been recommended by the Global Initiative of Asthma (GINA) strategy for global asthma management in Step 1 and 2 of treatment in children 6-11 years of age both in HIC and LMICs, but rather on the higher steps of asthma treatment where symptoms are more severe.
The investigators therefore propose in a randomized controlled trial to assess the efficacy of budesonide/formoterol compared to the standard of care (separate inhaled corticosteroid and bronchodilator) inhaler approach to prevent asthma exacerbations, improve asthma control and quality of life and to also assess the cost-effectiveness of budesonide/formoterol compared to standard of care in children and adolescents in South Africa. The data will be novel as the investigators will for the first time include a large number of children in a clinical trial comparing the two approaches, to provide definitive evidence of the efficacy and cost-effectiveness of this approach in children and adolescents.
### Conditions Module
**Conditions:**
- Asthma
**Keywords:**
- asthma
- budesonide/formoterol
- beclomethasone
- budesonide
- children
- adolescents
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomised Clinical Trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1038
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Budesonide-formoterol fumarate dihydrate at two dose strengths 80/4.5 and 160/4.5 administered via a pressurized metered dose inhaler (pMDI) or dry powder inhaler (DPI), respectively. The dosing will be dependent on asthma symptom severity ranging from 1 dose as needed and titrated up or down depending on asthma control.
**Intervention Names:**
- Drug: Budesonide/formoterol
**Label:** budesonide/formoterol group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard of care
**Intervention Names:**
- Drug: standard of care
**Label:** comparator: standard of care group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- budesonide/formoterol group
**Description:** The Investigational Medicinal Product (IMP) consists of a combination of Budesonide (corticosteroid) and Formoterol Furamate (fast-acting β2 agonist) dihydrate. The IMP is currently available and registered in dry powder form turbuhaler (Symbicort) and a pressurised metered dose inhaler (Vannair).
The recommended doses are pMDI/DPI 80/4.5 1-2 puffs twice daily OR 1 puff as needed (a maximum daily dose of 8 puffs) for children 6-11 years of age and 160/4.5 1-2 inhalations twice daily or 1 puff as needed (a maximum daily dose of 12 puffs) for adolescents 12-18 years.
**Name:** Budesonide/formoterol
**Other Names:**
- No other intervention names
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- comparator: standard of care group
**Description:** Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc
**Name:** standard of care
**Other Names:**
- beclomethasone or budesonide & salbutamol or mentelukast
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Questionnaire- based-tool to capture number of exacerbations will be administered biweekly via a short message system, 6 monthly telephonic consultations and alternative 6 monthly clinic visits. Unscheduled visits will be captured using the bi-weekly questionnaires.
**Measure:** Number of exacerbations in 52 weeks ( End of study)
**Time Frame:** 52 weeks
#### Secondary Outcomes
**Description:** Cost effectiveness will assessed using health economics , health facility and quality of life questionnaires that will be administered to the participants, caregivers and facility managers.
**Measure:** Cost effectiveness
**Time Frame:** 52 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age for inclusion children and adolescents 6-18 years at the time of consent
* Known asthmatic on treatment.
* Newly diagnosed asthma based on investigator review and/or medical report.
* All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks.
* Ability to perform Peak Expiratory Flow rate and/or bronchodilator reversibility testing.
* Only participants with mild, or moderate asthma , based on medical history
* At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for ≥3 days and/or a hospitalisation/emergency room visit for asthma requiring treatment with systemic corticosteroids.
* Written consent from the participant or parent/guardian and assent from study participants where applicable.
* Participant and/or parent/guardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits
Exclusion Criteria:
* Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months.
* Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months.
* Cardiac arrythmia.
* Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension.
* Uncontrolled diabetes mellitus
* Patients with Peak Expiratory Flow Rate \< 50% of predicted , as these would be classified as severe asthmatics.
* Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
* Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy).
* Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer's medical history.
* Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator's judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer's medical history.
* Inability to present for follow-up or leaving the study area within 12 months of enrolment.
**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:** Refiloe Masekela, PhD
**Phone:** +27794890936
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nompumelelo Ngobese
**Phone:** +27352510925
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Africa Health Research Institute
**Name:** Limakatso Lebina, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** A log of names, signatures and initials of all staff authorized or delegation to enter data into a participant's clinic file and eCRF will be kept. The Investigator will maintain paper or electronic source documentation for all study participants. Protocol-specific participant information will be captured in an eCRF. All records will be kept in a secure storage area password protected electronic source, with limited access. Clinical information will not be released without the written permission of the participant, except as necessary for monitoring, and auditing by the Regulatory Authority or the Institutional Review Board (IRB)/ BREC.
**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: M27137
- Name: Respiratory Aspiration
- 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
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000005938
- Term: Glucocorticoids
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000058666
- Term: Adrenergic beta-2 Receptor Agonists
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
### Intervention Browse Module - Browse Leaves
- ID: M3767
- Name: Albuterol
- Relevance: LOW
- As Found: Unknown
- ID: M21711
- Name: Budesonide
- Relevance: HIGH
- As Found: Metabolic
- ID: M4800
- Name: Beclomethasone
- Relevance: HIGH
- As Found: TDF
- ID: M304
- Name: Formoterol Fumarate
- Relevance: HIGH
- As Found: Central
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M274108
- Name: Montelukast
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- 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: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3670
- Name: Adrenergic beta-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
### Intervention Browse Module - Meshes
- ID: D000019819
- Term: Budesonide
- ID: D000001507
- Term: Beclomethasone
- ID: D000068759
- Term: Formoterol Fumarate
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429462
**Acronym:** K4L
**Brief Title:** Knee4Life Project: Empowering Knee Recovery After Total Knee Replacement Through Digital Health
**Official Title:** Empowering Knee Recovery After Total Knee Replacement Through Digital Health (Knee4life Project)
#### Organization Study ID Info
**ID:** 339937
#### Organization
**Class:** OTHER
**Full Name:** University of Exeter
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Institute for Health Research, United Kingdom
**Class:** UNKNOWN
**Name:** Exeter Biomedical Research Centre (BRC) grant
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Exeter
#### 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 research project will investigate the extent to which a smartphone camera sensor tool can help predict and measure knee stiffness and pain after Total Knee Replacement Surgery (TKR) and how a tool such as this could be implemented into the NHS.
Total knee replacement (TKR) is a frequent procedure undertaken in England and Wales, with more than 100,000 conducted each year. Although most patients have a successful outcome following their TKR, approximately 10-20% of patients are dissatisfied, predominantly because of pain and knee stiffness. A method to detect early problems with pain and stiffness could facilitate earlier referral to non-surgical treatments, which are effective in preventing the need for manipulation under anaesthetic (MUA). Here the investigators will validate and provide proof of concept for a smartphone camera sensor tool that measures knee range of motion alongside symptoms of pain for use in the home setting.
The study will comprise of 3 stages;
1. We will conduct 45 minute online interviews comprising of (1) people who have had total knee replacement surgery, (2) healthcare professionals and stakeholders.
2. We will invite 30 participants who are 5-9 weeks post TKR and 30 participants who have had no previous musculoskeletal injuries to attend a session at the university. The lab testing will be conducted at the VSimulator, a biomechanics research lab at the Exeter Science park, and at the teaching labs on St Lukes Campus, Exeter. Here participants be asked to answer 8 questionnaires and have some of their movements measured.
3. Participants will be asked to repeat the 'timed up and go' and the 'sit to stand' tests in their homes and record them using a mobile device.
The study is funded by the NIHR Exeter Biomedical Research Centre grant and sponsored by the University of Exeter.
**Detailed Description:** 1. Background
Total knee replacement (TKR) is a common procedure, with more than 100,000 per year undertaken in England and Wales. Although most patients have a successful outcome following their TKR, approximately 10-20% of patients are dissatisfied, chiefly because of pain and knee stiffness. A method to detect early problems with pain and stiffness could facilitate earlier referral to non-surgical treatments, which are effective in preventing the need for manipulation under anaesthetic \[MUA\]. Currently, rates of MUA are 2.5% (\~2,500 patients per year in England and Wales), costing \~£14k per procedure. Our current understanding of when stiffness develops and the timing and best treatment(s) for stiffness are limited. A recent James Lind Alliance Priority Setting Partnership identified stiffness after TKR as a top-10 research priority to better understand and test interventions. Current measures are not accurate or suitable for use in the home. The investigators need tools to accurately measure early indicators for stiffness.
2. Rationale
The investigators currently have no tool to remotely and accurately detect development of early post-surgical knee stiffness. This study aims to develop a cost-effective tool to measure and quantify knee stiffness before and after total knee replacement (TKR) surgery for use across the NHS. The research seeks to understand how knee range of motion (ROM) recovers after TKR and detect early signs of stiffness. It also aims to predict who might develop stiffness after TKR and explore the relationship between pain and stiffness.
Current methods for measuring knee range of motion (ROM), such as hand-held tools for measuring angles, have limitations in terms of accuracy and need trained healthcare staff to use them. The ideal tool would be low-cost, easy to use, and provide rapid feedback to patients and clinical teams. The study will involve the development and validation of a computer vision-based approach (using cameras to assess movements) to monitor knee flexion and extension, and a walking pattern assessment. Video-based technology or computer vision (CV) has recently been pioneered in Exeter to measure spine movement in patients with ankylosing spondylitis. Computer vision is an emerging technology that has great potential for monitoring knee flexion in people with knee stiffness. This approach involves the use of cameras and machine learning algorithms to detect and analyse knee joint angles during movement automatically. By providing objective and accurate measurements of knee flexion, computer vision has the potential to improve the assessment of knee stiffness and facilitate targeted treatment interventions. However, as with any new technology, there is a need to validate the method in the context of patients with knee stiffness to ensure its accuracy and reliability. Studies have highlighted the importance of developing machine learning algorithms specifically for this patient population to account for individual differences in movement patterns and limitations due to stiffness. Further research is needed to assess the validity and feasibility of computer vision-based approaches for monitoring knee flexion in people with knee stiffness, which could ultimately improve the diagnosis, monitoring, and management of this condition.
Validation of the computer vision-based approach for monitoring knee flexion in people with knee stiffness is essential to ensure its reliability and accuracy. This requires developing and refining machine learning algorithms that can accurately detect and measure knee joint angles in this patient population. This study will evaluate the accuracy and precision of the algorithm against gold-standard measurement methods, such as motion capture or goniometry. Furthermore, this study will examine the sensitivity of the approach to changes in knee flexion due to stiffness and pain and assess its feasibility in a clinical setting. Once validated, the computer vision-based approach has the potential to provide a non-invasive and objective means of monitoring knee flexion in people with knee stiffness, which could inform treatment decisions and improve patient outcomes.
Another tool which the investigators will use is the Gaitcapture app which takes advantage of the accelerometer and gyroscope sensor in a mobile phone and acts similarly to an inertial measurement unit (IMU) to provide us with acceleration and rotation data.
The validation of the computer vision-based approach will involve comparing it against gold-standard measurement methods (specialist physiotherapy assessment).
In addition to the computer vision-based approach, the study will utilise body-worn sensors and mobile apps to monitor the physical activity levels, walking patterns and step counts of participants. This data will provide insights into people with TKR's overall physical activity patterns and help evaluate the usability, acceptability, feasibility, and accuracy of the tools for diagnostics and monitoring.
The findings of this research project have the potential to improve the diagnosis, monitoring, and management of knee stiffness after total knee replacement (TKR), with the potential to reducing the need for MUA surgery. By providing accurate measurements and early detection, the tools developed in this study could enable earlier referral to non-surgical treatments and reduce the need for costly and risky procedures to improve knee range of motion (ROM) after total knee replacement (TKR) surgery, like a manipulation of the knee under anaesthesia.
Here, the investigators will conduct a validation study of a marker-less motion capture algorithm to determine its accuracy and assess its feasibility and usability for implementation on a large scale in the home. the investigators will also ascertain the test-retest reliability of algorithm outputs such as knee flexion/extension angles.
### Conditions Module
**Conditions:**
- Total Knee Replacement
**Keywords:**
- rehabilitation
- surgery
- motion capture
- focus group
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be asked to complete 8 questionnaires before the lab assessments: The data will be entered and saved onto REDCap by a member of the research team. The 8 questionnaires including baseline data are PROMIS-29 v2, Oxford Knee Score, IPAQ Short Last 7 Days, Numeric Rating Scale, Single Ease Question, Barthel Index for Activities of Daily Living and EQ-5D-5L.
Participants will be asked to complete the following:
2-minute walk on a treadmill 10 m walk (5 m x 2). Timed up and Go (TUG) Sit to stand test
At home:
TUG Sit to stand test
**Intervention Names:**
- Diagnostic Test: smartphone camera sensor tool
**Label:** Healthy Controls (lab assessment)
#### Arm Group 2
**Description:** Participants will be asked to complete 8 questionnaires before the lab assessments: The data will be entered and saved onto REDCap by a member of the research team. The 8 questionnaires including baseline data are PROMIS-29 v2, Oxford Knee Score, IPAQ Short Last 7 Days, Numeric Rating Scale, Single Ease Question, Barthel Index for Activities of Daily Living and EQ-5D-5L.
Participants will be asked to complete the following:
2-minute walk on a treadmill 10 m walk (5 m x 2). Timed up and Go (TUG) Sit to stand test
At home:
TUG Sit to stand test
**Intervention Names:**
- Diagnostic Test: smartphone camera sensor tool
**Label:** Participant post total knee replacement surgery (lab assessment)
#### Arm Group 3
**Description:** A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
**Label:** Healthcare professionals (focus group)
#### Arm Group 4
**Description:** A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
**Label:** Stakeholders (focus group)
#### Arm Group 5
**Description:** A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
**Label:** Participants post total knee replacement surgery
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy Controls (lab assessment)
- Participant post total knee replacement surgery (lab assessment)
**Description:** The study will involve the development and validation of a computer vision-based approach (using cameras to assess movements) to monitor knee flexion and extension, and a walking pattern assessment.
**Name:** smartphone camera sensor tool
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To validate in the lab and provide proof of concept for a smartphone camera sensor tool that measures knee range of motion (ROM) alongside symptoms of pain for use in the home setting. This will be assessed by comparing the knee joint angles and range of motion measures using two different forms of motion capture during different movements.
**Measure:** Validation of the accuracy and reliability of camera sensor tool through comparison of knee joint angles based on motion capture from different sources
**Time Frame:** through study completion, an average of 1 year
**Description:** To investigate who might develop stiffness after Total Knee Replacement surgery. This will be measured by looking at the range of motion of the knee using motion capture data.
**Measure:** Predicting knee stiffness after surgery through analysis of knee joint angles
**Time Frame:** through study completion, an average of 1 year
**Description:** Participants will be questioned on how painful their knee is post surgery using the Oxford pain score questionnaire.
**Measure:** Knee pain measured through the oxford pain score questionnaire
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** Through feedback from focus groups and assessment of accuracy and reliability, the camera sensor tool will be tested to see whether it could be considered a tool that would be used in clinical settings.
**Measure:** Feasibility of clinical integration of camera sensor tool
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* People aged ≥18 years old
* Recently had a total knee replacement surgery or has worked with people following this surgery as a clinical, carer or therapist
* Able to give informed consent
* Able to communicate in English with the research team
Exclusion Criteria:
* Any medical condition compromising the safety or the ability to take part in the study
* Unable to adhere to study procedures
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Convenience sampling will be used to recruit healthcare professionals and stakeholders. Participants need to be identified within the timeline and scope of the project. Obtaining volunteers who are easily available and willing is a sensible sampling strategy for the scope of the project. They will be identified through professional networks and associations and will be invited to take part in the study by the University of Exeter research team via email.
Participants post-TKR will be recruited using a purposive sampling method, where individuals are selected based on their unique characteristics or experiences. For instance, they will be identified through hospital records and invited to participate by the NHS trust research team.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maedeh Mansoubi, PhD
**Phone:** 07866138722
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Exeter
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maedeh Mansoubi
- **Phone:** 07427164717
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** University of Exeter
**Status:** RECRUITING
**Zip:** EX1 2LP
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429449
**Brief Title:** Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
**Official Title:** Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
#### Organization Study ID Info
**ID:** 24-0178.cc
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2027-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-12
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Denver
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.
**Detailed Description:** This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.
Cohort 1 will be a conventional 3+3 dose-escalation study to determine maximum tolerated (MTD) or recommended dose of mitoxantrone when used with venetoclax+azacitidine. Subjects who are refractory to first-line therapy with venetoclax+HMA, or who respond and then relapse after first line therapy with venetoclax+HMA, will enroll in the study and receive a subsequent cycle of venetoclax+azacitidine at the dose and schedule being administered per the standard of care, along with a starting dose of 4mg/m2 of mitoxantrone administered IV on days 1-4. Depending on the absence or frequency of dose-limiting toxicities, additional patients will be enrolled at the appropriate dose levels, increasing by 2mg/m2 per cycle, per the 3+3 design until the MTD or a dose of 10mg/m2 of mitoxantrone is reached. The dose escalation phase will conclude when the MTD is determined; if the MTD is not reached, a recommendation for a dose of mitoxantrone in combination with venetoclax+azacitidine will be made based on toxicity and efficacy data.
After the establishment of the MTD or recommended dose of mitoxantrone, an expansion cohort (cohort 2) will open. 10 subjects who are refractory to first-line therapy with venetoclax+HMA, or who respond and then relapse after first line therapy with venetoclax+HMA, will enroll in the study and receive a subsequent cycle of venetoclax+azacitidine at the dose and schedule being administered per the standard of care, with the determined MTD/recommended dose of IV mitoxantrone given on days 1-4. On day 28 +/- 7 days of this cycle, a bone marrow biopsy will be repeated. In the absence of a ≥50% blast reduction from baseline, the subject will discontinue the study. If a CR, CRi, MLFS or blast reduction from baseline of ≥50% occurs, the subject can continue sequential cycles of venetoclax+azacitidine at the dose and schedule being administered per the standard of care, with the MTD/recommended dose of mitoxantrone on days 1-4, for up to 3 total cycles. No subject will receive \>3 cycles of mitoxantrone. After mitoxantrone cycles have been completed, subjects will receive a bone marrow biopsy after the third cycle, and then continue bone marrow biopsies with MRD assessments every 6 months, until disease progression or the administration of any therapy other than venetoclax+azacitidine, at which time the subject will be discontinued from the study.
In cohort 3, subjects who are in a morphologic remission with MRD+ after ≤3 cycles of standard of care venetoclax+HMA will enroll and receive mitoxantrone on days 1-4 at a dose to-be-determined that is below the MTD from cohort 1, concurrently with venetoclax+azacitidine, at the dose and schedule being administered per the standard of care, over a 28-day treatment cycle. A bone marrow biopsy with MRD assessment will be performed on day 28 +/- 7 days. If MRD conversion to negative occurs, subsequent treatment cycles will continue to administer venetoclax+azacitidine, at the dose and schedule being administered per the standard of care, with the to-be-determined dose of mitoxantrone on days 1-4, for a maximum of three total cycles of mitoxantrone. If MRD conversion to negative does not occur, the next cycle may escalate the mitoxantrone dose to a level to-be-determined and not exceeding the MTD, with venetoclax+azacitidine at the dose and schedule being administered per the standard of care. If MRD conversion to negative occurs, subsequent treatment cycles will continue to administer venetoclax+azacitidine, at the dose and schedule being administered per the standard of care, with the to-be-determined dose of IV mitoxantrone on days 1-4, for a maximum of three total cycles of mitoxantrone. If MRD conversion to negative does not occur, the next cycle may escalate the mitoxantrone to a level to-be-determined and not exceeding the MTD, with venetoclax+azacitidine at the dose and schedule being administered per the standard of care. Subjects will not receive \>3 cycles of mitoxantrone. After mitoxantrone cycles have been completed, subjects will continue bone marrow biopsies with MRD assessments every 6 months, until disease progression or the administration of any therapy other than venetoclax+azacitidine, at which time the subject will be discontinued from the study.
In cohort 4, subjects who are in a morphologic remission with MRD+ after \>3 cycles of standard of care venetoclax/HMA will enroll 28-50 days after the start of the previous venetoclax/HMA cycle. They will receive mitoxantrone IV on days 1-4 at a dose to-be-determined that is below the MTD from cohort 1; on day 14, the subject will start venetoclax+azacitidine at the dose and schedule being administered per the standard of care. On day 42 +/- 7 days, a bone marrow biopsy, with MRD assessment, will be repeated. If MRD conversion to negative occurs, subsequent treatment cycles will continue to administer venetoclax+azacitidine, at the dose and schedule being administered per the standard of care, with the to-be-determined dose of IV mitoxantrone on days 1-4, for a maximum of three total cycles of mitoxantrone. If MRD conversion to negative does not occur, the next cycle will retain the same schedule, and may escalate the mitoxantrone to a dose level to-be-determined and not exceeding the MTD. If MRD conversion to negative occurs, one additional cycle of mitoxantrone at this dose, with venetoclax+azacitidine at the dose and schedule being administered per the standard of care, will be given. If MRD conversion to negative does not occur, the next cycle will retain the same schedule, and may escalate the mitoxantrone to a level to-be-determined and not exceeding the MTD. No subject will receive \>3 cycles of mitoxantrone. After mitoxantrone cycles have been completed, subjects will continue bone marrow biopsies with MRD assessments every 6 months, until disease progression or the administration of any therapy other than venetoclax+azacitidine, at which time the subject will be discontinued from the study.
### Conditions Module
**Conditions:**
- Leukemia
- Myeloid Leukemia
- Monocytic Leukemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cohort 1 will be a conventional 3+3 dose-escalation study to determine maximum tolerated (MTD) or recommended dose of mitoxantrone when used with venetoclax+azacitidine.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Mitoxantrone
**Label:** Cohort 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After establishing the MTD of mitoxantrone, an expansion cohort will open. 10 subjects refractory to first-line therapy w/venetoclax+HMA, or respond then relapse after first-line therapy w/venetoclax+HMA, will enroll in the study \& receive a subsequent cycle of venetoclax+azacitidine at the dose \& schedule being administered per the standard of care, w/the determined MTD/recommended dose of IV mitoxantrone given days 1-4. Day 28 +/- 7 days of this cycle, a bone marrow biopsy will be repeated. In the absence of a ≥50% blast reduction from baseline, the subject will discontinue the study. If a CR, CRi, MLFS or blast reduction from baseline of ≥50% occurs, the subject can continue sequential cycles of venetoclax+azacitidine at the dose \& schedule being administered per the standard of care, with the MTD/recommended dose of mitoxantrone on days 1-4, up to 3 cycles. No subject will receive \>3 cycles of mitoxantrone.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Mitoxantrone
**Label:** Cohort 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Subjects in a morph remission w/ MRD+ after ≤3 cycles of soc ven+HMA will enroll \& receive mitox on days 1-4 at dose tbd that is below the MTD from cohort 1, concurrently w/ven+aza, at the dose \& schedule being soc admin, over a 28-day cycle. A BMBX w/ MRD assessment will be done day 28. If MRD- occurs, subseq treatment cycles will continue to admin ven+aza, at the dose \& schedule being soc admin, w/ the tbd dose of mitox on days 1-4, for max of 3 cycles. If MRD- does not occur, the next cycle may escalate the mitox dose to a level tbd \& not exceeding the MTD, w/ ven+aza at the dose \& schedule being soc admin. If MRD- occurs, subseq treatment cycles will continue to admin ven+aza, at the dose \& schedule being soc admin, with the tbd dose of IV mitox on days 1-4, for a max of 3 cycles. If MRD- does not occur, the next cycle may escalate the mitox to a level tbd \& not exceeding the MTD, w/ ven+aza at the dose \& schedule being admin per the soc. Subjects will not receive \>3 cycles.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Mitoxantrone
**Label:** Cohort 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Subjects in a morphologic remission w/ MRD+ after \>3 cyc of soc ven/HMA will enroll 28-50 days after the previous ven/HMA cyc. Subjects will receive mitox IV days 1-4 at a dose tbd below the MTD from cohort 1; on day 14, the subject will start ven+aza at the dose \& schedule per the soc. On day 42, a BMBX, w/ MRD assessment, will be repeated. If MRD- occurs, subseq cyc will cont to admin ven+aza, at the dose \& schedule per the soc, with the tbd dose of IV mitox on days 1-4, for a max of 3 cyc of mitox. If MRD- does not occur, the next cyc will retain the same schedule \& may escalate the mitox to a dose level tbd \& not exceeding the MTD. If MRD- occurs, 1 add'l cyc of mitox at this dose, w/ ven+aza at the dose \& schedule per the soc, will be given. If MRD- does not occur, the next cyc will retain the same schedule \& may escalate the mitox to a level tbd \& not exceeding the MTD.
**Intervention Names:**
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Mitoxantrone
**Label:** Cohort 4
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1
- Cohort 2
- Cohort 3
- Cohort 4
**Description:** Venetoclax attaches to a protein called Bcl-2. This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down progression of the disease.
**Name:** Venetoclax
**Other Names:**
- Venclexta
- Venclyxto
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 1
- Cohort 2
- Cohort 3
- Cohort 4
**Description:** An analog of the pyrimidine nucleoside cytidine, has effects on cell differentiation, gene expression, and deoxyribonucleic acid (DNA) synthesis and metabolism, and causes cytotoxicity.
**Name:** Azacitidine
**Other Names:**
- Onureg
- Vidaza
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Cohort 1
- Cohort 2
- Cohort 3
- Cohort 4
**Description:** Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use.
**Name:** Mitoxantrone
**Other Names:**
- Novantrone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Determine the maximum tolerated (MTD) and/or recommended phase 2 dose (RP2D) of mitoxantrone in combination with venetoclax+azacitidine.
**Measure:** Maximum tolerated dose (MTD)
**Time Frame:** Reassessment at end of each cycle (28 days) until MTD reached, up to 5 cycles total if needed
**Description:** Overall response rate (CR+CRi+PR+MLFS) after treatment with mitoxantrone and venetoclax+azacitidine venetoclax+HMA in subjects who have failed first line therapy with this regimen
**Measure:** Overall response rate
**Time Frame:** Baseline to End of Treatment
**Description:** Determine the safety of mitoxantrone in combination or in sequence with standard of care venetoclax+azacitidine
**Measure:** Number of grade 4 or 5 adverse events
**Time Frame:** Baseline to End of Treatment
#### Secondary Outcomes
**Description:** Relapse free survival, remission duration, overall survival and adverse events by grade and attribution
**Measure:** Survival data
**Time Frame:** Through study completion, up to 5 years
**Description:** Determine the rate of conversion from MRD+ to MRD- after treatment with mitoxantrone
**Measure:** Number of conversions from MRD+ to MRD-
**Time Frame:** After each cycle of treatment (28 days), up to 3 cycles total
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax/HMA (azacitidine or decitabine).
2. Subject must have relapsed disease per IWG criteria or disease refractory to first line venetoclax/HMA defined by less than a PR response after ≥ 1 complete cycle of venetoclax/HMA.
3. Subject must have either measurable residual disease (MRD+), as measured by FDA-approved flow cytometric test performed by Hematologics (cohort 3 and 4) or relapsed/refractory disease (cohort 1 and 2).
4. Subject must have a projected life expectancy of at least 12 weeks.
5. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.
6. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation
7. Subject must have adequate heart function as measured by left ventricular ejection fraction (LVEF) \>50%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 1 month prior to study day 1
8. Subject must have adequate liver function as demonstrated by:
1. aspartate aminotransferase (AST) ≤ 3.0 × ULN\*
2. alanine aminotransferase (ALT) ≤ 3.0 × ULN\*
3. bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome\*
* Unless considered due to leukemic organ involvement
9. Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
10. Female subjects must be either:
1. Postmenopausal; defined as Age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR
2. Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
3. If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.
11. Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.
Exclusion Criteria:
1. Subject has known active CNS involvement from AML.
2. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
1. Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction.
2. Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
3. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g.
sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
4. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
5. Subject has a history of other malignancies prior to study entry, with the exception of:
1. Adequately treated in situ carcinoma of the breast or cervix uteri
2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
3. Prostate cancer not requiring therapy beyond hormonal therapy
4. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
6. Subject has a white blood cell count \> 25 × 109/L. Note: hydroxyurea or apheresis are permitted to meet this criterion (cohort 3 only).
7. Pregnant or breast-feeding females.
8. Known or suspected hypersensitivity to azacitidine or mannitol.
9. Any prior exposure to an anthracycline or anthracenedione
**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:** Derek Schatz
**Phone:** 720-848-0628
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aurora
**Country:** United States
**Facility:** University of Colorado Hospital
**State:** Colorado
**Zip:** 80045
#### Overall Officials
**Official 1:**
**Affiliation:** University of Colorado, Denver
**Name:** Andrew Kent, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- 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: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### 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: D000004791
- Term: Enzyme Inhibitors
- 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: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: Extended
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Conditioning
- ID: M4673
- Name: Azacitidine
- Relevance: HIGH
- As Found: Frequency
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001374
- Term: Azacitidine
- ID: C000579720
- Term: Venetoclax
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429436
**Brief Title:** Vending Machine Naloxone Distribution for Your Community (VENDY)
**Official Title:** Vending Machine Naloxone Distribution for Your Community (VENDY): Increasing Reach and Implementation of Naloxone Distribution
#### Organization Study ID Info
**ID:** 22-0546
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**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:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Southern Colorado Harm Reduction Association
**Class:** OTHER
**Name:** Denver Health and Hospital Authority
**Class:** UNKNOWN
**Name:** Summit County Public Health Department
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Denver
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Vending machines are an innovative strategy shown to increase access to naloxone, a medication used to reverse opioid overdose. The aim of this proposal is to study the reach of a community-initiated, stakeholder engaged adaptation of naloxone distribution, VEnding machine Naloxone Distribution for Your community (VENDY) program.
**Detailed Description:** This pilot assessment of the VENDY program will take place in 3 communities. Each community will have a machine (vending or kiosks) in which naloxone will be distributed for free to community members. Our preliminary work identified the locations desired by community members who use illegal drugs for machine placement. The pilot test test will include evaluation of the reach (naloxone distribution), adoption (% of sites and staff implementing), and implementation (fidelity to restocking and maintenance protocol) of VENDY in each community.
### Conditions Module
**Conditions:**
- Harm Reduction
- Naloxone
- Opioid Overdose
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** We will be using an interrupted time series design to evaluate naloxone distribution before and after vending machine implementation in each community.
##### Masking Info
**Masking:** NONE
**Masking Description:** There will be no masking.
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 1489
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution.
**Intervention Names:**
- Behavioral: VENDY
**Label:** VENDY
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VENDY
**Description:** At least 1 machine (vending machine like a snack machine or a machine like a newspaper kiosk) will be placed in the respective community served by the participating organizations. Any person in the community can get naloxone from the machine. The vending machine will require a code that will be placed on the machine for anyone to use. The kiosks are a box that you simply pull open and naloxone can be obtained. Naloxone kits will be provided for free as part of the current naloxone distribution program within each respective organization.
**Name:** VENDY
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Reach will be assessed using monthly counts of naloxone distribution in the 6 months before and after VENDY implementation. Naloxone counts will include distribution from all sources within the organization and captured through pharmacy fills from the electronic health record and distribution tracking logs. Naloxone machine distribution will be added to the total monthly count in the post implementation phase and obtained using the vending machine electronic software (reporting date and time of distribution) or (for kiosks) the staff monthly refill tracking log capturing quantity of naloxone kits required to fill the machine (captured at least monthly).
**Measure:** Reach
**Time Frame:** the 6 months pre VENDY implementation and the 6 months post VENDY implementation
#### Secondary Outcomes
**Description:** Adoption is the percentage of sites placing a naloxone vending machine in the respective community that is made available for community members to obtain naloxone.
**Measure:** Adoption
**Time Frame:** At the end of program development (program development is the first phase in which each site is developing VENDY over a 6-18 month period of time)
**Description:** The count of fatal opioid overdose events for each respective county in which the participating organization and vending machine reside in the year before and year after VENDY implementation. Overdose will be captured from publicly available data from death records reported by the Colorado Department of Public Health and Environment. To address temporality we will include fatal opioid overdose deaths in a comparison community matching community features (urban/rural status, community population, and opioid death rate).
**Measure:** Fatal Opioid Overdose Events-Effectiveness
**Time Frame:** pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program
**Description:** Fidelity is the percentage of time staff refill and maintain the machine per protocol as measured by the vending machine software and machine activity tracking log.
**Measure:** Fidelity-Implementation
**Time Frame:** the 6 months following VENDY implementation
**Description:** Number of months each organization implementing VENDY continues to make naloxone available in the machines for the 6 months following the initial implementation phase (6 months).
**Measure:** Maintenance
**Time Frame:** the 6 months following the initial implementation phase (6 months)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Any person in the community who desires to obtain naloxone will be able to use the machines
Exclusion Criteria:
* Inability to enter a code on a vending machine or open a kiosk.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nicole Wagner, PhD
**Phone:** (303)724-7095
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Meagan R Bean, MPH
**Phone:** (303)724-7095
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000062787
- Term: Drug Overdose
- ID: D000063487
- Term: Prescription Drug Misuse
- ID: D000076064
- Term: Drug Misuse
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000009293
- Term: Opioid-Related Disorders
- ID: D000079524
- Term: Narcotic-Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M2423
- Name: Opiate Overdose
- Relevance: HIGH
- As Found: Opioid Overdose
- ID: M30011
- Name: Drug Overdose
- Relevance: LOW
- As Found: Unknown
- ID: M1557
- Name: Drug Misuse
- Relevance: LOW
- As Found: Unknown
- ID: M30133
- Name: Prescription Drug Misuse
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced 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: M12244
- Name: Opioid-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000083682
- Term: Opiate Overdose
### Intervention Browse Module - Browse Branches
- Abbrev: NarcAntag
- Name: Narcotic Antagonists
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12221
- Name: Naloxone
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429423
**Brief Title:** Effects of Acute Physical Activity in Patients With Exhaustion Disorder
**Official Title:** Acute Psychological and Physiological Exercise Effects Among Patients With Stress-related Exhaustion Disorder. Role of Exercise Intensity.
#### Organization Study ID Info
**ID:** 2022-04943-01
#### Organization
**Class:** OTHER
**Full Name:** The Swedish School of Sport and Health Sciences
### Status Module
#### Completion Date
**Date:** 2024-01-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-04
**Type:** ACTUAL
#### Start Date
**Date:** 2023-02-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-06
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Avonova Health AB
**Class:** UNKNOWN
**Name:** Jenny Kling, Doctoral student, licensed psychologist, The Swedish School of Sport and Health Sciences
#### Lead Sponsor
**Class:** OTHER
**Name:** Victoria Blom
#### Responsible Party
**Investigator Affiliation:** The Swedish School of Sport and Health Sciences
**Investigator Full Name:** Victoria Blom
**Investigator Title:** Associate professor in psychology, head of department Institution for physical activity and health, licensed psychologist
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A new stress-related diagnosis, Exhaustion disorder (ED), was introduced in the Swedish version of ICD-10 in 2005 and has since then increased rapidly. The condition is long-lasting and debilitating, characterized by considerable and persistent fatigue, insomnia, and impaired cognitive function. The diagnosis is still relatively unexplored and there is no consistent knowledge of, among other things, which interventions that work. Research indicates that physical activity can have positive effects on depression, anxiety, and stress. However, there is little knowledge today about the relationship between the dose of physical activity and stress-related illness. It is also not clear how physical activity can be used in the treatment of stress-related illness. The purpose of this project is to gain increased knowledge about the immediate physiological and psychological effects of physical activity for people with diagnosed ED. The project will investigate the psychological and physiological effects of two different intensities of physical activity in people with ED compared to healthy controls. The information from the study also aims to provide a basis for a second part of the project where treatment including physical activity is carried out with people with ED, in a randomized controlled design.
**Detailed Description:** Background A new stress-related diagnosis, exhaustion disorder (ED), was introduced in the Swedish version of ICD-10 in 2005, and has since then increased rapidly. The condition is long-lasting and debilitating, characterized by considerable and persistent fatigue, insomnia and impaired cognitive function. The diagnosis is still relatively unexplored and there is no consistent knowledge of, among other things, which interventions that work.
There is extensive research on the association between mental health and physical activity in general and exercise specifically. When it comes to long-term, or habitual, exercise, it is established that it has beneficial effects on different aspects of mental health and physical activity interventions are helpful for people with mental illness. The most widely studied mental health-issues are depression, anxiety, and stress, and a recent umbrella review concludes that habitual exercise is beneficial for symptom reduction for depression, anxiety, and stress across different populations. Epidemiological evidence shows that physical activity is associated with lowered risk of experiencing fatigue and reduced energy.
Little is known about how physical activity in general and more specifically different intensities of physical activity affects people with ED. Does it have adverse effects or is it beneficial? This is imperative when it comes to intervention- and treatment planning for these patients. No studies have been done specifically on ED before with this focus. Although an acute study cannot show the optimal physical activity program, it can give insight into the relation between between ED and exercise. This in turn can help us construct better designs of exercise programs for this patient group.
Research aims and questions The purpose of the study is to gain increased understanding of the psychological and physiological response to acute exercise in ED-patients compared to a healthy population, and to determine if that response differs between two different intensities of exercise (low and moderate). The focus is on transient emotional states and how they might fluctuate in response to exercise. Specifically subjective feelings of fatigue, energy, anxiety, psychological discomfort, perceived exertion, recovery, and stress is studied. Salivary cortisol and heart rate variability (HRV) are the biomarkers in focus.
Knowledge from the study is planned to be used in the designing of a physical activity program as part of a treatment program for ED. The design can give us information about whether short bouts of exercise can have mood-altering effects in this patient group, and auonomic reactivity to physical activity.
Research questions:
1. Does level of fatigue, vigor/energy, state anxiety, and perceived stress differ between groups (ED/controls) and/or between exercise intensities (mild/moderate) and/or between timepoints (pre/post/30minpost/6hpost/24hpost)?
2. Does the level of subjective discomfort and perceived exertion differ between groups (ED/controls) and/or between exercise intensities (mild/moderate) and/or between time points (pre/5min/10min/15min)?
3. Does the level of salivary cortisol differ between groups (ED/controls) and/or between exercise intensities (mild/moderate) and/or between time points (pre/post/30 min post)?
4. Does level of heart rate variability (HRV) differ between groups (ED/controls) and/or between exercise intensities (mild/moderate) and/or between timepoints (pre/post/30minpost/6hpost/24hpost)?
If significant differences are found, intercation effects between the different variables will also be studied, as well as potential moderating variables.
Methods Study design The design is a two-armed trial (low and moderate intensity of physical activity) with two groups, one which is patients with ED, and the other an age- and sex matched control group with overall healthy individuals, that include sequential assessments of fatigue and energy states, stress, perceived exertion, perceived psychological distress and state anxiety.
Participants Approximately 30 patients with diagnosed exhaustion disorder (F43.8A in ICD-10-SE) and 30 age- and sex-matched healthy control participants are recruited for the study. ED-patients are recruited through occupational health care Avonova and through advertisement in social media Facebook and Instagram. Inclusion criteria in the studies for ED-patients: confirmed primary diagnosis ED by a physician; assessed to not be in the acute phase of ED; age of 35-55 years; considered by a physician and/or a psychologist as suitable for participating in a study including performing physical activity. Healthy control participants are recruited via the same social media channels as ED-patients. Inclusion criteria: age of 35-55 years; self-reported good health (no known somatic or psychiatric disease); considered as suitable for participating in a study including performing physical activity. Mini International Neuropsychiatric Interview 6.0.0. (MINI), as well as an additional diagnostic questionnaire targeting stress-related disorders based on diagnostic criteria from ICD-11, will be conducted with both ED-patients and healthy controls, to ensure the inclusion- and exclusion criteria. MINI is a diagnostic interview for the major DSM-IV psychiatric disorders. The participants will receive thorough written information about the study and written informed consent will be obtained before inclusion. The study was approved by the Regional Ethical Review Board in Linköping, Sweden (Approval Nr. 2022-04943-01) and will be conducted in accordance with the ethical principles of the Declaration of Helsinki.
Procedure The study takes place in a laboratory setting at GIH on three different days, separated by at least one week. Before enrollment, participants complete an online administered screening questionnaire measuring exhaustion, burnout, and diagnostic and general health information. Eligible participants are invited to GIH for a familiarization visit, where a structured clinical interview (MINI and stress diagnoses questionnaire) is performed. Participants will also complete a submaximal cardiorespiratory fitness test (CRF) to estimate maximal aerobic capacity. The test is performed on a calibrated mechanically braked cycle ergometer (model 828E, Monark, Varberg, Sweden) for 8 min. Pedal frequency throughout the test is 60 rpm. Cycling resistance starts at 0,5 kilopond (kp) for 4 minutes and is increased to a personalized higher work rate, which lasts for 4 minutes. VO2max is estimated from these 8 minutes using heart rate data collected during the test. The result on this test will be used in determining each participant's correct intensity level on the two trial conditions.
Conditions The two trial conditions are performed in a counter-balanced and randomly assigned order. The participants perform the two conditions of physical activity bouts at approximately the same time in the morning/forenoon (start time of test visit is either 8:30 or 10:30 a.m.) with at least one week in between conditions. The participants have the same test start time at the two test visits. At each test session participants perform a 22-minute exercise on a cycle ergometer (model 839E, Monark, Varberg, Sweden). Immediately before and at three time points during the exercise (after 5, 10, and 15 minutes on the low or moderate intensity), they rate level of exertion (RPE) and feelings of psychological distress on a VAS-scale. Immediately before, immediately after, 30 minutes after, 6 hours after, and 24 hours after exercise participants fill out questionnaires regarding feelings of fatigue, energy, anxiety, recovery, and stress. Participants wear a H10 heart rate sensor and Vantage M2 monitor (Polar, Kempele, Finland) for a little more than 24 hours, starting approximately 30 minutes before the exercise. HRV parameters will be calculated from 5-min window recordings using the software Kubios HRV (University of Eastern Finland, Kuopio, Finland), immediately before (pre), immediately after (post), 30 minutes after (30 min post), 6 hours after (6h post), and 24 hours after (24h post) exercise. Since HRV is influenced by several factors (caffeine intake, alcohol consumption, circadian rhythm, stress (both mental and physical), exercise, food- and water intake, certain medications, bladder filling, respiratory rate, and posture) these factors will be controlled for when at GIH. Salivary cortisol is collected pre, post and 30 min post exercise using Sarstedt Salivette Cortisol (Sarstedt, Nümbrecht, Germany). The follow-up measurements will determine the trajectory of the cortisol and HRV post-exercise. During the 24 hours following the exercise bout physical activity pattern is measured using a hip-worn accelerometer (Actigraph GT3X). Accelerometer data will be processed in Actilife.
There are two experimental exercise conditions, where participants will exercise at two different intensity levels. The intensity levels are standardized across participants by using results from EKBLOM-BAK test to determine a low and moderate intensity. Low intensity is defined as 40% and moderate intensity is defined as 55% of the participant's individual estimated VO2max. The 22-minute exercise starts with a 6-minute warm-up, with a load increase after 1 and 3 minutes and lowered load at the last minute. Then follows a 15-minute bout on either low or moderate intensity, that ends with a 1-minute cool-down. One of the researchers will be present during the complete test to assure correct intensity and length.
Baseline measures
In the week before the familiarization visit each participant completes a digitally administered questionnaire that includes socio-demographic and general health information together with the following questionnaires:
* Exhaustion disorder. Karolinska Exhaustion Disorder Scale (KEDS) was developed for the assessment of ED symptoms. It consists of nine items with a scale range of 0-54 and a cut-off of 19 has been proposed in the discrimination between healthy subjects and patients with ED.
* Burnout. Shirom-Melamed Burnout Questionnaire/Measure (SMBQ/SMBM) is widely used in measuring burnout. SMBM-12 is a short version with twelve items which captures core concepts of burnout: emotional and physiological exhaustion (e.g., "I feel tired"), and cognitive weariness (e.g., "I feel I am not thinking clearly"). A global score of burnout is calculated. SMBM-12 has good composite reliability and convergent validity.
* Trait anxiety. The trait subscale of The State-Trait Anxiety Inventory (STAI). Respondents rate how they generally feel on a 4-point Likert Scale (e.g., "I feel nervous and rested"). A global score of a general and enduring trait anxiety is calculated.
* Depression. Patient Health Questionnaire (PHQ-9) measures depression in line with DSM-IV. Respondents rate depression symptoms the last two weeks on a 4-point Likert Scale (e.g., "Little interest or pleasure in doing things").
* Sleep. Pittsburgh Sleep Quality Index (PSQI) is widely used in measuring sleep quality. It consists of 19 items that form seven components of retrospective sleep quality (1 month) and a global score.
* Physical activity. Saltin-Grimby Physical Activity Level Scale (SGPALS) is a four-level single-item instrument which has acceptable validity for measuring level of physical activity.
* Exercise attitudes. Two subscales of the Exercise Benefits/Barriers Scale (EBBS) were included: Psychological Outlook Subscale (benefits), and Physical Exertion Subscale (barriers).
2-3 days after the familiarization visit, heart rate variability (HRV) and physical activity pattern is measured during a 24-hour baseline measurement. Participants get oral and written instructions on the familiarization visit on how to initialize and conduct this measurement with a H10 heart rate sensor and Vantage M2 monitor together with a hip-worn accelerometer (Actigraph GT3X). Twice during the 24h-measurement, digital questionnaires including Single Item stress Question (SISQ), the vigor and fatigue subscales of Profile of Mood States (POMS), single-item recovery question, and state subscale of The State-Trait Anxiety Inventory (STAI-Y1) are completed.
Data analysis For each of the psychological variables (perceived exertion, psychological discomfort, fatigue, energy/vigor, state anxiety, and stress) a three factorial (group, time, intensity) ANOVA with repeated measures design will be the first hand choice if parametric assumptions are met. A secondary stratified analysis will be performed exploring potential variables that influenced the primary and secondary psychological variables.
For the data analysis of physiological variables, data analysis are yet to be decided. This will be done though before looking at the data.
### Conditions Module
**Conditions:**
- Exhaustion; Syndrome
**Keywords:**
- burnout
- fatigue
- psychological stress
- physical activity
- acute exercise
- mood
- heart rate variability
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The design is a two-armed intervention with two groups (30+30), one which is patients with ED, and the other an age- and sex matched control group with overall healthy individuals. The two trial conditions will be performed in a counter-balanced randomized order on two separate days with at least one week apart. Participants will be randomized regarding order of two different intensities of physical activity bouts. The participants will perform the two conditions of physical activity bouts at approximately the same time in the morning/forenoon with at least 1 week in between conditions.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with diagnosed exhaustion disorder (F43.8A in Swedish ICD-10).
**Intervention Names:**
- Behavioral: Acute exercise low intensity
- Behavioral: Acute exercise moderate intensity
**Label:** Exhaustion disorder (ED)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Age- and sex-matched healthy control participants.
**Intervention Names:**
- Behavioral: Acute exercise low intensity
- Behavioral: Acute exercise moderate intensity
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Exhaustion disorder (ED)
**Description:** A 15-minute exercise on low intensity on a cycle ergometer. Immediately before, immediately after and 30 minutes after exercise participants will fill out questionnaires regarding feelings of fatigue, energy, anxiety and stress and measure saliva cortisol. Three times during the exercise, they will rate level of exertion (RPE) and feelings of distress on a VAS-scale.
During the 24 hours following the exercise bout they will wear a heart rate strap and an accelerometer measuring heart rate variability and activity level. Twice during that time, once in the evening, and once in the morning after, participants will answer questionnaires regarding mood state.
**Name:** Acute exercise low intensity
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control group
- Exhaustion disorder (ED)
**Description:** A 15-minute exercise on moderate intensity on a cycle ergometer. Immediately before, immediately after and 30 minutes after exercise participants will fill out questionnaires regarding feelings of fatigue, energy, anxiety and stress and measure saliva cortisol. Three times during the exercise, they will rate level of exertion (RPE) and feelings of distress on a VAS-scale.
During the 24 hours following the exercise bout they will wear a heart rate strap and an accelerometer measuring heart rate variability and activity level. Twice during that time, once in the evening, and once in the morning after, participants will answer questionnaires regarding mood state.
**Name:** Acute exercise moderate intensity
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Fatigue is defined as "a persistent sense of physical, emotional, and/or cognitive tiredness or exhaustion". Feelings of energy and fatigue is measured with the vigor and fatigue subscales of Profile of Mood States (POMS). It assesses short-term mood states and respondents are instructed to rate how the feel "right now". The total score ranges from 0 to 28 and a higher score means a worse outcome. It is a valid and reliable measure of intensities of fatigue and energy mood states and is recommended to be used in experimental settings to measure short-term intensity of energy and fatigue moods.
**Measure:** Fatigue
**Time Frame:** Fatigue is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout.
**Description:** The adopted definition of energy is "an individual's potential to perform mental and physical activity". Feelings of energy and fatigue is measured with the vigor and fatigue subscales of Profile of Mood States (POMS). It assesses short-term mood states and respondents are instructed to rate how the feel "right now". The total score ranges from 0 to 32 and a higher score means a better outcome. It is a valid and reliable measure of intensities of fatigue and energy mood states and is recommended to be used in experimental settings to measure short-term intensity of energy and fatigue moods.
**Measure:** Energy/vigor
**Time Frame:** Energy/vigor is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout
**Description:** State anxiety will be measured using the 20-item state subscale of The State-Trait Anxiety Inventory (STAI-Y1). Respondents rate how they feel "right now" on a 4-point Likert Scale (e.g., "I am tense"). A global score of the transient condition of state anxiety is calculated, ranging from 20 to 80. Higher scores correlates with greater anxiety. It is extensively used in previous studies of acute exercise and there is support for the STAI-Y1 being sensitive to change in response to acute aerobic exercise.
**Measure:** State anxiety
**Time Frame:** State anxiety is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bou
#### Secondary Outcomes
**Description:** To measure subjective stress in the moment the Single Item stress Question (SISQ) was adapted and reformulated to measure stress "right now" instead of "these days". The scale ranges from 1 to 5, and higher scores correlates with higher level of stress.
**Measure:** Stress.
**Time Frame:** Stress is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout.
**Description:** Subjective Units of Distress (SUD) is used to assess the strength of subjective discomfort during the exercise bout. The respondent is asked to rate on a scale from 0 to 10 how much discomfort they experience. The scale ranges from 0 10 and a higher score indicates more discomfort.
**Measure:** Perceived psychological discomfort.
**Time Frame:** SUD is measured in both conditions at the following time-points: immediately before the exercise bout; during the exercise at 3 time points: 5 min into the exercise, 10 min into the exercise, and 15 min into the exercise
**Description:** Borg's 6-20 rating of perceived exertion scale (RPE) was used to assess exertion during exercise. It is a single-item scale ranging from 6 (not strenuous at all) to 20 (maximally strenuous).
**Measure:** Perceived Exertion.
**Time Frame:** RPE is measured in both conditions at the following time-points: immediately before the exercise bout; during the exercise at 3 time points: 5 min into the exercise, 10 min into the exercise, and 15 min into the exercise
**Description:** Is used as a biomarker indicator of the HPA-axis response to exercise. Saliva is collected with standard swabs; Sarstedt Salivette Cortisol, then stored and analyzed following standard procedures.
**Measure:** Salivary cortisol
**Time Frame:** Cortisol is measured in both conditions at the following time points: 10 minutes before each exercise bout; 5 minutes after each exercise bout; and 35 minutes after each exercise bout.
**Description:** Specific measures still to be decided upon. This will be decided before looking at the data.
**Measure:** Heart rate variablity (HRV)
**Time Frame:** HRV is measured in both conditions at the following time points: 5 minutes before exercise bout; ca 8 minutes after exercise bout; and ca 38 minutes after exercise bout.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For ED-patients:
* Confirmed primary diagnosis ED by a physician
* Assessed to not be in the acute phase of ED
* considered by a physician and/or a psychologist as suitable for participating in a study including performing physical activity
* Age of 35-55 years
For control group:
* Self-reported good health (no known somatic or psychiatric disease)
* Age of 35-55 years
Exclusion Criteria:
* Chronic fatigue syndrome (CFS)
* Post-covid
* Dementia
* Bipolar and/or psychotic disorder
* Current substance abuse
* Fibromyalgia
* Elevated suicide risk
* Medication with beta-blockers
Following exclusion criteria is also used, since it is not suitable to perform the EKBLOM-BAK-test:
* chronic obstructive lung disease
* hypertension/dyslipidemia
* cardiovascular disease
If participant has ongoing infection (such as a cold) on testday, testing is delayed until she/he is recovered.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 35 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Stockholm
**Country:** Sweden
**Facility:** Victoria Blom
**Zip:** 11433
#### Overall Officials
**Official 1:**
**Affiliation:** The Swedish School of Sport and Health Sciences
**Name:** Victoria Blom, Ass. prof.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Almén, N., & Jansson, B. (2021). The reliability and factorial validity of different versions of the Shirom-Melamed Burnout Measure/Questionnaire and normative data for a general Swedish sample. International Journal of Stress Management, 28(4), 314-325. https://doi.org/10.1037/str0000235
**Citation:** Bjorkman F, Ekblom-Bak E, Ekblom O, Ekblom B. Validity of the revised Ekblom Bak cycle ergometer test in adults. Eur J Appl Physiol. 2016 Sep;116(9):1627-38. doi: 10.1007/s00421-016-3412-0. Epub 2016 Jun 16.
**PMID:** 27311582
**Citation:** Borg G, Ljunggren G, Ceci R. The increase of perceived exertion, aches and pain in the legs, heart rate and blood lactate during exercise on a bicycle ergometer. Eur J Appl Physiol Occup Physiol. 1985;54(4):343-9. doi: 10.1007/BF02337176.
**PMID:** 4065121
**Citation:** Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
**PMID:** 2748771
**Citation:** World Health Organization: The ICD-10 classification of mental and behavioural disorders: Clinical descriptions and diagnostic guidelines. Geneva: World Health Organization, 1992.
**Citation:** Lindsater E, Svardman F, Wallert J, Ivanova E, Soderholm A, Fondberg R, Nilsonne G, Cervenka S, Lekander M, Ruck C. Exhaustion disorder: scoping review of research on a recently introduced stress-related diagnosis. BJPsych Open. 2022 Aug 24;8(5):e159. doi: 10.1192/bjo.2022.559.
**PMID:** 36458830
**Citation:** Singh B, Olds T, Curtis R, Dumuid D, Virgara R, Watson A, Szeto K, O'Connor E, Ferguson T, Eglitis E, Miatke A, Simpson CE, Maher C. Effectiveness of physical activity interventions for improving depression, anxiety and distress: an overview of systematic reviews. Br J Sports Med. 2023 Sep;57(18):1203-1209. doi: 10.1136/bjsports-2022-106195. Epub 2023 Feb 16.
**PMID:** 36796860
**Citation:** Spielberger, C.D., Gorsuch, R.L., & Lushene, R.E. (1970). The State-Trait Anxiety Inventory: Testmanual. Palo Alto, CA: Consulting Psychologist Press
**Citation:** Saltin B, Grimby G. Physiological analysis of middle-aged and old former athletes. Comparison with still active athletes of the same ages. Circulation. 1968 Dec;38(6):1104-15. doi: 10.1161/01.cir.38.6.1104. No abstract available.
**PMID:** 5721960
**Citation:** Sechrist KR, Walker SN, Pender NJ. Development and psychometric evaluation of the exercise benefits/barriers scale. Res Nurs Health. 1987 Dec;10(6):357-65. doi: 10.1002/nur.4770100603.
**PMID:** 3423307
**Citation:** Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.
**PMID:** 33390146
**Citation:** Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
**PMID:** 9881538
**Citation:** Puetz TW. Physical activity and feelings of energy and fatigue: epidemiological evidence. Sports Med. 2006;36(9):767-80. doi: 10.2165/00007256-200636090-00004.
**PMID:** 16937952
**Citation:** Paluska SA, Schwenk TL. Physical activity and mental health: current concepts. Sports Med. 2000 Mar;29(3):167-80. doi: 10.2165/00007256-200029030-00003.
**PMID:** 10739267
**Citation:** Rosenbaum S, Tiedemann A, Sherrington C, Curtis J, Ward PB. Physical activity interventions for people with mental illness: a systematic review and meta-analysis. J Clin Psychiatry. 2014 Sep;75(9):964-74. doi: 10.4088/JCP.13r08765.
**PMID:** 24813261
**Citation:** Mikkelsen K, Stojanovska L, Polenakovic M, Bosevski M, Apostolopoulos V. Exercise and mental health. Maturitas. 2017 Dec;106:48-56. doi: 10.1016/j.maturitas.2017.09.003. Epub 2017 Sep 7.
**PMID:** 29150166
**Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
**PMID:** 11556941
**Citation:** Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
**PMID:** 21694556
**Citation:** Beser A, Sorjonen K, Wahlberg K, Peterson U, Nygren A, Asberg M. Construction and evaluation of a self rating scale for stress-induced exhaustion disorder, the Karolinska Exhaustion Disorder Scale. Scand J Psychol. 2014 Feb;55(1):72-82. doi: 10.1111/sjop.12088. Epub 2013 Nov 15.
**PMID:** 24236500
**Citation:** Tanner BA. Validity of global physical and emotional SUDS. Appl Psychophysiol Biofeedback. 2012 Mar;37(1):31-4. doi: 10.1007/s10484-011-9174-x.
**PMID:** 22038278
**Citation:** Arapovic-Johansson B, Wahlin C, Kwak L, Bjorklund C, Jensen I. Work-related stress assessed by a text message single-item stress question. Occup Med (Lond). 2017 Dec 2;67(8):601-608. doi: 10.1093/occmed/kqx111.
**PMID:** 29016877
**Citation:** Ensari I, Greenlee TA, Motl RW, Petruzzello SJ. META-ANALYSIS OF ACUTE EXERCISE EFFECTS ON STATE ANXIETY: AN UPDATE OF RANDOMIZED CONTROLLED TRIALS OVER THE PAST 25 YEARS. Depress Anxiety. 2015 Aug;32(8):624-34. doi: 10.1002/da.22370. Epub 2015 Apr 21.
**PMID:** 25899389
**Citation:** Herring MP, Monroe DC, Gordon BR, Hallgren M, Campbell MJ. Acute Exercise Effects among Young Adults with Analogue Generalized Anxiety Disorder. Med Sci Sports Exerc. 2019 May;51(5):962-969. doi: 10.1249/MSS.0000000000001860.
**PMID:** 30531490
**Citation:** Loy BD, Cameron MH, O'Connor PJ. Perceived fatigue and energy are independent unipolar states: Supporting evidence. Med Hypotheses. 2018 Apr;113:46-51. doi: 10.1016/j.mehy.2018.02.014. Epub 2018 Feb 19.
**PMID:** 29523293
**Citation:** McNair D. M., Lorr M., & Droppleman L. Profile of Mood States questionnaire. San Diego (CA): EDITS, 1981.
**Citation:** O'Connor PJ. Evaluation of four highly cited energy and fatigue mood measures. J Psychosom Res. 2004 Nov;57(5):435-41. doi: 10.1016/j.jpsychores.2003.12.006.
**PMID:** 15581646
**Citation:** Sagelv EH, Hopstock LA, Johansson J, Hansen BH, Brage S, Horsch A, Ekelund U, Morseth B. Criterion validity of two physical activity and one sedentary time questionnaire against accelerometry in a large cohort of adults and older adults. BMJ Open Sport Exerc Med. 2020 Feb 26;6(1):e000661. doi: 10.1136/bmjsem-2019-000661. eCollection 2020.
**PMID:** 32153981
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M1658
- Name: Burnout, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9912
- Name: Hydrocortisone
- Relevance: LOW
- As Found: Unknown
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429410
**Brief Title:** Effects of Milk Powder Intervention on Body Composition and Physical Performance in Middle-aged and Older Adults
**Official Title:** Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial
#### Organization Study ID Info
**ID:** MN-2024-04
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Huilian Zhu
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Huilian Zhu
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Fortified formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks.
**Intervention Names:**
- Dietary Supplement: fortified formula milk powder
**Label:** fortified formula milk powder group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks.
**Intervention Names:**
- Dietary Supplement: formula milk powder
**Label:** formula milk powder group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
**Intervention Names:**
- Dietary Supplement: regular milk powder
**Label:** regular milk powder group
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** Participants in the observation group did not receive any supplementation.
**Label:** observation group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- fortified formula milk powder group
**Description:** Fortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks.
**Name:** fortified formula milk powder
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- formula milk powder group
**Description:** Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.
**Name:** formula milk powder
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- regular milk powder group
**Description:** Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
**Name:** regular milk powder
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.
**Measure:** lean body mass
**Time Frame:** up to 24 weeks
#### Secondary Outcomes
**Description:** At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.
**Measure:** cardiorespiratory fitness
**Time Frame:** up to 24 weeks
**Description:** At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.
**Measure:** muscle strength
**Time Frame:** up to 24 weeks
**Description:** At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.
**Measure:** physical performance
**Time Frame:** up to 24 weeks
**Description:** At baseline, and 24 weeks, blood samples will be drawn and serum indexes of bone and muscle metabolism will be test, including myostatin, PINP, CTx, and osteocalcin.
**Measure:** the levels of blood metabolic markers for bone and muscle
**Time Frame:** up to 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 50 years old and older;
* BMI \<22kg/m2;
* Calf circumference \<33cm in women or \<34cm in men, or SARC-F ≥ 4, or SARC-Claf ≥ 11;
* Living in Guangzhou and having no plan to move in the next 6 months;
* Willing to participate in the study.
Exclusion Criteria:
* Lactose intolerance;
* Complicated with severe diseases;
* Unable to conduct study procedures;
* Participating in any other intervention studies.
**Healthy Volunteers:** True
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Vi
- Name: Vitamins
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17550
- Name: Vitamin D
- Relevance: LOW
- As Found: Unknown
- ID: M6003
- Name: Cholecalciferol
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: T442
- Name: Cholecalciferol
- Relevance: LOW
- As Found: Unknown
- ID: T479
- Name: Vitamin D3
- Relevance: LOW
- As Found: Unknown
- ID: T440
- Name: Calciferol
- Relevance: LOW
- As Found: Unknown
- ID: T435
- Name: Whey Protein
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429397
**Brief Title:** First-line Anlotinib Combined With Penpulimab for Advanced Pheochromocytoma: A Single-arm, Multicenter, Prospective Phase II Study
**Official Title:** A Single-arm, Multicenter, Prospective Phase II Clinical Study of Anlotinib Combined With Penpulimab in the First-line Treatment of Advanced Pheochromocytoma/Paraganglioma
#### Organization Study ID Info
**ID:** 2023-FXY-304
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-05-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** ZHOU FANGJIAN
**Investigator Title:** Sun Yat-sen University Cancer Center
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.
**Detailed Description:** 1.1 Adrenal pheochromocytoma/paraganglioma pheochromocytoma (PCC) and Paraganglioma (PGL) (pheochromocytoma and paraganglioma (PPGL) are rare malignant tumors with neuroendocrine function and metastatic potential. The incidence is 0.4-2.1 persons/million, 80%-85% originate from the adrenal medulla, and 15%-20% originate from the neural crest tissue from the neck to the pelvis. The PPGL metastasis rate at initial diagnosis is 10%, and the risk of metastasis is as high as 34-69% for those with SDHB gene mutations. The recurrence rate of PPGL patients after radical resection was 30%, 47% recurred with multiple nodules, 58% with metastasis. The most common sites of metastasis were lymph nodes and bone (70-80%), followed by lung and liver (50%). In addition, some PPGL is difficult/unresectable due to its proximity to important structures such as large blood vessels or nerves, and the 5-year survival rate for advanced PPGL is 30%-60%.
Early PPGL can be cured by surgery, but late PPGL is mainly systemic therapy, such as chemotherapy, targeted drugs and nuclide therapy. The main chemotherapy regimen for advanced PPGL is cyclophosphamide - vincristine - dacarbazine (CVD regimen), and ESMO guidelines recommend CVD for patients with rapid tumor progression and heavy tumor burden. The objective response rate of CVD regimen was 33%, the median duration of response was 1.3 years, and the 5-year survival rate of patients with effective CVD was 51%. The main limitations of CVD in the treatment of advanced PPGL are (1) The average number of cycles required for CVD chemotherapy is 11.6±10.8 months; (2) The incidence of CVD related toxicity, such as bone marrow suppression and neurotoxicity, was 50%. Some patients could not maintain treatment due to intolerance, and long-term use of the above drugs could increase the incidence of hematological tumors, which may be related to the alkylating properties of daparbazine.
Domestic guidelines and the FDA recommend 131I-MIBG for the treatment of advanced PPGL. Loh et al. reviewed and analyzed 21 central LSA-131I-MIBG clinical studies: 30% patients could have Partial Response (PR); Gonias S et al. Phase II clinical study of HSA-131I-MIBG in the treatment of advanced PPGL: 22% of patients could have PR. Two 131I-MIBGs show good efficacy, but there are no phase III clinical studies to further validate efficacy and safety. Limitations of radionuclide therapy lie in (1) the narrow range of indications: (1) ESMO guidelines indicate that only 50% of patients with positive MIBG scan are suitable. ② Pregnant women and pregnant patients should not use; (2) Severe hematological toxicity: the incidence of myosuppression was 4%-79%, about 40% of patients treated with low-dose 131I-MIBG had grade 3/4 toxicity, while those treated with high-dose 131I-MIBG had up to 80%, of which 25% needed hematological therapy and secondary hematological tumors could be developed . (3) Hypogonadism. In addition, at present, the units that can carry out nuclide therapy in China are limited, and patients can not perform nuclide therapy again after receiving progress of nuclide therapy.
1.2 Tyrosine kinase inhibitors (TKI) and advanced adrenal pheochromocytoma/paraganglioma Tyrosine kinase (TK) is a key site in the activation and regulation of cell proliferation signaling pathways. Abnormal TK pathway caused by mutation, translocation or amplification can lead to tumor occurrence, progression, invasion and metastasis. Tyrosine kinase inhibitors (TKI) mainly act on vascular endothelial growth factor receptor (VEGFR), platelet growth factor (PDGFR) and insulin family receptor (InsR). TKI acts on advanced PPGL through the pseudo-hypoxia pathway and VEGF angiogenesis pathway.
Advanced PPGL with abundant blood supply and high expression of angiogenic factor (VEGF) can promote tumor neovascularization and provide oxygen and nutrition for tumors. TKI has a good therapeutic effect on advanced PPGL with high VEGF expression, which may be related to its blocking of VEGF signaling pathway, continuous inhibition of tumor neovascugenesis and promotion of abnormal blood vessel normalization. In addition, HIF axis misalignment can also promote the development and transfer of PPGL. SDH gene mutations are the most common in PPGL (including SDHA, SDHB, SDHC, SDHD), which cause abnormalities in the subunit encoding the succinate dehydrogenase complex (SDH) and block the tricarboxylic acid cycle (TCA). Abnormal TCA can inhibit hypoxia-inducing factor (HIF-α) proline hydroxylase, and HIF-α accumulation will activate the pseudo-hypoxia pathway and up-regulate the expression of VEGF and other factors.
ESMO guidelines recommend sunitinib for the treatment of advanced PPGL. Currently, the only prospective phase II clinical study showed that 3 cases (13%) had PR (SDHB, SDHD, RET gene mutations, respectively). A retrospective study of 17 cases of advanced PPGL treated by MD Anderson and Gustavvy-Roussy et al. showed that there were 3 cases of PR and 5 cases of SD (6 of which were SDHB or VHL gene mutations). In the study , grade 1-2 toxicity was the most common, with about 68% of patients presenting symptoms such as fatigue, nausea and vomiting, palm-plantar dyspepsia, etc., while only 56%/12% of patients presented 3/4 toxicity, mainly manifested as nausea, vomiting and hypertension, without hematological toxicity.
Retrospective studies have also shown that Renvastinib, pazopanib, acitinib and other TKI have certain efficacy in advanced PPGL, but there is a lack of prospective clinical evidence. Hassan Nelson L et al. treated 11 cases of advanced PPGL with lenvatinib, and the results were 5 cases PR, 3 cases SD, and the median PFS was 14.7 months. Mauricio Emmanuel Burotto Pichun et al. are conducting a study on the treatment of 11 cases of advanced PPGL with acitinib: 4 cases of PR and 6 cases of SD. The above studies show the preliminary efficacy of various TKI, and the effect may be better for SDHB mutations, with a controllable safety, mainly hypertension. In 2017, preliminary results of a prospective clinical study of cabotinib in the treatment of advanced PPGL were reported in the conference abstract: ORR of 45%, PFS of 11 months, and no grade 3/4 toxicity. In summary, TKI monotherapy in the treatment of advanced PPGL shows some effect, but it is still not satisfactory.
There is currently no standard first-line treatment for advanced PPGL. NCCN guidelines and China's expert consensus (2020 edition) recommend the use of tumor reduction surgery (palliative resection) combined with radiotherapy, radionuclide therapy or systemic chemotherapy and other treatment options, but the above methods have uncertain efficacy and certain limitations, still need to be confirmed by prospective experiments, so patients are recommended to participate in clinical trials.
1.3 Application of antirotinib hydrochloride in advanced adrenal pheochromocytoma/paraganglioma Allotinib (AL3818) is manufactured by Zhengda Tianqing Pharmaceutical Group Co., LTD. (CTTQ; Lianyungang, Jiangsu, China) self-developed TKI drugs, targeting VEGFR1-3, FGFR1-4, PDGFRα, G, β, rearrangement (RET) and stem cell factor receptor (c-Kit) during transfection \[26\]; Anlotinib has shown good anticancer activity in vitro/in vitro \[27\]. A multicentre, randomized, controlled Phase II clinical study of anlotinib in first-line treatment of metastatic renal cell carcinoma (mRCC) (NCT02072031)\[28\] showed similar efficacy of anlotinib and Sunitinib: There were no significant differences in median PFS (17.May vs. 16.June, P \> 0.05), OS, ORR and DCR (P \> 0.05), but the toxicity of anrotinib was lower, and the incidence of ≥3/4 toxicity was significantly lower than that of Sunitinib (28.9% vs.55.8%, P \< 0.01). The main symptoms were hypertension and hand-foot syndrome, and no hematological toxicity was found. In addition, Lin J et al. also confirmed that anlotinib and Sunitinib had similar efficacy but higher safety. TKI treatment of advanced PPGL has a similar mechanism of action, but anlotinib safety may be better. In addition, our team has a certain foundation in the study of anrotinib in the treatment of advanced PPGL. In the early stage, anrotinib monotherapy was used to treat advanced PPGL in 4 cases and PR in 2 cases (1 case was a SHDB mutation), and the adverse reactions were mostly grade 1-2, with hypertension and hand-foot syndrome as the main manifestations. Therefore, antirotinib may have better efficacy and safety in advanced PPGL, which is worthy of further clinical exploration.
1.4 Application of peamprizumab in advanced adrenal pheochromocytoma/paraganglioma PD-1/PD-L1 monoclonal antibody kills tumors by activating its own normal anti-tumor immune mechanism. In 2014, Pembrolizumab achieved results in melanoma, officially ushering in the era of global immunotherapy. Subsequently, indications and significant curative effects were also obtained in multi-tumor species such as non-small cell lung cancer, gastric cancer and kidney cancer.
PD-L1 is mainly expressed in tumor cells and antigen-presenting cells (APCs), and is closely related to tumor immune escape \[33\] : PD-L1 receptor of tumor cell membrane binds to PD-1 receptor of T cell membrane, which weakens the ability of cytotoxic T lymphocytes to kill tumor cells. PD-1/PD-L1 mab blocks the above signaling process and restores/activates the anti-tumor activity of T cells.
A study in Peking Union Medical College Hospital \[35\] showed that 59.7% were positive for PPGL PD-L1 expression (HIS\>10), and the positive rate of PD-L1 in advanced PPGL was 100%(1/1). Study \[36\] showed that PD-L1 expression was positive in 4 out of 10 advanced PPGL cases (40%). Studies indicated that the cytotoxic T lymphocyte infiltration level was increased in advanced PPGL (P=0.092). Therefore, PD-1 monoclonal antibody may have some significance in the treatment of advanced PPGL. At present, only A few cases have been reported in the treatment of advanced PPGL with PD-1 monoclonal antibody. The Phase II clinical study conducted by Naing A et al. in the treatment of advanced PPGL patients with pembrolizumab showed that 43% (4 cases) had no progress at 27 weeks (6.75 months). This suggests that PD-1 monoclonal antibody has a certain effect in the treatment of advanced PPGL, but PD-1 monotherapy can not meet the clinical needs.
KATO Y et al. proposed that the effective rate of PD-1 monoclonal antibody in the single treatment of solid tumors was 20%-30%, and the therapeutic effect was not satisfactory. The study of PD-1 monoclonal antibody combined with TKI in the treatment of liver cancer suggests that the combination of PD-1 monoclonal antibody can reverse the immunosuppressor tumor microenvironment in which PD-1 monoclonal antibody is ineffective, and assist PD-1/PD-L1 monoclonal antibody to activate cytotoxic T lymphocytes. The efficacy of acitinib combined with PD-1 mab in the second-line treatment of patients with metastatic renal cancer was significantly higher than that of acitinib (ORR: 33.6% vs. 20.1%, P=0.015) (PFS: 11.7 months vs. 7.5 months, P=0.002).
Piamprilizumab (Anicol) is a new PD-1 monoclonal antibody developed by Zhengda Tianqing Pharmaceutical Group Co., LTD., which has been approved for Hodgkin's lymphoma (R/R cHL) and squamous non-small cell lung cancer (NSCLC) indications in China. Pembrolizumab has achieved significant efficacy in the treatment of classic Hodgkin lymphoma, metastatic nasopharyngeal carcinoma, gastric/esophageal junction adenocarcinoma and other tumor species in clinical studies, with ORR of 89.4%, 29.7% and 26.3%, respectively .
Anicol is a humanized IgG1 subtype of PD-1 monoclonal antibody that eliminates Fc effects. The IgG1 subtype reduces immune escape by eliminating antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). The combination of anil with FcR can reduce the occurrence of adverse immune reactions , and the incidence of grade 3 and above toxicities such as immune-associated pneumonia, hepatitis, myocardium, and pancreatitis is lower than that of sindillizumab, tirellizumab, and triplizumab. Therefore, this study intends to use anicol combined with anlotinib to explore its efficacy and safety in advanced PPGL.
1.5 Application of antirotinib combined with PD-1 monoclonal antibody in advanced pheochromocytoma/paraganglioma The combination of TKI and PD-1 monoclonal antibody is a research hotspot in the treatment of advanced tumors. Target-free therapy has been widely used in renal, urothelial, lung, liver and other tumors, and has achieved remarkable efficacy \[46\].
Only a few cases of combined treatment for advanced PPGL have been reported at home and abroad. In Taizhou Hospital of Zhejiang Province in 2022, a patient was treated with palizumab injection 200 mg(once every 3 weeks) for intravenous immunotherapy, combined with anrotinib 10 mg orally (once a day, 14 days and 7 days, every 3 weeks for a course of treatment). The left adrenal mass (9.6cm →8.4cm) and the multiple intrahepatic mass (up to 9.3cm →8.8cm) were both reduced. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat 3 patients, and the efficacy reached PR 66% (2/3), including 1 case with SHDB mutation. This suggests that targeted immunotherapy for advanced PPGL may have better efficacy.
In an open, multicenter, phase Ib/II clinical study of anlotinib combined with piamprizumab in the treatment of advanced hepatocellular carcinoma, the ORR was 31% and the DCR was 82.8%. The median PFS was 8.8 months (95% CI 4.0-12.3 months). 80% were grade 1/2 toxicity, such as elevated AST, elevated ALT, elevated blood bilirubin, etc. Only 19.4% had grade 3/4 toxicity such as hypertension and rash. This is an improvement in efficacy and a decrease in toxicity compared to the treatment of advanced hepatocellular carcinoma with altilizumab combined with bevacizumab or carrilizumab combined with apatinib.
At present, there have been no studies on the combination of targeted drugs and immunodrugs in the treatment of advanced PPGL at home and abroad. Therefore, this study will for the first time apply the combination of TKI drugs (antirotinib) and PD-1 monoclonal antibody (Pembrolizumab) to metastatic/unresectable pheochromocytoma/paraganglioma, so as to explore the efficacy and safety of combined drugs in the treatment of advanced pheochromocytoma/paraganglioma.
### Conditions Module
**Conditions:**
- Pheochromocytoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive Penpulimab and anlotinib
**Intervention Names:**
- Drug: Anlotinib and Penpulimab
**Label:** Drug
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Drug
**Description:** Enrolled patients received a treatment cycle every 21 days: 200mg of piamprizumab was given intravenously on the first day of treatment, and 12mg of anrotinib hydrochloride capsule was given continuously for 14 days and suspended for 7 days.
**Name:** Anlotinib and Penpulimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The sum of the maximum tumor diameter decreased by ≥30%
**Measure:** Objective response rate
**Time Frame:** 2years
#### Secondary Outcomes
**Description:** The time before tumor diameters increased by less than 20%
**Measure:** progression-free survival
**Time Frame:** 2years
**Description:** The time before the patient died
**Measure:** Overall survival
**Time Frame:** 2years
**Description:** The duration of tumor remission
**Measure:** Duration of remission
**Time Frame:** 2years
**Description:** the number of patient with PR SD and CR
**Measure:** Clinical response rate
**Time Frame:** 2years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients voluntarily participate in this study and sign informed consent;
* Patients aged ≥18 years and ≤75 years;
* ECOG score ≤2 points; Expected survival ≥6 months;
* Pathological diagnosis of advanced pheochromocytoma/paraganglioma: including clinical stage IV unresectable pheochromocytoma/paraganglioma with postoperative recurrence or metastasis;
* Unwilling or unsuitable for chemotherapy and radionuclide therapy.
* At least one measurable lesion (RECIST 1.1);
* The main organs function well, and the laboratory examination indicators meet:
1. Blood routine examination:
Hemoglobin (HB) ≥ 90g/L(5.6 mmol/L); Absolute neutrophil count (ANC) ≥1.5×109/L; Total white blood cells ≥3.5×109/L;
③ Platelet (PLT) ≥ 80×109/L;
Blood biochemical examination:
① Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (liver metastasis/bone metastasis ≤5 × ULN; Bone metastases ≤5 ULN);
② Serum total bilirubin (TBIL) ≤1.5 × ULN;
③ Serum creatinine Cr≤1.5×ULN or creatinine clearance ≥60 ml/min; Blood urea nitrogen (BUN)≤2.5 × upper limit of normal value (ULN);
④ Albumin (ALB)≥30 g/L;
2. Blood clotting test:
* Activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;
* Women of reproductive age must confirm their non-pregnant status before enrollment, and all enrolled subjects (whether male or female) should take adequate contraceptive measures during the entire treatment period and within 4 weeks after the end of treatment;
* The subjects voluntarily joined the study and were willing to return to the hospital for follow-up, and the compliance was good; Myocardial enzymes and ejection fraction were normal.
Exclusion Criteria:
* known allergic reactions to anrotinib hydrochloride capsules, piamplizumab active ingredients or any excipients;
* Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment; Previous treatment with other anti-PD-1 monoclonal antibodies or other medications targeting PD-1 / PD-L1;
* previous use of anrotinib hydrochloride capsules or other anti-angiogenic drugs, such as Sunitinib, bevacizumab, etc.;
* Patients were taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (doses greater than 10mg/day prednisone or other equivalent hormones) and were still taking them within 2 weeks prior to enrollment;
* The patient has any active autoimmune disease or a history of autoimmune disease; Have clinical symptoms or diseases of the heart that are not well controlled;
* Congenital or acquired immune deficiency;
* History of gastrointestinal perforation or open biopsy within 4 weeks prior to enrollment; ≥CTCAE grade 3 for any bleeding event, presence of unhealed wounds, ulcers, or fractures;
* Hyperarterial/venous thrombosis events occurred within 6 months before the study period, such as non-cardiovascular and cerebrovascular events (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and cured by investigators), pulmonary embolism, etc.; Cardiac angioplasty or coronary bypass surgery for unstable arrhythmia, unstable angina pectoris or myocardial infarction;
* People with active bleeding or bleeding tendency;
* Correcting QT interval \> 480msec; If a patient has QT interval prolongation, but the cause of the prolongation is assessed by the investigator as a pacemaker (and no other cardiac abnormalities), the patient should be considered suitable for inclusion in the study after discussion with the sponsor study physician;
* Patients suspected of having other primary cancers; Patients with other primary malignancies within the 5 years prior to the study (other than adequately treated cervical or skin cancer in situ, such as basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer);
* Combined diseases/medical history:
1. Clinically significant hemoptysis (\> 50ml daily hemoptysis) occurred within 3 months prior to enrollment; Or clinically significant bleeding symptoms or definite bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood or above at baseline, or vasculitis;
2. hypertension, which is not well controlled by antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100mmHg); In the 6 months prior to randomization, the following conditions had occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supracentricular or ventricular arrhythmias, and symptomatic congestive heart failure;
3. interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as poorly controlled diabetes (fasting blood glucose (FBG) \> 10mmol/ L), pulmonary fibrosis and acute pneumonia, etc.); Renal failure requires hemodialysis or peritoneal dialysis; Liver cirrhosis, decompensated liver disease, active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or chronic hepatitis requiring antiviral therapy;
(6) Live attenuated vaccine vaccination history within 28 days prior to the first study or live attenuated vaccine vaccination expected during the study period; (7) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Combined with hepatitis B and hepatitis C co-infection; Severe infection, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. within 4 weeks before the first dose; Active infection of CTCAE grade ≥2 requiring systemic antibiotic treatment within 2 weeks prior to first administration, or unexplained fever \>38.5°C during screening/prior to first administration (fever due to tumor, as determined by the investigator, was eligible for inclusion); Evidence of active tuberculosis infection within 1 year prior to administration; Major surgery within 28 days prior to randomization (tissue biopsy required for diagnosis and insertion of a central venous catheter through peripheral venipentesis \[PICC\] or infusion PORT is permitted);
* Participants who have previously received or are preparing to receive allogeneic bone marrow transplantation or solid organ transplantation;
* Peripheral neuropathy ≥ grade 2; Patients with active brain metastases, malignant meningitis, spinal cord compression, or imaging CT or MRI findings of brain or pia disease during screening (patients with brain metastases who have completed treatment 14 days before enrollment and whose symptoms are stable can be enrolled, but only after brain MRI, CT or venography evaluation to confirm no symptoms of cerebral hemorrhage);
* significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and presence of clinically significant intestinal obstruction.
* Women who are pregnant, breastfeeding, planning to become pregnant during the study period, or men or women who are fertile but do not want to use appropriate contraceptive methods.
* The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, and patients who are deemed by the investigato
* not suitable for participation in the study;
* Patients with brain metastasis;
* Imaging shows that the tumor has invaded important blood vessels, or follow-up shows that the tumor is highly likely to invade important blood vessels and cause fatal bleeding;
* Drugs that interact with anlotinib hydrochloride capsules/piamplizumab are being used;
**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:** Fangjian Zhou, Doctor
**Phone:** 13922735659
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kai Yao, M.D Ph.D
- **Phone:** +8615913181211
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Shengjie Guo, M.D Ph.D
- **Phone:** 13416140919
- **Role:** CONTACT
***Contact 3:***
- **Name:** Kai Yao, M.D Ph.D
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Shengjie Guo, M.D Ph.D
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Cancer Center, Sun Yat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510060
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-sen University
**Name:** Shengjie Guo, Doctor
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010235
- Term: Paraganglioma
- ID: D000018358
- Term: Neuroendocrine Tumors
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13578
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: M13149
- Name: Paraganglioma
- Relevance: LOW
- As Found: Unknown
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- 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: T4530
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: T4409
- Name: Paragangliomas 1
- Relevance: LOW
- As Found: Unknown
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010673
- Term: Pheochromocytoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429384
**Brief Title:** Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial
**Official Title:** Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial
#### Organization Study ID Info
**ID:** Y-3-LC-02
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-18
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** NeuroDawn Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Tiantan Hospital
#### Responsible Party
**Investigator Affiliation:** Beijing Tiantan Hospital
**Investigator Full Name:** Yongjun Wang
**Investigator Title:** Chief Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this clinical trial was to explore the efficacy and safety of Y-3 injection at different doses in patients with acute ischemic stroke within 48 hours of onset.
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants.
Subjects press 1:1:1: 1 ratio of patients were randomly divided into Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60mg/ time, qd) and placebo control group, with 60 cases in each group. Random stratification factors include:
Time of onset (≤24 hours, \> 24 hours). The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.
The trial was divided into three phases: screening/baseline, treatment, and follow-up.
Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.
Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.
Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.
Stroke-related scale scores were performed at 10, 30, and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale (MSAS) and Hamilton Anxiety Scale (HAMA) were performed on the 10th and 90th days after the use of experimental drugs. Adverse events were recorded during treatment and follow-up to further assess safety
**Detailed Description:** A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants, who were randomly assigned to Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60 mg/ time, qd) and placebo control group in a ratio of 1:1:1:1. Each group had 60 cases.
Random stratification factors included: onset time (≤24 hours, \> 24 hours).The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.
The trial was divided into three phases:screening/baseline, treatment, and follow-up.
Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.Stroke-related scale scores were performed on the 10th, 30th and 90th days after the first use of the experimental drug, and Montgomery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAMA) scores were performed on the 10th and 90th days after the first use of the experimental drug. Adverse events were recorded during treatment and follow-up to further assess safety.
### Conditions Module
**Conditions:**
- Acute Ischemic Stroke
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Y-3 low dose group (20 mg/ time, qd), medium dose group (40 mg/ time qd), high dose group (60mg/ time, qd) and placebo control group.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** In a double-blind design, the researchers, the researchers involved in the trial effect evaluation, the data managers, the statistical analysts, and the subjects and their relatives or guardians were blind to the treatment groups.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Y-3 injection 20mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
**Intervention Names:**
- Drug: Y-3 Injection/Y-3 blank injection
**Label:** Y-3 low-dose group (20 mg/dose, qd)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Y-3 injection 40mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
**Intervention Names:**
- Drug: Y-3 Injection/Y-3 blank injection
**Label:** Y-3 medium dose group (40 mg/dose, qd)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Y-3 injection 60mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
**Intervention Names:**
- Drug: Y-3 Injection/Y-3 blank injection
**Label:** Y-3 high-dose group (60 mg/dose, qd)
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Y-3 blank injection 10ml was diluted with about 250 ml normal saline, intravenous infusion, qd, and continuous medication for 10 days.
**Intervention Names:**
- Drug: Y-3 Injection/Y-3 blank injection
**Label:** Blank control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Blank control group
- Y-3 high-dose group (60 mg/dose, qd)
- Y-3 low-dose group (20 mg/dose, qd)
- Y-3 medium dose group (40 mg/dose, qd)
**Description:** The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
**Name:** Y-3 Injection/Y-3 blank injection
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Montgomery Depression Rating Scale scores on day 10 and day 90 were \<, respectively; Proportion of patients with scores of 12, ≥12, and ≥22.There are 10 items in the scale, with a total score of 60 points. The higher the score, the higher the degree of depression. MADRS \< 12 indicates no depressive symptoms, 12≤MADRS \< 22 indicates mild depression, 22≤MADRS \< 30 indicates moderate depression, and MADRS≥30 indicates severe depression.
**Measure:** Montgomery Depression Rating Scale scores on day 10 and day 90 were <, respectively; Proportion of patients with scores of 12, ≥12, and ≥22;
**Time Frame:** On the 10th and 90th day of treatment
**Description:** Hamilton Anxiety Scale (HAMA) scores on day 10 and day 90 were \<, respectively; Proportion of patients with scores of 7, ≥7, and ≥14.The scale used a 5-level scoring method, and the criteria for each level were: 0-asymptomatic; 1- Light; 2- Medium; 3- heavy; 4- Extremely heavy. The total score of Hamilton anxiety Scale is a very important basis to reflect the severity of patients' anxiety, that is, the less severe the disease, the lower the total score; The more severe the condition, the higher the total score. A total score of less than 7 is considered to have no symptoms of anxiety; A score of 7-13 is considered to be likely to have anxiety; A score of 14 to 20 is considered to be definitely anxious; 21 to 28 points, is considered to have significant anxiety; A score greater than 29 is considered likely to be severe anxiety.
**Measure:** Hamilton Anxiety Scale scores on day 10 and day 90 were <, respectively; Proportion of patients with scores of 7, ≥7, and ≥14.
**Time Frame:** On the 10th and 90th day of treatment
**Description:** Incidence of adverse events (AE) in each group;
**Measure:** Incidence of adverse events (AE) in each group;
**Time Frame:** During the test
**Description:** The incidence of treatment-related adverse events (TEAEs) in each group;
**Measure:** The incidence of treatment-related adverse events (TEAEs) in each group;
**Time Frame:** During the test
**Description:** The occurrence of important adverse events in each group;
**Measure:** The occurrence of important adverse events in each group;
**Time Frame:** During the test
**Description:** The occurrence of serious adverse events (SAEs) in each group;
**Measure:** The occurrence of serious adverse events (SAEs) in each group;
**Time Frame:** During the test
**Description:** The occurrence of suspicious and unexpected serious adverse reactions (SUSAR) in each group;
**Measure:** The occurrence of suspicious and unexpected serious adverse reactions (SUSAR) in each group;
**Time Frame:** During the test
**Description:** Detect blood routine through a blood cell analyzer, including white blood cell count, neutrophil count, lymphocyte count, hemoglobin, and platelet count.Use a biochemical analyzer to detect blood biochemistry, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, direct bilirubin, creatinine, urea/urea nitrogen, uric acid, and so on. Detect coagulation function through a coagulation analyzer, including prothrombin time (PT), partially activated prothrombin time (APTT), international standardized ratio (INR), fibrinogen (FIB).Detect urine routine through a urine analyzer.These indicators are measured during the baseline period and post administration visit period to observe the impact of the drug on this indicator, whether the drug will cause AE and SAE，the occurrence of AE and SAE, the type and severity of AE and SAE, and ultimately to determine the safety of the drug.
**Measure:** Laboratory examination indicators: blood routine, urine routine, blood biochemistry, Laboratory examination indicators: blood routine, urine routine, blood biochemistry, coagulation function
**Time Frame:** During the test
**Description:** Detecting parameters such as heart rate, electrocardiogram, and QT interval through an electrocardiogram monitor.Detecting blood pressure through a blood pressure monitor.Detecting body temperature through a thermometer.Detect respiratory rate by observing changes in chest contour count of the subject.These indicators are measured during the baseline period and post administration visit period to observe the impact of the drug on this indicator, whether the drug will cause AE and SAE，the occurrence of AE and SAE, the type and severity of AE and SAE, and ultimately to determine the safety of the drug.
**Measure:** Vital signs: heart rate, blood pressure, body temperature, respiration
**Time Frame:** During the test
**Description:** Detect systems such as lungs, gastrointestinal tract, urinary system, musculoskeletal, skin, lymph nodes, etc. through observation, auscultation, percussion, palpation, and other examination methods. These indicators are measured during the baseline period and post administration visit period to observe the impact of the drug on this indicator, whether the drug will cause AE and SAE，the occurrence of AE and SAE, the type and severity of AE and SAE, and ultimately to determine the safety of the drug.
**Measure:** Physical examination of the whole body: lungs, gastrointestinal tract, urinary system, musculoskeletal system, skin, lymph nodes, and other systems.
**Time Frame:** During the test
**Description:** Laboratory evaluation not specified in the protocol, including parameters such as hematology, biochemical tests, urine analysis, etc. These indicators are measured during the baseline period and post administration visit period to observe the impact of the drug on this indicator, whether the drug will cause AE and SAE，the occurrence of AE and SAE, the type and severity of AE and SAE, and ultimately to determine the safety of the drug.
**Measure:** Clinical laboratory examination
**Time Frame:** During the test
**Description:** Discontinuation due to adverse events【AE includes abnormal laboratory test results (haematological, clinical biochemical, or urinalysis) or other safety assessments (e.g. electrocardiograms, radiological scans, vital signs measurements), including deterioration relative to baseline and deemed clinically significant in the medical and scientific judgment of the investigator; Exacerbation of pre-existing diseases; A new condition detected or diagnosed after the initiation of the investigational drug.】
**Measure:** Discontinuation due to adverse events;
**Time Frame:** During the test
**Description:** Discontinuation due to any other non-adverse event(Any discontinuation other than an adverse event)
**Measure:** Discontinuation due to any other non-adverse event.
**Time Frame:** During the test
#### Primary Outcomes
**Description:** The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
**Measure:** The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
**Time Frame:** 90th day of treatment
#### Secondary Outcomes
**Description:** Grade analysis of mRS Score on the 90th day of treatment;
**Measure:** Grade analysis of mRS Score on the 90th day of treatment;
**Time Frame:** 90th day of treatment
**Description:** The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;
**Measure:** The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;
**Time Frame:** 90th day of treatment
**Description:** Changes in NIH Stroke Scale from baseline on day 10 of treatment;
**Measure:** Changes in NIH Stroke Scale from baseline on day 10 of treatment;
**Time Frame:** 10th day of treatment
**Description:** Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.The content of NIHSS score included: consciousness level (consciousness level, consciousness level questioning, consciousness level command), gaze, visual field, facial paralysis, upper limb movement, lower limb movement, body aid movement, sensation, language, dysarthria, neglect. The score ranges from 0 to 42, with higher scores indicating more severe nerve damage.Score 0 to 1: normal or nearly normal Scores 1-4: mild stroke/minor stroke .5 to 15 points: moderate stroke .15-20 points: moderate to severe stroke Scores 21-42: severe stroke
**Measure:** Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.
**Time Frame:** On the 10th and 30th day of treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-
Only those who meet all the following criteria can be included in the group:
1. Age ≥ 18 years old and\<81 years old, regardless of gender;
2. After the onset of this disease, the National Institutes of Research Stroke Scale score was 6 ≤ NIHSS ≤ 20 points, and the sum of the 5th upper limb and 6th lower limb scores was ≥ 2 points. If patients receiving thrombolysis treatment were screened and evaluated based on the NIHSS score after thrombolysis;
3. Within 48 hours (including 48 hours) of onset;
4. Diagnosed as ischemic stroke according to the "Key Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019", with good recovery after the first or last onset (mRS score ≤ 1 point before this onset);
5. Obtain informed consent from the patient or their legal representative voluntarily signed and approved by the ethics committee.
Exclusion Criteria:
-
Those who meet one of the following criteria during filtering cannot be included in the group:
1. Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment;
2. Severe consciousness disorder: The item score of NIHSS's 1a consciousness level is greater than 1 point;
3. Transient ischemic attack (TIA);
4. After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
5. Previously diagnosed patients with severe mental disorders and severe dementia;
6. Patients previously diagnosed with depression or anxiety disorder;
7. Patients undergoing antidepressant or anti anxiety treatment;
8. Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc; Or ALT or AST\>2.0 × ULN;
9. Diagnosed with severe active kidney disease or renal insufficiency; Or serum creatinine\>1.5 × ULN;
10. After the onset of the disease, drugs with brain cytoprotection in the instructions have been used, such as edaravone, concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, CDPC, piracetam, oxiracetam, butylphenylpeptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (cerebroprotein hydrolysate), calf serum deproteinized injection Calf blood deproteinized extract injection, etc;
11. After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;
12. Previously diagnosed with concurrent malignant tumors and undergoing anti-tumor treatment;
13. Previously diagnosed with severe systemic diseases, with an estimated survival period of\<90 days;
14. The patient is in pregnancy, lactation, and there is a possibility of pregnancy in the patient/patient partner who plans to conceive during the trial period;
15. Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide);
16. A history of major surgeries within 4 weeks prior to enrollment and assessed by the researcher as affecting neurological function scores or affecting 90 day survival;
17. Have participated in other clinical studies or are currently participating in other clinical studies within the first 30 days of randomization;
18. The researcher believes that it is not suitable to participate in this clinical study.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Tiantan Hospital, Capital Medical University Beijing
**State:** Beijing
**Zip:** 100000
**Location 2:**
**City:** Liuzhou
**Country:** China
**Facility:** Liuzhou Workers Hospital
**State:** Guangxi
**Zip:** 545000
**Location 3:**
**City:** Cangzhou
**Country:** China
**Facility:** Cangzhou Central Hospital
**State:** Hebei
**Zip:** 061000
**Location 4:**
**City:** Hengshui
**Country:** China
**Facility:** Harrison International Peace Hospital
**State:** Hebei
**Zip:** 053000
**Location 5:**
**City:** Daqing
**Country:** China
**Facility:** Daqing Oilfield General Hospital
**State:** Heilongjiang
**Zip:** 163000
**Location 6:**
**City:** Daqing
**Country:** China
**Facility:** Daqing People's Hospital
**State:** Heilongjiang
**Zip:** 163000
**Location 7:**
**City:** Nanyang
**Country:** China
**Facility:** Nanyang Second People's Hospital
**State:** Henan
**Zip:** 473000
**Location 8:**
**City:** Nanyang
**Country:** China
**Facility:** Nanyang South Stone Hospital
**State:** Henan
**Zip:** 473000
**Location 9:**
**City:** Nanyang
**Country:** China
**Facility:** The First Affiliated Hospital of Nanyang Medical College
**State:** Henan
**Zip:** 473000
**Location 10:**
**City:** Changsha
**Country:** China
**Facility:** Hunan Provincial People's Hospital
**State:** Hunan
**Zip:** 410000
**Location 11:**
**City:** Baotou
**Country:** China
**Facility:** The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
**State:** Inner Mongolia Autonomous Region
**Zip:** 014000
**Location 12:**
**City:** Baotou
**Country:** China
**Facility:** Inner Mongolia Baotou Steel Hospital
**State:** Inner Mongolia Autonomous Region
**Zip:** 014100
**Location 13:**
**City:** Hohhot
**Country:** China
**Facility:** Inner Mongolia International Mongolian Medicine Hospital
**State:** Inner Mongolia Autonomous Region
**Zip:** 010000
**Location 14:**
**City:** Huai'an
**Country:** China
**Facility:** Huai 'an First People's Hospital
**State:** Jiangsu
**Zip:** 223001
**Location 15:**
**City:** Lianyungang
**Country:** China
**Facility:** Lianyungang First People's Hospital
**State:** Jiangsu
**Zip:** 222000
**Location 16:**
**City:** Lianyungang
**Country:** China
**Facility:** Lianyungang Second People's Hospital
**State:** Jiangsu
**Zip:** 222000
**Location 17:**
**City:** Taizhou
**Country:** China
**Facility:** Taizhou Second People's Hospital
**State:** Jiangsu
**Zip:** 225300
**Location 18:**
**City:** Xuzhou
**Country:** China
**Facility:** Xuzhou Central Hospital (Old Hospital Area)
**State:** Jiangsu
**Zip:** 221000
**Location 19:**
**City:** Xuzhou
**Country:** China
**Facility:** Xuzhou Central Hospital（New compound）
**State:** Jiangsu
**Zip:** 221000
**Location 20:**
**City:** Xuzhou
**Country:** China
**Facility:** Xuzhou First People's Hospital
**State:** Jiangsu
**Zip:** 221000
**Location 21:**
**City:** Pingxiang
**Country:** China
**Facility:** Pingxiang People's Hospital
**State:** Jiangxi
**Zip:** 337000
**Location 22:**
**City:** Beipiao
**Country:** China
**Facility:** Beipiao Central Hospital
**State:** Liaoning
**Zip:** 122100
**Location 23:**
**City:** Jinzhou
**Country:** China
**Facility:** The First Affiliated Hospital of Jinzhou Medical University
**State:** Liaoning
**Zip:** 121000
**Location 24:**
**City:** Shenyang
**Country:** China
**Facility:** Chinese People's Liberation Army Northern Theater Command General Hospital
**State:** Liaoning
**Zip:** 110000
**Location 25:**
**City:** Shenyang
**Country:** China
**Facility:** Shenyang First People's Hospital
**State:** Liaoning
**Zip:** 110000
**Location 26:**
**City:** Jinan
**Country:** China
**Facility:** Shandong Third Hospital
**State:** Shandong
**Zip:** 250000
**Location 27:**
**City:** Liaocheng
**Country:** China
**Facility:** Liaocheng People's Hospital
**State:** Shandong
**Zip:** 252000
**Location 28:**
**City:** Linyi
**Country:** China
**Facility:** Tancheng County First People's Hospital
**State:** Shandong
**Zip:** 276100
**Location 29:**
**City:** Tengzhou
**Country:** China
**Facility:** Tengzhou Central People's Hospital
**State:** Shandong
**Zip:** 277500
**Location 30:**
**City:** Dongyang
**Country:** China
**Facility:** Dongyang City People's Hospital
**State:** Zhejiang
**Zip:** 322100
#### Overall Officials
**Official 1:**
**Affiliation:** IRB of Beijing Tiantan Hospital Capital Medical University Beijing
**Name:** Shuya Li
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.
**PMID:** 19834014
**Citation:** Emberson J, Lees KR, Lyden P, Blackwell L, Albers G, Bluhmki E, Brott T, Cohen G, Davis S, Donnan G, Grotta J, Howard G, Kaste M, Koga M, von Kummer R, Lansberg M, Lindley RI, Murray G, Olivot JM, Parsons M, Tilley B, Toni D, Toyoda K, Wahlgren N, Wardlaw J, Whiteley W, del Zoppo GJ, Baigent C, Sandercock P, Hacke W; Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014 Nov 29;384(9958):1929-35. doi: 10.1016/S0140-6736(14)60584-5. Epub 2014 Aug 5.
**PMID:** 25106063
**Citation:** Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. Erratum In: Stroke. 2019 Dec;50(12):e440-e441.
**PMID:** 31662037
**Citation:** Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:
**PMID:** 29367334
**Citation:** van Horn N, Kniep H, Leischner H, McDonough R, Deb-Chatterji M, Broocks G, Thomalla G, Brekenfeld C, Fiehler J, Hanning U, Flottmann F. Predictors of poor clinical outcome despite complete reperfusion in acute ischemic stroke patients. J Neurointerv Surg. 2021 Jan;13(1):14-18. doi: 10.1136/neurintsurg-2020-015889. Epub 2020 May 15.
**PMID:** 32414889
**Citation:** Lee SH, Kim BJ, Han MK, Park TH, Lee KB, Lee BC, Yu KH, Oh MS, Cha JK, Kim DH, Nah HW, Lee J, Lee SJ, Kim JG, Park JM, Kang K, Cho YJ, Hong KS, Park HK, Choi JC, Kim JT, Choi K, Kim DE, Ryu WS, Kim WJ, Shin DI, Yeo M, Sohn SI, Hong JH, Lee J, Lee JS, Khatri P, Bae HJ. Futile reperfusion and predicted therapeutic benefits after successful endovascular treatment according to initial stroke severity. BMC Neurol. 2019 Jan 15;19(1):11. doi: 10.1186/s12883-019-1237-2.
**PMID:** 30646858
**Citation:** Meyer L, Alexandrou M, Leischner H, Flottmann F, Deb-Chatterji M, Abdullayev N, Maus V, Politi M, Roth C, Kastrup A, Thomalla G, Mpotsaris A, Fiehler J, Papanagiotou P. Mechanical thrombectomy in nonagenarians with acute ischemic stroke. J Neurointerv Surg. 2019 Nov;11(11):1091-1094. doi: 10.1136/neurintsurg-2019-014785. Epub 2019 Apr 27.
**PMID:** 31030188
**Citation:** Chamorro A, Lo EH, Renu A, van Leyen K, Lyden PD. The future of neuroprotection in stroke. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):129-135. doi: 10.1136/jnnp-2020-324283. Epub 2020 Nov 4.
**PMID:** 33148815
**Citation:** Li J, Zhang L, Xu C, Shen YY, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Chen R, Zhang ZP, Luo CX, Li F, Zhu DY. A pain killer without analgesic tolerance designed by co-targeting PSD-95-nNOS interaction and alpha2-containning GABAARs. Theranostics. 2021 Apr 3;11(12):5970-5985. doi: 10.7150/thno.58364. eCollection 2021.
**PMID:** 33897893
**Citation:** Li J, Zhang L, Xu C, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Luo CX, Li F, Zhu DY. Prolonged Use of NMDAR Antagonist Develops Analgesic Tolerance in Neuropathic Pain via Nitric Oxide Reduction-Induced GABAergic Disinhibition. Neurotherapeutics. 2020 Jul;17(3):1016-1030. doi: 10.1007/s13311-020-00883-w.
**PMID:** 32632774
**Citation:** Kaur H, Prakash A, Medhi B. Drug therapy in stroke: from preclinical to clinical studies. Pharmacology. 2013;92(5-6):324-34. doi: 10.1159/000356320. Epub 2013 Dec 12.
**PMID:** 24356194
**Citation:** Fisher M; Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003 Jun;34(6):1539-46. doi: 10.1161/01.STR.0000072983.64326.53. Epub 2003 May 15.
**PMID:** 12750546
**Citation:** Hackett ML, Kohler S, O'Brien JT, Mead GE. Neuropsychiatric outcomes of stroke. Lancet Neurol. 2014 May;13(5):525-34. doi: 10.1016/S1474-4422(14)70016-X. Epub 2014 Mar 28.
**PMID:** 24685278
**Citation:** Ferro JM, Caeiro L, Figueira ML. Neuropsychiatric sequelae of stroke. Nat Rev Neurol. 2016 May;12(5):269-80. doi: 10.1038/nrneurol.2016.46. Epub 2016 Apr 11.
**PMID:** 27063107
**Citation:** Murrough JW, Abdallah CG, Mathew SJ. Targeting glutamate signalling in depression: progress and prospects. Nat Rev Drug Discov. 2017 Jul;16(7):472-486. doi: 10.1038/nrd.2017.16. Epub 2017 Mar 17.
**PMID:** 28303025
**Citation:** Luscher B, Shen Q, Sahir N. The GABAergic deficit hypothesis of major depressive disorder. Mol Psychiatry. 2011 Apr;16(4):383-406. doi: 10.1038/mp.2010.120. Epub 2010 Nov 16.
**PMID:** 21079608
**Citation:** Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.
**PMID:** 19837031
**Citation:** Griebel G, Holmes A. 50 years of hurdles and hope in anxiolytic drug discovery. Nat Rev Drug Discov. 2013 Sep;12(9):667-87. doi: 10.1038/nrd4075.
**PMID:** 23989795
**Citation:** Shabel SJ, Proulx CD, Piriz J, Malinow R. Mood regulation. GABA/glutamate co-release controls habenula output and is modified by antidepressant treatment. Science. 2014 Sep 19;345(6203):1494-8. doi: 10.1126/science.1250469. Epub 2014 Sep 18.
**PMID:** 25237099
**Citation:** Li YF. A hypothesis of monoamine (5-HT) - Glutamate/GABA long neural circuit: Aiming for fast-onset antidepressant discovery. Pharmacol Ther. 2020 Apr;208:107494. doi: 10.1016/j.pharmthera.2020.107494. Epub 2020 Jan 25.
**PMID:** 31991195
**Citation:** Gould TD, Zarate CA Jr, Thompson SM. Molecular Pharmacology and Neurobiology of Rapid-Acting Antidepressants. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:213-236. doi: 10.1146/annurev-pharmtox-010617-052811. Epub 2018 Oct 8.
**PMID:** 30296896
**Citation:** Zhou L, Li F, Xu HB, Luo CX, Wu HY, Zhu MM, Lu W, Ji X, Zhou QG, Zhu DY. Treatment of cerebral ischemia by disrupting ischemia-induced interaction of nNOS with PSD-95. Nat Med. 2010 Dec;16(12):1439-43. doi: 10.1038/nm.2245. Epub 2010 Nov 21. Erratum In: Nat Med. 2011 Sep;17(9):1153.
**PMID:** 21102461
**Citation:** Luo CX, Lin YH, Qian XD, Tang Y, Zhou HH, Jin X, Ni HY, Zhang FY, Qin C, Li F, Zhang Y, Wu HY, Chang L, Zhu DY. Interaction of nNOS with PSD-95 negatively controls regenerative repair after stroke. J Neurosci. 2014 Oct 1;34(40):13535-48. doi: 10.1523/JNEUROSCI.1305-14.2014.
**PMID:** 25274829
## 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:** NCT06429371
**Brief Title:** Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain
**Official Title:** Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain
#### Organization Study ID Info
**ID:** 8
#### Organization
**Class:** OTHER
**Full Name:** University of Central Florida
### Status Module
#### Completion Date
**Date:** 2026-12-01
**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:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Florida
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Central Florida
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Irritability was defined by Geoffrey Maitland as the vigor of activity to provoke symptoms, the severity of symptoms, and time for symptoms to subside. Irritability is deeply embedded in the physical therapy clinical decision-making process. However, the mechanisms contributing to irritability are unknown. Therefore, the purpose of this study is to characterize pain sensitivity and pain-related psychological factors by irritability level in individuals with shoulder pain.
### Conditions Module
**Conditions:**
- Shoulder Pain
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Individuals with shoulder pain that is at least 3/10 within the past 24 hours.
**Intervention Names:**
- Other: Quantitative Sensory Testing
- Other: Pain-Related Psychological Factors
**Label:** Individuals with Shoulder Pain
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Individuals with Shoulder Pain
**Description:** Participants will undergo heat pain threshold, cold pain threshold, pressure pain threshold, temporal summation, and conditioned pain modulation to characterize pain sensitivity.
**Name:** Quantitative Sensory Testing
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Individuals with Shoulder Pain
**Description:** Participants will complete psychological questionnaires to characterize these factors.
**Name:** Pain-Related Psychological Factors
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A thermode will be applied to the deltoid, tibialis anterior, and lower back. The thermode will gradually increase temperature until the sensation changes from comfortable warmth to pain (pain threshold). Once pain threshold is reached, the temperature in degrees Celsius for heat pain threshold is recorded.
**Measure:** Heat pain Threshold
**Time Frame:** Day 1
**Description:** A thermode will be applied to the deltoid, tibialis anterior, and lower back. The thermode will gradually decrease temperature until the sensation changes from comfortable cold to pain (pain threshold). Once pain threshold is reached, the temperature in degrees Celsius for cold pain threshold is recorded.
**Measure:** Cold Pain Threshold
**Time Frame:** Day 1
**Description:** An algometer will be applied to the deltoid, tibialis anterior, and lower back. Pressure will be gradually applied until the sensation changes from comfortable pressure to pain (pain threshold). Once pain threshold is reached, the pressure in kilopascals will be recorded for pressure pain threshold.
**Measure:** Pressure Pain Threshold
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* shoulder pain symptom intensity rated as 3/10 or higher in the past 24 hours
* attending physical therapy for shoulder pain
Exclusion Criteria:
* non-English speaking systemic medical conditions that affect sensation, such as uncontrolled diabetes
* history of shoulder surgery or fracture within the past 6 months
* history of a chronic pain condition, such as fibromyalgia
* blood clotting disorder, such as hemophilia
* contraindication to the application of ice (blood pressure \> 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* currently pregnant
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Individuals with shoulder pain
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Abigail W Anderson
**Phone:** 4078231026
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Orlando
**Country:** United States
**Facility:** University of Central Florida
**State:** Florida
**Zip:** 32765
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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:** NCT06429358
**Brief Title:** The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women
**Official Title:** The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial
#### Organization Study ID Info
**ID:** 3388
#### Organization
**Class:** OTHER
**Full Name:** Frontier Medical and Dental College, Abbotabad
### Status Module
#### Completion Date
**Date:** 2024-01-15
**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:** 2023-11-14
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-28
**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:** Frontier Medical and Dental College, Abbotabad
#### Responsible Party
**Investigator Affiliation:** Frontier Medical and Dental College, Abbotabad
**Investigator Full Name:** Dr Saif ur Rehman
**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:** Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.
### Conditions Module
**Conditions:**
- Urinary Tract Infections
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomised Controlled Trial
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules.
**Intervention Names:**
- Dietary Supplement: Lactobacillus rhamnosus
**Label:** Probiotic Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Control Group
**Label:** Control Group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Probiotic Group
**Description:** The probiotic supplement was delivered in the form of easy-to-swallow capsules.
**Name:** Lactobacillus rhamnosus
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Control Group
**Description:** Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.
**Name:** Control Group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The test was performed to determine levels of neutrophils
**Measure:** Urinary Detailed Report Values
**Time Frame:** second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
**Description:** Urine Culture:
Urine samples were collected aseptically prior to and after intervention and cultured to detect bacterial pathogens linked with urinary tract infections. This assessment was carried out at two distinct time points:
Pre-Intervention: Before beginning the probiotic intervention, baseline urine samples were taken to detect any existing bacterial illnesses and create a point of comparison.
Post-Intervention: After the intervention period, individuals supplied an additional urine sample for culture investigation. This post-intervention evaluation sought to establish any changes in the prevalence of bacterial pathogens, particularly those known to cause urinary tract infection
**Measure:** Urine Culture
**Time Frame:** second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
**Description:** leukocytes in urine were evaluated
**Measure:** Leukocytes:
**Time Frame:** second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
**Description:** presence of nitrites in urine before and after intervention was investigated
**Measure:** Nitrites:
**Time Frame:** second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
**Description:** Urinary pH values were measured
**Measure:** pH
**Time Frame:** second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women aged 18-40 year
* History of recurrent urinary tract infections (two or more episodes in the past year).
* Singleton pregnancy.
Exclusion Criteria:
* Multiple gestations.
* History of preterm labor.
* Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
* Use of antibiotics or probiotics within the past month.
**Gender Based:** True
**Gender Description:** 14 week's gestation with diagnosed UTI
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Abbottābād
**Country:** Pakistan
**Facility:** Frontier Medical and Dental College
**State:** KPK
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014570
- Term: Urologic Diseases
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M17302
- Name: Urinary Tract Infections
- Relevance: HIGH
- As Found: Urinary Tract Infections
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000014552
- Term: Urinary Tract Infections
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T355
- Name: Acidophilus
- Relevance: HIGH
- As Found: Students
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429345
**Brief Title:** Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.
**Official Title:** Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.
#### Organization Study ID Info
**ID:** MS70/2024
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-11-01
**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:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.
**Detailed Description:** Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into 2 groups using their computer generated random numbers that group a will receive the coenzyme Q10 in addition to the standard preventive measures and group b will receive only the standard preventive measures without the coenzyme Q10.
### Conditions Module
**Conditions:**
- Contrast-induced Nephropathy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 250
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Coenzyme Group received coenzyme Q10 in addition to the the standard preventive measures
**Intervention Names:**
- Drug: Coenzyme Q10 100 Milligrams Oral Capsule
**Label:** Coenzyme Q10 100 Milligrams Oral Capsule
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo Group received only the standard preventive measures
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Coenzyme Q10 100 Milligrams Oral Capsule
**Description:** Patients will be randomly divided into two groups using a computer generated random number chart Coenzyme Q10 group will receive 400 milligrams coenzyme Q10 preoperative and 400 milligrams coenzyme Q10 for 3 days post operative in addition to the standard preventive measures.
**Name:** Coenzyme Q10 100 Milligrams Oral Capsule
**Other Names:**
- Coenzyme Q10
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** a rise in serum creatinine of at least 0.5 mg/dL or a 25% increase from baseline within 48 to 72 hours after contrast exposure
**Measure:** Percentage of the Creatinine rise in 1st 48-72 hrs in ccu
**Time Frame:** 48-72 hrs
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who are 18 years or older.
* ST-elevation myocardial infarction (STEMI).
* Non ST-elevation myocardial infarction( NSTEMI).
* Unstable Angina (UA)
Exclusion Criteria:
* Renal transplant patients.
* Preoperative bleeding .
* Intraoperative bleeding or hypotension.
* Patients taking any nephrotoxic medications
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ramy Mohamed, Resident
**Phone:** 01002820102
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ramy Mohamed mostafa, Resident
**Phone:** 01002820102
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ramy Mostafa, Resident
- **Phone:** 01002820102
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ramy Mohamed Mostafa, Resident
- **Phone:** 01002820102
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Ramy Mohamed Mostafa
#### Overall Officials
**Official 1:**
**Affiliation:** Resident of cardiology department,Ain shams university
**Name:** RAMY Mohamed
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000014570
- Term: Urologic Diseases
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Nephropathy
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- 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: M17319
- Name: Urologic 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000054058
- Term: Acute Coronary Syndrome
### Intervention Browse Module - Ancestors
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014815
- Term: Vitamins
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M17201
- Name: Ubiquinone
- Relevance: HIGH
- As Found: Levofloxacin
- ID: M271049
- Name: Coenzyme Q10
- Relevance: HIGH
- As Found: Degenerative
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: T383
- Name: Coenzyme Q10
- Relevance: HIGH
- As Found: Degenerative
### Intervention Browse Module - Meshes
- ID: D000014451
- Term: Ubiquinone
- ID: C000024989
- Term: Coenzyme Q10
### Misc Info Module
- Version Holder: 2024-05-31
|
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