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## Protocol Section
### Identification Module
**NCT ID:** NCT06429332
**Acronym:** I-CATCHER
**Brief Title:** International Care Bundle Evaluation in Cerebral Hemorrhage Research
**Official Title:** International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period
#### Organization Study ID Info
**ID:** 2024-02523-01
#### Organization
**Class:** OTHER
**Full Name:** Region Skane
### Status Module
#### Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The George Institute for Global Health, Australia
#### Lead Sponsor
**Class:** OTHER
**Name:** Region Skane
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.
**Detailed Description:** Spontaneous intracerebral hemorrhage (ICH) accounts for 10 to 15% of all strokes in high-income countries (HIC), and nearly twice this number in low-income to upper-middle-income countries (LMIC) (29.5%). It is the most devastating type of stroke given the high one-month case fatality of approximately 30-40%, and only 12-39% suffer persistent disability.
Despite several advances in the management of acute ischemic stroke supported by numerous randomized controlled trials (RCT), progress in establishing novel interventions to improve outcomes for ICH has been slow. Still today, the diagnosis of ICH evokes pessimism among treating physicians, and patients may be withheld guideline adherent treatment for this reason. This nihilistic approach is presumably due to an over-estimation of poor outcome, often influenced by the neurologically devastating features commonly present at ICH admission. Additionally, the scarcity of RCTs providing strong evidence for treatment recommendations may contribute to a more reluctant approach in the acute setting of ICH, particularly when presenting with debilitating symptoms.
The third INTEnsive care bundle with BP reduction in acute cerebral hemorrhage trial (INTERACT3) was recently published in 2023. This trial employed a stepped wedge cluster RCT design to evaluate the implementation of a Care Bundle protocol. This comprehensive protocol included early intensive BP lowering (EIBPL), management of pyrexia and hyperglycemia, and the early reversal of OAC treatment. The design of this trial drew inspiration from a post-hoc analysis of the INTERACT2 study that showed that the scoring of abnormal baseline variables, interventions included in the future INTERACT3 Care Bundle, independently predicted a poor functional outcome following ICH. The implementation of the time sensitive bundle of care in INTERACT3 resulted in an improved functional outcome at 6 months following ICH. However, as the trial included patients predominantly from LMIC, further studies are warranted to determine if these results are applicable to HIC with a more applicable Care Bundle for these populations. An earlier intervention study from the United Kingdom, published in 2019, studied a similar 'quality improvement' acute Care Bundle. This Care Bundle aimed to improve the speed of treatment delivery, access to acute care, and decrease case fatality following ICH. Despite certain limitations, including a non-randomized design, this study demonstrated significantly lower mortality rates in patients receiving the Care Bundle versus the pre-implementation standard of care.
I-CATCHER is an international, multicenter, batched, parallel, cluster, randomized clinical trial (RCT) to assess a multifaceted package of protocols in a broad range of patients with acute ICH. In each batch, hospitals will be randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (phase 1: usual care, phase 2: randomized evaluation - to intervention or usual care, phase 3: post-implementation follow-up - all hospitals implement the intervention). This design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join. Compared to a conventional stepped-wedge cluster RCT, the intervention effect in this design is less likely to be confounded by background temporal trends as only baseline and parallel comparison data (first 2 periods in bold black frame) are used to determine the effectiveness of the Care Bundle. All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice. Each batch period is 18 months (6 months per phase); whole study will be rolled out in 2.5 years.
This design involves implementation of an intervention package applied to all patients with ICH as part of routine care. Patients are only excluded if they refuse to have details of their management included and/or participate in follow-up procedures.
Study site inclusion criteria: Organized systems of acute stroke care; no established comprehensive protocols for the management of ICH; suitable location, infrastructure and willingness to participate in clinical research; suitable numbers of ICH patients (at least 30 per year).
Patient inclusion criteria: Adults (≥18 years) with spontaneous ICH confirmed by imaging and admitted hospital within 24 hours of the onset of symptoms.
### Conditions Module
**Conditions:**
- Intracerebral Hemorrhage
- Intracerebral Haemorrhage
- Intraventricular Hemorrhage
- Stroke
- Cerebrovascular Disease
**Keywords:**
- intracerebral hemorrhage
- oral anticoagulant
- blood pressure lowering
- early intensive blood pressure lowering
- care bundle
- implementation study
- reversal treatment
- outcome
- UW-mRS
- Modified Rankin Scale
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** international multicentre, batched, cluster. Patients are not randomized, hospitals will be randomized.
In each batch, hospitals are randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (usual care, randomized evaluation, post-implementation follow-up):
Phase 1 - baseline routine data collection, training and formative study (assess context and local resources, support adjustment of the protocol into local pathways) Phase 2 - start intervention implementation in the intervention group, data collection for comparison with usual care in the control group Phase 3 - all hospitals implement the intervention, data collection for quality improvement, assess sustainability and integration
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Treatment allocation is on a site-level and not on an individual level. The allocation is not blinded. Follow-up clinical outcome assessors, who have no prior association with the study and are unaware of the patients' allocation to either the intervention or control arm, will contact the participant by telephone at 6 months. At the initiation of contact, study subjects will be urged not to disclose their treatment allocation.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 3500
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways
**Intervention Names:**
- Other: Reversal of Oral anticoagulation within 30 minutes
- Other: Early intensive blood pressure lowering
- Other: Treatment of pyrexia
- Other: Hyperglycemia treatment
- Other: Do-not-resuscitate (DNR) or withdrawal of care
- Other: Referral to Intensive Care
- Other: Referral to Neurosurgery
- Diagnostic Test: Repeat brain imaging
**Label:** Intervention group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.
**Intervention Names:**
- Other: Standard care
**Label:** Usual care
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of hospital arrival to reach and maintain an INR target \<1.3; or where there has been recent use (\<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.
**Name:** Reversal of Oral anticoagulation within 30 minutes
**Other Names:**
- OAC reversal
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Intervention group
**Description:** A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of commencing treatment is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure \<200 mmHg). If blood pressure ≥200 and \<220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.
**Name:** Early intensive blood pressure lowering
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Intervention group
**Description:** To achieve a body temperature target \<37.5 °C
**Name:** Treatment of pyrexia
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Intervention group
**Description:** To maintain a blood glucose level 7-10 mmol/L
**Name:** Hyperglycemia treatment
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Intervention group
**Description:** Refrain from the use of DNR or withdrawal of care orders for 48 hours
**Name:** Do-not-resuscitate (DNR) or withdrawal of care
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Intervention group
**Description:** Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
**Name:** Referral to Intensive Care
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Intervention group
**Description:** Immediate (\<30 min) referral to neurosurgery if any of the following criteria are fulfilled:
* Large and/or rapidly evolving supratentorial ICH (\>20 ml volume)
* Any intraventricular extension
* Posterior fossa bleed, irrespective of volume
* Suspicion of a vascular malformation, independent of volume or location
* Reduction in reaction to sensory stimulation or drowsiness
**Name:** Referral to Neurosurgery
**Type:** OTHER
#### Intervention 8
**Arm Group Labels:**
- Intervention group
**Description:** Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment
**Name:** Repeat brain imaging
**Type:** DIAGNOSTIC_TEST
#### Intervention 9
**Arm Group Labels:**
- Usual care
**Description:** For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.
**Name:** Standard care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitates comparisons of health-related quality of life across an array of clinical settings. Utility weights, as referred to hereafter, reflect the spectrum between perfect health (a score of 1) and outcomes worse than death (where death is a score of 0 and negative values indicate an outcome worse than death). The primary outcome is UW-mRS at 3 months and will be analyzed by means of a linear regression, with mRS as a dependent variable with 7 levels (0 \[no residual symptom\] to 6 \[death\]).
**Measure:** Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
**Time Frame:** 180±30 days
#### Secondary Outcomes
**Description:** The assessment of shifts in the distribution of mRS scores through the evaluation of scores in ordinal groups
**Measure:** Ordinal shift analysis of mRS
**Time Frame:** 180 days±30 days
**Description:** This will be assessed using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
**Measure:** Assessment of health-related quality of life (HRQoL)
**Time Frame:** 180 days±30 days
**Description:** Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
**Measure:** Poor outcome defined as mRS 3-6
**Time Frame:** 180 days±30 days
**Description:** Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
**Measure:** Separate outcomes for death and disability
**Time Frame:** 180 days±30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults (age ≥18 years)
* Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage
* ≤24 hours from symptom onset or presumed symptom onset (last seen well)
Exclusion Criteria:
* Previous care limitation
* End-stage comorbidity with short life-expectancy (\<6 m; e.g. terminal cancer)
* ICH caused by brain tumor or cerebral venous thrombosis
* Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)
* Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Teresa Ullberg, MD, PhD
**Phone:** 0046175057
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sydney
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Menglu Ouyang, PhD, MPH
- **Phone:** 0061280524808
- **Role:** CONTACT
***Contact 2:***
- **Name:** Menglu Ouyang, PhD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Australia
**Facility:** The George Institute for Global Health
**Zip:** NSW 2000
**Location 2:**
**City:** Malmö
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Teresa Ullberg, MD, PhD
- **Phone:** +4646175057
- **Role:** CONTACT
***Contact 2:***
- **Name:** Trine Apostolaki-Hansson, MD PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Fredrik Buchwald, MD PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Sweden
**Facility:** Region Skåne, Skåne University Hospital in Malmö, Department of Neurology
**Zip:** 20502
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
**PMID:** 34487721
**Citation:** Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. doi: 10.1056/NEJM200105103441907. No abstract available.
**PMID:** 11346811
**Citation:** van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
**PMID:** 20056489
**Citation:** Parry-Jones AR, Sammut-Powell C, Paroutoglou K, Birleson E, Rowland J, Lee S, Cecchini L, Massyn M, Emsley R, Bray B, Patel H. An Intracerebral Hemorrhage Care Bundle Is Associated with Lower Case Fatality. Ann Neurol. 2019 Oct;86(4):495-503. doi: 10.1002/ana.25546. Epub 2019 Aug 16.
**PMID:** 31291031
**Citation:** Hemphill JC 3rd, Newman J, Zhao S, Johnston SC. Hospital usage of early do-not-resuscitate orders and outcome after intracerebral hemorrhage. Stroke. 2004 May;35(5):1130-4. doi: 10.1161/01.STR.0000125858.71051.ca. Epub 2004 Mar 25.
**PMID:** 15044768
**Citation:** Becker KJ, Baxter AB, Cohen WA, Bybee HM, Tirschwell DL, Newell DW, Winn HR, Longstreth WT Jr. Withdrawal of support in intracerebral hemorrhage may lead to self-fulfilling prophecies. Neurology. 2001 Mar 27;56(6):766-72. doi: 10.1212/wnl.56.6.766.
**PMID:** 11274312
**Citation:** Zahuranec DB, Brown DL, Lisabeth LD, Gonzales NR, Longwell PJ, Smith MA, Garcia NM, Morgenstern LB. Early care limitations independently predict mortality after intracerebral hemorrhage. Neurology. 2007 May 15;68(20):1651-7. doi: 10.1212/01.wnl.0000261906.93238.72.
**PMID:** 17502545
**Citation:** Song L, Hu X, Ma L, Chen X, Ouyang M, Billot L, Li Q, Munoz-Venturelli P, Abanto C, Pontes-Neto OM, Antonio A, Wasay M, Silva A, Thang NH, Pandian JD, Wahab KW, You C, Anderson CS; INTERACT3 investigators. INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial. Trials. 2021 Dec 20;22(1):943. doi: 10.1186/s13063-021-05881-7.
**PMID:** 34930428
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020300
- Term: Intracranial Hemorrhages
- 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: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M5792
- Name: Cerebral Hemorrhage
- Relevance: HIGH
- As Found: Intracerebral Hemorrhage
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: HIGH
- As Found: Cerebrovascular Disease
- ID: M11910
- Name: Mitral Valve Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M22113
- Name: Intracranial Hemorrhages
- 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: D000002561
- Term: Cerebrovascular Disorders
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Coag
- Name: Coagulants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M11767
- Name: Metronidazole
- Relevance: LOW
- As Found: Unknown
- ID: M17602
- Name: Warfarin
- Relevance: LOW
- As Found: Unknown
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
- ID: M16676
- Name: Thrombin
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429319
**Brief Title:** Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
**Official Title:** Multicenter Open Post-registration Study of the Safety and Effectiveness of the Medical Device HBIS Endoprosthesis of Synovial Fluid NOLTREX™ According to TU 9398-00152820385-2015 for Intraarticular Administration in the Treatment of Gonarthrosis.
#### Organization Study ID Info
**ID:** IA/PAAG-SI/OA/2020
#### Organization
**Class:** INDUSTRY
**Full Name:** Research Centre BIOFORM
### Status Module
#### Completion Date
**Date:** 2024-02-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-05-12
**Type:** ACTUAL
#### Start Date
**Date:** 2020-05-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Research Centre BIOFORM
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this open post-marketing study is to assess safety and efficacy duration of HBIS IA injection after 1st and 2nd course in patients with gonarthrosis with long-term follow-up
**Detailed Description:** Hydrous biopolymer with silver ions (further - HBIS) under trademark NOLTREX™ based on polyacrylamide hydrogel is intended for a symptomatic effect leading to the decrease of joint pain intensity and improvement of functional joint characteristics. Therefore, HBIS is intended for symptom-modifying therapy of joint osteoarthritis (hereinafter - OA). The aim of this study is to estimate safety and efficacy of intra-articular injections of HBIS after 1st and 2nd course in patients with gonarthrosis with long-term follow-up. Patients, who received 1 сourse - 2 injections of NOLTREX™ in first 6-month study IA/PAAG-SI/OA/2019, will receive a repeated course of treatment strictly according to indications. The scheme of the 2nd Course is one or two 4.0 ml dosage injections of NOLTREX™ with 1-week interval on week 0 or week 13 of the study. Outcomes will estimate by WOMAC Index at Week 13 and at Week 25.
### Conditions Module
**Conditions:**
- Osteoarthritis
**Keywords:**
- intra-articular
- polyacrylamide hydrogel
- PAAG
- HBIS (Hydrous biopolymer with silver ions)
- NOLTREX
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This is open-label MD NOLTREX™ safety assessment study includes eligible and non-eligible patients who received study MD as part of the IA/PAAG-SI/OA/2019 study. It was planned that 72 patients would take part in the study. In fact, 67 patients were screened into the study because not all patients from CS1 progressed to CS2; 2 of these patients failed screening measures, so the final population included 65 patients.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 67
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sixty-seven patients were screened for the study; 2 of them were screening failures, therefore, 65 patients were randomized to participate in the study, who were conventionally divided into subgroups:
* Group A included 5 patients. Patients in group A received 2 courses of therapy: both within IA/PAAG-SI/OA/2019 study and at Visit 1 (and as indicated at Visit 2) of the IA/PAAG-SI/OA/2020 study.
* Group B - 43 patients. Patients in group B also received 2 courses of therapy: both within IA/PAAG-SI/OA/2019 study and at Visit 3 (and as indicated at Visit 4) of the IA/PAAG-SI/OA/2020 study.
* Group C - 17 patients. Group C included patients who received only one course of injections in the placebo-controlled study IA/PAAG-SI/OA/2019. There were no early withdrawals from the study.
**Intervention Names:**
- Device: hydrous biopolymer with silver ions "Argiform"
**Label:** hydrous biopolymer with silver ions "Argiform"
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- hydrous biopolymer with silver ions "Argiform"
**Description:** Patients will receive an injection of MD NOLTREX™ into the target knee joint. MD will be administered in accordance with the instructions for use of MD NOLTREX™: 4.0 ml per injection (2.5 + 1.5 ml, or 2.0 + 2.0 ml from two syringes through one needle \[one puncture\]) at intervals of one week. The course within this open study is a maximum of 2 injections. The number of injections is determined by the doctor depending on the stage of gonarthrosis and the clinical response
**Name:** hydrous biopolymer with silver ions "Argiform"
**Other Names:**
- Polyacrylamide hydrogel with silver ions
- Synovial fluid endoprosthesis NOLTREX™
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** By Visit 3, the mean WOMAC-T (Osteoarthritis Index Total Score) compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has changed by 430.20 ± 470.50 (95% CI -1014.40 - 154.00) in patients from group A, by 727.16 ± 353.78 (95% CI -836.04 - -618.28) in patients from group B, by 654.35 ± 241.28 (95% CI -778.41 - -530 ,30) in patients from group C. Intergroup differences were not statistically significant (p = 0.169).
By Visit 5, the mean WOMAC-T score compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has changed by 470.60 ± 495.56 (95% CI -1085.92 - 144.72) in patients from group A, by 829.53 ± 367.38 (95% CI -942.60 - -716.47) in patients from group B, by 688.53 ± 231.50 (95% CI -807.56 - -569 .50) in patients from group C. Intergroup differences were not statistically significant (p = 0.057).
**Measure:** Change of the total score of WOMAC scale (WOMAC-T)
**Time Frame:** Change in WOMAC Total Score (WOMAC-T) at Visit 3 (Week 11), Visit 5 (Week 23) from baseline at Visit 0 (Screening) of the open-label study and from baseline at Visit 1 (Week 1) of IA/PAAG-SI/OA/2019 study;
#### Secondary Outcomes
**Description:** By Visit 3, the mean WOMAC-A (pain subscale) score compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has decreased by 87.80 ± 87.45 (95% CI -196.38 - 20.78) in patients from group A, by 146.00 ± 74.46 (95% CI -168.91 - -123.09) in patients from group B, by 151.88 ± 64.56 (95% CI -185.07 - -118 .69) in patients from group C. Intergroup differences were not statistically significant (p = 0.212).
By Visit 5, the mean WOMAC-A score compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has decreased by 95.80 ± 95.49 (95% CI -214.37 - 22.77) in patients from group A, by 163.05 ± 75.82 (95% CI -186.38 - -139.71) in patients from group B, by 155.06 ± 63.49 (95% CI -187.70 - -122 .41) in patients from group C. Intergroup differences were not statistically significant (p = 0.168).
**Measure:** Change of the pain subscale score (WOMAC-A)
**Time Frame:** Change in the subscale of pain (WOMAC-A) at Visit 3 (Week 11), Visit 5 (Week 23) from baseline at Visit 0 (Screening) of the open-label study and from baseline at Visit 1 (Week 1) of IA/PAAG-SI/OA/2019 study;
**Description:** By Visit 3, the mean WOMAC-B (subscale for assessing stiffness) score compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has decreased by 62.80 ± 69.82 (95% CI -149.49 - 23.89) in patients from group A, by 67.19 ± 40.91 (95% CI -79.78 - -54.60) in patients from group B, by 48.71 ± 28.08 (95% CI -63.14 - -34 .27) in patients from group C. Intergroup differences were not statistically significant (p = 0.291).
By Visit 5, the mean WOMAC-B score compared to Visit 1 of the IA/PAAG-SI/OA/2019 study has decreased by 66.40 ± 70.26 (95% CI -153.64 - 20.84) in patients from group A, by 74.60 ± 42.67 (95% CI -87.74 - -61.47) in patients from group B, by 57.82 ± 28.11 (95% CI -72.27 - -43 .37) in patients from group C. Intergroup differences were not statistically significant (p = 0.376).
**Measure:** Change of rigidity (WOMAC-B) and functionality (WOMAC-C) subscale scores
**Time Frame:** Change in the subscale of stiffness (WOMAC-B) and functionality (WOMAC-C) at Visit 3 (Week 11), Visit 5 (Week 23) from baseline at Visit 0 (Screening) of the open-label study and from baseline at Visit 1 (Week 1) of IA/PAAG-SI/OA/2019 study;
**Description:** During the period of this study (CS2), the decrease of this indicator continued, and at Visit 3, VAS scores of groups A, B and C patients were 11.2 ± 6.53, 29.07 ± 15.29 and 21.53 ± 6.32 mm, respectively, and by Visit 5 the indicators decreased to 6.2 ± 5.59, 16.56 ± 12.32 and 4.88 ± 3.14 mm, respectively. At both visits, the between-group differences were statistically significant, which was due to the higher scores in group B. Combined score of groups A and B was compared with the score in group C, and there were also statistically significant between-group differences (p \< 0.05 from Visit 3 to Visit 5), which was consistent with the approach to dividing patients into groups: patients in group C received only one course of injections in the placebo-controlled study CS1 (IA/PAAG-SI/OA/2019) and had no indications for repeated injections, while patients in groups A and B have a requirement to receive two courses of therapy
**Measure:** Intensity of pain in the target knee joint (100-mm VAS)
**Time Frame:** Change in the severity of pain in the target knee joint according to 100 mm visual analogue scale (100 mm VAS) at Visit 2 (week 1), Visit 3 (week 11), Visit 5 (week 23) from baseline at Visit 0 (Screening) of the open-label safety study and from baseli
**Description:** At visit 3 patients evaluation scores from Group B as, significant improvement was indicated by 3 patients, improvement - by 23 patients, weak improvement - 15 patients and no changes -0 patients. from patients Group C improvement was indicated by - 4 patients, weak improvement - 8 patients and no changes - 5 patients and from Group A patients was not indicate any changes with p (between the groups \<0.001) At visit 5 patients Group B scores as, significant improvement was indicated by 6 patients, improvement - by 25 patients, weak improvement - 12 patients and no changes -0 patients. from patients Group C improvement was indicated by - 16 patients, weak improvement - 1 patient and no changes - 0 patients and from Group A patients - significant improvement was indicated by - 4 patients and improvement were indicated by 1 patient, no changes were indicated by 0 patients with p (between the groups \<0.001)
**Measure:** Patient's assessment of the treatment efficacy
**Time Frame:** Evaluation of treatment effectiveness by the patient (using a scale from 1 - a definitive deterioration to 6 - a significant improvement) at Visits 3 and 5 (OEP-w11 and OEP-w23 scores, respectively);
**Description:** At visit 3 investigators evaluation for Group B scores as significant improvement was indicated by 3 investigators - improvement - by 23, weak improvement - 14 and no changes -3 investigators. from Group C - improvement was indicated by - 4 investigators, weak improvement - 8 and no changes - 5 and from Group A- significant improvement was indicated by - 2 investigators improvement - by 2 and weak improvement by 2 investigators with p (between the groups \<0.001) At visit 5 investigators evaluation for Group B scores as significant improvement was indicated by 3 investigators, improvement - by 23, weak improvement - 14 and no changes -3 from Group C - improvement was indicated by - 4, weak improvement - 8 and no changes - 5 and from Group A significant improvement was indicated by - 2 investigators improvement were indicated by 2 and weak improvement by 2 investigators with p (between the groups \<0.001)
**Measure:** Investigator's assessment of the treatment efficacy
**Time Frame:** Evaluation of treatment effectiveness by the investigator (using a scale from 1 - a definitive deterioration to 6 - a significant improvement) at Visits 3 and 5 (OEI-w11 and OEI-w23 scores, respectively);
**Description:** The results obtained show a favorable long-term effect of intra-articular NOLTREX™ in the treatment of Kellgren-Lawrence radiological stage II-III knee osteoarthritis on the function of the knee joint. It was impossible to evaluate the need for NSAID due to the fact during the study period of CS 2, no such cases were recorded.
**Measure:** Total number of NSAID tablets taken
**Time Frame:** Assessment of the total number of NSAID tablets taken according to the patient's diary starting from Day 1, at Visits 3 and 5 (NSAID-w11 and NSAID-w23, respectively);
**Description:** The JSN score of the target knee at Visit 5 of the open-label study compared with the baseline at Visit 0 of the IA/PAAG-SI/OA/2019 study in patients from group A was -0.02 ± 0.05, in patients from group B - 0.00 ± 0.19, in patients from group C - 0.02 ± 0.08. Intergroup differences were not statistically significant (p = 0.379). The JSN index of the target knee joint reflects the disease progression, and the absence of changes or a decrease in the index indicates a protective effect of NOLTREX™.
**Measure:** The JSN score of the target knee
**Time Frame:** The JSN score of the target knee at Visit 5 of the open-label study compared with the baseline at Visit 0 of the IA/PAAG-SI/OA/2019 study retrospectively.
**Description:** The results obtained show a favorable long-term effect of intra-articular NOLTREX™ in the treatment of Kellgren-Lawrence radiological stage II-III knee osteoarthritis on the function of the knee joint. It was impossible to evaluate the need for paracetamol due to the fact during the study period of CS 2, no such cases were recorded.
**Measure:** Total number of paracetamol tablets taken
**Time Frame:** Assessment of the total number of paracetamol tablets taken according to the patient's diary (one tablet = 500 mg) starting from Day 1, at Visits 3 and 5 (PARACETAMOL-w11 and PARACETAMOL-w23 scores, respectively);
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women above 50 years;
* A signed Patient Informed Consent Form by the study participant;
* Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one of the following signs: age above 50 years, knee crepitus or morning joint stiffness lasting for less than 30 minutes combined with radiologic signs of knee osteoarthritis);
* Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant involvement of the medial tibiofemoral region of the knee joint;
* Completion of participation in clinical study protocol IA / PAAG-SI / OA / 2019 in the NOLTREX ™ medical device group with the completion of all 5 visits (25 weeks)
Exclusion Criteria:
1. Pregnancy and breastfeeding;
2. History of trauma or surgery on the target knee joint;
3. Instability of the target knee joint;
4. Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
5. History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
6. Seronegative spondyloarthritis and reactive arthritis;
7. Increased rheumatoid factor;
8. Increased uric acid \> 360 µmol/l;
9. Intra-articular injection into the target knee joint:
* hyaluronates - within 12 months prior to patient enrollment in the study;
* other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
* glucocorticoids - within 1 month before enrollment in the study;
* NSAIDs - intra-articular injection at any time in the history.
10. Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
11. Effusion in the target joint;
12. The presence of inflammation or infection in the target joint, synovitis;
13. The need for continuous use of glucocorticoids in any dosage form;
14. Use of paracetamol within 48 hours prior to Visit 0;
15. A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
16. Severe liver disease, defined as an increase in one of the following: ALT, AST, alkaline phosphatase, total bilirubin, GGT more than 3 times the upper limit of normal;
17. Kidney disease with a glomerular filtration rate as assessed by the Cockcraft-Gault formula less than 60 mL/min/1.73 m2 (stages III-V chronic kidney disease \[CKD\]);
18. Clinical manifest coxarthrosis;
19. Severe decompensated chronic or acute diseases and other conditions or other causes that, in the investigator's opinion, may prevent the patient from participating in the study or affect the study results ;
20. Participation in any other clinical study other than study IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the study.
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Moscow
**Country:** Russian Federation
**Facility:** Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
**Location 2:**
**City:** Omsk
**Country:** Russian Federation
**Facility:** "Clinical Diagnostic Center "Ultramed", LLC
**Location 3:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
**Location 4:**
**City:** Yaroslavl
**Country:** Russian Federation
**Facility:** State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
## 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: Osteoarthritis
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Gonarthrosis
- 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:** NCT06429306
**Brief Title:** Study of Dexycu in Treating Intraocular Inflammation
**Official Title:** A Phase 3,Prospective, Randomized, Double-masked, Placebo-controlled, Parallel Study to Evaluate the Efficacy, PK and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery
#### Organization Study ID Info
**ID:** OT-502-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
### Status Module
#### Completion Date
**Date:** 2024-04-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-24
**Type:** ACTUAL
#### Start Date
**Date:** 2022-08-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.
**Detailed Description:** This is a prospective, randomized, double-blindmasked, placebo-controlled, parallel- design, multicenter study of subjects over 40 years undergoing cataract surgery. Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 2:1.
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery. The investigational drug comes with a special injection device and injection guide.
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery.
### Conditions Module
**Conditions:**
- Inflammation
- Cataract
**Keywords:**
- Cataract Surgery
- Postoperative Inflammation
### 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:** 285
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dexamethasone implant single injection in the treatment eye after cataract surgery.
**Intervention Names:**
- Drug: Dexycu
**Label:** Dexamethasone intraocular injection
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Blank placebo single injection in the treatment eye after cataract surgery.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dexamethasone intraocular injection
**Description:** 5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
**Name:** Dexycu
**Other Names:**
- Investigational product
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Acetyl triethyl citrate
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
**Measure:** Anterior chamber cell clearing rate
**Time Frame:** DAY 8
#### Secondary Outcomes
**Description:** The secondary efficacy outcome is anterior chamber cell clearing in the study eye at Day 1 \& 3 \& 15 \& 30. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
**Measure:** Anterior chamber cell clearing rates
**Time Frame:** DAY 1 & 3 & 15 & 30
**Description:** Percentage of subjects with anterior chamber flare grade 0 at Day 1, 3, 8, 15, and 30. The slit lamp examination for anterior chamber flare (ACF) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent), grade 1 (trace), grade 2 (mild intensity), grade 3 (moderate intensity), or grade 4 (strong intensity). Anterior chamber flare clearing occurs when all the ACC are absent (grade 0).
**Measure:** Anterior chamber flare clearing rates
**Time Frame:** DAY 1 & 3 & 8 & 15 & 30
**Description:** The secondary efficacy outcome is anterior chamber cell \& flare clearing in the study eye at Day 1 \& 3 \& 15 \& 30. The slit lamp examination for anterior chamber cells \& flare (ACCF) is a recognized way to measure inflammation in the anterior chamber.
**Measure:** Anterior chamber cell & flare clearing rates
**Time Frame:** DAY 1 & 3 & 15 & 30
**Description:** Calculate the mean score of anterior chamber cell and flare separately at Day 8 and 15.
**Measure:** Mean anterior chamber cell score and mean anterior chamber flare score
**Time Frame:** DAY 8 & 15
**Description:** Calculate the mean socre of anterior chamber cell + flare at Day 8 and 15.
**Measure:** Mean anterior chamber cell + flare score
**Time Frame:** DAY 8 &15
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye and better than 20/200 in the fellow eye.
4. The patient must be considered by the Investigator to have visual acuity potential. greater than 20/30 in the study eye.
5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
6. A female patient of childbearing potential must have a negative pregnancy test on Day 0 and be using an effective method of birth control from Screening for the duration of the study.
7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
Exclusion Criteria:
1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time.
4. Patients who anticipate requiring treatment with any corticosteroids( by any route,except inhalation), during the study.
5. Patients with an allergy or hypersensitivity to dexamethasone.
6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
11. Patients with any signs of intraocular inflammation in either eye at screening.
12. Patients with evidence of corneal abnormality or dystrophy (e.g. opacities, guttae,clouding, etc.) or an inability to obtain an acceptable specular micrograph at Screening.
13. Patients with a history of chronic uveitis from any cause in either eye.
14. Patients who have received any prior intravitreal injections in the study eye.
15. Patients with glaucomatous optic neuropathy or glaucomatous visual field loss in either eye.
16. Patients with ocular hypertension with an IOP in the study eye \> 21 mm Hg at Screening with or without treatment with anti-glaucoma monotherapy.
17. Patients with ocular hypertension receiving treatment with two or more anti-glaucoma Medications.
18. Patients treated with any investigational product within 30 days prior to screening or patients enrolled previouslyc study.
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Shanghai General Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Ocumension Therapeutics (Shanghai) Co., Ltd
**Name:** Zhixun Li
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007905
- Term: Lens Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M5638
- Name: Cataract
- Relevance: HIGH
- As Found: Cataract
- ID: M17353
- Name: Uveitis
- Relevance: LOW
- As Found: Unknown
- 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
- ID: D000007249
- Term: Inflammation
### 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
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M199152
- Name: BB 1101
- Relevance: LOW
- As Found: Unknown
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: T382
- Name: Citrate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429293
**Brief Title:** Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
**Official Title:** Impact of Cognitive Behavioral Therapy on Neural, Inflammatory, & Autonomic Markers in a Sample With PTSD and Cardiovascular Risk: Protocol for a Pilot Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2023P001621
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** American Heart Association
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts General Hospital
#### Responsible Party
**Investigator Affiliation:** Massachusetts General Hospital
**Investigator Full Name:** Michael T. Osborne
**Investigator Title:** Clinician Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)
**Detailed Description:** This study is a randomized controlled trial of CPT compared to waitlist control that is testing the effects of CPT on mechanisms of the PTSD-CVD link. Enrollment began in 2023 and is projected to continue through 2026. Participants include individuals with PTSD and CVD risk recruited from the Boston area (N = 30). Treatment assignment is randomized and stratified by sex. Participants are randomized to CPT (n = 15) or waitlist control (n = 15). Potentially eligible participants complete a screening visit to confirm inclusion/exclusion criteria. Upon confirmation of eligibility, participants are scheduled for a baseline session, where they complete surveys, brain and peripheral imaging, and resting measures of autonomic function. Following the baseline visit, participants are randomized into CPT or the waitlist control group. Those randomized to CPT complete sessions via telehealth. Following a 12-week treatment period, participants attend the post-treatment visit, consisting of the same assessments administered at baseline. Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.
### Conditions Module
**Conditions:**
- Posttraumatic Stress Disorder
**Keywords:**
- Cardiovascular disease
- Inflammation
- Autonomic function
- Stress-related neural activity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are randomized to 12 weeks of cognitive processing therapy or waitlist control.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Individuals who interpret images and data will be blinded to assigned intervention
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 12 week treatment period of cognitive processing therapy followed by a post-treatment visit.
**Intervention Names:**
- Behavioral: Cognitive processing therapy
**Label:** Cognitive processing therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.
**Label:** Control waitlist
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cognitive processing therapy
**Description:** The active intervention is Cognitive Processing Therapy (CPT) is a gold-standard cognitive behavioral therapy for PTSD. The CPT intervention consists of 12 60-minute sessions teaching skills to challenge trauma-relevant cognitions that are distorted or unhelpful. Trauma-relevant cognitions fall into five themes that are highlighted during treatment: safety, trust, power/control, esteem, and intimacy. The empirical base for CPT is strong with numerous studies demonstrating that it results in significant reduction of PTSD symptoms regardless of trauma type and that it is 89% more effective than control treatment. CPT has been successfully implemented in virtual formats with comparable efficacy levels to that of in-person CPT. CPT sessions for this study will be conducted virtually by a CPT-trained clinician
**Name:** Cognitive processing therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Measured via FDG-PET imaging
**Measure:** Arterial inflammation
**Time Frame:** Baseline and 12-weeks
**Description:** Calculated from the average resting HRV collected at baseline and post-treatment visits
**Measure:** Heart rate variability
**Time Frame:** Baseline and 12-weeks
#### Secondary Outcomes
**Description:** Measured as bone marrow activity via FDG-PET imaging
**Measure:** Leukopoiesis
**Time Frame:** Baseline and 12-weeks
**Description:** Heart rate in beats per minute
**Measure:** Heart rate
**Time Frame:** Baseline and 12-weeks
**Description:** Systolic and diastolic pressure
**Measure:** Blood pressure
**Time Frame:** Baseline and 12-weeks
**Description:** MRI measurements of atherosclerotic plaque components including necrotic tissue, loose connective tissue, and hemorrhage using black-blood imaging techniques
**Measure:** MRI based arterial plaque components (such as necrotic tissue, loose connective tissue, and hemorrhage)
**Time Frame:** Baseline and 12-weeks
**Description:** Measurements of wall thickness as an assessment of atherosclerotic plaque
**Measure:** MRI based arterial wall thickness
**Time Frame:** Baseline and 12-weeks
**Description:** Structural assessment of brain centers to assess volume and density of neural centers involved in the stress response
**Measure:** MRI based brain structure assessments of volume and density
**Time Frame:** Baseline and 12-weeks
**Description:** Connectivity assessment using mapping on functional MRI at baseline and in response to emotional faces of neural centers involved in the stress response to determine the interplay between neural centers before and after therapy by measuring alterations in blood oxygen content under various conditions in different parts of the brain
**Measure:** MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task)
**Time Frame:** Baseline and 12-weeks
**Description:** Activation assessment using functional MRI at both rest and in response to emotional faces of neural centers involved in the stress response before and after therapy by measuring blood flow under various conditions to different parts of the brain
**Measure:** MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)
**Time Frame:** Baseline and 12-weeks
**Description:** Measurement of axonal integrity using diffusion tensor imaging on MRI to determine the strength connections between important brain centers and neural networks related to stress perception in PTSD before and after therapy
**Measure:** Axonal integrity of resting neural connections between brain centers using MRI
**Time Frame:** Baseline and 12-weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 18-65 years (upper limit chosen to optimize changes in brain activation that diminish with age);
* criterion A trauma exposure and PTSD symptoms (clinically significant symptoms in at least two symptom clusters);
* subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking) ability to understand and sign informed consent
* fluent English speaker.
Exclusion Criteria:
* history of stroke, brain surgery, seizure
* use of certain CVD medications (e.g., beta-blockers, high-intensity statins \[e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg\], PCSK-9 inhibitors);
* psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed);
* currently in PTSD therapy;
* neurological or systemic inflammatory disease/current anti-inflammatory therapy;
* moderate/severe alcohol/substance use disorder;
* current mania/psychosis;
* weight \>300 lbs., claustrophobia, pregnancy, metal implants that are incompatible with magnetic resonance imaging (MRI), or uncontrolled hyperglycemia (for imaging);
* significant radiation exposure (\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) for research purposes during the preceding 12-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:** Michael Osborne, MD
**Phone:** 6177261843
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michael Osborne, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Massachusetts General Hospital
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02114
### IPD Sharing Statement Module
**Access Criteria:** To be determined based on website used
**Description:** Deidentified data from primary endpoints and analyses will be made available on a public website following study completion.
**IPD Sharing:** YES
**Time Frame:** Within 6 months of study completion
### References Module
#### References
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**PMID:** 24647756
**Citation:** Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available. Erratum In: Circulation. 2020 Jan 14;141(2):e33.
**PMID:** 30700139
#### See Also Links
**Label:** About Multiple Cause of Death
**URL:** https://wonder.cdc.gov/mcd-icd10.html
**Label:** The Life Events Checklist for DSM-5 (LEC-5)
**URL:** https://www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp
**Label:** The PTSD checklist for DSM-5 (PCL-5)
**URL:** https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### 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: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Posttraumatic Stress Disorder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related 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: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429280
**Brief Title:** Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
**Official Title:** Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
#### Organization Study ID Info
**ID:** R-AM-1
#### Organization
**Class:** INDUSTRY
**Full Name:** Luminopia
### Status Module
#### Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Luminopia
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.
For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.
### Conditions Module
**Conditions:**
- Amblyopia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
**Name:** N/A this is an observational study of Standard of Care
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Visual Acuity from baseline to consecutive visits
**Measure:** Change in Visual Acuity from baseline to consecutive visits
**Time Frame:** 3, 6,12, 24 months
**Description:** Duration of Visual Acuity treatment and number of follow-up visits
**Measure:** Duration of Visual Acuity treatment and number of follow-up visits
**Time Frame:** 3, 6,12, 24 months
**Description:** Durability of Visual Acuity results post-treatment cessation
**Measure:** Durability of Visual Acuity results post-treatment cessation
**Time Frame:** 3, 6,12, 24 months
**Description:** Adherence with Luminopia treatment
**Measure:** Adherence with Luminopia treatment
**Time Frame:** 3, 6,12, 24 months
**Description:** Change in Stereoacuity from baseline to consecutive visits
**Measure:** Change in Stereoacuity from baseline to consecutive visits
**Time Frame:** 3, 6,12, 24 months
#### Secondary Outcomes
**Description:** Visual Acuity analyses will also be conducted by Prior Treatment
**Measure:** Visual Acuity analyses will also be conducted by Prior Treatment
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity analyses will also be conducted by Amblyopia Type
**Measure:** Visual Acuity analyses will also be conducted by Amblyopia Type
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity Analyses will also be conducted by Age
**Measure:** Visual Acuity Analyses will also be conducted by Age
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
**Measure:** Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
**Measure:** Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity analyses will also be conducted by Adherence to Treatment
**Measure:** Visual Acuity analyses will also be conducted by Adherence to Treatment
**Time Frame:** 3, 6,12, 24 months
**Description:** Visual Acuity Analyses will also be conducted by Prescribed Dose
**Measure:** Visual Acuity Analyses will also be conducted by Prescribed Dose
**Time Frame:** 3, 6,12, 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Have a diagnosis of amblyopia
* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Exclusion Criteria:
-Have participated in prior Luminopia clinical trials
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients with a diagnosis of Amblyopia
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Ramon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** UCSF Benioff Children's Physicians
**State:** California
**Status:** RECRUITING
**Zip:** 94583
**Location 2:**
**City:** Santa Barbara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Sansum Clinic
**State:** California
**Status:** RECRUITING
**Zip:** 93110
**Location 3:**
**City:** Crestview
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Okaloosa Ophthalmology
**State:** Florida
**Status:** RECRUITING
**Zip:** 32536
**Location 4:**
**City:** Gainesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Family Focus Eye Care
**State:** Florida
**Status:** RECRUITING
**Zip:** 32605
**Location 5:**
**City:** Maitland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
***Contact 2:***
- **Name:** Louis Blumenfeld
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Eye Physicians of Central Florida
**State:** Florida
**Status:** RECRUITING
**Zip:** 32751
**Location 6:**
**City:** Savannah
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Children's Eye Institute of Savannah
**State:** Georgia
**Status:** RECRUITING
**Zip:** 31406
**Location 7:**
**City:** Honolulu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Honolulu Eye Clinic
**State:** Hawaii
**Status:** RECRUITING
**Zip:** 96813
**Location 8:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Lurie Children's Hospital
**State:** Illinois
**Status:** RECRUITING
**Zip:** 60611
**Location 9:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Riley Children's Hospital at IU Health
**State:** Indiana
**Status:** RECRUITING
**Zip:** 46202
**Location 10:**
**City:** Las Vegas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Nevada Eye Physicians
**State:** Nevada
**Status:** RECRUITING
**Zip:** 89149
**Location 11:**
**City:** Concord
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Concord Eye Center
**State:** New Hampshire
**Status:** RECRUITING
**Zip:** 03301
**Location 12:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Children's Hospital Of Philadelphia
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19104
**Location 13:**
**City:** Fort Worth
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Endri Angjeli
- **Phone:** 978-806-7080
- **Role:** CONTACT
**Country:** United States
**Facility:** Pediatric Eye Specialist
**State:** Texas
**Status:** RECRUITING
**Zip:** 76104
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014786
- Term: Vision Disorders
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3891
- Name: Amblyopia
- Relevance: HIGH
- As Found: Amblyopia
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17530
- Name: Vision Disorders
- 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
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000550
- Term: Amblyopia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429267
**Brief Title:** Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
**Official Title:** Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
#### Organization Study ID Info
**ID:** 6360
#### Organization
**Class:** OTHER
**Full Name:** Louisiana State University Health Sciences Center in New Orleans
### Status Module
#### Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-26
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Louisiana State University Health Sciences Center in New Orleans
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
**Detailed Description:** This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).
### Conditions Module
**Conditions:**
- Pediatric
- Fracture
- Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)
- Patient Satisfaction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomized to one of two groups which will determine the type of screw (stainless steel or bioabsorbable) in their surgery.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients that are randomly assigned to receive traditional, metal screws
**Intervention Names:**
- Device: Metal/Titanium Screw
**Label:** Control Group (Receiving Metal Screws)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients that are randomly assigned to receive Bioabsorbable screws
**Intervention Names:**
- Device: Bioabsorbable Screw
**Label:** Experimental Group (Receiving Bioabsorbable Screws)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group (Receiving Bioabsorbable Screws)
**Description:** Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide
**Name:** Bioabsorbable Screw
**Other Names:**
- Ossiofiber
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Control Group (Receiving Metal Screws)
**Description:** Traditional metal screw used in fracture fixation that requires hardware removal
**Name:** Metal/Titanium Screw
**Other Names:**
- OrthoPediatrics
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all.
**Measure:** Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys
**Time Frame:** 6 weeks, 6 months, 1 year
#### Secondary Outcomes
**Description:** Any complications of surgery (infection etc)
**Measure:** Complications
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary fractures requiring fixation with cannulated screws
Exclusion Criteria:
* Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
* Secondary fractures
* Non-union fractures
* Tibial tubercle osteotomies (TTOs)
* Slipped capital femoral epiphysis (SCFEs)
* Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
* Allergies or contraindications to screw materials
**Healthy Volunteers:** True
**Maximum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sylvia Culpepper, MS
**Phone:** 2283270278
**Role:** CONTACT
**Contact 2:**
**Name:** Carter Clement, MD, MBA
**Phone:** (504) 896-9569
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Orleans
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sylvia Culpepper, MS
- **Phone:** 228-327-0278
- **Role:** CONTACT
***Contact 2:***
- **Name:** Carter Clement, MD, MBA
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Sylvia Culpepper, MS
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Children's Hospital New Orleans
**State:** Louisiana
**Status:** RECRUITING
**Zip:** 70118
#### Overall Officials
**Official 1:**
**Affiliation:** LSUHSC
**Name:** Carter Clement, MD, MBA
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** all IPD that underlie results in a publication
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M26370
- Name: Fractures, Bone
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M11269
- Name: Magnesium Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M15630
- Name: Silicon
- Relevance: LOW
- As Found: Unknown
- ID: M5173
- Name: Boron
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429254
**Brief Title:** The Effect of Emotional Freedom Techniques on Pelvic Pain
**Official Title:** Effect of Emotional Freedom Techniques on Pelvic Pain and Quality of Life in Women With Endometriosis: A Randomized Controlled Study
#### Organization Study ID Info
**ID:** 01/05
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**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:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karabuk University
#### Responsible Party
**Investigator Affiliation:** Karabuk University
**Investigator Full Name:** Ayse Cuvadar
**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:** Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life.
EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.
Raising women's awareness for EFT
**Detailed Description:** Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life. EFT has become widely used in medical and psychological treatment settings in recent years.It is also used as a self-help technique by millions of people every year.EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.
### Conditions Module
**Conditions:**
- Woman
- Pelvic Pain
**Keywords:**
- Pelvic pain
- Woman
- quality of life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** First, the Personal Information Form, Visual Analogue Scale, and Quality of Life Scale will be administered as pre-tests to the EFT group. A high score obtained from the quality of life scale indicates a high quality of life.
After the pre-tests, the first EFT session will be conducted. A second EFT session will take place 30 days later, followed by post-tests. During this period, affirmations will be provided as needed based on individual difficulties, perspectives, support systems, past traumas, and emotional blockages experienced by the woman. Each session is planned to last approximately 45 minutes to 1 hour.
Procedure: Administering pre-tests followed by the first EFT session. Procedure: After 30 days, conducting post-tests followed by the second EFT session.
Procedure: After another 30 days, only post-tests will be conducted.
**Intervention Names:**
- Other: Experimental group
**Label:** Emotional Freedom Techniques group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After obtaining consent from the women included in the group, pre-tests will be conducted followed by breathing exercises. A program will be tailored according to the suitability of the women. Once an appropriate environment is provided for meeting with the women, information about the study will be provided. Pain coping methods will be explained, and breathing exercises will be taught. The exercises will commence when the woman feels ready. The breathing exercises typically last around 15-20 minutes.
With a plan for a total of 8 breathing exercises to be conducted over four weeks, consisting of 2 sessions per week, they will be scheduled to coincide with the EFT group, with sessions held every 5 days.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Emotional Freedom Techniques group
**Description:** Life Scale will be administered as pre-tests to the EFT group. After the pre-tests, the first EFT session will be conducted. A second EFT session will take place 30 days later, followed by post-tests. During this period, affirmations will be provided as needed based on individual difficulties, perspectives, support systems, past traumas, and emotional blockages experienced by the woman. Each session is planned to last approximately 45 minutes to 1 hour.
**Name:** Experimental group
**Other Names:**
- EFT group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Emotional Freedom Techniques
**Measure:** Examining the Effect of Emotional Freedom Technique on Pelvic Pain İn Endometriosis
**Time Frame:** 1 time per month up to 2 months, Pain will be assessed using the VAS (Visual Analogue Scale). A high score on the scale indicates high pain.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Being diagnosed with endometriosis
2. Experiencing pelvic pain
3. Being between the ages of 18-49
4. Those whose symptom complaints are 5 or above on the visual analogue scale
Exclusion Criteria:
1. Patients with known systemic diseases (e.g. hypertension, diabetes, coronary, kidney and liver diseases);
2. Patients with known malignancy;
3. Women in menopause;
4. Having any obstacle to communication
**Gender Based:** True
**Gender Description:** Women
**Healthy Volunteers:** True
**Maximum Age:** 49 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Edirne
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ayşe Çuvadar
- **Phone:** 05536217689
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Trakya University
**Status:** RECRUITING
**Zip:** 22100
**Location 2:**
**City:** Edirne
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ayşe Çuvadar
- **Phone:** 05536217689
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zuhal Guksu
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** Trakya University
**Status:** RECRUITING
**Zip:** 22100
### 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: HIGH
- As Found: Pelvic Pain
- ID: M7877
- Name: Endometriosis
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017699
- Term: Pelvic Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429241
**Brief Title:** Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
**Official Title:** A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
#### Organization Study ID Info
**ID:** 2023-TH-SC01-I-007
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The First Affiliated Hospital of Soochow University
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
**Detailed Description:** A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
### Conditions Module
**Conditions:**
- Anal Fistula
- Complex Perianal Fistulas
- Crohn's Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intralesional injection of expanded human umbilical cord-derived mesenchymal stem cells suspension.
**Intervention Names:**
- Biological: Mesenchymal Stem Cells (MSCs)
**Label:** MSCs treatment group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MSCs treatment group
**Description:** single dose injection (120 million cells)
**Name:** Mesenchymal Stem Cells (MSCs)
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
**Measure:** Standardized uptake value
**Time Frame:** 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour
#### Secondary Outcomes
**Description:** Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain.
**Measure:** Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection
**Time Frame:** Week 1，Week 4，Week 24
**Description:** All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12-lead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.
**Measure:** Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
**Time Frame:** Week 1，Week 4，Week 24，Month 24
**Description:** Based on the image data obtained by PET/CT scan, OLINDA's sphere model was used to delineate the injection site and important organs or tissues as areas of interest (ROI), obtain standardized uptake values (SUV) of each ROI, and obtain time-radioactive activity curves (TACs) of each tissue and organ. The absorbed dose of vital organs or tissues, the equivalent dose of the whole body, and the distribution and change of transplanted cells in different tissues or organs at different time points are described
**Measure:** Radiation exposure: Uptake rate (%ID), absorbed dose, and systemic effective dose in vital organs or tissues after local injection of nuclide labeled TH-SC01 cells.
**Time Frame:** Week 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed informed consent
2. Subjects with Crohn\&#39;s disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
3. For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
4. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
5. ECOG score 0\~1, ASA grade I\~II
6. Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.
Exclusion Criteria:
1. Subjects with active infection evaluated by the investigator.
2. Subjects with Crohn\&amp;amp;#39;s disease requiring immediate therapy.
3. Subjects with abscess or collections \&amp;amp;gt;2 cm.
4. Subjects with rectal and/or anal stenosis and/or active proctitis.
5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
6. Subjects with abnormal laboratory results: liver function: total bilirubin \&amp;amp;gt;=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \&amp;amp;gt;=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \&amp;amp;gt;=1.5 × upper limit of normal (ULN).
7. Subjects with malignant tumors or a history of malignant tumors.
8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn\&amp;amp;#39;s disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
10. Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
11. Subjects who has received stem cells therapy.
12. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
13. Subjects who has received any investigational drug within 3 months prior to the screening.
14. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
15. The female participant who is pregnant, or is lactating.
16. Not suitable for PET/CT examination.
17. Participants considered inappropriate to participate in this clinical trial
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** E-mail:[email protected]
**Name:** Miu Li Yan The First Affiliated Hospital of Soochow University
**Phone:** 86+0512-67972858
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015212
- Term: Inflammatory Bowel Diseases
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000007412
- Term: Intestinal Fistula
- ID: D000016154
- Term: Digestive System Fistula
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M8532
- Name: Fistula
- Relevance: HIGH
- As Found: Fistula
- ID: M14845
- Name: Rectal Fistula
- Relevance: HIGH
- As Found: Perianal Fistula
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- 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: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M10446
- Name: Intestinal Fistula
- Relevance: LOW
- As Found: Unknown
- ID: M18616
- Name: Digestive System Fistula
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003424
- Term: Crohn Disease
- ID: D000012003
- Term: Rectal Fistula
- ID: D000005402
- Term: Fistula
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429228
**Brief Title:** Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
**Official Title:** Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
#### Organization Study ID Info
**ID:** CAT_273219
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-04-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-24
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** IRCCS San Raffaele
#### Responsible Party
**Investigator Affiliation:** IRCCS San Raffaele
**Investigator Full Name:** Stefano Salvatore
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.
Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
### Conditions Module
**Conditions:**
- Catheter Related Complication
- Anterior Vaginal Wall Prolapse
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Catheter removal after surgery
**Label:** Catheter removal in postoperative day I
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Procedure: Catheter removal after surgery
**Label:** Catheter removal in postoperative day II
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Catheter removal in postoperative day I
- Catheter removal in postoperative day II
**Description:** Removal of catheter placed during the procedure in first or second post-surgical days.
**Name:** Catheter removal after surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows:
* if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated
* if the sum of diuresis and RV is \> 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.
**Measure:** differences in bladder catheter repositioning within 12 hours after bladder catheter removal
**Time Frame:** 12 hours
#### Secondary Outcomes
**Description:** Before removing the catheter, a chemical-physical examination will be carried out; if this is positive, urine culture will be carried out. The diagnosis of urinary tract infection will be made with leukocyturia greater than 25 cells per field, positivity for urinary nitrite, presence of at least 20 bacteria per field, bacteriuria and/or more than 100,000 colony forming units associated with at least one of the following signs (fever, dysuria, increased urinary frequency, suprapubic pain, burning on urination or worsening of urinary incontinence). Patients with a positive culture and/or who show symptoms attributable to urinary tract infection will be subjected to antibiotic therapy.
**Measure:** incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
**Time Frame:** During hospital stay
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women 18 years of age or older
* Patients who are candidates for cystopexy surgery
* Patients who have consented to the signing of the Informed Consent
Exclusion Criteria:
* Micturition dysfunction with preoperative bladder stagnation \> 200 cc at pessary evaluation
* History of recurrent cystitis
* Positive preoperative urine culture
* Azotemia \> 40 mg/dL or creatininemia \> 1 mg/dL
* Not collected signed consent endorsed
* Diabetes mellitus
* Contraindications to transurethral bladder catheterization
* Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefano Salvatore
**Phone:** 0226434930
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Vittoria Benini
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Stefano Salvatore
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Vittoria Benini
- **Role:** CONTACT
**Country:** Italy
**Facility:** IRCCS San Raffaele Hospital
**Status:** RECRUITING
**Zip:** 20132
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14261
- Name: Prolapse
- Relevance: HIGH
- As Found: Prolapse
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011391
- Term: Prolapse
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429215
**Acronym:** SCD-ReCODED
**Brief Title:** REducing the Risk of COgnitive DEcline ad Dementia in Patients With Subjective Cognitive Decline Through an Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: the SCD-ReCODED Study
**Official Title:** Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** PRIN 2022 PNRR P2022E3CZY
#### Organization
**Class:** OTHER
**Full Name:** I.R.C.C.S. Fondazione Santa Lucia
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** I.R.C.C.S. Fondazione Santa Lucia
#### Responsible Party
**Investigator Affiliation:** I.R.C.C.S. Fondazione Santa Lucia
**Investigator Full Name:** Maria Stefania De Simone
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.
### Conditions Module
**Conditions:**
- Subjective Cognitive Decline
**Keywords:**
- Subjective cognitive decline
- Multi-component training
- Non-pharmacological intervention
- Virtual reality
- Telemedicine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** VR cognitive training + Psychoeducation program
**Intervention Names:**
- Device: Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle
**Label:** Multi-component Intervention (MC-I)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** VR Cognitive training + Psychoeducation active control
**Intervention Names:**
- Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)
**Label:** Cognitive-only intervention (CO-I)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** VR Cognitive active control + Psychoeducation active control
**Intervention Names:**
- Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control
**Label:** Active control intervention (AC-I)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Multi-component Intervention (MC-I)
**Description:** In a period of 5 consecutive weeks, participants will receive:
* an interactive immersive virtual reality cognitive training for 30 minutes, 3 days per week. It consists in different tasks implemented in virtual real-like scenarios of daily living situations that target the following cognitive processes: long-term associative memory, relational binding, spatial pattern separation and pattern completion;
* an interactive immersive virtual reality health and lifestyle education program for 30 minutes, 1 day per week. It consists in 360° videos aimed at advancing awareness and knowledge of the various health conditions associated with an increased risk of cognitive decline and dementia and helping participants to develop a healthier lifestyle.
**Name:** Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Cognitive-only intervention (CO-I)
**Description:** In a period of 5 consecutive weeks, participants will receive:
* the interactive immersive virtual reality cognitive training as described in the MC-I condition, for about 30 minutes, 3 days per week;
* an active control of the immersive virtual reality psychoeducation program for 30 minutes, 1 day per week.
**Name:** Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Active control intervention (AC-I)
**Description:** In a period of 5 consecutive weeks, participants will receive:
* an active control of the immersive virtual reality cognitive training (participants will be requested to virtually carry out daily actions, in the same setting as those performed in cognitive immersive VR training, but they will follow prearranged instructions requiring very low cognitive demands) for about 30 minutes, 3 days per week;
* an active control of the immersive virtual reality psychoeducation program for about 30 minutes, 1 day per week.
**Name:** Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The Face-Name Associative Memory Exam (short form - FNAME12) is an associative long-term memory task that requires the participant to learn and retrieve 12 novel face-name and face-occupation pairs. It consists of two learning phases, followed by an immediate cued recall and a 30-min delayed recall and recognition trial.
**Measure:** Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Description:** The Visual Short-Term Memory Binding Test is a recognition task based on a change detection paradigm for arrays of stimuli presented on a computer screen. Two conditions are investigated, that is, a shape-only condition as the first and a shape-color condition as the second. In both conditions, participants are asked to remember visual arrays of two or three black polygons (in the shape-only condition) or colored polygons (in the shape-color condition) presented for 2 s (study phase).
**Measure:** Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Description:** The Spatial pattern separation test assesses the ability to differentiate partially overlapping patterns of activation in order to retrieve one pattern as separate from others that are similar. Specifically, it consists of 36 trials, in which the participant is required to learn the location of a grey circle on a sceen; then the participant is required to recognize the position of the previously-learned grey circle with respect to a foil located either to the left or the right of the target.
**Measure:** Cognitive functioning (3): change scores on the Spatial pattern separation test
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
#### Secondary Outcomes
**Description:** The Subjective Memory Complaints Questionnaire assesses the subjective experience of memory decline. It consists of two sections. Part I provides a global evaluation of memory concerns responses to four general questions (4 items); Part II provides an evaluation of memory concerns in daily life (27 items). For each of the 31 items, participants are asked to respond on a 4-point Likert scale (1 = No, it does not happen to me; 2 = Sometimes, but it does not worry me; 3 = Yes and it worries me; 4 = Yes and it constitutes a problemin at least one area ofmy life, e.g., work, family, leisure, relationships). Higher scores are indicative of more serious memory complaints.
**Measure:** Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Description:** Connectomics changes after intervention will be investigated between pairs of regions of the whole brain (with particular interest in areas mainly involved in training-related cognitive processes) and in the global and local topological properties of large-scale networks through graph theoretical approach.
**Measure:** Intervention-induced changes in whole-brain functional connectivity
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Measure:** Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Measure:** Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Measure:** Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
**Measure:** Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey
**Time Frame:** Baseline, post-intervention (around 6 weeks after baseline)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-perceived decline in cognition compared to five years ago
* Lack of objective cognitive impairment.
Exclusion Criteria:
* Clinically significant depression and anxiety;
* Psychiatric disorders;
* Unstable medical conditions.
* Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
* Dizziness or epilepsy history;
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## 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: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000003072
- Term: Cognition Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Decline
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003704
- Term: Dementia
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429202
**Brief Title:** The Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
**Official Title:** Examination of the Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis
#### Organization Study ID Info
**ID:** Acetinkaya003
#### Organization
**Class:** OTHER
**Full Name:** Halic University
### Status Module
#### Completion Date
**Date:** 2024-06-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Halic University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Scoliosis is a three-dimensional, multifactorial disease that becomes more prevalent in adolescents, disrupts the three-dimensional mechanism and posture of the vertebra, causes deterioration in the person's body perception and cosmetic perception, and also causes negative effects on social life and quality of life. Although idiopathic scoliosis is more common during adolescence, its cause is not yet known. It is divided into three subheadings according to the age of onset. These are respectively; It is classified as Juvenile Idiopathic Scoliosis (0-3 years), Infantile Idiopathic Scoliosis (4-10 years), Adolescent Idiopathic Scoliosis (10 years and above). The most common one is Adolescent Idiopathic Scoliosis. Its incidence in girls is 4 times higher than in boys. This study aimed to examine the effects of body image and self-esteem on quality of life in idiopathic adolescent scoliosis patients and to determine whether there is a difference between genders. Additionally, it will be examined what effect the duration of corset use has on these parameters.
**Detailed Description:** Scoliosis is a three-dimensional, multifactorial disease that becomes more prevalent in adolescents, disrupts the three-dimensional mechanism and posture of the vertebra, causes deterioration in the person's body perception and cosmetic perception, and also causes negative effects on social life and quality of life. Although idiopathic scoliosis is more common during adolescence, its cause is not yet known. It is divided into three subheadings according to the age of onset. These are respectively; It is classified as Juvenile Idiopathic Scoliosis (0-3 years), Infantile Idiopathic Scoliosis (4-10 years), Adolescent Idiopathic Scoliosis (10 years and above). The most common one is Adolescent Idiopathic Scoliosis. Its incidence in girls is 4 times higher than in boys. This study aimed to examine the effects of body image and self-esteem on quality of life in idiopathic adolescent scoliosis patients and to determine whether there is a difference between genders. Additionally, it will be examined what effect the duration of corset use has on these parameters. Thirty idiopathic adolescent scoliosis patients, boys and girls aged between 10 and 18, will be included in the study. Coopersmith Self-Esteem Inventory (CSEI) to evaluate body image, Walter Reed Visual Assessment Scale to evaluate body image, Scoliosis Research Society-22 Quality of Life Questionnaire to evaluate the level of quality of life, sociodemographic data form to obtain personal data, Statistical Package to analyze the data. for Social Science (SPSS) planned to use Windows version 22.0
### Conditions Module
**Conditions:**
- Scoliosis; Adolescence
- Self Esteem
- Quality of Life
**Keywords:**
- idiopathic scoliosis
- self esteem
- body perception
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Walter Reed Visual Assessment Scale (WRGDS) is an evaluation scale created from visual figures. It was developed by Pineda et al. in 2006, for use in individuals with scoliosis, to measure how a person thinks about the deformity in their own body and how severe it is perceived.
**Measure:** Walter Reed Visual Assessment Scale
**Time Frame:** at baseline
**Description:** It is a self-assessment scale developed by Stanley Coopersmith in 1967. This test aims to measure the individual's thoughts about himself and his general sense of self-esteem. The form consists of 58 questions and includes 50 self-esteem items and 8 lie items.
**Measure:** Coopersmith Self-Esteem Inventory (CSEI)
**Time Frame:** at baseline
**Description:** Scoliosis Research Society-22 is a 22-question quality of life scale specific to scoliosis. Developed by the Scoliosis Research Society, it has been translated into different languages and shown to be valid and reliable.
**Measure:** Scoliosis Research Society-22 Quality of Life Questionnaire
**Time Frame:** at baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteering to participate in the study and obtaining parental consent
* Being between the ages of 10-18
* Being diagnosed with idiopathic scoliosis
* Using a scoliosis brace for at least 3 months
* Being within the normal range in body mass index
Exclusion Criteria:
* Having previously undergone spine surgery, having any mental problems, having non-idiopathic scoliosis and orthopedic disease.
* Having a curve of less than 25 degrees
**Maximum Age:** 18 Years
**Minimum Age:** 10 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** 30 individuals between the ages of 10-18 diagnosed with Adolescent Idiopathic Scoliosis. As a general recommendation, Cohen states that if the d value is less than 0.2, the effect size can be defined as weak, if it is 0.5, it can be defined as medium, and if it is greater than 0.8, it can be defined as strong (Cohen, 1988). The minimum number of samples was calculated with the G\*Power 3.1.9 program. Accordingly, the minimum number of samples to be included in the study for an effect size of 0.5, statistical power of 80% and margin of error of 0.05 was calculated as 29.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ayşenur Çetinkaya
**Phone:** +905077218827
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Halic University
**State:** Eyupsultan
**Zip:** 2022
#### Overall Officials
**Official 1:**
**Affiliation:** Halic University
**Name:** Ayşenur Çetinkaya
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013121
- Term: Spinal Curvatures
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15417
- Name: Scoliosis
- Relevance: HIGH
- As Found: Scoliosis
- ID: M15918
- Name: Spinal Curvatures
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000012600
- Term: Scoliosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429189
**Brief Title:** Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer
**Official Title:** An Online Home-based Combined Exercise Intervention With Self-selected Intensity for Women With Breast Cancer: The Home-Combo Randomized Controlled Trial.
#### Organization Study ID Info
**ID:** Home-Combo
#### Organization
**Class:** OTHER
**Full Name:** Grupo Lusófona
### Status Module
#### Completion Date
**Date:** 2025-10-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Universidade Lusófona de Humanidades e Tecnologias
**Class:** UNKNOWN
**Name:** Grupo HPA
**Class:** UNKNOWN
**Name:** Associação Oncológica do Algarve
**Class:** UNKNOWN
**Name:** Liga Portuguesa Contra o Cancro
**Class:** OTHER
**Name:** Centro Hospitalar Universitario do Algarve
#### Lead Sponsor
**Class:** OTHER
**Name:** Grupo Lusófona
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy \<85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed.
Purpose. This study aims to investigate the effects of a self-selected intensity structured supervised home-based combined exercise intervention on the chemotherapy completion rates of women with BC. Secondly, the investigators intend to analyze the impact of this intervention on functional performance, quality of life, body composition, and physical activity levels. A 3-month follow-up will investigate if physically active behavior is sustained post-intervention.
Methods. A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments. The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy. Outcome measures will be obtained at baseline, mid-treatment (≈3 months), post-intervention (≈6 months), and 3-month follow-up. A mediation analysis will also be conducted.
Hypothesis 1: Women in the intervention will have a better completion rate than those in the control group.
Hypothesis 2: Women in the intervention will present better functional performance, body composition, PA levels, and quality of life than the control group.
Hypothesis 3: In the post-intervention period, women in the intervention group will maintain a more physically active lifestyle than women in the control group.
**Detailed Description:** Study setting The Home-Combo study will take place in the Algarve, and the sample will be recruited by medical referral from various public and private hospitals across the region.
The intervention design will consider the PA/exercise preferences, perceived barriers, and facilitators of women with BC. This information will be collected before the intervention through a mixed-methods qualitative study that will include a survey and focus groups. The intervention will be conducted online to ensure the participants' safety during the chemotherapy treatment phase, as they may have compromised immunity. Also, this option was made to attenuate participants' burden caused by commuting requirements. Participants will be enrolled in two cohorts.
Criteria for discontinuing or modifying allocated interventions Participants will be informed in the pre-study initial meeting that they may leave the study anytime. Participants will be asked to refrain from continuing the intervention if a worsening clinical condition prevents them from exercising and performing the assessments safely. The exercise program might be reviewed and tailored to the participants' condition across the intervention.
Strategies to improve adherence Before implementing this study, a survey and focus-group-based study will be performed to adjust the exercise program to the preferences, perceived barriers, and facilitators of women with a breast cancer diagnosis, considering the environmental and cultural context from where the intervention will be conducted. The supervising professional will monitor adherence to the supervised sessions through presence registration. This study will also consider the participants' adherence to the control group. To attempt dropout minimization, the investigators will have an active control group.
Concomitant care Physiotherapy treatments prescribed by the participant's primary physician and any exercises prescribed to be performed at home prescribed by the physiotherapist will be allowed during the intervention. Participants in the study will be asked not to engage in other exercise and PA programs or activities outside the program. Participants in the control group will not be prohibited from performing physical activities like brisk walking.
Sample size Considering this study design, sample size calculations were made for the primary outcome with a factorial variance analysis with repeated measures as reference statistical analysis, giving an initial estimation of 82 participants. Based on previous findings and considering a 20% dropout, the sample size was estimated at 98 participants with a moderate effect size (a=0.05; statistical power=0.80) according to Cohen's D calculations, using G\* Power 3.1.
Recruitment Recruitment will occur through medical referrals from primary physicians of several public and private hospitals in the Algarve region. Additionally, the project will be presented at breast cancer-themed congresses and events, and digital flyers with information about the study will be made to assist in disseminating the project and the recruitment process. A research team member will then contact patients referred by the doctors to receive detailed information about the study. Optionally, patients can call the research team directly or contact them through email if they prefer. After confirming eligibility criteria and interest in participating in the study, patients will be asked to attend an initial session where more information will be given, and the informed consent will be signed. During that session, participants will be told they are not obliged to participate in the study and may decide to leave the project. Consent for data collection or sharing will also be obtained.
Data collection methods Assessments will be conducted in standardized conditions, in a clinical setting, in a calm and comfortable environment, in small groups, and performed by a qualified exercise professional. The assessments will be conducted in the morning, starting with the body composition measurements, followed by a 15-minute pause so participants can eat (since they will be weighted while fasting), preceded by a 10-minute warm-up with general movements to mobilize big muscle groups and the physical tests, that will be performed in the following order: shoulder angular measurements, strength, mobility, and aerobic endurance. Participants will be divided into small groups to facilitate instruction and conduction of the tests. Participants will receive the accelerometers one week before the field tests and return them on the physical assessment day. After the field measurements, all questionnaires will be delivered and answered through email (Google Forms)
Plans to promote retention The conducting exercise professional will control participants' adherence to the exercise program through a presence registry collected by the research team member with access to the list of participants' numbers. After the session, the non-interventionist research team member will pass the presence list to the respective numbers of the participants for program adherence analysis. If a participant fails to attend a session, contact will be made to ensure the participant's welfare and motivate them to participate in the next session. The data analysis will not consider participants who fail to attend 50% or more sessions. Positive feedback will be given to the participants during the sessions, as positive feedback enhances feelings of competence, enjoyment, and interest in the activity 86. Additionally, participants will be encouraged to keep an activity diary where they may register all activities performed autonomously. Participants will be contacted one week before the assessment to confirm their availability and presence. Data from participants who fail to perform the assessments during the intervention period will be excluded from data analysis. After the intervention, participants will be contacted monthly to check their well-being and keep their interest and motivation in engaging in the follow-up assessment.
Data management All the data collected in this study will be kept confidential, computerized, and encrypted in a database without any elements that may allow identification of the participants. After the participants have expressed interest and written informed consent, a number corresponding to the participant ID during the study will be provided. When the participant receives her ID number, all data inserted in the databases will not be directly linked to the participant's personal identification. A dataset will be created for each assessment time point. All datasets will be maintained by the members responsible for the investigation on a secure server of CIDEFES-UL for ten years and will be used exclusively for research purposes. Datasets used for specific analyses or to develop sub-studies will contain only the necessary variables and the demographical indicators provided to the research team members upon request to the leading investigator.
Statistical methods All data will be analyzed using IBM SPSS (version 29.0). Factorial ANCOVAS with repeated measures will be used for the primary and secondary outcomes, adjusted for potential covariates (e.g., concomitant treatments, BC diagnosis, neo-adjuvant/ adjuvant chemotherapy). Independent sample T-tests will be used to compare results between groups at each time point, considering chemotherapy completers versus non-completers. A Fisher's exact test will compare the proportion of participants who needed chemotherapy adjustments from those who did not. The intention-to-treat analysis will be conducted to ensure that all participants are included in the overall assessment, considering their compliance with the study protocol. The Last Observation Carried Forward method will be used to input missing data values. A per-protocol analysis will also be conducted without participants who failed to complete at least 50% of the training sessions. Normality plots and Kolmogorov-Smirnov tests will be performed to test the normality of outcome variables. If normality is not satisfied, non-parametric tests will be applied (e.g., Krustal-Wallis). Mediators of change (i.e., mechanisms by which RDI) will be explored using structural equation modeling (AMOS 18.0) and multiple mediation analysis (PROCESS macro for SPSS). Putative candidates will include treatment (e.g., dose planned vs. given dose, planned cycles minimum/maximum, treatment interruption ratios, response to treatment, percentage of participants who needed dose adjustments, and the mean value of dose adjustment), and physiological (e.g., body composition, functional performance, handgrip strength, PA levels) variables. Mediation occurs when a causal effect of an independent variable occurs on a dependent variable, partly or entirely explained by a mediator. Indirect effects testing will be performed using Preacher and Hayes' procedures.
Data monitoring A data monitoring committee will not be required for this trial as the interventions pose minimal risk, and participants will be protected by personal insurance throughout the study.
Harms All participants will have their adverse events monitored throughout the study, whether directly related to the intervention or not (if applicable). This monitoring will be done through self-reporting at the start of each session, registered for analysis and report purposes, or by their primary care physicians. Participants will be advised to contact the clinical team if they have difficulties.
Auditing Two authors will supervise all trial procedures and cross-check the interventionist actions and study processes. Additionally, an independent person external to the project will review the protocol.
Research ethics approval This study has received ethical approval from the collaborating hospital (UAIF 069/2024). This trial will follow the World Medical Association's Declaration of Helsinki for Human Studies.
Consent or assent Healthcare professionals will approach potential participants to determine if they are interested in participating. If they express interest, they will be referred to a research team member who will contact them. Additionally, interested participants will be allowed to share the study information with other women who have been diagnosed with breast cancer. If any of these women express interest in participating, they will also be considered after obtaining medical clearance. Once the eligibility criteria for the study are confirmed and the women express their interest in participating, they will receive the Informed Consent through email. In the informational session, women will be asked to digitally fill out and sign the Informed Consent. It will be clear to the participants that they can withdraw their consent anytime. After the informational session, a PDF copy of the signed Informed Consent will be emailed to each participant. The research team will also take additional measures to collect and share the participants' data.
### Conditions Module
**Conditions:**
- Breast Cancer
- Chemotherapy Effect
**Keywords:**
- Breast cancer
- Home-based exercise
- Functional performance
- Body composition
- Physical activity
- Quality of life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 2-arm pragmatic and superiority randomized controlled trial with an intervention and an active control group, with a 1:1 allocation ratio.
Participants in this group will perform a home-based combined exercise program throughout their chemotherapy treatments, starting within 1-2 weeks of its start and ending within 3-4 weeks post-treatment completion.
Women randomized to the control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation during the intervention period.
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Participants will be told they are part of an exercise intervention without any mention of a control group.
Healthcare professionals responsible for the chemotherapy prescription and administration and registering all clinical information will be blinded to the participants' groups.
None of the research team members will know the number of participants, so data analysis will be performed in a blinded setting.
If, at any given moment, a participant reveals her number to a research team member, all posterior data from that participant will be disregarded.
If a participant decides to leave the study or must abandon it due to health complications, the team member with the number information will be informed, and data will be disregarded from the analysis.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 98
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Exercise intervention will be led by qualified exercise professionals online via Zoom. It will consist of two weekly 60-minute online exercise group sessions: a 5-minute warm-up, 30-minute resistance training, and a 20-minute aerobic exercise component, finishing with a 5-minute cooldown.
The warm-up will consist of mobility and activation movements. The resistance training component will consist of 9 exercises involving large muscle groups, performed with body weight or free weights. The exercises will be completed in 2-3 sets of 10-15 repetitions. The aerobic component will consist of low-impact dance exercises that move large muscle groups to increase heart rate. The cooldown will consist of breathing exercises and light stretches.
**Intervention Names:**
- Behavioral: Home-based combined exercise program with self-selected intensity
**Label:** Home-based combined exercise
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation.
**Intervention Names:**
- Behavioral: Home-based combined exercise program with self-selected intensity
**Label:** Active control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active control group
- Home-based combined exercise
**Description:** Before the beginning of the exercise program, participants will receive an education session on how to use Borg's Perceived Rate of Exertion Scale (RPE) to monitor their effort during aerobic and resistance training and tips on when they may increase the exercise intensity. During the training sessions, participants in the intervention group will be asked to choose their preferred load to execute each exercise in the resistance component, told to perform the aerobic exercises at their preferred speed, and informed that they can stop exercising whenever they need to rest. The exercise professional may suggest increasing loads in specific exercises, but these increases will not be imposed on the participants. Attendance to the sessions in the intervention and control groups will be registered. Additionally, women in this group will be encouraged to perform brisk walking at their preferred intensity and receive a pedometer to increase walking motivation.
**Name:** Home-based combined exercise program with self-selected intensity
**Other Names:**
- Home-combo
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Participants' demographic information (e.g., age, education, marital status, and economic status) will be collected through a general information questionnaire
**Measure:** Demographics
**Time Frame:** Assessments will be performed at two time points: baseline (throughout recruitment period completion, 1 year), post-intervention (6-12 months)
**Description:** PA history will be collected through a general information questionnaire
**Measure:** Physical activity history
**Time Frame:** Assessments will be performed atbaseline (throughout recruitment period completion, 1 year)
**Description:** Clinical history data will be retrieved from their medical records after they sign the informed consent form.
**Measure:** Medical history
**Time Frame:** Assessments will be performed at three time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months)
#### Primary Outcomes
**Description:** The outcome will be reported as the mean RDI (mg.m-2/wk-1), which corresponds to a fraction of the planned chemotherapy dose intensity, by dividing the dose of chemotherapy per square meter (of surface area where the drug is related) in each cycle by the number of weeks in a cycle. Information regarding the planned chemotherapy treatment and the effectively received treatment (i.e., dose, type, and duration) will be acquired from medical records after signing the informed consent 53,19. Successful chemotherapy completion rate will be considered if the RDI is ≥85% of the planned treatment. Calculations to compare the actual chemotherapy dose intensity received and the initially planned dose intensity will be calculated as total milligrams of chemotherapy divided by the product of the body surface (in square meters) and total weeks of treatment. The RDI results from the actual dose intensity received are divided by the planned dose intensity.
**Measure:** Chemotherapy completion rates
**Time Frame:** Assessments will be performed at three time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months).
#### Secondary Outcomes
**Description:** The 6-minute walk test will assess aerobic endurance, a standardized field test performed indoors in a 30-meter corridor with two turning points. Participants will be asked to walk the maximum distance possible.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Arm curls will assess upperbody strength. Participants will be instructed to perform as many repetitions as possible for 30 seconds with a 5-pound dumbbell.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Sit-to-stand tests assess lower body strength. Participants will be instructed to stand upright and sit entirely back on a chair as many times as possible within 30 seconds, maintaining their feet steady on the ground and the arms crossed with hands on the shoulders
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Handgrip strength will be measured using a dynamometer and considered to the nearest 0.1kg. While performing the handgrip test for each hand, participants will be instructed to stand upright with feet at hip width and elbows completely stretched while applying the maximum grip continuously for more than 3 seconds.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Timed up-and-go tests will assess participants' overall mobility. Participants will be instructed to rise from a chair, walk 2.44 meters, turn around, walk back to the chair, and sit down.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** A goniometer will perform shoulder flexion and abduction angular measures on both sides.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Upper limb flexibility will be assessed using the back scratch test. Participants will be instructed to pass one hand over the shoulder and the other from the bottom of the back, trying to reach both hands as close as possible.
**Measure:** Functional performance
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Body composition will be measured through bioelectrical impedance (Impedimed Australia). Data regarding weight, fat mass, lean mass, water percentage, bone mass, visceral fat, and phase angle will be collected from the scale. Participants will be asked to maintain their dietary patterns before the test and refrain from intense exercise the day before. The measurement will be performed under standardized conditions. The height measurement will be considered to the nearest 0.1 cm of the participants and will be performed using a balance-mounted stadiometer (SECA, Germany), with the participants standing and bare-footed. Body weight will be measured to the nearest 0.1kg with a digital scale. BMI (kg/m2) will be calculated from weight (kg) and height (m). Participants will be asked to maintain their dietary patterns before the test and refrain from intense exercise the day before.
**Measure:** Body composition
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** The height measurement will be considered to the nearest 0.1 cm of the participants and will be performed using a balance-mounted stadiometer (SECA, Germany), with the participants standing barefoot.
**Measure:** Body composition
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Body weight will be measured with a digital scale to the nearest 0.1kg.
**Measure:** Body composition
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** BMI (kg/m2) will be calculated from weight (kg) and height (m).
**Measure:** Body composition
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** PA levels and SB will be assessed using accelerometry (GT9 link, Actigraph). Participants will be instructed to wear the device on an elastic belt on the non-dominant hip for seven days during all waking hours, removing only to sleep. The sampling units (epochs) will be settled to 1s to ease data analysis and ensure the appropriate sensitivity of the device during low-intensity activities. According to specific established thresholds, the accelerometer counts will be categorized into sedentary, light, moderate, and vigorous activity levels. Any interval of 60 or more minutes with continuous zero counts will be considered non-wear time.
**Measure:** Physical Activity and Sedentary Behavior
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** The International Physical Activity Questionnaire Short-Form (IPAQ-SF) comprises nine items that measure the weekly time spent on all intensities PA (i.e., light, moderate, and vigorous) and time spent sitting on week and weekend days. Total PA scores are calculated from the collected data and discriminated by intensity.
**Measure:** Physical Activity and Sedentary Behavior
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).The EORT QLQ-C30 questionnaire consists of 30 items, grouped into 8 multi-item scales (i.e., functional: physical, role, emotional, cognitive, and social; symptom: fatigue, pain, and nausea), one global health status and quality of life subscale, and 6 single-item questions (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
**Measure:** General quality of life and breast-cancer specitfic quality of life
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
**Description:** The specific module EORTC QLQ-BR45 will measure breast cancer-related quality of life. The breast cancer module QLQ-BR45 comprises five functional subscales (body image, future perspective, sexual functioning, sexual enjoyment, and breast satisfaction) and seven symptoms subscales (arm symptoms, breast symptoms, endocrine therapy, skin mucositis, endocrine sexual symptoms, systemic therapy side effects, and upset hair loss), for a total of 45 items.
**Measure:** General quality of life and breast-cancer specitfic quality of life
**Time Frame:** Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Breast cancer stage I-III diagnosis
* Scheduled to receive neoadjuvant or adjuvant chemotherapy
* Have acess to a computer
Exclusion Criteria:
* Medical conterindication to perform exercise or physical assessments due to concomitant comorbidity
* Non-controlled health conditions or diseases
* Psychological illness
* Currently enrolled in a structured exercise program
* Unable to complete the entire program (e.g., due to scheduled surgery or personal commitments)
* Pregnancy
* Worsening of clinical condition during intervention
**Gender Based:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pedro GF Ramos, Msc
**Phone:** 928159936
**Phone Ext:** 351
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pedro B. Júdice, PhD
**Phone:** 217515500
**Phone Ext:** 351
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lisboa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pedro B. Júdice, PhD
- **Phone:** 217515500
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Eliana V. Carraça, PhD
- **Phone:** 217515500
- **Role:** CONTACT
***Contact 3:***
- **Name:** Pedro GF Ramos, Msc
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Nuno Dias, Msc
- **Role:** SUB_INVESTIGATOR
**Country:** Portugal
**Facility:** Universidade Lusófona, Centro de Lisboa
**Zip:** 1749-024
#### Overall Officials
**Official 1:**
**Affiliation:** CIDEFES
**Name:** Pedro B. Júdice, PhD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** CIDEFES
**Name:** Eliana V. Carraça, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** The corresponding author will make anonymized trial data available for non-commercial research purposes upon reasonable request.
**Description:** The corresponding author will make anonymized trial data available for non-commercial research purposes upon reasonable request.
This trial's findings will be disseminated through publication in leading international oncology scientific journals and presentations at national and international conferences. In addition. the results and mediation analysis will be produced and published. As this is a pragmatic trial with highly applicable outcomes for participants and decision-makers, it presents potential for future widespread implementation through relevant stakeholders.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Dissemination policy This trial's findings will be disseminated through publication in leading international oncology scientific journals and presentations at national and international conferences. In addition. the results and mediation analysis will be produced and published. As this is a pragmatic trial with highly applicable outcomes for participants and decision-makers, it presents potential for future widespread implementation through relevant stakeholders.
### References Module
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**Citation:** Imran M, Al-Wassia R, Alkhayyat SS, Baig M, Al-Saati BA. Assessment of quality of life (QoL) in breast cancer patients by using EORTC QLQ-C30 and BR-23 questionnaires: A tertiary care center survey in the western region of Saudi Arabia. PLoS One. 2019 Jul 10;14(7):e0219093. doi: 10.1371/journal.pone.0219093. eCollection 2019.
**PMID:** 31291302
**Citation:** Curigliano G, Dunton K, Rosenlund M, Janek M, Cathcart J, Liu Y, Fasching PA, Iwata H. Patient-reported outcomes and hospitalization data in patients with HER2-positive metastatic breast cancer receiving trastuzumab deruxtecan or trastuzumab emtansine in the phase III DESTINY-Breast03 study. Ann Oncol. 2023 Jul;34(7):569-577. doi: 10.1016/j.annonc.2023.04.516. Epub 2023 May 12.
**PMID:** 37179020
**Citation:** Trewick N, Neumann DL, Hamilton K. Effect of affective feedback and competitiveness on performance and the psychological experience of exercise within a virtual reality environment. PLoS One. 2022 Jun 8;17(6):e0268460. doi: 10.1371/journal.pone.0268460. eCollection 2022.
**PMID:** 35675309
**Citation:** Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
**PMID:** 3806354
**Citation:** Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008 Aug;40(3):879-91. doi: 10.3758/brm.40.3.879.
**PMID:** 18697684
**Citation:** World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
**PMID:** 24141714
**Citation:** Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.
**PMID:** 14506122
**Citation:** Lopez P, Galvao DA, Taaffe DR, Newton RU, Souza G, Trajano GS, Pinto RS. Resistance training in breast cancer patients undergoing primary treatment: a systematic review and meta-regression of exercise dosage. Breast Cancer. 2021 Jan;28(1):16-24. doi: 10.1007/s12282-020-01147-3. Epub 2020 Aug 19.
**PMID:** 32815096
**Citation:** Scheede-Bergdahl C, Minnella EM, Carli F. Multi-modal prehabilitation: addressing the why, when, what, how, who and where next? Anaesthesia. 2019 Jan;74 Suppl 1:20-26. doi: 10.1111/anae.14505.
**PMID:** 30604416
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-29
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 291458
- Type Abbrev: Prot
- Upload Date: 2024-05-20T09:53
## 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: BXM
- Name: Behaviors and Mental Disorders
### 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: T6034
- Name: Quality of Life
- 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:** NCT06429176
**Brief Title:** Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
**Official Title:** A Phase 2a, Randomized, Placebo-Controlled, Double Blind Multiple Ascending Dose Study in Patients With Cystic Fibrosis Carrying the 3849 +10 Kb C->T Mutation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84
#### Organization Study ID Info
**ID:** SPL84-002
#### Organization
**Class:** INDUSTRY
**Full Name:** SpliSense Ltd.
#### Secondary ID Infos
**ID:** 2024-511184-28
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** SpliSense Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation.
The purpose of this research study is to:
* test the safety and effectiveness of multiple doses of the study drug, SPL84
* test how multiple doses of the drug are processed by the body
Researchers will compare drug SPL84 to a placebo (a look-alike substance that contains no drug) to see if drug SPL84 is safe and if it works to treat CF.
Participants will:
Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 17.5 weeks for checkups and tests
### Conditions Module
**Conditions:**
- Cystic Fibrosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SPL84
**Label:** SPL84
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SPL84
**Description:** SPL84 solution for nebulization
**Name:** SPL84
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo solution for nebulization
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence, nature, and severity of AEs and SAEs
**Measure:** Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
**Time Frame:** Day 1 through Day 87
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
**Time Frame:** Day 1 through Day 87
**Description:** using an ECG machine that automatically calculates heart rate and measure PR, QRS, QT, and QTc intervals
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
**Time Frame:** Day 1 through Day 87
**Description:** Complete physical examinations include general appearance, head, ears, eyes, nose, throat, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
**Time Frame:** Day 1 through Day 87
**Description:** Pulmonary function tests will be performed according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) and forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced mid-expiratory flow (FEF25-75) will be measured
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal pulmonary function tests results
**Time Frame:** Day 1 through Day 87
**Description:** Sputum microbiology will be performed with a microbiology based assay; organism growth will be identified.
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal sputum microbiology results results
**Time Frame:** Day 1 through Day 87
**Description:** assessment of anti-SPL84 antibodies will be performed both in serum and sputum
**Measure:** Safety and Tolerability of SPL84 as assessed by number of participants with abnormal immunogenicity results
**Time Frame:** Day 1 through Day 87
#### Secondary Outcomes
**Measure:** Characterization of pharmacokinetics (PK) of SPL84: maximum serum concentration (Cmax)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of PK of SPL84: Time to Cmax (Tmax)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of PK of SPL84: terminal elimination half-life (t1/2)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of PK of SPL84: Apparent clearance (CL/F)
**Time Frame:** Predose and 15 and 30 minutes and 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 and Day 57; predose on Days 8 and 29; Days 64 and 87
**Measure:** Characterization of excretion of SPL84: concentration of SPL84 in urine
**Time Frame:** Day 1 through Day 87
**Description:** Pulmonary function tests will be performed according to the ATS/ERS
**Measure:** Preliminary efficacy of SPL84 as assessed by change from baseline in percent predicted FEV1
**Time Frame:** Day 1 through Day 87
**Description:** The score for is standardized on a 0- to 100-point scale on which higher scores represent a higher quality of life
**Measure:** Preliminary efficacy of SPL84 as assessed by change from baseline in Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score
**Time Frame:** Day 1 through Day 87
**Measure:** Preliminary efficacy of SPL84 as assessed by change from baseline in body weight
**Time Frame:** Day 1 through Day 87
**Measure:** Preliminary efficacy of SPL84 as assessed by change from baseline of antibiotic treatment
**Time Frame:** Day 1 through Day 87
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of CF and two CF causing mutations; 3849+10 Kb C-\>T mutation on one allele in the CF transmembrane conductance regulator (CFTR) gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required.
* Body mass index (BMI) of ≥ 17 kg/m2.
* FEV1 40-90% predicted at screening.
* Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report.
Exclusion Criteria:
* Use of Kalydeco, Orkambi, Symdeko/Symkevi or Trikafta/Kaftrio within 30 days of first dose with study intervention.
* Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention.
* Use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. Use of inhaled steroids above 1 mg.
* Use of CF medications, e.g. inhaled antibiotics, dornase alfa (Pulmozyme), hypertonic saline and physiotherapy should be on stable regimen for the period 28 days prior to screening; those participants taking inhaled antibiotics for prophylaxis must be on a stable regimen of these drugs for at least 90 days prior to first dose with study intervention.
* Any acute infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation, changes in therapy for pulmonary disease, or any non CF-related illness which results in the initiation of any new therapy within 14 days prior to first dose with study intervention.
* Hemoptysis of greater than 30 mL within 90 days prior to Day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention.
* Liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension.
* History of any organ transplantation.
* Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kathryn Monroe
- **Phone:** 205-638-5599
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Alabama at Birmingham
**State:** Alabama
**Status:** RECRUITING
**Zip:** 35233
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8485
- Name: Fibrosis
- Relevance: HIGH
- As Found: Fibrosis
- ID: M6755
- Name: Cystic Fibrosis
- Relevance: HIGH
- As Found: Cystic Fibrosis
- ID: M13102
- Name: Pancreatic 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: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1710
- Name: Cystic Fibrosis
- Relevance: HIGH
- As Found: Cystic Fibrosis
### Condition Browse Module - Meshes
- ID: D000003550
- Term: Cystic Fibrosis
- ID: D000005355
- Term: Fibrosis
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429163
**Acronym:** WINPLEX
**Brief Title:** Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
**Official Title:** Влияние прединцизионной инфильтрации ран и блокады гипогастрального нервного сплетения с использованием ропивакаина на болевой синдром после лапароскопической миомэктомии. Одноцентровое проспективное рандомизированное плацебо-контролируемое двойное слепое экспериментальное исследование
#### Organization Study ID Info
**ID:** WINPLEX
#### Organization
**Class:** OTHER
**Full Name:** Saint Petersburg State University, Russia
### Status Module
#### Completion Date
**Date:** 2024-11-04
**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:** 2024-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Saint Petersburg State University, Russia
#### Responsible Party
**Investigator Affiliation:** Saint Petersburg State University, Russia
**Investigator Full Name:** Nikita Kharlov
**Investigator Title:** Head of Gynecology department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the effectiveness of a comprehensive approach to anesthesia in patients with uterine myoma using pre-incisional infiltration of the anterior abdominal wall and presacral blockade of the hypogastric nerve plexus during laparoscopic myomectomy
**Detailed Description:** On admission, patients will complete the EQ-5D quality of life questionnaire to assess the level of problems including pain, anxiety and depression, as well as the level of quality of life in general. The Central Sensitization Inventory (CSI-R) is also completed.
Each patient is randomly assigned to one of three groups on admission: standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics), prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia or prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia. Randomisation is done in a 1:1:1 ratio. In the early postoperative period, a questionnaire is administered to patients to determine the intensity and nature of pain: hourly VAS value, localisation of pain and conditions of its onset are noted. At discharge, patients fill out the EQ-5D questionnaire and the Picker questionnaire to assess the patient's impressions of her hospital stay.
### Conditions Module
**Conditions:**
- Fibroid Uterus
- Pain, Postoperative
**Keywords:**
- Uterine fibroid
- Laparoscopic myomectomy
- Postoperative pain
- Pre-incisional infiltration
- Hypogastric plexus block
- EQ-5D questionnaire
- Picker questionnaire
- The Central Sensitization Inventory (CSI-R)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A single-centre prospective randomized placebo-controlled double-blind pilot study
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 198
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Standard variant of postoperative analgesia (systemic administration - intravenous, intramuscular, oral - non-steroidal anti-inflammatory drugs, paracetamol, opioid analgesics).
**Intervention Names:**
- Procedure: Infiltration of the anterior abdominal wall
- Procedure: Upper hypogastric plexus blockade
**Label:** Standart analgesia
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Prophylactic pre-incisional infiltration of the anterior abdominal wall + standard variant of postoperative analgesia
**Intervention Names:**
- Procedure: Infiltration of the anterior abdominal wall
**Label:** Pre-incisional infiltration
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Prophylactic pre-incisional infiltration of the anterior abdominal wall + presacral blockade + standard variant of postoperative analgesia
**Intervention Names:**
- Procedure: Upper hypogastric plexus blockade
**Label:** Presacral blockade
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pre-incisional infiltration
- Standart analgesia
**Description:** Infiltration of the anterior abdominal wall is performed with 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle.
**Name:** Infiltration of the anterior abdominal wall
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Presacral blockade
- Standart analgesia
**Description:** At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium.
**Name:** Upper hypogastric plexus blockade
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Frequency of severe pain syndrome (≥ 4 points on the visual analogue scale) in the postoperative period after laparoscopic conservative myomectomy.
**Measure:** Frequency of severe pain syndrome
**Time Frame:** In the postoperative period, an average of 2 days
#### Secondary Outcomes
**Description:** Timing of post-surgery mobilization (hours after surgery)
**Measure:** Mobilization
**Time Frame:** In the early postoperative period, an average of 24 hours
**Description:** Frequency of opioid analgesic requirements
**Measure:** Opioid analgesic
**Time Frame:** In the early postoperative period, an average of 24 hours
**Description:** A questionnaire is administered to patients to determine the nature of pain: localisation of pain and conditions of its onset are noted The questionnaire indicates the localisation of pain (anterior abdominal wall, small pelvis, right shoulder), the conditions of its occurrence (lying, standing, and during the stress test).
**Measure:** Localisation of pain syndrome
**Time Frame:** In the postoperative period, an average of 2 days
**Description:** patients fill out the EQ-5D questionnaire to assess the patient's impressions of her hospital stay. EQ-5D is a multidimensional tool for assessing the quality of life, which can be expressed using a single indicator - an index. In this regard, it is also called a health index. Each component is divided into three levels according to the severity of the problem: no problem, moderately severe problem, severe problem. Combining these levels in five components allows to get 243 variants of 'health status'. The second part of the questionnaire is a visual analogue scale, the so-called 'health thermometer'. This is a twenty-centimetre vertical graduated ruler with 0 representing the worst and 100 representing the best state of health.
**Measure:** Patients' satisfaction level
**Time Frame:** At discharge, an average 2 days after surgery
**Description:** The Picker Patient Experience Questionnaire is designed for patient evaluation of 7 aspects of care: information, consistency, psychological aspect, consideration of patient preferences, physical well-being, involvement of family and friends, and continuity of care laparoscopic myomectomy performed. The total score is calculated as a percentage (0 - no problem in any aspect, 100 - presence of problems in all domains).
**Measure:** level of problems on different aspects of functioning
**Time Frame:** At discharge, an average 2 days after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients with large nodal (≥ 6 cm) and/or multiple uterine myomas who are indicated for surgical treatment in the scope of laparoscopic myomectomy on the basis of the gynaecological department of the Pirogov Gynecological Centre of St. Petersburg State University,
* age - 18 years and over,
* informed consent of patients to participate in the research study
Exclusion Criteria:
* conversion to laparotomy,
* subserous uterine myoma 'on a pedicle' (type 7 according to FIGO),
* the start of the surgical intervention is after 15.00,
* presence of malignant diseases, diabetes mellitus, external genital endometriosis of 3-4 stage,
* presence of psychiatric and cognitive impairment in female patients that, in the opinion of the physician, precludes participation in the study,
* the need for abdominal drainage,
* severe adhesions in the sacral region
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Saint Petersburg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nikita Kharlov
- **Phone:** 89262839377
- **Role:** CONTACT
**Country:** Russian Federation
**Facility:** Saint Petersburg State University Hospital
**Status:** RECRUITING
## 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
- 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: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Pain, Postoperative
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Fibroid Uterus
- ID: M25846
- Name: Myofibroma
- Relevance: HIGH
- As Found: Fibroid Uterus
- 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
- 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
### Condition Browse Module - Meshes
- ID: D000007889
- Term: Leiomyoma
- ID: D000047708
- Term: Myofibroma
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M1700
- Name: Ropivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429150
**Brief Title:** Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
**Official Title:** Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy
#### Organization Study ID Info
**ID:** GIMI-IRB-24001
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Geno-Immune Medical Institute
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-07-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** The No.2 Clinical Hospital of the Ministry of Health
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Geno-Immune Medical 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 aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.
**Detailed Description:** Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.
BCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.
GPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.
This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.
### Conditions Module
**Conditions:**
- Multiple Myeloma
- Plasmacytoma
**Keywords:**
- multiple myeloma
- chimeric antigen receptor
- BCMA
- GPRC5D
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Biological: CAR-T cells
**Label:** CAR-T cells to treat MM
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CAR-T cells to treat MM
**Description:** Infusion of multi-CAR-T cells
**Name:** CAR-T cells
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0
**Measure:** Percentage of patients with treatment related adverse effects
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood
**Measure:** Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion
**Time Frame:** 1 year
**Description:** Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators
**Measure:** Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female subjects with multiple myeloma or plasmacytoma
* Strictly complete remission (sCR) is a treatment goal
* Expected survival \> 12 weeks
* After prior auto-SCT is eligible regardless of other prior therapies
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given and commitment to continued follow-up
Exclusion Criteria:
* Pregnant or lactating women
* Uncontrolled active infection
* Active HIV, hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Any medical conditions that may preclude participation
**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:** Lung-Ji Chang, ph.D
**Phone:** 86-0755 86725195
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lung-Ji Chang, ph.D
- **Phone:** 86-0755-86725195
- **Role:** CONTACT
***Contact 2:***
- **Name:** Vitaly Dubov, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shenzhen Geno-immune Medical Institute
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 518000
**Location 2:**
**City:** Vladivostok
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vitaly Dubov, MD
- **Phone:** 8(924)3321996
- **Role:** CONTACT
**Country:** Russian Federation
**Facility:** Hematologist of the Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
**Status:** RECRUITING
**Zip:** 690105
### 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: D000020141
- Term: Hemostatic Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010265
- Term: Paraproteinemias
- ID: D000001796
- Term: Blood Protein Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12058
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M27588
- Name: Neoplasms, Plasma Cell
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M13844
- Name: Plasmacytoma
- Relevance: HIGH
- As Found: Plasmacytoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13178
- Name: Paraproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M5077
- Name: Blood Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3947
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: T4587
- Name: Plasmacytoma
- Relevance: HIGH
- As Found: Plasmacytoma
### Condition Browse Module - Meshes
- ID: D000009101
- Term: Multiple Myeloma
- ID: D000054219
- Term: Neoplasms, Plasma Cell
- ID: D000010954
- Term: Plasmacytoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429137
**Brief Title:** A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
**Official Title:** A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects
#### Organization Study ID Info
**ID:** 1519-0001
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2023-510318-25-00
**Type:** REGISTRY
**Domain:** WHO International Clinical Trials Registry Platform (ICTRP)
**ID:** U1111-1304-0523
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**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:** Boehringer Ingelheim
#### 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 main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 4
**Type:** EXPERIMENTAL
#### Arm Group 5
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 5
**Type:** EXPERIMENTAL
#### Arm Group 6
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 6
**Type:** EXPERIMENTAL
#### Arm Group 7
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 7
**Type:** EXPERIMENTAL
#### Arm Group 8
**Intervention Names:**
- Drug: BI 3731579
**Label:** BI 3731579 dose group 8
**Type:** EXPERIMENTAL
#### Arm Group 9
**Intervention Names:**
- Drug: Matching placebo to BI 3731579
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BI 3731579 dose group 1
- BI 3731579 dose group 2
- BI 3731579 dose group 3
- BI 3731579 dose group 4
- BI 3731579 dose group 5
- BI 3731579 dose group 6
- BI 3731579 dose group 7
- BI 3731579 dose group 8
**Description:** BI 3731579
**Name:** BI 3731579
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Matching placebo to BI 3731579
**Name:** Matching placebo to BI 3731579
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
**Time Frame:** up to 14 days
#### Secondary Outcomes
**Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
**Time Frame:** up to 4 days
**Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
**Time Frame:** up to 4 days
**Measure:** Maximum measured concentration of the analyte in plasma (Cmax)
**Time Frame:** up to 4 days
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Boehringer Ingelheim
**Phone:** 1-800-243-0127
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.mystudywindow.com/msw/datatransparency
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Related Info
**URL:** http://www.mystudywindow.com
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429124
**Acronym:** TREAD
**Brief Title:** Time Restricted Eating in Alzheimer's Disease (TREAD)
**Official Title:** Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial
#### Organization Study ID Info
**ID:** HX-23-500-347-30-03
#### Organization
**Class:** OTHER
**Full Name:** St. Joseph's Hospital and Medical Center, Phoenix
### Status Module
#### Completion Date
**Date:** 2025-03-14
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Arizona State University
**Class:** OTHER
**Name:** Karlsruhe Institute of Technology
**Class:** OTHER
**Name:** Mayo Clinic
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Joseph's Hospital and Medical Center, Phoenix
#### 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 pilot and feasibility study will enable the research team to determine the feasibility of implementing a time-restricted eating regimen among adults with mild cognitive impairment (MCI) and the impact of time-restricted eating on cognitive performance and biomarkers of metabolic health in this population. Study staff will execute the specific aims using a pre-post, non-randomized study design in which all participants receive the intervention. The intervention is a 16/8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months. Assessments will be performed at baseline and after the 3-month time-restricted eating intervention with the following outcome measures.
Outcome measures for feasibility include participant recruitment, retention and metrics of acceptability, safety, and adherence to the intervention. Outcome measures for cognitive performance and metabolic health include neuropsychological tests, blood biomarkers, and surveys of psychological well-being.
**Detailed Description:** The goal of this pilot study on time restricted eating regimens in the mild cognitive impairment (MCI) patient population will be to determine the feasibility of implementing the intervention and impact of time-restricted eating on cognitive performance and biomarkers of metabolic health. Researchers at the Barrow Neurological Institute, Alzheimer\&#39;s Disease Program in collaboration with the Arizona State University College of Health Solutions will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of intervention.
Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Primary outcomes will include participant recruitment, retention, acceptability, safety, and adherence to the 16 hours of fasting and 8-hour eating window. Researchers hypothesize that participants who follow a time-restricted eating pattern will have improvements in attention, working memory and semantic fluency domains. Study staff hypothesize that there will be improvements or trends toward improvements in inflammatory and cardiometabolic biomarkers (i.e., interleukin-6, tumor necrosis factor alpha, C-reactive protein, insulin, hemoglobin A1c, and lipids).
The results of this project will provide critical preliminary data for a longer-term, large-scale, randomized controlled trial of time-restricted eating on cognitive trajectory among adults with MCI. The novel findings from the proposed project and future studies will contribute significantly to the body of knowledge that will advance the field, with the ultimate goal of preventing or delaying the progression of MCI to dementia.
### Conditions Module
**Conditions:**
- Intermittent Fasting
**Keywords:**
- Alzheimer's Disease
- Mild Cognitive Impairment
- Intermittent Fasting
- Nutritional Strategies
- Time Restricted Eating
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** We will execute the specific aims using a pre-post non-randomized study design in which all participants receive the intervention. Outcome assessments for specific aim 2 will include neuropsychological tests, blood biomarkers, and psychological well-being measured at baseline and after 3 months of intervention.
##### Masking Info
**Masking:** NONE
**Masking Description:** This study will not use any masking.
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.
**Intervention Names:**
- Behavioral: Dietary Intervention
**Label:** Interventional
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional
**Description:** Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.
**Name:** Dietary Intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Insulin resistance will be estimated using HOMA-IR.
**Measure:** Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** Feasibility will be assessed based on the average number of days per week that participants eat within the 8-hour eating window. The intervention goal is 5 or more days per week.
**Measure:** Average number of days per week of time-restricted eating
**Time Frame:** The eating window is assessed daily throughout the 3-month intervention.
#### Secondary Outcomes
**Description:** The Physical Activity and Sedentary Behavior Questionnaire will assess active time and time spent on exercise (PASB-Q; English Version) (Sattler et al., 2020)
**Measure:** Physical Activity and Sedentary Behavior Questionnaire Score
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Comprehensive Trail Making Test (CTMT) is a measure of organized visual search, attention, set shifting and divided attention (Reynolds 2002).
**Measure:** Memory as measured by the Comprehensive TrailMaking Test (CTMT)
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Mini Mental State Examination (MMSE) is used extensively in clinical and research settings to systematically measure and assess mental status. It is an 11- question measure that tests five areas of cognitive function: orientation, registration, attention, and calculation, recall, and language (Folstein et al., 1975).
**Measure:** Cognitive Impairment as measured by the Mini Mental State Examination (MMSE)
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Auditory Verbal Learning Test (AVLT) evaluates verbal memory by presenting a 15- word list five times followed by attempted recall. This is followed by a second 15-word recall interference list, followed by recall of the original list (Rey A. 1964).
**Measure:** Verbal Memory as Measured by the Auditory VerbalLearning Test (AVLT)
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Digit Span Forward/Backward is a subset of the Wechsler Adult Intelligence Scale (WAIS) that captures attention efficiency and working memory.
**Measure:** Working Memory as measured by the WAIS-IV Digit Span Forward/Backward
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT) is a 23 item questionnaire that measures ACT processes, including psychological flexibility (Francis et al., 2016).
**Measure:** Psychological Flexibility as Measured by the Comprehensive Assessment of Acceptance and Commitment Therapy Process (CompACT)
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Brief Resilience Scale (BRS) has 6 items and is a reliable means of assessing resilience as the ability to bounce back or recover from stress (Smith et al., 2008).
**Measure:** Brief Resilience Scale (BRS) Score
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Perceived Stress Scale (PSS) is used for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes questions about current levels of experienced stress (Cohen et al, 1983).
**Measure:** Perceived Stress Scale (PSS) Score
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire designed to measure sleep quality and disturbance over past month (Buysse et al.,1989).
**Measure:** Pittsburgh Sleep Quality Index (PSQI) Score
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** The WHO QOL has four domains (physical health, psychological, social relationships, and environment). The four domain scores denote an individual's perception of quality of life in each particular domain (WHOQOL Group, 1998).
**Measure:** WHO Quality of Life Questionnaire
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** Glycemic control will be assessed by hemoglobin A1c obtained via venipuncture.
**Measure:** Hemoglobin A1c
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention)
**Description:** Levels of inflammatory biomarkers will be assessed by C-reactive protein obtained via venipuncture.
**Measure:** C-reactive protein
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
**Description:** Study staff will be obtaining a participant blood pressure using an electronic blood pressure cuff.
**Measure:** Blood Pressure
**Time Frame:** Will be assessed at baseline (pre-intervention) and after the 3-month intervention (post-intervention).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. aged 60-80 years
2. meet Mayo Clinic Criteria for MCI
3. body mass index \>18.5 and \<40.0 kg/m2
4. access to the internet through computer or smart phone
5. supportive family member (e.g., spouse or adult child) who will help to facilitate study visits and intervention activities
6. education level \> 8 years
7. proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
Exclusion Criteria:
1. diabetes mellitus that requires insulin treatment or is not well managed
2. eating disorder
3. contraindication to time-restricted eating
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yonas E Geda, MD, MSc
**Phone:** 833-233-3073
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Geetika Chahal, MBBS
**Phone:** 602-406-7240
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Phoenix
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Susan Racette, Ph.D.
- **Phone:** 602-543-1563
- **Role:** CONTACT
**Country:** United States
**Facility:** Arizona State University, College of Health Solutions
**State:** Arizona
**Status:** RECRUITING
**Zip:** 85004
**Location 2:**
**City:** Phoenix
**Country:** United States
**Facility:** Barrow Neurological Institute, Division of Alzheimer's Disease
**State:** Arizona
**Status:** ENROLLING_BY_INVITATION
**Zip:** 85013
#### Overall Officials
**Official 1:**
**Affiliation:** Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division
**Name:** Yonas E Geda, MD, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The results of this proposed Barrow Neurological Foundation project will provide critical preliminary data for a future large-scale R01 grant application to the National Institutes of Health (NIH), but no individual participant data will be shared.
**IPD Sharing:** NO
### References Module
#### References
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**PMID:** 12724520
**Citation:** Anton SD, Lee SA, Donahoo WT, McLaren C, Manini T, Leeuwenburgh C, Pahor M. The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Nutrients. 2019 Jun 30;11(7):1500. doi: 10.3390/nu11071500.
**PMID:** 31262054
**Citation:** Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
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**Citation:** Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health. 1998 Sep;88(9):1337-42. doi: 10.2105/ajph.88.9.1337.
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**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.
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**Citation:** Carlson AJ, Hoelzel F. Apparent prolongation of the life span of rats by intermittent fasting. J Nutr. 1946 Mar;31:363-75. doi: 10.1093/jn/31.3.363. No abstract available.
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**Citation:** Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
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**Citation:** Dimitratos SM, German JB, Schaefer SE. Wearable Technology to Quantify the Nutritional Intake of Adults: Validation Study. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e16405. doi: 10.2196/16405.
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**Citation:** Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
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**Citation:** Francis, A. W., D. L. Dawson and N. Golijani-Moghaddam (2016).
**Citation:** Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider N. Effects of intermittent feeding upon body weight and lifespan in inbred mice: interaction of genotype and age. Mech Ageing Dev. 1990 Jul;55(1):69-87. doi: 10.1016/0047-6374(90)90107-q.
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**Citation:** Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider NL. Differential effects of intermittent feeding and voluntary exercise on body weight and lifespan in adult rats. J Gerontol. 1983 Jan;38(1):36-45. doi: 10.1093/geronj/38.1.36.
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**Citation:** Gudden J, Arias Vasquez A, Bloemendaal M. The Effects of Intermittent Fasting on Brain and Cognitive Function. Nutrients. 2021 Sep 10;13(9):3166. doi: 10.3390/nu13093166.
**PMID:** 34579042
**Citation:** Halagappa VK, Guo Z, Pearson M, Matsuoka Y, Cutler RG, Laferla FM, Mattson MP. Intermittent fasting and caloric restriction ameliorate age-related behavioral deficits in the triple-transgenic mouse model of Alzheimer's disease. Neurobiol Dis. 2007 Apr;26(1):212-20. doi: 10.1016/j.nbd.2006.12.019. Epub 2007 Jan 13.
**PMID:** 17306982
**Citation:** HARMAN D. Aging: a theory based on free radical and radiation chemistry. J Gerontol. 1956 Jul;11(3):298-300. doi: 10.1093/geronj/11.3.298. No abstract available.
**PMID:** 13332224
**Citation:** Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
**PMID:** 29653606
**Citation:** Lee SA, Sypniewski C, Bensadon BA, McLaren C, Donahoo WT, Sibille KT, Anton S. Determinants of Adherence in Time-Restricted Feeding in Older Adults: Lessons from a Pilot Study. Nutrients. 2020 Mar 24;12(3):874. doi: 10.3390/nu12030874.
**PMID:** 32213965
**Citation:** Martens CR, Rossman MJ, Mazzo MR, Jankowski LR, Nagy EE, Denman BA, Richey JJ, Johnson SA, Ziemba BP, Wang Y, Peterson CM, Chonchol M, Seals DR. Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults. Geroscience. 2020 Apr;42(2):667-686. doi: 10.1007/s11357-020-00156-6. Epub 2020 Jan 23.
**PMID:** 31975053
**Citation:** Mattson MP, Moehl K, Ghena N, Schmaedick M, Cheng A. Intermittent metabolic switching, neuroplasticity and brain health. Nat Rev Neurosci. 2018 Feb;19(2):63-80. doi: 10.1038/nrn.2017.156. Epub 2018 Jan 11. Erratum In: Nat Rev Neurosci. 2020 Aug;21(8):445.
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**Citation:** McCay CM, Crowell MF, Maynard LA. The effect of retarded growth upon the length of life span and upon the ultimate body size. 1935. Nutrition. 1989 May-Jun;5(3):155-71; discussion 172. No abstract available.
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**Citation:** Mitchell SJ, Bernier M, Mattison JA, Aon MA, Kaiser TA, Anson RM, Ikeno Y, Anderson RM, Ingram DK, de Cabo R. Daily Fasting Improves Health and Survival in Male Mice Independent of Diet Composition and Calories. Cell Metab. 2019 Jan 8;29(1):221-228.e3. doi: 10.1016/j.cmet.2018.08.011. Epub 2018 Sep 6.
**PMID:** 30197301
**Citation:** Ooi TC, Meramat A, Rajab NF, Shahar S, Ismail IS, Azam AA, Sharif R. Intermittent Fasting Enhanced the Cognitive Function in Older Adults with Mild Cognitive Impairment by Inducing Biochemical and Metabolic changes: A 3-Year Progressive Study. Nutrients. 2020 Aug 30;12(9):2644. doi: 10.3390/nu12092644.
**PMID:** 32872655
**Citation:** Ooi TC, Meramat A, Rajab NF, Shahar S, Sharif R. Antioxidant Potential, DNA Damage, Inflammation, Glycemic Control and Lipid Metabolism Alteration: A Mediation Analysis of Islamic Sunnah Intermittent Fasting on Cognitive Function among Older Adults with Mild Cognitive Impairment. J Nutr Health Aging. 2022;26(3):272-281. doi: 10.1007/s12603-022-1757-0.
**PMID:** 35297471
**Citation:** Reiman EM, Caselli RJ, Yun LS, Chen K, Bandy D, Minoshima S, Thibodeau SN, Osborne D. Preclinical evidence of Alzheimer's disease in persons homozygous for the epsilon 4 allele for apolipoprotein E. N Engl J Med. 1996 Mar 21;334(12):752-8. doi: 10.1056/NEJM199603213341202.
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**Citation:** Reynolds, C. R. (2002). Comprehensive trail-making test : examiner's manual. Austin, Tex., Pro-Ed.
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**Citation:** Rubinsztein DC, Frake RA. Yoshinori Ohsumi's Nobel Prize for mechanisms of autophagy: from basic yeast biology to therapeutic potential. J R Coll Physicians Edinb. 2016 Dec;46(4):228-233. doi: 10.4997/jrcpe.2016.403.
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**Citation:** Sattler MC, Jaunig J, Tosch C, Watson ED, Mokkink LB, Dietz P, van Poppel MNM. Current Evidence of Measurement Properties of Physical Activity Questionnaires for Older Adults: An Updated Systematic Review. Sports Med. 2020 Jul;50(7):1271-1315. doi: 10.1007/s40279-020-01268-x.
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**Citation:** Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
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**Citation:** Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
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**Citation:** Wilson, K. G., Sandoz, E. K., Kitchens, J., & Roberts, M. E. (2010).
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429111
**Brief Title:** Effectiveness and Safety in Maternal and Neonatal Outcomes in Water Birth.
**Official Title:** Effectiveness and Safety in Maternal and Neonatal Outcomes of Waterbirth Compared to Delivery in Women Using Epidural Analgesia
#### Organization Study ID Info
**ID:** water birth
#### Organization
**Class:** OTHER
**Full Name:** Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
### Status Module
#### Completion Date
**Date:** 2023-03-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-02-24
**Type:** ACTUAL
#### Start Date
**Date:** 2020-06-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Universitat Jaume I
**Class:** OTHER
**Name:** Hospital Universitario de la Plana
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
#### Responsible Party
**Investigator Affiliation:** Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
**Investigator Full Name:** Soledad Carregui Villar
**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:** Childbirth is a unique and non-transferable experience in the life of a woman, her partner and her family. It is a very intense process that requires accompaniment and, in the vast majority of cases, requires analgesic support in order to overcome this life event in an optimal and atraumatic way.
Among the analgesic methods for pain relief during the labor process, there are pharmacological and non-pharmacological methods. From the evidence we know that the most effective pharmacological method is epidural analgesia (EA), while the most recognized non-pharmacological method is immersion in hot water (bathtub) for dilatation and delivery, called waterbirth(WB) At present there is controversy and doubts about the increase in the number of interventions involving the use of epidural analgesia, but there is also controversy about the safety of the use of water, especially in those processes where the birth ends in water. Given the popularity of these two methods, the aim is to study and compare the maternal and neonatal outcomes derived from the use of both methods in order to provide greater knowledge to women in their decision making.
**Detailed Description:** At present there is controversy and doubts about the increase in the number of interventions involving the use of epidural analgesia(EA), but there is also controversy about the safety of the use of water, especially in those processes where the birth ends in water, called Waterbirth (WB). Given the popularity of these two methods, the aim is to study and compare the maternal and neonatal outcomes derived from the use of both methods in order to provide greater knowledge to women in their decision making.
For this purpose, a prospective observational study will be carried out in low-risk pregnant women (who do not present any complication at the time of delivery) who freely choose one or the other method at the beginning of their labor process. For this reason, the socio-demographic characteristics, the obstetric interventions carried out during the process, the results, the possible maternal and neonatal complications, aspects of breastfeeding, as well as the evaluation of the degree of satisfaction will be described and compared between the two groups.
The study was carried out at the Hospital Universitario La Plana, a referral center for normal childbirth, where the healthcare team has experience in the management of both methods. After obtaining the approval of the ethics committee (CEI), recruitment of the cases began and was carried out between June 2020 and February 2023. Overall, 642 cases were recruited, distributed in a total of 359 women who chose water immersion, of whom 40 women subsequently opted for epidural analgesia and 283 women who chose epidural analgesia initially. Women who completed the water birth totaled 263 cases.
The data concerning clinical variables were extracted from the electronic clinical records of the medical history of both the mother and the neonate and subsequently transcribed into a web portal designed to facilitate the transcription of the multiple variables. The final database is exploited from this web portal in Excel format and exported to the Statistical Package for Social Sciences (SPPSS) program version for subsequent analysis.
The variables collected for subsequent analysis are classified into sociodemographic variables, maternal clinical variables, neonatal clinical variables and satisfaction variables.
Satisfaction will be measured according to the Women's Satisfaction with Childbirth Experience Scale. Translated and validated version of the Mackey Satisfaction Childbirth Rating Scale. This scale, originally developed in English, measures women's satisfaction with the experience of childbirth and childbirth. It is a self-completed questionnaire, which is administered to the woman before discharge from the hospital. It consists of 34 items grouped into five subscales referring to the woman (9 items), the partner (2 items), the newborn (3 items), the midwife (9 items) and the obstetrician (8 items). It also contains a subscale for overall assessment of the experience (3 items). Each item is evaluated on a 5-point Likert scale ranging from very dissatisfied (1) to very satisfied (5), with a neutral central value. The final score of the scale is obtained by adding the values assigned to each item, so that the higher the score, the greater the satisfaction. Similarly, partial scores can be obtained for each subscale.
In our study, the obstetrician dimension was eliminated since in women in the waterbirth group the care offered during the process is carried out by the midwife and the women do not receive assistance from the physician.
OBJECTIVES
The General Objective of the study is to compare the effectiveness and safety of the use of water during dilatation and delivery versus the administration of epidural analgesia in low-risk women.
The Specific Objectives are:
. To describe and compare between the two groups the socio-demographic and obstetric characteristics of the pregnant women participating in the study (age, parity, weeks of gestation, type of breastfeeding chosen, level of education, country of origin, vagino-rectal colonization by beta-hemolytic streptococcus, weight of the NB, sex).
To describe and compare between the two groups the difference in obstetric interventions (administration of oxytocin, amniorrhexis, bladder catheterization, fetal calcium levels, need for other analgesic support during the process, episiotomy and position adopted by the mother for the birth).
* To describe and compare between both groups the maternal outcomes of the process (end of labor, dilatation time, expulsion time, perineal tears, duration of admission, visits to the emergency department during the first month of life).
* To describe and compare between both groups the possible maternal complications that occur in the process (instrumental delivery, cesarean section, Fetal Healt rate(FHR),alterations, III and IV degree tear, presence of obstetric emergency, intrapartum fever and puerperal infection).
* To describe and compare between both groups the neonatal outcomes (Apgar of the newborn at one minute, 5 and 10 minutes, cord arterial pH, venous arterial pH, base excess, need for neonatal ventilation support, admission to the neonatal unit or Neonatal Intensive care unit (NICU), reason and duration of admission).
* To describe and compare between both groups the initiation and evolution of breastfeeding (initial choice, breastfeeding at discharge, neonatal alertness at birth, type of latch, supplementation during hospital stay).
* To describe and compare between the two groups the degree of satisfaction with childbirth between the epidural and water use groups according to the validated Mackey Scale, assessing the dimensions of woman, partner, newborn, midwife and overall assessment of the experience.
TREATMENT OF SUBJECTS - SAMPLING TECHNIQUE
The non-probabilistic consecutive sampling technique will be used, offering the study to women who meet the inclusion criteria and have no exclusion criteria.
The women will be recruited in the Delivery Service when the pregnant woman finishes the delivery process, while still in the dilation room, and who meet the inclusion criteria and have no exclusion criteria. After the information, the patient will be offered an information sheet and the informed consent form to be signed before leaving the delivery room. The variable recorded in the form of the labor dilatation sheet of the mother's medical history that defines whether the woman is low risk at the time of delivery will be taken into account, this characteristic is defined in the partogram and is a mandatory field that is filled in by the professional to the question "candidate use of water" YES/NO to alert the researcher about the possible case to be considered in the study, this response is conditioned by the protocol for the use of water available at the Hospital de La Plana (the characteristics that indicate whether or not the use of water in childbirth is indicated are clearly defined). After delivery, the midwife will offer the woman the possibility of entering the study, offering her the information sheet and the informed consent form that she will have to sign before discharge from the hospital. In the event that the consent and information is not offered in the delivery service for any reason, it can be done later as long as it is before discharge from the hospital.
Entry into the study will not influence routine clinical practice, since it does not involve any action on the subjects under study. The intervention will be in the analysis of the variables to be studied, this implies the consent of the woman for the exploitation of the data from her Electronic Medical Record and that of her newborn through the forms that are usually used in all childbirth processes. On the other hand, it is necessary to fill in a satisfaction questionnaire, which will be given by the midwife before the woman leaves the delivery service. This questionnaire can be completed from the postpartum period until the woman is discharged from the hospital, and will be collected by the midwife who visits the hospital ward during the days that the woman remains hospitalized, before discharge.
. Before starting the study, a meeting will be held to review the protocol, the data collection booklet and the guidelines to be followed by the personnel involved in the study.
The researcher is committed to compliance with the Organic Law 3/2018, of December 5, on Personal Data Protection (LOPD) and guarantee of digital rights, published in the Boletin Oficial del Estado (BOE), as wel as Regulation (EU) 2016/679 of the European Parliament. The data collected for the study will be pseudonymized, so that it does not include information that can identify patients.
In accordance with Law 41/2002, of November 14, 2002, basic law regulating patient autonomy and rights and obligations regarding information and clinical documentation, all potential candidates will be given an informative document of the study and informed consent so that they can make a rational, free decision in accordance with their values and preferences. No patient can be included in the study without prior informed consent.
The investigator consents, when signing the protocol, to adhere to the instructions and procedures described in them and thus follow the principles of good clinical practice that they imply.
The investigator submitted the relevant documentation to the Research and Ethics Committee (CEI). The study was not initiated until CEI approval was obtained.
Similarly, the managers and the management team were informed for their express consent.
The safety of the study will be controlled through the delivery staff of the Hospital Universitario La Plana, since this study not modify the usual clinical practice by not performing any intervention required by the study in any of the groups.
In the design of the study, priority is given to not randomizing the sample, since ethically, the woman's ability to choose and the fulfillment of her expectations regarding childbirth are prioritized.
The researcher attaches a declaration of absence of conflict of interest. This study will be carried out according to the Standards of Good Clinical Practice and in accordance with the Declaration of Helsinki 1975, amended in 1983. Patients' names and initials will not be included.
DATA MANAGEMENT AND ARCHIVING OF RECORDS
The data necessary for carrying out the study will be collected from the Pregnancy Chart, which classifies whether the pregnant woman has any risk factors, from the hospital medical record entered in the Conficita program of the Hospital Universitario La Plana, where we will access the Obstetric Admission Sheet, the Dilatation-Delivery Sheet, the Newborn Sheet and the Neonatal Follow-Up Sheet in order to collect the variables described in the study. These variables will be collected in a Data Collection Notebook (Annex II).
Subsequently, these data will be collected in the SPSS database and stored in a Clinical Research File (FIC), included in the FIC of the research project of the Department of Health of the Hospital La Pana, attached to the FIC whose owner is the Conselleria de Sanitat. Only the researchers will have access to these data; their sole purpose will be to carry out the present study and the data analysis will be performed with the help of the SPSS statistical package for Windows.
On the occasion of the study, a file will be generated with all the documentation of the study, which will be kept by the researcher. The study documentation will be kept for the time required by current legislation, after which it will be destroyed according to the rules of the service on destruction of documents with personal information.
The investigator allows direct access to the data or source documents for monitoring, auditing and review by the IRB. The study may be audited by the Health Authorities during the study or even when the study is completed, to assess compliance with Good Clinical Practice guidelines.
No data revealing the identity of the patients should leave the center.
PUBLICATION POLICY
The results of the study will be the property of the investigator who will establish the publication policy. In addition, the anonymity of the patients participating in the study will be guaranteed at all times.
This work is a doctoral thesis of the Biomedical Sciences program of the Universitat Jaume I of Castellón, tutored by Dr. Eladio Collado Boira, Dr. Eva Moya Artuñedo and Dr. Ricardo Tosca Segura.
### Conditions Module
**Conditions:**
- Natural Childbirth
- Water Birth
- Neonatal Asphyxia
- Outcome, Adverse Birth
- Labor Pain
- Obstetric Pain
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 642
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors who meet criteria according to the protocol for the use of water and who choose epidural analgesia at the time of admission to the dilatation room in active labor.
* Over 17 years of age
* Psychic and cognitive capacity for decision making
* Willingness to take part in the study and signature of the informed consent form.
* Absence of ideomatic barrier
**Intervention Names:**
- Procedure: Epidural analgesia
**Label:** low-risk pregnant women who freely chooses to use epidural analgesia during labor
#### Arm Group 2
**Description:** Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors who meet criteria according to the protocol for the use of water and who choose immersion water at the time of admission to the dilatation room in active labor.
* Over 17 years of age
* Psychic and cognitive capacity for decision making
* Willingness to take part in the study and signature of the informed consent form.
* Absence of ideomatic barrier
**Intervention Names:**
- Procedure: Immersion water
**Label:** low-risk pregnant woman who freely chooses the use of water during childbirt
### Interventions
#### Intervention 1
**Arm Group Labels:**
- low-risk pregnant women who freely chooses to use epidural analgesia during labor
**Description:** Consists of a central nerve block by injecting a local anesthetic near the nerves that transmit pain, in the lumbar region, for pain relief during labor.
**Name:** Epidural analgesia
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- low-risk pregnant woman who freely chooses the use of water during childbirt
**Description:** Consists of the use of hot water immersion in a birthing tub during labor and/or delivery.
**Name:** Immersion water
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** How labor is terminated :
Normal in water Normal underwater Instrumented delivery Cesarean section
**Measure:** Completion of labor
**Time Frame:** 24 hours
**Description:** Yes/no intrapartum oxytocin required
**Measure:** intrapartum administration of oxytocin
**Time Frame:** 24 hours
**Description:** If intrapartum amniotomy is needed YES/NO
**Measure:** Amniotomy
**Time Frame:** 24 hours
**Description:** Frequency of non-reassuring or pathological episodes in the cardiotocographic recording.
(Scale)
**Measure:** presence of fetal heart rate abnormalities Frequency of non-reassuring or pathological episodes in the cardiotocographic recording.
**Time Frame:** 24 hours
**Description:** Number of times bladder catheterization is performed during the delivery process (Scale)
**Measure:** Number of bladder catheterizations
**Time Frame:** Up to 24 hours
**Description:** Determination of pH and lactate from fetal scalp blood to study the management of intrapartum fetal hypoxia. Only when when there is suspicion of risk of loss of fetal well-being due to a non-reassuring or pathological cardiotocographic monitor.
(Scale)
**Measure:** Number of scalp blood determinations
**Time Frame:** Up to 24 hours
**Description:** Presence of intrapartum fever YES/NO
**Measure:** Intrapartum fever
**Time Frame:** Up tu 24 hours
**Description:** An obstetric emergency is considered to be the occurrence of any episode of:
Cord rupture puerperal hemorrhage Shoulder impaction Manual removal of placenta Risk of loss of fetal well-being (Nominal)
**Measure:** Presence of obstetric emergency
**Time Frame:** Up to 24 hours
**Description:** Injury to the genital tract due to spontaneous trauma as a result of childbirth. These traumas are classified according to Sultan 1999 according to the injury produced:
First degree: Injury to the perineal skin and mucosa. Second degree: Injury to perineal muscles without affecting the anal sphincter. Third degree a.- Injury that reaches the external anal sphincter affecting less than 50%.
Third degree b.- Injury reaching the external anal sphincter affecting more than 50%.
Third degree c.- Injury reaching the complete external anal sphincter and internal anal sphincter.
Fourth degree: Injury to the external anal sphincter plus the internal anal sphincter plus the anal epithelium.
(Nominal)
**Measure:** Perineal tear
**Time Frame:** Up to 24 hours
**Description:** A one-minute assessment of five items that determine a numerical value called the "Apgar test" that evaluates cardiac activity, respiratory effort, reflexes, muscle tone and skin color.
If the value is less than or equal to 7, it is interpreted as a poor neonatal adaptation; if it is greater than 7, it is interpreted as an adequate adaptation.
(Scale)
**Measure:** Apgar score at one minuto of life of the neonate.
**Time Frame:** Up to 24 hours
**Description:** A five minutes assessment of five items that determine a numerical value called the "Apgar test" that evaluates cardiac activity, respiratory effort, reflexes, muscle tone and skin color.
If the value is less than or equal to 7, it is interpreted as a poor neonatal adaptation; if it is greater than 7, it is interpreted as an adequate adaptation.
(Scale)
**Measure:** Apgar score at five minuts of life of the neonate.
**Time Frame:** Up to 24 hours
**Description:** Value determining the analysis of blood samples from the umbilical cord artery after birth. The purpose of this analysis is to determine the degree of possible fetal hypoxia suffered by the newborn during delivery. The blood sample will be taken without clamping the umbilical cord in the case of late cord. A value lower than 7.10 can be interpreted as a higher risk of fetal hypoxia.
(Scale)
**Measure:** Arterial cord blood ph
**Time Frame:** Up to 24 hours
**Description:** If the neonate requires after birth support with positive ventilation, oxygen administration or intubation. YES/NO
**Measure:** Neonatal ventilation support
**Time Frame:** Up to 24 hours
**Description:** Presence of respiratory distress in the neonate during the first two hours of life.
YES/NO
**Measure:** Presence of distress neonatal
**Time Frame:** Up to 48 hours
**Description:** Describes if the neonate needs to be admitted to the neonatal unit. YES/NO
**Measure:** Neonatal admission
**Time Frame:** Up to 30 days
**Description:** Describes whether neonatal sepsis has occurred.YES/NO
**Measure:** Neonatal sepsis
**Time Frame:** Up to 30 days
**Description:** Describes whether the neonate has a diagnosis of hypoxic ischemic encephalopathy.
**Measure:** Presence of hypoxic ischemic encephalopathy
**Time Frame:** 1 month
**Description:** Presence of any type of maternal infection in the postpartum period (urinary tract infection, endometritis, mastitis or others), YES/NO
**Measure:** Maternal infection
**Time Frame:** Up to 1 month
**Description:** Type of breastfeeding established at hospital discharge:
Breastfeeding Artificial breastfeeding Mixed breastfeeding
**Measure:** Breastfeeding upon hospital discharge
**Time Frame:** Up to 1 week
**Description:** Number of urgent hospital visits made by the woman during the first postpartum month.
(Scale)
**Measure:** Visits to the hospital emergency department during the first month postpartum
**Time Frame:** Up to1 month
**Description:** Measured according to the validation of the Mackey Childbirth Satisfaction Rating Scale. It consists of 34 items grouped in five subscales referring to the woman (9 items), the partner (2 items), the newborn (3 items), the midwife (9 items) and the obstetrician (8 items). It also contains a subscale for overall assessment of the experience (3 items). Each item is evaluated on a 5-point Likert scale ranging from very dissatisfied (1) to very satisfied (5), with a neutral central value. The final score of the scale is obtained by adding the values assigned to each item, so that the higher the score, the greater the satisfaction. Similarly, partial scores can be obtained for each subscale.
The questionnaire is offered to the woman in the postpartum period and is collected before discharge from the hospital.
**Measure:** Maternal satisfaction
**Time Frame:** Up to 3 days
#### Secondary Outcomes
**Description:** cervical dilatation in centimeters at the time of analgesic method choice
**Measure:** cervical dilatation at the time of choice of analgesic method
**Time Frame:** Up to 24 hours
**Description:** vagino-rectal colonization with positive result for group B streptococcus at the time of delivery
**Measure:** group b streptococcus colonization during gestation
**Time Frame:** Up to 24 hours
**Description:** Duration in minutes of the dilation phase from admission to the delivery room until the beginning of the active expulsion period (Scale)
**Measure:** Duration of the dilatation phase
**Time Frame:** Up to 24 hours
**Description:** Duration in minutes of the active phase of the second stage of labor from the start of pushing to delivery.
**Measure:** Duration of the active second stage of labor
**Time Frame:** Up to 24 hours
**Description:** Type of pushes performed by the woman during the second stage of labor. They can be directed pushes or spontaneous pushes.
**Measure:** Type of expulsion
**Time Frame:** Up to 24 hours
**Description:** Management of third stage of labor:
* Active if oxytocin and directed labor are used
* Passive -physiologic management
**Measure:** Management of the third stage of labor
**Time Frame:** Up to 24 hours
**Description:** newborn birth weight expressed in grams
**Measure:** newborn birth weight
**Time Frame:** Up to 24 hours
**Description:** sex of the newborn
* male
* female
**Measure:** sex of the newborn
**Time Frame:** Up to 24 hours
**Description:** Breastfeeding chosen after birth
* Breastfeeding
* Artificial feeding
**Measure:** Breastfeeding chosen after birth
**Time Frame:** Up to 24 hours
**Description:** * Spontaneous onset
* Spontaneous onset
* Onset with maternal support
* Onset with professional help
* No initiation
**Measure:** Type of latch-on of the baby at the onset of breastfeeding during the first two hours postpartum
**Time Frame:** Up to 48 hours
**Description:** * Infectious risk
* Glycemic control
* Jaundice
* Feeding problems
* Fetal malformations
* Distress
* Neonatal Sepsis
* Transfer to neonatal ICU
* Other
* No admission
**Measure:** Reason for admission
**Time Frame:** Up to 1 month
**Description:** Number of times the baby is offered supplementation with formula during hospital stay (Scale)
**Measure:** Supplementation during hospital stay
**Time Frame:** At the time of hospital discharge
**Description:** Days the newborn stays in the hospital
**Measure:** Length of stay in days
**Time Frame:** At the time of hospital discharge
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors that preclude the use of water and epidural analgesia at the time of admission to the delivery room.
Pregnant women who are 18 years of age or older or who will turn 18 in the year of delivery.
* Have the psychic and cognitive capacity to make decisions.
* Desire to be part of the study and signature of informed consent to participate in the study.
Exclusion Criteria:
* .Presence of any maternal or fetal risk factor that precludes the choice of water or epidural analgesia at the time of admission to the dilation room in active labor.
Under 17 years of age or under 18 years of age in the year of delivery.
.Ideomatic barrier that makes it impossible for the patient to understand the study and to agree to the informed consent, .Unwillingness to participate or failure to sign the informed consent form.
**Maximum Age:** 46 Years
**Minimum Age:** 17 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** The Hospital Universitario La Plana is the reference center of the Health Department No. 3, is a regional hospital located in the city of Vila-real, province of Castellon.
Candidates for participation in the study are full-term pregnant women who meet the inclusion criteria and who are admitted to the dilation room during the active labor period in the Delivery Service of the Hospital Universitario La Plana during the period from April 2020 to June 2023.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Vila-real
**Country:** Spain
**Facility:** Hospital Universitario La Plana
**State:** Castellon
**Zip:** 12540
#### Overall Officials
**Official 1:**
**Affiliation:** Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
**Name:** Soledad Carregui Vilar, Midwife
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** We plan to publish the data available to other researchers, including the study protocol, the protocol for water use at la plana university hospital and the informed consent form.
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Cluett ER, Burns E, Cuthbert A. Immersion in water during labour and birth. Cochrane Database Syst Rev. 2018 May 16;5(5):CD000111. doi: 10.1002/14651858.CD000111.pub4.
**PMID:** 29768662
**Citation:** Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
**PMID:** 29781504
**Citation:** Shaw-Battista J. Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth? J Perinat Neonatal Nurs. 2017 Oct/Dec;31(4):303-316. doi: 10.1097/JPN.0000000000000260.
**PMID:** 28520654
**Citation:** Lewis L, Hauck YL, Butt J, Hornbuckle J. Obstetric and neonatal outcomes for women intending to use immersion in water for labour and birth in Western Australia (2015-2016): A retrospective audit of clinical outcomes. Aust N Z J Obstet Gynaecol. 2018 Oct;58(5):539-547. doi: 10.1111/ajo.12758. Epub 2018 Jan 17.
**PMID:** 29344940
**Citation:** Bovbjerg ML, Cheyney M, Caughey AB. Maternal and neonatal outcomes following waterbirth: a cohort study of 17 530 waterbirths and 17 530 propensity score-matched land births. BJOG. 2022 May;129(6):950-958. doi: 10.1111/1471-0528.17009. Epub 2021 Dec 1.
**PMID:** 34773367
**Citation:** Liu Y, Liu Y, Huang X, Du C, Peng J, Huang P, Zhang J. A comparison of maternal and neonatal outcomes between water immersion during labor and conventional labor and delivery. BMC Pregnancy Childbirth. 2014 May 6;14:160. doi: 10.1186/1471-2393-14-160.
**PMID:** 24886438
**Citation:** Yu M, Qian H, Gan M. Comparison of different interventions for the reduction of labor pain: A systematic review and network meta-analysis. Medicine (Baltimore). 2024 Mar 8;103(10):e37047. doi: 10.1097/MD.0000000000037047.
**PMID:** 38457589
**Citation:** McKinney JA, Vilchez G, Jowers A, Atchoo A, Lin L, Kaunitz AM, Lewis KE, Sanchez-Ramos L. Water birth: a systematic review and meta-analysis of maternal and neonatal outcomes. Am J Obstet Gynecol. 2024 Mar;230(3S):S961-S979.e33. doi: 10.1016/j.ajog.2023.08.034. Epub 2024 Jan 9.
**PMID:** 38462266
**Citation:** Seed E, Kearney L, Weaver E, Ryan EG, Nugent R. A prospective cohort study comparing neonatal outcomes of waterbirth and land birth in an Australian tertiary maternity unit. Aust N Z J Obstet Gynaecol. 2023 Feb;63(1):59-65. doi: 10.1111/ajo.13555. Epub 2022 Jul 7.
**PMID:** 35796252
**Citation:** Zhang G, Yang Q. Comparative Efficacy of Water and Conventional Delivery during Labour: A Systematic Review and Meta-Analysis. J Healthc Eng. 2022 Mar 29;2022:7429207. doi: 10.1155/2022/7429207. eCollection 2022.
**PMID:** 35392147
**Citation:** Ulfsdottir H, Saltvedt S, Edqvist M, Georgsson S. Management of the active second stage of labor in waterbirths compared with conventional births - a prospective cohort study. Midwifery. 2022 Apr;107:103283. doi: 10.1016/j.midw.2022.103283. Epub 2022 Feb 8.
**PMID:** 35172265
**Citation:** Reviriego-Rodrigo E, Ibargoyen-Roteta N, Carregui-Vilar S, Mediavilla-Serrano L, Uceira-Rey S, Iglesias-Casas S, Martin-Casado A, Toledo-Chavarri A, Ares-Mateos G, Montero-Carcaboso S, Castello-Zamora B, Burgos-Alonso N, Moreno-Rodriguez A, Hernandez-Tejada N, Koetsenruyter C. Experiences of water immersion during childbirth: a qualitative thematic synthesis. BMC Pregnancy Childbirth. 2023 May 29;23(1):395. doi: 10.1186/s12884-023-05690-7.
**PMID:** 37248449
**Citation:** Burns E, Feeley C, Hall PJ, Vanderlaan J. Systematic review and meta-analysis to examine intrapartum interventions, and maternal and neonatal outcomes following immersion in water during labour and waterbirth. BMJ Open. 2022 Jul 5;12(7):e056517. doi: 10.1136/bmjopen-2021-056517. Erratum In: BMJ Open. 2022 Sep 27;12(9):e056517corr1.
**PMID:** 35790327
**Citation:** Vanderlaan J, Hall P. Systematic Review of Case Reports of Poor Neonatal Outcomes With Water Immersion During Labor and Birth. J Perinat Neonatal Nurs. 2020 Oct/Dec;34(4):311-323. doi: 10.1097/JPN.0000000000000515.
**PMID:** 33079805
**Citation:** Ulfsdottir H, Saltvedt S, Georgsson S. Women's experiences of waterbirth compared with conventional uncomplicated births. Midwifery. 2019 Dec;79:102547. doi: 10.1016/j.midw.2019.102547. Epub 2019 Sep 30.
**PMID:** 31610362
**Citation:** Committee Opinion No. 679 Summary: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):1198-1199. doi: 10.1097/AOG.0000000000001765.
**PMID:** 27776069
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000003643
- Term: Death
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000007232
- Term: Infant, Newborn, Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- 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: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M26008
- Name: Labor Pain
- Relevance: HIGH
- As Found: Labor Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M4545
- Name: Asphyxia Neonatorum
- Relevance: HIGH
- As Found: Neonatal Asphyxia
- ID: M4544
- Name: Asphyxia
- Relevance: HIGH
- As Found: Asphyxia
- ID: M14127
- Name: Pregnancy Complications
- Relevance: HIGH
- As Found: Outcome, Adverse Birth
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, 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: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: T513
- Name: Asphyxia Neonatorum
- Relevance: HIGH
- As Found: Neonatal Asphyxia
### Condition Browse Module - Meshes
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000001238
- Term: Asphyxia Neonatorum
- ID: D000048949
- Term: Labor Pain
- ID: D000001237
- Term: Asphyxia
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429098
**Brief Title:** Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
**Official Title:** Study of A Venetoclax-based, Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβ::MYH11-positive Acute Myeloid Leukemia
#### Organization Study ID Info
**ID:** 2023371
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital of Soochow University
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2023-12
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Affiliated Hospital of Soochow University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.
**Detailed Description:** Primary Objectives:
To determine the CR (complete remission) / CRi (complete remission with incomplete blood count recovery) rate of 2 cycles of VEN/HMA in patients with newly diagnosed (ND) CBFβ::MYH11-positive acute myeloid leukemia(AML).
Secondary Objectives:
1. To determine the overall response rate (ORR) of 2 cycles of VEN/HMA in patients with ND CBFβ::MYH11-positive AML.
2. To determine the safety of the combination regimen.
3. To study the trajectories of molecular measurable residual disease (MRD) during the therapy.
4. To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen.
5. To assess the duration of response, overall survival (OS) and event free survival (EFS) of patients.
OUTLINE:
INDUCTION:
Patients with newly diagnosed CBFβ::MYH11(+) AML receive 2 cycles of VEN/HMA as induction therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously (SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5.
CONSOLIDATION:
Patient fitness will be reassessed according to the Ferrara criteria if CR or CRi is achieved after 2 cycles of VEN/HMA. Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3) combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA until disease progression.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
### Conditions Module
**Conditions:**
- Acute Myeloid Leukemia
**Keywords:**
- venetoclax
- acute myeloid leukemia
### 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:** INDUCTION: Patients receive 2 cycles of VEN/HMA as induction therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously (SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5.
CONSOLIDATION: Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3) combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA until disease progression.
**Intervention Names:**
- Drug: Venetoclax
- Drug: azacitidine
- Drug: decitabine
- Drug: Cytarabine
**Label:** Venetoclax, Azacitidine/Decitabine/, Cytarabine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Venetoclax, Azacitidine/Decitabine/, Cytarabine
**Description:** Given PO, once daily. Treatment in cycle 1, the dose is 100 mg on day 1, then ramp up to 400mg. In all subsequent cycles, the dose of venetoclax is initiated at 400 mg daily.
**Name:** Venetoclax
**Other Names:**
- ABT-199
- ABT199
- Venclexta
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Venetoclax, Azacitidine/Decitabine/, Cytarabine
**Description:** Given SC
**Name:** azacitidine
**Other Names:**
- 5 AZC
- 5-AZC
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Venetoclax, Azacitidine/Decitabine/, Cytarabine
**Description:** Given IV
**Name:** decitabine
**Other Names:**
- Dacogen
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Venetoclax, Azacitidine/Decitabine/, Cytarabine
**Description:** Given IV
**Name:** Cytarabine
**Other Names:**
- 1-.beta.-Cytosine arabinoside
- Ara-C
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** CR/CRi rate will be determined.
**Measure:** composite complete remission rate
**Time Frame:** after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).
#### Secondary Outcomes
**Description:** ORR will be determined.
**Measure:** Overall response rate (ORR)
**Time Frame:** after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).
**Description:** Safety profile based on NCI CTCAE version 5.0 will be determined.
**Measure:** Incidence of adverse events
**Time Frame:** From the start of treatment until death or last follow-up, assessed for up to 3 years.
**Description:** MRD will be assessed by real-time qRCR.
**Measure:** measurable residual disease (MRD) negativity
**Time Frame:** From the start of treatment until death or last follow-up, assessed for up to 3 years.
**Description:** The impact of concurrent gene mutations ( analysis via an 81-gene institutional next-generation sequencing platform) on response and the survival of the combination regimen will be assessed.
**Measure:** Impact of concurrent gene mutations
**Time Frame:** Baseline
**Description:** OS will be assessed.
**Measure:** Overall survival (OS)
**Time Frame:** From the start of treatment until death or last follow-up, assessed for up to 3 years.
**Description:** EFS will be assessed.
**Measure:** Event-free survival (EFS)
**Time Frame:** up to 3 years.
**Description:** DOR will be assessed.
**Measure:** Duration of response (DOR)
**Time Frame:** up to 3 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults ≥ 18 years.
2. Newly diagnosed CBFβ::MYH11(+) AML.
3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
4. Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures.
Ferrara's criteria are used to determine whether a patient is unfit, and a patient is deemed unfit if at least one of the following criteria is met:
1. Age\>75 years.
2. There are serious underlying heart, lung, kidney, liver complications.
3. There are active infections that do not respond to anti-infective therapy.
4. There is cognitive impairment.
5. Other comorbidities that the doctor determines are not suitable for intensive chemotherapy.
Exclusion Criteria:
1. Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell count).
2. Pregnant or lactating women.
3. To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the required study procedures.
4. Other conditions deemed unsuitable for participation in this study by the investigator.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ying Wang
**Phone:** 008613656214782
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Suzhou
**Contacts:**
***Contact 1:***
- **Name:** Zhou-lin Lu
- **Phone:** 008613914086271
- **Role:** CONTACT
**Country:** China
**Facility:** Ethical Committee of the First Affiliated Hospital of Soochow University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 215000
**Location 2:**
**City:** Suzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ying Wang
- **Phone:** 008613656214782
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 215000
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital of Soochow University
**Name:** Ying Wang
**Role:** PRINCIPAL_INVESTIGATOR
## 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 - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000004791
- Term: Enzyme Inhibitors
### 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: M6766
- Name: Cytarabine
- Relevance: HIGH
- As Found: Multi-
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: Hepatocellular Carcinoma
- ID: M4673
- Name: Azacitidine
- Relevance: HIGH
- As Found: Frequency
- ID: M1697
- Name: Decitabine
- Relevance: HIGH
- As Found: ?
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003561
- Term: Cytarabine
- ID: D000001374
- Term: Azacitidine
- ID: D000077209
- Term: Decitabine
- ID: C000579720
- Term: Venetoclax
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429085
**Acronym:** RAPPER IV
**Brief Title:** Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV
**Official Title:** Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV
#### Organization Study ID Info
**ID:** Protocol Version 2.0
#### Organization
**Class:** OTHER_GOV
**Full Name:** East Kent Hospitals University NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2020-03-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2018-12-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Rex Bionics
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** East Kent Hospitals University NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Multiple Sclerosis (MS) poses challenges to balance and mobility, impacting the daily lives of affected individuals. The RAPPER IV study is a clinical trial to evaluate a balance and mobility training intervention supported by a powered Rex robotic exoskeleton for people living with MS.
Aims and objectives:
This study aims to gain an insight into the potential health benefits of using a Rex robot to assist in a neuro-rehabilitation intervention program focused on improving balance and functional mobility with supervision from a specialist clinician.
Objectives
* to evaluate the feasibility of using the Rex robotic walking device for rehabilitation with people who have mobility restrictions due to Multiple Sclerosis (MS)
* to assess and evaluate the clinical effectiveness of a 5-week robotic assisted exercise program focused on core stability exercises, balance and walking using patient related outcome measures
* to gain an insight into the experiences of participants and their spouses of using the robotic walking device for rehabilitation and how this has impacted on their lives
A single cohort group of 20 people who were living with MS who met trial eligibility criteria were recruited. A variety of clinical outcome measurements were taken pre, during and post trial and results were analysed by a statistician.
**Detailed Description:** The key research questions:
* Is it feasible for a person with balance and mobility impairment caused by MS to use a robotic walking device to exercise in standing and walking with supervision safely?
* What are the key outcome measures most sensitive to measurable change in this study population sample, which may reflect potential improvement during the trial period? (Clinical outcome scales and self-reported questionnaires)
* Is this robotic assisted balance and mobility training program feasible, safe and effective?
* Does the completion of this balance and mobility exercise treatment intervention result in measurable improvements in balance, mobility, spasticity, lower limb joint range of movement and achievable individual patient goals?
To answer these questions, we invited 20 people diagnosed with MS (as defined by "McDonald" criteria, Polman et al, 2011) to undertake a 5-week balance exercise intervention program supported by the use of the Rex robotic walking device, designed to strengthen their postural body and leg muscles and improve their balance.
Participants were monitored and progressed on an individual basis throughout the treatment program as appropriate and a range of standardised assessments, questionnaires and relevant clinical outcome scales were used to capture and measure change related to this trial.
Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance, mobility and cardiovascular fitness for people living with MS.
A purposive sample of 20 adults, who have a primary diagnosis of MS, aged between 18 and 80 years old, with an Expanded Disability Status Scale (EDSS) as defined by Kurtzke (1983), with scores between 4 and 6.5 were recruited into this study.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
**Keywords:**
- Balance
- Core stability
- Mobility
- Powered exoskeleton
- Neuro-rehabilitation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance and mobility for people living with MS.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Use of powered Rex robotic exoskeleton to enable the practice of core stability balance exercises
**Intervention Names:**
- Device: Rex robotic assisted balance exercises
**Label:** People diagnosed with Multiple Sclerosis
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- People diagnosed with Multiple Sclerosis
**Description:** Individual is supported by a Rex robotic exoskeleton which enables assisted and supervised practise of balance exercises. This intervention took place as a supported and supervised series of 5 sessions over 5 weeks as an Out-patient.
**Name:** Rex robotic assisted balance exercises
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Timed transfer into the Rex device with appropriate level of assistance
**Measure:** Timed transfer into the Rex device
**Time Frame:** Time point 1 - Week 1
**Description:** Completion of sit to stand and stand to sit within the Rex device with hands on assistance from trial therapist
**Measure:** Completion of sit to stand and stand to sit within the Rex device
**Time Frame:** Time point 1 - Week 1
**Description:** Completion of 1 Rex robotic assisted balance rehabilitation exercise session with hands on assistance from trial therapist
**Measure:** Completion of 1 Rex robotic assisted balance rehabilitation exercise session
**Time Frame:** Time point 1 - Week 1
**Description:** Number of individuals screened and those eligible who entered the trial and those who completed the trial
**Measure:** Screening loss analysis
**Time Frame:** End of recruitment period - Week 30
#### Secondary Outcomes
**Description:** Timed up and Go
**Measure:** Timed up and Go
**Time Frame:** Time point 1 - Week 1
**Description:** Berg Balance Scale
**Measure:** Berg Balance Scale
**Time Frame:** Measured at 3 time points: Weeks 1, 6 and 10
**Description:** Visual Analog Scale (Pain)
**Measure:** Visual Analog Scale (Pain)
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Balance and falls risk
**Measure:** Modified Falls Efficacy Scale
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Balance and confidence in balance
**Measure:** Activities-specific Balance Confidence scale
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Perception of impact of spasticity on life
**Measure:** Spasticity Impact Scale
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Perceived Health Related Quality of Life
**Measure:** EQ-5D-5L
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Perceived impact of MS on life
**Measure:** MSIS-29
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Joint range of movement
**Measure:** Joint range of movement
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
**Description:** Goal Attainment Scale
**Measure:** Goal Attainment Scale
**Time Frame:** Set at Week 1 and measured and reviewed at Week 25
**Description:** Modified Ashworth Scale for muscle spasticity
**Measure:** Modified Ashworth Scale
**Time Frame:** Measured at 2 time points: Weeks 1 and 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* • Are aged greater than 18 years and less than 80 years
* Have a confirmed diagnosis of MS by a Consultant Neurologist as per McDonald Criteria.
* Have moderate mobility restriction as defined by an Extended Disability Status Scale (EDSS) score of between 4 to 6.5
* Ten participants to be recruited from EDSS 4 to 5.5
* Ten participants to be recruited from EDSS 5.5 to 6.5
* Within the anthropometric requirements of the REX device (See 'RAPPER III- MS 014 TF-04 v 3.0 REX Clinical Assessment Guide A4' for details of weight, height, size and range of motion requirements)
* Offer written informed consent to take part in the study
Exclusion Criteria:
* a history of osteoporosis or osteoporosis related bone fractures.
* skin integrity issues that could be adversely affected by the REX device
* severe hypertonia (spasticity) as indicated by a score equal to or greater than 4 on the modified Ashworth scale for any muscle in their lower limbs.
* a behavioural, cognitive or communication impairment which could interfere with the ability to participate in a rehabilitation program, as noted during screening (e.g., agitation, inability to follow two step commands)
* are unable or unwilling to provide informed consent
* are considered medically unsuitable for rehabilitation in the opinion of the screening medical specialist
* a known allergy (skin contact) to materials used in Rex
* are pregnant
* taking part in any other medical research trial at the same time
**Maximum Age:** 79 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Canterbury
**Country:** United Kingdom
**Facility:** East Kent Hospitals University NHS Trust
**State:** Kent
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003 Nov 8;362(9395):1517-26. doi: 10.1016/S0140-6736(03)14738-1.
**PMID:** 14615106
**Citation:** Straudi S, Fanciullacci C, Martinuzzi C, Pavarelli C, Rossi B, Chisari C, Basaglia N. The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial. Mult Scler. 2016 Mar;22(3):373-84. doi: 10.1177/1352458515620933. Epub 2015 Dec 10.
**PMID:** 26658817
**Citation:** Bethoux F, Bennett S. Introduction: enhancing mobility in multiple sclerosis. Int J MS Care. 2011 Spring;13(1):1-3. doi: 10.7224/1537-2073-13.1.1. No abstract available.
**PMID:** 24453699
**Citation:** Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
**PMID:** 23669008
**Citation:** Donze C. Update on rehabilitation in multiple sclerosis. Presse Med. 2015 Apr;44(4 Pt 2):e169-76. doi: 10.1016/j.lpm.2014.10.019. Epub 2015 Mar 4.
**PMID:** 25746432
**Citation:** Wiles CM, Newcombe RG, Fuller KJ, Shaw S, Furnival-Doran J, Pickersgill TP, Morgan A. Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):174-9. doi: 10.1136/jnnp.70.2.174.
**PMID:** 11160464
**Citation:** Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
**PMID:** 17875557
**Citation:** Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.
**PMID:** 28629390
**Citation:** Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
**PMID:** 6685237
**Citation:** Sakel M, Saunders K, Hodgson P, Stephensen D, Phadke CP, Bassett PA, Wilkinson D. Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). J Rehabil Med. 2022 Dec 9;54:jrm00357. doi: 10.2340/jrm.v54.4544.
**PMID:** 36484722
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000012598
- Term: Sclerosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429072
**Acronym:** I-MASS
**Brief Title:** Integration of Mindfulness and Acupuncture After Spine Surgery
**Official Title:** Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2
#### Organization Study ID Info
**ID:** Pro00114814
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-04
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The Integration of mHealth Mindfulness and auricular Acupuncture (AA) for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to address postsurgical pain.
This is a single-site, two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery. Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app (the mHealth platform used for delivering mindfulness training and collecting data). Outcomes will focus on feasibility and acceptability of I-MASS, feasibility of recruitment and retention strategies, and data collection procedures through both the Lift app and electronic health record. Feasibility will be supported by mindfulness module completion rates, acupuncture visits attended, participant retention, and questionnaire completion rates. Acceptability will be supported by patient-reported satisfaction, acceptability and usability thresholds.
**Detailed Description:** Participants will be randomized to one of two study arms: 1) the I-MASS program plus enhanced education or 2) the enhanced education intervention only.
Overview of I-MASS: The I-MASS program includes pre-surgical and post-surgical components. I-MASS begins with one introductory telephone call by a mindfulness coach (co-I Gremore) within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and AA, discuss how to access the Healthwise educational content, and lead a brief (\~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery). The initial AA session will occur within one week prior to surgery. The second AA session will occur within the first week following surgery. Afterwards, participants will receive AA in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery. The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between AA sessions. Using push notifications, the Pattern Health app will remind patients when they are within their window for AA treatment.
Details of AA delivery: AA will be performed by formally trained and certified acupuncturists in the community contracted with Duke to provide services for this trial. AA will involve the placement of needles in up to 5 sites (Cingulate Gyrus, Thalamus, Omega 2, Shen Men, and Point Zero) on each ear corresponding to the previously developed battlefield acupuncture protocol to treat pain. Points are always inserted in the same order and the number of needles inserted is determined by the patient's change in pain level. The AA protocol includes pain assessment before starting, after each needle is placed as that informs how many needles are placed, and at the end of the session. The protocol will include use of semi-permanent needles (Seirin Pyonex press-tacks (0.2x1.5mm) or ASP needles). These needles can remain in place for several days for continued pain relief. Participants will be instructed to remove the needles 2 days before their next visit, or sooner if site irritation or soreness warrants. Prior research has demonstrated consistency of acupuncture outcomes across different providers, however the specific components of each acupuncture treatment will be recorded according to the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to allow for post-hoc assessment of treatment fidelity. Follow-up acupuncture visits will be scheduled with the study acupuncturists. If participants are unable to tolerate aurcular acupuncture, they will be offered the option of a more traditional full body acupuncture protocol focused on pain management.
Details of the Pattern Health app and mHealth mindfulness training: Mindfulness training via the Pattern Health app will be modeled after the protocol used in prior studies of this app with patients recovering from critical illness. Introductory call. All participants in the I-MASS treatment arm will receive an initial introductory call with a mindfulness coach. Each \~30-minute introductory call will be composed of four parts: (1) brief discussion about participants' major current stressor(s); (2) rationale and discussion of the didactic focus; (3) practice and review, and (4) discussion about participant's use of mindfulness skills, challenges in applying the skills, how these skills integrate with the use of AA, and how to maintain progress. The coach will answer questions about use and navigation of the app, and review the overall timeline for completion of the self-directed modules. Mindfulness modules. Study participants will complete 4 self-directed mindfulness training modules (called the Lift program) through the Pattern Health app (1 prior to surgery, 3 following surgery). The training will include a guided series of videos, audio files and interactive text features. Each week-long module includes daily sessions comprised of a short (4-5 min) background video, a 6-8 min guided mediation (users could choose either a female or male voice) and interactive suggestions for how to apply mindfulness within their daily routine (\~10-12 min total per session). The pre-operative training (module 1) focuses on developing an awareness of breath, which is a fundamental mindfulness technique. Following surgery, participants will initiate training module 2, building awareness of body systems, followed by modules 3 and 4 over the subsequent 2 weeks. Automated activity reminders in the app will alert the participant to complete the daily session. Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules. Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain, giving participants an opportunity to reflect on their experiences during the AA session.
Enhanced Education: The program consists of education prior to and after surgery for all participants. This will constitute the only intervention in the education only arm. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healtwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.
Participants in the trial will not be prevented from receiving any other care deemed necessary by their health care team and surgeon. This program is designed to complement their usual care, not replace it.
Participant involvement with the study will be complete at 3 months following surgery. The will be able to receive up to 8 acupuncture sessions total (cost covered by the study) during their time in the study. All questionnaires will be administered through the Pattern Health app.
### Conditions Module
**Conditions:**
- Single Level Spinal Fusion
- Discetomy
- Laminectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### 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:** Integrated program that combines Mindfulness Based Stress Reduction (MBSR) delivered via mobile app (mHealth) with auricular Acupuncture (AA) in individuals undergoing Spine Surgery (I-MASS) plus enhanced education. I-MASS begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and AA (auricular acupuncture), discuss how to access the Healthwise educational content, and lead a brief (\~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery).
**Intervention Names:**
- Behavioral: Mindfulness Based Stress Reduction (MBSR)
- Other: Auricular acupuncture
- Behavioral: Enhanced education
**Label:** I-MASS Program plus Enhanced Education
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The program consists of education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healthwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.
**Intervention Names:**
- Behavioral: Enhanced education
**Label:** Enhanced Education Intervention Only
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- I-MASS Program plus Enhanced Education
**Description:** Each mindfulness module is anticipated to last one week and includes a short (4-5 min) introductory video, daily sessions comprised of a 6-8 min guided mediation, and interactive suggestions for how to apply mindfulness within a daily routine (\~10-12 min total per daily session).
**Name:** Mindfulness Based Stress Reduction (MBSR)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- I-MASS Program plus Enhanced Education
**Description:** This technique involves inserting tiny needles in specific areas of the outer ear to target points believed to influence pain.
**Name:** Auricular acupuncture
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Enhanced Education Intervention Only
- I-MASS Program plus Enhanced Education
**Description:** Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain.
**Name:** Enhanced education
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The CSQ-8 assesses credibility and satisfaction with health-related services (8 items, 4-point Likert, with higher scores indicating higher credibility/satisfaction).
**Measure:** Client Satisfaction Questionnaire (CSQ-8)
**Time Frame:** up to 6 months
**Description:** The SUS is ten-item attitude Likert scale (5 response options; from Strongly agree to Strongly disagree) giving a global view of subjective assessments of usability. It provides a single score on a scale of 0-100, with higher scores indicating better usability.
**Measure:** System Usability Scale (SUS)
**Time Frame:** up to 6 months
#### Secondary Outcomes
**Description:** Measure of self-reported physical function that uses 4 items of the 29-item PROMIS short form. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.
**Measure:** PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function
**Time Frame:** up to 6 months
**Description:** The BPI uses a 0 to 10 numeric rating scale for item rating. Pain severity can be measured from the average of the four severity items: 1-4 = Mild Pain, 5-6 = Moderate Pain, 7-10 = Severe Pain
**Measure:** Brief Pain Inventory 4-item Severity Scale (BPI)
**Time Frame:** up to 6 months
**Description:** The PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five.
**Measure:** PROMIS Pain Interference
**Time Frame:** up to 6 months
**Description:** OSPRO-YF is a 10-item multidimensional assessment tool for general and pain-related psychological distress. The tool is capable of accurately estimating scores on 11 full-length psychological questionnaires measuring constructs of depression, anxiety, anger, fear avoidance beliefs for work and physical activity, kinesiophobia, pain anxiety, self-efficacy for rehabilitation, pain self-efficacy and chronic pain acceptance.
**Measure:** Optimal Screening for Prediction of Referral and Outcome Yellow Flag (OSPRO-YF) Assessment Tool
**Time Frame:** up to 6 months
**Description:** PROMIS Sleep Disturbance measures concepts such as trouble staying asleep, not getting enough sleep, restlessness, feeling refreshed after sleep, and difficulty falling asleep in 'the past 7 days'.
**Measure:** PROMIS Sleep Disturbance
**Time Frame:** up to 6 months
**Description:** The Q-LES-Q is a validated 14-item scale to measure satisfaction with function at work, household duties, school, leisure, social relations, and general activities over the past week.
**Measure:** Quality of Life Enjoyment and Satisfaction Questionnaire (QLES- Q)
**Time Frame:** up to 6 months
**Description:** Medication prescriptions for Opioids, Benzodiazepines, Gabapentin/Neurontin, and NSAIDs from the time of enrollment until 6 months. Presented as morphine equivalents.
**Measure:** Change in number of Medication Prescriptions
**Time Frame:** baseline, up to 6 months
**Measure:** Number of emergency room visits
**Time Frame:** up to 6 months
**Measure:** Number of hospital readmissions related to spine surgery
**Time Frame:** up to 6 months
**Description:** The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.
**Measure:** Mindful Attention Awareness Scale (MAAS)
**Time Frame:** up to 6 months
**Description:** Persistent postsurgical pain defined as chronic pain that develops or increases in intensity after a surgical procedure or a tissue injury and persists beyond the healing process, i.e., at least 3 months after the surgery or tissue trauma.
**Measure:** Number of participants with persistent postsurgical pain
**Time Frame:** up to 6 months
**Description:** Participants will rate the 3-item PEG (pain, enjoyment, and general activity) scale assessing pain severity over the past week on 0 to 10 rating scales. A PEG summary score of 12 or greater (i.e., equivalent to an average score of 4 or greater across the 3 items) indicates bothersome chronic pain, whereas a PEG score of 11 or less will classify subjects as having mild chronic pain.
**Measure:** Number of participants with high impact chronic pain as measured by the PEG (pain, enjoyment, and general activity) scale
**Time Frame:** up to 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
2. 18 years of age or older
3. has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.
Exclusion Criteria:
1. have conditions making consent, follow-up data collection and/or use of the intervention prohibitive (e.g., Non-English speaking, serious psychiatric conditions \[i.e., schizophrenia\], traumatic brain injury, or dementia-type illness)
2. undergoing surgery for neoplastic disease
3. current daily opioid use greater than 100mg morphine equivalents
4. unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
5. not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)
6. currently practicing mindfulness or receiving acupuncture
7. in Hospice, receiving palliative care.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Durham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Suzanne Finley, EMT-P
- **Phone:** 919-684-5431
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Cassandra Rhodes, ATC
- **Phone:** 9196842042
- **Role:** CONTACT
***Contact 3:***
- **Name:** Trevor Lentz, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Duke Sports Science Institute
**State:** North Carolina
**Zip:** 27705
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University
**Name:** Trevor Lentz, 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:** NCT06429059
**Brief Title:** ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
**Official Title:** ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
#### Organization Study ID Info
**ID:** Pro00114385
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Temple University
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
### Description Module
**Brief Summary:** GenieUs developed an analysis platform that will be tested to separate study participants with ALS into four categories based on blood work. These general categories are neuroinflammation, oxidative stress, impaired autophagy \& axonal transport, and mitochondrial dysfunction. Once a disease category is established, participants in this study will receive one of four individualized supplements for 6 months and we will determine whether these are slowing ALS progression: Astaxanthin will be given for the category of neuroinflammation, Protandim for oxidative stress, Melatonin for impaired autophagy and MitoQ for mitochondrial dysfunction. During the first 3 months, participants will have routine monitoring and in months 3 through 9 they will receive the assigned supplement.
**Detailed Description:** This will be a widely inclusive, largely remote/virtual, two-center, open-label pilot trial utilizing 50 participants as their own controls. Following informed consent and screening, participants will provide demographics, disease characteristics, co-morbidities, and concomitant medications. They will have a baseline ALSFRS-R score obtained and blood will be drawn for DIGAP classification, PBMCs (which will be used to generate iPSCs from which motor neurons and/or microglia can be generated), baseline mechanistic biomarkers and baseline neurofilament light chain. A urine pregnancy test will be obtained for pre-menopausal females who have not had one by their own doctor in the past 7 days. Each month after that, they will be contacted by phone by study coordinators to review adverse events, new co-morbidities, and concomitant medications, and to generate a new ALSFRS-R score. At month 3, DIGAP classification will be revealed to each participant and based on this, they will receive 1 of 4 treatments. They will take their assigned treatment for 6 months. At months 3, 5 and 9 they will be asked to return for in person blood draws for repeat mechanistic biomarkers and neurofilament light chain measurements. All of the described blood tests and investigational treatments are being performed exclusively for research purposes.
### Conditions Module
**Conditions:**
- Amyotrophic Lateral Sclerosis ALS
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** At month 3, DIGAP classification will be revealed to each participant and based on this, they will receive 1 of 4 treatments. They will take their assigned treatment for 6 months.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants in this category are expected to have inflammation in their brains and spinal cords.
**Intervention Names:**
- Drug: Astaxanthin
**Label:** Neuroinflammation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Study participants in this category are expected to have too many damaging "free radical" chemicals in their brains and spinal cords.
**Intervention Names:**
- Drug: Protandim
**Label:** Oxidative Stress
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Study participants in this category are expected to have motor neurons that have trouble transporting materials up and down their length, and/or trouble with the turnover of damaged proteins and intracellular structures.
**Intervention Names:**
- Drug: Melatonin
**Label:** Impaired Autophagy and Axonal Transport
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Study participants in this category are expected to have motor neurons that are unable to produce normal amounts of energy.
**Intervention Names:**
- Drug: MitoQ
**Label:** Mitochondrial Dysfunction
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neuroinflammation
**Description:** Astaxanthin is a red-orange natural pigment belonging to a group of carotenoids called xanthophylls. In nature, astaxanthin is synthesized by microalgae and phytoplankton and biomagnifies in higher marine animals through the food chain. Natural astaxanthin is available as capsules, soft gels, tablets, powders, biomass, creams, energy drinks, oils and extracts and often contains other carotenoids. The compound is available as a United States Pharmacopeia (USP) verified supplement which ensures federally recognized standards for quality and purity (https://www.quality-supplements.org/verified-products/verified-products-listings).
**Name:** Astaxanthin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Oxidative Stress
**Description:** Protandim is an oral tablet derived from five different plants: Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), Curcuma longa (turmeric) and Bacopa monniera.
**Name:** Protandim
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Impaired Autophagy and Axonal Transport
**Description:** Melatonin is a hormone that has long been known to play a role in regulating sleep. Melatonin supplements are commonly used to treat insomnia, but in recent years, melatonin has been found to play a wider role in human physiology including the potential regulation of autophagy.
**Name:** Melatonin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Mitochondrial Dysfunction
**Description:** The active ingredient in MitoQ is ubiquinone, the same as found in coenzyme Q10 and idebenone. However, the ubiquinone in MitoQ is attached to a positively charged, lipophilic molecule called TPP (triphenyl phosphonium), which allows it to selectively accumulate in mitochondria. This makes it more potent than untargeted ubiquinone analogs at protecting mitochondria in cultured cells. It can be administered orally and, at least in animals, can cross the blood brain barrier and accumulate in brain mitochondria.
**Name:** MitoQ
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant to people living with ALS.The ALSFRS-R declines linearly with time over a wide range during the course of ALS and it has been validated for telephone use.
**Measure:** ALS Functional Rating Scale, Revised (ALSFRS-R)
**Time Frame:** baseline and at each of the subsequent 9 telephone or in person visits (approximately 9 months)
#### Secondary Outcomes
**Description:** They are neuron-specific components of the cytoskeleton. They exist in heavy, medium, and light chain forms. Neurofilament light chain levels are elevated in the spinal fluid and the blood of patients with ALS and other neurodegenerative diseases, and higher levels predict more severe disease progression. These levels rise dramatically when asymptomatic carriers of ALS-causing genetic mutations begin to convert to an ALS phenotype.
**Measure:** Neurofilament Light Chain levels
**Time Frame:** baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)
**Description:** Used to measure neuroinflammation. These are known to be abnormal in patients with ALS, their levels correlate with disease progression and they can be altered by drugs in trials.
**Measure:** Neuroinflammation measured by C-reactive protein (CRP)
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** Used to measure neuroinflammation. These are known to be abnormal in patients with ALS, their levels correlate with disease progression and they can be altered by drugs in trials.
**Measure:** Neuroinflammation measured by monocyte chemoattractant protein-1 (MCP-1)
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** Used to measure neuroinflammation. These are known to be abnormal in patients with ALS, their levels correlate with disease progression and they can be altered by drugs in trials.
**Measure:** Neuroinflammation measured by chitotriosidase (CHIT1)
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** Used to measure oxidative stress.
**Measure:** Oxidative stress measured by total antioxidant capacity (TAC)
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** Uric acid is an antioxidant and levels of uric acid have been reported to be lower in ALS subjects and correlated with progression. It has also been shown to be responsive to treatments in trials
**Measure:** Oxidative stress measured by uric acid levels.
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** To measure impaired autophagy, we will use Beclin-1. This highly conserved eukaryotic protein has a major regulatory role in autophagy. It is a component of the phosphatidylinositol-3-kinase (PI3K) complex which mediates vesicle-trafficking thereby inducing autophagy. Beclin-1 dysfunction has been implicated in many disorders, including cancer and neurodegenerative diseases
**Measure:** Impaired autophagy measured by Beclin-1
**Time Frame:** baseline, 3 months, 5 months and 9 months
**Description:** Compromised mitochondrial oxidative phosphorylation shifts the cellular bioenergetic system to anaerobic respiration and increases the level of lactate. Lactate has been used as a biomarker for mitochondrial disease in many previous studies.
**Measure:** Mitochondrial dysfunction measured by lactate.
**Time Frame:** baseline, 3 months, 5 months and 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female aged at least 18 years.
2. Sporadic or familial ALS diagnosed as per Gold Coast Criteria.
3. Patient is able to understand and express informed consent (in the opinion of the site investigator).
4. Patient is able to read and write English.
5. Patient is expected to survive for the duration of the trial.
6. Able to swallow tablets at enrollment and expected to be able to swallow tablets for the duration of the trial.
7. Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal)
8. Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
Exclusion Criteria:
1. Actively or recently (within past 30 days) participating in another intervention trial.
2. Currently or recently (within 30 days) taking any of the 4 investigational treatments being used in this trial.
3. Prior side effects from any of the 4 investigational treatments being used in this trial.
4. Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study.
5. Pregnant women or women currently breastfeeding.
6. Life expectancy shorter than the duration of the trial.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michelle ward, RN
**Phone:** 919-613-2681
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hailey Zampa
**Phone:** 919-613-2681
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Durham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michelle Ward, RN
- **Phone:** 919-613-2681
- **Role:** CONTACT
***Contact 2:***
- **Name:** Richard Bedlack, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Duke University Medical Center
**State:** North Carolina
**Zip:** 27705
**Location 2:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** John Furey
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Christopher Pizzica
- **Role:** CONTACT
***Contact 3:***
- **Name:** Terry Heiman-Patterson, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Temple University
**State:** Pennsylvania
**Zip:** 19122
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000057177
- Term: TDP-43 Proteinopathies
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- 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: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System 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: 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: D000016472
- Term: Motor Neuron Disease
- ID: D000000690
- Term: Amyotrophic Lateral Sclerosis
### Intervention Browse Module - Ancestors
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000002492
- Term: Central Nervous System Depressants
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17201
- Name: Ubiquinone
- Relevance: LOW
- As Found: Unknown
- ID: M271049
- Name: Coenzyme Q10
- Relevance: LOW
- As Found: Unknown
- ID: M11533
- Name: Melatonin
- Relevance: HIGH
- As Found: Profile
- ID: M342247
- Name: Turmeric extract
- Relevance: LOW
- As Found: Unknown
- ID: M5592
- Name: Carotenoids
- Relevance: LOW
- As Found: Unknown
- ID: M273909
- Name: Idebenone
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: T244
- Name: Orange
- Relevance: LOW
- As Found: Unknown
- ID: T383
- Name: Coenzyme Q10
- Relevance: LOW
- As Found: Unknown
- ID: T410
- Name: Melatonin
- Relevance: HIGH
- As Found: Profile
- ID: T229
- Name: Milk Thistle
- Relevance: LOW
- As Found: Unknown
- ID: T319
- Name: Turmeric
- Relevance: LOW
- As Found: Unknown
- ID: T312
- Name: Tea
- Relevance: LOW
- As Found: Unknown
- ID: T407
- Name: Lutein
- Relevance: LOW
- As Found: Unknown
- ID: T61
- Name: Ashwagandha
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008550
- Term: Melatonin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429046
**Brief Title:** Effect of Lidocaine Gel and Cold Lidocaine Gel on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound
**Official Title:** Effect of Lidocaine Gel and Cold Lidocaine Gel Applied to the Rectal Area on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound: Randomized Controlled Study
#### Organization Study ID Info
**ID:** CukurovaUSFırat2
#### Organization
**Class:** OTHER
**Full Name:** Cukurova University
### Status Module
#### Completion Date
**Date:** 2023-09-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-07-29
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cukurova University
#### Responsible Party
**Investigator Affiliation:** Cukurova University
**Investigator Full Name:** Sevda Fırat
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Prostate cancer is one of the most common types of malignancy in men. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is considered the current gold standard method in the diagnosis of prostate cancer. Some patients experience serious discomfort during the procedure because the ultrasound probe is placed in the rectal area. Although no anesthetic or analgesic is used in some centers during the prostate biopsy procedure, in some centers lidocaine gel, cream or spray is applied before entering the rectal area, and lidocaine ampoule is injected during the procedure. However, most patients experience pain and discomfort due to the way the procedure is performed.
Today, in addition to pharmacological methods, non-pharmacological methods are also used to control pain. Cold application has an important place among non-pharmacological methods. In this randomized controlled intervention study, the effect of cold lidocaine gel application on pain level in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) will be evaluated. In this study, it is thought that application of cold lidocaine gel will reduce the pain level of patients.
The research will be conducted at the Urology Polyclinic of Çukurova University Faculty of Medicine Balcalı Practice and Research Hospital. The sample of the research; Ç.Ü.T.F. Volunteer patients who have undergone prostate biopsy at the Urology Polyclinic of Balcalı Practice and Research Hospital and meet the research criteria will be recruited. Patients consisting of 3 groups: control, experiment 1 (Lidocaine Gel) and experiment 2 (Cold Lidocaine Gel) will be determined by randomization. A power analysis was carried out by obtaining statistical support for the sample size. As a result of the sample calculation calculated with power with a confidence interval of 95%, beta value of 95% and alpha value of 0.05, a total of 114 patients will be included, 38 each in the control group, Lidocaine gel and Cold Lidocaine Gel groups. . Data will be collected with the "Personal Information Form" and "Pain Assessment Form". The data will be analyzed in the SPSS (Statistical Package for the Social Sciences) package program.
In this context, in our study, the effect of lidocaine gel and cold lidocaine gel applied to the rectal area on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy will be evaluated and the effect of cold application on pain control will be compared. This result will make great contributions to patient benefit in terms of pain management.
**Detailed Description:** Prostate cancer is one of the most common types of malignancy in men. According to GLOBOCAN (Global cancer statistics) 2020 data, the age-standardized incidence rate of prostate cancer varies between 11.3-37.5 per hundred thousand in the world, depending on the development level of the countries, and it is seen to be 42.5 per hundred thousand in our country. It ranks second after lung cancer in terms of incidence in men in our country and in the world. Prostate cancer screening aims to reduce mortality and morbidity by detecting prostate cancer at an early stage. Digital rectal examination (DRE), prostate specific antigen (PSA) value, transrectal ultrasonography (TRUS) and biopsy are used to diagnose prostate cancer. Ultrasound-guided prostate biopsy has been used since 1981 and is one of the most important urological diagnostic methods. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is currently considered the gold standard method in the diagnosis of prostate cancer. In the TRUSG-guided biopsy procedure, after the patients are placed in the left lateral or lithotomy position, the needle-guided rectal probe is inserted into the anal canal with the help of lubricating gel, and the prostate tissue is monitored under USG guidance and a biopsy is taken. The procedure takes approximately 20 minutes, and approximately 15 minutes pass during the entry and exit of the probe into the rectal area. In recent years, the importance of pain control has increased due to prostate biopsy being performed on younger patients, biopsies being taken from more quadrants, and repeated prostate biopsies. Due to severe pain, the rate of tolerance of the procedure by the patient decreases, and this may lead to a decrease in the number of biopsy samples taken from the planned quadrant and a decrease in cancer detection rates. Therefore, ensuring pain control and increasing patient tolerance in TRUSG-PBx is extremely important. Many different methods are used to reduce pain and discomfort. In recent studies, local anesthesia is used in transrectal ultrasound-guided prostate biopsies; Methods such as periprostatic nerve block (PPSB), lidocaine injection, intrarectal lidocaine gel, transperineal periprostatic block (TPPB with gel combination), low-dose spinal anesthesia and intravenous (IV) sedation application have been used and results have been reported showing that these methods increase the pain tolerance in the patient. One of the most important obstacles to the biopsy process is anal area pain. The pain felt during the biopsy occurs for 2 reasons:
1. Pain felt when the biopsy needle penetrates the prostate capsule and enters the stroma.
2. Pain caused by stretching of the anal sphincter as the transrectal ultrasound probe enters the anus (passing the ultrasound probe through the anus, advancing it into the rectum, and manipulating it within the rectum).
For periprostatic nerve blockade before biopsy, penetration into the rectum with a rectal probe is required before anesthesia, and this first penetration is the main cause of the patients' complaints. Due to pain resulting from anal canal sensation during biopsy, intrarectal local anesthesia, which is highly absorbed through the rectal mucosa, is frequently used. Although the procedure is easy to perform and causes very low mortality, efforts to reduce the discomfort and pain that patients may feel lead to the development of new protocols for pre-procedure preparations and anesthesia and analgesia. Most patients who will undergo transrectal biopsy experience anxiety due to the possibility of the result being cancer, the psychological discomfort caused by the fact that the procedure will be performed rectally, and the procedure is painful for the patient. Nurses have an important and indispensable role in pain control and within the team. To reduce pain, nurses; They should inform patients about pain preventive approaches and pain control methods and give the message to patients that everything necessary has been done before painful procedures. Nurses should also apply non-pharmacological methods to reduce the consumption of analgesic drugs or increase their effect by providing adequate analgesia. The patient, whose anxiety decreases, will perceive the intensity and duration of pain as decreased as his sense of pain control will improve.
Non-pharmacological methods are used alone or together with pharmacological methods in order to reduce the use of analgesics and at the same time improve the quality of life of the patient by relieving the patient's pain as much as possible. Cold application also has an important place among non-pharmacological methods.
Cold application is effective in reducing pain, indirectly or directly. It indirectly reduces pain by eliminating edema, swelling and muscle spasm resulting from inflammation or trauma, and has a direct effect by changing the conduction properties of peripheral nerves. In this context, evidence-based studies should be examined and pharmacological and non-pharmacological methods that reduce pain should be used in patient care areas.
A study in the literature showed that applying intrarectal lidocaine gel by massaging the anal area increases patient tolerance and provides balanced and adequate anesthesia at every stage of the biopsy.
In another study in the literature, they compared the application of three intrarectal anesthesia methods along with periprostatic nerve block (periprostatic nerve block with intrarectal lidocaine gel, lidocaine cream and indomethacin suppository) during transrectal ultrasonography-guided prostate biopsy. They stated that intrarectal lidocaine cream application together with PPSB provided more effective pain control.
In the literature, studies conducted to evaluate the effect of cold application on pain during removal of mediastinal and thorax tubes have observed that the application reduces pain, and it has been stated that applying cold to the entry point of the chest tubes reduces the pain and the amount of analgesic consumption during movement and coughing.
As can be seen, various studies have been conducted to determine which anesthesia technique will reduce pain and to evaluate the rectal pain and sensitivity caused by the probe. However, it is still controversial which local anesthesia method is more suitable and will cause less pain. However, although there are many national and international studies on the subject in the literature, no experimental study has been found on the effect of cold lidocaine gel application on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy. The purpose of our research, which we planned in the light of this information, is to compare the effect of applying cold lidocaine gel to the rectal area on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy.
### Conditions Module
**Conditions:**
- Prostate Cancer XXX
- TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY
**Keywords:**
- Cold application
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study was planned to compare the effects of lidocaine gel and cold lidocaine gel application to the rectal area on the pain level in patients who underwent TRUSG-guided prostate biopsy.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 120
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For patients in the control group, "Personal Information Form" will be applied before the procedure and pain will be evaluated with "Numeric Pain Scale".
NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3).
However, no treatment will be performed on control group patients.
**Label:** CONTROL
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Data will be collected in two stages. To LG group patients, 20 ml lidocaine gel will be applied intrarectally (double application: 5cc to the perianal region, covering the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed in the rectum. Patients in the LG group will be administered a "Personal Information Form" before the procedure, and their pain will be evaluated with the "Numeric Pain Scale". NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3).
**Intervention Names:**
- Other: LIDOCAINE GEL
**Label:** LIDOCAINE GEL (LG)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Similarly, patients in the CLG group will be administered "Personal Information Form" before the procedure and pain will be evaluated with "Numeric Pain Scale". In CLG group patients, 20 ml of cold lidocaine gel kept in the refrigerator at +4 0C will be applied intrarectally (double application: 5cc to the perianal region, including the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed into the rectum.NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3).
**Intervention Names:**
- Other: COLD LIDOCAINE GEL
**Label:** COLD LIDOCAINE GEL (CLG)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LIDOCAINE GEL (LG)
**Description:** To LG group patients, 20 ml lidocaine gel will be applied intrarectally (double application: 5cc to the perianal region, covering the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed in the rectum.
**Name:** LIDOCAINE GEL
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- COLD LIDOCAINE GEL (CLG)
**Description:** In CLG group patients, 20 ml of cold lidocaine gel kept in the refrigerator at +4 0C will be applied intrarectally (double application: 5cc to the perianal region, including the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed into the rectum.
**Name:** COLD LIDOCAINE GEL
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The scale used in the first part of this form, which aims to evaluate pain severity, is the Numerical Pain Scale (NPS). On this scale, it starts with no pain (0) and reaches the level of unbearable pain (10). It was applied according to the determined measurement times of the patients \[At the beginning of the biopsy/while the ultrasound probe was being inserted (NPS) -1), During the biopsy/5 minutes after the ultrasound probe was placed (NPS-2), At the end of the biopsy/when the ultrasound probe was being removed (NPS-3)\].
**Measure:** Pain Evaluation Form
**Time Frame:** The first 24 hours: NPS 1, 2, 3.
#### Secondary Outcomes
**Description:** This form, prepared by the researchers in line with the literature, aims to determine the individual characteristics of the patients (age, marital status, height/weight/body mass index, educational status, chronic disease status, previous rectal examination/procedure/biopsy, previous rectal 8 questions are included (e.g. pain status and level experienced during the examination/procedure/biopsy performed in the area).
**Measure:** Personal Information Form
**Time Frame:** Personal Information Form was applied before the transaction
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being able to communicate effectively,
* Being over 40 years old,
* Being literate,
* Volunteering to participate in the research.
Exclusion Criteria:
* Having a previous history of chronic pain,
* Having alcohol and drug addiction,
* Having bleeding diathesis and active urinary tract infection,
* Having a cognitive disorder, neurological or psychiatric disease,
* Having a disease in the anal and rectal area (wound, fistula, fissure, hemorrhoids, etc.).
* Not agreeing to participate in the research.
**Gender Based:** True
**Gender Description:** PROSTATE
**Healthy Volunteers:** True
**Minimum Age:** 40 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Adana
**Country:** Turkey
**Facility:** Cukurova University
**State:** Sariçam
**Zip:** 01330
## 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
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- 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
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429033
**Acronym:** PEP
**Brief Title:** Purified Exosome Product (PEP) Injected Into the Hypodermis
**Official Title:** A Prospective, Within-Subject Controlled Study to Evaluate the Safety and Histological Profile of Purified Exosome Product Into the Hypodermis of Healthy Adults
#### Organization Study ID Info
**ID:** PEP-23-002
#### Organization
**Class:** OTHER
**Full Name:** Clinical Testing of Beverly Hills
### Status Module
#### Completion Date
**Date:** 2025-12-31
**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:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Clinical Testing of Beverly Hills
#### 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:** This clinical trial aims to learn if Purified Exosome Product (PEP) is safe and tolerable when injected into the hypodermis of healthy adults. The main questions this study aims to answer are:
Is PEP safe and tolerable when injected into the hypodermis of healthy adults? Are there signals of Collagen I/II and Elastin biostimulation?
Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.
**Detailed Description:** This is a prospective, non-randomized, within-subject, controlled, single center, open-label study. Up to 9 healthy adult participants with planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 12 to ≤ 18 weeks will be enrolled and injected with a single dose of PEP Drug Product reconstituted in Lactated Ringers (USP) solution in a defined area of the abdominal hypodermis. Similar tissue from the participant's contralateral side of the abdomen will serve as the control. Excised tissue will be harvested and analyzed for histological findings (collagen, pre-collagen, elastin) as an exploratory endpoint. The primary goal of this investigator-initiated study is to determine safety of subcutaneous PEP Drug Product when reconstituted in Lactated Ringers solution. Safety data will be collected with frequent monitoring for adverse events, laboratory testing, vital signs, and ECGs.
Note: The decision to undergo abdominoplasty will be made outside of this study and data/safety in the plastic surgery procedure for abdominoplasty, other than informed consent, will not be a collected as a part of this study.
### Conditions Module
**Conditions:**
- Safety
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 9
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A single dose of Purified Exosome Product in Lactated Ringers at doses of 1 vial (75 mg) (Low Dose/Cohort 1) or 2 vials (150 mg) (Target Dose/Cohort 2) will be injected intradermally into the hypodermis of a 5 cm by 10 cm section of abdomen (to the right of the umbilicus) that is planned for removal during abdominoplasty surgery. The solution will be injected into the hypodermis in approximately 50 each 0.2 mL boluses, approximately 1cm apart.
**Intervention Names:**
- Drug: Purified Exosome Product (PEP)
**Label:** Treatment Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment Group
**Description:** Injection of PEP into hypodermis of abdomen
**Name:** Purified Exosome Product (PEP)
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Histology evaluation
**Measure:** Histopathology
**Time Frame:** 6-months
#### Primary Outcomes
**Description:** The number of subjects with acute dose-limiting toxicities
**Measure:** Safety: Dose limiting toxicities
**Time Frame:** 14-days
**Description:** The maximum tolerated dose determined by testing increasing doses of PEP
**Measure:** Maximum Tolerated Dose
**Time Frame:** 14-days
#### Secondary Outcomes
**Description:** The number of subjects experiencing serious adverse events, as adjudicated by the Data Safety Monitoring Board (DSMB)
**Measure:** Serious Adverse Events
**Time Frame:** 14 days
**Description:** The number of subjects experiencing adverse events
**Measure:** Adverse Events
**Time Frame:** 26-weeks
**Description:** The number of CTRs experienced by the subject, as recorded in the diary
**Measure:** Common Treatment Responses (CTRs)
**Time Frame:** 14-days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult participants aged 18-65 (inclusive)
* Capacity to sign informed consent.
* Planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 3 to ≤ 5 months
* Participant is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests.
* Participant should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods (laser devices, topical prescriptions, or other known hair growth treatments) in the treatment area during the entire study period.
* Females of childbearing potential must be using an approved method of birth control for the past month and during the entire study period. Participants who can become pregnant will undergo a pregnancy test prior to treatment.
Exclusion Criteria:
* Participants with clinically abnormal hematology, serum chemistries, or screening laboratory results as reviewed by the clinical investigator.
* Known history of MRSA (methicillin-resistant staphylococcus aureus).
* Known history of COVID-19 infection in past 6 months.
* COVID vaccine or booster dose within past 12 weeks.
* Participants who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody, or HIV.
* History of antibiotic use in past 12 weeks.
* Major surgery in past 3 months.
* If taking hormone replacement therapy or hormones for birth control, dose must be stable for at least 6 months prior to study entry.
* Current or regular use of corticosteroids during the previous 4 weeks, excluding inhaled or topical steroids outside of the planned treatment area.
* Known sensitivity/allergy to study product ingredients.
* Pregnancy and nursing or lactating.
* Sexually active women of childbearing potential who are unwilling to use approved contraception method for three months after receiving dose of investigational drug.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, history of any malignancies or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
* Participants with hepatic impairment
* Participants with poorly controlled diabetes mellitus (HbA1C ≥ 8%).
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* Any surgery or treatment such as laser or chemicals in the treatment area within 6 months prior to treatment
* Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the participant or quality of the study data.
* Current, or past participation in a clinical trial within the past 30 days.
**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:** Mary Hayes
**Phone:** 818-616-3880
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429020
**Brief Title:** Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
**Official Title:** Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study
#### Organization Study ID Info
**ID:** CMMC11201-010
#### Organization
**Class:** OTHER
**Full Name:** Chimei Medical Center
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chimei Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination.
Among different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan.
**Detailed Description:** Study Design and Sample The retrospective study included female patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022. The patients' breast cancer history and COVID-19 vaccination history were collected and analyzed.
Analysis of Breast Sonography Lymphadenopathy is defined as an enlarged lymph node with cortical thickening \>3 mm, either concentric or eccentric, with or without effacement of fatty hilum, or in-creased non-hilar vascularity on color or power Doppler. The positive axillary lymph node findings were correlated by confirming a link to SARS-CoV-2 vaccination history within 90 days in the ipsilateral arm.
Statistical Analysis All statistical analyses were performed using the R Stats package. Descriptive summaries were reported as mean ± standard deviation for continuous variables and percentages for categorical variables. For non-parametric variables, median with interquartile range and Mann-Whitney U test were used. Statistical significance was set at a p-value \<0.05.
### Conditions Module
**Conditions:**
- Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population
**Keywords:**
- Breast Neoplasms
- covid-19 vaccine
- lymphadenopathy
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1089
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** non SARS-COV-2 vaccinated group
**Label:** control group
#### Arm Group 2
**Description:** SARS-COV-2 vaccinated group
**Intervention Names:**
- Biological: the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
**Label:** vaccinated group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- vaccinated group
**Description:** record the condition of vaccination
**Name:** the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Presentation of axillary lymphadenopathy in sonographic examination
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* female patients receiving breast sonography
Exclusion Criteria:
* receive Covid 19 vaccine other than AZ, BNT, Moderna
* Ongoing primary breast malignancy
* History of malignancy other than primary breast malignancy
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tainan City
**Country:** Taiwan
**Facility:** ChiMei Medical Center
**Zip:** 710402
#### Overall Officials
**Official 1:**
**Affiliation:** ChiMei Medical Center, Taiwan, R.O.C.
**Name:** Pin Chi Huang
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008206
- Term: Lymphatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M994
- Name: Lymphadenopathy
- Relevance: HIGH
- As Found: Lymphadenopathy
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
- ID: D000072281
- Term: Lymphadenopathy
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: HIGH
- As Found: Other
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014612
- Term: Vaccines
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06429007
**Brief Title:** A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
**Official Title:** A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
#### Organization Study ID Info
**ID:** IRB-P00048370
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2027-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Boston Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Boston Children's Hospital
**Investigator Full Name:** Martha Sola-Visner
**Investigator Title:** Research Director, Department of Newborn Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.
### Conditions Module
**Conditions:**
- Hypoxic-Ischemic Encephalopathy
- HIE
- Neurodevelopment
- Infant Development
**Keywords:**
- HIE
- metformin
- Hypoxic-Ischemic Encephalopathy
- Pharmacokinetic modeling
- Neonates
- Brain Injury
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will complete a pre-study visit with baseline bloodwork including a complete blood count (CBC), liver and renal function, basic chemistry, glucose, and lactate. At this visit, parents will be taught how to administer metformin and given a 6-week supply of metformin at 50% of the target dose to minimize potential gastrointestinal upset. Parents will be educated on adverse effects and receive a diary to log dose administration and noted side effects. After six weeks, participants will return for a study visit with repeat labs. Bloodwork at this visit will include plasma metformin levels for measurement of pharmacokinetics. Study staff will also review diary completion for adverse effects and to ensure there have been no missed doses. Parents will then receive a 6-week supply of metformin 25mg/kg for 6 weeks. A final study visit will then occur following 12-weeks of metformin therapy, with repeat labs including plasma metformin levels.
**Intervention Names:**
- Drug: Metformin
**Label:** Metformin Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Metformin Intervention
**Description:** Infants in the study will receive 50% of the target dose (12.5mg/kg) for the first 6 weeks of participation. At the 6 week visit, the patient will be assessed and if found still eligible, will receive the full dose (25mg/kg) for the remaining 6 weeks of participation.
**Name:** Metformin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A renal function panel (chem 10 with renal function) will be performed prior to the initiation of therapy and at all subsequent study visits.
**Measure:** Safety profile of kidney function
**Time Frame:** 12 weeks
**Description:** A liver function test (LFT) will be performed prior to the initiation of therapy and at all subsequent study visits.
**Measure:** Safety profile of liver function
**Time Frame:** 12 weeks
**Description:** To assess feasibility, the number of eligible patients will be compared to the number of patients who consent to participate in the study.
**Measure:** Recruitment feasibility
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Plasma metformin levels will be analyzed by investigators with whole blood obtained at study visits.
**Measure:** Validity of neonatal model of metformin pharmacokinetics
**Time Frame:** 12 weeks
**Description:** Parents/caregivers will be sent a survey that utilizes a 5 point Likert scale to assess key factors that prevented or encouraged participation.
**Measure:** Stakeholder Satisfaction
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infants born \> 35 weeks' gestational age AND
* Received therapeutic hypothermia for clinically diagnosed HIE
Exclusion Criteria:
* Infants with known genetic or chromosomal disorders
* Infants with a liver or kidney disease that may affect drug metabolism
* Maternal metformin use while actively breastfeeding
* Infant weight is below the 10th percentile (as defined by World Health Organization) at time of study drug initiation.
**Maximum Age:** 6 Months
**Minimum Age:** 3 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vanessa Young, MS, RN
**Phone:** 617-355-8330
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kate Eident, BS
**Phone:** 617-355-2184
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Children's Hospital
**Name:** Martha Sola-Visner, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000000860
- Term: Hypoxia
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000002534
- Term: Hypoxia, Brain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M4185
- Name: Hypoxia
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: HIGH
- As Found: Brain Injury
- ID: M5794
- Name: Brain Ischemia
- Relevance: HIGH
- As Found: Ischemic Encephalopathy
- ID: M5204
- Name: Brain Diseases
- Relevance: HIGH
- As Found: Encephalopathy
- ID: M22660
- Name: Hypoxia-Ischemia, Brain
- Relevance: HIGH
- As Found: Hypoxic Ischemic Encephalopathy
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5783
- Name: Hypoxia, Brain
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001930
- Term: Brain Injuries
- ID: D000001927
- Term: Brain Diseases
- ID: D000002545
- Term: Brain Ischemia
- ID: D000020925
- Term: Hypoxia-Ischemia, Brain
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M11667
- Name: Metformin
- Relevance: HIGH
- As Found: Assessment
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008687
- Term: Metformin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428994
**Brief Title:** Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
**Official Title:** Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
#### Organization Study ID Info
**ID:** No. 201800172B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2022-02-28
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-02-28
**Type:** ACTUAL
#### Start Date
**Date:** 2019-03-01
**Type:** ACTUAL
**Status Verified Date:** 2018-02
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chang Gung Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A retrospective analysis of 329 patients at one single institution between January 2014 and December 2019 who underwent free fibula flap reconstruction was conducted. A variety of clinicopathological postoperative parameters were identified and assessed.
**Detailed Description:** The study was conducted as a monocentric, retrospective study. Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019 at one single institution in Taiwan were identified. All charts including surgical records, progress notes, nursing records, clinic notes, imaging study after surgery were reviewed. Data extraction was performed for the following variables: Patient demographics, primary diagnosis, cancer location and staging, treatment prior to index surgery, postoperative hemoglobin and albumin, operating time, flap type, mandibular defect length, type of the defect according to Jewer's classification, ischemia time, number of fibula segments, plate type, re-exploration, time of hospitalization, postoperative radiotherapy and/or chemotherapy, ORN cases, identification time of ORN and management for ORN. The patients were then organized into two groups: ORN and non-ORN. This research was approved by the Institutional Review Board of our hospital (No. 201800172B0), which was available until 2022/02/28. The investigators completed data analysis before 2022/02/28 and then initiated manuscript preparing.
### Conditions Module
**Conditions:**
- Head and Neck Cancer
- Fibula Flap
- Osteoradionecrosis
- Mandibulectomy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 580
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** ORN in this study is defined as exposed irradiated bone tissue that fails to heal over a period of three months without residual or recurrent tumors.
**Intervention Names:**
- Radiation: Radiotherapy
**Label:** ORN
#### Arm Group 2
**Description:** Patients without ORN.
**Label:** non-ORN
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ORN
**Description:** Post-operative radiotherapy for head and neck cancer
**Name:** Radiotherapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** The incidence of osteoradionecrosis in patients who received free fibula flap reconstruction
**Measure:** The incidence on development osteoradionecrosis(ORN) in free fibula flaps
**Time Frame:** Up to 7 years postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.
Exclusion Criteria:
* Cases with incomplete medical records.
* Patients who did not attend at least 6 months of follow ups.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Between January 2014 and December 2019, 580 patients received free fibula flap mandibular reconstruction, with 374 of them attributed to head and neck cancer reconstruction. Cases with incomplete medical records were excluded (n = 9). Additionally, patients who did not attend at least 6 months of follow-up were also excluded (n = 36). Finally, 329 patients including 309 males and 20 females met the inclusion criteria of this study.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Taoyuan
**Country:** Taiwan
**Facility:** Angela Chien-Yu Chen
**Zip:** 333
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000011832
- Term: Radiation Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: HIGH
- As Found: Head and Neck Cancer
- ID: M12948
- Name: Osteoradionecrosis
- Relevance: HIGH
- As Found: Osteoradionecrosis
- ID: M14679
- Name: Radiation Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000010025
- Term: Osteoradionecrosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428981
**Brief Title:** Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery
**Official Title:** (Holistic Health Care) Influence of Surgical Intervention on the Body-mind-spirit of Patients Undergoing Cervical Spine Surgery
#### Organization Study ID Info
**ID:** 202200381B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-08-02
**Type:** ACTUAL
**Status Verified Date:** 2022-04
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chang Gung Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.
**Detailed Description:** Degenerative cervical disease induces cervical radiculopathy and myelopathy, which have a significant impact on the patients' health. The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.
### Conditions Module
**Conditions:**
- Cervical Spine Degeneration
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 35
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The inclusion criteria consisted of patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.
**Intervention Names:**
- Other: degenerative cervical diseases
**Label:** spine surgery
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- spine surgery
**Description:** Including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.
**Name:** degenerative cervical diseases
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) before surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery
**Time Frame:** Before surgery
**Description:** The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale before surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery
**Time Frame:** Before surgery
**Description:** The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale before surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery
**Time Frame:** Before surgery
**Description:** The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health before surgery
**Time Frame:** Before surgery
**Description:** The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) six months after surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery
**Time Frame:** six months after surgery
**Description:** The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale six months after surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery
**Time Frame:** six months after surgery
**Description:** The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale six months after surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery
**Time Frame:** six months after surgery
**Description:** The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.
**Measure:** Quality of life, mental health, pain relief, and spiritual health after surgery
**Time Frame:** six months after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.
Exclusion Criteria:
* Patients who were unable to attend follow-up visits or complete the questionnaires, and those patients who expressed doubts or were unable to provide satisfactory responses regarding the trial.
**Maximum Age:** 100 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kaohsiung
**Country:** Taiwan
**Facility:** Kaohsiung Chang Gung Memorial Hospital
**Zip:** 83301
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428968
**Brief Title:** Investigating the Insulin Resistance in Individuals With Type 2 Diabetes
**Official Title:** Investigating the Central and Peripheral Insulin Resistance in Individuals With Type 2 Diabetes
#### Organization Study ID Info
**ID:** T2DM2024
#### Organization
**Class:** OTHER
**Full Name:** Central South University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Central South University
#### Responsible Party
**Investigator Affiliation:** Central South University
**Investigator Full Name:** Renrong Wu
**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:** Numerous studies have provided evidence of a correlation between Type 2 Diabetes Mellitus (T2DM) and cognitive dysfunction, specifically in the realms of complex attention, information processing, and executive function. These impairments have been observed in middle-aged and elderly individuals with T2DM, with longer diabetes duration, suboptimal glycemic control, and the presence of diabetic complications being contributing factors. Recent research in young adults and adolescents diagnosed with T2DM has revealed cognitive and brain structural alterations in this growing demographic, suggesting that early disease mechanisms, rather than solely vascular and age-related neurodegeneration, contribute to pathogenesis. However, there remains uncertainty regarding the interplay between central and peripheral insulin resistance and its impact on cognitive dysfunction in individuals with T2DM. This study aims to investigate central insulin resistance in T2DM, elucidating its association with peripheral insulin resistance and the effects on cognitive impairments.
**Detailed Description:** Participants screened through inclusion and exclusion criteria will accept cross-sectional evaluation. The information of demographic data, medical history, previous and current medication regimen, details of complications, and family history regarding metabolic diseases will be collected. The assessments includes physical examination, anthropometry, blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, serum insulin，thyroid function and glycosylated hemoglobin A 1c), MRI scan( High-resolution T1-weighted Anatomical Images, Diffusion Tensor Imaging, Resting-state functional MRI and Arterial Spin Labeling) and psychiatry scales(Hamilton Depression Scale, Young Mania Rating Scale and Self-reporting Inventory-90); cognitive function will be assessed by the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery; biological samples also will be collected and stored to explore related mechanisms.
### Conditions Module
**Conditions:**
- Type 2 Diabetes
**Keywords:**
- Insulin resistance
- Cognitive impairments
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Individual with type 2 diabetes
**Intervention Names:**
- Drug: 160 units nasal insulin spray
**Label:** Individual with type 2 diabetes
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: 160 units nasal insulin spray
**Label:** Healthy volunteers
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy volunteers
- Individual with type 2 diabetes
**Description:** Initially, a series of MRI scans, including high-resolution T1-weighted anatomical images, diffusion tensor imaging, resting-state functional MRI, and arterial spin labeling, will be conducted. Subsequently, 160 units of nasal insulin spray will be administered, followed by a second round of MRI scans after a 30-minute interval, encompassing high-resolution T1-weighted anatomical images, resting-state functional MRI, and arterial spin labeling.
**Name:** 160 units nasal insulin spray
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Whole brain cerebral blood flow (CBF) will be recorded by arterial spin labeling (ASL). the changes in CBF (c-CBF) before and after the application of 160 units nasal insulin spray of interventional participants will be calculated. The c-CBF is an index of central insulin response.
**Measure:** The difference of changes of brain cerebral blood flow by arterial spin labeling between type 2 diabetes and healthy volunteers.
**Time Frame:** Baseline
**Description:** Phosphorylated insulin receptor substrate 1 and its downstream mediators represent the state of neuronal insulin resistance, whose improvement means better insulin signaling. For individuals with type 2 diabetes mellitus and healthy volunteers, blood samples will be collected and stored at -80℃ at baseline. The NEVs isolation and biomarker measurements will be processed uniformly, and the difference of the level of insulin signaling between two groups will be used for exploring underlying mechanism of disease.
**Measure:** The difference of the level of insulin signaling in Extracellular Vesicles of neuronal origin isolated from blood between type 2 diabetes and healthy volunteers.
**Time Frame:** Baseline
**Description:** The cognitive function of interventional participants will be assessed using the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery. Evaluator convert raw scores to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. The difference of T scores between two groups will be used for evaluating cognitive function. (higher score means better function).
**Measure:** The difference of the score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery between type 2 diabetes and healthy volunteers.
**Time Frame:** Baseline
**Description:** The resting-state functional MRI(fMRI) will be conducted at fasting state and after the application of 160 units nasal insulin spray. For every participants, the changes in fMRI (c-fMRI) under the application of nasal insulin spray will be analysed. The c-fMRI between type 2 diabetes and healthy volunteers may reflect the underlying mechanism of disease.
**Measure:** The difference of c-fMRI between type 2 diabetes and healthy volunteers.
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences. The analysis of DTI will be conducted to investigate the difference of brain structure and morphology between type 2 diabetes and healthy volunteers.
**Measure:** The difference of Diffusion Tensor Imaging scanned by MRI between type 2 diabetes and healthy volunteers
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meeting the diagnostic criteria for Type 2 diabetes: typical symptoms of diabetes plus random blood glucose level of ≥11.1 mmol/l, or fasting blood glucose level of ≥7.0 mmol/l, or 2-hour post-OGTT (Oral Glucose Tolerance Test) blood glucose level of ≥11.1 mmol/l, or HbA1c level of ≥6.5%; for those without typical symptoms of diabetes, re-examination on a different day is required for confirmation.
Exclusion Criteria:
* Having history of substance dependence or abuse or whose symptoms are caused by diagnosable mental disorders;
* Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
* Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
* Taking drugs that could affect cognitive function.
* The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
* Pregnant or lactating women.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jing Huang, MD
**Phone:** 15874290980
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jingmei Xiao, MD
**Phone:** 17673129702
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Changsha
**Country:** China
**Facility:** Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University
**State:** Hunan
**Zip:** 410011
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Psychiatry, The Second Xiangya Hospital of Central South University
**Name:** Renrong Wu, PhD
**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
- ID: D000006946
- Term: Hyperinsulinism
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes
- ID: M10370
- Name: Insulin Resistance
- Relevance: HIGH
- As Found: Insulin Resistance
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9997
- Name: Hyperinsulinism
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
- ID: D000007333
- Term: Insulin Resistance
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428955
**Acronym:** PRECISE
**Brief Title:** Evaluation of a Monofocal Intraocular Lens
**Official Title:** Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study))
#### Organization Study ID Info
**ID:** GPAS-SAS-023-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Carl Zeiss Meditec AG
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### 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:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Carl Zeiss Meditec AG
#### 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 aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.
### Conditions Module
**Conditions:**
- Cataract
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 44
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Monofocal IOL
**Intervention Names:**
- Device: CT LUCIA 621P
**Label:** Bilateral implantation of investigational device
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bilateral implantation of investigational device
**Description:** The device under investigation, CT LUCIA 621P IOL (Carl Zeiss Meditec, Jena, Germany) is a posterior chamber intraocular lens which is indicated for aphakia after surgical extraction of the cataractous natural lens. It is a monofocal aspheric IOL made of hydrophobic material and coated with heparin. The modified C-loop haptic is step-vaulted.
**Name:** CT LUCIA 621P
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary efficacy endpoint is the proportion of patients with monocular CDVA of 20/40 or better at three months
**Measure:** Monocular best corrected distance visual acuity (CDVA)
**Time Frame:** Three (3) Months
#### Secondary Outcomes
**Measure:** Binocular Corrected Distance Visual Acuity
**Time Frame:** Three (3) Months
**Measure:** Binocular Uncorrected Corrected Distance Visual Acuity
**Time Frame:** Three (3) Months
**Measure:** Monocular Uncorrected Visual Acuity
**Time Frame:** Three (3) Months
**Measure:** Monocular Distance Corrected Intermediate Visual Acuity
**Time Frame:** Three (3) Months
**Measure:** Monocular Uncorrected Intermediate Visual Acuity
**Time Frame:** Three (3) Months
**Measure:** Manifest Refraction Spherical Equivalent
**Time Frame:** Three (3) Months
**Description:** Manifest refraction will be evaluated at 1 and 3 months to determine refractive predictability. The predicted refraction is the goal or target refraction from the IOLMaster IOL calculation and the observed refraction is the 3 Month postoperative Manifest Refraction Spherical Equivalent measurement.
**Measure:** Refractive Predictability
**Time Frame:** Three (3) Months
**Description:** Manifest refraction will be obtained at 1 and 3 months to evaluate whether refractive stability is achieved by 3 months. Refractive stability will be evaluated at the 1 to 3 months interval as a parameter of interest to determine the proportion of eyes that achieve stability of manifest refraction.
**Measure:** Refractive Stability
**Time Frame:** Three (3) Months
**Measure:** Contrast Sensitivity - mesopic and photopic with and without glare
**Time Frame:** Three (3) Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Be at least 50 years of age or older, male or female, of any race or ethnicity.
2. Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
3. Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
4. Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).
5. Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
6. No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.
7. Provide written informed consent and a signed HIPPA form.
8. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.
Exclusion Criteria:
1. Corneal Astigmatism of \>1.0 D.
2. Planned monocular cataract extraction.
3. Visual field loss which has an impact on visual acuity.
4. Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.
5. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma)
6. History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.
7. Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject
8. Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (e.g., vitrectomy, laser iridotomy)
9. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions).
10. Capsular or zonular abnormalities or other conditions that increase the risk of zonular rupture during cataract extraction procedure and/or may affect the postoperative centration or tilt of the lens
11. Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)
12. Cycloplegic pupil diameter \<6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).
13. Usage of contact lenses during study participation
14. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes
15. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.
**Healthy Volunteers:** True
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Grant Sharpe
**Phone:** +447918937014
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9579
- Name: Heparin
- Relevance: LOW
- As Found: Unknown
- ID: M46053
- Name: Calcium heparin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428942
**Acronym:** LPV in CKD
**Brief Title:** Low-potassium Content Vegetables in Chronic Kidney Disease
**Official Title:** Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 12-XD-093
#### Organization
**Class:** OTHER
**Full Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
#### Responsible Party
**Investigator Affiliation:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
**Investigator Full Name:** Szu-Chun Hung
**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:** Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
**Detailed Description:** Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
### Conditions Module
**Conditions:**
- the Recommended Target of Daily Vegetables Intake
- Risk of Hyperkalemia
**Keywords:**
- chronic kidney disease
- vegetables
- hyperkalemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are randomized to intervention group or control group with ratio of 50:25.
##### Masking Info
**Masking:** NONE
**Masking Description:** Masking is not allowed in this study
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants in the intervention group would receive their daily low-potassium vegetables 3 to 5 serving according to their daily suggested requirement and routine CKD dietary education for 8 weeks.
**Intervention Names:**
- Other: low-potassium vegetables
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The participants in the control group would receive routine CKD dietary education for 8 weeks.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** low-potassium vegetables 3 to 5 serving according to their daily suggested requirement
**Name:** low-potassium vegetables
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants who reach the targets of daily vegetable recommended
**Measure:** Percentage of participants who reach the targets of daily vegetable recommended target
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)
**Measure:** Gut-derived uremic toxins
**Time Frame:** 8 weeks
**Description:** Change in serum creatinine in mg/dL
**Measure:** Serum creatinine
**Time Frame:** 8 weeks
**Description:** Change in proteinuria in g/day
**Measure:** Proteinuria
**Time Frame:** 8 weeks
**Description:** serum \[potassium\] \>=5.5 mmol/L
**Measure:** Occurrence of moderate hyperkalemia
**Time Frame:** 8 weeks
**Description:** Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.
**Measure:** Status of constipation
**Time Frame:** 8 weeks
**Description:** Change in alpha- and beta-diversities indices
**Measure:** Gut microbiome
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* CKD stage 3b\~5, not yet on dialysis
* Age ≥20 years
* Stable doses of medications for 4 weeks
* Serum potassium level: ≥3.5 and \< 5.5 mmol/L
Exclusion Criteria:
* Anticipated to receive dialysis within 3 month
* Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
* Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
* Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
* Patients with kidney transplants
* Patients who receive immunosuppressant
* Pregnant women or patients who are planning to become pregnant
**Maximum Age:** 99 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** TIng-Yun Lin, MD
**Phone:** 886-266289779
**Phone Ext:** 2350
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Szu-Chun Hung, MD
**Phone:** 886-266289779
**Phone Ext:** 2350
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Taipei City
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ting-Yun Lin, MD
- **Phone:** 8862-6628-9779
- **Phone Ext:** 2350
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Szu-chun Hung, MD
- **Phone:** 8862-6628-9779
- **Phone Ext:** 2350
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** Taipei Tzu Chi Hospital
**Status:** RECRUITING
**Zip:** 231
**Location 2:**
**City:** New Taipei City
**Contacts:**
***Contact 1:***
- **Name:** Szu-Chun Hung, MD
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** Taipei Tzu Chi Hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Taichung Tzu Chi Hospital
**Name:** Szu-Chun Hung, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** We do not have IPD sharing plan.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Wakasugi M, Yokoseki A, Wada M, Momotsu T, Sato K, Kawashima H, Nakamura K, Onodera O, Narita I. Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. J Ren Nutr. 2023 Jul;33(4):566-574. doi: 10.1053/j.jrn.2023.01.011. Epub 2023 Feb 13.
**PMID:** 36791982
**Citation:** Saglimbene VM, Wong G, Ruospo M, Palmer SC, Garcia-Larsen V, Natale P, Teixeira-Pinto A, Campbell KL, Carrero JJ, Stenvinkel P, Gargano L, Murgo AM, Johnson DW, Tonelli M, Gelfman R, Celia E, Ecder T, Bernat AG, Del Castillo D, Timofte D, Torok M, Bednarek-Skublewska A, Dulawa J, Stroumza P, Hoischen S, Hansis M, Fabricius E, Felaco P, Wollheim C, Hegbrant J, Craig JC, Strippoli GFM. Fruit and Vegetable Intake and Mortality in Adults undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):250-260. doi: 10.2215/CJN.08580718. Epub 2019 Jan 31.
**PMID:** 31738182
**Citation:** Pourafshar S, Sharma B, Kranz S, Mallawaarachchi I, Kurland E, Ma JZ, Scialla JJ. Patterns of Fruit and Vegetable Intake in Adults With and Without Chronic Kidney Disease in the United States. J Ren Nutr. 2023 Jan;33(1):88-96. doi: 10.1053/j.jrn.2022.06.007. Epub 2022 Jul 5.
**PMID:** 35798188
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014883
- Term: Water-Electrolyte Imbalance
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M9998
- Name: Hyperkalemia
- Relevance: HIGH
- As Found: Hyperkalemia
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- 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: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M17624
- Name: Water-Electrolyte Imbalance
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
- ID: D000006947
- Term: Hyperkalemia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428929
**Brief Title:** The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw
**Official Title:** The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** EysanUmac
#### Organization
**Class:** OTHER
**Full Name:** Koç University
### Status Module
#### Completion Date
**Date:** 2022-07-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-07-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Koç University
#### Responsible Party
**Investigator Affiliation:** Koç University
**Investigator Full Name:** Eysan Hanzade Umac
**Investigator Title:** Research Assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** It is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country. Nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns. Toys with sounds, lights, and different features have been found to effectively capture infants' attention. Consequently, it is anticipated that baby crib mobiles, which combine these attention-grabbing features, could serve as effective distractions during needle interventions, potentially reducing pain and stress. However, there is a lack of research on this specific application.
**Detailed Description:** Newborns often undergo needle procedures shortly after birth, such as vitamin K injections, hepatitis B vaccinations, screenings, and routine immunizations. Depending on the baby's condition, these procedures may need to be repeated, and additional blood samples might be required. These painful procedures can cause significant stress for the newborn and may lead to neurocognitive, physiological, metabolic, and behavioral issues. Pain experienced during these procedures can negatively impact the newborn's future reactions to pain. Therefore, inadequate pain management can result in both immediate and long-term adverse effects.
Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures, recommending non-pharmacological methods as the first line of management. These methods, aimed at providing analgesic effects by creating a relaxing environment, are important because they do not have side effects. Some proven non-pharmacological techniques include breastfeeding, skin-to-skin contact, swaddling, music therapy, oral glucose, and pacifier use.
Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns. Studies have shown its effectiveness in various settings. For instance, research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions. Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times. Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures.
### Conditions Module
**Conditions:**
- Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Newborns were randomly assigned groups as the musical and lighted baby crib mobile (intervention) group (40 newborns) and the control group (40 newborns) by the computer program (www.randomizer.org). Newborns of parents who did not meet the study criteria and did not agree to participate in the random selection were not included in the study. Parents and researchers could not be blinded. Newborns were included in the study by evaluating their compliance with the inclusion criteria according to the order of admission to the hospital. 10 children in the control group (5 parents did not volunteer and 5 newborns were crying) and 10 children in the intervention group (7 newborns received paracetamol and 3 newborns were crying) were excluded from the study. For this reason, the research was completed with 60 newborns.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Infants in the control group received standard care, with no pharmacological or non-pharmacological methods used to reduce pain, except for allowing the parents to be present. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. After the procedure, they were asked to mark the maximum pain and stress experienced by the baby on the "ALPS-Neo pain and stress rating scale." This assessment was done immediately after the needle was removed and a tampon was placed to stop the bleeding, approximately one minute after the procedure.
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Before the procedure, the researcher informed the parents of the newborns in the musical and lighted baby crib mobile group about the study procedure and purpose. The mobile was fixed 60 cm above the newborn's eye level to prevent contamination and trauma. After obtaining written consent, the researcher collected data using the 'Newborn Information Form' through face-to-face interviews. Once the form was completed, the mobile was activated. One minute later, the nurse performed the blood draw. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. They were then asked to mark the maximum pain and stress experienced by the baby on the ALPS-Neo pain and stress rating scale.
**Intervention Names:**
- Other: The musical and lighted baby crib mobile:
**Label:** Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** The musical and lighted baby crib mobile: It measures 43.5x33x9.5 cm and is made of plastic. It is recommended for use in infants 0-12 months. It has music that makes it easier for babies to fall asleep by reducing stress. This baby mobile has a projection and music function. In addition, the mobile has a 360° flexible swivel bracket that can be adjusted as desired. The surface of the apparatus of the mobile, which is designed to be environmentally and baby friendly, is smooth. There are four rattles on the mobile
**Name:** The musical and lighted baby crib mobile:
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** In this study, researchers used a mobile crib to help reduce pain in infants during needle procedures. Our primary outcome was the level of pain experienced by the infants. Pain was assessed using standardized pain assessment tools that are suitable for neonates. By comparing pain scores during the needle procedures, researchers aimed to determine the effectiveness of the mobile crib in reducing the infants' pain levels.
**Measure:** ALPS-Neo pain and stress assessment scale
**Time Frame:** immediately after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* born between 38-42 weeks,
* being 0-28 days,
* absence of visual and auditory problems,
* not using any pain reliever or sedative medication in the last four hours,
* parents' willingness to participate in the study,
* parents' knowledge of Turkish,
* parents' ability to read and write.
Exclusion Criteria:
* having a preterm birth,
* having a disease that causes chronic pain,
* having visual or auditory problems,
* using any pain or sedative medication in the last four hours.
**Healthy Volunteers:** True
**Maximum Age:** 28 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Koc University
**State:** Zeytinburnu
#### Overall Officials
**Official 1:**
**Affiliation:** Koç University
**Name:** Eyşan Savaş, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### 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
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428916
**Brief Title:** Facilitated Tucking Position During Endotracheal Suctioning
**Official Title:** The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates
#### Organization Study ID Info
**ID:** KafrelsheikhU2
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2023-07-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kafrelsheikh University
#### Responsible Party
**Investigator Affiliation:** Kafrelsheikh University
**Investigator Full Name:** Eman Wardany Abdelaal Mohamed
**Investigator Title:** assistant professor of pediatric nursing
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates.
Research Hypotheses
1. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
2. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.
### Conditions Module
**Conditions:**
- Respiratory Distress Syndrome
**Keywords:**
- Physiological measurement
- Behavioral Responses of the Preterm Neonates
- Facilitated Tucking Position
- Endotracheal Suctioning
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Consisted of 20 neonates who will receive tucking position during endotracheal suctioning
**Intervention Names:**
- Procedure: tucking position during endotracheal suctioning
**Label:** Study Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Consisted of 20 neonates who will receive routine care during Endotracheal suctioning
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study Group
**Description:** , the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention
**Name:** tucking position during endotracheal suctioning
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR)
**Measure:** Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
**Time Frame:** during procedural and immediately after procedure
**Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR)
**Measure:** Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
**Time Frame:** during procedural and immediately after procedure
**Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2)
**Measure:** Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
**Time Frame:** during procedural and immediately after procedure
#### Secondary Outcomes
**Description:** This scale was adopted from Anderson et al.(1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral states are assessed by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is sleeping. Scores from 6 to 8 indicate that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a state of restless activity or fussiness, which takes substantial energy
**Measure:** change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure
**Time Frame:** during procedural and immediately after procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
* Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
* Have endotracheal intubation.
Exclusion Criteria:
* Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
* Preterm neonates who received sedatives within four hours before the intervention
* Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.
**Healthy Volunteers:** True
**Maximum Age:** 36 Weeks
**Minimum Age:** 32 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kafr Ash Shaykh
**Country:** Egypt
**Facility:** Kafrelsheikh University
**State:** Kafr el-Sheikh
**Zip:** 33516
### 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- 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: 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: 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
### 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:** NCT06428903
**Brief Title:** Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose
**Official Title:** A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189
#### Organization Study ID Info
**ID:** ADC-DNXV-189-GR
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiaxing AnDiCon Biotech Co.,Ltd
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Jiaxing AnDiCon Biotech Co.,Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.
The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.
**Detailed Description:** In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.
In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.
### Conditions Module
**Conditions:**
- Healthy Volunteer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 16 patients.
**Intervention Names:**
- Drug: ADC189 tablet
- Drug: ADC189 granules
**Label:** ADC189 tablet Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 16 patients.
**Intervention Names:**
- Drug: ADC189 tablet
- Drug: ADC189 granules
**Label:** ADC189 granules Group B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 8 patients.
**Intervention Names:**
- Drug: ADC189 180mg
**Label:** ADC189 180mg Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ADC189 granules Group B
- ADC189 tablet Group A
**Description:** ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)
**Name:** ADC189 tablet
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- ADC189 granules Group B
- ADC189 tablet Group A
**Description:** ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
**Name:** ADC189 granules
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- ADC189 180mg Group
**Description:** ADC189 tablet, 180 mg, single oral dose. (Part 2 study)
**Name:** ADC189 180mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ADC189 plasma exposure, area under the concentration-time curve
**Measure:** ADC189 Granules
**Time Frame:** 15 days
**Description:** ADC189 plasma exposure, area under the concentration-time curve
**Measure:** ADC189 Tablet
**Time Frame:** 15 days
**Description:** Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve
**Measure:** ADC189 Ultra high dose
**Time Frame:** 15 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Healthy male subjects aged 18-45 years old
* 2. Male subjects weight over 50 kg
Exclusion Criteria:
* 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
* 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
* 3. Blood donation or blood loss \> 400 mL in 3 months before screening
**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:** Zhao Wei
**Phone:** 0531-89268212
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Name:** Wei Zhao, Dr
- **Role:** CONTACT
**Country:** China
**Facility:** Zhao Wei
**State:** Shang Dong
**Status:** RECRUITING
**Zip:** 250000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428890
**Brief Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension
**Official Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension
#### Organization Study ID Info
**ID:** 030-2223-EXP
#### Organization
**Class:** OTHER
**Full Name:** California Baptist University
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** California Baptist University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.
**Detailed Description:** Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI.
### Conditions Module
**Conditions:**
- Prehypertension
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 12
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants received the supplement (600 mg, capsules) via cross-over design for 7 days
**Intervention Names:**
- Dietary Supplement: Grape Seed Extract
- Dietary Supplement: Placebo
**Label:** Dietary Supplementation with Grape Seed Extract
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants received the placebo (600 mg, capsules) via cross-over design for 7 days
**Intervention Names:**
- Dietary Supplement: Grape Seed Extract
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dietary Supplementation with Grape Seed Extract
- Placebo
**Description:** dietary supplements that rich in polyphenolic compounds
**Name:** Grape Seed Extract
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Dietary Supplementation with Grape Seed Extract
- Placebo
**Description:** Starch
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** heart rate (bpm)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** stroke volume (ml)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** cardiac output (l/min)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** systolic blood pressure (mmHg)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** diastolic blood pressure (mmHg)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex
**Measure:** total peripheral resistance (mmHg/l/min)
**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg
Exclusion Criteria:
* taking medications that could affect cardiovascular function or BP
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Riverside
**Country:** United States
**Facility:** California Baptist University
**State:** California
**Zip:** 92504
#### Overall Officials
**Official 1:**
**Affiliation:** California Baptist University
**Name:** Jong-Kyung Kim, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** This study needs the Institutional Research Board (IRB) and participant's approvals to share the data. Without the approval, the data collected from this study will not be shared.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M29007
- Name: Prehypertension
- Relevance: HIGH
- As Found: Prehypertension
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
- ID: D000058246
- Term: Prehypertension
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M28517
- Name: Grape Seed Extract
- Relevance: HIGH
- As Found: Platelet transfusion
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: T173
- Name: Grape
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000056604
- Term: Grape Seed Extract
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428877
**Acronym:** ACSSim
**Brief Title:** Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation
**Official Title:** Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation
#### Organization Study ID Info
**ID:** 69HCL24_0514
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-04-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### 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:** andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. Rupture risk is driven by aneurysm diameter and growth rate. Aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. Open surgery and endovascular treatment are the two types of interventions. Open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. This invasive procedure is associated with a 3-10% post-operative mortality. Endovascular repair (EVAR) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. This minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . However, hostile proximal neck anatomy including high angulation is associated with higher rates of type IA endoleak, reintervention and long-term mortality . For this reason, a conformable design of the Excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . However, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the Gore ACS is lacking. Study Device Description Numerical simulation has been used successfully to predict stent-graft behavior during FEVAR . Preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . The potential of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated necks appears very promising to enhance patient selection.
### Conditions Module
**Conditions:**
- Vascular Diseases
- Surgery
**Keywords:**
- Endoprosthesis
- Numerical simulation
- Proximal neck
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.
**Intervention Names:**
- Other: analyzed on the post-operative scanner
**Label:** Patients who underwent EVAR with ACS Gore excluder.
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients who underwent EVAR with ACS Gore excluder.
**Description:** analyzed on the post-operative scanner
**Name:** analyzed on the post-operative scanner
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Quantitative neck apposition parameters (including but not limited to malapposition length, width, angle) will be extracted both from numerical simulation and post-operative CT.
Quantitative values will then be compared Comparison between quantitative neck apposition parameters (malapposition length, width, angle) derived from simulation and the one observed on post-op CT and/ or follow-up CT
**Measure:** The aim of the present study is to investigate the accuracy of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated proximal AAA necks.
**Time Frame:** up to 16 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The patient:
1. Is age ≥18 at the time of inclusion.
2. Underwent EVAR with ACS Gore Excluder
3. AAA proximal neck angulation superior to 60 degrees
4. Pre-op CT and post-operative/follow-up CT available
Exclusion Criteria:
1. Slice thickness of Pre-op or post-op / follow-up CT superior to 2mm.
2. Non-injected or poorly injected pre-operative CT-scan precluding technical feasibility of the aortic digital twin
3. Absence of post-operative or follow-up CT-scan
4. Patient refusal of his personal information/medical data to be used in the context of the study
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bron
**Country:** France
**Facility:** Hôpital Louis Pradel
**Zip:** 69500
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- 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: M17400
- Name: Vascular Diseases
- Relevance: HIGH
- As Found: Vascular Disease
### Condition Browse Module - Meshes
- ID: D000014652
- Term: Vascular Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428864
**Acronym:** GSSCAN
**Brief Title:** Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
**Official Title:** Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
#### Organization Study ID Info
**ID:** 69HCL24_0513
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2023-11-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** 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:** Neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. Thoracic braces are necessary to slow down the deformation. In France, Garchois brace is largely used in this context because of a better pulmonary tolerance.
Historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. He/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). The position during molding could be very uncomfortable and anxious.
With the development of new technologies, a 3D scan application on smartphone to obtain the volume and deformations of the patient was developed. This tool enables digital acquisition of trunk and head volume while bypassing the seated patient. No plaster strips are used. The resulting negative is digitally filled to obtain a positive. The positive is then corrected before the corset is made, either digitally or after 3D scanning, in plaster or foam. This application was first used in our department in 2017.
The aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding.
### Conditions Module
**Conditions:**
- Neuromuscular Diseases
- Scoliosis
**Keywords:**
- Scoliosis
- Neuromuscular Diseases
- Orthotic device
- Brace
- Cast
- 3D Scan application
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient with a Garchois brace produced after a plaster cast
**Intervention Names:**
- Device: Plaster cast
**Label:** Cast
#### Arm Group 2
**Description:** Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan
**Intervention Names:**
- Device: 3D Scanning
**Label:** Scan
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cast
**Description:** Wearing a Garchois brace produced after a plaster cast
**Name:** Plaster cast
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Scan
**Description:** Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan
**Name:** 3D Scanning
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Mean differences in Cobb angles measured by spinal X-rays before and after wearing the brace for the 2 groups of patients
**Measure:** Assessment of Cobb angles
**Time Frame:** Up to 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical suspicion or genetically confirmed neuromuscular disease
* Neuromuscular scoliosis, with Garchois brace indication
* Under 18 at the time of the first Garchois brace molding
Exclusion Criteria:
* Other neuro-orthopaedic disease such as cerebral palsy
* Other thoracic brace than Garchois
* Any spine surgery
**Maximum Age:** 18 Years
**Minimum Age:** 1 Year
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** Neuromuscular patients from a paediatric rehabilitation center
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bron
**Country:** France
**Facility:** L'Escale - HFME
**Zip:** 69500
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013121
- Term: Spinal Curvatures
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009422
- Term: Nervous System 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: M15417
- Name: Scoliosis
- Relevance: HIGH
- As Found: Scoliosis
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: HIGH
- As Found: Neuromuscular Diseases
- ID: M15918
- Name: Spinal Curvatures
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012600
- Term: Scoliosis
- ID: D000009468
- Term: Neuromuscular Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428851
**Brief Title:** Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain
**Official Title:** Comparison of Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions
#### Organization Study ID Info
**ID:** 2023-174
#### Organization
**Class:** OTHER
**Full Name:** Hitit University
### Status Module
#### Completion Date
**Date:** 2024-05-17
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-17
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-26
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hitit University
#### Responsible Party
**Investigator Affiliation:** Hitit University
**Investigator Full Name:** Pınar Özge Başaran
**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:** This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other.
**Detailed Description:** Cerebrovascular events, which are estimated to affect approximately 9 million people worldwide, have emerged as a serious cause of morbidity and mortality due to prolonged human lifespan. With the use of effective treatment methods in acute treatment, the level of expectation regarding prognosis has increased. Secondary complications that develop after stroke are frequently encountered. These complications cause serious disruptions in the rehabilitation process. The upper extremity is affected more frequently than the lower extremity and recovery is more difficult and slower. Most of the functional impairments related to the upper extremity are shoulder problems. The most important reason is impaired shoulder biomechanics. Pain may occur in the first 2 weeks after stroke or typically occurs 1 to 3 months after stroke. Pain in the hemiplegic shoulder significantly reduces patients' function and rehabilitation capacity. Reducing pain with effective methods applied for pain increases participation in rehabilitation and increases the range of motion measurements and functional capacity.
There are many physical therapy approaches in the treatment of hemiplegic shoulder pain. Light amplification by stimulated emission of radiation (laser) is one of these treatment approaches and briefly means intensified light. Laser principles are based on the quantum concept introduced by Einstein in 1927. Theodore Maiman developed the first laser device in 1960. According to the basic working principle of laser devices; the photon energy emitted from a light source is passed through a specific medium and it is thought to be effective in reducing pain in the tissue, increasing the range of motion, and improving upper extremity functions. As a result of all these mechanisms of action, laser beams are used in medicine to utilize their regenerative, biostimulating, analgesic, anti-inflammatory, and anti-edematous effects. These laser methods have been previously studied in knee osteoarthritis and shoulder adhesive capsulitis. Laser has also been investigated in hemiplegia.
Neuromuscular electrical nerve stimulation (NMES) produces muscle contractions using electrical pulses. These electrical pulses are delivered to the current muscles through superficial electrodes. The action potential from the central nervous system is mimicked with NMES and contraction is produced in the muscle.
There is no study in the literature comparing laser and neuromuscular electrical nerve stimulation in the hemiplegic shoulder.
This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other. In this prospective randomized controlled study, 75 stroke patients aged 18-85 years with shoulder pain who were diagnosed with ischemic stroke for the first time and who applied to the Physical Therapy and Rehabilitation Outpatient Clinic between December 2023 and May 2024 were included in the study. The patients included in the study were divided into 3 groups by the same physiotherapist by envelope drawing method. Due to the nature of the study, the physiotherapist administering the treatment was aware of the groups of the patients. On the other hand, all evaluations were performed by the same researcher who was blinded to the type of treatment. All patients underwent a multidisciplinary rehabilitation program 5 days a week for 4 weeks for a total of 20 sessions. Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. 1st group laser group (n:25) received laser for 5 minutes a day 3 days a week in addition to classical physical therapy, 2nd group ES group (n:25) received Neuromuscular electrical nerve stimulation for 20 minutes a day 5 days a week in addition to classical physical therapy. 3. Group, control group (n:25), classical physical therapy exercises were applied.
### Conditions Module
**Conditions:**
- Hemiplegic Shoulder Pain
**Keywords:**
- hemiplegic shoulder pain
- electrical nerve stimulation
- laser
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1. Laser therapy
2. Neuromuscular electrical nerve stimulation therapy (NMES)
3. Control: classical physical therapy exercises
3)
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Participants: stroke patients with shoulder pain Care provider: physiotherapist who applied the treatments to the patients Investigator: Researchers who were blinded to the treatment groups
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 75
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. Group 1 Laser therapy group (n:25) in addition to classical physical therapy, laser was applied to the shoulder group muscles for 5 minutes a day, 3 days a week for 4 weeks.
**Intervention Names:**
- Other: Laser therapy
**Label:** Laser therapy Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. In Neuromuscular electrical nerve stimulation group, in addition to these exercises, Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscle groups for 20 minutes a day, 5 days a week for a total of 4 weeks.
**Intervention Names:**
- Other: Neuromuscular electrical nerve stimulation
**Label:** Neuromuscular electrical nerve stimulation Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises.
**Intervention Names:**
- Other: Control
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Laser therapy Group
**Description:** Shoulder girdle muscles were lasered for 5 minutes a day, 3 days a week, total of 4 weeks.
**Name:** Laser therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Neuromuscular electrical nerve stimulation Group
**Description:** Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscles for 20 minutes a day 5 days a week, total of 4 weeks.
**Name:** Neuromuscular electrical nerve stimulation
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Control Group
**Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises 5 days a week for 1 hour, total of 4 weeks.
**Name:** Control
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain.
**Measure:** Pain Level
**Time Frame:** baseline and through study completion, an average of 4 weeks
#### Secondary Outcomes
**Description:** upper extremity functions were evaluated with Fugl-Meyer. Fugl-Meyer is a stroke-specific performance-based scale, fully filled by the same investigator, each parameter is scored between 0-2. The total score is between 0 to 100. 0: unsuccessful, 1: partially successful, 2: completely successful performance. A higher score indicates better performance
**Measure:** upper extremity functions
**Time Frame:** baseline and through study completion, an average of 4 weeks
**Description:** he Shoulder Pain and Disability Index is a patient-completed scale consisting of 5 items on pain and 8 items on disability. Each item is marked by the patient on a 0-10 cm scale. High scores indicate high pain and disability.
**Measure:** Disability
**Time Frame:** baseline and through study completion, an average of 4 weeks
**Description:** Barthel index It is filled out after the examination by the same investigator to evaluate the activities of daily living of the patients. Turkish version of the scale has been adapted. The Barthel index consists of 10 items related to activities of daily living and mobility. Nutrition, transition from wheelchair to bed and back, self-care, bathing, walking, climbing up and down stairs, dressing, bladder and bowel continence are evaluated. The items can be divided into two parts related to self-care and mobility. A scoring is based on whether the person is assisted in performing these tasks. The highest total score that can be achieved is 100, which means that the individual is completely independent in their physical functioning. The lowest score is 0, indicating that the individual is completely dependent
**Measure:** Daily living activities
**Time Frame:** baseline and through study completion, an average of 4 weeks
**Description:** The Modified Ashworth Scale, the most widely used scale for tonus assessment, was used to evaluate spasticity. In this scale, muscle tone is evaluated between 0 normal and 4 being rigid. In our study, spasticity in shoulder adductors and internal rotators, forearm flexors, wrist flexors and finger flexors were recorded by the same investigator.
**Measure:** Spasticity
**Time Frame:** baseline and through study completion, an average of 4 weeks
**Description:** Brunnstrom Recovery Stage is a 6-step scale that includes movement patterns with progressively increasing recovery evaluated separately for upper extremity, hand and lower extremity. 0: no movement, 6: full movement. Higher values indicate better motor recovery and were recorded by the same investigator.
**Measure:** Recovery Stage
**Time Frame:** baseline and through study completion, an average of 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* diagnosed with unilateral ischemic stroke for the first time
* 18-85 years old,
* patients with shoulder pain
Exclusion Criteria:
* another disease that will affect the central nervous system
* injections or physical therapy to the same shoulder in the last 3 months,
* history of shoulder surgery,
* cervical radiculopathy,
* inflammatory rheumatic disease or infection,
* serious cardiovascular disease such as heart failure, arrhythmia, myocardial infarction that will affect functional status,
* disease that will cause cognitive dysfunction,
* Alzheimer's disease, dementia,
* severe visual loss,
* pregnancy and lactation,
* malignancy,
* psychiatric diseases
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Corum
**Country:** Turkey
**Facility:** Hitit University
**Zip:** 19040
#### Overall Officials
**Official 1:**
**Affiliation:** HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
**Name:** MUSTAFA KESER, Ass Prof
**Role:** STUDY_CHAIR
## 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:** NCT06428838
**Brief Title:** Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
**Official Title:** Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)
#### Organization Study ID Info
**ID:** Medvedev_001
#### Organization
**Class:** INDUSTRY
**Full Name:** HealthTech Connex Inc.
### Status Module
#### Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** H. Lundbeck A/S
**Class:** UNKNOWN
**Name:** Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.
**Class:** UNKNOWN
**Name:** Royal Columbian Hospital
**Class:** UNKNOWN
**Name:** Surrey Memorial Hospital
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Dr George Medvedev
#### Responsible Party
**Investigator Affiliation:** HealthTech Connex Inc.
**Investigator Full Name:** Dr George Medvedev
**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:** The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.
Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.
Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.
This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.
### Conditions Module
**Conditions:**
- Migraine
- Chronic Migraine
**Keywords:**
- acute treatment
- emergency
- monoclonal antibody
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized (1:1), controlled trial with standard of care (SoC) as control arm.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 102
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SoC will be delivered at the discretion of the treating physician
**Intervention Names:**
- Other: Standard of Care
**Label:** Standard of Care
**Type:** OTHER
#### Arm Group 2
**Description:** In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).
**Intervention Names:**
- Biological: Eptinezumab
- Other: Standard of Care
**Label:** Standard of Care + Eptinezumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard of Care + Eptinezumab
**Description:** The study treatment consists of a single infusion of eptinezumab (100mg/mL).
**Name:** Eptinezumab
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Standard of Care
- Standard of Care + Eptinezumab
**Description:** SoC may include a combination of Toradol, Metoclopramide, and/or Benadryl. Ketamine and/or Midazolam may also be used, according to a stepwise approach, at the discretion of the treating physician. The timing and dose of all medication(s) administered in the ED will be recorded.
**Name:** Standard of Care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of migraine days at week 1, as reported in daily Headache Diary
**Measure:** Number of migraine days at week 1
**Time Frame:** Baseline to Week 1
#### Secondary Outcomes
**Description:** Readmission to the Emergency Department (ED) as assessed by patient chart
**Measure:** Readmission to the Emergency Department (ED)
**Time Frame:** Baseline to Month 3
**Description:** The Generalized Anxiety Disorder 7-item (GAD-7) will be assessed at baseline, month 1 and month 3. The GAD-7 is a short self-report questionnaire assessing the severity of anxiety disorder. For each item, the participant is asked how bothered they have been by the problem in the last 2 weeks. The total score ranges from 0-21, and a score greater than 15 indicates severe anxiety. The recall period for the GAD-7 is 2 weeks.
**Measure:** Generalized Anxiety Disorder 7-item (GAD-7)
**Time Frame:** Baseline to Month 3
**Description:** The Headache Impact Test (HIT-6) will involve an assessment at baseline and at months 1 and 3. The HIT-6 (v1.0) is a Likert-type, self-reported questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The assessment was developed to measure a wide spectrum of factors contributing to headache burden, and it has demonstrated reliability and validity. The recall period for the HIT-6 is 4 weeks.
**Measure:** Headache Impact Test (HIT-6)
**Time Frame:** Baseline to Month 3
**Description:** The PHQ-9 is a short self-report questionnaire assessing signs and symptoms of depression. The questionnaire consists of nine items which ask about the frequency and severity of depressive symptoms based on DSM-IV criteria. For each item, the participant is asked to rate the severity of the symptom on a scale from 0 to 3. The total score ranges from 0-27 with a higher score indicating more severe depressive symptoms. The recall period for the PHQ-9 is 2 weeks.
**Measure:** Patient Health Questionnaire (PHQ-9)
**Time Frame:** Baseline to Month 3
**Description:** The PGI-C will involve an assessment at 24-72hrs, week 1, month 1 and month 3. PGI-C is a one-item measure rating of the overall patient perceived improvement on a seven-point scale. Patients rate their change since treatment initiation as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse.
**Measure:** Patient Global Impression of Change (PGI-C)
**Time Frame:** Baseline to Month 3
**Description:** Number of monthly headache days as assessed by the Migraine Disability Assessment (MIDAS)
**Measure:** Number of monthly headache days
**Time Frame:** Baseline to Month 3
**Description:** Recurrence of migraine as reported in daily Headache Diary
**Measure:** Migraine recurrence
**Time Frame:** Baseline to Month 3
**Description:** The WPAI is a six-item validated instrument that measures aspects of work productivity and activity impairment due to migraine over the past 7 days with higher values, in the form of percentages, indicating greater impairment due to the respondent's health. Only patients that are currently employed (full-time, part-time, or self-employed) are eligible to respond to the items assessing work-related activities. Item 6 in the WPAI will be administered to those not in employment, providing the possibility of calculating activity impairment for patients that are not employed. The six items are used to derive four subscales: Absenteeism (proportion of missed work hours out of the total; scale 0-100%), Presenteeism (level of work impairment; scale 0-10), Overall work impairment (combination of absenteeism and presenteeism; scale 0-100%), and Activity impairment (impairment in daily activities; scale 0-10).
**Measure:** Work Productivity and Activity Impairment (WPAI)
**Time Frame:** Baseline to Month 3
**Description:** Sleep quality will be assessed with the question, "On average, about how many hours of sleep do you get per night?" with responses including "7-9 hrs", "6-6.9 hrs", "5-5.9 hrs" or "less than 5 hrs". The recall period will be 1 week.
**Measure:** Sleep Quality
**Time Frame:** Baseline to Month 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart;
2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
3. Provided signed informed consent;
4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.
Exclusion Criteria:
1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
2. Current or history of severe cardiovascular disease or renal dysfunction
3. A systemic condition in the stage of active treatment (vasculitis, etc.)
4. Pregnant or at risk of becoming pregnant (absent contraception)
5. Currently enrolled in another investigational drug trial
6. Dosed with eptinezumab within the past 3 months
7. Currently on anti-CGRP therapy with monoclonal antibodies
8. Currently involved in active litigation
9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
10. Hypersensitivity to the active substance or to any of the excipients
**Maximum Age:** 75 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Julia Joyes Clinical Research Coordinator
**Phone:** 778-735-1945
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Westminster
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vesna Ivkov
- **Role:** CONTACT
***Contact 2:***
- **Name:** George Medvedev Neurologist, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** Royal Columbian Hospital
**State:** British Columbia
**Zip:** V3L 3W7
**Location 2:**
**City:** Surrey
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vesna Ivkov
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dr George Medvedev Neurologist, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** Surrey Memorial Hospital
**State:** British Columbia
**Zip:** V3V 1Z2
### IPD Sharing Statement Module
**Description:** If the results of the study are published in the public domain, only aggregate/group data will be published.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000051270
- Term: Headache Disorders, Primary
- ID: D000020773
- Term: Headache Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M11852
- Name: Migraine Disorders
- Relevance: HIGH
- As Found: Migraine
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M9351
- Name: Headache
- Relevance: LOW
- As Found: Unknown
- ID: M22529
- Name: Headache Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M26657
- Name: Headache Disorders, Primary
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008881
- Term: Migraine Disorders
- ID: D000004630
- Term: Emergencies
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: AAll
- Name: Anti-Allergic Agents
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M11845
- Name: Midazolam
- Relevance: LOW
- As Found: Unknown
- ID: M10674
- Name: Ketamine
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M22645
- Name: Ketorolac
- Relevance: LOW
- As Found: Unknown
- ID: M22646
- Name: Ketorolac Tromethamine
- Relevance: LOW
- As Found: Unknown
- ID: M11760
- Name: Metoclopramide
- Relevance: LOW
- As Found: Unknown
- ID: M7338
- Name: Diphenhydramine
- Relevance: LOW
- As Found: Unknown
- ID: M14268
- Name: Promethazine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428825
**Brief Title:** A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure
**Official Title:** Study in Participants With Mild to Moderate Arterial Hypertension to Investigate Safety and Tolerability of BAY3283142 in a Randomized, Single-blind, Placebo-controlled, Multi-center, Group Comparison Design
#### Organization Study ID Info
**ID:** 22723
#### Organization
**Class:** INDUSTRY
**Full Name:** Bayer
#### Secondary ID Infos
**Domain:** CTIS (EU)
**ID:** 2024-512060-58-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**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:** Bayer
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** In this study, researchers want to learn about the safety of BAY3283142 after a single dose and multiple doses in participants with mild to moderate high blood pressure. The study treatment called BAY3283142 helps to relax blood vessels. It is currently under development for the treatment of chronic kidney disease (CKD) and nonproliferative diabetic retinopathy (NPDR). CKD is a condition in which the kidneys' ability to work gradually decrease over time. NPDR is a condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes. During this study, participants will take either different doses of the study drug BAY3283142 as tablets by mouth or a placebo. A placebo looks like the study drug but does not have any medicine in it. At the start of this study, the study doctor will check the medical history and current medications of the participants. They will also perform a complete health check on all the participants. Researchers will collect blood and urine samples from the participants at different time points to assess the safety and effects of BAY3283142. Each treatment scheme will consist of three doses that are given in a consecutive manner. For the first 7 days, participants will receive a lower dose of BAY3283142 in each treatment scheme. The middle and the higher dose of each treatment scheme will be given for 14 days each. Participants will not know which treatment (placebo or BAY3283142) they will be given, but the study doctor will know which group received which treatment. A participant can be in the study for 10 weeks. This study will be conducted on men or postmenopausal women participants with mild to moderate high blood pressure who may not directly benefit from treatment with BAY3283142. However, information collected in this study will serve as a basis for the development of BAY3283142 for the treatment of people with CKD or NPDR. Participants may experience pain and discomfort when blood samples are taken.
The researchers will closely monitor and manage any medical problems that the participants may have during the study.
### Conditions Module
**Conditions:**
- Chronic Kidney Disease
- Non-proliferative Diabetic Retinopathy
- Arterial Hypertension
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 72
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose.
**Intervention Names:**
- Drug: BAY3283142
- Drug: Placebo to BAY3283142
**Label:** Treatment scheme 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose.
**Intervention Names:**
- Drug: BAY3283142
- Drug: Placebo to BAY3283142
**Label:** Treatment scheme 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose.
**Intervention Names:**
- Drug: BAY3283142
- Drug: Placebo to BAY3283142
**Label:** Treatment scheme 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose.
**Intervention Names:**
- Drug: BAY3283142
- Drug: Placebo to BAY3283142
**Label:** Treatment scheme 4
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment scheme 1
- Treatment scheme 2
- Treatment scheme 3
- Treatment scheme 4
**Description:** oral administration
**Name:** BAY3283142
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Treatment scheme 1
- Treatment scheme 2
- Treatment scheme 3
- Treatment scheme 4
**Description:** oral administration
**Name:** Placebo to BAY3283142
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of participants with treatment-emergent adverse events per treatment arm (pooled placebo analysis)
**Time Frame:** up to 7 days after last intake of study intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant must be 30 to 72 years of age inclusive, at the time of signing the informed consent.
* Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs
* No planned changes to antihypertensive treatment during active treatment phase of the study.
* Estimated glomerular filtration rate ≥45 mL/min/1.73 m2 (CKD-Epi formula) at screening and Study Day -2.
* Men and confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels \>40 miU/mL) or women with iatrogenic menopause due to bilateral oophorectomy
Exclusion Criteria:
* Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis)
* Any surgical or medical condition which significantly alters the absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal tract surgery, cholecystectomy, inflammatory bowel disease, chronic diarrhea, currently active gastritis, and pancreatitis
* Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
* PDE inhibitors starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
* sGC stimulators or activators starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
**Maximum Age:** 72 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bayer Clinical Trials Contact
**Phone:** (+)1-888-84 22937
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mannheim
**Country:** Germany
**Facility:** Clinical Research Services | Clinical Research Services Mannheim - Phase one unit
**State:** Baden-Württemberg
**Zip:** 68167
**Location 2:**
**City:** Berlin
**Country:** Germany
**Facility:** CRS Clinical Research Services Berlin GmbH
**Zip:** 13353
### IPD Sharing Statement Module
**Description:** Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular 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: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012164
- Term: Retinal Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System 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: BC11
- Name: Eye Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- 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: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Arterial Hypertension
- ID: M7125
- Name: Diabetic Retinopathy
- Relevance: HIGH
- As Found: Diabetic Retinopathy
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- 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: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003930
- Term: Diabetic Retinopathy
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428812
**Brief Title:** The Effect of Perineal Protective Package Application on Pelvic Floor in Labor
**Official Title:** Phd Student Msc Midwife
#### Organization Study ID Info
**ID:** Hayatoktem02
#### Organization
**Class:** OTHER
**Full Name:** Gulhane School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Öznur Hayat Öktem
#### Responsible Party
**Investigator Affiliation:** Gulhane School of Medicine
**Investigator Full Name:** Öznur Hayat Öktem
**Investigator Title:** Phd student Msc midwife
**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 aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually.
**Detailed Description:** The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary, genital and gastrointestinal systems. When tissues in a region of the pelvic floor are damaged for any reason, pelvic floor dysfunction develops.
Pregnancy and childbirth are important risk factors for pelvic floor dysfunction. Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function. During pregnancy, weight gain and increase in uterine weight increase intra-abdominal pressure. Therefore, ligaments and pelvic floor muscles are overstretched. He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger. During the passage and descent of the fetal head through the vaginal canal, the pelvic floor muscles can be overstretched, torn or damaged. Obstetric factors that cause pelvic floor damage include early or late age at first birth, high body mass index, large baby, length of the second stage of trauma (labor), forceps, vacuum, episiotomy and fundal compression.
Damage to the pelvic floor during labor has many short- and long-term effects on a woman\'s quality of life. These can be summarized as chronic perineal pain, pelvic organ prolapse, urinary and anal incontinence, fistula, sexual dysfunction, labor dissatisfaction, physical and psychological morbidities, and decreased quality of life. In addition, breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period. Therefore, it is important to prevent pelvic floor damage in childbirth, which negatively affects physical, social and psychological well-being and leads to many short and long-term morbidities. The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery.
In the literature, there are many studies examining interventions to protect the pelvic floor in labor. Studies show that perineal massage, perineal warm application, birth positions, hand maneuvers, pushing techniques, and limited episiotomy reduce the incidence of perineal injury.
However, studies on these techniques and practices are generally studies investigating the effectiveness of a single method. In a recent qualitative study, midwives were asked to evaluate the effect of some protective practices called; perineal package; as a whole. However, in this study, midwives; own practices and opinions were evaluated, and their effects on the pelvic floor or labor were not examined. International organizations recommend the application of evidence-based, perineal, and pelvic floor supportive and protective methods to pregnant women in labor. However, the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence, which are indicators of pelvic floor damage, is unclear and studies to evaluate this relationship are limited.
The research will be conducted in 4 stages. In Phase 1, pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room. In the first interview, the relevant sections of the data collection form will be filled out, pelvic floor muscle strength will be measured with a perineometer, and the IIQ-7 and UDI-6 scales will be filled out. Pregnant women with incontinence detected in these scales will be excluded. Then, pregnant women will be randomized using the true random number generation method on the random.org website and assigned to the study and control groups. Then, the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form.
In phase 2, the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins. The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born. During this stage, the study group will receive a perineal protection package while the control group will receive routine care. Postpartum perineal pain, episiotomy length if episiotomy was applied and perineal length will be measured in both groups. The results of the trauma will be recorded in the labor follow-up form.
In the 3rd stage, pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS.
In the 4th stage, the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer, perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum. UDI-6 (urinary distress inventory) and IIQ-7 (incontinence impact questionnaire) will be completed.
### Conditions Module
**Conditions:**
- Pregnancy
- Labor
- Pelvic Floor
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made
**Intervention Names:**
- Other: Experimental: perineal package application group
**Label:** perineal package application group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine hospital care
**Label:** Routine hospital care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- perineal package application group
**Description:** This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made
**Name:** Experimental: perineal package application group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Perineal muscle strength will be measured in cmH2o with a perineometer.
**Measure:** Perineal muscle strengt
**Time Frame:** On initial admission to the delivery room and after 6 weeks postpartum
**Description:** Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum.
**Measure:** Perineal Pain
**Time Frame:** 1st hour postpartum
#### Secondary Outcomes
**Description:** Episypotomy will be measured in cm with a paper ruler according to the application status.
**Measure:** Episiotomy and laseration status
**Time Frame:** 1st hour postpartum
**Description:** Urinary incontinence status will be measured with UDI-6 and IIQ-7.
**Measure:** Urinary incontinence status
**Time Frame:** 6 weeks postpartum
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18- 35 years old
* Primipar
* Singleton pregnancy in the vertex position between 38 and 42 weeks
* A reactive NST tracing
* Without a systemic disease (heart, HT, diabetes)
* No problem speaking and understanding Turkish
* Who agreed to participate in the study
Exclusion Criteria:
* Obese pregnant women
* Pregnant women who gained more than 25 kilograms during pregnancy
* Pregnant women with urinary incontinence according to UDI-6
* Multiple pregnancies
* Pregnant women with a neurological disease affecting the pelvic floor
* Pregnant women who have undergone pelvic surgery
* Contraindications for normal delivery (placenta previa, anomalies of presentation, etc.)
* Estimated fetal weight of 4000 g or more
* Who wants to opt out of the study
* Pregnant women who are scheduled for cesarean section at any time of trauma
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nazan KARAHAN, Assosition Prof.
**Phone:** 05074861414
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karabük
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Öznur HAYAT ÖKTEM, Phd Student Msc Midwife
- **Phone:** 05050532025
- **Role:** CONTACT
***Contact 2:***
- **Name:** Nazan KARAHAN, Associate professor
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** MEHMET BÜLBÜL KBÜ, Associate professor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Karabuk Training and Research Hospital, obstetrics clinic
**Zip:** 78100
#### Overall Officials
**Official 1:**
**Affiliation:** Gulhane School of Medicine
**Name:** Nazan KARAHAN, Associate professor
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Karabuk University
**Name:** MEHMET BÜLBÜL, Associate professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** undefined
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428799
**Acronym:** EMBLEDDA-MMG
**Brief Title:** Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
**Official Title:** Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study
#### Organization Study ID Info
**ID:** 00003
#### Organization
**Class:** INDUSTRY
**Full Name:** Carebot s.r.o.
### Status Module
#### Completion Date
**Date:** 2024-04-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-24
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Carebot s.r.o.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)
1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)
**Detailed Description:** The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall).
The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively.
For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.
### Conditions Module
**Conditions:**
- Breast Cancer
- Breast Tumor Benign
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 122
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno).
The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022.
**Intervention Names:**
- Device: Carebot AI MMG
**Label:** Retrospective collection of DICOM patient files for Site 1
#### Arm Group 2
**Description:** A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.).
The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023.
**Intervention Names:**
- Device: Carebot AI MMG
**Label:** Retrospective collection of DICOM patient files for Site 2
#### Arm Group 3
**Description:** A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute).
The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022.
**Intervention Names:**
- Device: Carebot AI MMG
**Label:** Retrospective collection of DICOM patient files for Site 3
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Retrospective collection of DICOM patient files for Site 1
- Retrospective collection of DICOM patient files for Site 2
- Retrospective collection of DICOM patient files for Site 3
**Description:** Carebot AI MMG is a software solution that utilizes artificial intelligence methods, specifically deep learning and computer vision algorithms, to evaluate and localize suspicious regions of potential lesions during the interpretation of digital breast x-rays as part of standard mammography screening procedures. The Carebot AI MMG medical device is not intended for use in diagnostic mammography. The Carebot AI MMG is intended for use in women over the age of 18.
The predictive outputs of the Carebot AI MMG medical device are intended to aid decision-making in screening clinical practice, always in conjunction with other relevant patient information and based on the professional judgment of the examining clinician. The Carebot AI MMG is specifically designed to provide a supporting layer of analysis that helps in evaluating or prioritizing mammography images with additional patient information and the professional judgment of the examining physician.
**Name:** Carebot AI MMG
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** A multicenter, multi-reader, retrospective study was designed to validate the clinical efficacy of the proposed Carebot AI MMG (also referred to as "DLAD"). Using a non-certified medical device, a test set of retrospectively collected mammography studies in standard projections (CC and MLO). The performance of the DLAD was evaluated against the ground truth for individual indications (breast density evaluation, breast lesion detection) using Accuracy.
**Measure:** Performance Test
**Time Frame:** 2024
#### Secondary Outcomes
**Description:** Carebot AI MMG v2.2 classified mammography studies according to the ACR BI-RADS 5th edition, i.e. breast tissue density assessment into A/B/C/D classes. The performance of the Carebot AI MMG device was assessed relative to the ground truth and then compared with the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). A rigorous statistical analysis was used in the BI-RADS breast density classification to evaluate the performance of each method - the proposed Carebot AI MMG v2.2 medical device and the compared radiologists in the multi-reader study. The analysis focused on key metrics including Accuracy, F1 Score (Macro-Averaged), Precision (Macro-Averaged), Recall (Macro-Averaged) and Cohen's Kappa (κ) to assess the strength of agreement. Given that all scans were evaluated by all radiologists in the comparison, a bootstrapping method that involves resampling the test data 1000 times.
**Measure:** Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment
**Time Frame:** 2024
**Description:** The medical device (DLAD, Carebot AI MMG v2.2) analyzed mammography studies in standard projections (CC and MLO) and classified the presence of lesions ("present" x "absent") at the mammography study level. DLAD performance was assessed relative to the ground truth and then compared to the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). The investigators quantified the performance of diagnostic tests based on Sensitivity, Specificity and Balanced Accuracy. The investigators further assessed the statistical significance of differences between DLAD and individual radiologists using appropriate statistical tests. To determine the reliability of the metrics examined, the investigators calculated 95% confidence intervals using Wilson scores. To evaluate the statistical significance of differences in Sensitivity and Specificity between DLAD and individual radiologists, the investigators applied McNemar's test with a continuity correction.
**Measure:** Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection
**Time Frame:** 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.
Exclusion Criteria:
* The medical device cannot be used in patients with breast implants.
* The medical device cannot be used in male breast examination.
* The medical device cannot be used in patients under 18 years of age.
**Gender Based:** True
**Gender Description:** The medical device cannot be used in male breast examination.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Brno
**Country:** Czechia
**Facility:** EUC Mamocentrum Brno
**Zip:** 60200
**Location 2:**
**City:** Brno
**Country:** Czechia
**Facility:** Masaryk Memorial Cancer Institute
**Zip:** 60200
**Location 3:**
**City:** Šumperk
**Country:** Czechia
**Facility:** Hospital Šumperk
**Zip:** 78701
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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 Tumor
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428786
**Acronym:** PCOS
**Brief Title:** The Effect of Polycystic Ovary Syndrome Phenotypes on Quality of Life and Sexual Function
**Official Title:** The Effect of Polycystic Ovary Syndrome Phenotypes on Quality of Life and Sexual Function
#### Organization Study ID Info
**ID:** 02/08 28.02.2024
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
**Investigator Full Name:** Mujde Can Ibanoglu
**Investigator Title:** Assoc. Prof
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study was planned to examine whether different phenotypes of PCOS have an effect on quality of life, depression inventory and sexual function.
**Detailed Description:** Polycystic ovary syndrome (PCOS) is the most common endocrinologic pathology in women of reproductive age. Although the prevalence varies according to race, ethnicity and geographical region, it averages between 5-10%. The so-called Rotterdam criteria are: 1. Oligo- and/or anovulation, 2. Clinical and/or biochemical signs of hyperandrogenism, 3. Polycystic ovarian morphology on ultrasound, 4. Other conditions causing or associated with androgen elevation must be ruled out before a diagnosis of PCOS is made. Treatment needs, types and options vary according to phenotypic characteristics. The OD+HA+PKOM phenotype is considered a complete (classic) phenotype according to the Rotterdam classification and has the highest rate. Other phenotypes according to the Rotterdam criteria can be OD+HA (non-PCO phenotype), HA+PKOM (ovulation phenotype) or OD+PKOM (non-HA phenotype). Clinical pictures (phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD+PCOM group among these 4 different phenotypes. The prevalence and distribution characteristics of metabolic abnormalities (insulin resistance, metabolic disease pattern and glucose intolerance) did not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not used to differentiate the different clinical PCOS phenotypes.
Studies have shown that the "classic" PCOS group (phenotypes A and B) is more strongly associated with marked menstrual irregularity, elevated insulin levels and risk of metabolic syndrome; body mass index and obesity compared to the non-classic or non-hyperandrogenic PCOS phenotypes (phenotypes C and D).
There are numerous studies on whether phenotypic differences are based on ethnicity. Studies have shown that African-American women and women of Hispanic origin are more prone to obesity and the development of metabolic syndrome, while Middle Eastern women and women of Mediterranean origin are more prone to hirsutism. PCOS symptoms such as clinical hyperandrogenism, anovulation and menstrual irregularities can lead to a reduced quality of life, depression, mood disorders and sexual dysfunction. The physical, emotional and environmental scores were significantly lower in Group A patients compared to the other PCOS groups and the control group. The Short Form 36 (SF 36), which has the characteristics of a general scale among quality of life scales and provides broad measurement, was developed and put into use by the Rand Corporation in 1992. The scale was designed to be short and easy to administer and has a wide range of applications. The main feature of the SF-36, whose psychometric properties and scope have been expanded, is that it is a self-report scale that includes items on physical functioning, social functioning, role limitations related to physical functioning, role limitations related to emotional problems, mental health, energy/vitality, pain, and general perception of health.
The relationship between the severity of depressive symptoms and the different PCOS phenotypes is controversial. The Beck Depression Inventory (BDI-II), developed by Dr. Aaron T. Beck, is a questionnaire with 21 multiple-choice questions that can be used to measure the severity of depression. Scores ≥17 indicate severe depression requiring treatment.The depression inventory scores were higher in PCOS patients with infertility problems. A study found that there was no difference in depression scores between infertile and fertile groups.
The Female Sexual Function Index (FSFI) inventory was used to assess sexual dysfunction in obese PCOS patients. The Female Sexual Function Index was developed in 2000 to assess sexual function in women. The scale consists of 19 items and has 6 sub-dimensions: Pleasure, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The scale reflects women's sexual functioning in the past month by calculating 6 subgroup scores and the FSFI score. The FSFI score is calculated by adding the subgroup scores. The Female Sexual Function Index has proven to be a valid and reliable tool for measuring sexual function in Turkish women.
Based on this information, the aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
### Conditions Module
**Conditions:**
- Polycystic Ovary
- Depression
- Sexual Dysfunction
**Keywords:**
- Female Sexual Function Index
- phenotypes
- polycystic ovary syndrome
- The Beck Depression Inventory
- Quality of life
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 176
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + Polycystic ovary morphology 44 participants
**Intervention Names:**
- Other: Female Sexual Function Index
**Label:** Phenotype A
#### Arm Group 2
**Description:** PHENOTYPE B: Hyperandrogenism + Ovulatory Dysfunction 44 participants
**Intervention Names:**
- Other: Female Sexual Function Index
**Label:** Phenotype B
#### Arm Group 3
**Description:** PHENOTYPE C: Hyperandrogenism + Polycystic ovary morphology 44 participants
**Intervention Names:**
- Other: Female Sexual Function Index
**Label:** Phenotype C
#### Arm Group 4
**Description:** PHENOTYPE D: Ovulatory Dysfunction + Polycystic ovary morphology 44 participants
**Intervention Names:**
- Other: Female Sexual Function Index
**Label:** Phenotype D
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Phenotype A
- Phenotype B
- Phenotype C
- Phenotype D
**Description:** As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes.
**Name:** Female Sexual Function Index
**Other Names:**
- Beck Depression Inventory
- Short Form 36
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
**Measure:** Effect of PCOS phenotypes on SF-36.
**Time Frame:** 6 months
**Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
**Measure:** Effect of PCOS phenotypes on FSFI.
**Time Frame:** 6 months
**Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
**Measure:** Effect of PCOS phenotypes on Beck Deppression scale
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* least 1 year after menarche
* over 18 years old
* Patients who have given verbal and written informed consent will be included.
Exclusion Criteria:
* under 18 years of age
* Endocrine disorders such as hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorders
* Neuromuscular, hepatic, pancreatic or gastrointestinal diseases
* Users of hormone preparations such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers, lipid regulators
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Sexually active people who are cared for at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital form the study group.
The study involves 176 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing.
The ESHRE/ASRM 2023 guidelines will be used as a basis and those who fulfill both criteria below will be included in the PCOS group:
1. Oligo and/or anovulation\*
2. Clinical and/or biochemical hyperandrogenism
3. Polycystic ovarian morphology or AMH elevation
Definition of the phenotype groups: PCOS has been categorized into 4 phenotypes:
Phenotype A: Hyperandrogenism + ovarian dysfunction + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PKOM were grouped as.
### 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:** Tian X, Ruan X, Du J, Cheng J, Ju R, Mueck AO. Sexual function in Chinese women with different clinical phenotypes of polycystic ovary syndrome. Gynecol Endocrinol. 2023 Dec;39(1):2221736. doi: 10.1080/09513590.2023.2221736.
**PMID:** 37302412
**Citation:** Yilmaz M, Isaoglu U, Delibas IB, Kadanali S. Anthropometric, clinical and laboratory comparison of four phenotypes of polycystic ovary syndrome based on Rotterdam criteria. J Obstet Gynaecol Res. 2011 Aug;37(8):1020-6. doi: 10.1111/j.1447-0756.2010.01478.x. Epub 2011 Apr 12.
**PMID:** 21481088
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- 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: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- 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: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M13970
- Name: Polycystic Ovary Syndrome
- Relevance: HIGH
- As Found: Polycystic Ovary Syndrome
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- 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
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000011085
- Term: Polycystic Ovary Syndrome
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428773
**Brief Title:** Effect of Exercise on Vessel Diameter in Hemodialysis Patients
**Official Title:** Effect of Exercise on Vessel Diameter in Hemodialysis Patients
#### Organization Study ID Info
**ID:** 2021-4/35
#### Organization
**Class:** OTHER
**Full Name:** Kirsehir Ahi Evran Universitesi
### Status Module
#### Completion Date
**Date:** 2023-11-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-10
**Type:** ACTUAL
#### Start Date
**Date:** 2023-05-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kirsehir Ahi Evran Universitesi
#### Responsible Party
**Investigator Affiliation:** Kirsehir Ahi Evran Universitesi
**Investigator Full Name:** Mehmet Hanifi Kaya
**Investigator Title:** Pilot Project Manager Lecturer Doctor.
**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, 100 hemodialysis patients aged between 18-65 were examined. Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercises for 30 minutes three times a week during hemodialysis sessions. Additionally, they engaged in walking exercises for 30 minutes three times a week outside of hemodialysis sessions, maintaining their heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels 2-3 days a week outside of hemodialysis sessions. The vessel diameters of the patients were measured by ultrasound at the beginning and after 12 weeks.
**Detailed Description:** Background: As it is known, many negative situations occur in CKD patients on hemodialysis. One of these is the problems seen in the vascular access. The prevention and management of vascular access complications may benefit from exercise The purpose of this study is to investigate the effect of exercise on the vessel diameter in HD patients.
Methods: Present study we were included 100 hemodialysis patients between the ages of 18-65.Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. And the vessel diameters of patients were measured by ultrasound at the beginning and after 12 weeks.
### Conditions Module
**Conditions:**
- Chronic Kidney Diseases
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions.
**Intervention Names:**
- Other: Exercise
**Label:** Exercise Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The control group did not engage in any exercise.
**Intervention Names:**
- Other: Exercise
**Label:** control group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise Group
- control group
**Description:** Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions.
**Name:** Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Baseline Vessel Diameter (mm)
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between 18-65 years of age
* Undergoing hemodialysis treatment for at least 6 months
* Using arteriovenous fistula, arteriovenous graft, or permanent catheter as the vascular access type.
* Having no orthopedic, neurological, cardiac, or respiratory diseases that could hinder exercise
* Willingness to participate in exercise.
Exclusion Criteria:
* Access complications such as acute or chronic infections, inflammation, bleeding, aneurysms, stenosis, thrombosis, or any condition that hindered exercise,
* Acute or chronic cardiovascular complications such as cardiac arrhythmias, ischemia, heart failure.
* Hypertension, or hypotension that hindered exercise.
* Acute or chronic musculoskeletal injuries, pain, inflammation, or deformities that hindered exercise.
* Refusal to participate in exercise. were excluded from the study.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kırşehir
**Country:** Turkey
**Facility:** Kırşehir Ahi Evran University
**Zip:** 40100
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- 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: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428760
**Brief Title:** Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk
**Official Title:** The Effect of Preoperative Subcutaneous Trochanteric Fat Thickness and Trochanteric Soft Tissue Thickness on Postoperative Infection Risk in Patients Undergoing Hemiarthroplasty for Femoral Neck Fracture
#### Organization Study ID Info
**ID:** ashmehmetonut
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ankara City Hospital Bilkent
#### 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 effect of preoperative subcutaneous trochanteric fat thickness and trochanteric soft tissue thickness on postoperative infection risk in patients undergoing hemiarthroplasty for femoral neck fracture
**Detailed Description:** Obesity is a growing problem for healthcare systems and orthopaedic surgeons, with 29% of the adult population in the UK and 40% in the US affected by obesity. The most commonly used measure of obesity in healthcare is body mass index (BMI), and the World Health Organisation defines obesity as a BMI ≥ 30 kg/m2. Much of the arthroplasty literature has also focused on the use of BMI as a measure of obesity.
BMI-defined obesity is associated with an increased risk of perioperative complications (including infection and dislocation) in total hip arthroplasty. It has also been shown that there is a gradual increase in anaesthetic time, operative time and length of hospital stay as BMI increases in obese patients.
BMI is an imperfect measure because it does not take into account age, sex, race, fat distribution or muscle mass. Previous studies have shown that subcutaneous fat depth (FD) is an independent risk factor for wound infection in cervical and lumbar spine surgery and after laparotomy. It is not known whether increased subcutaneous fat and soft tissue mass are associated with an increased risk of complications after arthroplasty for femoral neck fractures.
The aim of this study was to investigate whether preoperative measurement of subcutaneous adipose tissue by radiography and computed tomography (CT) and muscle thickness in the gluteus medius/minus, gluteus maximus, anterior and medial compartments by computed tomography (CT) in femoral neck fractures correlate with infection rates at postoperative follow-up.
Hypothesis: In patients with high body mass index (BMI) with femoral neck fractures, the investigators believe that the relationship between increased subcutaneous adipose tissue on radiographs and CT sections and wound infection is as effective as the relationship between increased muscle thickness in the gluteus medius/minimus, gluteus maximus, anterior and medial compartments measured on CT sections and wound infection.
### Conditions Module
**Conditions:**
- Hip Infection
**Keywords:**
- subcutaneous trochanteric fat thickness
- infection
- femoral neck fracture
- soft tissue thickness
- obesity
- hemiarthroplasty
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Outcomes Module
#### Primary Outcomes
**Description:** The aim of this study was to evaluate the effect of peritrochanteric fat thickness and hip soft tissue parameters on postoperative wound infection in patients with femoral neck fracture.
Peritrochanteric fat thickness will be measured on preoperative radiographs along with sourcil to skin surface, greater trochanter tip to skin surface, and lateral greater trochanter to skin surface values.
Hip soft tissue assessment will be measured with the parameters of gluteus medius/minus, gluteus maximus, muscle thickness in the anterior and medial compartments on preoperative CT sections.
**Measure:** Effect of trochanteric fat and soft tissue
**Time Frame:** Pre-operative
**Description:** Wound infection is assessed using investigator dressings. In assessing surgical wound infection, an ASEPSIS score will be calculated for each patient to standardise for serous exudate, erythema, purulent exudate, deep tissue separation at the wound site.
**Measure:** Wound infection
**Time Frame:** First 3 months after surgery
#### Secondary Outcomes
**Description:** Hospital Length of Stay (LOS): Evaluate the duration of hospitalization following surgery, as prolonged LOS may be associated with increased risk of nosocomial infections including SSIs.
**Measure:** Hospital Length of Stay (LOS)
**Time Frame:** 1 months
**Description:** Mortality Rate: Assess mortality rates within a defined follow-up period following surgery, as postoperative infections, especially in vulnerable populations such as elderly patients with femoral neck fractures, may contribute to increased mortality.
Mortality risk is measured by the Charlson comorbidity index.
**Measure:** Mortality Rate
**Time Frame:** 6 months
**Description:** It has been suggested that there is a relationship between body mass index and post-operative wound infection. This index is measured in kg/m2 using the patient's height and weight.
**Measure:** Body Mass Index
**Time Frame:** Measured once preoperatively
**Description:** WBC, leukocyte, neutrophil, lymphocyte, albumin, CRP parameters will be evaluated in routine biochemistry scans
**Measure:** Biochemistry Scans
**Time Frame:** 1 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients over 65 years of age
* Femoral neck fractures
* Female patients
* Patients undergoing hemiarthroplasty
Exclusion Criteria:
* Patients younger than 65 years
* Male patients
* Patients with immunosuppressive conditions
* Intertrochanteric fractures
* Patients with revision surgery
* Pathological femoral neck fractures
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Female patients over 65 years of age who were admitted to our hospital with a history of a femoral neck fracture and who underwent hemiarthroplasty.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Ankara Bilkent City Hospital
**State:** Cankaya
**Zip:** 06800
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006620
- Term: Hip Fractures
- ID: D000005264
- Term: Femoral Fractures
- ID: D000050723
- Term: Fractures, Bone
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000025981
- Term: Hip Injuries
- ID: D000007869
- Term: Leg Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M26370
- Name: Fractures, Bone
- Relevance: LOW
- As Found: Unknown
- ID: M8403
- Name: Femoral Neck Fractures
- Relevance: HIGH
- As Found: Femoral Neck Fractures
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M9696
- Name: Hip Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M8402
- Name: Femoral Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M23105
- Name: Hip Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000005265
- Term: Femoral Neck Fractures
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428747
**Brief Title:** Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units
**Official Title:** Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units
#### Organization Study ID Info
**ID:** Doha Sholkamy
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Doha Fahmy
**Investigator Title:** Assistant lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact.
**Detailed Description:** Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. pRBCs are prepared from donated whole blood and can be stored for up to 35 days.During storage, modifications of RBCs occur and affect product quality. Among other changes, these "storage lesions" induce microparticle (MP) formation. MPs are membrane particles measuring 0.1 to 1 µm produced by stimulated or apoptotic cells through modulation of membrane lipid organization and cytoskeleton reorganization. MPs can be produced from any cell type and express antigens characteristic of their original cell. Blood contains platelet-derived MPs (PMPs), which are the most frequent; RBC (erythrocyte)-derived MPs (ERMPs), representing 4% to 8% of total blood MPs; and, more rarely, MPs produced by endothelial cells and leukocyctes. In vivo, aging RBCs release ERMPs over their whole life cycle as a preventive effect of phagocytosis by macrophages. It seems that MPs quickly spread through the body, leading to a variety of biological effects by contact and interactions with many cells. MPs are well-known bioeffectors that mediate strong procoagulant potential, mainly because of phosphatidylserine and tissue factor expression. In this way, MPs are involved in coagulation disorders associated with atherothrombosis and cardiovascular diseases.Their ability to modulate inflammatory and immune responses is increasingly being studied as well as their capacity to carry and transport RNA, DNA, major histocompatibility complex molecules, and infectious agents. Moreover, depending on the type of stimulation that induces MP production, the size and biological functions of the MP can vary.
### Conditions Module
**Conditions:**
- Packed Red Cells Causing Adverse Effects in Therapeutic Use
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 7 Days
### Arms Interventions Module
#### Arm Group 1
**Description:** detection of micro-particles.
**Intervention Names:**
- Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
**Label:** 30 filtered backed RBCs.
#### Arm Group 2
**Description:** detection of micro-particles
**Intervention Names:**
- Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
**Label:** 30 non-filtered backed RBCs.
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 30 filtered backed RBCs.
- 30 non-filtered backed RBCs.
**Description:** detection of micro-particles
**Name:** b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
* CD235 for red blood cell micro particles.
* CD 45 for leukocyte micro particles.
* CD41 for platelet micro particles.
**Measure:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). - CD235 for red blood cell micro particles. - CD 45 for leukocyte micro particles. - CD41 for platelet micro particles. formation.
**Time Frame:** 7 days
#### Secondary Outcomes
**Description:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
* CD235 for red blood cell micro particles.
* CD 45 for leukocyte micro particles.
* CD41 for platelet micro particles.
**Measure:** d. Quantification of micro particles in non filtered packed RBCs (pRBCs) versus filtered (pRBCs) over storage period at 4°C.
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Donors who met criteria of Egyptian National Transfusion Services.
* Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab and Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).
Exclusion Criteria:
* Donors who not met criteria of Egyptian National Transfusion Services.
* Reactive serology.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** Group 1: 30 filtered backed RBCs. Group 2: 30 non-filtered backed RBCs.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Doha Sholkamy, phD
**Phone:** 01097858588
**Phone Ext:** 02
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** khaled Amir, phD
**Phone:** 01141110942
**Phone Ext:** 02
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** khaled Amir, phD
- **Phone:** 01141110942
- **Phone Ext:** 02
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Assiut university
**Status:** RECRUITING
**Zip:** 71511
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428734
**Brief Title:** Clinical Outcome in Patients With INPH
**Official Title:** Phenotypes, Biomarkers and Pathophysiology in INPH
#### Organization Study ID Info
**ID:** XWCOPINPH
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xuanwu Hospital, Beijing
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.
**Detailed Description:** Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging.
At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.
Optionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.
### Conditions Module
**Conditions:**
- Hydrocephalus
- Idiopathic Normal Pressure Hydrocephalus
- CSF
- Glympathic System
- Omic
**Keywords:**
- Hydrocephalus
- Idiopathic Normal Pressure Hydrocephalus
### Design Module
#### Bio Spec
**Description:** Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
**Intervention Names:**
- Diagnostic Test: hydrocephalus group
**Label:** hydrocephalus
#### Arm Group 2
**Description:** Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
**Intervention Names:**
- Other: normal group
**Label:** Normal group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- hydrocephalus
**Description:** Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
**Name:** hydrocephalus group
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Normal group
**Description:** Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
**Name:** normal group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Change of DTIALPS singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed.
**Measure:** DTIALPS
**Time Frame:** Change from Baseline at 6 months after VP shunt
#### Secondary Outcomes
**Description:** A score for iNPH severity; range 0-26; higher indicates higher severity.
**Measure:** Kiefer score
**Time Frame:** Change from Baseline at 6 months after VP shunt
**Description:** A score for cognitive ability; range 0-30; higher indicates higher severity.
**Measure:** Mini mental state Examination
**Time Frame:** Change from Baseline at 6 months after VP shunt
**Description:** 10 meters walking test were evaluated of iNPH patients.
**Measure:** Gait evaluation
**Time Frame:** Change from Baseline at 6 months after VP shunt
**Description:** A score for functional neurological status ; range 0-5; higher indicates higher severity.
**Measure:** modified Rankin scale
**Time Frame:** Change from Baseline at 6 months after VP shunt
**Description:** Change of BOLD singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed.
**Measure:** Change in the resting state fMRI
**Time Frame:** Change from Baseline at 6 months after VP shunt
**Description:** Comparing the omic pattern differences in CSF between iNPH patients and normal age-matched normal volunteers by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed.
**Measure:** omic pattern of CSF in iNPH patients
**Time Frame:** Before surgery in lumbar CSF
**Description:** Comparing the omic pattern differences in CSF of iNPH patients before surgery and after VP shunt by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed.
**Measure:** omic pattern of CSF in iNPH patients
**Time Frame:** Change from Baseline at 6 months after VP shunt
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients who was diagnosed as idiopathic normal pressure hydrocephalus
Exclusion Criteria:
* patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients who was diagnosed as idiopathic normal pressure hydrocephalus
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** fengzeng jian, md
**Phone:** 01083198899
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** xin qu, md
**Phone:** 01083198899
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yuan Chenghua
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jian Fengzeng
- **Role:** CONTACT
***Contact 3:***
- **Name:** xin qu, dr
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Fengzeng Jian
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100053
### References Module
#### References
**Citation:** Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3.
**PMID:** 37010581
**Citation:** Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1.
**PMID:** 37724800
**Citation:** Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28.
**PMID:** 38014747
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9907
- Name: Hydrocephalus
- Relevance: HIGH
- As Found: Hydrocephalus
- ID: M9908
- Name: Hydrocephalus, Normal Pressure
- Relevance: HIGH
- As Found: Normal Pressure Hydrocephalus
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006849
- Term: Hydrocephalus
- ID: D000006850
- Term: Hydrocephalus, Normal Pressure
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428721
**Brief Title:** The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
**Official Title:** The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
#### Organization Study ID Info
**ID:** 2023-346
#### Organization
**Class:** OTHER
**Full Name:** Wright State University
### Status Module
#### Completion Date
**Date:** 2031-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2031-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wright State University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
### Conditions Module
**Conditions:**
- Actinic Keratoses
- Aging
- Non-Melanoma Skin Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Right forearm treatment of fractionated laser resurfacing.
**Intervention Names:**
- Device: Fractionated Laser Resurfacing
**Label:** Fractionated Laser Resurfacing - Right Arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Left forearm treatment of fractionated laser resurfacing.
**Intervention Names:**
- Device: Fractionated Laser Resurfacing
**Label:** Fractionated Laser Resurfacing - Left Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fractionated Laser Resurfacing - Left Arm
- Fractionated Laser Resurfacing - Right Arm
**Description:** A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
**Name:** Fractionated Laser Resurfacing
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Investigator will assess the number of actinic keratosis on both forearms at each visit.
**Measure:** Change from baseline in the number of actinic keratosis due to FLR treatment.
**Time Frame:** Up to 5 years
**Description:** Investigator will assess the number of actinic keratosis on both forearms at each visit.
**Measure:** Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
**Time Frame:** Up to 5 years
#### Secondary Outcomes
**Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
**Measure:** Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
**Time Frame:** Up to 5 years
**Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
**Measure:** Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.
**Time Frame:** Up to 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult Males and Females aged 60 and older
* Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
* Skin type fair (Fitzpatrick I-II)
* Females must be post-menopausal and not be on systemic hormone replacement therapy
* Able to comprehend procedures and risks
Exclusion Criteria:
* More than 10 AKs on an extremity
* AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
* AKs that are very thick (\>3 mm)
* Medical history of diabetes
* History of poor wound healing or scarring
* Large tattoos that can interfere with study
* Other serious health issues and other skin diseases that could interfere with the study
* Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
* Planning to leave region in next 5 years
* Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Manager, Clinical Research Operations
**Phone:** 937-245-7500
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Regulatory Specialist
**Phone:** 937-245-7500
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fairborn
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pharmacology Translational Unit
- **Phone:** 937-245-7500
- **Role:** CONTACT
**Country:** United States
**Facility:** Wright State Physicians
**State:** Ohio
**Status:** RECRUITING
**Zip:** 45324
#### Overall Officials
**Official 1:**
**Affiliation:** Wright State University
**Name:** Jeffrey Travers, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000012871
- Term: Skin Diseases
- ID: D000011230
- Term: Precancerous Conditions
### 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: M28268
- Name: Keratosis, Actinic
- Relevance: HIGH
- As Found: Actinic Keratosis
- ID: M10668
- Name: Keratosis
- Relevance: HIGH
- As Found: Keratosis
- ID: M15681
- Name: Skin Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14111
- Name: Precancerous Conditions
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055623
- Term: Keratosis, Actinic
- ID: D000007642
- Term: Keratosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428708
**Brief Title:** [18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma
**Official Title:** Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma
#### Organization Study ID Info
**ID:** ReDA 11465
#### Organization
**Class:** OTHER
**Full Name:** Western University
### Status Module
#### Completion Date
**Date:** 2025-09
**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:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-01-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Western University
#### Responsible Party
**Investigator Affiliation:** Western University
**Investigator Full Name:** Melissa Huynh
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.
**Detailed Description:** This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 30 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.
### Conditions Module
**Conditions:**
- Metastatic Clear Cell Renal Cell Carcinoma
**Keywords:**
- PSMA PET
- Metastatic clear cell renal cell carcinoma
- [18F]PSMA-1007
- PSMA
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT
**Intervention Names:**
- Diagnostic Test: [18F] PSMA-1007 PET/CT
**Label:** [18F] PSMA-1007 PET/CT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- [18F] PSMA-1007 PET/CT
**Description:** \[18F\] PSMA-1007 PET/CT scan
**Name:** [18F] PSMA-1007 PET/CT
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.
**Measure:** Number of metastatic lesions
**Time Frame:** 5 weeks from initial baseline conventional imaging
**Description:** To determine the proportion of patients in which results from the PSMA-PET imaging changes management.
**Measure:** Change in management
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** To determine histopathological correlation in lesions that are biopsied or removed surgically.
**Measure:** Pathologic correlates
**Time Frame:** 1 month or not applicable
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)
2. Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 8 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).
Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure
Exclusion Criteria:
1. Pregnant or breastfeeding
2. Age less than 18
3. Histology does not have any clear cell component
4. Unable to lie flat for 30 minutes for the scan
5. History of prior malignancy (except non-melanoma skin cancer)
6. Unable to provide informed consent
7. Inadequate liver function
8. Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place
9. Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kaydee Connors
**Phone:** 519-685-6366
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nicole Phillips
**Phone:** 519-685-6366
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kaydee Connors
- **Phone:** 519-685-6366
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Nicole Phillips
- **Phone:** 519-685-6366
- **Role:** CONTACT
***Contact 3:***
- **Name:** Melissa Huynh, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** London Health Sciences Centre - Victoria Hospital
**State:** Ontario
**Status:** RECRUITING
**Zip:** N6A5W9
#### Overall Officials
**Official 1:**
**Affiliation:** Western University
**Name:** Melissa Huynh, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Mittlmeier LM, Unterrainer M, Rodler S, Todica A, Albert NL, Burgard C, Cyran CC, Kunz WG, Ricke J, Bartenstein P, Stief CG, Ilhan H, Staehler M. 18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2031-2037. doi: 10.1007/s00259-020-05165-3. Epub 2020 Dec 28.
**PMID:** 33369689
**Citation:** Giesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26.
**PMID:** 27889802
**Citation:** Rhee H, Blazak J, Tham CM, Ng KL, Shepherd B, Lawson M, Preston J, Vela I, Thomas P, Wood S. Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour. EJNMMI Res. 2016 Dec;6(1):76. doi: 10.1186/s13550-016-0231-6. Epub 2016 Oct 22.
**PMID:** 27771904
**Citation:** Yin Y, Campbell SP, Markowski MC, Pierorazio PM, Pomper MG, Allaf ME, Rowe SP, Gorin MA. Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Mol Imaging Biol. 2019 Jun;21(3):567-573. doi: 10.1007/s11307-018-1271-2.
**PMID:** 30218388
**Citation:** Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.
**PMID:** 31147927
**Citation:** Baccala A, Sercia L, Li J, Heston W, Zhou M. Expression of prostate-specific membrane antigen in tumor-associated neovasculature of renal neoplasms. Urology. 2007 Aug;70(2):385-90. doi: 10.1016/j.urology.2007.03.025.
**PMID:** 17826525
**Citation:** Chang SS, Reuter VE, Heston WD, Gaudin PB. Metastatic renal cell carcinoma neovasculature expresses prostate-specific membrane antigen. Urology. 2001 Apr;57(4):801-5. doi: 10.1016/s0090-4295(00)01094-3.
**PMID:** 11306418
**Citation:** Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.
**PMID:** 16555021
**Citation:** Prasad V, Steffen IG, Diederichs G, Makowski MR, Wust P, Brenner W. Biodistribution of [(68)Ga]PSMA-HBED-CC in Patients with Prostate Cancer: Characterization of Uptake in Normal Organs and Tumour Lesions. Mol Imaging Biol. 2016 Jun;18(3):428-36. doi: 10.1007/s11307-016-0945-x.
**PMID:** 27038316
**Citation:** Park JW, Jo MK, Lee HM. Significance of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography for the postoperative surveillance of advanced renal cell carcinoma. BJU Int. 2009 Mar;103(5):615-9. doi: 10.1111/j.1464-410X.2008.08150.x. Epub 2008 Oct 24.
**PMID:** 19007371
**Citation:** Majhail NS, Urbain JL, Albani JM, Kanvinde MH, Rice TW, Novick AC, Mekhail TM, Olencki TE, Elson P, Bukowski RM. F-18 fluorodeoxyglucose positron emission tomography in the evaluation of distant metastases from renal cell carcinoma. J Clin Oncol. 2003 Nov 1;21(21):3995-4000. doi: 10.1200/JCO.2003.04.073.
**PMID:** 14581422
**Citation:** Lawrentschuk N, Davis ID, Bolton DM, Scott AM. Functional imaging of renal cell carcinoma. Nat Rev Urol. 2010 May;7(5):258-66. doi: 10.1038/nrurol.2010.40.
**PMID:** 20448659
**Citation:** Sawicki LM, Buchbender C, Boos J, Giessing M, Ermert J, Antke C, Antoch G, Hautzel H. Diagnostic potential of PET/CT using a 68Ga-labelled prostate-specific membrane antigen ligand in whole-body staging of renal cell carcinoma: initial experience. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):102-107. doi: 10.1007/s00259-016-3360-2. Epub 2016 Mar 21.
**PMID:** 26996777
**Citation:** Aide N, Cappele O, Bottet P, Bensadoun H, Regeasse A, Comoz F, Sobrio F, Bouvard G, Agostini D. Efficiency of [(18)F]FDG PET in characterising renal cancer and detecting distant metastases: a comparison with CT. Eur J Nucl Med Mol Imaging. 2003 Sep;30(9):1236-45. doi: 10.1007/s00259-003-1211-4. Epub 2003 Jul 4.
**PMID:** 12845486
## 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: D000000230
- Term: Adenocarcinoma
- ID: D000007680
- Term: Kidney Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5548
- Name: Carcinoma, Renal Cell
- Relevance: HIGH
- As Found: Clear Cell Renal 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: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M10703
- Name: Kidney Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4906
- Name: Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Renal Cell Carcinoma
- ID: T1341
- Name: Clear Cell Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Clear Cell Renal Cell Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002292
- Term: Carcinoma, Renal Cell
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428695
**Brief Title:** Education Session to Improve Program Adherence
**Official Title:** Implementation of Education on Calorie Tracking Application to Improve Adherence to a Calorie Restricted Weight Management Program
#### Organization Study ID Info
**ID:** IRB00110851
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wake Forest University Health Sciences
#### 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 examine is user knowledge of a dietary self-monitoring (DSM) calorie tracking app and improving patient adherence to daily caloric food intake to help with weight loss.
**Detailed Description:** The research question guiding this project is: In adults with a BMI greater than 25 kg/m2, does a 1-hour education session on using a calorie-tracking application improve adherence to a calorie-restricted weight management program over eight weeks? This project aimed to increase patient knowledge with the DSM tool. To Increase adherence to the calorie-restricted diet program and, finally, to increase weight loss in the program participants of the 8-week program
### Conditions Module
**Conditions:**
- Weight Management
**Keywords:**
- calorie tracking
- weight loss
- weight management program
- food intake
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** The subject population will consist of adults 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program
**Intervention Names:**
- Behavioral: one-hour dietary self-monitoring tool education session
**Label:** dietary self-monitoring tool education session
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- dietary self-monitoring tool education session
**Description:** access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program
**Name:** one-hour dietary self-monitoring tool education session
**Other Names:**
- education session
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project. This will be the 4 questions pretest/posttest utilized. A 1-hour education session will provide training on the use of a DSM calorie-tracking app. Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal. Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence. Scores are summed and then averaged for each subscale, resulting in four separate subscale means.
**Measure:** Perceived Competence Scale (PCS) Score
**Time Frame:** Baseline
**Description:** The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project. This will be the 4 questions pretest/posttest utilized. A 1-hour education session will provide training on the use of a DSM calorie-tracking app. Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal. Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence. Scores are summed and then averaged for each subscale, resulting in four separate subscale means.
**Measure:** Perceived Competence Scale (PCS) Score
**Time Frame:** Week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2
Exclusion Criteria:
* Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ben Ramirez, APNP, DNP
**Phone:** 414-219-4263
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Winston-Salem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ben Ramirez, APNP, DNP
- **Phone:** 414-219-4263
- **Role:** CONTACT
**Country:** United States
**Facility:** Wake Forest University Health Sciences
**State:** North Carolina
**Zip:** 27157
#### Overall Officials
**Official 1:**
**Affiliation:** Wake Forest University Health Sciences
**Name:** Melanie Smith, DO
**Role:** PRINCIPAL_INVESTIGATOR
### 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
### Condition Browse Module - Browse Leaves
- ID: M18102
- Name: Weight Loss
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Weight
### Condition Browse Module - Meshes
- ID: D000001835
- Term: Body Weight
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428682
**Brief Title:** Role of TXA in Patients Undergoing Breast Free Flap Reconstruction
**Official Title:** Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** HSR220370
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2026-05-13
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Virginia
#### Responsible Party
**Investigator Affiliation:** University of Virginia
**Investigator Full Name:** John Stranix
**Investigator Title:** Assistant Professor of Plastics Surgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with ERAS protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as DVT/PE.
### Conditions Module
**Conditions:**
- Breast Cancer
- Blood Loss, Surgical
**Keywords:**
- Autologous breast reconstruction
- Free Flap
- Tranexamic Acid
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA
**Intervention Names:**
- Drug: Tranexamic acid
**Label:** TXA group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TXA group
**Description:** Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.
**Name:** Tranexamic acid
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** Control group will receive same volume equivalent of saline intravenously at the time of their surgery.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Post-op day 1 Hemoglobin - Pre-op Hemogobin
**Measure:** Delta Hemoglobin
**Time Frame:** 1 day after surgery
**Description:** Transfusion rate during hospital stay
**Measure:** Transfusion rate
**Time Frame:** Typically 0-72 hours after surgery
#### Secondary Outcomes
**Description:** Thromboembolic event, hematoma, seroma, flap compromise/ failure
**Measure:** Surgical complications
**Time Frame:** 30 days after surgery
**Description:** Total length of stay after surgery
**Measure:** Length of Stay
**Time Frame:** typically 2-4 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
Exclusion Criteria:
* Subjects with ages \<18 years
* Allergy to TXA
* Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
* Subjects who have anemia (defined as baseline hemoglobin \<8 g/dL
* Subjects who cannot read or understand English
* Subjects who are pregnant
**Gender Based:** True
**Gender Description:** Biological females
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rachel Park, MD
**Phone:** 5714287278
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charlottesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rachel H Park, MD
- **Phone:** 571-428-7278
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Virginia Medical Center
**State:** Virginia
**Status:** RECRUITING
**Zip:** 22902
#### Overall Officials
**Official 1:**
**Affiliation:** University of Virginia
**Name:** John Stranix, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006470
- Term: Hemorrhage
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007431
- Term: Intraoperative Complications
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M18560
- Name: Blood Loss, Surgical
- Relevance: HIGH
- As Found: Blood Loss, Surgical
- ID: M10465
- Name: Intraoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016063
- Term: Blood Loss, Surgical
### Intervention Browse Module - Ancestors
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
### Intervention Browse Module - Browse Branches
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428669
**Brief Title:** Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial
**Official Title:** The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial
#### Organization Study ID Info
**ID:** HSR220217
#### 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:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Virginia
#### Responsible Party
**Investigator Affiliation:** University of Virginia
**Investigator Full Name:** John Stranix
**Investigator Title:** Assistant Professor, Department of Plastic Surgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
### Description Module
**Brief Summary:** Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.
**Detailed Description:** Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery utilizing double incision with free nipple grafting technique. We will conduct a prospective, randomized, single-blinded study where we will compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome.
### Conditions Module
**Conditions:**
- Gender Dysphoria
**Keywords:**
- Gender affirming surgery
- Chest masculinizing Surgery
- Nitropaste
- Wound healing
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 256
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.
**Label:** No nitropaste group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will then get 2 packets of nitropaste applied (1 on each chest) around the free nipple graft and surgical sites. They will then get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.
**Intervention Names:**
- Drug: Nitro-Bid 2 % Topical Ointment
**Label:** Nitropaste group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nitropaste group
**Description:** Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively
**Name:** Nitro-Bid 2 % Topical Ointment
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Partial nipple graft loss (0-50%, 50% or more), Complete nipple graft loss
**Measure:** Free Nipple Graft
**Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op
**Description:** Superficial wound, deep wound, delayed wound healing
**Measure:** Wounds
**Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op
#### Secondary Outcomes
**Description:** hematoma, seroma, infection, hypertrophic scarring
**Measure:** Complications
**Time Frame:** Will be tracked up until 3 months post-op
**Description:** Need for any sharp debridement (office or OR)
**Measure:** Sharp debridement
**Time Frame:** Will be tracked up until 3 months post-op
**Description:** Need for any revision
**Measure:** Revision
**Time Frame:** Will be tracked up until 3 months post-op
**Description:** 30 day ED or inpatient admission rate
**Measure:** Readmission
**Time Frame:** Will be tracked 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.
Exclusion Criteria:
* Minor patients (younger than 18), anyone who's not getting free nipple grafting, anyone who's not utilizing double incision pattern, prisoners, anyone who is allergic to nitropaste, anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil), anyone who's taking soluble guanylate cyclase stimulator riociguatdz
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rachel H Park, MD
**Phone:** 434-327-2140
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charlottesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rachel H Park, MD
- **Phone:** 571-428-7278
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Virginia Medical Center
**State:** Virginia
**Status:** RECRUITING
**Zip:** 22902
#### Overall Officials
**Official 1:**
**Affiliation:** UVA
**Name:** John T Stranix, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020018
- Term: Sexual Dysfunctions, Psychological
- 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: LOW
- As Found: Unknown
- ID: M227
- Name: Gender Dysphoria
- Relevance: HIGH
- As Found: Gender Dysphoria
- ID: M21873
- Name: Sexual Dysfunctions, Psychological
- 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: D000068116
- Term: Gender Dysphoria
### Intervention Browse Module - Ancestors
- ID: D000014665
- Term: Vasodilator Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9102
- Name: Nitroglycerin
- Relevance: HIGH
- As Found: Pre-natal
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000005996
- Term: Nitroglycerin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428656
**Acronym:** PostBioExIn
**Brief Title:** Postbiotics Supplementation, Gut Microbiota Composition, and Exercise-induced Inflammation
**Official Title:** The Effect of Postbiotics Supplementation on Gut Microbiota Composition and Exercise-induced Inflammation
#### Organization Study ID Info
**ID:** PB-GM-Exercise-Inflammation
#### Organization
**Class:** OTHER
**Full Name:** University of Thessaly
### Status Module
#### Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Thessaly
#### Responsible Party
**Investigator Affiliation:** University of Thessaly
**Investigator Full Name:** Chariklia K. Deli
**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:** This study will investigate the effect of postbiotics supplementation on gut microbiota (GM) composition, exercise-induced oxidative stress and performance following eccentrically biased exercise. The study will be a cross-over, randomized, double-blind, controlled study that will be conducted in two cycles. Participants will be randomly assigned into one of the two trials: i) Postbiotics supplementation for 4 weeks, ii) Placebo supplementation for 4 weeks. Participants will then perform a 45-min treadmill running at (-15% slope, \~70% VO2max) followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before, as well as 24 h, 48 h and 72 h following exercise, assessment of GM composition and metabolites (short-chain fatty acids), exercise induced muscle damage (EIMD) (delayed onset of muscle soreness, creatine kinase), complete blood count (CBC), blood inflammatory status (tumor necrosis factor alpha, interleukin 6, C-reactive protein), gut inflammatory status (lipopolysacharides-binding protein, zonulin), blood redox status (total antioxidant capacity, catalase, protein carbonyls, reduced glutathione, oxidized glutathione, and performance (knee-extensors' and knee-flexors' isometric, concentric, eccentric torque, countermovement jump) will be performed. In addition, metabolism (lactic acid) will be assessed before and 4 min following exercise. Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, CBC, blood inflammatory status, blood redox status and performance at the same time-points. At the second cycle, the participants will repeat the above procedures under the remaining condition. Between conditions, there will be a 14-day washout period. The results of the research will provide important information for coaches and physically active individuals, regarding the effectiveness of postbiotics to favorably change the gut microbiota composition and alleviate gut inflammation, exercise-induced inflammation and oxidative stress, and improve performance after intense exercise.
**Detailed Description:** Acute, vigorous and/or unaccustomed eccentric exercise can induce muscle injury and inflammatory reactions, and oxidative stress, but also reduced muscle performance. For this reason, many professional as well as amateur athletes, often consume nutritional supplements such as antioxidants, anticipating to reduce inflammation and oxidative stress after intense exercise.
The human gastrointestinal tract is inhabited by various microorganisms, called the gut microbiome (GM). GM, among other things, contributes to the normal functioning of the immune system, contributes to the production of short-chain fatty acids (SCFAs) and vitamin synthesis as well as the digestion and absorption of food, protects against enteropathogens and regulates inflammatory and redox responses. Recent evidence also suggests that GM may be involved in athletic performance. In contrast, disruption of GM composition (dysbiosis) is characterized by reduced diversity, reduced abundance of health-promoting bacteria, and increased abundance of gram-negative and other pathogenic bacteria and is associated with various metabolic diseases such as obesity, diabetes, and various forms of cancer, systemic inflammation, oxidative stress and reduced performance. Thus, the supplementation of several "biotics" has been emerged as a means to regulate the GM in favor of health-promoting bacteria.
Postbiotics is defined as a "preparation of inanimate microorganisms and/or their components that confers a health benefit on the host". Evidence suggests that supplementation with postbiotics may regulate the GM, and consequently, strengthen the immune system, reduce intestinal permeability, improve antioxidant mechanisms, as well as accelerate recovery after exercise-induced inflammation, enhance adaptations to exercise, and improve performance. However, the scientific data regarding the possible beneficial effect of supplemental administration of postbiotics is limited. More research is needed, in order to determine the role of postbiotics supplementation on GM composition and function, exercise-induced inflammation and redox status, but also on performance after intense exercise.
This study will investigate the potential of postbiotics supplementation to alter the GM composition and affect the recovery of exercise-induced oxidative stress and performance following intense, eccentrically biased acute exercise. The study will be cross-over, randomized, double-blind, controlled, and will be conducted in two cycles. The participants, will be primarily informed regarding the study procedures, as well as the benefits and possible risks, and will sign an informed consent form for participation in the study. Before the experimental procedure, they will be involved in a week of familiarization to the evaluation tests and the exercise protocol, at a low intensity. Participants will undergo baseline measurements: anthropometric characteristics (body height, body mass, body mass index) via a stadiometer-scale (Stadiometer 208; Seca, Birmingham, UK), body composition (amount of body fat, lean body mass, fat mass, bone density) via by dual emission X-ray absorptiometry (DXA, GE-Healthcare, Lunar DPX NT, Belgium), aerobic capacity (VO2max) via an automated online pulmonary gas analyzer (Vmax Encore 29, BEBJO296, Yorba Linda, CA, USA) during a graded exercise protocol on a treadmill (Stex 8025T, Korea), isokinetic strength (isometric, concentric and eccentric torque of the knee extensors and knee flexors) on an isokinetic dynamometer (Cybex, HUMAC NORM 360, Ronkonkoma, NY), and muscle power via the assessment of countermovement jump (CMJ) via an optical measurement system (Optojump next, Microgate, USA). In addition, the participants will record their diet via a 7-days recall before their participation in the first experimental condition, and dietary data will be analyzed with ScienceFit Diet 200A diet analysis program (Science Technologies, Athens, Greece), in order to estimate that they do not consume nutrients that may affect muscle injury, inflammation and oxidative stress (e.g. antioxidants, etc.). Participants will then be randomized in one of the two conditions: i) Postbiotics supplementation (50mg/day of Heatkilled Lactobacillus plantarum L-137, Immuno-LP20TM) for 4 weeks, or ii) placebo supplementation for 4 weeks. Randomization of the conditions will be done by a software generating random integers available on the internet (Random.org). Participants will then perform an exercise protocol comprised of 45 min downhill running (-15% slope, \~70-75% VO2max) on a treadmill followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before the exercise protocol, as well as 24 h, 48 h and 72 h after exercise, exercise-induced muscle damage (EIMD) \[delayed onset of muscle soreness (DOMS) via palpation of the knee extensors and knee flexors on a scale of 1 to 10 (1 = no pain at all; 10 = extreme pain), and muscle performance (CMJ, isometric, concentric and eccentric torque of the knee extensors and knee flexors)\], will be assessed. At the same time points, feces samples will be collected for the analysis of GM composition and function, and GM metabolites, as well as blood samples for the assessment of complete blood count (CBC), blood inflammatory status (creatine kinase, tumor necrosis factor alpha, interleukin 6, C-reactive protein), gut inflammatory status (lipopolysacharides-binding protein, zonulin), and blood redox status \[reduced glutathione (GSH), oxidized glutathione (GSSG), GSH/GSSG ratio, total antioxidant capacity, catalase, protein carbonyls, uric acid, bilirubin). Furthermore, metabolism (lactic acid) will be assessed before and 4 min following exercise by analyzing capillary blood with a portable lactate analyzer (Lactate Plus, Nova Biomedical, USA). Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, CBC, blood inflammatory status, blood redox status and performance at the same time-points. At the second cycle, participants will repeat the exact same procedures for the remaining condition. Between cycles, a 14-days washout period will be applied. Additionally, the 7-day diet recall from the first cycle, will be given to the participants to follow the same diet before the experimental exercise protocol at the second cycle.
### Conditions Module
**Conditions:**
- Postbiotics Supplementation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The randomization of the participants to the supplement or placebo condition will be performed via a random integer set generator (Random.org) available online.
Neither the participants, nor the care provider, nor the investigator will be aware of whether participants receive the postbiotic supplement or the placebo. Additionally, blood samples will be masked during the biochemical analysis, and during the statistical analysis.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Supplementation of postbiotics for 4 weeks
**Intervention Names:**
- Dietary Supplement: Postbiotics supplementation
**Label:** Postbiotics supplementation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Supplementation of placebo for 4 weeks
**Intervention Names:**
- Dietary Supplement: Placebo supplementation
**Label:** Placebo supplementation
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Postbiotics supplementation
**Description:** The participants will consume one capsule of postbiotics supplement per day
**Name:** Postbiotics supplementation
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo supplementation
**Description:** The participants will consume one capsule of placebo per day
**Name:** Placebo supplementation
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Gut microbiota composition will be assessed in feces
**Measure:** Changes in gut microbiota composition
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Butyrate will be assessed in feces
**Measure:** Changes in butyrate
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Propionate will be assessed in feces
**Measure:** Changes in propionate
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Acetate will be assessed in feces
**Measure:** Changes in acetate
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Complete blood count will be assessed in whole blood
**Measure:** Changes in complete blood count
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Creatine kinase activity will be assessed in serum
**Measure:** Changes in creatine kinase activity
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** TNF-α concentration will be assessed in serum
**Measure:** Changes in TNF-α concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** IL-6 concentration will be assessed in serum
**Measure:** Changes in IL-6 concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** C-reactive protein concentration will be assessed in serum
**Measure:** Changes in high-sensitivity C-reactive protein concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Lipopolysacharides-binding protein concentration will be assessed in serum
**Measure:** Changes in lipopolysacharides-binding protein concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Zonulin concentration will be assessed in serum and in feces
**Measure:** Changes in zonulin concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Protein carbonyls concentration will be assessed in plasma
**Measure:** Changes in protein carbonyls concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Malondialdehyde concentration will be assessed in plasma
**Measure:** Changes in malondialdehyde concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Glutathione concentration will be assessed in red blood cells lycate
**Measure:** Changes in reduced glutathione concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Oxidized glutathione concentration will be assessed in red blood cells lycate
**Measure:** Changes in oxidized glutathione concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** GSH/GSSG ratio will be assessed in red blood cells lycate
**Measure:** Changes in GSH/GSSG ratio
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Catalase concentration will be assessed in red blood cells lycate
**Measure:** Changes in catalase concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Total antioxidant capacity will be assessed in red blood cells lycate
**Measure:** Changes in total antioxidant capacity
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Uric acid concentration will be assessed in serum
**Measure:** Changes in uric acid concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Bilirubin concentration will be assessed in serum
**Measure:** Changes in bilirubin concentration
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Bilirubin concentration will be assessed in whole blood
**Measure:** Changes in blood lactate concentration
**Time Frame:** At baseline (pre), 4 min post-exercise
**Description:** Muscle soreness of the KF and KE will be assessed via palpation of the muscle belly and the distal regions following 3 squats, and the subjective pain will be recorded on a 10-point scale (1 = no pain, 10 = extreme pain)
**Measure:** Changes in delayed onset of muscle soreness in the knee flexors and extensors of both limbs
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Countermovement jump height will be measured with an optical system
**Measure:** Changes in countermovement jump height
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
**Description:** Isometric, concentric and eccentric peak torque of the knee extensors and knee flexors of both limbs will be assessed on an isokinetic dynamometer
**Measure:** Changes in isokinetic strength of knee extensors and knee flexors
**Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Physically active subjects (VO2max ≥35ml/kg/min)
* Absence of musculoskeletal injury (≥6 months)
* Abstinence from the use of ergogenic supplements (≥1 month)
* Abstinence from anti-inflammatory drugs (≥1 month)
* Abstinence from pre-pro-postbiotic supplements (≥6 months)
* Abstinence from participating in exercise with eccentric content for at least 7 days before exercise
* Abstinence from alcohol and energy drinks before exercise
Exclusion Criteria:
* Recent history of musculoskeletal injury (\<6 months)
* Use of ergogenic performance supplements (\<1 month)
* Taking anti-inflammatory drugs (\<1 month)
* Taking pre-pro-postbiotic supplements (\<6 months)
* Participation in exercise with eccentric content in the previous 7 days before exercise
* Consumption of alcohol and energy drinks before exercise
**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:** Chariklia K Deli, PhD
**Phone:** +302431047011
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Athanasios Z Jamurtas, PhD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Thessaly
**Name:** Chariklia K Deli, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
### Condition Browse Module - Meshes
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428643
**Brief Title:** A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
**Official Title:** A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities in Black Youth Living in the Deep South
#### Organization Study ID Info
**ID:** 2024-377
#### Organization
**Class:** OTHER
**Full Name:** Tulane University
### Status Module
#### Completion Date
**Date:** 2029-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institutes of Health (NIH)
**Class:** NIH
**Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Lead Sponsor
**Class:** OTHER
**Name:** Tulane University
#### Responsible Party
**Investigator Affiliation:** Tulane University
**Investigator Full Name:** Patricia Kissinger
**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:** This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment.
### Conditions Module
**Conditions:**
- Chlamydia
- Gonorrhea
- Hiv
- Syphilis
**Keywords:**
- Screening
- Expedited Treatment
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Community based screening of young men for chlamydia, gonorrhea, HIV, and syphilis. Expedited treatment for positive subjects and their sexual partners.
##### Masking Info
**Masking:** NONE
**Masking Description:** None (Open Label)
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 2322
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Community screening of individuals for chlamydia and gonorrhea is not normally done. We are testing to see if this intervention will impact the rates of chlamydia among women.
**Intervention Names:**
- Other: Chlamydia, gonorrhea, syphilis, and HIV screening
**Label:** Chlamydia, gonorrhea, syphilis, and HIV screening
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chlamydia, gonorrhea, syphilis, and HIV screening
**Description:** Individuals aged 15-26 years old will be tested for chlamydia, gonorrhea, HIV, and syphilis at community based venues. Individuals who test positive for chlamydia and gonorrhea and their sexual partners will be offered expedited treatment at participating pharmacies. Individuals who test positive will be asked to be rescreened for Ct/GC at 3 months post treatment.
**Name:** Chlamydia, gonorrhea, syphilis, and HIV screening
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Primary outcome
**Measure:** Rate of chlamydia in women
**Time Frame:** up to 60 months
#### Secondary Outcomes
**Description:** Secondary outcome
**Measure:** Rate of gonorrhea in women
**Time Frame:** up to 60 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Identifies as African American or Black
* 15-26 years of age
* Lives or spends most of their time in Orleans Parish
* Had vaginal sex at least once
Exclusion Criteria:
* Unwilling or unable to provide informed consent
* Unable to speak or understand English
* Previously enrolled in the study
* Known to be pregnant
* Known HIV positive status
**Healthy Volunteers:** True
**Maximum Age:** 26 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Patricia Kissinger, PhD
**Phone:** 504-988-7320
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002694
- Term: Chlamydiaceae Infections
- ID: D000016905
- Term: Gram-Negative Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000015231
- Term: Sexually Transmitted Diseases, Bacterial
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000003141
- Term: Communicable Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000016870
- Term: Neisseriaceae Infections
- ID: D000014211
- Term: Treponemal Infections
- ID: D000013145
- Term: Spirochaetales Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16364
- Name: Syphilis
- Relevance: HIGH
- As Found: Syphilis
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M5934
- Name: Chlamydia Infections
- Relevance: HIGH
- As Found: Chlamydia
- ID: M9174
- Name: Gonorrhea
- Relevance: HIGH
- As Found: Gonorrhea
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19249
- Name: Gram-Negative Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17935
- Name: Sexually Transmitted Diseases, Bacterial
- 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: M19218
- Name: Neisseriaceae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M16964
- Name: Treponemal Infections
- Relevance: LOW
- As Found: Unknown
- ID: T5701
- Name: Treponema Infection
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002690
- Term: Chlamydia Infections
- ID: D000006069
- Term: Gonorrhea
- ID: D000013587
- Term: Syphilis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428630
**Brief Title:** Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
**Official Title:** Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
#### Organization Study ID Info
**ID:** STUDY00004549
#### Organization
**Class:** OTHER
**Full Name:** Tufts University
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tufts University
#### Responsible Party
**Type:** SPONSOR
### 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 objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group).
### Conditions Module
**Conditions:**
- Oral Lichen Planus
- Oral Lichenoid Reaction
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Investigative group: Subjects with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) Control Group: Those otherwise healthy
Both groups will receive the same intervention. 5 of the control subjects will swish for 5 minutes, 5 of the control subjects will swish for 2 minutes.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The investigative will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
**Intervention Names:**
- Drug: dexamethasone oral rinse
**Label:** Investigative group- Those with OLP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The first control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 5 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
**Intervention Names:**
- Drug: dexamethasone oral rinse
**Label:** Control 1 - 5 minute rinse
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The second control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
**Intervention Names:**
- Drug: dexamethasone oral rinse
**Label:** Control 2- 2 minute rinse
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control 1 - 5 minute rinse
- Control 2- 2 minute rinse
- Investigative group- Those with OLP
**Description:** The study drug is FDA approved (NDC- 0054-3177) and will be used as it would be used in a standard of care setting. The rinse will be administered on the same therapeutic dose to OLP/OLR (0.5 mg/5ml of dexamethasone oral rinse once (rinse for 2 minutes or 5 minutes), then spit the excess into a cup.
The oral rinse dexamethasone 0.5 mg/5ml will be used only on the subjects who participated in the study.
**Name:** dexamethasone oral rinse
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** If there is systemic absorption, does it differ based on length of time of rinsing? This is for those in the control group who will be rinsing for either 2 minutes or 5 minutes. The evaluation is if there is varying amounts of the rinse detected in the blood after the various blood draws.
**Measure:** Length of rinsing impact on systemic absorption
**Time Frame:** 2 hours per subject
#### Primary Outcomes
**Description:** To investigate the amount (level detected in blood), through blood draw, of how much dexamethasone oral rinse is absorbed in the blood stream over two hours.
**Measure:** Systemic absorption of a standard dose of dexamethasone oral rinse
**Time Frame:** 2 hours per subject
#### Secondary Outcomes
**Description:** A clinical oral examination will be conducted for the REU scoring system this will determine what severity category they are in (what their REU score is out of 30 with 30 being most severe and 0 being mild lichen planus). The oral cavity will be examined based on REU scoring system to determine the subject belong to mild , moderate or severe group.
**Measure:** Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder
**Time Frame:** 2 hours per subject
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Over 18 years old
2. Non-pregnant
3. Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time
4. Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit
5. Experimental group is clinically diagnosed with OLP/OLR
6. Controls must have no history of OLP/OLR
Exclusion Criteria:
1 . Under 18 years old 2. Pregnant women 3. Recent history (\< than one month) of exposure to topical or systemic corticosteroids.
4. History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vidya Sankar, DMD, MHS
**Phone:** 617-636-3932
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ann-Marie Billig
**Phone:** 6176363931
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Tufts University School of Dental Medicine
**State:** Massachusetts
**Zip:** 02111
#### Overall Officials
**Official 1:**
**Affiliation:** Tufts University School of Dental Medicine
**Name:** Vidya Sankar, DMD, MHS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19.
**PMID:** 29055500
**Citation:** Meikle AW, Lagerquist LG, Tyler FH. A plasma dexamethasone radioimmunoassay. Steroids. 1973 Aug;22(2):193-202. doi: 10.1016/0039-128x(73)90085-8. No abstract available.
**PMID:** 4795381
**Citation:** Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
**PMID:** 24400953
**Citation:** Jarvinen A, Granander M, Laine T, Viitanen A. Effect of dose on the absorption of estradiol from a transdermal gel. Maturitas. 2000 Apr 28;35(1):51-6. doi: 10.1016/s0378-5122(00)00101-8.
**PMID:** 10802400
**Citation:** Aalto-Korte K, Turpeinen M. Quantifying systemic absorption of topical hydrocortisone in erythroderma. Br J Dermatol. 1995 Sep;133(3):403-8. doi: 10.1111/j.1365-2133.1995.tb02668.x.
**PMID:** 8546995
**Citation:** Georgaki M, Piperi E, Theofilou VI, Pettas E, Stoufi E, Nikitakis NG. A randomized clinical trial of topical dexamethasone vs. cyclosporine treatment for oral lichen planus. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e113-e124. doi: 10.4317/medoral.25040.
**PMID:** 34564686
**Citation:** Joly P, Roujeau JC, Benichou J, Picard C, Dreno B, Delaporte E, Vaillant L, D'Incan M, Plantin P, Bedane C, Young P, Bernard P; Bullous Diseases French Study Group. A comparison of oral and topical corticosteroids in patients with bullous pemphigoid. N Engl J Med. 2002 Jan 31;346(5):321-7. doi: 10.1056/NEJMoa011592.
**PMID:** 11821508
**Citation:** Varoni EM, Molteni A, Sardella A, Carrassi A, Di Candia D, Gigli F, Lodi F, Lodi G. Pharmacokinetics study about topical clobetasol on oral mucosa. J Oral Pathol Med. 2012 Mar;41(3):255-60. doi: 10.1111/j.1600-0714.2011.01087.x. Epub 2011 Sep 22.
**PMID:** 21950548
**Citation:** Sankar V, Hearnden V, Hull K, Juras DV, Greenberg MS, Kerr AR, Lockhart PB, Patton LL, Porter S, Thornhill M. Local drug delivery for oral mucosal diseases: challenges and opportunities. Oral Dis. 2011 Apr;17 Suppl 1:73-84. doi: 10.1111/j.1601-0825.2011.01793.x.
**PMID:** 21382140
**Citation:** Plemons JM, Rees TD, Zachariah NY. Absorption of a topical steroid and evaluation of adrenal suppression in patients with erosive lichen planus. Oral Surg Oral Med Oral Pathol. 1990 Jun;69(6):688-93. doi: 10.1016/0030-4220(90)90349-w.
**PMID:** 2356081
**Citation:** Einarsdottir MJ, Bankvall M, Robledo-Sierra J, Rodstrom PO, Bergthorsdottir R, Trimpou P, Hasseus B, Ragnarsson O. Topical clobetasol treatment for oral lichen planus can cause adrenal insufficiency. Oral Dis. 2024 Apr;30(3):1304-1312. doi: 10.1111/odi.14588. Epub 2023 Apr 27.
**PMID:** 37103329
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19896
- Name: Lichen Planus, Oral
- Relevance: HIGH
- As Found: Oral Lichen Planus
- ID: M11012
- Name: Lichen Planus
- Relevance: HIGH
- As Found: Lichen Planus
- ID: M19775
- Name: Lichenoid Eruptions
- Relevance: HIGH
- As Found: Lichenoid Reaction
- ID: M8219
- Name: Exanthema
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19713
- Name: Skin Diseases, Papulosquamous
- 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: D000017676
- Term: Lichen Planus, Oral
- ID: D000008010
- Term: Lichen Planus
- ID: D000017512
- Term: Lichenoid Eruptions
### 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: 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:** NCT06428617
**Brief Title:** Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)
**Official Title:** A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
#### Organization Study ID Info
**ID:** RGT-002
#### Organization
**Class:** OTHER
**Full Name:** True You Weight Loss
### Status Module
#### Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** True You Weight Loss
#### 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 this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss.
**Detailed Description:** Obesity is a chronic, progressive, multifactorial disease that contributes to increasing morbidity, mortality, and economic costs worldwide. The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin. Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides, leading to calorie-ingesting behaviors and weight gain. A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity. This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site in Cary, NC or Atlanta, GA. Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. Study participants will receive follow-up care according to standard of care practices, regardless of their involvement in the research study. Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring. Patient weights and adverse events will be collected at each visit. Adverse events will be communicated to medical team members in between dedicated visits. We aim to establish a multi-site, prospective registry to longitudinally describe GMFA in adults with obesity, including patient characteristics, weight loss, improvement in weight-related medical conditions, and adverse events.
### Conditions Module
**Conditions:**
- Obesity
**Keywords:**
- obesity
- ghrelin
- hunger
- ablation
- True You Weight Loss
- hunger hormone
- fundus
- fundus ablation
- fundic ablation
- GFMA
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Outcomes Module
#### Primary Outcomes
**Description:** Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.
**Measure:** Percent Change in Total Body Weight Loss (TBWL) from Baseline
**Time Frame:** 12 Months
#### Secondary Outcomes
**Description:** Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.
**Measure:** Percent Change in Total Body Weight Loss (TBWL) from Baseline
**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
**Description:** Measured excess weight loss percentage from baseline following Gastric Fundic Mucosal Ablation. %EWL = (pre-op weight - post op body weight) / (pre-op weight - ideal body weight) \* 100
Ideal Body Weight (IBW):
Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet
**Measure:** Percent Excess Weight Loss from Baseline (EWL)
**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
**Description:** Measured Body Mass Index (BMI) from baseline following Gastric Fundic Mucosal Ablation. Body Mass Index (BMI) = (Weight in kilograms) / ((Height in meters)\^2)
**Measure:** Change in Body Mass Index (BMI) from Baseline
**Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years and ≤ 65 years old
2. BMI ≥ 27 and ≤55 kg/m²
3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
4. Ability to give informed consent
5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
6. Those who plan to receive the gastric fundus mucosal ablation procedure at True You Weight Loss regardless of the research
Exclusion Criteria:
1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
3. Patients who are pregnant or breast-feeding.
4. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
5. Patients with previous or current tobacco use
6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
9. At the discretion of the PI for subject safety
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. All eligibility criteria must be met at the time of enrollment.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chase Wooley, BS
**Phone:** 919-336-4171
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Shannon Casey, BS, MS
**Phone:** (919) 391-7843
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Atlanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chase Wooley, BS
- **Phone:** 919-336-4171
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Shannon Casey, BS, MS
- **Phone:** (919) 391-7843
- **Role:** CONTACT
***Contact 3:***
- **Name:** Christopher McGowan, MD, MSCR
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Daniel Maselli, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Lauren Donnangelo, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** True You Weight Loss
**State:** Georgia
**Zip:** 30342
**Location 2:**
**City:** Cary
**Country:** United States
**Facility:** True You Weight Loss
**State:** North Carolina
**Zip:** 27513
### References Module
#### See Also Links
**Label:** Sponsor Website for more information
**URL:** http://www.trueyouweightloss.com
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001835
- Term: Body Weight
- ID: D000001836
- Term: Body Weight Changes
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M18102
- Name: Weight Loss
- Relevance: HIGH
- As Found: Weight Loss
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M5115
- Name: Body Weight Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015431
- Term: Weight Loss
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428604
**Brief Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients
**Official Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients
#### Organization Study ID Info
**ID:** 2019/64
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2019-07-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-07-31
**Type:** ACTUAL
#### Start Date
**Date:** 2019-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Sevil Azazoglu ERBEK
**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:** Hypothermia that may develop in the perioperative period is associated with many adverse clinical outcomes. In particular, pediatric patients were more susceptible to hypothermia and related complications such as respiratory distress, metabolic acidosis, hypoglycemia, hypoxemia, cardiac disorders, coagulopathy, and wound infection than adults. In this study, the effect of preoperative carbohydrate-rich feeding on temperature regulation in pediatric patients was investigated.
### Conditions Module
**Conditions:**
- Perioperative Hypothermia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** patient group given only 5 ml kg-1 oral water 3 hours before the surgery,
**Label:** GRUP W
#### Arm Group 2
**Description:** Patient group given 5 ml kg-1 clear carbohydrate-rich liquid orally 3 hours before surgery
**Label:** GRUP C
### Outcomes Module
#### Primary Outcomes
**Description:** In order to benefit from the thermic effects of nutrients, intravenous or oral administration of nutrients before or during the operation has been used. These include administering amino acid solutions and administering carbohydrate solutions Providing essential nutrients increases metabolic heat production, reducing the inequality between heat production and loss. The primary goal of this approach is to increase energy expenditure following the administration of essential nutrients, causing a response known as diet-induced thermogenesis.
The body temperatures of the patients were measured perioperative with a tympanic thermometer at regular intervals. Values lower than 36.0oC were considered as hypothermia.
**Measure:** the effect of oral clear liquid intake containing carbohydrates 3 hours before preoperatively on body temperature in the pediatric age group, compared to the group taking water 3 hours before surgery.
**Time Frame:** 1 March 2019- 31 july 2019
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients to be operated on by the Department of Pediatric Surgery
2. Being between the ages of 2 and 15
3. Not restricting oral intake
4. ASA I-II-III patients in anesthesia risk score
5. Patients operated between 01.03.2019 and 31.07.2019
6. Not having any communication problems (mental retardation, not knowing Turkish, etc.)
7. Not having gastroesophageal reflux
8. Not having any muscle disease
9. Informed volunteer consent must be obtained
10. Patients for whom emergency surgery is not planned
11. No disease related to the central nervous system
Exclusion Criteria:
1. Pediatric patients outside the 2-15 age range
2. Having limited oral intake
3. ASA IV and above in anesthesia risk scoring
4. Patients operated before 01.03.2019 or after 31.07.2019
5. Patients who may have communication problems with their parents or themselves
6. Patients with gastroesophageal reflux
7. Patients with muscle disease
8. Patients for whom informed voluntary consent has not been obtained
9. Patients who will undergo emergency surgery
10. Patients with diseases related to the central nervous system
**Maximum Age:** 15 Years
**Minimum Age:** 2 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Being between the ages of 2 and 15
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Başakşehir Çam and Sakura City Hospital
### References Module
#### References
**Citation:** Yatabe T, Kawano T, Yamashita K, Yokoyama M. Preoperative carbohydrate-rich beverage reduces hypothermia during general anesthesia in rats. J Anesth. 2011 Aug;25(4):558-62. doi: 10.1007/s00540-011-1170-z. Epub 2011 May 24.
**PMID:** 21607766
**Citation:** Dilmen OK, Yentur E, Tunali Y, Balci H, Bahar M. Does preoperative oral carbohydrate treatment reduce the postoperative surgical stress response in lumbar disc surgery? Clin Neurol Neurosurg. 2017 Feb;153:82-86. doi: 10.1016/j.clineuro.2016.12.016. Epub 2016 Dec 29.
**PMID:** 28073036
**Citation:** Castillo-Zamora C, Castillo-Peralta LA, Nava-Ocampo AA. Randomized trial comparing overnight preoperative fasting period Vs oral administration of apple juice at 06:00-06:30 am in pediatric orthopedic surgical patients. Paediatr Anaesth. 2005 Aug;15(8):638-42. doi: 10.1111/j.1460-9592.2005.01517.x.
**PMID:** 16033337
**Citation:** Carvalho CALB, Carvalho AA, Nogueira PLB, Aguilar-Nascimento JE. CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. Arq Bras Cir Dig. 2017 Jan-Mar;30(1):7-10. doi: 10.1590/0102-6720201700010003.
**PMID:** 28489159
**Citation:** Ozer AB, Demirel I, Kavak BS, Gurbuz O, Unlu S, Bayar MK, Erhan OL. Effects of preoperative oral carbohydrate solution intake on thermoregulation. Med Sci Monit. 2013 Jul 31;19:625-30. doi: 10.12659/MSM.883991.
**PMID:** 23900128
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001832
- Term: Body Temperature Changes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10085
- Name: Hypothermia
- Relevance: HIGH
- As Found: Hypothermia
- ID: M5111
- Name: Body Temperature Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007035
- Term: Hypothermia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428591
**Brief Title:** Tandem Freedom - Feasibility Trial 1
**Official Title:** Tandem Freedom - Feasibility Trial 1
#### Organization Study ID Info
**ID:** TP-0017517
#### Organization
**Class:** INDUSTRY
**Full Name:** Tandem Diabetes Care, Inc.
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1307-6267
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-06-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Tandem Diabetes Care, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights.
**Detailed Description:** After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 3 days/nights in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
### Conditions Module
**Conditions:**
- Diabetes Mellitus, Type 1
**Keywords:**
- type 1 diabetes
- T1D
- Tandem
- t:slim X2
- automated insulin delivery
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system for 3 days/nights.
**Intervention Names:**
- Device: t:slim X2 insulin pump with Tandem Freedom Algorithm
**Label:** Tandem Freedom
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Tandem Freedom
**Description:** Participants will use the Tandem Freedom system for 3 day/nights in a supervised hotel setting, performing meal and exercise challenges.
**Name:** t:slim X2 insulin pump with Tandem Freedom Algorithm
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
**Measure:** Severe Hypoglycemia events
**Time Frame:** 3 days
**Description:** Number of diabetic ketoacidosis events
**Measure:** Diabetic Ketoacidosis events
**Time Frame:** 3 days
**Description:** Number of unanticipated adverse device effects
**Measure:** Unanticipated adverse device effects
**Time Frame:** 3 days
**Description:** Number of other serious device-related adverse events
**Measure:** Other serious device-related adverse events
**Time Frame:** 3 days
#### Secondary Outcomes
**Description:** CGM measured percent time \<70 mg/dL, overall
**Measure:** Percent Time <70 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time \<70 mg/dL, during the daytime
**Measure:** Percent Time <70 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time \<70 mg/dL, during the nighttime
**Measure:** Percent Time <70 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured percent time \<54 mg/dL, overall
**Measure:** Percent Time <54 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time \<54 mg/dL, during the daytime
**Measure:** Percent Time <54 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time \<54 mg/dL, during the nighttime
**Measure:** Percent Time <54 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 180 mg/dL, overall
**Measure:** Percent Time in Range 70 - 180 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 180 mg/dL, daytime
**Measure:** Percent Time in Range 70 - 180 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 180 mg/dL, nighttime
**Measure:** Percent Time in Range 70 - 180 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 140 mg/dL, overall
**Measure:** Percent Time in Range 70 - 140 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 140 mg/dL, daytime
**Measure:** Percent Time in Range 70 - 140 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time in range 70 - 140 mg/dL, nighttime
**Measure:** Nighttime Percent between 70-140 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured percent time \>180 mg/dL, overall
**Measure:** Percent Time >180 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time \>180 mg/dL, daytime
**Measure:** Percent Time >180 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time \>180 mg/dL, nighttime
**Measure:** Percent Time >180 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured percent time \>250mg/dL, overall
**Measure:** Percent Time >250 mg/dL, overall
**Time Frame:** 3 days
**Description:** CGM measured percent time \>250mg/dL, daytime
**Measure:** Daytime Percent time >250 mg/dL, daytime
**Time Frame:** 3 days
**Description:** CGM measured percent time \>250mg/dL, nighttime
**Measure:** Nighttime Percent time >250 mg/dL, nighttime
**Time Frame:** 3 days
**Description:** CGM measured mean glucose (mg/dL), overall
**Measure:** Mean glucose (mg/dL), overall
**Time Frame:** 3 days
**Description:** CGM measured mean glucose (mg/dL), daytime
**Measure:** Mean glucose (mg/dL), daytime
**Time Frame:** 3 days
**Description:** CGM measured mean glucose (mg/dL), nighttime
**Measure:** Mean glucose (mg/dL), nighttime
**Time Frame:** 3 days
**Description:** CGM measured Coefficient of Variation (%), overall
**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), overall
**Time Frame:** 3 days
**Description:** CGM measured Coefficient of Variation (%), daytime
**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), daytime
**Time Frame:** 3 days
**Description:** CGM measured Coefficient of Variation (%), nighttime
**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), nighttime
**Time Frame:** 3 days
**Description:** CGM measured Standard Deviation (mg/dL), overall
**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), overall
**Time Frame:** 3 days
**Description:** CGM measured Standard Deviation (mg/dL), daytime
**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime
**Time Frame:** 3 days
**Description:** CGM measured Standard Deviation (mg/dL), nighttime
**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime
**Time Frame:** 3 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years old
* Diagnosis of type 1 diabetes for at least 1 year
* Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
* HbA1c ≤10%, recorded in the last 3 months
* Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
* Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
* Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)
Exclusion Criteria:
* More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
* More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
* Inpatient psychiatric treatment in the past 6 months
* For Female: Currently pregnant or planning to become pregnant during the time period of study participation
1. A negative pregnancy test will be required for all females of child-bearing potential
2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential
* Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
* Hemophilia or any other bleeding disorder
* Hemoglobinopathy
* History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
* History of allergic reaction to Humalog or Novorapid
* Use of any medications determined by investigator to interfere with study
* Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
* Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
* History of adrenal insufficiency
* History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
* History of gastroparesis
* A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
* Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
* Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Christchurch
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Renee Meier
- **Phone:** 64 3 372 6763
- **Role:** CONTACT
***Contact 2:***
- **Name:** Martin de Bock, FRACP PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** New Zealand
**Facility:** University of Otago
**Status:** RECRUITING
**Zip:** 8140
#### Overall Officials
**Official 1:**
**Affiliation:** Tandem Diabetes Care
**Name:** Jordan Pinsker, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Diabetes Mellitus, Type 1
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428578
**Brief Title:** Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
**Official Title:** Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
#### Organization Study ID Info
**ID:** HSC-SPH-23-0795
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
#### Secondary ID Infos
**Domain:** American Heart Association
**ID:** 24FIM1264463
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** American Heart Association
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center, Houston
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center, Houston
**Investigator Full Name:** Alexandra van den Berg
**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 purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.
### Conditions Module
**Conditions:**
- Food Insecurity in Post Partum Women
**Keywords:**
- Food is Medicine (FIM)
- food insecurity
- free delivered nutritious meals
- food boxes
- Community Health Workers
- The University of Texas Health Science Center at Houston School of Public Health
- Austin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: FBM-In person
- Other: home delivered food boxes
**Label:** FBM-In person
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: FBM-Virtual
- Other: home delivered food boxes
**Label:** FBM-Virtual
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Other: home delivered food boxes
**Label:** home delivered food
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FBM-In person
**Description:** Participants will receive two home visits by a CHW. Each home visit will last about 30 minutes, during which the CHW will assist the woman with community resources and help with enrolling in any state or federal nutrition and medical programs. Furthermore, the participants will be given access to a private Facebook group for nutrition, health education, and social support. Home visits will occur during the second and fifth weeks of the study.
**Name:** FBM-In person
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- FBM-Virtual
**Description:** Participants will receive access to a virtual platform which will have information on national, state, and local food and medical resources, as well as local community resources, and will have access to a private Facebook group for nutrition, health education, and social support.
**Name:** FBM-Virtual
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- FBM-In person
- FBM-Virtual
- home delivered food
**Description:** Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.
**Name:** home delivered food boxes
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity.
**Measure:** Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
**Description:** This data will be reported categorically for 14 different food items as follows:
1. fruit
2. green leafy or lettuce salad
3. fried potatoes
4. other kind of potatoes
5. refired/baked/ cooked beans
6. other vegetables that were not deep-fried
7. salsa made with tomato
8. pizza
9. tomato sauce
10. lean protein
11. plant-based protein
12. brown rice or other cooked whole grains
13. whole grain bread
14. regular soda/pop
**Measure:** Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
**Measure:** Number of participants that initiated breastfeeding as assessed by the pre test questionnaire
**Time Frame:** Baseline
**Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires
**Time Frame:** end of study (after 8 weeks of food delivery boxes)
**Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires
**Time Frame:** 3 months follow up
**Description:** This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome
**Measure:** Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
**Description:** Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week.
**Measure:** Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
**Description:** Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress.
**Measure:** Change in financial stress as assessed by the financial stress questionnaire
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
**Description:** A single item from the Financial Self Efficacy scale will be used.
**Measure:** Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale
**Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* food insecure
* to communicate in English or Spanish.
Exclusion Criteria:
* not living within the food produce zip code delivery radius
* having any dietary allergies.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alexandra van den Berg, MPH, PhD
**Phone:** (512) 391-2529
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Aida Nielsen, MPH
**Phone:** (512) 482-6183
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Austin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alexandra van den Berg, MPH,PhD
- **Phone:** 512-391-2529
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Aida Nielsen, MPH
- **Phone:** (512) 482-6183
- **Role:** CONTACT
**Country:** United States
**Facility:** Ascension Seton Medical Center
**State:** Texas
**Status:** RECRUITING
**Zip:** 78705
**Location 2:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alexandra van den Berg, MPH, PhD
- **Phone:** 512-391-2529
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Aida Nielsen
- **Phone:** (512) 482-6160
- **Role:** CONTACT
**Country:** United States
**Facility:** The University of Texas Health Science Center at Houston
**State:** Texas
**Status:** RECRUITING
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** The University of Texas Health Science Center, Houston
**Name:** Alexandra van den Berg, MPH, 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:** NCT06428565
**Brief Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
**Official Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/713
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-29
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Low back pain (LBP) is a significant health issue. It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. To find out what changes occurred after the application of two exercise modalities \[Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP.
### Conditions Module
**Conditions:**
- Low Back Pain
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** uses low-level lasers or light-emitting diodes to stimulate cellular function and improve healing. Physiotherapy, sports medicine, and rehabilitation use it as a non-invasive, painless complement or adjuvant therapy
**Intervention Names:**
- Diagnostic Test: Low-level laser therapy (LLLT) or cold laser therapy
**Label:** Low-level laser therapy (LLLT) or cold laser therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Low-level laser therapy (LLLT) or cold laser therapy
**Description:** Low-level laser therapy (LLLT) or cold laser therapy
**Name:** Low-level laser therapy (LLLT) or cold laser therapy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** it is a simple and widely used tool for measuring pain intensity. It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable). Patients are asked to rate their pain by selecting the number that best describes their current pain intensity
**Measure:** The Numeric Pain Rating Scale (NRS)
**Time Frame:** 12 Months
**Description:** it is a patient-completed questionnaire used to measure the level of disability caused by low back pain. It is a widely used and validated tool in both research and clinical settings. Studies show high test-retest reliability of 0.90
**Measure:** The Oswestry Disability Index (ODI)
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Both male and female ages between 18 and 45 years (11).
* Patients diagnosed with nonspecific low back pain (11).
* patients with pain intensity of "3" or greater on numeric pain rating scale
Exclusion Criteria:
* Patients with neurological symptoms.
* Patients diagnosed with fatigue syndrome
* Females having pregnancy
* History of low back surgery
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Hameed Latif Hospital Lahore
### 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
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6392
- Name: Complement System Proteins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428552
**Brief Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP
**Official Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric Patients With Cerebral Palsy
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/712
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The world of technology is changing and becoming more advanced. Children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications. A lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills.
**Detailed Description:** They may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable. This work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility. This is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions. Cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation. Therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives. Caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy. This might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment.
### Conditions Module
**Conditions:**
- Cerebral Palsy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks
**Intervention Names:**
- Device: Mobile Application
**Label:** Usual care at home for 12 weeks
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Usual care at home for 12 weeks
**Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks
**Name:** Mobile Application
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** questionnaire(QUIS)the application software has been given to the intervention group and after using the software for one week, all participants answered the user satisfaction interaction questionnaire(QUIS).This step has taken to assess the software's usability based on feedback taken from parents or caregivers of patient with cerebral palsy and to assess the impact of utilizing this mobile application.
**Measure:** questionnaire(QUIS)the application software
**Time Frame:** 12 Months
**Description:** Pedi Cat Questionnaire To assess amount of recovery in patients with cerebral palsy, the intervention group answered valid and reliable Pedi Cat questionnaire at the first day of the study. The intervention group used the content and rehabilitation protocol of the app under the supervision of therapist for 12 weeks at home. After 12 weeks, the Pedi Cat questionnaire was answered by intervention group to assess recovery increasing or any change in the patients.
**Measure:** Pedi Cat Questionnaire
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children with cerebral palsy
* Children aged between 5 to 16 years
Exclusion Criteria:
* Children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions
* undergone botulinum neurotoxin A (BoNT-A)injections or surgery in the previous 2 months or 6 months respectively. "
**Maximum Age:** 16 Years
**Minimum Age:** 5 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Hope Rehabilitaion Centre, Mansoor Hospital Lahore , ChildRehab Sangla Hill
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428539
**Brief Title:** T Regulatory Cells IN LUPUS NEPHRITIS
**Official Title:** T Regulatory Cells in Lupus Nephritis
#### Organization Study ID Info
**ID:** T cells in lupus LN
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Mohamed AbdEllah Ahmed Hussein
**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:** * To study the role FoxP3-positive T regulatory cells in the pathogenesis of Lupus Nephritis, and determine the factors associated with levels of T regs .
* To compare the functional capacity of T regs in LN and in normal individuals.
**Detailed Description:** Lupus Nephritis (LN) encompasses a group of glomerulonephrites, that occur in association with systemic lupus erythematosus (SLE). The mainstream theory that it is an immune disease resulting from loss of immune tolerance against body cells. The regulatory T cells (T regs ) are a subpopulation of immune cells that maintain tolerance to self-antigens and suppress autoimmune diseases. The main marker of Tregs is FoxP3 (forkhead box protein 3) positivity. Moreover, It has been suggested that functional capacity of Tregs is also compromised in autoimmune diseases. Studying the role of T regs in LN is a promising field that can help tailor current immune therapy and develop new treatment strategies.
### Conditions Module
**Conditions:**
- Lupus Nephritis
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 65
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients with active lupus nephritis as active urinary sediment, or rising renal chemistry
**Intervention Names:**
- Diagnostic Test: T-reg cells
**Label:** patients with active lupus nephritis
#### Arm Group 2
**Description:** Patients who were previously active, but now in remission
**Intervention Names:**
- Diagnostic Test: T-reg cells
**Label:** patients with lupus nephritis in remission
#### Arm Group 3
**Description:** normal healthy participants
**Intervention Names:**
- Diagnostic Test: T-reg cells
**Label:** normal individuals
### Interventions
#### Intervention 1
**Arm Group Labels:**
- normal individuals
- patients with active lupus nephritis
- patients with lupus nephritis in remission
**Description:** laboratory test
**Name:** T-reg cells
**Other Names:**
- t regulatory cells
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** mean difference of FoxP3 between groups.
**Measure:** FoxP3 between groups
**Time Frame:** baseline
**Description:** correlation between level of FoxP3 and activity index in the group with active LN.
**Measure:** Association of FoxP3 and activity index
**Time Frame:** baseline
**Description:** mean difference of suppression capacity of Tregs between normal participants and patients with active LN.
**Measure:** Tregs in normal and lupus participants
**Time Frame:** baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
adults both genders clinical diagnosis of lupus nephritis
Exclusion Criteria:
patients diagnosed with other renal pathologies, e.g. diabetic kidney disease
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients with lupus nephritis, both currently active or in remission, divided in Group 1: active lupus nephritis, Group 2: lupus nephritis in remission. Besides including normal Group 3: healthy volunteers
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohamed AH Hussein
**Phone:** +966554599271
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Doglio M, Alexander T, Del Papa N, Snowden JA, Greco R; Autoimmune Diseases Working Party (ADWP) of the European Society for Blood and Marrow Transplantation (EBMT). New insights in systemic lupus erythematosus: From regulatory T cells to CAR-T-cell strategies. J Allergy Clin Immunol. 2022 Dec;150(6):1289-1301. doi: 10.1016/j.jaci.2022.08.003. Epub 2022 Sep 20.
**PMID:** 36137815
## Derived Section
### Condition Browse Module - Ancestors
- 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
- ID: D000008180
- Term: Lupus Erythematosus, Systemic
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### 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: 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: 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: M11177
- Name: Lupus Erythematosus, Systemic
- 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: 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428526
**Brief Title:** Impact of Sensory Electrical Stimulation on Sensation and Tremor
**Official Title:** Effects of Afferent-specific Peripheral Electrical Stimulation (asES) on Sensorimotor Control and Tremor
#### Organization Study ID Info
**ID:** STU00217703
#### Organization
**Class:** OTHER
**Full Name:** Shirley Ryan AbilityLab
### Status Module
#### Completion Date
**Date:** 2028-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shirley Ryan AbilityLab
#### Responsible Party
**Investigator Affiliation:** Shirley Ryan AbilityLab
**Investigator Full Name:** Jose Pons
**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 purpose of this study is to understand the acute, short-term and long-term impact of transcutaneous and/or percutaneous electrical stimulation with afferent-specific electrical stimulation (asES) on proprioception and fine motor control in the upper extremity. For this purpose, the researchers will use transcutaneous and/or percutaneous asES, high-density electromyography (HD-EMG), arm kinematic measurements, and standardized clinical assessments. This study will be conducted in healthy able-bodied individuals and patients with essential tremor (ET).
**Detailed Description:** The purpose of this study is to evaluate the impact of afferent-specific electrical stimulation (asES), delivered either transcutaneous or percutaneous electrodes, on proprioception and fine motor control. The researchers will study the effect of asES in force perception, joint position perception, and touch sensitivity as proxies for proprioception. The researchers will also study the effect of asES on fine motor control by investigating the change in neural drive to the muscles before and after asES using the motor unit spike trains extracted from HD-EMG recordings. Furthermore, the researchers will also study the difference in effects of transcutaneous versus percutaneous asES on proprioception, fine motor control, and tremor in ET through HD-EMG and standard clinical measurements such as TETRAS and Perdue pegboard test. These results will help the researchers understand the acute, short-term, and long-term effects of various methods of asES delivery (transcutaneous or percutaneous) and their impact on proprioception and fine motor control.
Aim 1: Investigate the acute, short-term, and long-term effects of transcutaneous asES on proprioception and fine motor control. The overall goal of this study is to provide insight into the effect of transcutaneous stimulation of la afferent pathways targeted to modulate spinal reflexes in patients with ET to reduce tremors, which consequently might cause disruption in proprioception leading to changes in performance of fine motor control. The researchers hypothesize that asES might disrupt proprioception causing decreased performance in fine motor control tasks in the acute (during stimulation), and short-term (e.g., immediately following stimulation to 30 minutes post) but the effects will diminish in the long-term (up to 24 hours post stimulation) time periods.
Aim 2: Investigate the acute, short-term, and long-term effects of percutaneous asES on proprioception and fine motor control. The goal of this aim is to evaluate the effects of percutaneous asES to modulate Ia afferents and spinal reflexes to result in tremor reduction in ET, which consequently might cause disruption in proprioception leading to changes in performance of fine motor control. The researchers hypothesize that percutaneous asES will disrupt proprioception and fine motor control, but will also result in tremor reduction in the acute, short-term and long-term periods.
### Conditions Module
**Conditions:**
- Essential Tremor
- Healthy Individuals
**Keywords:**
- Essential Tremor
- Proprioception
- Fine motor control
- Electrical nerve stimulation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist
**Intervention Names:**
- Device: Continuous stimulation strategy
- Device: Closed-loop stimulation strategy
**Label:** Transcutaneous asES
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist
**Intervention Names:**
- Device: Continuous stimulation strategy
- Device: Closed-loop stimulation strategy
**Label:** Percutaneous asES
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Percutaneous asES
- Transcutaneous asES
**Description:** Participants will be administered stimulation with a constant frequency stimulation.
**Name:** Continuous stimulation strategy
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Percutaneous asES
- Transcutaneous asES
**Description:** Participants will be administered with an activity-dependent stimulation.
**Name:** Closed-loop stimulation strategy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Force perception will be measured by evaluating the participant's ability to match a target force.
**Measure:** Force perception via force matching tasks
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit
**Description:** Position perception will be measured by evaluating the participant's ability to match a target joint position.
**Measure:** Position perception via position matching tasks
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit
**Description:** Touch perception will be assessed through Semmes-Weinstein monofilament testing. Roshen scores will be computed based on the filaments that are perceived by the participant. The range of Roschen scores can be from 0 -5. Higher scores mean better touch perception.
**Measure:** Touch perception using Semmes Weinstein monofilament testing
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit
**Description:** Fine motor control at the wrist and hands will be measured by evaluating the performance of the participants in tracking various forms of trajectory by moving their wrist and hand in flexion-extension movements.
**Measure:** Fine motor control as assessed by visuomotor tracking performance
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit
#### Secondary Outcomes
**Description:** The Essential Tremor Rating Assessment Scale (TETRAS) will be used to quantify tremor of the participants. The TETRAS scale ranges from 0 - 64. Higher scores mean worse tremor in the participant.
**Measure:** Tremor assessment using TETRAS
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit
**Description:** Upper limb kinematics using inertial measurement units (IMUs) will be used to quantify tremor of the participants. IMUs will be placed on the hand, forearm, and upper arm of the participants.
**Measure:** Tremor assessment using arm kinematics
**Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for Healthy Participants:
* Age from 18 to 80 years, inclusive
* No history of a brain and/or skull lesion
* Normal hearing and (corrected) vision
* Able to understand and give informed consent
* No neurological disorders
* No tremor
* Able to understand and speak English
Exclusion Criteria for Healthy Participants:
* History of significant head trauma (i.e., extended loss of consciousness, neurological damage)
* Known structural brain lesion
* Prior neurosurgical procedures
* Tremors (as determined by study team)
* Co-existence of other neurological diseases
* Parkinsonism
* Medical (e.g., cardiological, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
* Pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, etc.)
* Inability to perform study tasks or assessments (e.g., follow instructions to stay still during asES procedures) or unable/unwilling to complete study forms
* Non-prescribed drug use or recreational marijuana use
* History of current substance abuse (exception: current nicotine use is allowed)
* Pregnancy
* Prisoners
Inclusion Criteria for ET Patients:
* Age from 18 to 80 years, inclusive
* No prior history of skull lesions or craniotomy
* Normal hearing and (corrected) vision
* Able to understand and give informed consent
* Diagnosis of ET (Tremor Research investigation Group criteria) by a physician
* At least moderate-severe tremor (based on the TETRAS Tremor Rating Scale) in an upper limb with pure flexion-extension wrist tremor during posture
* Stable medication doses for at least 30 days prior to study enrollment and during entire study period
* Able to understand and speak English
Exclusion Criteria for ET Patients:
* History of significant head trauma (i.e., extended loss of consciousness, neurological damage)
* Known structural brain lesion
* Prior neurosurgical procedures
* Mixed or complex tremors (as determined by study team)
* Co-existence of other neurological diseases
* Parkinsonism
* Medical (e.g., cardiological, renal, hepatic, oncological) or psychiatric disease that would - interfere with study procedures
* Pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, etc.)
* Inability to perform the study tasks or assessments (e.g., follow instructions to stay still during asES procedures) or unable/unwilling to complete study forms
* Non-prescribed drug use or recreational marijuana use
* History of current substance abuse (exception: current nicotine use is allowed)
* Pregnancy
* Prisoners
**Healthy Volunteers:** True
**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:** Jose L Pons, PhD
**Phone:** 312-238-4549
**Role:** CONTACT
**Contact 2:**
**Name:** Grace Hoo, MS
**Phone:** 312-238-4548
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Country:** United States
**Facility:** Shirley Ryan AbilityLab
**State:** Illinois
**Zip:** 60611
#### Overall Officials
**Official 1:**
**Affiliation:** Shirley Ryan AbilityLab
**Name:** Jose L Pons, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000002493
- Term: Central 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: M16956
- Name: Tremor
- Relevance: HIGH
- As Found: Tremor
- ID: M22137
- Name: Essential Tremor
- Relevance: HIGH
- As Found: Essential Tremor
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014202
- Term: Tremor
- ID: D000020329
- Term: Essential Tremor
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428513
**Acronym:** HCTP
**Brief Title:** Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease.
**Official Title:** SHEBA-9466-22-RP-CTIL Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease: A Feasibility Study
#### Organization Study ID Info
**ID:** 9466-22-SMC
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheba Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-19
**Type:** ACTUAL
**Status Verified Date:** 2023-08
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Sheba Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Lung transplantation has become standard of care for selected patients with end stage pulmonary disease. While on the lung transplantation waiting list, patient health, emotional wellbeing and quality of life can deteriorate. By improving or changing patient physical activity, healthy nutrition, tobacco cessation, patient preparation for lung transplantation can be optimized, risk of complications can be reduced, and outcomes post transplantation can be improved.
The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine.
No studies so far have addressed the potential effect of a pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease.
**Detailed Description:** SCIENTIFIC BACKGROUND Lung transplantation has become an established standard of care for selected patients with end stage pulmonary disease. Candidate selection begins with a referral from the non-transplant pulmonologist and if deemed suitable, begins an evaluation process that determines eligibility for transplantation. Candidates who meet all requirements are listed for transplantation. While on the waiting list, physical activity, healthy nutrition, tobacco cessation, and a few other health behaviors are essential to maintain candidacy. In addition to the physical limitations imposed by end-stage lung disease, transplant candidates face a range of psychosocial issues relating to changes in functional capacity, including social roles, relationships, perceptions of self, and life plans and goals. Efforts targeted at these domains may improve quality of life, optimize patient preparation for transplantation, reduce the risk of complications, and improve outcomes.
Health coaching has emerged as a widely adopted intervention that may help individuals with chronic conditions adopting health behaviors that improve quality of life, health, and emotional wellbeing. It is a patient-centered approach wherein the individual and coach work together through active health education processes and motivational interviewing to set goals that improve health outcomes. The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine; and recently, it has developed national standards and accreditations in the US. Therefore, health coaching was selected as our telemedicine approach, and a novel health coaching telemedicine program (HCTP) was developed at Sheba Medical Center for lung transplantation candidate.
No studies so far have addressed the potential effect of pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease.
SPECIFIC AIMS Specific Aim 1: To assess whether HCTP is feasible among participants with end stage lung disease who are candidate for lung transplantation.
Specific Aim 2: To collect data on the impact of a HCTP on health-related quality of life, lung functions, functional capacity, cardiometabolic parameters (e.g., weight, lipid profile, fasting glucose), and hospital services utilization of participants with end stage lung disease who are candidate for lung transplantation Specific Aim 3: To collect data on experience and capacity to cope with the demands of the illness of participants with end stage lung disease who are candidate for lung transplantation.
STUDY DESIGN Detailed Plan of the Study The health coaching tele-medicine program study is a randomized controlled feasibility trial in which study participants are randomly assigned into either a study group or a control group.
Source of participants and recruitment methods: This study is a collaboration between the lung transplant program and the center of lifestyle medicine, within Sheba's cardiometabolic prevention center, a unique center in Israeli health care services that promote innovative lifestyle interventions. Our target population is 56 adults with end stage lung disease who refer to The Sheba Medical Center lung transplantation program for evaluation; over a period of 12 months.
METHODS:
This study is expected to be ongoing for 24 months but conducted for each subject in a 12-month timeframe. Data collection time points every quarter for 12 months.
Assessment include:
* Health related quality of life (HRQL)
* Lung functions tests
* Hospital services usage: will be evaluate using the hospital medical record. These services include health professional services in the rehabilitation hospital.
* Health behaviors: Nutritional intake will be evaluated by a 4-day food record.
* Physical activity questionnaire.
* Cardiometabolic outcomes
* Qualitative data: Investigators also expect to deepen our understanding about participants' experience in the program and their capacity to cope with the demands of their illness through the study's qualitative component. Qualitative data will be included in analyses for both participants who completed the intervention and participants who dropout.
Information regarding demographics, medications, other health behaviors (e.g., smoking status, physical activity status), and use of other nutritional education resources during the program (e.g., dietitian and physician visits, apps) will be extracted from the medical record.
PROCEDURE INTERVENTION: Both the intervention and control groups will receive the standard care for lung transplantation candidates. In addition for:
Study group participants - study group participants will complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom, delivered by a credential health coach (health care professional who also completed a health coaching certification). Prior to the beginning of the program participant will complete intake assessment that will include past and current medical history, medications, current lifestyle practices, self-reported health status, psychosocial status, and other relevant information. At the first session, participants identify their health vision and 3-month health goals. During each subsequent meeting, participants will review their progress towards reaching the prior week's goals and identify goals for the coming week, using a self-discovery process facilitated by the health coach. Based on the initial assessment individualized action plan will be formulated to help each participant achieve his/her goals. The action plan will focus on important lifestyle practices (especially physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Based on their interaction with the participant and/or input from the participant's physician or other health care providers, health coaches will revise goals and action plans. When patients detect the need for health care advice that is necessary for their progress, s/he will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidate.
2. Control group: Control group participants will receive HCTP after the end of the study.
Statistical methods: Patients will be randomized 1:1 between the 2 study arms. Investigators will use block randomization stratified by site. Power calculation indicates that 28 participants (14/ group) are required in each of the intervention groups in order to estimate a retention rate of 80% with 10% precision and 80% confidence. Every effort will be made to minimize dropouts, and further to follow-up with participants who do not complete the program to obtain measurements of study outcomes. In the event of missing data, the impact will be assessed and addressed, if necessary, according to current best practices. Demographic and other baseline characteristics as well as feasibility outcomes will be summarized using means and standard deviations for normally distributed variables, medians and interquartile ranges for non-normally distributed variables, and frequencies for count or dichotomous variables. For all outcomes and to address exploratory hypotheses. P-values and 95% confidence intervals will be presented for all effects of interest.
### Conditions Module
**Conditions:**
- Copd
- End Stage Lung Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 56
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom. Follow up will be for a year in total.
**Intervention Names:**
- Behavioral: HCTP
**Label:** HCTP program
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control group participants do not receive the intervention but will receive HCTP after the end of the study.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HCTP program
**Description:** 10 weekly 1-on-1 30-minute tele-sessions via Zoom, delivered by a certified health coach. At baseline assessment including full medical history, medications, lifestyle practices, self-reported health status, psychosocial status, and other relevant information will be taken. At the first session, participants identify their health vision and 3-month health goals. At subsequent meetings, participants review their progress towards reaching the prior week's goals and identify goals for the next week. An individualized action plan will be formulated to help each participant achieve their goals. The action plan will focus on important lifestyle practices (physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Patients can request further health care advice felt necessary for their progress, and will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidates.
**Name:** HCTP
**Other Names:**
- Health coaching telemedicine program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Retention of participants in the program/research. Calculated as a percentage of participants completing all visits of the intervention.
**Measure:** Feasibility outcomes
**Time Frame:** Every quarter for one year
**Description:** Participant percentage that adhered to the intervention. Calculated as a percentage of the intervention.
**Measure:** Participant adherence
**Time Frame:** Every quarter for one year
**Description:** FEV1/FVC ratio expressed as a percentage. The lower the percentage, the more severe the lung condition.
Predictive (normal) values are equal to or greater than 70%. Abnormal values are graded:
Mild: 60-69% Moderate: 50-59% Severe: Under 50%
**Measure:** Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio
**Time Frame:** Every quarter for one year
**Description:** Total lung capacity (TLC), recorded in Liters (L)
**Measure:** Total lung capacity (TLC)
**Time Frame:** Every quarter for one year
**Description:** Changes in DLCO test from the baseline used to determine progression or regression of disease.
DLCO (also known as Transfer factor for carbon monoxide (TLCO)) Units ml/min/mmHg/L. Initial and final Carbon monoxide (CO) concentration, in mmol CO, and breath-holding time in minutes, are used to calculate DLCO
Severity and classification of DLCO reduction:
Normal DLCO: \>75% of predicted, up to 140% Mild: 60% to LLN (lower limit of normal) Moderate: 40% to 60% Severe: \<40%
**Measure:** Diffusing capacity of the lungs for carbon monoxide (DLCO)
**Time Frame:** Every quarter for one year
**Description:** To assess a patient's functional status / to track functional change resulting from disease progression or therapeutic intervention.
The higher a patient's score, the better their lung capacity. A low score correlates with lower function.
Calculation measurements: weight in kilograms, height in centimetres, age of patient in years, distance walked meters.
Calculation
MEN:
6MWD = (7.57 × height) - (5.02 × age) - (1.76 × weight) - 309
WOMEN:
6MWD = (2.11 × height) - (2.29 × weight) - (5.78 × age) + 667
Heart rate and oxygen saturation will also be measured separately but included to provide an assessment of functional status.
**Measure:** Functional lung capacity using six-minute walk test (6MWT)
**Time Frame:** Every six months for one year
**Description:** Oxygen saturation, measured as a percentage. Taken at rest and breathing room air, and during taken during exercise test.
This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity.
**Measure:** Oxygen saturation
**Time Frame:** Every six months for one year
**Description:** Heart Rate measured as a beats per minute. Taken at rest and breathing room air, and during taken during exercise test.
This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity.
**Measure:** Heart Rate
**Time Frame:** Every six months for one year
**Description:** Physical activity will be measured by the international physical activity questionnaire. A change in physical activity
Scoring a HIGH level of physical activity on the IPAQ means the participant's physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
Scoring a MODERATE level of physical activity on the IPAQ means the participant is doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.
Scoring a LOW level of physical activity on the IPAQ means that the participant is not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.
**Measure:** Physical activity variable
**Time Frame:** Every quarter for one year
**Description:** • Health behaviours: Nutritional intake will be evaluated by a 4-day food record in which subjects document and report their food consumption. Intake will be analyzed for its caloric content, nutritional values and group classifications and its Mediterranean index.
**Measure:** Behavioural and nutritional evaluation
**Time Frame:** Every quarter for one year
**Description:** Evaluated using the St. George's respiratory questionnaire. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
**Measure:** Patient functioning and quality of life
**Time Frame:** Every quarter for one year
#### Secondary Outcomes
**Description:** Height (cm) and weight (kg) will be combined to report BMI in kg/m\^2
**Measure:** Body mass index (BMI)
**Time Frame:** Every quarter for one year
**Description:** Hemoglobin A1c (glycated hemoglobin), HbA1c measured as percentage (%)
Changes in measurements between visits over time will be analysed.
**Measure:** Glucose control - glycated hemoglobin HbA1c
**Time Frame:** Every quarter for one year
**Description:** Includes total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides. Measured in milligrams (mg) of cholesterol per deciliter (dL) of blood (mg/dl)
Changes in measurements between visits over time will be analysed.
**Measure:** Blood lipid profile
**Time Frame:** Every quarter for one year
**Description:** Cardio-metabolic outcomes: (2) blood pressure systolic and diastolic
Changes in measurements between visits over time will be analysed.
**Measure:** Cardio-metabolic evaluation
**Time Frame:** Every quarter for one year
**Description:** Changes in the number of hospital services / engagements used i.e., physiotherapist, social worker, nutritionist, hospitalizations, and emergency room admissions engagements per month.
**Measure:** Rate of hospital service usage
**Time Frame:** One year
**Description:** Qualitative data: To deepen our understanding about subjects' experience in the program and their capacity to cope with the demands of their illness through the study's qualitative component. Qualitative data will be included in analyses for both subjects who completed the intervention and subjects who dropout.Baseline/Visit 1 - a questionnaire with open questions to fill out about the subject's challenges and expectations before the program starts (both intervention and control group).
**Measure:** Participant perception of the program
**Time Frame:** Month 0
**Description:** Qualitative data Visit 2 - a questionnaire with open retrospective questions to fill out about the subject's experience at the HCTP (Intervention group only)
**Measure:** Behavioural and psychosocial outcome
**Time Frame:** Month 3
**Description:** Qualitative data Visit 3 - a follow-up interview to sum up the subject's experience
**Measure:** Participant evaluation
**Time Frame:** Month 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with end stage lung disease assessed suitable for lung transplantation.
* Able and willing to watch online instructional videos.
Exclusion Criteria:
* Unwilling or unable to provide consent
* Uncooperative or combative
* Unable to use / connect to video conferencing
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Liran Levy, MD
**Phone:** +97235302735
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rani Polak, PhD
**Phone:** +97235307824
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ramat Gan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rani Polak, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Daniel Zubli, BSc
- **Role:** CONTACT
***Contact 3:***
- **Name:** Liran Levi, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Israel
**Facility:** Sheba Medical Center
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Sheba Medical Center
**Name:** Rani Polak, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
### 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: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Lung Disease
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: End Stage Lung Disease
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008171
- Term: Lung Diseases
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428500
**Brief Title:** QTX3046 in Patients With KRAS G12D Mutations
**Official Title:** A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
#### Organization Study ID Info
**ID:** QTX3046-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Quanta Therapeutics
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Quanta Therapeutics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment
**Intervention Names:**
- Drug: QTX3046
**Label:** Part 1a: QTX3046 monotherapy dose escalation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment
**Intervention Names:**
- Drug: QTX3046
- Combination Product: Cetuximab
**Label:** Part 1b: QTX3046 dose escalation in combination with cetuximab
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment
**Intervention Names:**
- Drug: QTX3046
**Label:** Part 2: QTX3046 monotherapy dose expansion
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment
**Intervention Names:**
- Drug: QTX3046
- Combination Product: Cetuximab
**Label:** Part 3: QTX3046 dose expansion in combination with cetuximab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1a: QTX3046 monotherapy dose escalation
- Part 1b: QTX3046 dose escalation in combination with cetuximab
- Part 2: QTX3046 monotherapy dose expansion
- Part 3: QTX3046 dose expansion in combination with cetuximab
**Description:** QTX3046 will be administered at protocol defined dose.
**Name:** QTX3046
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 1b: QTX3046 dose escalation in combination with cetuximab
- Part 3: QTX3046 dose expansion in combination with cetuximab
**Description:** Cetuximab will be administered at protocol defined dose.
**Name:** Cetuximab
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
**Measure:** Number of participants with Treatment-emergent Adverse Events (TEAEs)
**Time Frame:** up to 2 years
**Description:** DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
**Measure:** Number of participants with Dose Limiting Toxicities (DLTs)
**Time Frame:** up to 21 days
#### Secondary Outcomes
**Description:** Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046
**Measure:** Area under the plasma concentration-time curve (AUC) of QTX3046
**Time Frame:** up to 2 years
**Description:** Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046
**Measure:** Peak plasma concentration of QTX3046 (Cmax)
**Time Frame:** up to 2 years
**Description:** The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
**Measure:** Objective response rate (ORR)
**Time Frame:** up to 2 years
**Description:** Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.
**Measure:** Duration of response (DoR)
**Time Frame:** up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1
Exclusion Criteria:
* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor
Other protocol-defined Inclusion/Exclusion Criteria may apply
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Quanta Therapeutics Clinical Trials
**Phone:** 415-599-3892
**Role:** CONTACT
## Derived Section
### 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: M315
- Name: Cetuximab
- Relevance: HIGH
- As Found: Solid
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068818
- Term: Cetuximab
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428487
**Brief Title:** Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer
**Official Title:** Phase II,Open-label, Non-randomized Study of Neoadjuvant Prolgolimab Monotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair (dMMR) Deficiency
#### Organization Study ID Info
**ID:** 125
#### Organization
**Class:** OTHER
**Full Name:** Blokhin's Russian Cancer Research Center
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-03-31
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-05
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Blokhin's Russian Cancer Research Center
#### Responsible Party
**Investigator Affiliation:** Blokhin's Russian Cancer Research Center
**Investigator Full Name:** Mikhail Fedyanin
**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:** In this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles)
**Detailed Description:** In this open-label phase II non-randomized study the investigators will enroll 30 patients with stage II-III MSI/dMMR colorectal cancer to receive anti-PD1 inhibitor prolgolimab.
Patients will be treated with 12 cycles (6 months) of prolgolimab 1 mg/kg every 2 weeks until surgery.
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- colorectal cancer
- immune checkpoint inhibitors
- microsatellite instability
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients will be treated with prolgolimab 1 mg/kg every 2 weeks during 6 months (12 cycles) until surgery
**Intervention Names:**
- Drug: Prolgolimab
**Label:** Prolgolimab monotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prolgolimab monotherapy
**Description:** Prolgolimab infusions 1 mg/kg
**Name:** Prolgolimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy
**Measure:** Pathological complete response (pCR)
**Time Frame:** up to 8 months
#### Secondary Outcomes
**Description:** a continuous response \[complete or partial objective response\] beginning within 6 months of treatment and lasting ≥6 months
**Measure:** Durable complete clinical response rate (DRR)
**Time Frame:** up to 12 months
**Description:** Time from initiation of treatment to the occurrence of disease progression or death.
**Measure:** Progression-free survival (PFS)
**Time Frame:** 12 months
**Description:** Time from initiation of treatment to death.
**Measure:** Overall survival (OS)
**Time Frame:** 12 months
**Description:** percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
**Measure:** Objective response rate (ORR)
**Time Frame:** up to 8 months
**Description:** Rate of R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
**Measure:** R0 resection rate
**Time Frame:** up to 8 months
**Description:** Rate of pathologic response TRG 1-2
**Measure:** Major pathologic response (MPR)
**Time Frame:** up to 8 months
**Description:** Incidence of Adverse Events assessed according to CTCAE version 5
**Measure:** Incidence of Treatment-Related Adverse Events as assessed by investigator
**Time Frame:** up to 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Availability of voluntarily signed informed consent from the patient
* Histologically confirmed adenocarcinoma of the colon or rectum;
* Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer;
* Presence of MSI/dMMR in the tumor;
* ECOG 0-2;
* No contraindications to surgical treatment of malignancy
Exclusion Criteria:
* Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
* The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
* Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
* Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
* Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF \[tumor necrosis factor\] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
* The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed.
* Active, known or suspected autoimmune diseases (patients with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as autoimmune diseases with only skin manifestations \[for example, vitiligo, alopecia or psoriasis without symptoms of psoriatic arthritis\] are allowed to participate), that do not require systemic therapy);
* Patients with HIV infection, active hepatitis B, active hepatitis C.
* Life expectancy less than 6 months.
* The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.
* Complicated course of the primary tumor, requiring urgent surgical intervention.
* Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago;
* Persistence, progression or recurrence of the underlying disease or the presence of distant metastases
* Conditions limiting the patient's ability to comply with the requirements of the protocol (in the opinion of the investigator);
* Vaccination with live vaccines within 28 days before randomization;
* Participation in other interventional clinical trials less than 30 days before randomization (except in cases of dropout before the introduction of study therapy) and while participating in an ongoing clinical trial;
* Significant adverse events from previous therapy, with the exception of chronic and/or irreversible events that cannot influence the assessment of the safety of the study therapy (for example, alopecia);
* Hypersensitivity or allergic reactions to the administration of drugs manufactured using Chinese hamster ovary cells, severe allergic reactions, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies, prolgolimab or any of the components of the study drug.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Olesya Kuznetsova
**Phone:** +79279702179
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Moscow
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olesya Kuznetsova
- **Phone:** +79279702179
- **Role:** CONTACT
**Country:** Russian Federation
**Facility:** N.N. Blokhin NMRCO
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000042822
- Term: Genomic Instability
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M27510
- Name: Microsatellite Instability
- Relevance: HIGH
- As Found: Microsatellite Instability
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25088
- Name: Genomic Instability
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000053842
- Term: Microsatellite Instability
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428474
**Brief Title:** Implementation of Oral Health Educational Program on Orphan Children
**Official Title:** Effectiveness of Oral Health Educational Program on the Knowledge and Practice of Institutionalized Orphan Children in Alexandria, Egypt
#### Organization Study ID Info
**ID:** UREAC-04-3-219
#### Organization
**Class:** OTHER
**Full Name:** Pharos University in Alexandria
### Status Module
#### Completion Date
**Date:** 2024-03-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pharos University in Alexandria
#### Responsible Party
**Investigator Affiliation:** Pharos University in Alexandria
**Investigator Full Name:** Inas Karawia
**Investigator Title:** Lecturer, Faculty of Dentistry, Pharos University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Oral diseases are most prevalent among children. Orphans children are one of the most vulnerable groups to diseases especially oral diseases.
Knowledge toward oral cavity and oral hygiene measures is low among this group, leading to poor practice of oral hygiene measures, which outcomes to oral diseases. Implementation of health education program orphan children who are living in orphanages is important. the aim of this study is to evaluate the effectiveness of health education program on the knowledge and practice of orphan children. 80 children were enrolled in this study from different orphanages in Alexandria, Egypt. Knowledge and practice were evaluated before and after intervention using predesigned questionnaire, and oral hygiene was evaluated using simplified oral hygiene index
**Detailed Description:** Background: Dental caries is a lifetime disease, with highest priority risk group between 11-14 years of age group. Environmental factors such as culture, socioeconomic status, life style and dietary pattern can have a greater impact on caries-resistance or development. It has been well-documented in dentistry and other health areas that correct health information or knowledge alone does not necessarily lead to desirable health behaviors. However knowledge gained may serve as a tool to empower population groups with accurate information about health and health care technologies, enabling them to take action to protect their health. According to global review of oral health, despite great improvements in the oral health of populations in several countries, the oral problem persists. This is particularly among underprivileged groups, in both developed and developing countries. One of the known high-risk groups is orphans. An orphan is defined as a child under 18 years, who has lost his father, mother, or both In developing countries like Egypt, there is little access to oral healthcare due to a lack of knowledge, insufficient financial resources, and inadequate dental manpower in the national healthcare system Aim of the study: is to evaluate the effectiveness of oral health education programs on knowledge and practice of participated orphan children Materials and Methods: A specially designed questionnaire was used to assess the dental problems and existing oral hygiene maintenance practice among children between 6 - 12 years of age (n=80) in orphanages. DMFT \[Decayed Missing Filled Teeth index (for permanent teeth)\] and dft \[ decayed filled teeth index ( for primary teeth) \], pre- and post-interventional intra-oral examinations was carried out to check their oral hygiene status which included and OHIS (Simplified Oral Hygiene Index).
Information regarding tooth cleaning habits was obtained by a questionnaire to the children themselves, before, immediately and after 6 months.
Statistical analysis Collected data will be analyzed using SPSS software
### Conditions Module
**Conditions:**
- Dental Caries
- Knowledge
- Practice
**Keywords:**
- Oral health education
- knowledge
- practice
- oral hygiene
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 80
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Orphan children aged 6-12
**Intervention Names:**
- Other: Health education
**Label:** children who are living in orphanages
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- children who are living in orphanages
**Description:** Oral health education program designed for orphans children
**Name:** Health education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The questionnaire consisted of 8 questions to collect data about the children knowledge about teeth number in each dentition, the parts of teeth and its function, causes of oral disease, and how to prevent it.
**Measure:** Knowledge will be assessed using predesigned questionnaire
**Time Frame:** Knowledge was measured immediately and after 6 months
#### Secondary Outcomes
**Description:** practices were measured using a predesigned questionnaire, consisting of 6 questions to collected data about the children's practices regarding tooth brushing, flossing and eating habits.
**Measure:** Practice will be assessed using predesigned questionnaire
**Time Frame:** Practice was evaluated after 6 months
**Description:** Oral hygiene was evaluated using the simplified oral hygiene index - scores were ranged from 0-6 and 6 is the poorest oral hygiene score
**Measure:** oral hygiene
**Time Frame:** oral hygiene was evaluated after 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Orphan children aged between 6-12 years old
Exclusion Criteria:
* children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications
**Maximum Age:** 12 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Alexandria
**Country:** Egypt
**Facility:** Pharos University in Alexandria
**Zip:** 536733
#### Overall Officials
**Official 1:**
**Affiliation:** Pharos University in Alexandria
**Name:** Inas M Karawia
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017001
- Term: Tooth Demineralization
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6928
- Name: Dental Caries
- Relevance: HIGH
- As Found: Dental Caries
- ID: M19339
- Name: Tooth Demineralization
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003731
- Term: Dental Caries
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428461
**Brief Title:** Evaluation of Supraclavicular Brachial Plexus Blocks at Various Volumes: Impact on Optic Nerve Sheath Diameter
**Official Title:** Evaluation of Supraclavicular Brachial Plexus Blocks at Different Volumes Under Ultrasound Guidance in Upper Extremity Surgery and Their Impact on Optic Nerve Sheath Diameter
#### Organization Study ID Info
**ID:** PAU-ANEST-RHE-IC-01
#### Organization
**Class:** OTHER
**Full Name:** Pamukkale University
### Status Module
#### Completion Date
**Date:** 2024-09-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pamukkale University
#### Responsible Party
**Investigator Affiliation:** Pamukkale University
**Investigator Full Name:** ismet çopur
**Investigator Title:** Investigator - Medical doctor
**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 aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative pain relief effectiveness of supraclavicular brachial plexus blocks administered at different volumes under ultrasound guidance. Additionally, the investigators utilized ultrasound to measure optic nerve sheath diameters and investigated their relationship with intracranial pressure across varying block volumes.
**Detailed Description:** Regional anesthesia involves temporarily blocking nerve transmission and pain sensation in specific areas of the body without causing loss of consciousness. Regional anesthesia techniques include peripheral nerve blocks (PNB), topical anesthesia, infiltration anesthesia, regional intravenous anesthesia (RIVA), and neuroaxial blocks (spinal and epidural anesthesia).
Brachial plexus blocks are among the most commonly used regional anesthesia methods within peripheral nerve block applications. Peripheral nerve blocks of the upper extremity can be used either alone for surgical anesthesia or added to general anesthesia for postoperative pain control. Brachial plexus blocks can be performed using various approaches including interscalene, supraclavicular, infraclavicular, and axillary approaches.
The supraclavicular block aims to effectively control pain through a procedure targeting the shoulder and upper extremity nerves known as the brachial plexus. Complications of supraclavicular blocks may include pneumothorax secondary to lung trauma, hoarseness due to ipsilateral recurrent laryngeal nerve blockade, Horner syndrome due to stellate ganglion blockade, and hemidiaphragmatic paralysis due to phrenic nerve blockade. The incidence and severity of these complications are reduced with the use of ultrasound (USG) guidance and low-volume techniques.
Intracranial pressure (ICP) refers to the pressure formed by the brain and spinal fluid, tissues, and blood surrounding the brain and spinal cord. Normally ranging between 5-15 mmHg, this pressure is critical for brain function and circulation. Abnormal increases in intracranial pressure can lead to intracranial hypertension, with main causes including brain tumors, edema, head trauma, brain aneurysms, intracranial hemorrhage, and issues related to the production and drainage of cerebrospinal fluid. External ventricular drainage (EVD) catheterization is the gold standard method for evaluating increased intracranial pressure. Measurement of optic nerve sheath diameter (ONSD) has been described as a valuable diagnostic method in clinical applications for evaluating intracranial pressure.
Observational studies have shown that in cervical sympathetic blocks and interscalene blocks, indirect increases in intracranial pressure can be demonstrated through ultrasound (USG) measurements of optic nerve sheath diameter. It has been shown that hemidiaphragmatic paralysis due to ipsilateral phrenic nerve involvement, which is frequently seen in interscalene brachial plexus blocks, also occurs in supraclavicular brachial plexus blocks in a volume-dependent manner. There are studies in the literature on supraclavicular block applications with different volumes and doses. However, the investigators have not come across a study evaluating the clinical outcomes of optic nerve sheath diameter measurement along with anesthesia quality, side effects, and complications in ultrasound-guided supraclavicular blocks at different volumes.
In this study, the investigators aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative analgesic efficacy of supraclavicular brachial plexus blocks performed at different volumes in our clinical practice under ultrasound guidance. Additionally, the investigators aimed to measure optic nerve sheath diameters with ultrasound and establish their relationship with intracranial pressure according to these different volumes.
### Conditions Module
**Conditions:**
- Upper Limb Injury
- Intracranial Pressure Increase
**Keywords:**
- Supraclavicular brachial plexus block
- Intracranial pressure
- Optic nerve sheath diameter
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Four different volumes will be administered for the supraclavicular block:
1. For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVICAINE-POLIFARMA-TEKIRDAG) and 7.5 mL of 2% prilocaine (PRILOC-VEM İlaç San. ve Tic. A.Ş. Kapaklı/TEKIRDAĞ) for a total of 15 mL.
2. For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine and 10 mL of 2% prilocaine for a total of 20 mL.
3. For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine and 12.5 mL of 2% prilocaine for a total of 25 mL.
4. For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine and 15 mL of 2% prilocaine for a total of 30 mL.
Glob axis and optic nerve sheath diameter measurements for both eyes will be re-measured and recorded using B-mode ultrasound at 20 and 60 minutes after the supraclavicular block.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 7.5 mL of 2% prilocaine (PRİLOC®) for a total of 15 mL. single shot supraclavicular brachial plexus block.
**Intervention Names:**
- Procedure: Supraclavicular brachial plexus block
- Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound
- Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement
- Device: End-Tidal Carbon Dioxide (EtCO2) Measurement
**Label:** Total of 15 mL.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine (BUVİCAİNE®) and 10 mL of 2% prilocaine (PRİLOC®) for a total of 20 mL.
**Intervention Names:**
- Procedure: Supraclavicular brachial plexus block
- Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound
- Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement
- Device: End-Tidal Carbon Dioxide (EtCO2) Measurement
**Label:** Total of 20 mL.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 12.5 mL of 2% prilocaine (PRİLOC®) for a total of 25 mL.
**Intervention Names:**
- Procedure: Supraclavicular brachial plexus block
- Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound
- Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement
- Device: End-Tidal Carbon Dioxide (EtCO2) Measurement
**Label:** Total of 25 mL.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine (BUVİCAİNE®) and 15 mL of 2% prilocaine (PRİLOC®) for a total of 30 mL.
**Intervention Names:**
- Procedure: Supraclavicular brachial plexus block
- Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound
- Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement
- Device: End-Tidal Carbon Dioxide (EtCO2) Measurement
**Label:** Total of 30 mL.
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Total of 15 mL.
- Total of 20 mL.
- Total of 25 mL.
- Total of 30 mL.
**Description:** A supraclavicular brachial plexus block will be performed under ultrasound guidance. The patient will be taken to the preoperative block room, positioned supine with the bed elevated at a 30° angle, and the head turned away from the arm being blocked. To avoid intraneural injection, the block will use both ultrasound and a nerve stimulator (Plexygon, Vygon-Italy) with a 22G 50 mm 20° stimulating needle (Echoplex, Braun-France). A low-frequency ultrasound probe will be placed above the clavicle to visualize the subclavian artery and vein. Using an in-plane approach, the needle will be inserted laterally to medially from the mid-clavicular point through the skin and subcutaneous tissue. Under ultrasound guidance, the needle will be advanced towards the anatomical corner where the brachial plexus and subclavian artery are adjacent (corner pocket), and a local anesthetic agent will be injected to perform the block.
**Name:** Supraclavicular brachial plexus block
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Total of 15 mL.
- Total of 20 mL.
- Total of 25 mL.
- Total of 30 mL.
**Description:** Before the block, both eyes will be measured for optic nerve sheath diameter (ONSD) using B-mode ultrasound (USG) with a GE LOGIQ E device. The patient will be supine with the bed elevated at a 30° angle, eyes closed, and a protective barrier applied. Both globes will be filled with water-soluble ultrasound gel, and imaging will be done with a 7.5 MHz linear probe at a 7 cm depth. For transverse ONSD measurement, the probe will be placed transversely in the coronal plane, with the marker notch pointing right. When the optic nerve entry into the globe is clear, transverse ONSD will be measured 3 mm below. For sagittal measurement, the probe will be placed sagittally in the coronal plane, with the marker notch pointing towards the body. Sagittal ONSD will be measured 3 mm below the entry point. Both internal and external diameters of the optic nerve sheath will be measured in transverse and sagittal planes, and the transverse diameter of the globe will also be measured.
**Name:** Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Total of 15 mL.
- Total of 20 mL.
- Total of 25 mL.
- Total of 30 mL.
**Description:** Investigator plan to measure the Perfusion Index (PI) as an objective method for determining the success of peripheral nerve blocks, different from traditional tests. PI is an indicator of peripheral perfusion that can be continuously measured non-invasively with a pulse oximeter. PI represents the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. The Mindray uMEC 12 device will be used for this measurement.
**Name:** Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement
**Type:** DEVICE
#### Intervention 4
**Arm Group Labels:**
- Total of 15 mL.
- Total of 20 mL.
- Total of 25 mL.
- Total of 30 mL.
**Description:** End-tidal carbon dioxide (EtCO2) measurement: The Medtronic Capnostream 35 device will be used for EtCO2 measurements. All patients will receive oxygen support at a rate of 1-2 L/min. If peripheral oxygen saturation falls below 95%, oxygen support will be increased to 3-6 L/min via nasal cannula.
**Name:** End-Tidal Carbon Dioxide (EtCO2) Measurement
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Optic nerve sheath diameter will be measured using B-mode ultrasonography.
**Measure:** Optic nerve sheath diameter measured by ultrasonography
**Time Frame:** Before block, After block 20 minutes, After block 60 minutes
#### Secondary Outcomes
**Description:** PI, an objective method different from traditional tests, to determine the success of peripheral nerve block. PI is an indicator of peripheral perfusion that can be measured continuously and non-invasively with a pulse oximeter. PI is the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. Its normal value ranges from 0.02 to 20. After peripheral nerve block, vasodilation occurs in the vessels due to sympathetic blockade, resulting in an increase in PI values, which occurs earlier than motor and sensory block. PI monitoring provides more objective results for evaluating the onset of the block. The cut-off value indicating that the block is successful is a PI increase to 3.03 times the baseline value 10 minutes after the block is administered.
**Measure:** Perfusion index (PI)
**Time Frame:** The PI values will be measured and recorded at 0, 2, 4, 6, 8, 10, 15, 20, and 25 minutes in both arms.
**Description:** Non-invasive EtCO2 measurement is a method used to monitor the concentration of carbon dioxide (CO2) at the end of expiration.
**Measure:** Non-invazive end-tidal carbon dioxide (EtCO2)
**Time Frame:** EtCO2 will be measured and recorded at 0, 10, 20, 30, 60 minutes, and at the end of surgery after the block is performed.
**Description:** The pinprick test is a clinical procedure used to evaluate sensory nerve function. A small, sharp object, such as a pin or needle, is gently pressed against the skin to assess the patient's ability to feel pain.
**Measure:** Pinprick test
**Time Frame:** The pinprick test will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations.
**Description:** The Modified Bromage Scale is a clinical tool used to assess the degree of motor block in patients who have received regional anesthesia. The scale ranges from 0 to 3, with each level indicating a different degree of motor impairment:
* 0: No motor block; full flexion of knees and feet.
* 1: Partial motor block; able to move knees but not feet.
* 2: Almost complete motor block; able to move feet only.
* 3: Complete motor block; unable to move knees or feet.
**Measure:** Modified Bromage Scale
**Time Frame:** The Modified Bromage Scale will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations.
**Description:** The Verbal Pain Score is a subjective measure used to assess a patient's level of pain. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
**Measure:** Verbal Pain Score
**Time Frame:** The Verbal Pain Score will be assessed at the following intervals after surgery: immediately in the recovery room, at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged between 18 and 50, of both genders, with planned surgery on the finger, wrist, elbow joint, and distal region, and classified as ASA I-II, will be included in the study. In this study, patients will be informed about the anesthesia method and the tests to be conducted, and those who consent will be asked to sign an informed consent form as voluntary participants.
Exclusion Criteria:
* Patients who do not accept the procedures and tests
* Those with diseases that may cause increased intracranial pressure
* Patients with severe heart failure
* Patients with second or third degree atrioventricular block
* Patients with unstable angina history
* Patients with COPD and chronic asthma
* Patients with a history of myocardial infarction (MI) within the last 6 weeks
* Patients with a heart rate below 50 beats/min
* Patients with systolic blood pressure below 90 mmHg
* Patients with liver failure
* Patients with kidney failure
* Patients for whom supraclavicular block anatomically cannot be performed
* Those with neurological or psychological diseases that make it difficult to assess the tests
* Patients allergic to any of the study drugs
* Pregnant women
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ismet çopur, MD
**Phone:** 5318469060
**Phone Ext:** +90
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Denizli
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ismet çopur, MD
- **Phone:** 5318469060
- **Phone Ext:** +90
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Pamukkale University
**State:** Pamukkale
**Zip:** 20020
#### Overall Officials
**Official 1:**
**Affiliation:** Pamukkale University
**Name:** Rıza Hakan Erbay
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gundogdu O, Avci O. Evaluation of the Effect of Interscalene Brachial Plexus Block on Intracranial Pressure Using Optic Nerve Sheath Diameter and Internal Jugular vein Collapsibility Index. J Coll Physicians Surg Pak. 2022 Oct;32(10):1249-1254. doi: 10.29271/jcpsp.2022.10.1249.
**PMID:** 36205266
**Citation:** Pansell J, Bell M, Rudberg P, Friman O, Cooray C. Optic nerve sheath diameter measurement by ultrasound: Evaluation of a standardized protocol. J Neuroimaging. 2022 Jan;32(1):104-110. doi: 10.1111/jon.12936. Epub 2021 Sep 23.
**PMID:** 34555223
**Citation:** Hylkema C. Optic Nerve Sheath Diameter Ultrasound and the Diagnosis of Increased Intracranial Pressure. Crit Care Nurs Clin North Am. 2016 Mar;28(1):95-9. doi: 10.1016/j.cnc.2015.10.005. Epub 2015 Dec 23.
**PMID:** 26873762
## 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: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M21521
- Name: Intracranial Hypertension
- Relevance: HIGH
- As Found: Intracranial Pressure Increase
- ID: M4444
- Name: Arm Injuries
- Relevance: HIGH
- As Found: Upper Limb Injury
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019586
- Term: Intracranial Hypertension
- ID: D000001134
- Term: Arm Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M14191
- Name: Prilocaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428448
**Brief Title:** Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
**Official Title:** A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections
#### Organization Study ID Info
**ID:** SN-OR-001
#### Organization
**Class:** INDUSTRY
**Full Name:** OsteoRemedies, LLC
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** MCRA
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** OsteoRemedies, LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is Unapproved Device:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.
### Conditions Module
**Conditions:**
- Periprosthetic Joint Infection
**Keywords:**
- Ankle-related Infections
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This is the REMEDY Spectrum IM Spacer Nail treatment group.
**Intervention Names:**
- Combination Product: REMEDY Spectrum IM Spacer Nail
**Label:** Subjects with REMEDY Spectrum IM Spacer Nail
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Subjects with REMEDY Spectrum IM Spacer Nail
**Description:** The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin.
The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools.
**Name:** REMEDY Spectrum IM Spacer Nail
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen.
**Measure:** Successful Treatment of Infection Based on Lab Values and Culture
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
6. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.
Exclusion Criteria:
1. Infections that do not involve the ankle
2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
3. Affected limb is dysvascular
4. Where adequate soft-tissue coverage cannot be achieved
5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
7. Are currently a prisoner
8. Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
9. History of vancomycin or gentamicin allergy
10. Are implanted with other antibiotic eluting products.
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Grace Montes
**Phone:** 5712292683
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jacob Schafer
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** OsteoRemedies, LLC
**Name:** Rachel McGuire Kennedy
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M17388
- Name: Vancomycin
- Relevance: LOW
- As Found: Unknown
- ID: M8951
- Name: Gentamicins
- Relevance: LOW
- As Found: Unknown
- ID: M21783
- Name: Polymethyl Methacrylate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428435
**Acronym:** NGHVA
**Brief Title:** Next Generation Home Vision Assessment
**Official Title:** Next Generation Home Vision Assessment
#### Organization Study ID Info
**ID:** 1.5
#### Organization
**Class:** OTHER_GOV
**Full Name:** NHS Forth Valley
#### Secondary ID Infos
**Domain:** IRAS Project ID
**ID:** 286078
**Type:** OTHER
**Domain:** REC Number
**ID:** 20/WM/0285
**Type:** OTHER
**Domain:** Edge ID
**ID:** 136640
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** NHS Greater Glasgow and Clyde
**Class:** OTHER
**Name:** Birmingham Children's Hospital
**Class:** OTHER_GOV
**Name:** NHS Fife
**Class:** OTHER
**Name:** NHS Highland
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** NHS Forth Valley
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic
**Detailed Description:** Study Overview The "Next Generation Home Vision Assessment" study aims to evaluate the feasibility and accuracy of conducting vision assessments at home using a web-based platform. This prospective, non-interventional, multi-center study will compare home-based vision tests with traditional hospital-based assessments.
Study Background The COVID-19 pandemic has significantly limited patients' ability to attend in-person eye clinic appointments, impacting vision assessments and management. Ramifications in delays continue to have an impact.
Study Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely. The use of a web-based platform for vision tests could offer a reliable alternative, reducing hospital visits and maintaining care standards.
Objectives and Endpoints Primary Objective: To compare the accuracy of home-based visual acuity tests to hospital-based assessments.
Secondary Objectives: To evaluate other aspects of visual function (e.g., visual fields, color vision, contrast sensitivity) and measure patient engagement and test duration.
Study Design Type: Prospective, non-interventional Participants: Adults and children attending hospital eye services Sample Size: 360 completed assessments Duration: Minimum of 6 months
Study Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet. Those willing to participate will undergo a visual acuity test +/- additional vision tests (secondary outcomes) during a video consultation. Hospital-based assessment results will be compared to home-based test results to determine accuracy.
### Conditions Module
**Conditions:**
- Amblyopia
- Vision; Low, One Eye (Other Eye Normal)
- Pediatric Disorder
**Keywords:**
- teleophthalmology
- remote consultations
- amblyopia
- paediatrics
- telemedicine
- digital health
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 360
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tested with Ibis technology
**Intervention Names:**
- Diagnostic Test: Vision Test
**Label:** Ibis
#### Arm Group 2
**Description:** Tested with Optonet Technology
**Intervention Names:**
- Diagnostic Test: Vision Test
**Label:** Optonet
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ibis
- Optonet
**Description:** Remote vision testing via digital screen
**Name:** Vision Test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Home versus Remote Acuity difference
**Measure:** Acuity
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Description:** Digital versus in clinic standard
**Measure:** Colour Vision
**Time Frame:** 2 weeks
**Description:** Digital versus in clinic standard
**Measure:** Visual field
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
- Patients attending hospital eye services will be eligible for enrolment.
Age: less than 90 years old English speakers, as no available resource for translation services. Parents / patients must be able to provide consent Patient must be able to communicate what he / she sees on a vision assessment chart.
Must have access to smartphone, tablet or home computer that can run video conferencing platforms.
Exclusion criteria
Non English speakers or lack of ability to consent Inability to communicate what is seen on a chart, or inability to complete a preferential looking visual acuity test Inability to connect to a video conferencing platform.
**Maximum Age:** 90 Years
**Minimum Age:** 0 Months
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients attending hospital and at home
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Falkirk
**Country:** United Kingdom
**Facility:** NHS Forth Valley Research & Development Office
**State:** Stirlingshire
**Zip:** FK1 5SU
**Location 2:**
**City:** Birmingham
**Country:** United Kingdom
**Facility:** Birmingham Womens and Childens Hospital
**Zip:** B4 6NH
**Location 3:**
**City:** Glasgow
**Country:** United Kingdom
**Facility:** NHS Greater Glasgow & Clyde
**Location 4:**
**City:** Inverness
**Country:** United Kingdom
**Facility:** NHS Fife
**Zip:** IV2 3JH
#### Overall Officials
**Official 1:**
**Affiliation:** NHS Forth Valley
**Name:** Iain Livingstone, MBChB MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Open Access
**Description:** Anonymised data will be made available as part of publication
**IPD Sharing:** YES
**Time Frame:** Aim: 12 months post completion of study
## 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: D000014786
- Term: Vision Disorders
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3891
- Name: Amblyopia
- Relevance: HIGH
- As Found: Amblyopia
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17530
- Name: Vision Disorders
- 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
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000550
- Term: Amblyopia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428422
**Brief Title:** The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
**Official Title:** The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)
#### Organization Study ID Info
**ID:** BL-32769
#### Organization
**Class:** OTHER
**Full Name:** Necmettin Erbakan University
### Status Module
#### Completion Date
**Date:** 2026-12-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Health Institutes of Türkiye (TUSEB)
#### Lead Sponsor
**Class:** OTHER
**Name:** Necmettin Erbakan University
#### Responsible Party
**Investigator Affiliation:** Necmettin Erbakan University
**Investigator Full Name:** Mehmet Artac
**Investigator Title:** Prof.Dr.
**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 evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.
**Detailed Description:** Despite modern treatments, lung cancer remains a leading cause of high mortality worldwide. Over the past decade, significant improvements in patient survival have been achieved with immune checkpoint inhibitors, which enhance the T cell-mediated immune response to eradicate cancer cells. However, therapeutic resistance, drug side effects, and heterogeneous treatment responses limit their effectiveness. Recent studies have established a clear relationship between gut microbiota and cancer immunotherapy. The intestinal microbiota has been shown to stimulate the anti-tumor immune response by modulating immune system cells. Evidence from preclinical and clinical studies indicates that gut microbiota plays a crucial role in the efficacy of immunotherapy and the modulation of drug toxicity. Identifying the microbiota as a potential biomarker could facilitate personalized treatment protocols. Genetic, epigenetic, and microbiota modulation factors are essential for optimizing cancer immunotherapy outcomes. Consequently, research is increasingly focusing on personalized treatment protocols for microbiota modulation, including diet regulation, fecal microbiota transfer, prebiotics, and probiotics. There has been a significant rise in studies demonstrating the clinical benefits of microbial therapy products as complementary treatments.
The functional role of microbiota in modulating the systemic immune response has prompted investigations into its impact on cancer immunotherapy, particularly with agents targeting immunological checkpoints like PD-1. Recent studies have identified both positive and negative regulatory bacteria that influence immunotherapy effectiveness. However, sociocultural and dietary lifestyle differences affect gut microbiota composition, leading to variations between populations. Therefore, studies are needed to identify the unique microbiome composition of each population to develop microbiota biological indicators for cancer immunotherapy. No research has been conducted in this area in our country. Our study aims to identify bacterial species that may serve as biomarkers for the microbiota specific to our country's cancer patients receiving immunotherapy and use them for prognostic purposes.
Understanding the significant role of probiotics in modulating intestinal microbiota has increased the demand for these food supplements. Studies show that anti-tumor efficacy is specific to the bacterial strain. For instance, Bifidobacteriums have been reported to enhance the effectiveness of PD-1 blockers in experimental rat models. In another study, B. lactis BL-04 reduced immunotherapy-induced colitis in animals.
Our planned study will investigate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on clinical objective response, clinical benefit rates, and intestinal microbiota in patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab. The results may facilitate the development of specific probiotic supplements as a complementary therapy for mNSCLC treatment.
### Conditions Module
**Conditions:**
- Metastatic Non-small Cell Lung Cancer
**Keywords:**
- immunotherapy
- lung cancer
- probiotics
- Bifidobacterium animalis
- microbiota
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention group will receive an oral dosage of 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.
A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.
**Intervention Names:**
- Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.
In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.
**Intervention Names:**
- Other: Plasebo
**Label:** Plasebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks
**Name:** Bifidobacterium animalis subsp. lactis Bl-04
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Plasebo group
**Description:** 1 g/day maltodextrin for 12 weeks
**Name:** Plasebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis.
**Measure:** Evaluation of Clinical Response
**Time Frame:** Week 12
**Description:** The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression.
**Measure:** Progression-free survival
**Time Frame:** Basaline and the date of radiological progression
**Description:** The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause.
**Measure:** Overall survival
**Time Frame:** Basaline and the date of death from any case
#### Secondary Outcomes
**Description:** Microbiota and fatty acid analyses, including acetic acid, propionic acid, and butyric acid, will be conducted on fecal samples."
**Measure:** Intestinal microbiota modulation
**Time Frame:** Basaline and Week 12
**Description:** The concentrations of CD4+ T cell subgroups (Th1, Th2, Th9, Th17, Th1Th17, and Treg) and sitokins (IL-1β, IL-4, IL-10, IL-17, TNF-α, TGF-beta, IFN-gamma, IL-36 and trimethylamine N-oxide) will be quantified in the serum samples of the patients.
**Measure:** Immunological findings
**Time Frame:** Basaline and Week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteering to participate in the study.
* Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
* Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).
* Male or female patients aged \>18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.
* Laboratory findings must confirm adequate bone marrow function, indicated by:
White Blood Cell (WBC) count \> 2,000/mm³, Neutrophil count \> 1,500/mm³,Platelet count \> 100,000/mm³
Exclusion Criteria:
* Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.
* Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.
* Antibiotic utilization within the past month
* Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.
* A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.
* Presence of uncontrolled adrenal insufficiency.
* Pregnancy or breastfeeding.
* Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.
* Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.
**Maximum Age:** 90 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mehmet Artaç, MD
**Phone:** +90332236000
**Phone Ext:** 6434
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Konya
**Country:** Turkey
**Facility:** Necmettin Erbakan University
**Zip:** 42090
### 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
### 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 - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1854
- Name: Nivolumab
- Relevance: LOW
- As Found: Unknown
- ID: T367
- Name: Bifidobacterium
- Relevance: HIGH
- As Found: Neonates
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428409
**Brief Title:** A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
**Official Title:** A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
#### Organization Study ID Info
**ID:** 9999-02A
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-9999-02A
**Type:** OTHER
**Domain:** EU CT
**ID:** 2023-508703-21
**Type:** OTHER
**Domain:** WHO/UTN
**ID:** U1111-1298-8273
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-12-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-12-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-19
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:
* About the safety and how well people tolerate sacituzumab tirumotecan lone or with chemotherapy
* How many people have the cancer respond (get smaller or go away) to treatment
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Pancreatic Ductal Carcinoma
- Biliary Tract Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 130
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
**Intervention Names:**
- Biological: Sacituzumab tirumotecan
- Drug: Fluorouracil (5-FU)
- Drug: Leucovorin (LV) or levoleucovorin
**Label:** Sacituzumab tirumotecan + Chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancner gets worse or they don't tolerate the treatment.
**Intervention Names:**
- Biological: Sacituzumab tirumotecan
**Label:** Sacituzumab tirumotecan
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sacituzumab tirumotecan
- Sacituzumab tirumotecan + Chemotherapy
**Description:** Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)
**Name:** Sacituzumab tirumotecan
**Other Names:**
- MK-2870
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Sacituzumab tirumotecan + Chemotherapy
**Description:** 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks
**Name:** Fluorouracil (5-FU)
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Sacituzumab tirumotecan + Chemotherapy
**Description:** LV or levoleucovorin is administered by IV infusion every 2 weeks
**Name:** Leucovorin (LV) or levoleucovorin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. DLTs will be measured during Cycle 1 (the first 4 weeks) of treatment.
**Measure:** Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
**Time Frame:** Up to approximately 4 weeks
**Description:** An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
**Measure:** Number of Participants Who Experience One or More Adverse Events (AEs):
**Time Frame:** Up to approximately 54 months
**Description:** An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
**Measure:** Number of Participants who Discontinue Study Medication due to an AE
**Time Frame:** Up to approximately 54 months
**Description:** ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
**Measure:** Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
**Time Frame:** Up to approximately 54 months
#### Secondary Outcomes
**Description:** For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
**Measure:** Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
**Time Frame:** Up to approximately 54 months
**Description:** PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
**Measure:** Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
**Time Frame:** Up to approximately 54 months
**Description:** OS is the length of time from when the participant starts treatment until death from any cause
**Measure:** Overall Survival (OS)
**Time Frame:** Up to approximately 54 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has one of the following cancers:
* Unresectable or metastatic colorectal cancer
* Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
* Advanced and/or unresectable biliary tract cancer (BTC)
* Has received prior therapy for the cancer
* Has recovered from any side effects due to previous cancer treatment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* History of severe eye disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Merck Sharp & Dohme LLC
**Name:** Medical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** https://www.merckclinicaltrials.com
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000001660
- Term: Biliary Tract Diseases
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000018299
- Term: Neoplasms, Ductal, Lobular, and Medullary
- ID: D000010190
- Term: Pancreatic Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M25356
- Name: Carcinoma, Ductal
- Relevance: HIGH
- As Found: Ductal Carcinoma
- ID: M22725
- Name: Carcinoma, Pancreatic Ductal
- Relevance: HIGH
- As Found: Pancreatic Ductal Carcinoma
- ID: M4947
- Name: Biliary Tract Neoplasms
- Relevance: HIGH
- As Found: Biliary Tract Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: HIGH
- As Found: Gastrointestinal Cancer
- 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: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- 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: M13110
- Name: Pancreatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T761
- Name: Biliary Tract Cancer
- Relevance: HIGH
- As Found: Biliary Tract Cancer
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001661
- Term: Biliary Tract Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000044584
- Term: Carcinoma, Ductal
- ID: D000021441
- Term: Carcinoma, Pancreatic Ductal
### Intervention Browse Module - Ancestors
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000931
- Term: Antidotes
- ID: D000020011
- Term: Protective Agents
- ID: D000014803
- Term: Vitamin B Complex
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M6191
- Name: Leucovorin
- Relevance: HIGH
- As Found: Video
- ID: M8600
- Name: Fluorouracil
- Relevance: HIGH
- As Found: According
- ID: M29233
- Name: Levoleucovorin
- Relevance: HIGH
- As Found: IMO-
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M4250
- Name: Antidotes
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective 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: T447
- Name: Folinic Acid
- Relevance: HIGH
- As Found: IMO-
- 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: D000002955
- Term: Leucovorin
- ID: D000005472
- Term: Fluorouracil
- ID: D000058766
- Term: Levoleucovorin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428396
**Brief Title:** Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
**Official Title:** A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)
#### Organization Study ID Info
**ID:** 6482-029
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-6482-029
**Type:** OTHER
**Domain:** Merck
**ID:** LITESPARK-029
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-05-24
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.
### Conditions Module
**Conditions:**
- Metastatic Breast Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive belzutifan 120 mg orally once daily (QD) PLUS fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until progressive disease or discontinuation.
**Intervention Names:**
- Drug: Belzutifan
- Drug: Fulvestrant
**Label:** Belzutifan + Fulvestrant
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive everolimus 10 mg orally QD PLUS investigator's choice of fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter OR exemestane 25 mg orally QD until progressive disease or discontinuation.
**Intervention Names:**
- Drug: Fulvestrant
- Drug: Everolimus
- Drug: Exemestane
**Label:** Everolimus + ET (fulvestrant or exemestane)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Belzutifan + Fulvestrant
**Description:** Belzutifan 120 mg administered QD as an oral tablet.
**Name:** Belzutifan
**Other Names:**
- MK-6482
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Belzutifan + Fulvestrant
- Everolimus + ET (fulvestrant or exemestane)
**Description:** Fulvestrant 500 mg administered as an IM injection.
**Name:** Fulvestrant
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Everolimus + ET (fulvestrant or exemestane)
**Description:** Administered at 10mg via oral tablets QD.
**Name:** Everolimus
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Everolimus + ET (fulvestrant or exemestane)
**Description:** Administered at 25 mg via oral tablets QD.
**Name:** Exemestane
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.
**Measure:** Progression-free Survival (PFS)
**Time Frame:** Up to Approximately 30 months
#### Secondary Outcomes
**Description:** PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 6 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 30 months.
**Measure:** Progression-free Survival (PFS) at 6 months
**Time Frame:** Up to Approximately 30 months
**Description:** PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 12 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 30 months.
**Measure:** Progression-free Survival (PFS) at 12 months
**Time Frame:** Up to Approximately 30 months
**Description:** OS is defined as the time from randomization to death due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to Approximately 30 months
**Description:** ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to Approximately 30 months
**Description:** CBR is defined as the percentage of participants who have CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of diameters of target lesions, or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.
**Measure:** Clinical Benefit Rate (CBR)
**Time Frame:** Up to Approximately 30 months
**Description:** An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
**Measure:** Number of Participants Who Experience an Adverse Event (AE)
**Time Frame:** Up to Approximately 46 months
**Description:** An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
**Measure:** Number of Participants Who Discontinue Study Treatment Due To an AE
**Time Frame:** Up to Approximately 46 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent
* Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)
* Provides a new or the most recently obtained core biopsy, taken from a locally advanced unresectable or from a metastatic lesion
* Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization
Exclusion Criteria:
* Has Breast cancer amenable to treatment with curative intent
* Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane)
* Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass
* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has active, bleeding diathesis, or on oral anti-vitamin K medication
* Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease
* Has uncontrolled diabetes as defined as fasting serum glucose \>1.5 × upper limit of normal (ULN)
* Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting
* Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting
* Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting
* Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention
* Is currently receiving strong inducers of CYP3A4 that cannot be discontinued for the duration of the study
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has concurrent active Hepatitis B and Hepatitis C virus infection
* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure
* Has not adequately recovered from major surgery or have ongoing surgical complications
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Merck Sharp & Dohme LLC
**Name:** Medical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** https://www.merckclinicaltrials.com/
## 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: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M20559
- Name: Disease Progression
- 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
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000091203
- Term: MTOR Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000065171
- Term: Estrogen Receptor Antagonists
- ID: D000004965
- Term: Estrogen Antagonists
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000047072
- Term: Aromatase Inhibitors
- ID: D000065088
- Term: Steroid Synthesis Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M255
- Name: Everolimus
- Relevance: HIGH
- As Found: Criteria
- ID: M1723
- Name: Fulvestrant
- Relevance: HIGH
- As Found: Probe
- ID: M247237
- Name: Exemestane
- Relevance: HIGH
- As Found: Filled
- ID: M348353
- Name: Belzutifan
- Relevance: HIGH
- As Found: Multiple System Atrophy
- ID: M8116
- Name: Estrogens
- Relevance: LOW
- As Found: Unknown
- ID: M21960
- Name: Sirolimus
- Relevance: LOW
- As Found: Unknown
- ID: M353695
- Name: Temsirolimus
- Relevance: LOW
- As Found: Unknown
- ID: M2827
- Name: MTOR Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
- ID: M8114
- Name: Estrogen Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M30483
- Name: Estrogen Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M25769
- Name: Aromatase Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068338
- Term: Everolimus
- ID: D000077267
- Term: Fulvestrant
- ID: C000056516
- Term: Exemestane
- ID: C000720612
- Term: Belzutifan
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428383
**Brief Title:** Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)
**Official Title:** A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)
#### Organization Study ID Info
**ID:** 1242-043
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-1242-043
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2032-04-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2032-04-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### 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 objective of this study is to monitor the safety and tolerability of vericiguat.
### Conditions Module
**Conditions:**
- Systolic Dysfunction
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 342
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Vericiguat administered orally in either tablet or suspension once daily until end of treatment
**Intervention Names:**
- Drug: Vericiguat tablet
- Drug: Vericiguat suspension
**Label:** Vericiguat
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Vericiguat
**Description:** Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily
**Name:** Vericiguat tablet
**Other Names:**
- MK-1242
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Vericiguat
**Description:** Vericiguat suspension at doses 0.2 mg/mL,
1 mg/mL taken orally once daily
**Name:** Vericiguat suspension
**Other Names:**
- MK-1242
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants with AEs
**Measure:** Participants with adverse events (AEs)
**Time Frame:** Up to approximately 8 years
**Description:** Percentage of participants who discontinued study drug due to an AE
**Measure:** Participants who discontinued study drug due to an AE
**Time Frame:** Up to approximately 8 years
#### Secondary Outcomes
**Description:** Change in NT-proBNP from baseline at Week 16.
**Measure:** Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)
**Time Frame:** Baseline and Week 16
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study.
* A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
* Is able to receive medication via the oral or gastric route .
Exclusion Criteria:
* Is hypotensive for age at Visit 1
* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
* Has undergone heart transplantation or has an implanted ventricular assist device.
* Has severe chronic kidney disease
* Has hepatic disorder
* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
* Has concurrent or anticipated use of an sGC stimulator.
* Is both ≥18 years of age and vericiguat is commercially available to the participant
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Merck Sharp & Dohme LLC
**Name:** Clinical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** http://www.merckclinicaltrials.com
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006337
- Term: Heart Murmurs
- ID: D000018754
- Term: Ventricular Dysfunction
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M27583
- Name: Systolic Murmurs
- Relevance: HIGH
- As Found: Systolic
- ID: M20591
- Name: Ventricular Dysfunction, Left
- Relevance: HIGH
- As Found: Left Ventricular Systolic Dysfunction
- ID: M20824
- Name: Ventricular Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M9425
- Name: Heart Murmurs
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000018487
- Term: Ventricular Dysfunction, Left
- ID: D000054160
- Term: Systolic Murmurs
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428370
**Acronym:** DACOSAD
**Brief Title:** Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)
**Official Title:** An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD)
#### Organization Study ID Info
**ID:** LCU MEDS-06/A 01/2024
#### Organization
**Class:** OTHER
**Full Name:** Link Campus University
### Status Module
#### Completion Date
**Date:** 2025-06-01
**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:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Link Campus University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To analyze the possible benefit of damage control surgery by performing bowel resection, open abdomen, and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis.
**Detailed Description:** Hartmann procedure (HP) is still widely performed in the treatment of purulent or fecal generalized peritonitis as a consequence of a complicated acute large bowel diverticulitis (the so labeled III and IV grade of the Hinchey's classification). More than half of those patients do not undergo to stoma reversal because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) should be preferred, as it is reported in the literature that it is more favorable than HP in terms of morbidity, mortality, and length of postoperative stay. However, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination while HP is performed in the elderly. Initially described for the treatment of major abdominal injuries, indications for Damage Control Surgery (DCS) have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. In the last decade, DCS has emerged as a valid alternative to HP and Resection-Anastomosis (RA) in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Although DCS is cited as an option in case of impaired hemodynamic status in face of perforated acute diverticulitis, there is still no consensus about such use of DCS. Previous study demonstrated that DCS reduce the Hartmann rate in patients otherwise scheduled for such procedure.
The aim of this study was to describe the potential rationale and outcome of the Damage Control Surgery in patients with purulent and fecal peritonitis.
### Conditions Module
**Conditions:**
- Diverticular Perforation
- Open Abdomen
**Keywords:**
- Diverticulitis
- Surgery
- Open abdomen
- Septic shock
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Simple resection, drop, and open abdomen in case of Hinchey III-IV
**Name:** Damage Control Surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Mortality rate related to treatment
**Measure:** Mortality
**Time Frame:** 60 days
**Description:** Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system
**Measure:** Morbidity
**Time Frame:** 60 days
**Description:** Morbidity calculated by means of the Comprehensive Complication Index
**Measure:** Total morbidity
**Time Frame:** 60 days
#### Secondary Outcomes
**Description:** Observed to expected (O:E) ratio of Hartmann's procedures
**Measure:** Upfront Hartmann rate
**Time Frame:** 60 days
**Description:** Days of stay as inpatient
**Measure:** Length of stay (LOS)
**Time Frame:** 60 days
**Description:** Days of stay in ICU
**Measure:** ICU length of stay
**Time Frame:** 60 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients \>18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen
Exclusion Criteria:
* Subjects \<18 year-old
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Same as above
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gianluca Costa, Prof.
**Phone:** +39 06 22541 8851
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Giuseppina Catanzaro, Prof.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Name:** Marco Caricato, MD, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gabriella T Capolupo, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Fondazione Policlinico Universitario Campus Bio-Medico
**State:** Lazio
**Status:** RECRUITING
**Zip:** 00128
**Location 2:**
**City:** Ostia
**Contacts:**
***Contact 1:***
- **Name:** Gianluca Mazzoni, MD, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Anna Maria Bellotti, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Loretta Di Cristofaro, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** UOC Chirurgia Generale - Ospedale GB Grassi
**State:** Roma
**Status:** RECRUITING
**Zip:** 00122
**Location 3:**
**City:** Palestrina
**Contacts:**
***Contact 1:***
- **Name:** Gianluca Liotta, MD, PhD
- **Phone:** +39 06 95321
- **Role:** CONTACT
**Country:** Italy
**Facility:** UOC Chirurgia Generale Ospedale Coniugi Bernardini
**State:** Roma
**Status:** RECRUITING
**Zip:** 00036
**Location 4:**
**City:** Caserta
**Contacts:**
***Contact 1:***
- **Name:** Mauro Andreano, Prof.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alberto Mingione, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano
**Status:** RECRUITING
**Zip:** 81100
**Location 5:**
**City:** Pisa
**Contacts:**
***Contact 1:***
- **Name:** Massimo Chiarugi, MD, FACS
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dario Tartaglia, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital
**Status:** RECRUITING
**Zip:** 56124
**Location 6:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Name:** Gabriele Sganga, MD, FACS
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pietro Fransvea, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Fondazione Policlinico Universitario "A.Gemelli"
**Status:** RECRUITING
**Zip:** 00168
**Location 7:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Name:** Luca Lepre, MD, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michela Giulii Capponi, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia
**Status:** RECRUITING
**Zip:** 00193
**Location 8:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Name:** Andrea Mingoli, Prof.
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gioia Brachini, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Bruno Cirillo, MD, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Italy
**Facility:** Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Link Campus University
**Name:** Gianluca Costa, Prof.
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Perrone G, Giuffrida M, Abu-Zidan F, Kruger VF, Livrini M, Petracca GL, Rossi G, Tarasconi A, Tian BWCA, Bonati E, Mentz R, Mazzini FN, Campana JP, Gasser E, Kafka-Ritsch R, Felsenreich DM, Dawoud C, Riss S, Gomes CA, Gomes FC, Gonzaga RAT, Canton CAB, Pereira BM, Fraga GP, Zem LG, Cordeiro-Fonseca V, de Mesquita Tauil R, Atanasov B, Belev N, Kovachev N, Melendez LJJ, Dimova A, Dimov S, Zelic Z, Augustin G, Bogdanic B, Moric T, Chouillard E, Bajul M, De Simone B, Panis Y, Esposito F, Notarnicola M, Lauka L, Fabbri A, Hentati H, Fnaiech I, Aurelien V, Bougard M, Roulet M, Demetrashvili Z, Pipia I, Merabishvili G, Bouliaris K, Koukoulis G, Doudakmanis C, Xenaki S, Chrysos E, Kokkinakis S, Vassiliu P, Michalopoulos N, Margaris I, Kechagias A, Avgerinos K, Katunin J, Lostoridis E, Nagorni EA, Pujante A, Mulita F, Maroulis I, Vailas M, Marinis A, Siannis I, Bourbouteli E, Manatakis DK, Tasis N, Acheimastos V, Maria S, Stylianos K, Kuzeridis H, Korkolis D, Fradelos E, Kavalieratos G, Petropoulou T, Polydorou A, Papacostantinou I, Triantafyllou T, Kimpizi D, Theodorou D, Toutouzas K, Chamzin A, Frountzas M, Schizas D, Karavokyros I, Syllaios A, Charalabopoulos A, Boura M, Baili E, Ioannidis O, Loutzidou L, Anestiadou E, Tsouknidas I, Petrakis G, Polenta E, Bains L, Gupta R, Singh SK, Khanduri A, Bala M, Kedar A, Pisano M, Podda M, Pisanu A, Martines G, Trigiante G, Lantone G, Agrusa A, Di Buono G, Buscemi S, Veroux M, Gioco R, Veroux G, Oragano L, Zonta S, Lovisetto F, Feo CV, Pesce A, Fabbri N, Lantone G, Marino F, Perrone F, Vincenti L, Papagni V, Picciariello A, Rossi S, Picardi B, Del Monte SR, Visconti D, Osella G, Petruzzelli L, Pignata G, Andreuccetti J, D'Alessio R, Buonfantino M, Guaitoli E, Spinelli S, Sampietro GM, Corbellini C, Lorusso L, Frontali A, Pezzoli I, Bonomi A, Chierici A, Cotsoglou C, Manca G, Delvecchio A, Musa N, Casati M, Letizia L, Abate E, Ercolani G, D'Acapito F, Solaini L, Guercioni G, Cicconi S, Sasia D, Borghi F, Giraudo G, Sena G, Castaldo P, Cardamone E, Portale G, Zuin M, Spolverato Y, Esposito M, Isernia RM, Di Salvo M, Manunza R, Esposito G, Agus M, Asti ELG, Bernardi DT, Tonucci TP, Luppi D, Casadei M, Bonilauri S, Pezzolla A, Panebianco A, Laforgia R, De Luca M, Zese M, Parini D, Jovine E, De Sario G, Lombardi R, Aprea G, Palomba G, Capuano M, Argenio G, Orio G, Armellino MF, Troian M, Guerra M, Nagliati C, Biloslavo A, Germani P, Aizza G, Monsellato I, Chahrour AC, Anania G, Bombardini C, Bagolini F, Sganga G, Fransvea P, Bianchi V, Boati P, Ferrara F, Palmieri F, Cianci P, Gattulli D, Restini E, Cillara N, Cannavera A, Nita GE, Sarnari J, Roscio F, Clerici F, Scandroglio I, Berti S, Cadeo A, Filippelli A, Conti L, Grassi C, Cattaneo GM, Pighin M, Papis D, Gambino G, Bertino V, Schifano D, Prando D, Fogato L, Cavallo F, Ansaloni L, Picheo R, Pontarolo N, Depalma N, Spampinato M, D'Ugo S, Lepre L, Capponi MG, Campa RD, Sarro G, Dinuzzi VP, Olmi S, Uccelli M, Ferrari D, Inama M, Moretto G, Fontana M, Favi F, Picariello E, Rampini A, Barberis A, Azzinnaro A, Oliva A, Totaro L, Benzoni I, Ranieri V, Capolupo GT, Carannante F, Caricato M, Ronconi M, Casiraghi S, Casole G, Pantalone D, Alemanno G, Scheiterle M, Ceresoli M, Cereda M, Fumagalli C, Zanzi F, Bolzon S, Guerra E, Lecchi F, Cellerino P, Ardito A, Scaramuzzo R, Balla A, Lepiane P, Tartaglia N, Ambrosi A, Pavone G, Palini GM, Veneroni S, Garulli G, Ricci C, Torre B, Russo IS, Rottoli M, Tanzanu M, Belvedere A, Milone M, Manigrasso M, De Palma GD, Piccoli M, Pattacini GC, Magnone S, Bertoli P, Pisano M, Massucco P, Palisi M, Luzzi AP, Fleres F, Clarizia G, Spolini A, Kobe Y, Toma T, Shimamura F, Parker R, Ranketi S, Mitei M, Svagzdys S, Pauzas H, Zilinskas J, Poskus T, Kryzauskas M, Jakubauskas M, Zakaria AD, Zakaria Z, Wong MP, Jusoh AC, Zakaria MN, Cruz DR, Elizalde ABR, Reynaud AB, Hernandez EEL, Monroy JMVP, Hinojosa-Ugarte D, Quiodettis M, Du Bois ME, Latorraca J, Major P, Pedziwiatr M, Pisarska-Adamczyk M, Waledziak M, Kwiatkowski A, Czyzykowski L, da Costa SD, Pereira B, Ferreira ARO, Almeida F, Rocha R, Carneiro C, Perez DP, Carvas J, Rocha C, Ferreira C, Marques R, Fernandes U, Leao P, Goulart A, Pereira RG, Patrocinio SDD, de Mendonca NGG, Manso MIC, Morais HMC, Cardoso PS, Calu V, Miron A, Toma EA, Gachabayov M, Abdullaev A, Litvin A, Nechay T, Tyagunov A, Yuldashev A, Bradley A, Wilson M, Panyko A, Lateckova Z, Lacko V, Lesko D, Soltes M, Radonak J, Turrado-Rodriguez V, Termes-Serra R, Morales-Sevillano X, Lapolla P, Mingoli A, Brachini G, Degiuli M, Sofia S, Reddavid R, de Manzoni Garberini A, Buffone A, Del Pozo EP, Aparicio-Sanchez D, Dos Barbeito S, Estaire-Gomez M, Viton-Herrero R, de Los Angeles Gil Olarte-Marquez M, Gil-Martinez J, Alconchel F, Nicolas-Lopez T, Rahy-Martin AC, Pelloni M, Banolas-Suarez R, Mendoza-Moreno F, Nisa FG, Diez-Alonso M, Rodas MEV, Agundez MC, Andres MIP, Moreira CCL, Perez AL, Ponce IA, Gonzalez-Castillo AM, Membrilla-Fernandez E, Salvans S, Serradilla-Martin M, Pardo PS, Rivera-Alonso D, Dziakova J, Huguet JM, Valle NP, Ruiz EC, Valcarcel CR, Moreno CR, Salazar YTM, Garcia JJR, Mico SS, Lopez JR, Farre SP, Gomez MS, Petit NM, Titos-Garcia A, Aranda-Narvaez JM, Romacho-Lopez L, Sanchez-Guillen L, Aranaz-Ostariz V, Bosch-Ramirez M, Martinez-Perez A, Martinez-Lopez E, Sebastian-Tomas JC, Jimenez-Riera G, Jimenez-Vega J, Cuellar JAN, Campos-Serra A, Munoz-Campana A, Gracia-Roman R, Alegre JM, Pinto FL, O'Sullivan SN, Antona FB, Jimenez BM, Lopez-Sanchez J, Carmona ZG, Fernandez RT, Sierra IB, de Leon LRG, Moreno VP, Iglesias E, Cumplido PL, Bravo AA, Simo IR, Dominguez CL, Caamano AG, Lozano RC, Martinez MD, Torres AN, de Quiros JTMB, Pellino G, Cloquell MM, Moller EG, Jalal-Eldin S, Abdoun AK, Hamid HKS, Lohsiriwat V, Mongkhonsupphawan A, Baraket O, Ayed K, Abbassi I, Ali AB, Ammar H, Kchaou A, Tlili A, Zribi I, Colak E, Polat S, Koylu ZA, Guner A, Usta MA, Reis ME, Mantoglu B, Gonullu E, Akin E, Altintoprak F, Bayhan Z, Firat N, Isik A, Memis U, Bayrak M, Altintas Y, Kara Y, Bozkurt MA, Kocatas A, Das K, Seker A, Ozer N, Atici SD, Tuncer K, Kaya T, Ozkan Z, Ilhan O, Agackiran I, Uzunoglu MY, Demirbas E, Altinel Y, Meric S, Hacim NA, Uymaz DS, Omarov N, Balik E, Tebala GD, Khalil H, Rana M, Khan M, Florence C, Swaminathan C, Leo CA, Liasis L, Watfah J, Trostchansky I, Delgado E, Pontillo M, Latifi R, Coimbra R, Edwards S, Lopez A, Velmahos G, Dorken A, Gebran A, Palmer A, Oury J, Bardes JM, Seng SS, Coffua LS, Ratnasekera A, Egodage T, Echeverria-Rosario K, Armento I, Napolitano LM, Sangji NF, Hemmila M, Quick JA, Austin TR, Hyman TS, Curtiss W, McClure A, Cairl N, Biffl WL, Truong HP, Schaffer K, Reames S, Banchini F, Capelli P, Coccolini F, Sartelli M, Bravi F, Vallicelli C, Agnoletti V, Baiocchi GL, Catena F. Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago. World J Emerg Surg. 2024 Apr 16;19(1):14. doi: 10.1186/s13017-024-00543-w.
**PMID:** 38627831
**Citation:** Cirocchi R, Sapienza P, Anania G, Binda GA, Avenia S, di Saverio S, Tebala GD, Zago M, Donini A, Mingoli A, Nascimbeni R. State-of-the-art surgery for sigmoid diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):1-14. doi: 10.1007/s00423-021-02288-5. Epub 2021 Sep 23.
**PMID:** 34557938
**Citation:** Sohn M, Agha A, Iesalnieks I, Gundling F, Presl J, Hochrein A, Tartaglia D, Brillantino A, Perathoner A, Pratschke J, Aigner F, Ritschl P. Damage control strategy in perforated diverticulitis with generalized peritonitis. BMC Surg. 2021 Mar 16;21(1):135. doi: 10.1186/s12893-021-01130-5.
**PMID:** 33726727
**Citation:** Zizzo M, Castro Ruiz C, Zanelli M, Bassi MC, Sanguedolce F, Ascani S, Annessi V. Damage control surgery for the treatment of perforated acute colonic diverticulitis: A systematic review. Medicine (Baltimore). 2020 Nov 25;99(48):e23323. doi: 10.1097/MD.0000000000023323.
**PMID:** 33235095
**Citation:** Khan A, Hsee L, Mathur S, Civil I. Damage-control laparotomy in nontrauma patients: review of indications and outcomes. J Trauma Acute Care Surg. 2013 Sep;75(3):365-8. doi: 10.1097/TA.0b013e31829cb65e.
**PMID:** 23928745
**Citation:** Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446. doi: 10.7759/cureus.28446. eCollection 2022 Aug.
**PMID:** 36176861
**Citation:** Tartaglia D, Costa G, Camillo A, Castriconi M, Andreano M, Lanza M, Fransvea P, Ruscelli P, Rimini M, Galatioto C, Chiarugi M. Damage control surgery for perforated diverticulitis with diffuse peritonitis: saves lives and reduces ostomy. World J Emerg Surg. 2019 Apr 16;14:19. doi: 10.1186/s13017-019-0238-1. eCollection 2019.
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**Citation:** Berg A, Rosenzweig M, Kuo YH, Onayemi A, Mohidul S, Moen M, Sciarretta J, Davis JM, Ahmed N. The results of rapid source control laparotomy or open abdomen for acute diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):259-265. doi: 10.1007/s00423-021-02304-8. Epub 2021 Aug 28.
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**Citation:** Costa G, La Torre M, Frezza B, Fransvea P, Tomassini F, Ziparo V, Balducci G. Changes in the surgical approach to colonic emergencies during a 15-year period. Dig Surg. 2014;31(3):197-203. doi: 10.1159/000365254. Epub 2014 Aug 28.
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**Citation:** Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner J, Gutman M, Zmora O, Tulchinsky H. Comparison between laparoscopic and open Hartmann's reversal: results of a decade-long multicenter retrospective study. Surg Endosc. 2018 Dec;32(12):4780-4787. doi: 10.1007/s00464-018-6227-8. Epub 2018 May 15.
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**Citation:** Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Tulchinsky H, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner JM, Gutman M, Zmora O. Considerations for Hartmann's reversal and Hartmann's reversal outcomes-a multicenter study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6.
**PMID:** 28879552
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000076385
- Term: Diverticular Diseases
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15577
- Name: Shock
- Relevance: LOW
- As Found: Unknown
- ID: M7414
- Name: Diverticulitis
- Relevance: HIGH
- As Found: Diverticulitis
- ID: M15580
- Name: Shock, Septic
- Relevance: LOW
- As Found: Unknown
- ID: M7416
- Name: Diverticulum
- Relevance: LOW
- As Found: Unknown
- ID: M1603
- Name: Diverticular Diseases
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004238
- Term: Diverticulitis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428357
**Brief Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
**Official Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
#### Organization Study ID Info
**ID:** 23-3039
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** TurtleTree Labs Inc
#### Lead Sponsor
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf.
Participants: To account for an approximate \~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110.
Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected.
### Conditions Module
**Conditions:**
- Exercise Performance
**Keywords:**
- Iron regulation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Randomized cross-over design
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Double-Blind
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 110
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks.
**Intervention Names:**
- Dietary Supplement: Recombinant Bovine Lactoferrin
- Dietary Supplement: Bovine Milk-Derived Lactoferrin
**Label:** Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
**Intervention Names:**
- Dietary Supplement: Recombinant Bovine Lactoferrin
- Dietary Supplement: Bovine Milk-Derived Lactoferrin
**Label:** Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks.
**Intervention Names:**
- Dietary Supplement: Recombinant Bovine Lactoferrin
- Dietary Supplement: Placebo
**Label:** Males: Recombinant Bovine Lactoferrin (rbLf), then placebo
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.
**Intervention Names:**
- Dietary Supplement: Recombinant Bovine Lactoferrin
- Dietary Supplement: Placebo
**Label:** Males: Placebo, then recombinant bovine lactoferrin (rbLf)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin
- Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin
- Males: Placebo, then recombinant bovine lactoferrin (rbLf)
- Males: Recombinant Bovine Lactoferrin (rbLf), then placebo
**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
**Name:** Recombinant Bovine Lactoferrin
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin
- Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin
**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
**Name:** Bovine Milk-Derived Lactoferrin
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Males: Placebo, then recombinant bovine lactoferrin (rbLf)
- Males: Recombinant Bovine Lactoferrin (rbLf), then placebo
**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
**Name:** Placebo
**Other Names:**
- Sugar Pill
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** change in serum blood values obtained before and after supplementation
**Measure:** Change in serum iron (mcg/dL)
**Time Frame:** baseline to 4 weeks
**Description:** change in blood values obtained before and after supplementation
**Measure:** Change in ferritin iron (ng/mL)
**Time Frame:** baseline to 4 weeks
**Description:** change in blood values obtained before and after supplementation
**Measure:** Change in red blood cell count (trillion cells/L)
**Time Frame:** baseline to 4 weeks
**Description:** change in blood values obtained before and after supplementation
**Measure:** change in iron binding capacity (mcg/dL)
**Time Frame:** baseline to 4 weeks
#### Secondary Outcomes
**Description:** change in treadmill running to exhaustion before and after supplementation
**Measure:** change in time to exhaustion running (seconds)
**Time Frame:** baseline to 4 weeks
**Description:** change in blood values obtained before and after supplementation
**Measure:** change on tumor necrosis factor-a (pg/mL)
**Time Frame:** baseline to 4 weeks
**Description:** change in blood values obtained before and after supplementation
**Measure:** change in interleukin-6 (pg/ml)
**Time Frame:** baseline to 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-42 years
* Body mass index less than 35 kg/m\^2
* Finger prick hemoglobin levels fitting within "normal range"
* Males: 14-18g/dL
* Females: 12-16g/dL
* Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of
● For females specifically:
* Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.
Exclusion Criteria:
* Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.
* Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy
* Smokers or vapers of nicotine or nicotine products
* Immunocompromised or diagnosed with Type I or II diabetes
* Irritable Bowel Disease, Crohn's disease, Celiacs
* Bowel movements less than three times per week, or clinically constipated
* Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.
* Pregnant or nursing
* Chronic eczema or clinically diagnosed asthma.
* Current antibiotic use or antibiotic use within the past 6 weeks
* If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.
* Vegan (due to supplement ingredients).
**Healthy Volunteers:** True
**Maximum Age:** 42 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Abbie E. Smith-Ryan, PhD
**Phone:** 9199622574
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Name:** Abbie Smith-Ryan
- **Role:** CONTACT
**Country:** United States
**Facility:** Applied Physiology Laboratory
**State:** North Carolina
**Zip:** 27599
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** Abbie Smith-Ryan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Clear specific study aims and ethics approval must be present.
**Description:** Deidentified individual data that supports the results will be shared beginning 9 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina. Additionally, clear aims and scope of the data request must be included.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** 9-24 Months after publication
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M10799
- Name: Lactoferrin
- Relevance: HIGH
- As Found: Peripheral Neuropathy
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007781
- Term: Lactoferrin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428344
**Brief Title:** Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
**Official Title:** Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
#### Organization Study ID Info
**ID:** KY2024060
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2027-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhejiang Provincial People's Hospital
#### Responsible Party
**Investigator Affiliation:** Zhejiang Provincial People's Hospital
**Investigator Full Name:** Fan Yang
**Investigator Title:** Chief Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.
### Conditions Module
**Conditions:**
- Dental Caries
- Artificial Intellegence
- Diagnosis
- Machine Learning
**Keywords:**
- Dental Caries
- AI Diagnosis
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 220
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dentist specializing in endodontics with over five years of experience independently reviewed the participants' oral panoramic radiographs in a random order.
**Label:** Control group
#### Arm Group 2
**Description:** The diagnoses of caries on oral panoramic radiographs were made with the assistance of an artificial intelligence-aided oral panoramic diagnostic system.
**Label:** Trial group
### Outcomes Module
#### Primary Outcomes
**Description:** Sensitivity: Sensitivity assesses the diagnostic method's ability to identify the disease, that is, how many true cases of caries can be correctly identified among all actual cases of caries.
Specificity: Specificity evaluates the diagnostic tool's ability to recognize the absence of disease, meaning how many true non-caries cases can be correctly identified among all actual non-caries cases.
Accuracy: Accuracy evaluates the overall correctness of the diagnostic tool in diagnosing the disease.
**Measure:** Sensitivity, specificity, and accuracy of caries diagnosis
**Time Frame:** Immediately after the completion of all participant information collection.
#### Secondary Outcomes
**Description:** Miss rate (False Negative Rate): The miss rate refers to the proportion of true caries cases that the diagnostic method fails to correctly identify among all actual cases of caries. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the miss rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience.
False positive rate: The false positive rate refers to the proportion of cases that are incorrectly identified as having caries among all actual non-caries cases. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the false positive rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience.
**Measure:** Miss rate and false positive rate of caries diagnosis
**Time Frame:** Immediately after the completion of all participant information collection.
**Description:** This study utilizes the International Caries Detection and Assessment System (ICDAS) to evaluate the grading of caries severity, categorizing caries severity into five levels: E0, E1, E2, D1, and D2. Wherein: E0 indicates no apparent signs of caries; E1 represents early caries, primarily initial enamel lesions; E2 designates enamel caries without involvement of the dentin; D1 denotes superficial dentin caries, not reaching half of the dentin thickness; D2 signifies deep dentin caries, reaching or exceeding half of the dentin thickness. This study will assess and compare the diagnostic accuracy at each grading level between the trial group and the control group.
**Measure:** Accuracy of Caries Severity Level Diagnosis
**Time Frame:** Immediately after the completion of all participant information collection.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-
Inclusion Criteria:
1. Patients presenting with clinical manifestations of caries as their chief complaint;
2. Age ≥18 and ≤70 years, irrespective of gender;
3. Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
4. On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
5. Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts;
6. Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form.
Exclusion Criteria:
1. Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
2. Insufficient number of teeth available for study;
3. Severe tooth wear or erosion leading to significant alteration in tooth morphology;
4. Presence of supernumerary teeth, microdontia, or missing teeth;
5. Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
6. Limited mouth opening that precludes clinical examination;
7. Neurological disorders, psychiatric illnesses, or psychological impairments;
8. Participation in another clinical trial within the last three months;
9. Any other condition deemed by the researchers as unsuitable for inclusion in the study.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients visiting the all the three centers during the study period with symptoms of caries as their chief complaint.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000017001
- Term: Tooth Demineralization
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6928
- Name: Dental Caries
- Relevance: HIGH
- As Found: Dental Caries
- ID: M19339
- Name: Tooth Demineralization
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003731
- Term: Dental Caries
- ID: D000004194
- Term: Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428331
**Brief Title:** A Study of SKB518 in Patients With Advanced Solid Tumors
**Official Title:** A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** SKB518-I-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.
**Detailed Description:** This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level.
### Conditions Module
**Conditions:**
- Advanced Solid Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Several dose levels are tentatively planned for Phase 1
**Intervention Names:**
- Drug: SKB518 for injection
**Label:** Dose Escalation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose Escalation
**Description:** SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
**Name:** SKB518 for injection
**Other Names:**
- SKB518
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possiblyrelated to study drug.
**Measure:** Number of subjects achieving Dose-limiting toxicity (DLT)
**Time Frame:** From data of initial dose until up to 21 days for treatment
**Description:** Once the dose escalation stopping criteria are met, the MTD estimated by mTPI-2 will be the dose at which the probability of posterior mean of the DLT rate is between 25% and 35%, closest to 30%, and no more than 35%.
**Measure:** Maximum Tolerated Dose (MTD)
**Time Frame:** From data of initial dose until up to 21 days for treatment
#### Secondary Outcomes
**Description:** The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumorpatients (CR + PR) divided by the total number of cases.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to 24 months
**Description:** Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients withtumors.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Up to 24 months
**Description:** Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to 24 months
**Description:** Time from start of treatment to death due to any reason.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject must be at least 18 years of age at the time of signing the informed consent;
2. Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
3. Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing.
4. At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Life expectancy of at least 3 months as assessed by the investigators.
7. Subjects with adequate organ and bone marrow function confirmed bylaboratory results within 7 days prior to the first dose.
8. Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
9. Subjects of childbearing potential (male or female) must use effectivemedical contraception during the study until 6 months after the last dose.
10. Subjects must be able to provide documented voluntary informed consent.
Exclusion Criteria:
1. Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
3. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases.
4. Has serious and/or uncontrolled concomitant diseases.
5. Has known active tuberculosis.
6. Has known human immunodeficiency virus (HIV) infection that is not well controlled.
7. Has any active viral hepatitis, hepatitis B or hepatitis C.
8. Has had major surgery within 28 days prior to the first dose.
9. Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518.
10. Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids.
11. Clinically serious lung injuries caused by lung diseases.
12. History of documented severe dry eye syndrome.
13. Has a history of allogeneic tissue/solid organ transplant.
14. Has known uncontrollable effusion.
15. Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
16. Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or has received BCRP inhibitors within 2 weeks prior to the first dose.
17. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks; or who received any small molecular tyrosine kinase inhibitor, antitumor hormonal therapy, system immune-stimulator, or therapy with traditional Chinese medicines approved for antitumor treatment, etc. within 2 weeks before the first dose.
18. Has an active infection requiring systemic therapy.
19. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
20. Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of fist dose.
21. Before the first dose, the subject's condition deteriorates rapidly.
22. Has a known psychiatric or substance abuse disorders.
23. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaoping Jin, PhD
**Phone:** 86-028-67255165
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Jian Zhang
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Fudan University
**Name:** Xiaohua Wu
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428318
**Brief Title:** Diagnostic Value of the Biofire®in Community Acquired Pneumonia
**Official Title:** Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia
#### Organization Study ID Info
**ID:** FMASU MS267/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Rania Maher Hussien, MD
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.
**Detailed Description:** the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.
This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.
### Conditions Module
**Conditions:**
- Pneumonia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients subjected to Routine sputum culture Conventional Methods
**Intervention Names:**
- Diagnostic Test: Conventional Sputum culture
**Label:** Group A: Routine Conventional Methods
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients subjected to BioFire Pneumonia Panel (BFPP
**Intervention Names:**
- Diagnostic Test: BioFire Pneumonia Panel (BFPP)
**Label:** GroupB: BioFire Pneumonia Panel (BFPP).
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A: Routine Conventional Methods
**Description:** Sputum culture was done to patients and they received Antibiotics According to its results
**Name:** Conventional Sputum culture
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- GroupB: BioFire Pneumonia Panel (BFPP).
**Description:** BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results
**Name:** BioFire Pneumonia Panel (BFPP)
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The potential correlation between the use of BFPP and its relation to the ICU length of stay
**Measure:** the ICU length of stay
**Time Frame:** Five days after admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients admitted to the ICU with community acquired pneumonia
Exclusion Criteria:
* Age less than 18 years old.
* End stage malignant patients,
* Patients admitted to the ICU with Acute Lung Injury (ALI).
* Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).
* Patients with radiological findings suggesting atypical pneumonia.
* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other immunosuppressants.
* Solid organ or bone marrow transplant patients, cystic fibrosis.
* Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Ain Shams University
**State:** Abassia
## 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
### 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: 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
### Condition Browse Module - Meshes
- ID: D000011014
- Term: Pneumonia
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428305
**Brief Title:** Providing Hygiene Education Using the Teach-back Method to Pregnant Women Diagnosed With Urinary Tract Infections
**Official Title:** The Effect of Hygiene Education Given Using the Teach-Back Method to Pregnant Women Diagnosed With Urinary Tract Infections on Hygiene Behaviors and Symptoms: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** KARATAYU-EBE-AÇ-01
#### Organization
**Class:** OTHER
**Full Name:** KTO Karatay University
### Status Module
#### Completion Date
**Date:** 2025-05-27
**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:** 2024-05-21
**Type:** ACTUAL
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** KTO Karatay University
#### Responsible Party
**Investigator Affiliation:** KTO Karatay University
**Investigator Full Name:** Arzu Çiftçi
**Investigator Title:** Graduate student
**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 proves that the hygiene education given to pregnant women diagnosed with tract infection by explaining what they have learned increases the duration of genital health, thus ensuring the positive health development of women and protecting and improving their health. At the same time, it is aimed to inform the professional "tell what you have learned" method and to guide the practices of those working in the field of health. The research will be conducted in a randomized control design with a pretest-posttest control group. The population of the research will consist of pregnant women who were followed up in the relevant hospital and who met the inclusion criteria on the dates the research was conducted. The number of samples for the study was determined as 70 participants, 35 in each group. While hygiene training will be given to the intervention group using the tell-what-you-learned method, no training will be given to the control group. Personal Information Form and Genital Hygiene Behavior Scale will be used as data collection tools in the research. Data will be collected at the first encounter, day 7, day 21, and day 30. In evaluating the data, the suitability of the variables to normal distribution will be examined using visual analytical methods. When comparing application results within and between groups, parametric or nonparametric tests will be used depending on whether they show a normal distribution or not, and t test or Mann-Withney U Test will be used to compare the difference between two groups. Wilcoxon test will be used to analyze pre- and post-intervention results within the same group. Statistical significance level will be accepted as p\<0.05. When the literature is examined, there are studies on different health education plans for women diagnosed with urinary tract infection during pregnancy, but since there is no research on the tell-what-you-learned method, it is an original study, and at the same time, the previous knowledge levels of pregnant women diagnosed with UTI were learned and the effect of the education given on their behavior was examined. It is thought that this teaching method will contribute positively to the knowledge level and behavior of women.
**Detailed Description:** Urinary tract infection in women is the second most common discomfort after anemia that occurs during certain periods of life during pregnancy and is also one of the most common bacterial infections (Fihn, 2003; Griebling, 2005; Czajkawski, Bras-Konopeielka and Teliga-Czajkowska, 2021). About 50% of women have urinary tract infections at least once in their lifetime (Gilbert, O'bien, Hutgen et al., 2013). In the presence of urinary tract infection, painful urination is usually observed, frequent emergency toilet trips, while other symptoms include lower abdominal or pelvic pain and pressure, blood in the urine, milky, cloudy or pink/red urine color, fever, heavily scented urine, nausea, vomiting and diarrhea (Habak and Griggs Dec, 2023). Pregnancy, number of pregnancies, age, diabetes mellitus, urethrogenital anomalies, genetic and behavioral factors, hygiene deficiency, anemia, history of urinary system infection (Bekzac, Orgul, Tanacan et al., 2019), factors such as low socio-economic level, inadequate perineal hygiene, vaginal douching, long-term use of antibiotics and steroids, smoking, alcohol consumption and immune deficiencies increase the incidence (Özdemir, Ortabağ, Tosun et al., 2012; Ejder Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). The frequency of sexual experience, the number of sexual partners (current or previous years), not urinating after sexual intercourse, the direction of wiping the perineum after the toilet, urine retention, daily insufficient water consumption also play an important role (Seid, Markas, Aklilu et al., 2023).
Physiological, anatomical and hormonal changes experienced during pregnancy increase the predisposition to urinary tract infection (Helli, Dolapçıoğlu and Hammer, 2011). Urinary tract infection has a prevalence rate of 20% among pregnant women (Abdel- Deciz Elzayat, Barnett-Vanes, Dabour et al., 2013; Salari, Khoshbakht, Hemmati et al., 2023). Approximately 5-12% of pregnant women are affected by asymptomatic bacteria, while 30% of women with symptoms may develop cystitis or 50% pyelonephritis. Asymptomatic bacteriuria can lead to many undesirable maternal and neonatal problems if left untreated (De Oliveira Neto et al., 2021). Preeclampsia can cause undesirable consequences such as hypertensive diseases, pyelonephritis, permanent kidney damage, anemia, premature rupture of membranes, premature birth threat, low birth weight, fetal deaths and cesarean section (Lawani, Alade and Oyelaran, 2015; Willy, Wanyoike and Mugo, 2015). These are conditions that cause many physiological and anatomical damages and are common, requiring urgent treatment (Sevil, Özdemir, Aleattin et al., 2013; Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). In addition, more than half of the patients complain of clinical depression and 38.5% of them complain of anxiety. It is reported that significant improvement in quality of life has been observed after appropriate treatment and prophylaxis (Renard, Ballarini, Mascarenhas et al., 2015). It is an important public health problem and can negatively affect the life of women and families, causing deterioration of the quality of life (Sevil, Özdemir, Aleattin et al., 2013; Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). It causes a significant financial impact of up to billions of dollars on both the health system and society (Akram, Shahid and Khan, 2007; Martini, Horner, Roehrs et al., 2007; De Oliveira Neto et al., 2021). Therefore, it is important to plan and implement initiatives aimed at improving and preventing urinary tract infections.
When the studies were examined, it was found that incorrect, incomplete or faulty hygiene behaviors increased the incidence of urinary tract infections (Özdemir et al., 2012; Sevil et al., 2013; Karahan, 2017). In urinary tract infections, it is necessary to determine the wrong behaviors first about hygiene and to provide permanent and positive behavioral changes by providing trainings for them (Karahan, 2017).
Genital hygiene behaviors are an important factor in the formation and prevention of urinary tract infections. Öner and Çeber Turfan (2020) stated that in addition to medical treatment, urinary tract infection symptoms can be prevented with hygiene education and that it also positively affects genital hygiene behaviors (Öner and Çe October Turfan, 2020). Regarding the educational methods, Sinan et al. A study conducted by (2020) concluded that genital infection awareness training based on the knowledge-motivation-behavior skills model increases women's knowledge level and positively reinforces women's hygiene behaviors (Sinan, Kaplan, Sahin et al., 2020). In another study conducted on genital hygiene behavior training given using audiovisual and brochure, it was found that the intervention group developed more positive behaviors than the control group (Hayati et al., 2018). Parlas and Eryilmaz (2023) It is stated that the knowledge, attitudes and behaviors of women who receive education based on the PRECEDE-PROCEED model are positively affected (Parlas \& Eryilmaz, 2023). In particular, in another study, it is stated that planned education and home visits on genital hygiene have a positive effect (Abic, Yatmaz, Altınışık et al., 2024). In addition, web-based genital hygiene education has a positive effect on self-care power and genital hygiene behaviors (Gül and Yağmur, 2023), peer education provided under the guidance of the health improvement model is effective and increases the knowledge levels of young October adults about genital hygiene behaviors (Polat, Küçükkelepçe et al., 2022) is stated. Another study conducted to determine the effect of genital hygiene education given by three different methods, oral education after medical curettage, education with written material and just demonstration on genital hygiene behaviors, found that oral education alone is not effective in providing and developing genital hygiene behaviors, and the demonstration method is more effective than oral and written education methods (Uzun and Göktaş, 2022). As a result of the current literature review, although the importance of genital hygiene education is emphasized, it is clear that there is a need for teaching techniques that will provide permanent behavioral changes. Midwives, who are in contact the most during the pregnancy period and conduct face-to-face interviews, undertake the most important task in teaching genital hygiene behaviors effectively and correctly (Ünsal, Özyazıcıoğu, Sezgin et al. 2010). For this reason, midwives should plan training with a permanent teaching technique that fills in gaps in the lack of knowledge, can get feedback, can be evaluated, while advising pregnant women diagnosed with urinary tract infection on genital hygiene behaviors.
The teach back method is a method used for the education, learning, evaluation and development of personal care behaviors of individuals. This approach provides an opportunity for individuals to understand educational materials, improve their level of retention in mind, and evaluate themselves. One of the important advantages is that the educational content is presented as simply as possible, free from medical terms, and that the clients repeat the practices at the end of the training (Ahmed Abd El- hamed, 2023). The practice involves asking patients by a health professional to explain in their own sentences what they have just been told. If there is any misunderstanding, it is clarified by the health professional and the understanding status is evaluated by checking again. This condition continues until the patient tells the truth and remembers the information given to him (Farris, 2015; Talevski, Wong Shee, Rasmussen et al., 2020). The patient's learning about issues related to health information can be improved through continuous feedback. It is stated that this method-based communication approach helps patients to better understand their own medical conditions and health information, and provides benefits in improving their skills of remembering and applying medical information (Tamura, 2013; Laws, 2018; Cheng, Chen, 2023).The Tell what you have learned method provides positive effects on information acquisition, remembering, keeping in mind, as well as health behavior management, personal care behavior development, hospitalization, quality of life and patient satisfaction (Yen and Leasure, 2019; Talevski et al., 2020; Cheng et al., 2023). In addition, it is stated that self-care increases strength and comfort, reduces the cost of health care (Badeczewski et al., 2017; Imanipour, Molazem, Rakhshan et al., 2022). For this reason, midwives can use the tell what you've learned method, which is a permanent teaching technique that fills in gaps in the lack of information, can be reversed, evaluated, while advising pregnant women diagnosed with urinary tract infection on genital hygiene behaviors.
Pregnant women diagnosed with urinary tract infection have been given trainings on genital hygiene behaviors in many different methods in the literature, but when the trainings given were examined, it was determined that teaching techniques aimed at improving the education, learning level, evaluation and personal care behaviors of individuals are needed. It is thought that using the tell what you have learned method in order to fill these gaps in education will be beneficial. In this context, the fact that there are no studies on the subject in our country, the fact that evidence-based teaching techniques are tried in new areas constitutes the original value of the project and our main motivation. The project has unique value for a sustainable future in terms of its effects on pregnant women in particular and qualified midwifery care at the social level in general. It will also enable data to be obtained for comparing innovative educational methods with traditional educational methods. Thus, it will help to improve, organize or develop capacity for future initiatives.
Hypotheses
1. The education given to pregnant women who have been diagnosed with urinary tract infection by the tell me what you have learned method positively affects genital hygiene behavior.
2. Education given to pregnant women who have been diagnosed with urinary tract infection by the tell-what-you-learned method reduces the level of symptoms.
### Conditions Module
**Conditions:**
- Urinary Tract Infections During Pregnancy
**Keywords:**
- Pregnant
- Genital hygiene
- Teach Back Method
- Health Educatio
- Urinary system ınfections
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The intervention group receiving planned education on genital hygiene using the teach-back method and the control group not receiving education
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** The statistician will be blinded in the research. Researcher blinding cannot be done because he is a practitioner. But the researcher will open the envelope created by the statistician just before the application and find out which group the mother belongs to. In order to prevent bias in the evaluation of the data, groups will be coded as A and B, and the analysis of the data will be carried out by an independent statistical expert. After the analysis and interpretation of the data are completed, the codes of the intervention and control groups of the study will be revealed.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All pregnant women diagnosed with UTI at the maternity outpatient clinic are prescribed antibiotics containing the active substance fosfomycin tromethamol, which is recommended for uncomplicated urinary tract infections of adults. The duration of the antibiotic's effect is seven days (Due date). After completing the treatment process determined according to the physician's request, training and counseling will be provided using the Genital Hygiene Training Guide based on the Tell me what you have learned method. In this context, 4 interviews will be held during the project.
**Intervention Names:**
- Other: Providing hygiene education based on the method of teaching what has been learned in the context of a genital hygiene guide
**Label:** The intervention group receiving planned education on genital hygiene using the teach-back method
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control Group: Research data were collected from pregnant women who were in the control group at the December intervals with the experimental group, as shown in the Flow Chart of the study. After the completion of the study, this group will also be given an education and training booklet.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The intervention group receiving planned education on genital hygiene using the teach-back method
**Description:** As shown in the Flow Chart of the study, research data were collected from pregnant women who were in the control group at the December intervals with the experimental group. After the completion of the study, this group will also be given an education and training booklet.
**Name:** Providing hygiene education based on the method of teaching what has been learned in the context of a genital hygiene guide
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It was developed by Karahan (2017) to evaluate genital hygiene behaviors in women. General hygiene habits (top 12 items), menstrual hygiene (13th item on the five-point likert scale).-20. substances) and abnormal finding awareness (21-23. it consists of three sub-dimensions (substances) and a total of 23 substances. The cronbach alpha value of the entire scale is 0.80, and it is stated that the general hygiene sub-dimension is 0.70, the menstrual hygiene sub-dimension is 0.74, and the abnormal finding awareness sub-dimension is 0.81. 7 of the scale., 14., 19., 20., 23. items are scored in reverse. The lowest 23 highest 115 points are taken from the scale and the high scores indicate that genital hygiene behavior is positive (Karahan, 2017).
**Measure:** The Scale of Genital Hygiene Behaviors
**Time Frame:** 1. day, 7. day, 21, day, 30.. day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able to read and write Turkish,
* Those between the ages of 18-35 December,
* Diagnosed with urinary tract infection,
* Pregnant women who are open to communication (who are competent to understand and answer questions) will be included in the sample.
Exclusion Criteria:
* Leaving the research of his own accord,
* Having a diagnosis related to risky pregnancy other than the diagnosis of urinary tract infection
* With a history of psychiatric illness (self-report),
* Pregnant women with a history of gynecological diseases (self-information) will be excluded from the research.
**Gender Based:** True
**Gender Description:** Pregnant women who have been diagnosed with a urinary tract infection
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arzu YL ÇİFTÇİ, post graduate
**Phone:** +905545618080
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hediye KARAKOÇ, assistant professor
**Phone:** 05412291726
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Konya
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hediye KARAKOÇ, assistant professor
- **Phone:** +905412291726
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Arzu ÇİFTÇİ, post graduate
- **Phone:** +905545618080
- **Role:** CONTACT
***Contact 3:***
- **Name:** Hediye KARAKOÇ, assistant professor
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Arzu ÇİFTÇİ, post graduate
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** KTO Karatay University
**Status:** RECRUITING
**Zip:** 42020
#### Overall Officials
**Official 1:**
**Affiliation:** KTO Karatay University
**Name:** Hediye KARAKOÇ, assistant professor
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** KTO Karatay University
**Name:** Arzu ÇİFTÇİ, post graduate
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** have no plans to make individual participant data (IPD) available to other researchers.
**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: 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: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M8700
- Name: Fosfomycin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428292
**Brief Title:** Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy
**Official Title:** Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy
#### Organization Study ID Info
**ID:** IstanbulUC-FTR-OA-01
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Omer Ayhan
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Omer Ayhan
**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:** This study was conducted in children diagnosed with Cerebral Palsy (CP); It is a prospective randomized clinical study planned to examine the effects of treadmill and bicycle ergometer applications combined with fully immersive virtual reality (TISG) on motor function, balance and walking.
**Detailed Description:** The aim of this study is in children diagnosed with Cerebral Palsy (CP); It is a comparative study of the effects of treadmill and bicycle ergometer applications combined with total immersive virtual reality (TISG) on motor function, balance and walking. 34 cases diagnosed with Cerebral Palsy between the ages of 12-18 and attending a rehabilitation center will be included in the study. The sample will be divided into two groups by randomization (TİSG combined with treadmill group n = 17, TİSG combined with bicycle ergometer group = 17). Evaluations will be made before and at the end of treatment. An exercise program that will last 45 minutes twice a week for six weeks will be applied to both study groups. The treadmill combined with TİSG group will be given walking training on the treadmill in a virtual environment using virtual reality glasses. The TISG and combined bicycle ergometer group will be given exercise training on the bicycle ergometer in a virtual environment using virtual reality glasses. For both groups, this process will continue in the same order for each exercise in the session. It is assumed that performing the bicycle ergometer in a sitting position makes this exercise safe, easier to perform, and can be performed at different levels of motor function, regardless of the severity of motor impairment. Based on this assumption, this study aimed to compare the use of bicycle ergometer combined with TISG with the treadmill combined with TISG in improving functional capacity, balance and walking functions in children with CP.
### Conditions Module
**Conditions:**
- Cerebral Palsy
**Keywords:**
- Virtual Reality
- Function
- Balance
- Physical Therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Combining a virtual reality device with a treadmill and using it in a virtual environment, allowing the person to walk in different virtual environments
**Intervention Names:**
- Device: Virtual reality device branded ''Meta Quest 2''
**Label:** combined treadmill with virtual reality
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Combining a virtual reality device with a stationary bike and using it in a virtual environment, allowing the person to walk in different virtual environments
**Intervention Names:**
- Device: Virtual reality device branded ''Meta Quest 2''
**Label:** stationary bike combined with virtual reality
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- combined treadmill with virtual reality
- stationary bike combined with virtual reality
**Description:** Combining different exercise equipment with a virtual reality device and using them in a virtual environment can be used to decide which one is more effective.
**Name:** Virtual reality device branded ''Meta Quest 2''
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Gross Motor Function Measure - 88 is a well-known scoring system that evaluates changes in gross motor function. Gross Motor Function Measure - 88 has no age limit and is divided into five gross motor function dimensions: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running and jumping. It consists of 88 items. Each item is scored on a 4-point scale (0-1-2-3). A higher score means better motor function.
**Measure:** Gross Motor Function Measure - 88
**Time Frame:** 2 times in 8 weeks
**Description:** 6 Minute Walk Test is a standardized, inexpensive and easy-to-implement walking test in which the distance walked in 6 minutes is measured under controlled conditions, the person determines his/her own pace. 6 Minute Walk Test is commonly used to assess functional capacity in children with cerebral palsy (CP)
**Measure:** 6 Minute Walk Test
**Time Frame:** 2 times in 8 weeks
#### Secondary Outcomes
**Description:** It is a test used to evaluate the walking speed of individuals. They walk at their normal speed, with or without assistance, on a 14-meter walkway, and the time required for each participant to cover a 10-meter walking distance is measured, starting from 2 marked points 2 m after the starting point and 2 m before the end point.
**Measure:** 10 Meter Walk Test
**Time Frame:** 2 times in 8 weeks
**Description:** Timed Up and Down Stair Test attempts to obtain information about the individual's functional mobility by evaluating how long it takes to ascend and descend a 14-step staircase.
**Measure:** Timed Up And Down Stairs Test
**Time Frame:** 2 times in 8 weeks
**Description:** Timed Up and Go Test is a valid and reliable test method used to evaluate functional mobility and static and dynamic balance in children with CP. Participants have to stand up from a chair without armrests from the starting position with hips, knees and ankles bent at 90°, walk 3 meters, and return. and they are asked to sit on the chair. Completing the test in less time means more mobility.
**Measure:** Timed Up and Go Test
**Time Frame:** 2 times in 8 weeks
**Description:** Gross Motor Function Classification System was developed to measure the 'severity of movement disability' in children with cerebral palsy (CP). Gross Motor Function Classification System provides a method to classify the functional abilities of children with CP into one of five levels. As the grade level approaches five, it means that the child's functional ability decreases and he becomes more dependent.
**Measure:** Gross Motor Function Classification System
**Time Frame:** 2 times in 8 weeks
**Description:** The Pediatric Berg Balance Scale, a modified version of the Berg Balance Scale, is a 14-item, criterion-referenced measurement method that examines functional balance in the context of daily tasks. The 14 items that make up the Pediatric Berg Balance Scale are scored on a 4-point scale. A higher score means better balance.
**Measure:** Pediatric Berg Balance Scale
**Time Frame:** 2 times in 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being diagnosed with spastic cerebral palsy
* Being between the ages of 12 - 18
* Being at Level 1 and 2 according to the Gross Motor Function Classification System (GMFSS)
* Being able to understand and speak Turkish
* Not using medical treatment (including botox) in the last six months
* No visual or auditory problems that would hinder communication during applications.
* Having the cognitive skills to adapt to the application and application controls where the intervention is required.
Exclusion Criteria:
* Presence of secondary orthopedic and neurological problems/problems that are severe enough to affect participation in the study (advanced joint instability, severe scoliosis, nystagmus, etc.).
* Having a neurodegenerative disease that may cause attacks during virtual reality applications
* Presence of epilepsy
* Having undergone lower extremity surgery within the last year
* Presence of hypersensitivity to visual stimuli
* Development of vestibular problems with the use of virtual reality devices
**Maximum Age:** 18 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ömer Ayhan, BSc
**Phone:** +905350848014
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ayşenur Erekdağ, MSc
**Phone:** 05548959013
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Secde N Atamtürk
- **Phone:** +902124040300
- **Phone Ext:** 16601-16602
- **Role:** CONTACT
**Country:** Turkey
**Facility:** İstanbul Ünivesitesi - Cerrahpaşa
**State:** Büyükçekmece
**Status:** RECRUITING
**Zip:** 34500
#### Overall Officials
**Official 1:**
**Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Name:** Ipek Yeldan, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.
**PMID:** 36328390
**Citation:** Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213.
**PMID:** 26947315
**Citation:** Zeng N, Pope Z, Gao Z. Acute Effect of Virtual Reality Exercise Bike Games on College Students' Physiological and Psychological Outcomes. Cyberpsychol Behav Soc Netw. 2017 Jul;20(7):453-457. doi: 10.1089/cyber.2017.0042.
**PMID:** 28715263
**Citation:** Gagliardi C, Turconi AC, Biffi E, Maghini C, Marelli A, Cesareo A, Diella E, Panzeri D. Immersive Virtual Reality to Improve Walking Abilities in Cerebral Palsy: A Pilot Study. Ann Biomed Eng. 2018 Sep;46(9):1376-1384. doi: 10.1007/s10439-018-2039-1. Epub 2018 Apr 27.
**PMID:** 29704186
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428279
**Acronym:** S&C
**Brief Title:** Survey of Sexual Health in Cancer Patients
**Official Title:** Sexual Health in Cancer Patients: a Survey and Pilot Study of Psychosexual Therapy as a Non-pharmacological Supportive Care
#### Organization Study ID Info
**ID:** IR-2024-001
#### Organization
**Class:** OTHER
**Full Name:** Institut Rafael
#### Secondary ID Infos
**Domain:** ANSM
**ID:** 2024-A00387-40
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-05-19
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-19
**Type:** ACTUAL
#### Start Date
**Date:** 2024-04-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut Rafael
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality.
The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (\>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent.
**Detailed Description:** Sexual health, a vital aspect of the overall human health can be negatively affected by cancer and cancer treatments. Sexual dysfunctions affect the quality of life of an individual since sexual health is a critical component of overall quality of life. The World Health Organization (WHO) defines sexual health as "a state of physical, emotional, mental and social well-being in relation to sexuality; and not merely the absence of disease, dysfunction or infirmity". Indeed, regular sexual activity reduces stress, regularizes sleep cycle, and regulates our mental wellbeing as a whole.
Although prevalence rates of sexual difficulties vary among cancer patients and depend on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates can range from 40% to 100%. For example, in a French national survey focusing on sexual health of patients with colorectal or breast cancer two years after diagnosis, 54% of patients (235 of 435) reported to have a decrease in sexual desire and 61% had a decrease in frequency of intercourse.
Despite these problems have been well documented in the literature and in practice guidelines, many cancer survivors have limited access to high quality information on sexual health. Indeed, communication about sexual health is often absent or inadequate between patients and the medical team. Among barriers reported by health care providers for avoiding discussing this topic are lack of time, insufficient training, absence of awareness about the subject and unavailable access to integrative medicine solutions where they could send their patients. Cultural values, religious beliefs and social norms may also have significant implications.
Recognizing patients' sexual problems can help health care providers to offer appropriate integrative non-pharmacological interventions to different group of patients. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France.
### Conditions Module
**Conditions:**
- Integrative Oncology
**Keywords:**
- Sexual health
- Quality of life
- Integrative oncology
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 200
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** survey
**Name:** Survey
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** questionnaire
**Measure:** patients' satisfaction with their sexual lives
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** questionnaire
**Measure:** identification of the main physiological and psychological difficulties encountered by patients in their sexual lives
**Time Frame:** 1 month
**Description:** questionnaire
**Measure:** patients perceived emotions
**Time Frame:** 1 month
**Description:** questionnaire
**Measure:** description of the impact of sex therapy sessions on the sexual health of the participants
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* cancer patients
* adults aged \> 18 years old
Exclusion Criteria:
* \<18years old
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Eligible participants will be adults aged 18 years old or older diagnosed with cancer and undergoing non-pharmacological supportive care during or after their standards cancer treatments at Rafael Institute
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Levallois Perret
**Country:** France
**Facility:** Institute Rafaël
**State:** Institut Rafael
**Zip:** 92300
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428266
**Acronym:** DICvsBIcanal
**Brief Title:** Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction
**Official Title:** Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients
#### Organization Study ID Info
**ID:** CI 09 015 008
#### Organization
**Class:** OTHER
**Full Name:** Instituto de Oftalmología Fundación Conde de Valenciana
### Status Module
#### Completion Date
**Date:** 2022-07-31
**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:** 2022-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Instituto de Oftalmología Fundación Conde de Valenciana
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In Mexico, upper lacrimal duct obstruction (ULDO) is a common pathology, and the standard surgical treatment is closed dracryointubation. Based on statistics from our headquarters, in 30% of cases there is a failure of the technique and recurrence of symptoms due to associated complications. Because of this, the application of a self-stable bicananlicular intubation set is proposed. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (FCI) and closed dacryointubation in patients with ULDO .
**Detailed Description:** Upper lacrimal duct obstruction (ULDO) or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point, in superior and inferior canaliculi, or in the common canaliculus. When the ULDO is at the level of the canaliculi (superior, inferior or common), the alternatives available for its management are closed dacryointubation with Crowford catheter, conjunctivadacryocystorhinostomy, and bicanalicular intubation.
Closed dacryointubation with Crowford tube is a technique effective in approximately 90% of children diagnosed with congenital occlusion of the lacrimal duct, however, in adults the reported surgical success rate is lower, approximately 70% according to different authors.
The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction.
The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set (FCI R), an FDA-approved silicone bicanalicular retention device, is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction.
The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (ICF) and closed dacryointubation in patients with ULDO
### Conditions Module
**Conditions:**
- Lacrimal Duct Obstruction
- Lacrimal Apparatus Diseases
- Lacrimal Stenosis
- Lacrimal Elimination
**Keywords:**
- upper lacrimal duct obstruction
- bicanalicular intubation
- closed dacriointubation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients from the consultation of the Oculoplastics Department of the Institute of Ophthalmology "Conde de Valenciana I.A.P", between July 2021 and July 2022 who met the inclusion and exclusion criteria were enrolled
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 31
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients undergoing conventional closed dacryointubation with Crawford's tube
**Intervention Names:**
- Procedure: Closed dacryointubation
**Label:** Closed dacryointubation
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI
**Intervention Names:**
- Device: Bicanalicular intubation
**Label:** Bicanalicular Intubation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bicanalicular Intubation
**Description:** Placement of the bicanalicular intubation set at each lacrimal point and fixed by means of its flaps at the level of the opening of the lacrimal sac.
**Name:** Bicanalicular intubation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Closed dacryointubation
**Description:** Placement of dacryointubation tube through the canaliculus until it reaches the medial wall of the lacrimal sac and then passed the nasolacrimal duct until it empties out at the level of the inferior meatus.
**Name:** Closed dacryointubation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Irrigation of the lacrimal duct with saline solution to seek for permeability
**Measure:** Irrigation of tha lacrimal duct
**Time Frame:** three and four months after the procedure
**Description:** evidence of epiphora as told by the subject
**Measure:** Epiphora
**Time Frame:** one, three and four months after surgery
#### Secondary Outcomes
**Description:** postoperative bleeding throug the nose
**Measure:** Occurrence of epistaxis
**Time Frame:** one, three and four months after surgery
**Description:** extruded or non-extruded
**Measure:** Presence of extrusion of bicanalicular intubation tubes
**Time Frame:** one, three and four months after surgery
**Description:** how well positioned or poorly positioned the tubes are
**Measure:** How well is the positioning of the silicone tubes
**Time Frame:** one, three and four months after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients over 18 years of age
* Patients with stenosis and incomplete obstruction of the upper lacrimal duct with epiphora \> 2 on the Munk scale who have not previously undergone surgery on the affected tear duct
* Patients who may undergo general anesthesia and sedation
* Patients who are able to present and continue follow-up for the duration of the study
* Acceptance to participate in the study by signing an informed consent
Exclusion Criteria:
* Patients with ocular surface involvement affecting the upper lacrimal duct, such as blepharitis with tear point epithelialization
* Patients with lacrimal point malposition and/or eyelid malposition due to entropion or ectropion
* Patients with congenital or acquired obstruction of the lower lacrimal duct
* Patients with a history of facial paralysis
* Patients with systemic inflammatory disease such as scarring pemphigoid or Steven Johnson
* Patients in whom tumour involvement of the lacrimal duct is suspected
* Patients with reflex tear hypersecretion due to ocular surface involvement or other causes.
* Pregnancy and breastfeeding
* Active infection, eye trauma, history of facial trauma with broken bones of the nose, or history of sinus surgery.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mexico City
**Country:** Mexico
**Facility:** Institiuto de Oftalmología Fundación Conde de Valenciana
**Zip:** 06800
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** 1. Schaefer DP. Acquired Etiologies of Lacrimal System Obstructions. In: Cohen AJ, Mercandetti M, Brazzo BG, editors. The Lacrimal System [Internet]. Springer New York; 2006 [cited 2020 Jan 15]. p. 43-65.
**Citation:** Fulcher T, O'Connor M, Moriarty P. Nasolacrimal intubation in adults. Br J Ophthalmol. 1998 Sep;82(9):1039-41. doi: 10.1136/bjo.82.9.1039.
**PMID:** 9893595
**Citation:** Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014.
**PMID:** 454271
**Citation:** Tabatabaie SZ, Rajabi MT, Rajabi MB, Eshraghi B. Randomized study comparing the efficacy of a self-retaining bicanaliculus intubation stent with Crawford intubation in patients with canalicular obstruction. Clin Ophthalmol. 2012;6:5-8. doi: 10.2147/OPTH.S25172. Epub 2011 Dec 20.
**PMID:** 22259230
#### See Also Links
**Label:** characteristics of the Self-Stable Intubation Set II FCI
**URL:** http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130375.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M10787
- Name: Lacrimal Duct Obstruction
- Relevance: HIGH
- As Found: Lacrimal Duct Obstruction
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: HIGH
- As Found: Lacrimal Apparatus Diseases
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007767
- Term: Lacrimal Duct Obstruction
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428253
**Brief Title:** Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet
**Official Title:** A Single Center, Subject & Evaluator-blind, Randomized, Matched Pairs, Active-controlled, Confirmatory Study to Evlualte the Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet
#### Organization Study ID Info
**ID:** HMM1-022
#### Organization
**Class:** INDUSTRY
**Full Name:** Humedix Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Humedix Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet
### Conditions Module
**Conditions:**
- Crows Feet
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** subject/evaluator blinding
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 171
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.
**Intervention Names:**
- Device: HMM1-022
**Label:** HMM1-022
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.
**Intervention Names:**
- Device: HMM1-022
**Label:** REJURAN®
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HMM1-022
- REJURAN®
**Description:** intradermal injection
**Name:** HMM1-022
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Compared to Rejuran, the improvement rate on the crow's feet at rest evaluation scale (IGA-LCL severity scale) by external independent evaluators to prove that HMM1-022 is non-inferior
**Measure:** IGA-LCL severity scale
**Time Frame:** 18 weeks after initial inejction
### Eligibility Module
**Eligibility Criteria:** Crows feet (both eyes) is at least 3 points (Moderate) on the lGA-LCL severity scale, and the wrinkles are symmetrical by the investigator
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** development Humedix
**Phone:** 82-70-7492-5647
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Beom Joon Kim, M.D
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Chung-Ang University Hospital
**State:** Heukseok-ro, Dongjak-gu
**Status:** RECRUITING
**Zip:** 06973
#### Overall Officials
**Official 1:**
**Affiliation:** Dermatology
**Name:** Beom-joon Kim, M.D.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428240
**Acronym:** AMI_CAT
**Brief Title:** Acute Mesenteric Ischemia, Reality in Catalonia
**Official Title:** Reality of Acute Mesenteric Ischemia in Catalonia, is There a Chance to Improvement?
#### Organization Study ID Info
**ID:** AMICat Reality
#### Organization
**Class:** OTHER
**Full Name:** Hospital del Mar
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital Clinic of Barcelona
**Class:** UNKNOWN
**Name:** Hospital Germans Tries i Pujol
**Class:** UNKNOWN
**Name:** Hospital Parc Taulí
**Class:** UNKNOWN
**Name:** Hospital Santa Creu i Sant Pau
**Class:** OTHER
**Name:** Hospital Vall d'Hebron
**Class:** UNKNOWN
**Name:** Hospital Joan XXIII
**Class:** UNKNOWN
**Name:** Hospital de Manresa
**Class:** OTHER
**Name:** Hospital de Mataró
**Class:** UNKNOWN
**Name:** Hospital de Reus
**Class:** OTHER
**Name:** Hospital de Sant Joan Despí Moisès Broggi
**Class:** UNKNOWN
**Name:** Hospital de Tortosa
**Class:** OTHER
**Name:** Hospital d'Igualada
**Class:** UNKNOWN
**Name:** Hospital de Vic
**Class:** OTHER
**Name:** Hospital Arnau de Vilanova
**Class:** UNKNOWN
**Name:** Hospital Mora d'Ebre
**Class:** UNKNOWN
**Name:** Hospital de la Cerdanya
**Class:** UNKNOWN
**Name:** Hospital de Mollet
**Class:** OTHER
**Name:** Hospital de Terrassa
**Class:** UNKNOWN
**Name:** Hospital de Martorell
**Class:** OTHER
**Name:** Hospital Universitari de Bellvitge
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital del Mar
#### Responsible Party
**Investigator Affiliation:** Hospital del Mar
**Investigator Full Name:** Ana María González Castillo
**Investigator Title:** Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. The aim of this study is to analyse the results of the patients admited with an AMI in Catalonia.
**Detailed Description:** Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality from 50 to 80%. Even though AMI is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of AMI has been reported higher than that of acute appendicitis. AMI patients benefit from early assessment in a surgical unit with capabilities to definitive management. The diagnosis and management of AMI are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary.
The aim of this study is to analyse the management and results of the patients admitted with an AMI in Catalonia from November 2024 to April 2026.
### Conditions Module
**Conditions:**
- Acute Mesenteric Ischemia
**Keywords:**
- Mesenteric ischemia
- Acute Mesenteric ischemia
- Abdominal pain
- Elderly
- Complications
- Mortality
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To describe the mortality in patients with a diagnostic of AMI
**Measure:** Mortality
**Time Frame:** 2024-2026
#### Secondary Outcomes
**Description:** To describe the complications in patients with a diagnostic of AMI
**Measure:** Complications
**Time Frame:** 2024-2026
**Description:** To describe the management in patients with a diagnostic of AMI
**Measure:** Management
**Time Frame:** 2024-2026
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnostic of Acute Mesenteric Ischemia
Exclusion Criteria:
* Chronic Mesenteric Ischemia
* Ischemic Colitis
* Bowel obstruction strangulation
* Inflammatory bowel necrosis
**Gender Based:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study populations is all pacients with the diagnostic of Acute Mesenteric Ischemia that are admitted in the Hospital in Catalonia.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010532
- Term: Peritoneal 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: BC06
- Name: Digestive System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemia
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M30554
- Name: Mesenteric Ischemia
- Relevance: HIGH
- As Found: Mesenteric Ischemia
- ID: M18311
- Name: Abdominal Pain
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13441
- Name: Peritoneal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000065666
- Term: Mesenteric Ischemia
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428227
**Brief Title:** Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness
**Official Title:** A Comparison of Exercise Capacity, Respiratory Functions, and Quality of Life in Heart Failure Patients With and Without Inspiratory Muscle Weakness and Healthy Controls
#### Organization Study ID Info
**ID:** GaziU5
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2024-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-01-01
**Type:** ACTUAL
#### Start Date
**Date:** 2010-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gazi University
#### Responsible Party
**Investigator Affiliation:** Gazi University
**Investigator Full Name:** Meral Boşnak Güçlü
**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:** In patients with heart failure, diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Patients exhibit reduced exercise capacity, peripheral and respiratory muscle strength, decreased respiratory function, increased dyspnea, fatigue, and worsened quality of life. However, it is unclear how these parameters will change in patients with inspiratory muscle weakness. Therefore, the study aimed to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness and healthy controls
**Detailed Description:** It is believed that respiratory muscle abnormalities develop earlier and more extensively than extremity muscle abnormalities in heart failure. Diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Heart failure patients exhibit increased airway resistance and ventilatory response during exercise. Fatigue and dyspnea are common symptoms associated with exercise intolerance and decreased quality of life in heart failure patients.There is no study in the literature comparing functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness (IMW). The aim of the study was to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without IMW and healthy controls.
The study was planned as a cross-sectional, retrospective. Heart failure patient were divided into IMW group or not IMW group due to their MIP values. Also healthy controls who were matched for age-gender were included.
### Conditions Module
**Conditions:**
- Heart Failure
**Keywords:**
- heart failure
- exercise capacity
- respiratory muscle
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 102
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.
**Label:** Heart failure patients with inspiratory muscle weakness
#### Arm Group 2
**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.
**Label:** Heart failure patients without inspiratory muscle weakness
#### Arm Group 3
**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.
**Label:** Healthy controls
### Outcomes Module
#### Primary Outcomes
**Description:** According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity
**Measure:** Functional exercise capacity
**Time Frame:** First day
#### Secondary Outcomes
**Description:** Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria
**Measure:** Pulmonary function FEV1
**Time Frame:** First day
**Description:** Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria
**Measure:** Pulmonary function FVC
**Time Frame:** First day
**Description:** Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria
**Measure:** Pulmonary function FEV1/FVC
**Time Frame:** First day
**Description:** Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria
**Measure:** Pulmonary function PEF
**Time Frame:** First day
**Description:** Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria
**Measure:** Pulmonary function FEF25-75
**Time Frame:** First day
**Description:** Respiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines.
**Measure:** Respiratory muscle strength
**Time Frame:** First day
**Description:** Peripheral muscle strength was assessed by using a hand-held dynamometer
**Measure:** Peripheral muscle strength
**Time Frame:** First day
**Description:** The dyspnea was assessed with The Modified Medical Research Council (MMRC)dyspnea scale. Levels of dyspnea were graded 0-4. Higher scores mean a worse dyspnea level.
**Measure:** Dyspnea
**Time Frame:** First day
**Description:** The Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue.
**Measure:** Fatigue
**Time Frame:** First day
**Description:** Quality of life was evaluated with The Short Form 36 (SF-36) questionnaire. The scores range from 0 to 100. Higher values are indicative of better health.
**Measure:** The quality of life
**Time Frame:** Fist day
**Description:** The International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity level. The total scores of \<600 MET-min/week, 600-3000 MET-min/week, and \>3000 MET-min/ week were classified as inactive, minimally active, and sufficiently active, respectively
**Measure:** Physical activity level
**Time Frame:** First day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* HF patients were being aged over18 years
* clinically stable at least four weeks
* having no change in medications over three months
The inclusion criteria for healthy controls were being aged over 18 without a chronic disease
Exclusion Criteria:
* having unstable angina, acute myocardial infarction, uncontrolled hypertension, significant valvular disease, history of malignancy or orthopedic, rheumatologic, neurological, or pulmonary diseases
The exclusion criteria for the healthy controls were having any chronic or systemic disease, and having physical limitation
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Forty-one heart failure patients with inspiratory muscle weakness, 30 heart failure patients without inspiratory muscle weakness and 41 healthy controls were included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
**State:** Çankaya
**Zip:** 06490
#### Overall Officials
**Official 1:**
**Affiliation:** Gazi University
**Name:** Meral Boşnak Güçlü, Prof. Dr
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Mustafa Kemal University
**Name:** Nihan Katayıfçı, Dr.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish.
**PMID:** 37839949
**Citation:** Silva Andrade NS, Almeida L, Noronha I, Lima JM, Eriko Tenorio de Franca E, Pedrosa R, Siqueira F, Onofre T. Analysis of respiratory muscle strength and its relationship with functional capacity between different field tests in patients with heart failure. Physiother Theory Pract. 2023 Nov 2;39(11):2427-2437. doi: 10.1080/09593985.2022.2077270. Epub 2022 May 26.
**PMID:** 35619283
**Citation:** Kasahara Y, Izawa KP, Watanabe S, Osada N, Omiya K. The Relation of Respiratory Muscle Strength to Disease Severity and Abnormal Ventilation During Exercise in Chronic Heart Failure Patients. Res Cardiovasc Med. 2015 Sep 15;4(4):e28944. doi: 10.5812/cardiovascmed.28944. eCollection 2015 Nov.
**PMID:** 26528451
**Citation:** Miyagi M, Kinugasa Y, Sota T, Yamada K, Ishisugi T, Hirai M, Yanagihara K, Haruki N, Matsubara K, Kato M, Yamamoto K. Diaphragm Muscle Dysfunction in Patients With Heart Failure. J Card Fail. 2018 Apr;24(4):209-216. doi: 10.1016/j.cardfail.2017.12.004. Epub 2017 Dec 28.
**PMID:** 29289723
**Citation:** Bosnak Guclu M, Bargi G, Katayifci N, Sen F. Comparison of functional and maximal exercise capacity, respiratory and peripheral muscle strength, dyspnea, and fatigue in patients with heart failure with pacemakers and healthy controls: a cross-sectional study. Physiother Theory Pract. 2021 Feb;37(2):295-306. doi: 10.1080/09593985.2019.1630878. Epub 2019 Jun 17.
**PMID:** 31204872
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M20944
- Name: Muscle Weakness
- Relevance: HIGH
- As Found: Muscle Weakness
- ID: M13204
- Name: Paresis
- Relevance: HIGH
- As Found: Muscle Weakness
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018908
- Term: Muscle Weakness
- ID: D000010291
- Term: Paresis
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428214
**Acronym:** ARTIST
**Brief Title:** A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies
**Official Title:** A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface
#### Organization Study ID Info
**ID:** 05DF2307
#### Organization
**Class:** INDUSTRY
**Full Name:** Galderma R&D
### Status Module
#### Completion Date
**Date:** 2024-09-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Galderma R&D
#### 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:** The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
### Conditions Module
**Conditions:**
- Chin Augmentation
**Keywords:**
- lower face
- Mid face
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive Restylane Shaype in the chin area only.
**Intervention Names:**
- Device: Restylane Shaype
**Label:** Restylane Shaype
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin.
**Intervention Names:**
- Device: Restylane Shaype
- Device: Restylane Defyne
**Label:** Restylane Shaype with Restylane Defyne
**Type:** OTHER
#### Arm Group 3
**Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline.
**Intervention Names:**
- Device: Restylane Shaype
- Device: Restylane Defyne
- Device: Restylane Lyft lidocaine
**Label:** Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Restylane Shaype
- Restylane Shaype with Restylane Defyne
- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine
**Description:** Injection
**Name:** Restylane Shaype
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Restylane Shaype with Restylane Defyne
- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine
**Description:** Injection
**Name:** Restylane Defyne
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine
**Description:** Injection
**Name:** Restylane Lyft lidocaine
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
**Time Frame:** At week 8
#### Secondary Outcomes
**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4
**Time Frame:** At week 4
**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8
**Time Frame:** At weeks 4 and 8
**Measure:** Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8
**Time Frame:** At week 8
**Measure:** Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8
**Time Frame:** At week 8
**Measure:** Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
**Time Frame:** At week 8
**Measure:** Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8
**Time Frame:** At week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, over the age of 18.
* Intent to receive treatment for temporary augmentation in the chin region.
Exclusion Criteria:
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
* Any previous aesthetic procedures or implants.
* Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
* Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Galderma Research & Development
**Phone:** 1-866-735-4137
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vancouver
**Country:** Canada
**Facility:** Galderma Investigational Site # 8754
**State:** British Columbia
**Status:** RECRUITING
**Zip:** V6H 4E1
**Location 2:**
**City:** Burlington
**Country:** Canada
**Facility:** Galderma Investigational Site 8379
**State:** Ontario
**Status:** RECRUITING
**Zip:** L7N3N2
**Location 3:**
**City:** Westmount
**Country:** Canada
**Facility:** Galderma Investigational Site 8690
**State:** Quebec
**Status:** RECRUITING
**Zip:** H3Z 1C3
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- 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: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000276
- Term: Adjuvants, Immunologic
- ID: D000007155
- Term: Immunologic Factors
- ID: D000055675
- Term: Viscosupplements
- ID: D000020011
- Term: Protective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: HIGH
- As Found: Bromide
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M28295
- Name: Viscosupplements
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
- ID: D000006820
- Term: Hyaluronic Acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428201
**Brief Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement
**Official Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement in Multiple Sclerosis (MS) Patients
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/711
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** "This study investigates the feasibility of tele-rehabilitation combined with targeted training for cognitive enhancement in individuals with Multiple Sclerosis (MS). Multiple sclerosis (MS) is a chronic illness that affects the central nervous system, often resulting in cognitive impairments that significantly impact quality of life. Tele-restoration provides an accessible and effective method for delivering therapeutic interventions, particularly beneficial for those with mobility limitations.
**Detailed Description:** The study was a randomized controlled trial with multiple sclerosis patients divided into two groups: one receiving tele-rehabilitation-based task-specific training and the other receiving conventional care. The mediation group participated in structured cognitive training sessions conducted using a tele-rehabilitation platform, focusing on tasks designed to enhance memory, attention, and executive functions. Psychological assessments were conducted during the mediation period to measure improvements.
### Conditions Module
**Conditions:**
- Sclerosis, Multiple
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 52
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Control Group
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Combination Product: Experimental Group
**Label:** EXP group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group
**Description:** The control group receives standard care, which includes routine medical management and general physical rehabilitation exercises. This involves regular consultations with healthcare providers and exercises aimed at maintaining mobility and physical function. The control group also follows a schedule of three 45-minute sessions per week for 12 weeks, ensuring a consistent comparison with the experimental group.
**Name:** Control Group
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- EXP group
**Description:** The experimental intervention involves tele-rehabilitation-based task-specific training to enhance cognitive functions in multiple sclerosis (MS) patients. This program includes cognitive exercises targeting memory, attention, executive function, and processing speed, conducted remotely via a tele-rehabilitation platform. Patients participate in three 45-minute sessions per week for 12 weeks. Each session is guided by a trained therapist, ensuring personalized support and real-time feedback.
**Name:** Experimental Group
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** The MoCA scale is a comprehensive tool designed to evaluate various cognitive domains, including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. It provides a detailed assessment of cognitive performance, making it an ideal measure for tracking cognitive improvements in MS patients participating in the tele-rehabilitation and task-specific training programs.
**Measure:** Montreal Cognitive Assessment (MoCA) scale
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals with a diagnosis of MS confirmed by a neurologist.
* Between 18 and 65 years of age.
* Presence of psychosis confirmed by standardized psychometric testing.
* A stable treatment environment that allows intervention.
* Internet access with camera and computer/tablet.
* Ability to understand and follow course directions.
* Willingness to give informed consent.
Exclusion Criteria:
* Severe psychiatric co-morbidities affecting cognitive function.
* Concurrent intervention with other psychological rehabilitation programs.
* Lack of availability or use of technology necessary for tele-rehabilitation.
* Further research interventions.
* Unstable medical condition
**Maximum Age:** 45 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** District Head Quarters Hospital Narowal, Circular Road, Near Jassar Bypass, Narowal Location: Khalid Eye & Medical Care Block C Commercial Area, Jubilee Town, Lahore
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Sclerosis, Multiple
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000012598
- Term: Sclerosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428188
**Acronym:** BAH247
**Brief Title:** Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
**Official Title:** Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
#### Organization Study ID Info
**ID:** ESBI202497
#### Organization
**Class:** OTHER
**Full Name:** Essen Biotech
### Status Module
#### Completion Date
**Date:** 2026-12-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Essen Biotech
#### 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 an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.
**Detailed Description:** Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may have the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19/BCMA in patients with Autoimmune Disease. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.
The purpose of this clinical trial is to assess the feasibility, safety, and efficacy of multiple CAR T-cell therapy that combines CAR T cells against Autoimmune Disease B Cells with CAR T cells targeting BCMA or CD19 or both in patients with relapsed and refractory Autoimmune Disease. The study also aims to learn more about the function of CAR T cells and their persistence in Autoimmune Disease patients.
### Conditions Module
**Conditions:**
- Autoimmune Diseases
- Systemic Lupus Erythematosus
- Systemic Lupus Erythematosus Acute
- Sjogren's Syndrome
**Keywords:**
- Sjogren's Syndrome
- Systemic Lupus Erythematosus
- Autoimmune Diseases
- CAR-T
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Before the infusion of BCMA and CD19 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for CAR-T cell therapy to effectively target and eliminate B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells.
##### Masking Info
**Masking:** NONE
**Masking Description:** Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive BCMA/CD19 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of BCMA/CD19 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of BCMA/CD19 CAR T cells.
**Intervention Names:**
- Biological: BCMA/CD19 CAR-T cells
**Label:** CD19/BCMA-CAR T cells, chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CD19/BCMA-CAR T cells, chemotherapy
**Description:** The intervention in this clinical trial involves a novel approach using BCMA/CD19 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.
Treatment Regimen:
Patients in the trial will undergo the following regimen:
Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.
Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.
BCMA/CD19 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, BCMA/CD19 CAR T cells, over 10-20 minutes on day 0.
Additional Doses: Eligible patients responding well to the initial BCMA/CD19 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.
**Name:** BCMA/CD19 CAR-T cells
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined.
**Measure:** Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells
**Time Frame:** 28 days
#### Secondary Outcomes
**Description:** satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA)
**Measure:** Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells
**Time Frame:** 60 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Expected survival time ≥3 months;
* Subjects with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
* Liver and kidney function, cardiopulmonary function meet the following requirements:
* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
* Blood oxygen saturation \>91% in non-oxygen state;
* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.
* No serious mental disorders;
* Can understand this test and have signed the informed consent.
Exclusion Criteria:
* Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;
* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;
* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
* Participated in other clinical studies 1 month before screening;
* Evidence of central nervous system invasion during subject screening;
* Mental patients with depression or suicidal thoughts;
* Situations considered unsuitable for inclusion by other researchers.
**Maximum Age:** 90 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** JAMAL ALKHAYER
**Phone:** +97333799773
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** SAMI XI, dr
- **Phone:** +14012275001
- **Role:** CONTACT
**Country:** China
**Facility:** District One Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 086-373
**Location 2:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Sami Madsion
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone:** +97336386689
- **Role:** CONTACT
**Country:** China
**Facility:** District one hospital
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000001172
- Term: Arthritis, Rheumatoid
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000014987
- Term: Xerostomia
- ID: D000012466
- Term: Salivary Gland Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M15664
- Name: Sjogren's Syndrome
- Relevance: HIGH
- As Found: Sjogren's Syndrome
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: HIGH
- As Found: Autoimmune Diseases
- ID: M11177
- Name: Lupus Erythematosus, Systemic
- Relevance: HIGH
- As Found: Systemic Lupus Erythematosus
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M4480
- Name: Arthritis, Rheumatoid
- 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
- ID: M17724
- Name: Xerostomia
- Relevance: LOW
- As Found: Unknown
- ID: M15285
- Name: Salivary Gland 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: M18040
- Name: Dry Eye Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012859
- Term: Sjogren's Syndrome
- ID: D000008180
- Term: Lupus Erythematosus, Systemic
- ID: D000001327
- Term: Autoimmune Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M283230
- Name: Fludarabine
- Relevance: LOW
- As Found: Unknown
- ID: M225513
- Name: Fludarabine phosphate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428175
**Acronym:** H2H-CYSHCN
**Brief Title:** Hospital-to Home Care Care Transition Interventions (H2H-CTI) Children/Youth With Special Health Care Needs (CYSHCN)
**Official Title:** Hospital-to-Home Care Transition Intervention (H2H-CTI) for Children and Youth With Special Health Care Needs (CYSHCN)
#### Organization Study ID Info
**ID:** Pro00114934
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2028-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN. Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.
**Detailed Description:** Primary Aims Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN.
Hypothesis: Extended H2H-CTI will be associated with lower acute care use and higher confidence than focused H2H-CTI.
Secondary Aims Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups.
Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI.
Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.
The study populations consist of adult parent/caregivers' dyad and children/youth with special health care needs. Participants will be randomized to focused dose intervention after discharge or an extended dose intervention. the single dose will receive one phone call from an interventionist post discharge, the extended dose group will receive weekly phone calls for one month from an interventionist.
Analysis of data from the confidence-mediated and vulnerable patient/family characteristics-moderated pathways will address Aims 1 and 2, respectively.
During extraction of data from each site's Electronic Health Record (EHR) data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina (UNC). During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information (PHI) as much as and as early as is practical. All datasets will be stored and reviewed on a secure, cloud-based Protected Analytical and Computing Environment (PACE) at Duke and at UNC in the Secure Research Workspace (SRW).
The investigators will plan to create a Data Safety and Monitoring Board (DSMB) that includes expert clinicians who are not active study team members and are independent of the study sponsor. The DSMB will oversee the safety of volunteers participating in the study as needed.
### Conditions Module
**Conditions:**
- Health Care
- Pediatrics
- Transitional Care
- Comparative Effectiveness
- Family Engagement
**Keywords:**
- Special Needs
- Hospital to Home Care
- Children and Youth with Special Health Care Needs
- Randomized Trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 480
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Focused Dose Hospital-to-Home Care Transition Intervention
**Label:** Focused Dose Hospital-to-Home Care Transition Intervention
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Behavioral: Extended Dose Hospital-to-Home Care Transition Intervention
**Label:** Extended Dose Hospital-to-Home Care Transition Intervention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Focused Dose Hospital-to-Home Care Transition Intervention
**Description:** Focused dose H2H-CTIs will consist of a one-time post-discharge phone call completed within 72 hours post-hospital discharge by a clinical interventionist (e.g., nurse care coordinator or care manager). Calls will follow a structured template that provides empirically supported core H2H-CTI functions (follow-up care access, contingency planning, medication review, family education). The interventionist will also conduct a pre-hospital discharge clinical needs assessment with the parent.
**Name:** Focused Dose Hospital-to-Home Care Transition Intervention
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Extended Dose Hospital-to-Home Care Transition Intervention
**Description:** Extended dose H2H-CTIs will include a pre-discharge clinical needs assessment and initial phone call within 72 hours post-discharge, similar to the focused arm. After the initial contact, the dose of the extended H2H-CTI will increase as subjects receive high-intensity support during weekly post-discharge phone contacts through 30 days post-discharge. All contacts in the extended dose arm will be completed by a transition coach interventionist (e.g., nurse care coordinator or care manager) who will be formally trained on pillars of the Care Transitions Intervention© (CTI), a multi-faceted H2H-CTI that is the basis for the extended dose arm.
**Name:** Extended Dose Hospital-to-Home Care Transition Intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** 30-day, all-cause composite readmission and emergency department (ED) visit rate
**Measure:** 30-day acute care use
**Time Frame:** 30 days post-hospital discharge
**Description:** Change in caregiver-reported confidence that their child can avoid hospitalization within the next one month (1=not confident; 10=fully confident; \<5 is low confidence)
**Measure:** Caregiver confidence
**Time Frame:** Baseline, 30 days post-discharge
#### Secondary Outcomes
**Description:** All-cause composite readmission and ED visit rate at 7 days
**Measure:** 7-day acute care use
**Time Frame:** 7-days post-discharge
**Description:** All-cause composite readmission and ED visit rate at 14 days
**Measure:** 14-day acute care use
**Time Frame:** 14 days post-discharge
**Description:** All-cause readmission rate at 7, 14, and 30 days
**Measure:** Readmissions
**Time Frame:** 7, 14, 30 days post-discharge
**Description:** All-cause ED visits at 7, 14, and 30 days
**Measure:** Emergency Department (ED) visits
**Time Frame:** 7, 14, 30 days post-discharge
**Description:** Completed outpatient visits by clinical area (primary, specialty, allied health)
**Measure:** Outpatient follow-up visit attendance
**Time Frame:** 7, 14, 30 days post-discharge
**Description:** Annualized days without clinical visits (clinical days without healthcare visits)
**Measure:** Days at home
**Time Frame:** 30 and 90 days post-discharge
**Description:** Change in caregiver-reported strain (measured by scores on seven-item Caregiver Strain Questionnaire Short Form 7, CGSQ-SF7 survey), where a higher score indicates a higher level of caregiver strain.
**Measure:** Caregiver strain
**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge
**Description:** Change in caregiver-reporter PROMIS global health status survey. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.
**Measure:** Global health status
**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge
**Description:** Change in caregiver-reported mental HR-QOL as scored on the Medical Outcomes Short Form 12 (SF12) survey.
**Measure:** Caregiver mental health-related quality of life (HR-QOL)
**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge
**Description:** Pediatric Transition Experience Measure (P-TEM): eight-item, parent-reported measure of overall process and quality of hospital-to-home transitions.
**Measure:** Quality of hospital-to-home care transitions
**Time Frame:** 30 days post-discharge
**Description:** Percentage of intervention core components delivered as planned (goal: ≥80%)
**Measure:** Fidelity
**Time Frame:** approximately 90 days post-discharge
**Description:** Clinical staff and caregiver-reported composite score responses to Feasibility of Implementation, Acceptability of Implementation, and Implementation Appropriateness surveys (4 items each)
**Measure:** Feasibility Acceptability Appropriateness
**Time Frame:** approximately 90 days post-discharge
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria:
1. Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date
2. Age of hospitalized child is under 18 years old
3. Child hospitalized on a general pediatrics inpatient service line at participating site
4. Adult parent/caregiver for the child is 18 years or older
Exclusion Criteria:
* Child exclusion criteria:
1. Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility)
2. Child is a ward of the state or has an ongoing social services investigation
* Parent/caregiver exclusion criteria include:
1. Age less than 18 years old
2. Diminished capacity to provide consent/participate
3. Primary language for parent/caregiver is any language besides English
**Maximum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shannon A Widman
**Phone:** 919-681-7252
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University
**Name:** David Ming, MD
**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:** NCT06428162
**Brief Title:** a Cross-sectional Study of Pharmacovigilance Practices Adherence Between Healthcare Providers in North African Nation
**Official Title:** an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation
#### Organization Study ID Info
**ID:** 2024 PV
#### Organization
**Class:** OTHER
**Full Name:** Deraya University
### Status Module
#### Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Deraya University
#### Responsible Party
**Investigator Affiliation:** Deraya University
**Investigator Full Name:** Soad Ali
**Investigator Title:** associate professor of pharamcy practices, faculaty of pharmacy, Deraya University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** a predesignated survey about information on drug adverse events and pharmacovigilance role in detection and reporting was distributed in different regions (urban/rural/mixed) in Egypt. the survey composed of three sections; demographics, person reported or not reported and was directed for health care providers to study their awareness about pharmacovigilance cores and its practices. additionally the survey included further questions about reported adverse events.
### Conditions Module
**Conditions:**
- Drug Reaction
- Drug Hypersensitivity
- Drug Abuse
- Drug Interaction
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 300
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** three sections questioner including: demographics, reported cases, unreported cases
**Name:** questionner
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** collect recent adverse drug reaction reports
**Measure:** reported adverse drug reactions
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* all health care providers are invited to share in the study
* minimum experience required is one year in health carrier.
* accept sharing in the study
Exclusion Criteria:
* health care providers who refuse to complete all data required in the survey.
* fresh experience or participants who left health carrier
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 25 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Minya
**Country:** Egypt
**Facility:** Deraya university
**Zip:** 05673
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Hypersensitivity
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: HIGH
- As Found: Drug Reactions
- ID: M7517
- Name: Drug Hypersensitivity
- Relevance: HIGH
- As Found: Drug Hypersensitivity
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Drug Abuse
- ID: M10200
- Name: Immune System Diseases
- 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: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006967
- Term: Hypersensitivity
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
- ID: D000004342
- Term: Drug Hypersensitivity
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428149
**Brief Title:** Three Types of Papilla Incision in Periodontal Surgery
**Official Title:** Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 2937/2020
#### Organization
**Class:** OTHER
**Full Name:** Universidad de Murcia
### Status Module
#### Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidad de Murcia
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Three types of papilla incision in periodontal reconstruction techniques will be compared.
### Conditions Module
**Conditions:**
- Periodontitis
- Periodontal Diseases
- Periodontal Pocket
### 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:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.
**Intervention Names:**
- Procedure: Midline interproximal soft-tissue incision
**Label:** Midline interproximal soft-tissue incision
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.
**Intervention Names:**
- Procedure: Marginal approach by palatal incision
**Label:** Marginal approach by palatal incision
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.
**Intervention Names:**
- Procedure: Minimally invasive surgical technique
**Label:** Minimally invasive surgical technique
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Midline interproximal soft-tissue incision
**Description:** Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth.
**Name:** Midline interproximal soft-tissue incision
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Marginal approach by palatal incision
**Description:** First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed.
**Name:** Marginal approach by palatal incision
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Minimally invasive surgical technique
**Description:** The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine.
**Name:** Minimally invasive surgical technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Bleeding on probing could be positive or negative
**Measure:** Bleeding on probing
**Time Frame:** 12 months
**Description:** Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket
**Measure:** Clinical attachment level (CAL)
**Time Frame:** 12 months
**Description:** Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
**Measure:** Probing pocket depth (PD)
**Time Frame:** 12 months
**Description:** Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
**Measure:** Recession (REC)
**Time Frame:** 12 months
**Description:** Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.
**Measure:** Location of the tip of the papillae (TP)
**Time Frame:** 12 months
**Description:** Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
**Measure:** Keratinized tissue width (KT)
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.
**Measure:** Supra-alveolar attachment gain (SUPRA-AG)
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients diagnosed with periodontal disease.
* Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
* Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
* Plaque index and bleeding index less than 30%.
Exclusion Criteria:
* Systemic disease that contraindicates periodontal surgery.
* Pregnant women.
* Third molars or teeth with incorrect endodontic or restorative treatment.
**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:** ANTONIO J ORTIZ-RUIZ, MD
**Phone:** +34 868888581
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Murcia
**Contacts:**
***Contact 1:***
- **Name:** JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS
- **Phone:** +34 620538483
- **Role:** CONTACT
**Country:** Spain
**Facility:** Centro Odontologico Del Sureste Slp
**Status:** RECRUITING
**Zip:** 30007
## Derived Section
### Condition Browse Module - Ancestors
- 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
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M13423
- Name: Periodontal Pocket
- Relevance: HIGH
- As Found: Periodontal Pocket
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13419
- Name: Periodontal Diseases
- Relevance: HIGH
- As Found: Periodontal Diseases
- ID: M1112
- Name: Surgical Wound
- 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: D000010518
- Term: Periodontitis
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000010514
- Term: Periodontal Pocket
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428136
**Brief Title:** Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function
**Official Title:** Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/709
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.
**Detailed Description:** There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.
### Conditions Module
**Conditions:**
- Tibial Muscular Dystrophy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 62
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
**Label:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Conservative Treatment (CT)
**Label:** Conservative Treatment (CT)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
**Description:** Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week
Electrical muscle stimulation:
Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance
**Name:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Conservative Treatment (CT)
**Description:** Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day
**Name:** Conservative Treatment (CT)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.
**Measure:** Measured using a numeric pain rating scale (NPRS)
**Time Frame:** 12 Months
**Description:** Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up
**Measure:** Lower Extremity Functional Scale (LEFS)
**Time Frame:** 12 months
**Description:** Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.
**Measure:** ITBT length
**Time Frame:** 12 months
**Description:** Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."
**Measure:** Range of motion (ROM):
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults aged 45-65 years old (Jeong et al., 2019)
* Both genders will be included (Jeong et al., 2019)
* Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
* Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)
Exclusion Criteria:
* Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
* Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
* Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
* Neurological conditions affecting leg function (Peterson et al., 2022)
* Pregnancy (Jeong et al., 2019)
**Maximum Age:** 65 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** The University of Lahore Teaching Hospital
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020966
- Term: Muscular Disorders, Atrophic
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
### 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
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12093
- Name: Muscular Dystrophies
- Relevance: HIGH
- As Found: Muscular Dystrophy
- ID: M26047
- Name: Distal Myopathies
- Relevance: HIGH
- As Found: Tibial Muscular Dystrophy
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M22697
- Name: Muscular Disorders, Atrophic
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T3963
- Name: Muscular Dystrophy
- Relevance: HIGH
- As Found: Muscular Dystrophy
### Condition Browse Module - Meshes
- ID: D000009136
- Term: Muscular Dystrophies
- ID: D000049310
- Term: Distal Myopathies
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428123
**Brief Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP
**Official Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in Above Knee Amputee Patients: A Comparative Study
#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/708
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Superior University
#### Responsible Party
**Investigator Affiliation:** Superior University
**Investigator Full Name:** Muhammad Naveed Babur
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Limb amputation results in many types of pain, including localized pain at the stump and projected pain experienced by the patient in the location where the amputated limb used to be, known as phantom limb pain (PLP). The aim of this study is to determine the relative benefits of mirror therapy vs mental imagery in reduction of phantom limb pain. Randomized clinical trial study design will be followed.
### Conditions Module
**Conditions:**
- Phantom Limb Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 24
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Mirror Therapy on present Lower Limb
**Label:** Mirror Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: Mental Imagery on present Lower Limb
**Label:** Mental Imagery
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mirror Therapy
**Description:** Patients will be seated close to a table on which a mirror will placed vertically. The normal (i.e., no amputated limb) will be placed in front of the mirror and made to perform movements of the different joints while the patient looking into the mirror.
**Name:** Mirror Therapy on present Lower Limb
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Mental Imagery
**Description:** Mental imagery technique in which patients will be instructed to concentrate on sensations from each area of the body, including the phantom limb. Patients will be advised to imagine comfortable, thorough movement and sensation in the phantom limb, such that they could "stretch away the pain," and finally to "allow the limb to rest in a comfortable position." The actual therapy of "moving" and "feeling" the limb will lasted for 5 minutes. Patients will be asked to perform 40 minutes of meditation and imagery exercises.
**Name:** Mental Imagery on present Lower Limb
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** it is a simple and widely used tool for measuring pain intensity. It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable). Patients are asked to rate their pain by selecting the number that best describes their current pain intensity
**Measure:** The Numeric Rating (NRS)
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Both male and female gender with ages from 12 to 75 years (17).
* Individuals with a unilateral above-knee amputation (AKA) at least 6 months prior to the study.
* Experiencing phantom limb pain at least 3 months (16).
Exclusion Criteria:
* History of neurological disorders affecting pain perception or motor function (e.g., stroke, spinal cord injury, brain injury).
* Uncontrolled diabetes or other medical conditions that could affect healing or participation in the study.
* Pregnancy or breastfeeding.
**Maximum Age:** 75 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Azra Naheed Medical College, Superior University
**State:** Punjab
**Location 2:**
**City:** Lahore
**Country:** Pakistan
**Facility:** Ghurkee Hospital
**State:** Punjab
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010468
- Term: Perceptual Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010149
- Term: Pain, Postoperative
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13498
- Name: Phantom Limb
- Relevance: HIGH
- As Found: Phantom Limb
- ID: M13379
- Name: Perceptual Disorders
- 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: M13069
- Name: Pain, Postoperative
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010591
- Term: Phantom Limb
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428110
**Brief Title:** A Prospective Cohort Study on Warfarin Personalized Medication
**Official Title:** Personalized Medication Research of Warfarin Based on Vascular Aging Assessment
#### Organization Study ID Info
**ID:** 2020081
#### Organization
**Class:** OTHER
**Full Name:** Shanghai 5th People's Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-12
**Type:** ACTUAL
#### Start Date
**Date:** 2021-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Haobin Li
#### Responsible Party
**Investigator Affiliation:** Shanghai 5th People's Hospital
**Investigator Full Name:** Haobin Li
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Analyze the impact of the degree of blood vessel aging on the anticoagulant effect and bleeding risk of warfarin. Evaluating the possibility of using the degree of blood vessel aging to guide individualized use of the anticoagulant drug warfarin.
### Conditions Module
**Conditions:**
- Warfarin Sodium Causing Adverse Effects in Therapeutic Use
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 272
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** Patients taking warfarin with vascular aging group
#### Arm Group 2
**Label:** Patients taking warfarin with normal vascular group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients taking warfarin with normal vascular group
- Patients taking warfarin with vascular aging group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Numbers of patients with bleeding events during warfarin treatment
**Measure:** Numbers of patients with bleeding events
**Time Frame:** 1 year during the follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged 65 years and older, taking warfarin, with or without premature vascular aging, regardless of gender.
* Patients who have not concurrently or intermittently used anticoagulant drugs, including antiplatelet drugs, heparin, low molecular weight heparin, and non-vitamin K-dependent oral anticoagulants, such as dabigatran and apixaban.
* Signing an informed consent form before blood sample collection.
Exclusion Criteria:
* Patients who are allergic to warfarin or lactose.
* Patients who are receiving immunosuppressive agents or low molecular weight heparin anticoagulants.
* Patients with bleeding tendencies, blood disorders with platelet counts \> 400 × 10\^9 /L or \< 100 × 10\^9 /L, hemoglobin \> 169 or \< 100 g/L.
* History of peptic ulcer disease.
* Malignant tumors, severe multi-organ dysfunction or failure such as heart, liver, and kidney.
* Neurological disorders such as epilepsy.
**Maximum Age:** 100 Years
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Patients taking warfarin
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** The Fifth People's Hospital of Shanghai
**State:** Shanghai
**Zip:** 200240
#### Overall Officials
**Official 1:**
**Affiliation:** The Fifth People's Hospital of Shanghai
**Name:** Guangchun Sun
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17602
- Name: Warfarin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428097
**Acronym:** Levo
**Brief Title:** Levothyroxine Supplementation for Heart Transplant Recipients
**Official Title:** Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
#### Organization Study ID Info
**ID:** 23-39323
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
### Status Module
#### Completion Date
**Date:** 2027-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of California, San Francisco
#### 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 will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
**Detailed Description:** Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at University of California San Francisco using a double-blinded and placebo controlled randomized control trial study design. This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
### Conditions Module
**Conditions:**
- Heart Transplant Failure
- Heart Transplant Infection
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 97
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be double-blinded and randomized to receive levothyroxine.
**Intervention Names:**
- Drug: Levothyroxine
**Label:** Levothyroxine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.
**Intervention Names:**
- Drug: Normal saline
**Label:** No Levothyroxine
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Levothyroxine
**Description:** Dosing will be based on pre-existing protocols in the setting of organ donation.This will be the protocol for the first 18-38 hours starting intra-operatively after the donated heart is sewn in.
**Name:** Levothyroxine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- No Levothyroxine
**Description:** Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
**Name:** Normal saline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Measured using the vasoactive-inotropic score (VIS) scale.
VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)
**Measure:** Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.
**Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
#### Secondary Outcomes
**Description:** Measured as a yes or no diagnosis.
**Measure:** Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?
**Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
**Description:** Measured using the vasoactive-inotropic score (VIS) scale.
VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)
**Measure:** Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?
**Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
**Description:** Cardiac output is calculated using stroke volume and heart rate and measured in liters/minute.
(Cardiac output = stroke volume x heart rate)
**Measure:** Do the participants have improved cardiac output?
**Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants must be listed for heart transplantation
2. Age ≥18 years
3. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
2. Patients with a known allergy or intolerance to levothyroxine
3. Patients participating in another study evaluating an investigational drug within the past 30 days.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lea Daran
**Phone:** 415-502-4320
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lea Daran
- **Phone:** 415-502-4320
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jason Smith, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of California, San Francisco
**State:** California
**Status:** RECRUITING
**Zip:** 94143
#### Overall Officials
**Official 1:**
**Affiliation:** University of California, San Francisco
**Name:** Jason Smith, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428084
**Brief Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV
**Official Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** AN-202405.01
#### Organization
**Class:** OTHER
**Full Name:** Universitas Padjadjaran
### Status Module
#### Completion Date
**Date:** 2024-02-28
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-28
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitas Padjadjaran
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Nausea and vomiting following laparoscopic cholecystectomy remain common, with occurrence rates of 40-70% during the initial 24 hours post-operation. The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors. Consequently, employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised. Ondansetron's antiemetic properties derive from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine receptors, and Dexamethasone reduces prostaglandin production.
**Detailed Description:** Postoperative nausea and vomiting (PONV) are also known as the little problem interpreted as a seemingly less significant complication but lead to increased morbidity, longer hospital stays, increased medical costs, and diminished patient satisfaction with healthcare services. These symptoms are reported more frequently than postoperative pain, making its prevention as important as postoperative pain management. In laparoscopic cholecystectomy, the occurrence of PONV can range from 40 - 70%, which is higher than the 33 - 49% observed in other types of surgeries under general anesthesia within the first 24 hours post-procedure. The mechanism of PONV is complex, involving multiple neurotransmitters. Targeted neurotransmitter receptors in the action of antiemetic drugs include muscarinic-1-acetylcholine (M1), dopamine-2 (D2), histamine-1 (H1), 5-Hydroxytryptamine-3-serotonin (5HT3), and neurokinin1-substance P (NK1) receptors. Based on this, the prevention of postoperative nausea and vomiting is recommended using a combination of various groups of antiemetics that work on different receptors. Studies have shown that combining different antiemetic classes is more effective than using a single agent. A meta-analysis study stated that dexamethasone, ondansetron, and droperidol are the most used types of antiemetics alone or in combination. Dexamethasone with a 5HT3 antagonist such as ondansetron is the most used antiemetic combination. Another viable option includes dexamethasone with Butypherone group drugs, such as droperidol, which acts as a D2 antagonist. However, droperidol was subject to FDA black box warnings in 2003 due to its association with arrhythmias caused by QT interval prolongation. Subsequent research has suggested haloperidol, another Butypherone group drug, as a safer alternative to droperidol.
### Conditions Module
**Conditions:**
- Laparoscopic Cholecystectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 38
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 19 participants in group O received 4 mg of ondansetron intravenously.
**Intervention Names:**
- Drug: Ondansetron
**Label:** Ondansetron
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 19 participants in group H received 1 mg of Haloperidol intravenously.
**Intervention Names:**
- Drug: Haloperidol
**Label:** Haloperidol
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ondansetron
**Description:** 4 mg of ondansetron intravenously
**Name:** Ondansetron
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Haloperidol
**Description:** 1 mg of Haloperidol intravenously
**Name:** Haloperidol
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Score 0 (No nausea, no vomiting); Score 1 (Nausea present, no vomiting); Score 2 (Nausea present, vomiting present); Score 3 (Vomiting \>2 episodes in 30 minutes)
**Measure:** Nausea and Vomiting Score
**Time Frame:** 24 hours post-operation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients undergoing laparoscopic cholecystectomy
* aged 18 - 65 years
* ASA physical status 1 and 2
* Apfel score ≥2
Exclusion Criteria:
* a history of allergies
* routine use of antipsychotic drugs, steroids, antihistamines, and antiemetics before surgery
* cardiac rhythm disorders
* elevated liver enzyme levels (SGOT/SGPT) ≥5 times upper limit normal
* BMI ≥35 kg/m2
Dropout Criteria:
* if they experienced hypotension, defined as systolic blood pressure below 90 mmHg or mean arterial pressure (MAP) below 60 mmHg, or a decrease in systolic blood pressure and/or MAP greater than 20% from baseline for a duration exceeding two minutes, surgical procedures extending \>3 hours, and any alterations in the planned surgical intervention.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bandung
**Country:** Indonesia
**Facility:** Hasan Sadikin General Hospital
**State:** West Java
**Zip:** 40161
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of Medicine Universitas Padjadjaran Bandung
**Name:** Dian Mardiani, M.D
**Role:** PRINCIPAL_INVESTIGATOR
### 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
### Condition Browse Module - Browse Leaves
- ID: M12273
- Name: Nausea
- Relevance: LOW
- As Found: Unknown
- ID: M17582
- Name: Vomiting
- Relevance: LOW
- As Found: Unknown
- ID: M22074
- Name: Postoperative Nausea and Vomiting
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000000982
- Term: Antipruritics
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000058831
- Term: Serotonin 5-HT3 Receptor Antagonists
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000014150
- Term: Antipsychotic Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018492
- Term: Dopamine Antagonists
- ID: D000015259
- Term: Dopamine Agents
- ID: D000018726
- Term: Anti-Dyskinesia Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M19588
- Name: Ondansetron
- Relevance: HIGH
- As Found: Dual
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M9312
- Name: Haloperidol
- Relevance: HIGH
- As Found: Window
- ID: M215475
- Name: Haloperidol decanoate
- Relevance: HIGH
- As Found: Window
- ID: M235549
- Name: Dexamethasone acetate
- 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: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M29246
- Name: Serotonin 5-HT3 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M16904
- Name: Antipsychotic 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: M20596
- Name: Dopamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006220
- Term: Haloperidol
- ID: D000017294
- Term: Ondansetron
- ID: C000033563
- Term: Haloperidol decanoate
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428071
**Brief Title:** Decompression Versus Heat and Decompression in Knee OA
**Official Title:** Mechanical Knee Decompression With and Without Heating: Impact on Pain, Function, and Range of Motion
#### Organization Study ID Info
**ID:** H-2024-265
#### Organization
**Class:** OTHER
**Full Name:** University of Hail
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Hail
#### Responsible Party
**Investigator Affiliation:** University of Hail
**Investigator Full Name:** Hisham Mohamed Hussein
**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 controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.
**Detailed Description:** Osteoarthritis (OA) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. The knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of OA worldwide. Subjects having KOA demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (ROM), and declined functional status.
Except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. Medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability.
Interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. However, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 3 arm parallel randomized controlled trial
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** This study will be double-blinded consequently neither the assessor nor the data analyzer will be aware of the allocation sequence. Each participant will be coded using special numbers that refer to the correct allocation. The interpretation of these code numbers will be kept with the senior author who will not be involved in the treatment or assessment. The therapist will only be allowed to get the code number interpretation after the end of the allocation process and at the beginning of the study. In this study, the participants and the therapist will be blind.
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks
**Intervention Names:**
- Other: standard physical therapy
**Label:** Standard physical therapy program
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The ACUTRAC AT270 Traction System device will be used for traction. The patient will assume the supine position with the hip of the treated limb in semi-flexion and the ipsilateral knee in 25-30º flexion. 15 minutes of continuous mechanical traction using 20% of the patient's weight will be used. The session will be 15 minutes, once a day, three-times a week for 6 weeks.
This group will receive decompression and standard physical therapy.
**Intervention Names:**
- Other: standard physical therapy
- Other: knee Decompression
**Label:** knee Decompression
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session
**Intervention Names:**
- Other: standard physical therapy
- Other: knee Decompression
- Other: hot pack
**Label:** Decompression plus heating
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Decompression plus heating
- Standard physical therapy program
- knee Decompression
**Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks to all the participants
**Name:** standard physical therapy
**Other Names:**
- routine physical therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Decompression plus heating
- knee Decompression
**Description:** continuous mechanical decompression using 20% of the body weight as a traction force for 15 minutes.
**Name:** knee Decompression
**Other Names:**
- knee traction
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Decompression plus heating
**Description:** hot pack over the treated knee joint will be applied for 20 minutes. this application will be performed while the patient is receiving the decompression session
**Name:** hot pack
**Other Names:**
- superficial heating
- moist heat
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.
**Measure:** pain intensity
**Time Frame:** at base line
**Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.
**Measure:** pain intensity
**Time Frame:** after the end of the treatment (after 6 weeks)
**Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.
**Measure:** active knee range of motion
**Time Frame:** at baseline
**Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.
**Measure:** active knee range of motion
**Time Frame:** after the end of the treatment (after 6 weeks)
**Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability
**Measure:** function
**Time Frame:** at baseline
**Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability
**Measure:** function
**Time Frame:** after the end of the treatment (after 6 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Both sexes
* age between 45 to 60 years.
* Normal and or overweight categories of BMI 19-30 kg/m2
* Unilateral (grade 2 and 3) knee OA according to the Kellgren-Lawrence radiological rating scale
Exclusion Criteria:
* lower limb deformities as genu varum, valgus, flat foot
* leg length discrepancy
* previous trauma and or surgery to the knee joint
* Bone disease
* Inability to refrain from analgesic/anti-inflammatory medications for 6 weeks
**Maximum Age:** 60 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hail
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hisham Hussein
- **Role:** CONTACT
**Country:** Saudi Arabia
**Facility:** Hisham Hussein
**Zip:** 3994
### IPD Sharing Statement Module
**Description:** the data will be available with the senior author up on request
**IPD Sharing:** NO
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- 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:** NCT06428058
**Acronym:** THP-2
**Brief Title:** Training for Health Professionals 2: Aim 1
**Official Title:** Evaluating the Effects of Reproductive Health Training on Provider Behavior
#### Organization Study ID Info
**ID:** R01HD092655
**Link:** https://reporter.nih.gov/quickSearch/R01HD092655
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Minnesota
### Status Module
#### Completion Date
**Date:** 2026-09
**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:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Muhimbili University of Health and Allied Sciences
**Class:** OTHER
**Name:** Johns Hopkins University
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Minnesota
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this randomized, controlled, single blinded trial is to evaluate the medium to long-term effects of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health in Tanzania.
**Detailed Description:** All enrollees will be health students at MUHAS recruited through announcements in class, flyers on student noticeboards, and email. Students who are interested in learning more about the study can do so by asking questions of the recruiting faculty member, by going to, telephoning, or emailing the study office (at MUHAS). Students can also visit the study website. In addition, all students who contact the office will be given a copy of a flyer advertising the study and a copy of the consent documents to preview prior to participation. Students contacting the office by email will be sent electronic versions of the same documents.
Participants in Aim 1 are informed to schedule an appointment (in the month prior to the seminar) to complete a pre-evaluation. At the study site, participants complete pen and paper surveys, and are videotaped interviewing two standardized patients. Next, participants are randomized to either the intervention or waitlist control condition. Participants in the intervention will attend the 4-day sexual health seminar and complete a short post-test. In addition, at 6- and 12-month follow-up after the pre-test, participants in both arms complete surveys and two videotaped interviews (at each follow-up) and a final survey at 24-month follow-up. At the end of the study, participants assigned to the control condition can attend the seminar.
### Conditions Module
**Conditions:**
- Health Knowledge, Attitudes, Practice
- Training
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Testing of an Afrocentric sexual health curriculum for Midwifery, Nursing and Medical Students.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** A randomized, controlled, single blinded trial, stratified by health profession, of the intervention vs waitlist control.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 310
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants received a four-day comprehensive sexual health curriculum tailored for Africa.
**Intervention Names:**
- Behavioral: Comprehensive sexual health curriculum
**Label:** Comprehensive Sexual Health Curriculum
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this arm completed a follow-up survey and scheduled to receive the intervention after the end of the trial.
**Label:** Waitlist Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Comprehensive Sexual Health Curriculum
**Description:** This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing the effects on sexual health knowledge, attitudes, and sexual history and counseling skills at medium (6-) and long-term (12 and 24 months) follow-up. At the end of the intervention as compared with waitlist controls.
The intervention was a 4-day, Afrocentric, comprehensive sexual health curriculum. Tanzanian faculty wrote the curriculum in English and Kiswahili to address the most common sexual health challenges clinicians experience in Tanzania. The 4-day curriculum covers sexual health across the lifespan, lesbian, gay, bisexual, and transgender (LGBT) and sexual violence, clinical skills training, ethics, and community resources and cultural considerations.
**Name:** Comprehensive sexual health curriculum
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Sexual health knowledge was assessed using 16 multichoice items created by the research team. The items covered female sexual health concerns (2 items), sexual development and masturbation (3 items), sexual orientation (3 items), sexual violence (3 items), sexuality in middle age (3 items), sexual history taking and sexual counseling (2 items). Total scores were used for analysis (maximum total score of 16). Participants get one point for every item answer correctly. Because there are 16 items in this section, participants can have a minimum total score of 0 and a maximum total score of 16. A higher score signifies better sexual health knowledge.
**Measure:** Change in Sexual Health Knowledge Score
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
**Description:** Confidence in their ability to discuss the sexual health of patients, and confidence in their ability to discuss their patients' sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in the ability to discuss sexual health topics.
**Measure:** Change in Sexual Health Attitudes: Confidence in Ability to Discuss
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
**Description:** Confidence in their knowledge to assess the sexual health of patients, and confidence in their ability to discuss their patient's sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in having knowledge of sexual health topics.
**Measure:** Change in Sexual Health Attitudes: Confidence in Having Knowledge
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
**Description:** Skills were assessed by faculty raters assessing two videos (per each time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Each participant was rated on 10 items assessing their interpersonal communication (IC) abilities. Each item was on a 3-point scale (0=not done; 1=partially done; 2=done). The scale has a minimum score of 0 and a maximum score of 20 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 40. A higher score value signifies better interpersonal communication skills.
**Measure:** Change in Sexual Counseling Skills: Interpersonal Communications
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
**Description:** Skills were assessed by faculty raters assessing the two videos (per time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Medical history taking (MHT) was rated by six key pieces of information on a 2-point scale, where 0=not obtained information and 1=obtained information. The scale has a minimum score of 0 and a maximum score or 6 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 12.
**Measure:** Change in Sexual Counseling Skills: Medical History Taking
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
**Description:** The SHEPS Attitudes section comprises 27 items. Participants rate their level of agreement (1=strongly agree; 5=strongly disagree), with 13 items being reverse coded. Because there are 27 items in this section, participants can have a minimum total score of 27 and a maximum total score of 135. Low scores correspond to "liberal" views and high scores correspond to "conservative" views.
**Measure:** Change in Sexual Health Beliefs
**Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A health student studying at MUHAS and verified by being registered as a pre-final year midwifery, nursing or medical student (or its equivalent).
* "Pre-final" year is defined as a student who is just about to enter year 3 of nursing, or year 4 of midwifery or medicine.
* Living or studying in Tanzania
* Experienced, operationalized as having worked at least 100 hours as a health worker in a clinic, hospital or community setting so students can discuss what happens in the clinical setting
* Able to speak English and Kiswahili.
Exclusion Criteria:
* Students who will not be able to attend all days of the seminar at their health institution or be on their campus for the follow-up.
* Students who express any reservations about attending (e.g., due to religious objections)
* Students who express a fear of violence due to attending (e.g., from a spouse or relative).
* Students who attended the sexual health seminar (e.g., during THP-1 or at another site). This is to prevent a student participating more than once.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** B.R. Simon Rosser, PhD
**Phone:** 612-624-0358
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Michael Ross, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dar Es Salaam
**Contacts:**
***Contact 1:***
- **Name:** Dickson Mkoka, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lucy Mgopa, MD
- **Role:** CONTACT
**Country:** Tanzania
**Facility:** Muhimbili University of Health and Allied Sciences
#### Overall Officials
**Official 1:**
**Affiliation:** University of Minnesota
**Name:** B.R. Simon Rosser, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Only group data will be analyzed.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06428045
**Acronym:** STARLITE
**Brief Title:** STARLITE for Unresectable High-Grade Gliomas
**Official Title:** Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study
#### Organization Study ID Info
**ID:** 20231163
#### Organization
**Class:** OTHER
**Full Name:** University of Miami
### Status Module
#### Completion Date
**Date:** 2029-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Medtronic
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Miami
#### Responsible Party
**Investigator Affiliation:** University of Miami
**Investigator Full Name:** Ashish Shah
**Investigator Title:** Assistant Professor of Clinical
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.
### Conditions Module
**Conditions:**
- High Grade Glioma
**Keywords:**
- Unresectable High Grade Glioma
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** Phase 1 dose escalation/de-escalation and dose expansion design.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) on Day 0 after stereotactic needle biopsy. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and dose escalation/de-escalation of Ritonavir (RTV), to determine the recommended Phase 2 dose (RP2D) of Ritonavir. Participants will receive up to 12 months of ART.
Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days). Participants will be administered Temozolomide up to Day 180.
Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months.
**Intervention Names:**
- Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
- Drug: Abacavir
- Drug: Lamivudine
- Drug: Ritonavir
- Drug: Temozolomide
- Radiation: Focal Radiotherapy
**Label:** Part 1: STARLITE Dose Escalation/De-Escalation Cohort
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) after biopsy on Day 0. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and the recommended phase 2 dose (RP2D) of Ritonavir determined in Part 1. Participants will receive up to 12 months of ART.
Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days), and Temozolomide therapy, during and following radiotherapy up to Day 180.
Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months.
Total participation is approximately two years.
**Intervention Names:**
- Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
- Drug: Abacavir
- Drug: Lamivudine
- Drug: Ritonavir
- Drug: Temozolomide
- Radiation: Focal Radiotherapy
**Label:** Part 2: STARLITE Dose Expansion Cohort
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.
**Name:** Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
**Other Names:**
- MR-Guided LITT
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).
**Name:** Abacavir
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)
**Name:** Lamivudine
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels:
* Dose Level -1: 100mg
* Dose Level 1 (starting dose): 300mg
* Dose Level 2: 450mg
* Dose Level 3: 600mg
**Name:** Ritonavir
**Other Names:**
- Norvir
- RTV
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered 150-200 mg/m2 on days 1 through 5 of a four-week cycle for a total of six cycles of maintenance therapy.
**Name:** Temozolomide
**Other Names:**
- TMZ
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Part 1: STARLITE Dose Escalation/De-Escalation Cohort
- Part 2: STARLITE Dose Expansion Cohort
**Description:** Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist.
**Name:** Focal Radiotherapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0).
**Measure:** Number of Participants Experiencing Dose-Limiting Toxicity
**Time Frame:** Up to 28 days
**Description:** The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0).
**Measure:** Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events
**Time Frame:** Up to 12 months
#### Secondary Outcomes
**Description:** PFS is defined as percentage of participants without disease progression at time of study discontinuation.
**Measure:** Progression-Free Survival (PFS)
**Time Frame:** Up to 24 months
**Description:** Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years.
2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.
a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1).
3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists.
5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).
6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
2. Platelets ≥ 100,000 cells/mm3
3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
4. Blood urea nitrogen (BUN) ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate \> 50 mL per minute.
5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4
7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
7. Patients must be able to understand and sign informed consent.
Exclusion Criteria:
1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7).
2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
3. Patients with a previous history of HIV infection.
4. Patients with uncontrolled hepatitis B or C infection.
5. Patients who have received any surgical resection for this tumor.
a. Patients who have received an open biopsy for this disease are still eligible for participation.
6. Patients who have received chemotherapy or radiation for this disease.
7. Patients who are taking dofetilide (Section 4.10.1).
8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10.
9. Patients not eligible to obtain MRI with and without contrast.
10. Recurrent HGG.
11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
12. Fever within 48 hours of surgery (Temperature\> 38.0°C).
13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
15. Pregnant women.
16. Patients must be willing to use contraception as described in Section 4.11.
17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
18. Prisoners.
19. Adults unable to consent.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ashish Shah, MD
**Phone:** (305) 243-6946
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Macarena De La Fuente, MD
**Phone:** (305) 243-2858
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Miami
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ashish Shah, MD
- **Phone:** 305-243-6946
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Macarena De La Fuente, MD
- **Phone:** (305) 243-2858
- **Role:** CONTACT
***Contact 3:***
- **Name:** Ashish Shah, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Macarena De La Fuente, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Miami
**State:** Florida
**Zip:** 33136
#### Overall Officials
**Official 1:**
**Affiliation:** University of Miami
**Name:** Ashish Shah, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Miami
**Name:** Macarena De La Fuente, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9020
- Name: Glioma
- Relevance: HIGH
- As Found: Glioma
- 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: T2519
- Name: Glioma
- Relevance: HIGH
- As Found: Glioma
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005910
- Term: Glioma
### Intervention Browse Module - Ancestors
- ID: D000017320
- Term: HIV Protease Inhibitors
- ID: D000084762
- Term: Viral Protease Inhibitors
- ID: D000011480
- Term: Protease Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000019380
- Term: Anti-HIV Agents
- ID: D000044966
- Term: Anti-Retroviral Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000065692
- Term: Cytochrome P-450 CYP3A Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000018894
- Term: Reverse Transcriptase Inhibitors
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M21394
- Name: Ritonavir
- Relevance: HIGH
- As Found: Additional
- ID: M21243
- Name: Lamivudine
- Relevance: HIGH
- As Found: Resistant
- ID: M350770
- Name: Abacavir
- Relevance: HIGH
- As Found: Exchange
- ID: M1692
- Name: Temozolomide
- Relevance: HIGH
- As Found: Head
- ID: M25428
- Name: Anti-Retroviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M21350
- Name: Anti-HIV Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M30564
- Name: Cytochrome P-450 CYP3A Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M30537
- Name: Cytochrome P-450 Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20935
- Name: Reverse Transcriptase Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000019438
- Term: Ritonavir
- ID: D000019259
- Term: Lamivudine
- ID: C000106538
- Term: Abacavir
- ID: D000077204
- Term: Temozolomide
### Misc Info Module
- Version Holder: 2024-05-31
|
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