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protocolSection identificationModule nctId: NCT06387472, orgStudyIdInfo id: 23-007636, briefTitle: DermAI to Evaluate Human Factor of Testing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home., conditionsModule conditions: Contact Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: AI algorithm to evaluate photographs of skin test patch regions, interventions name: Allergen Patch, outcomesModule primaryOutcomes measure: Classification of test site region reaction, secondaryOutcomes measure: Classification of test site region using a 5-point scale, secondaryOutcomes measure: False Positive Rate, secondaryOutcomes measure: False Negative Rate, secondaryOutcomes measure: Early termination of testing, secondaryOutcomes measure: Participants that removed patches early, secondaryOutcomes measure: Adverse events related to allergen exposure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Laura Pacheco-Spann, role: CONTACT, phone: 904-953-0408, email: FLAQHSCS@mayo.edu, contacts name: Matthew Hall, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06387459, orgStudyIdInfo id: 2022M3C1A3090827, briefTitle: Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-14, completionDateStruct date: 2026-05-14, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Ministry of Science and ICT, descriptionModule briefSummary: This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation., conditionsModule conditions: Gait, conditions: Fall, conditions: Orthotic Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis, outcomesModule primaryOutcomes measure: Completion Rate, secondaryOutcomes measure: Dropout Rate, secondaryOutcomes measure: User Feedback, secondaryOutcomes measure: 6-Minute Walk Test, secondaryOutcomes measure: 10-Meter Walk Test, secondaryOutcomes measure: Surface Electromyography, secondaryOutcomes measure: Gait Analysis, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387446, orgStudyIdInfo id: RB-P00044611, briefTitle: Allogeneic Valve Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve., conditionsModule conditions: Valve Heart Disease, conditions: Valve Disease, Heart, conditions: Valve Disease, Aortic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Valve transplant, outcomesModule primaryOutcomes measure: Valve Regurgitation, primaryOutcomes measure: Valve Annulus Growth, primaryOutcomes measure: Leaflet Growth, secondaryOutcomes measure: Ventricular Function, secondaryOutcomes measure: Survival, eligibilityModule sex: ALL, minimumAge: 30 Days, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Sitaram Emani, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06387433, orgStudyIdInfo id: mHealth, secondaryIdInfos id: SG-222/R3-05/RDC/DUHS/1478, type: OTHER_GRANT, domain: National Institutes of Health Pakistan, briefTitle: Effectiveness of an mHealth Mobile App, acronym: mHealth, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Dow University of Health Sciences, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study we will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. We will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. We will also determine how much economic costs would be saved by using this app to improve medication compliance, conditionsModule conditions: Type II Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: mobile app use, outcomesModule primaryOutcomes measure: adherence to medication, primaryOutcomes measure: self-management among diabetics, secondaryOutcomes measure: Intervention usability, secondaryOutcomes measure: economic effectiveness of the app, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Diabetes and Endocrinology, city: Karachi, state: Sindh, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False

protocolSection identificationModule nctId: NCT06387420, orgStudyIdInfo id: AK117-206, briefTitle: A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML., conditionsModule conditions: ACUTE MYELOID LEUKEMIA; AML, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: AK117, interventions name: Azacitidine, interventions name: Venetoclax, interventions name: Placebo, outcomesModule primaryOutcomes measure: Phase 1b: Number of participants with dose limiting toxicity (DLT), primaryOutcomes measure: Phase 1b/2: Number of participants with adverse events (AEs), primaryOutcomes measure: Phase 1b/2: Composite complete remission rate (CCR), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Time to CCR (TTCCR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Duration of CCR (DoCCR), secondaryOutcomes measure: Rate of CCR Without Minimal Residual Disease (CCR MRD-), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Peak of Serum Concentration (Cmax), secondaryOutcomes measure: Anti-drug antibody (ADA), secondaryOutcomes measure: Receptor occupancy (RO), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, city: Tianjin, country: China, contacts name: Jianxiang Wang, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False

protocolSection identificationModule nctId: NCT06387407, orgStudyIdInfo id: 2024037K, briefTitle: Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-10, completionDateStruct date: 2025-11-25, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital Of Guizhou Medical University, class: OTHER, descriptionModule briefSummary: According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate., conditionsModule conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dabigatran Etexilate 150mg, outcomesModule primaryOutcomes measure: Plasma drug concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06387394, orgStudyIdInfo id: M21-416, briefTitle: A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-12-27, completionDateStruct date: 2026-01-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires., conditionsModule conditions: Masseter Muscle Prominence, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: BOTOX, interventions name: Placebo, outcomesModule primaryOutcomes measure: Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time, secondaryOutcomes measure: Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time, secondaryOutcomes measure: Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT), secondaryOutcomes measure: Percentage of Participants who Responded as "Much improved" or "Moderately improved" on the MMP Participant Self-Assessment of Change (MMP-PSAC), secondaryOutcomes measure: Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP), secondaryOutcomes measure: Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Delricht Research /ID# 249825, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70115, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Clarkston Dermatology /ID# 248888, status: RECRUITING, city: Clarkston, state: Michigan, zip: 48346, country: United States, geoPoint lat: 42.73586, lon: -83.41883, hasResults: False

protocolSection identificationModule nctId: NCT06387381, orgStudyIdInfo id: CYYY-KY-2024-048-01, briefTitle: 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases., conditionsModule conditions: PSMA, conditions: FAP, conditions: Positron-Emission Tomography, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-PSFA, outcomesModule primaryOutcomes measure: Diagnostic efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400016, country: China, contacts name: Xiaoyang Zhang, PhD, role: CONTACT, phone: 023-89011755, email: zhangxy@mail.bnu.edu.cn, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False

protocolSection identificationModule nctId: NCT06387368, orgStudyIdInfo id: HE-202303, briefTitle: Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Health Science Center of Xi'an Jiaotong University, class: OTHER, collaborators name: LinkDoc Technology (Beijing) Co. Ltd., collaborators name: Huazhong University of Science and Technology, descriptionModule briefSummary: This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer., conditionsModule conditions: Pancreatic Cancer Non-resectable, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 488, type: ESTIMATED, armsInterventionsModule interventions name: Huaier Granule, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Conversion surgery rate, secondaryOutcomes measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE), secondaryOutcomes measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387355, orgStudyIdInfo id: SURG-006-23S, briefTitle: Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization, acronym: CAD in sPAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2029-08-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization., conditionsModule conditions: Peripheral Artery Disease, conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Coronary computed topography (CT) angiography with FFR-CT, outcomesModule primaryOutcomes measure: Major adverse cardiovascular events (MACE), secondaryOutcomes measure: Cardiovascular-related death, secondaryOutcomes measure: Myocardioal infarction, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Amputation-free survival, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Mountain Regional VA Medical Center, Aurora, CO, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Clay Quint, MD PhD, role: CONTACT, phone: 210-606-2940, email: clay.quint@va.gov, contacts name: Clay Quint, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: North Florida/South Georgia Veterans Health System, Gainesville, FL, city: Gainesville, state: Florida, zip: 32608-1135, country: United States, contacts name: Salvatore Scali, MD, role: CONTACT, phone: 352-376-1611, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Louis Stokes VA Medical Center, Cleveland, OH, city: Cleveland, state: Ohio, zip: 44106-1702, country: United States, contacts name: Michael Rosenbaum, MD, role: CONTACT, phone: 216-791-3800, geoPoint lat: 41.4995, lon: -81.69541, locations facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, city: Pittsburgh, state: Pennsylvania, zip: 15240, country: United States, contacts name: Edith Tzeng, MD, role: CONTACT, phone: 866-482-7488, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, city: Nashville, state: Tennessee, zip: 37212-2637, country: United States, contacts name: John Curci, MD, role: CONTACT, phone: 615-327-4751, geoPoint lat: 36.16589, lon: -86.78444, locations facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, city: Dallas, state: Texas, zip: 75216-7167, country: United States, contacts name: Shirling Tsai, MD, role: CONTACT, phone: 469-797-2100, geoPoint lat: 32.78306, lon: -96.80667, locations facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA, city: Seattle, state: Washington, zip: 98108-1532, country: United States, contacts name: Gale Tang, MD, role: CONTACT, phone: 800-329-8387, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06387342, orgStudyIdInfo id: CF102-222PC, briefTitle: Namodenoson Treatment of Advanced Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-15, primaryCompletionDateStruct date: 2026-07-15, completionDateStruct date: 2026-12-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Can-Fite BioPharma, class: INDUSTRY, descriptionModule briefSummary: This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients., conditionsModule conditions: Pancreatic Adenocarcinoma, conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open-label study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Namodenoson 25mg, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall survival, otherOutcomes measure: Quality of Life evaluation with EORTC QLQ-C30, otherOutcomes measure: Quality of Life evaluation with EORTC QLQ-PAN26, otherOutcomes measure: Pharmacokinetics of namodenoson: Cmax, otherOutcomes measure: Pharmacokinetics of namodenoson: Cmin, otherOutcomes measure: Pharmacokinetics of namodenoson: AUC(0-12), otherOutcomes measure: Cancer antigen 19-9 (CA 19-9), otherOutcomes measure: Carcinoembryonic Antigen (CEA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rabin Medical Center Institute of Oncology, city: Petach Tikva, zip: 49100, country: Israel, contacts name: Salomon M Stemmer, MD, role: CONTACT, geoPoint lat: 32.08707, lon: 34.88747, hasResults: False

protocolSection identificationModule nctId: NCT06387329, orgStudyIdInfo id: WRNMMC-2023-0438, briefTitle: Bladder Botox UTI Antibiotic Prophylaxis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Walter Reed National Military Medical Center, class: FED, descriptionModule briefSummary: Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection., conditionsModule conditions: Overactive Bladder, conditions: Bladder Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Nonblinded, randomized, noninferiority trial of single dose nitrofurantoin vs 3 day twice daily course of nitrofurantoin for prevention of post-procedure urinary tract infections after intradetrusor onabotulinumtoxinA injections for OAB and IC/BPS., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Nitrofurantoin 100 MG, outcomesModule primaryOutcomes measure: Urinary tract infection, secondaryOutcomes measure: Urinary tract infection symptoms, secondaryOutcomes measure: Urinary retention, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Walter Reed National Military Medical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20899, country: United States, contacts name: Jordan Gisseman, MD, role: CONTACT, phone: 301-400-2468, email: jordan.gisseman.mil@health.mil, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False

protocolSection identificationModule nctId: NCT06387316, orgStudyIdInfo id: 2023-1526, briefTitle: Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Purdue University, class: OTHER, descriptionModule briefSummary: This study will focus on changes in blood sugar in response to tasting different types of sweeteners using continuous glucose monitoring (CGM) technology., conditionsModule conditions: Pre Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: solutions are coded, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: No Oral Stimulation, interventions name: Oral water stimulation, interventions name: Oral Salt Stimulation, interventions name: Oral Sucralose Stimulation, interventions name: Oral Sucrose stimulation, outcomesModule primaryOutcomes measure: Blood glucose concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Purdue University, city: West Lafayette, state: Indiana, zip: 47907, country: United States, geoPoint lat: 40.42587, lon: -86.90807, hasResults: False

protocolSection identificationModule nctId: NCT06387303, orgStudyIdInfo id: HSR230492, briefTitle: Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-12, primaryCompletionDateStruct date: 2026-05-11, completionDateStruct date: 2026-05-11, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: Moderate to severe postoperative pain is relatively common after major abdominal surgery and is associated with less than optimal surgical experience, poor quality of recovery, and development of persistent postsurgical pain. Opioids remain a major component of postoperative pain management. Side effects of opioids used for treatment of postoperative pain include constipation, pruritus, nausea, and vomiting.1,2 Enhanced recovery after surgery (ERAS) protocols involve utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morphine. IT morphine reduces postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia.3,4 Significant number of patients that receive IT morphine still experience moderate to severe postoperative pain.5 Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications; thrombocytopenia and/or coagulopathy.6Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties.7-9 It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery.10-13 Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery.14,15 IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.Our hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surgery. It offers the advantage of being a noninvasive analgesic, modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: a single blind study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 218, type: ESTIMATED, armsInterventionsModule interventions name: Methadone, interventions name: Morphine, outcomesModule primaryOutcomes measure: Quality of Recovery 15 score, primaryOutcomes measure: Overall Benefits of Analgesic Score (OBAS), primaryOutcomes measure: morphine milligram equivalent, primaryOutcomes measure: Verbal Rating Scale (VRS) pain scores, secondaryOutcomes measure: McGill Pain questionnaire score, secondaryOutcomes measure: Verbal Rating Scale (VRS) pain scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22908-0710, country: United States, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False

protocolSection identificationModule nctId: NCT06387290, orgStudyIdInfo id: 00172836, briefTitle: Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2030-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: Rutgers University, descriptionModule briefSummary: The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy., conditionsModule conditions: Chronic Pain, conditions: Prescription Opioid Misuse, conditions: Substance-Related Disorders, conditions: Pain, conditions: Narcotic-Related Disorders, conditions: Chemically-Induced Disorders, conditions: Mental Disorders, conditions: Opioid-Related Disorders, conditions: Neurologic Manifestations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Hybrid implementation-effectiveness trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigators, study staff, and statistician will be blinded to treatment condition., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness Oriented Recovery Enhancement, interventions name: Patient-Centered Chronic Pain Management Visits, outcomesModule primaryOutcomes measure: Opioid Misuse, primaryOutcomes measure: Chronic Pain, secondaryOutcomes measure: Change in Quality of Life, secondaryOutcomes measure: Opioid Dosing, secondaryOutcomes measure: Opioid Craving, secondaryOutcomes measure: PTSD Symptoms, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Generalized Anxiety, otherOutcomes measure: Decentering, otherOutcomes measure: Mindful Reappraisal of Pain Sensations, otherOutcomes measure: Savoring, otherOutcomes measure: Reappraisal, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rutgers University Primary Care Clinics, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, contacts name: Thanusha Puvananayagam, MPH, role: CONTACT, phone: 732-235-4341, email: puvanath@rwjms.rutgers.edu, contacts name: Taylor Scott, MSW, role: CONTACT, phone: 732-235-7453, email: taylor.m.scott@rutgers.edu, contacts name: Nina Cooperman, PsyD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.48622, lon: -74.45182, locations facility: University of Utah Primary Care Clinics, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Kelly A Hendrickson, MS, role: CONTACT, phone: 801-585-6354, email: kelly.hendrickson@utah.edu, contacts name: Layla Lincoln, BA, role: CONTACT, phone: 801-581-7508, email: layla.lincoln@utah.edu, contacts name: Eric L Garland, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False

protocolSection identificationModule nctId: NCT06387277, orgStudyIdInfo id: RV1551P20220376, briefTitle: Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-19, primaryCompletionDateStruct date: 2022-12-12, completionDateStruct date: 2022-12-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Pierre Fabre Dermo Cosmetique, class: INDUSTRY, descriptionModule briefSummary: The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser., conditionsModule conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: RV1551P GB3224, outcomesModule primaryOutcomes measure: Time to re-epithelialization as assessed by in vivo examination by the investigator and standardized photographs taken with a C Cube Camera®, secondaryOutcomes measure: Skin microbiota diversity from swab samples., secondaryOutcomes measure: Skin microbiota composition from swab samples., secondaryOutcomes measure: Metabolomic analysis from swab samples, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Skin Research Centre, city: Toulouse, state: Haute-Garonne, zip: 31300, country: France, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False

protocolSection identificationModule nctId: NCT06387264, orgStudyIdInfo id: 2022PHC032, briefTitle: Compont - Varicose Veins of the Lower Extremities, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-11, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, collaborators name: Peking University First Hospital, collaborators name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, collaborators name: First Affiliated Hospital Xi'an Jiaotong University, collaborators name: Liaocheng People's Hospital, collaborators name: The Second Affiliated Hospital of Chongqing Medical University, descriptionModule briefSummary: The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.Participants will:Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring., conditionsModule conditions: Varicose Veins of Lower Limb, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 188, type: ACTUAL, armsInterventionsModule interventions name: Medical Adhesive, interventions name: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter, outcomesModule primaryOutcomes measure: Clinical success rate, secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Target vascular closure rate at 12 weeks after operation., secondaryOutcomes measure: Clinical signs, secondaryOutcomes measure: Venous Clinical Severity Score (VCSS), secondaryOutcomes measure: Aberdeen Varicose Vein Questionnaire (AVVQ), secondaryOutcomes measure: Operation duration, secondaryOutcomes measure: Evaluation of product performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06387251, orgStudyIdInfo id: 2023-11-437-0003, briefTitle: Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peryam & Kroll Research Corporation, class: OTHER, collaborators name: Alticor Inc., descriptionModule briefSummary: The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being., conditionsModule conditions: Digestive Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: 30 day wellness program, outcomesModule primaryOutcomes measure: Bristol Stool Scale, primaryOutcomes measure: Digestive symptom frequency questionnaire, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Improvements in sleep, secondaryOutcomes measure: Improvements in stress, secondaryOutcomes measure: Fitness Level, secondaryOutcomes measure: Satiety Responsiveness and Hunger, secondaryOutcomes measure: Craving Intensity, secondaryOutcomes measure: Cognitive Abilities, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Skin Appearance, secondaryOutcomes measure: General Health, secondaryOutcomes measure: Program Feedback, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wilkins Research, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, geoPoint lat: 35.04563, lon: -85.30968, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-11, uploadDate: 2024-03-07T13:19, filename: ICF_000.pdf, size: 144142, hasResults: False

protocolSection identificationModule nctId: NCT06387238, orgStudyIdInfo id: PSMA-mHSPC, briefTitle: Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: 1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis., conditionsModule conditions: Prostate Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: PSMA PET/CT, outcomesModule primaryOutcomes measure: rPFS, secondaryOutcomes measure: PSA-PFS, secondaryOutcomes measure: OS, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387225, orgStudyIdInfo id: RC23_0248, briefTitle: Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients, acronym: HYPERION-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions., conditionsModule conditions: Cardiac Arrest, conditions: Neurologic Symptoms, conditions: Intensive Care Neurological Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 608, type: ESTIMATED, outcomesModule primaryOutcomes measure: Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care, primaryOutcomes measure: Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care, primaryOutcomes measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS), secondaryOutcomes measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care, secondaryOutcomes measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS), secondaryOutcomes measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHD Vendée, city: La Roche-sur-Yon, zip: 85025, country: France, contacts name: Gwenael COLIN, role: CONTACT, geoPoint lat: 46.66667, lon: -1.43333, locations facility: APHP - Hôpital Cochin, city: Paris, zip: 75679, country: France, contacts name: Sarah BENGHANEM, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH Saint-Nazaire, city: Saint-Nazaire, zip: 44600, country: France, contacts name: Julien LORBER, role: CONTACT, geoPoint lat: 47.28333, lon: -2.2, hasResults: False

protocolSection identificationModule nctId: NCT06387212, orgStudyIdInfo id: HUI0001, briefTitle: Clinical Efficacy and Safety of 35 kDa Hyaluronan Fragment (HA35) Injection in the Treatment of Skin Problems., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Nakhia Impex LLC, class: INDUSTRY, descriptionModule briefSummary: To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems., conditionsModule conditions: Skin Inflammation, conditions: Cosmetic Skin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: 35 kDa hyaluronan fragment HA35 injection, outcomesModule primaryOutcomes measure: A skin dryness scale, primaryOutcomes measure: A fair or smooth skin scale, primaryOutcomes measure: A skin pore size scale, primaryOutcomes measure: A inflammatory skin thick hardness scale, primaryOutcomes measure: An erythema color and area scale, secondaryOutcomes measure: Self-satisfaction evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nahia Impex LLC, city: Ulaanbaatar, country: Mongolia, contacts name: Mizhou Hui, role: CONTACT, phone: 13484005199, email: mizhou.hui@alumni.utoronto.ca, geoPoint lat: 47.90771, lon: 106.88324, hasResults: False

protocolSection identificationModule nctId: NCT06387199, orgStudyIdInfo id: 2024-10227, briefTitle: Alleviating Carbohydrate Counting for Patients With Type-1 Diabetes Using a Closed Loop System With Weekly Subcutaneous Semaglutide, acronym: SEMA SMA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control., conditionsModule conditions: Type 1 Diabetes, conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized placebo-controlled crossover 2x3 factorial designed trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide with 4 meal strategies, interventions name: Placebo with 4 meal strategies, outcomesModule primaryOutcomes measure: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo), secondaryOutcomes measure: Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L, secondaryOutcomes measure: Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L, secondaryOutcomes measure: Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L, secondaryOutcomes measure: Mean glucose level, secondaryOutcomes measure: Standard deviation of glucose levels as a measure of glucose variability, secondaryOutcomes measure: Percentage coefficient of variation of glucose levels, secondaryOutcomes measure: Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Area under the curve 0-2h post meal, 0-3h post peal, secondaryOutcomes measure: Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire, secondaryOutcomes measure: Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire, secondaryOutcomes measure: Average scores between interventions based on the Hypoglycemic Fear Survey - II, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Measure of body weight, secondaryOutcomes measure: Measure of body mass index, secondaryOutcomes measure: Measure of waist circumference and hip circumference, secondaryOutcomes measure: Measure of waist-to-hip ratio, secondaryOutcomes measure: Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides, secondaryOutcomes measure: Urine albumin-creatinine ratio, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Institute of the McGill University Health Centre, city: Montreal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Nicholas Sabelli, BSc, role: CONTACT, phone: (514) 377-9455, email: nicholas.sabelli@mail.mcgill.ca, contacts name: Michael Tsoukas, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmad Haidar, Ph.D, role: SUB_INVESTIGATOR, contacts name: Vanessa Tardio, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False

protocolSection identificationModule nctId: NCT06387186, orgStudyIdInfo id: 2023P003233, briefTitle: Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Elizabeth Anne Thiele, class: OTHER, collaborators name: Ajinomoto USA, INC., collaborators name: Ajinomoto Co., Inc., descriptionModule briefSummary: The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy., conditionsModule conditions: Refractory Epilepsy, conditions: Drug Resistant Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Leucine-Enriched Essential Amino Acid powder, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events, secondaryOutcomes measure: Number of participants with improved nutritional status as assessed by weight., secondaryOutcomes measure: Number of participants with improved nutritional status as assessed by body mass index (BMI)., secondaryOutcomes measure: Number of participants with improved nutritional status as assessed by serum ketone and glucose level., otherOutcomes measure: Changes in seizure frequency as assessed by seizure diary., otherOutcomes measure: Changes in behavior and cognitive function as assessed by a questionnaire., otherOutcomes measure: Changes in seizure severity and overall health as assessed by a questionnaire., eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Lydia Tsega, MD, MPH, role: CONTACT, phone: 617-726-6524, email: ltsega@mgh.harvard.edu, contacts name: Carolyn Wilson, role: CONTACT, email: cwilson41@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06387173, orgStudyIdInfo id: 23-001743, secondaryIdInfos id: NCI-2024-01240, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-04, primaryCompletionDateStruct date: 2025-01-03, completionDateStruct date: 2099-01-03, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer., conditionsModule conditions: Early Stage Breast Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Prospectively track patients who undergo cryoablation for breast cancer and record post-treatment related events., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Aletta Deranteriassian, role: CONTACT, phone: 310-206-6114, email: ADeranteriassian@mednet.ucla.edu, contacts name: Nimmi S. Kapoor, MD, role: CONTACT, phone: 818-995-8044, email: nskapoor@mednet.ucla.edu, contacts name: Nimmi S. Kapoor, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False

protocolSection identificationModule nctId: NCT06387160, orgStudyIdInfo id: ILBS-ACLF-18, briefTitle: To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-02-27, completionDateStruct date: 2026-02-27, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \<40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction, failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required., conditionsModule conditions: Acute-On-Chronic Liver Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: as per institutional protocol, outcomesModule primaryOutcomes measure: To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL], secondaryOutcomes measure: Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up, secondaryOutcomes measure: Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months., secondaryOutcomes measure: Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months, secondaryOutcomes measure: Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values, secondaryOutcomes measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days., secondaryOutcomes measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months., secondaryOutcomes measure: Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year., secondaryOutcomes measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year., secondaryOutcomes measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of liver and Biliary Sciences, city: New Delhi, state: Delhi, zip: 110070, country: India, contacts name: Dr Shreyas Sarvesh, MD, role: CONTACT, phone: 01146300000, email: shreyassarvesh@gmail.com, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False

protocolSection identificationModule nctId: NCT06387147, orgStudyIdInfo id: APHP220818, briefTitle: ORal Antibiotics In Acute Mesenteric Ischemia, acronym: ORIAMI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24/7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias., conditionsModule conditions: Acute Mesenteric Ischemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind Gentamicin + Metronidazole versus placebo, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, interventions name: Placebo, interventions name: Metronidazole, outcomesModule primaryOutcomes measure: The primary objective is to assess the efficacy of oral antibiotics compared to placebo on reducing the rate of intestinal necrosis or death (composite primary outcome) in AMI patients within 30 days following the randomisation., secondaryOutcomes measure: the rate of intestinal necrosis in the 30 days following the randomisation, secondaryOutcomes measure: the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation, secondaryOutcomes measure: the length of intestinal resection at day-30 following the randomisation, secondaryOutcomes measure: the occurrence of organ failures within the 30 days following the randomisation, secondaryOutcomes measure: the length of ICU stay, secondaryOutcomes measure: the length of hospital stay, secondaryOutcomes measure: expected minor side effects during the 14 days of treatment, secondaryOutcomes measure: hypersensitivity reactions during the 14 days of treatment, secondaryOutcomes measure: unexpected or serious adverse event throughout the duration of the study, secondaryOutcomes measure: the occurrence of healthcare-associated infection, secondaryOutcomes measure: the gentamicin during the 14 days of treatment, secondaryOutcomes measure: the metronidazole during the 14 days of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gastroentérologie-Hépatologie Beaujon, city: Clichy, zip: 92110, country: France, contacts name: Alexandre NUZZO, Dr, role: CONTACT, phone: (0)1 40 87 56 57, email: alexandre.nuzzo@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Réanimation - Beaujon, city: Clichy, zip: 92110, country: France, contacts name: Emmanuel WEISS, Dr, role: CONTACT, email: emmanuel.weiss@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Chirurgie vasculaire, city: Paris, zip: 75018, country: France, contacts name: Yves Hervé CASTIER, role: CONTACT, email: yves.castier@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Réanimation Bichat, city: Paris, zip: 75018, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06387134, orgStudyIdInfo id: TCM for early-stage LUAD, briefTitle: Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Henan University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine, conditionsModule conditions: Early Stage Lung Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lifei Xiaoji Wan, interventions name: Conventional treatment with Western medicine, outcomesModule primaryOutcomes measure: Lung Cancer Quality of Life Scale (FACT-L), primaryOutcomes measure: TCM symptoms and syndromes, primaryOutcomes measure: Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body, secondaryOutcomes measure: Tumor markers：CEA, secondaryOutcomes measure: Tumor markers：CA211, secondaryOutcomes measure: Tumor markers：squamous cell carcinoma antigen, secondaryOutcomes measure: Complete blood count: white blood cells, secondaryOutcomes measure: Complete blood count: haemoglobin, secondaryOutcomes measure: Complete blood count: Platelet, secondaryOutcomes measure: Liver function tests: ALT, secondaryOutcomes measure: Liver function tests: AST, secondaryOutcomes measure: Renal function tests: BUN, secondaryOutcomes measure: Renal function tests: Cr, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mingli Zhao, status: RECRUITING, city: Zhengzhou, country: China, contacts name: Mingli Zhao, MD, role: CONTACT, phone: 0371-66246152, email: 13937159120@163.com, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False

protocolSection identificationModule nctId: NCT06387121, orgStudyIdInfo id: IIT2023060-EC-1, briefTitle: Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival., conditionsModule conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Vincristine, interventions name: Cyclophosphamide, interventions name: Dexamethasone, interventions name: Venetoclax, interventions name: Inotuzumab ozogamicin, interventions name: Blinatumomab, interventions name: 6-mercaptopurine, interventions name: Methotrexate, interventions name: Cytarabine, interventions name: Prednisone, outcomesModule primaryOutcomes measure: MRD-negative complete remission rate measured by flow cytometry., secondaryOutcomes measure: Complete remission (CR) rate, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Relapse free survival (RFS), secondaryOutcomes measure: Disease-free Survival (DFS), secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387108, orgStudyIdInfo id: 24-0045, briefTitle: Evaluation of a Training Course for Educational Professionals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ludwig-Maximilians - University of Munich, class: OTHER, collaborators name: Prof. OTTO Beisheim Stiftung (Germany), descriptionModule briefSummary: The aim of this study is to evaluate the efficacy of a two-hour online training course on depression and mental health in childhood and adolescence in educational professionals to improve depression and mental health literacy. It will further be investigated whether the course leads to changes in attitudes towards the illness (reduction of stigma) and to an increased behavioural confidence and behavioral change in dealing with pupils with symptoms and illnesses., conditionsModule conditions: Depression, conditions: Depression in Children, conditions: Depression in Adolescence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: training course, outcomesModule primaryOutcomes measure: increase in Knowledge, primaryOutcomes measure: decrease in depression stigma, secondaryOutcomes measure: Change in helping behaviour towards pupil, secondaryOutcomes measure: Change in conficende in dealing with pupils with mental health issues, otherOutcomes measure: Evaluation of the training, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LMU University Hospital (recruitment is conducted online), status: RECRUITING, city: Munich, country: Germany, contacts name: Lisa Feldmann, PhD, role: CONTACT, email: lisa.feldmann@med.uni-muenchen.de, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False

protocolSection identificationModule nctId: NCT06387095, orgStudyIdInfo id: 2024/01/756, briefTitle: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-16, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: 1. no block, interventions name: 2. superficial parasternal block, interventions name: 3. deep parasternal block, outcomesModule primaryOutcomes measure: postoperative chronic pain, secondaryOutcomes measure: postoperative 24 hours acute pain, secondaryOutcomes measure: extubation time, secondaryOutcomes measure: icu time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kosuyolu High Education and Training Hospital, status: RECRUITING, city: Istanbul, state: Kartal, country: Turkey, contacts name: münire deniz, role: CONTACT, phone: +905556461015, email: muniredeniz.md@gmail.com, contacts name: ömer savluk, role: CONTACT, phone: +905056877440, email: dromersavluk@hotmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06387082, orgStudyIdInfo id: 2023-506-00CH1, briefTitle: A Clinical Study of HMPL-506 in Patients With Hematological Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-09, primaryCompletionDateStruct date: 2027-10-08, completionDateStruct date: 2027-12-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hutchmed, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase., conditionsModule conditions: Hematological Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: HMPL-506, outcomesModule primaryOutcomes measure: Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs), primaryOutcomes measure: Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug, primaryOutcomes measure: Efficacy evaluation: Anti-tumor efficacy evaluation., secondaryOutcomes measure: Incidence of adverse events (AEs) and Relationship to Study Drug, secondaryOutcomes measure: Adverse Events Associated with Dose Modifications, secondaryOutcomes measure: Evaluate electrocardiogram (ECG) assessments., secondaryOutcomes measure: Complete response rate (CR rate), secondaryOutcomes measure: Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate, secondaryOutcomes measure: Composite complete response (CRc) rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh), secondaryOutcomes measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) +incomplete hematological recovery (CRi), secondaryOutcomes measure: Time to disease response (TTR), secondaryOutcomes measure: Duration of Complete response (CR)+Complete response with partial recovery of hematology (CRh), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Relapse-free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Pharmacokinetic analysis-Maximum concentration (Cmax), secondaryOutcomes measure: Pharmacokinetic analysis: Peak time (Tmax), secondaryOutcomes measure: Pharmacokinetic analysis: Clearance half-life (T1/2), secondaryOutcomes measure: Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC0-t), otherOutcomes measure: Evaluate the changes of the Pharmacodynamic Biomarker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387069, orgStudyIdInfo id: 2023-306-00CH1, briefTitle: A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-06-03, completionDateStruct date: 2028-06-29, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hutchmed, class: INDUSTRY, descriptionModule briefSummary: An open-label design is adopted in this study. All patients will first undergo pre-screening to determine the mutation status of IDH, and all patients will be assigned to the registry study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results. Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed independently and will be analyzed separately for statistical hypothesis testing. Patients in both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web Response System (IWRS) into the test or control group, patients in the test group will receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD \[starting from Cycle 2 (C2)\]. Patients in the control group will receive salvage chemotherapy (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC), conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 316, type: ESTIMATED, armsInterventionsModule interventions name: HMPL-306 Regimen, interventions name: Salvage Chemotherapy Regimen, outcomesModule primaryOutcomes measure: OS, secondaryOutcomes measure: CR rate, secondaryOutcomes measure: CR + CRh rate, secondaryOutcomes measure: CR + CRi + CRh rate, secondaryOutcomes measure: Assessments for PK (pharmacokinetics), secondaryOutcomes measure: Assessments for PK (pharmacokinetics), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Transfusion-dependence conversion ratio, secondaryOutcomes measure: HSCT(hematopoietic stem cell transplantation) ratio, secondaryOutcomes measure: Safety, secondaryOutcomes measure: Quality of life (QoL), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: EFS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387056, orgStudyIdInfo id: XMYY-2024KY040, briefTitle: Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO), acronym: SEGNO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer., conditionsModule conditions: Locally Advanced Prostate Cancer, conditions: Oligometastatic Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Rezvilutamide, interventions name: Goserelin Microspheres for Injection, interventions name: Docetaxel, interventions name: Pamiparib, interventions name: Cisplatin, interventions name: Tislelizumab, outcomesModule primaryOutcomes measure: Rate of clinical complete response (cCR), primaryOutcomes measure: Rate of pathological minimal residual disease (pMRD), primaryOutcomes measure: Rate of complete pathologic response (pCR), secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361000, country: China, contacts name: Kaiyan Zhang, M.D., role: CONTACT, phone: +865922139714, email: zkyken@163.com, contacts name: Haichao Huang, M.D., role: CONTACT, phone: +865922139493, email: hhc_pku@163.com, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False

protocolSection identificationModule nctId: NCT06387043, orgStudyIdInfo id: MS and Balance, briefTitle: Effects of Balance Exercises Performed With Different Visual Stimuli, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, collaborators name: Fenerbahce University, collaborators name: Biruni University, collaborators name: Istanbul University - Cerrahpasa (IUC), descriptionModule briefSummary: The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Balance exercises with Virtual Reality Glasses, interventions name: Balance Exercises with Stroboscopic Glasses, interventions name: Balance Exercises with Visual-Based Metaphor Training, interventions name: Traditional Balance Exercises, outcomesModule primaryOutcomes measure: Functional Near Infrared Ray Spectroscopy (fNIRS), primaryOutcomes measure: Timed Up and Go Test, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Timed 25 Step Walking Test, secondaryOutcomes measure: Lower Extremity Motor Coordination Test, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Quality of Life in Multiple Sclerosis Patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Haliç University, city: Istanbul, state: Eyüpsultan, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06387030, orgStudyIdInfo id: APHP231662, briefTitle: EDN and Eosinophilic Esophagitis, acronym: OesEDN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: INRAe - Micalis Institute - Jouy en Josas, descriptionModule briefSummary: Eosinophilic esophagitis is a recent and emerging chronic disease, secondary to eosinophilic infiltration of the esophageal mucosa leading to esophageal dysfunction. The diagnosis of this pathology, and monitoring of the efficacy of therapies, relies on the assessment of eosinophilic density on esophageal biopsies: follow-up requires numerous digestive endoscopies under general anesthesia, at each therapeutic change, to assess remission. The search for non-invasive biomarkers of active eosinophilic esophagitis is therefore a subject of major interest.The first step is to study EDN (Eosinophil-Derived Neurotoxin), a protein secreted when eosinophils are activated. Several studies have investigated the association between serum EDN, EDN on esophageal brushing or esophageal biopsies with eosinophilic esophagitis activity, and the results look promising. Urinary EDN is associated with atopy but has not been studied in eosinophilic esophagitis. EDN is a biomarker of interest because it is stable over time and, above all, can be measured routinely, making it applicable to routine patient management and care. Our main objective is to evaluate the correlation of EDN in urine, blood and esophageal brushings with the eosinophilic infiltrate counted on esophageal biopsies in patients undergoing upper GI endoscopy at Trousseau Hospital for suspected eosinophilic esophagitis, or as part of the re-evaluation of known eosinophilic esophagitis under treatment.Finally, esophageal and salivary dysbiosis has been described in eosinophilic esophagitis without direct evidence of its influence on esophageal inflammation and disease. Our secondary objective is to study the esophageal, salivary and fecal microbiota in these same patients in order to describe the composition, alpha and beta-diversity of bacterial and mycological flora between patients and controls, as well as their association with pathology, and to propose possible alternative therapies aimed at modulating the esophageal and/or salivary microbiota in the management of eosinophilic esophagitis.This study will be carried out on a cohort of pediatric patients followed up in the pediatric nutrition and gastroenterology department of the Trousseau-APHP hospital and hospitalized for upper GI endoscopy, either as part of a suspected case of eosinophilic esophagitis, or during follow-up of a previously known case of eosinophilic esophagitis. Blood, urine, stool, saliva, 4 additional esophageal biopsies and esophageal brushings were collected on the day of the digestive endoscopy. Depending on the eosinophilic densitý on the biopsies, subjects will be classified into either the "patient with active eosinophilic esophagitis" group, the "patient with eosinophilic esophagitis in remission" group, or the "control without eosinophilic esophagitis" group. The investigator aim to include 60 patients undergoing upper GI endoscopy, at least half of whoḿ will have active or remitting eosinophilic esophagitis.Furthermore, the study of the immunological, allergological and metabolomic signature of this disease is essential to enable the identification of new biomarkers to guide the creation of models combining several biomarkers predictive of eosinophilic density on esophageal biopsies. In a second step, the concentration of a panel of cytokines in blood and esophageal biopsies, the allergic sensitization profile in blood and esophageal biopsies, and an untargeted description of esophageal metabolomics will be compared between groups. In terms of clinical prospects, the investigator plan to develop a patient follow-up strategy based on the biomarkers studied, which is better adapted to clinical practice, better tolerated by patients and less costly than repeated endoscopies with esophageal biopsies., conditionsModule conditions: Eosinophilic Esophagitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, interventions name: Esophageal biopsies, interventions name: Unstimulated saliva sampling, interventions name: Urine sampling, interventions name: Stool sampling, outcomesModule primaryOutcomes measure: Urinary EDN, secondaryOutcomes measure: Serum EDN, secondaryOutcomes measure: Endoluminal EDN, secondaryOutcomes measure: Eosinophilic infiltrate of esophagus, secondaryOutcomes measure: Blood eosinophilia, secondaryOutcomes measure: Concentrations of a panel of serum cytokines, secondaryOutcomes measure: Concentrations of a panel of cytokines on esophageal biopsies, secondaryOutcomes measure: Esophagus metabolomic profile, secondaryOutcomes measure: Total IgE and tryptase, secondaryOutcomes measure: Food or respiratory allergens sensitivity, secondaryOutcomes measure: Serum specific-IgE, secondaryOutcomes measure: Specific-IgE on esophageal biopsies, secondaryOutcomes measure: Composition of esophageal, salivary and fecal microbiota, secondaryOutcomes measure: Quality of life scale, secondaryOutcomes measure: Symptom score, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital, city: Paris, zip: 75012, country: France, contacts name: Anaïs LEMOINE, Doctor, role: CONTACT, phone: 00 33 1 44 73 60 69, email: anais.lemoine@aphp.fr, contacts name: Patrick TOUNIAN, Professor of University, role: CONTACT, phone: 00 33 1 44 73 60 69, email: p.tounian@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06387017, orgStudyIdInfo id: RCAPHM22_0411, briefTitle: Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway, acronym: BIOCEPTION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2029-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique Hopitaux De Marseille, class: OTHER, descriptionModule briefSummary: Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation., conditionsModule conditions: Smoking-related Pathology, conditions: Atheroma, conditions: Non-progressive Cancer > 5 Years, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: blood sampling, interventions name: stool collection, interventions name: low dose CT scan, outcomesModule primaryOutcomes measure: biomarker group validation, secondaryOutcomes measure: Describe changes in biomarkers over time, secondaryOutcomes measure: Describe and compare biomarkers according to clinical characteristics of participants, secondaryOutcomes measure: Describe changes in quality of life over time, secondaryOutcomes measure: Describe changes in smoking habits over time, secondaryOutcomes measure: Describe changes in anxiety over time, secondaryOutcomes measure: Describe and compare biomarkers according to medical characteristics of participants, secondaryOutcomes measure: Describe and compare biomarkers according to geographic characteristics of participants, secondaryOutcomes measure: Describe and compare biomarkers according to socioeconomic characteristics of participants, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assistance Publique Hopitaux de Marseille, status: RECRUITING, city: Marseille, country: France, contacts name: David Boulate, role: CONTACT, email: david.boulate@ap-hm.fr, geoPoint lat: 43.29551, lon: 5.38958, hasResults: False

protocolSection identificationModule nctId: NCT06387004, orgStudyIdInfo id: 2023-A01971-44, briefTitle: Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2), acronym: R-2D-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2026-02-18, completionDateStruct date: 2026-02-18, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hopital Forcilles, class: OTHER, descriptionModule briefSummary: Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy.Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy., conditionsModule conditions: Swallowing Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 112, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy., secondaryOutcomes measure: Inter and intra-rater evaluation, otherOutcomes measure: Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development, otherOutcomes measure: Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy., otherOutcomes measure: Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy., otherOutcomes measure: Predictive capacity of ultrasound markers for anticipating quality of life assessed by the MD Anderson Dysphagia Inventory questionnaire at 30 days of radiotherapy treatment, otherOutcomes measure: Ratio of ultrasound measurements of tongue, hyoid bone, and suprahyoid muscle morphology and/or movement successfully conducted, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Forcilles, status: RECRUITING, city: Férolles-Attilly, zip: 77150, country: France, contacts name: Aymeric Le Neindre, PhD, role: CONTACT, phone: +33160646093, email: aleneindre@cognacq-jay.fr, contacts name: Carlos DIAZ LOPEZ, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.73184, lon: 2.63088, hasResults: False

protocolSection identificationModule nctId: NCT06386991, orgStudyIdInfo id: 2024/206, briefTitle: Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year., conditionsModule conditions: Endodontic Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments, outcomesModule primaryOutcomes measure: Determining and recording pain levels on the pain scale between treatment sessions, secondaryOutcomes measure: In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography., eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi, status: RECRUITING, city: Kayseri, zip: 38039, country: Turkey, contacts name: ERASLAN AKYÜZ, role: CONTACT, phone: 4447138, phoneExt: 0352, email: ipekemamak@hotmail.com, contacts name: ÜSTÜN, role: CONTACT, phone: 4447138, phoneExt: 0352, email: yustun@erciyes.edu.tr, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False

protocolSection identificationModule nctId: NCT06386978, orgStudyIdInfo id: 2024/209, briefTitle: Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: This study was designed as a prospective, randomized observational clinical trial.A total of 90 adult women were included in the study performed elective cesarean section.After excluding patients, the care of 90 was included and 3 of these amounts were reserved.TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;, conditionsModule conditions: Obstetric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Transverse Facia Plane Block (TAP Block), interventions name: Transversalis Facia Plane Block (TFP Block), interventions name: Control, outcomesModule primaryOutcomes measure: VAS score evaluation, secondaryOutcomes measure: time until the first analgesic request, otherOutcomes measure: Satisfaction/Dissatisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Erciyes University, status: RECRUITING, city: Kayseri, zip: 38039, country: Turkey, contacts name: Kudret Dogru, Prof, role: CONTACT, phone: +905334735112, email: kdogru@erciyes.edu.tr, contacts name: Sibel Pehlivan, Asssoc Prof., role: CONTACT, phone: +905052532919, email: sibelpehlivan@erciyes.edu.tr, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False

protocolSection identificationModule nctId: NCT06386965, orgStudyIdInfo id: 010.99/15, briefTitle: Sevoflurane Versus Propofol: Effect on Stress Response, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Dr. Lutfi Kirdar Kartal Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods., conditionsModule conditions: Propofol, conditions: Sevoflurane, conditions: Inflammatory Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: taking blood sample, outcomesModule primaryOutcomes measure: compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital, city: İstanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06386952, orgStudyIdInfo id: 02/2024-2025, briefTitle: To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Diabetes Foundation, India, class: OTHER, collaborators name: National Diabetes Obesity and Cholesterol Foundation, descriptionModule briefSummary: Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no humpObjectives: To correlate single and double hump with diabetes complication T2DM patient will be recruited from endocrine OPD1. Clinical History and Examination:1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.2. Complications Assessment: Patient will be analyzed for:Micro Vascular(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFRMacro Vascular1. Low ABI/PAD2. CVD-MI/PTCA/CABG/Heart Failure3. CVS-Stroke/ TIA/Carotid Blockage \>50%, conditionsModule conditions: Type 2 Diabetes Mellitus With Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Double Hump increases diabetes complications, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anoop misra, status: RECRUITING, city: New Delhi, state: Delhi, zip: 110048, country: India, contacts name: Anoop Misra, MD, role: CONTACT, phone: 01149101222, email: anoopmisra@gmail.com, contacts name: Koel Dutta, M.Sc, role: CONTACT, phone: 01149101222, email: koelduttac@gmail.com, contacts name: Anoop Misra, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Koel Dutta, M.Sc, role: SUB_INVESTIGATOR, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False

protocolSection identificationModule nctId: NCT06386939, orgStudyIdInfo id: 01/2024-2025, briefTitle: Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Diabetes Foundation, India, class: OTHER, collaborators name: National Diabetes Obesity and Cholesterol Foundation, descriptionModule briefSummary: Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complicationMethodology:T2DM patient will be recruited from endocrine OPD1. Clinical History and Examination:1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.2. Complications Assessment: Patient will be analysed for:Micro Vascular(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFRMacro Vascular1. Low ABI/PAD2. CVD-MI/PTCA/CABG/Heart Failure3. CVS-Stroke/ TIA/Carotid Blockage \>50%, conditionsModule conditions: Type 2 Diabetes Mellitus With Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Moderate to Severe Acanthosis Nigricans increases diabetes complications, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anoop misra, status: RECRUITING, city: New Delhi, state: Delhi, zip: 110048, country: India, contacts name: Anoop Misra, MD, role: CONTACT, phone: 01149101222, email: anoopmisra@gmail.com, contacts name: Koel Dutta, M.Sc, role: CONTACT, phone: 01149101222, email: koelduttac@gmail.com, contacts name: Anoop Misra, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Koel Dutta, M.Sc, role: SUB_INVESTIGATOR, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False

protocolSection identificationModule nctId: NCT06386926, orgStudyIdInfo id: P.T.REC/012/005075, briefTitle: Radial Shockwave Versus Ultrasound Phonophoresis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy), exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy), conditionsModule conditions: Supraspinatus Tendinitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Electro Therapy, outcomesModule primaryOutcomes measure: change in the thickness of supraspinatus tendon, primaryOutcomes measure: change in pain intesity, primaryOutcomes measure: Change in shoulder range of motion, secondaryOutcomes measure: Function of the Upper Limb, secondaryOutcomes measure: measure weight in kg and height in cm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo university, city: Giza, country: Egypt, contacts name: Shady Alkadry, role: CONTACT, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06386913, orgStudyIdInfo id: IRB-20-1065, briefTitle: Implementation and Evaluation of Measurement-Based Care (MBC) Training, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-09, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Carilion Clinic, class: OTHER, collaborators name: Virginia Polytechnic Institute and State University, descriptionModule briefSummary: The purpose of this study is to get feedback on a new standardized Measurement-Based Care (MBC) provider training program., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinicians completed pre- and post-training surveys. Patient satisfaction was assessed prior to and after clinician training., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Training, outcomesModule primaryOutcomes measure: Digital MBC training rate, primaryOutcomes measure: Assessing feasibility of a novel digital MBC training in mental health providers (FIM), primaryOutcomes measure: Assessing acceptability of a novel digital MBC training program in mental health providers (AIM), primaryOutcomes measure: Assessing appropriateness of a novel digital MBC training program in mental health providers (IAM), otherOutcomes measure: Monitoring and Feedback Attitudes Scale (MFA), otherOutcomes measure: Attitudes Towards Standardized Assessment Scales: Monitoring and Feedback (ASA-MF), otherOutcomes measure: Clinician Attitude and Satisfaction Survey (CASS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Carilion Clinic, city: Roanoke, state: Virginia, zip: 24014, country: United States, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False

protocolSection identificationModule nctId: NCT06386900, orgStudyIdInfo id: S67595, briefTitle: The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, descriptionModule briefSummary: This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists., conditionsModule conditions: Overreaching, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Cyclist, outcomesModule primaryOutcomes measure: Serum metabolome abundance of cyclists participating in a Grand Tour, primaryOutcomes measure: Sleep efficiency during the Grand Tour, primaryOutcomes measure: Total sleep time during the Grand Tour, primaryOutcomes measure: Blood haemoglobin concentration, secondaryOutcomes measure: Wakefulness after sleep onset, secondaryOutcomes measure: Light sleep, secondaryOutcomes measure: Deep sleep, secondaryOutcomes measure: REM sleep, secondaryOutcomes measure: Red blood cell concentration, secondaryOutcomes measure: Subjective fatigue, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: KU Leuven, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06386887, orgStudyIdInfo id: CASE1824, briefTitle: Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are:* Is it feasible to use intermittent fasting during neoadjuvant chemotherapy?* Is it safe to use intermittent fasting during neoadjuvant chemotherapy?* Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy?Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes.Participants will:* Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy.* All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing.* Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week., conditionsModule conditions: Epithelial Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two arm, randomized, controlled study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participants' cross-sectional skeletal muscle areas will be measured. Measurements will be performed on CT scans obtained within 4-6 weeks of treatment initiation (with a 7-day screening window) by a fellowship-trained, experienced radiologist and imaging specialist in consensus who will be blinded to participant clinical variables and treatment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Fasting, interventions name: Neoadjuvant chemotherapy, outcomesModule primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by self-reported assessment, primaryOutcomes measure: Intermittent fasting compliance as measured by self-reported assessment, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Pre body composition, primaryOutcomes measure: Post body composition, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 2, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 3, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 4, secondaryOutcomes measure: Chemotherapy related toxicity at post treatment, secondaryOutcomes measure: ESAS Score at Enrollment, secondaryOutcomes measure: ESAS Score at Cycle 2, secondaryOutcomes measure: ESAS Score at Cycle 3, secondaryOutcomes measure: ESAS Score at Post Treatment, secondaryOutcomes measure: SF-125 Score at Baseline, secondaryOutcomes measure: SF-125 Score at Cycle 2, secondaryOutcomes measure: SF-125 Score at Cycle 3, secondaryOutcomes measure: SF-125 Score at Post Treatment, secondaryOutcomes measure: Pre Quality of Life (QLQ-C30) Score at Baseline, secondaryOutcomes measure: Post Quality of Life (QLQ-C30) Score Post Treatment, secondaryOutcomes measure: Pre Functional Assessment (FACT-O) Score at Baseline, secondaryOutcomes measure: Post Functional Assessment (FACT-O) Score Post Treatment, secondaryOutcomes measure: AIM Survey Score at Cycle 2, secondaryOutcomes measure: AIM Survey Score at Cycle 3, secondaryOutcomes measure: AIM Survey Score at Post Treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386874, orgStudyIdInfo id: BQ7, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False

protocolSection identificationModule nctId: NCT06386861, orgStudyIdInfo id: 24.210.01e, briefTitle: Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM)., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Boston College, class: OTHER, descriptionModule briefSummary: the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population., conditionsModule conditions: Adult ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 500 English-speaking Latinx individuals 500 Spanish-speaking Latinx individuals, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Attitudes Toward Genomics and Precision Medicine (English), interventions name: Attitudes Toward Genomics and Precision Medicine (Spanish), outcomesModule primaryOutcomes measure: Psychometric properties, secondaryOutcomes measure: Health literacy/numeracy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston College, status: RECRUITING, city: Chestnut Hill, state: Massachusetts, zip: 02467, country: United States, contacts name: Andrew A Dwyer, FNP-BC, PhD, role: CONTACT, phone: 617-552-1711, email: andrew.dwyer@bc.edu, contacts name: Maria Pineros-Leano, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.33065, lon: -71.16616, hasResults: False

protocolSection identificationModule nctId: NCT06386848, orgStudyIdInfo id: 2023PI187, briefTitle: Strategy to Adapt Botulinum Toxin Doses in Dystonia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.We we ll study the increase of the dose injected over the time, the side effects...The hypothesis is that we inject smaller doses than we could regarding the recommandations, conditionsModule conditions: Dystonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin, outcomesModule primaryOutcomes measure: First dose of botulinum toxin injected, U, secondaryOutcomes measure: Effective dose of botulinum toxin, secondaryOutcomes measure: Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06386835, orgStudyIdInfo id: CREC2021.724-T, briefTitle: Collagen Paste vs Mucosal Advancement Flap for FIA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano., conditionsModule conditions: Fistula-in-ano, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: Collagen Paste, interventions name: Mucosal advancement, outcomesModule primaryOutcomes measure: Clinical healing of Fistula-in-ano, secondaryOutcomes measure: 30-day morbidity, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Postoperative pain score, secondaryOutcomes measure: Faecal incontinence rate, secondaryOutcomes measure: Hospital readmission rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, Chinese University of Hong Kong, status: RECRUITING, city: Shatin, state: New Territories, country: Hong Kong, contacts name: Kaori Futaba, role: CONTACT, email: kfutaba@surgery.cuhk.edu.hk, geoPoint lat: 22.38333, lon: 114.18333, locations facility: Prince of Wlaes Hospital, status: RECRUITING, city: Sha Tin, country: Hong Kong, contacts name: Kaori Futaba, role: CONTACT, phone: 35051495, email: kfutaba@surgery.cuhk.edu.hk, geoPoint lat: 22.38333, lon: 114.18333, hasResults: False

protocolSection identificationModule nctId: NCT06386822, orgStudyIdInfo id: 23-1562H, briefTitle: The Development of a System for the Measurement of Tremor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Bionics Institute of Australia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia). The main questions it aims to answer are:* Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality (VR)* Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR* Can Essential Tremor be quantified using a measurement system* Can Dystonia be quantified using a measurement system.Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour., conditionsModule conditions: Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group assignment. Up to 90 participants with Essential Tremor and up to 30 Control participants will be recruited to the study. Both groups will undergo the same intervention., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HTC Vive Pro Eye, interventions name: HTC Vive Tracker, interventions name: Valve Index Controllers, interventions name: Biokin, outcomesModule primaryOutcomes measure: To quantify Essential Tremor and dystonia using a measurement system, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Royal Victorian Eye and Ear Hospital, status: RECRUITING, city: East Melbourne, state: Victoria, zip: 3002, country: Australia, contacts name: Sarah Osborn, BSc, role: CONTACT, phone: 061396677500, email: sosborn@bionicsinstitute.org, geoPoint lat: -37.81667, lon: 144.9879, hasResults: False

protocolSection identificationModule nctId: NCT06386809, orgStudyIdInfo id: 2024 -25, briefTitle: Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Bandırma Onyedi Eylül University, class: OTHER, descriptionModule briefSummary: Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions., conditionsModule conditions: Bruxism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TAVNS, interventions name: Exercise program, outcomesModule primaryOutcomes measure: Pain Severity, primaryOutcomes measure: Oral Health Quality of Life, primaryOutcomes measure: Stress Level, primaryOutcomes measure: Sleep Quality, primaryOutcomes measure: Pressure Pain Threshold, primaryOutcomes measure: Muscle Activation Measurement, primaryOutcomes measure: Measurement of heart rate variability/ Autonomic nervous system evaluation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bandırma Onyedi Eylül University, city: Balıkesir, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False

protocolSection identificationModule nctId: NCT06386796, orgStudyIdInfo id: Asw.U./867/11/23, briefTitle: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels., conditionsModule conditions: Acute Kidney Injury, conditions: Critical Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Early detection of acute kidney injury., primaryOutcomes measure: Diagnosis of acute kidney injury., secondaryOutcomes measure: To grade the severity of AKI., secondaryOutcomes measure: To predict clinical outcome (clinical improvement), secondaryOutcomes measure: To predict clinical outcome (necessity for renal replacement therapy), secondaryOutcomes measure: To predict clinical outcome (death), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aswan University, status: RECRUITING, city: Aswan, zip: 81528, country: Egypt, contacts name: Soudy S Hammad, role: CONTACT, phone: +201014761523, email: soudi.salah@aswu.edu.eg, contacts name: Tarek S Hemaida, role: CONTACT, phone: 01007363190, email: dr.tarek@aswu.edu.eg, contacts name: mohamed H Abolwafa, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.09082, lon: 32.89942, hasResults: False

protocolSection identificationModule nctId: NCT06386783, orgStudyIdInfo id: Asw.U./823 /7/23, briefTitle: Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anesthesia ; Peritoneal Symptomatic Effects, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms., conditionsModule conditions: Dexmedetomidine, conditions: Fentanyl, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: concealed based on study drugs assigned to each group \& to conduct this double -blinded clinical trials, our study drugs will be prepared by the senior anesthesiologist who won't be involved in further observations of the patients and neither patients nor outcome assessor will be aware of which drugs they will receive., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine Injection [Precedex], interventions name: Fentanyl HCl, outcomesModule primaryOutcomes measure: intraoperative peritoneal symptoms during appendectomy., secondaryOutcomes measure: Assessment of motor block with Modified Bromage scale, secondaryOutcomes measure: Degree of post-operative analgesia, secondaryOutcomes measure: Assessment of sensory block by using pin prick method, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aswan University, status: RECRUITING, city: Aswan, zip: 81528, country: Egypt, contacts name: Soudy S Hammad, MD, role: CONTACT, phone: +201014761523, email: soudi.salah@aswu.edu.eg, contacts name: Ahmed M Hagag, MSc, role: CONTACT, phone: 01141097536, contacts name: Ayman M Eldemrdash, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed A Mahmoud, MD, role: SUB_INVESTIGATOR, geoPoint lat: 24.09082, lon: 32.89942, hasResults: False

protocolSection identificationModule nctId: NCT06386770, orgStudyIdInfo id: Asw.U./742 /2/23, briefTitle: Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries., conditionsModule conditions: Erector Spinae Block, conditions: Dexmedetomidine, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine Injection [Precedex], interventions name: Bupivacaine Hydrochloride, interventions name: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML), outcomesModule primaryOutcomes measure: The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics., secondaryOutcomes measure: 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period ., secondaryOutcomes measure: Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed, secondaryOutcomes measure: Intraoperative hemodynamic parameters blood pressure, secondaryOutcomes measure: Minimum alveolar concentration (MAC) requirements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aswan University, status: RECRUITING, city: Aswan, zip: 81511, country: Egypt, contacts name: soudy S hammad, role: CONTACT, phone: +201014761523, email: soudi.salah@aswu.edu.eg, contacts name: tarek S hemaida, role: CONTACT, phone: 01007363190, email: dr.tarek@aswu.edu.eg, contacts name: Rehab A Mahmoud, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 24.09082, lon: 32.89942, hasResults: False

protocolSection identificationModule nctId: NCT06386757, orgStudyIdInfo id: Asw.U. 911/3/24, briefTitle: Incidence Of Nasal and Oropharyngeal Bleeding: Video Laryngoscopy Versus Direct Laryngoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension, conditionsModule conditions: Maxillofacial Injuries, conditions: Nasal Bleeding, conditions: Intubation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: These prospective, randomized, controlled clinical trials will be conducted at Aswan University Hospital on 62 patients who are scheduled for maxillofacial surgeries requiring nasal intubation., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Combined Video Laryngoscopy (VL) and Bougie, interventions name: Combined Direct Laryngoscopy (DL) and Bougie, outcomesModule primaryOutcomes measure: Incidence of nasal and oropharyngeal bleeding, secondaryOutcomes measure: Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff, secondaryOutcomes measure: Overall rate of first trial success., secondaryOutcomes measure: The use of magill forceps, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aswan University, status: RECRUITING, city: Aswan, zip: 81528, country: Egypt, contacts name: Soudy S Hammad, MD, role: CONTACT, phone: +201014761523, email: soudi.salah@aswu.edu.eg, contacts name: Mohammed E Yahia, MSc, role: CONTACT, phone: 01125257916, contacts name: Mohammed A Alazhary, MD, role: SUB_INVESTIGATOR, geoPoint lat: 24.09082, lon: 32.89942, hasResults: False

protocolSection identificationModule nctId: NCT06386744, orgStudyIdInfo id: DUS-AUBD-01, briefTitle: Dusquetide for the Treatment of Behcet's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Soligenix, class: INDUSTRY, descriptionModule briefSummary: This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks., conditionsModule conditions: Behçet Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Dusquetide, outcomesModule primaryOutcomes measure: Number of Oral Ulcers, primaryOutcomes measure: Number of Genital Ulcers, secondaryOutcomes measure: Pain of Oral Ulcers, secondaryOutcomes measure: Pain of Genital Ulcers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06386731, orgStudyIdInfo id: SYNEO-01, briefTitle: Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-05, primaryCompletionDateStruct date: 2022-11-25, completionDateStruct date: 2023-04-28, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Goztepe Prof Dr Suleyman Yalcın City Hospital, class: OTHER, descriptionModule briefSummary: One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy., conditionsModule conditions: Neonatal Jaundice, conditions: Phototherapy Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ACTUAL, armsInterventionsModule interventions name: Intermittent Phototherapy, outcomesModule primaryOutcomes measure: Comparison of the effectiveness of CPT and IPT, secondaryOutcomes measure: Comparison of side effect frequency of CPT and IPT, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 15 Days, stdAges: CHILD, contactsLocationsModule locations facility: Göztepe Prof. Dr. Suleyman Yalcin City Hopital, city: Kadıköy, state: İstanbul, zip: 34730, country: Turkey, geoPoint lat: 40.62015, lon: 29.22536, hasResults: False

protocolSection identificationModule nctId: NCT06386718, orgStudyIdInfo id: USG for ped art can, briefTitle: Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ankara University, class: OTHER, descriptionModule briefSummary: Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients., conditionsModule conditions: Ulnar and Radial Artery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 184, type: ESTIMATED, outcomesModule primaryOutcomes measure: Determining the Diameter and Depth at different angles, primaryOutcomes measure: Comparing Ulnar and Radial Artery Diameters Across Age Groups, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ankara University School Of Medicine, status: RECRUITING, city: Ankara, zip: 06100, country: Turkey, contacts name: Zeynep Altinbas, MD, role: CONTACT, phone: +905356082156, email: szpostalcioglu@gmail.com, contacts name: Ozlem S Can, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Zeynep S Altinbas, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06386705, orgStudyIdInfo id: TSN084-101CH, briefTitle: A Study of TSN084 in Patients With Advanced Malignant Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-20, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tyligand Bioscience (Shanghai) Limited, class: INDUSTRY, descriptionModule briefSummary: TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China., conditionsModule conditions: Malignant Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: TSN084, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (TEAE), secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to Cmax (Tmax), secondaryOutcomes measure: Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Jie Wang, MD, PhD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking university cancer hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Minglei Zhuo, MD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06386692, orgStudyIdInfo id: Aarhus111, briefTitle: Community Based Promotion of Physical Activity in Nepal (COBIN-PA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity., conditionsModule conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: FCHVs-led community based educational physical activity intervention, outcomesModule primaryOutcomes measure: Mean moderate to vigorous physical activity, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06386679, orgStudyIdInfo id: R016634005, briefTitle: Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-08-17, primaryCompletionDateStruct date: 2023-11-23, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, descriptionModule briefSummary: Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Ten elderly patients from both gender diagnosed with knee osteoarthritis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with amniotic fluid mesenchymal stem cells developed for chondrogenic treatment. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: allogenic amniotic fluid mesenchymal stem cell, outcomesModule primaryOutcomes measure: Incidence of abnormal physical examination, primaryOutcomes measure: Incidence of abnormal vital sign, primaryOutcomes measure: Incidence of abnormal laboratory test results, primaryOutcomes measure: Incidence of abnormal ECG parameters, primaryOutcomes measure: The type of Adverse event (AE), numbers of AE and proportion of patients with AE., secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: Degree of cartilage change, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Siriraj Hospital, city: Bangkok Noi, state: Bangkok, zip: 10700, country: Thailand, geoPoint lat: 13.76266, lon: 100.47798, hasResults: False

protocolSection identificationModule nctId: NCT06386666, orgStudyIdInfo id: RLRL-CTP, briefTitle: A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-04-29, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Suzhou Kerui Medical Technology Co., Ltd, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal., conditionsModule conditions: Intervertebral Disc Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Disposable fibrous ring sutures, outcomesModule primaryOutcomes measure: Success rate of suture, secondaryOutcomes measure: Annulus fibril cleft decreased in value, secondaryOutcomes measure: Reduced proportion of annular fibril cleft, secondaryOutcomes measure: Intraoperative blood loss, secondaryOutcomes measure: Suture time, secondaryOutcomes measure: Treatment success rate, secondaryOutcomes measure: VAS pain score (lower back, bilateral lower limbs), secondaryOutcomes measure: SF-12 rating, secondaryOutcomes measure: ODI index, otherOutcomes measure: Recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06386653, orgStudyIdInfo id: [123I]I-DARPIN-Ec1, briefTitle: Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tomsk National Research Medical Center of the Russian Academy of Sciences, class: OTHER, collaborators name: Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences, collaborators name: Uppsala University, descriptionModule briefSummary: The study should evaluate the biological distribution of \[123I\]I-DARPIN-Ec1 in patients with lung and ovarian cancerThe primary objective are:1. To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.2. To evaluate dosimetry of \[123I\]I-DARPIN-Ec1 .3. To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage.The secondary objective are:1. To compare the obtained \[123I\]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients., conditionsModule conditions: Lung Cancer, conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic Test: whole body study and SPECT with [123I]I-DARPIN-Ec1, outcomesModule primaryOutcomes measure: Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%), primaryOutcomes measure: SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts), primaryOutcomes measure: SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts), primaryOutcomes measure: Tumor-to-background ratio (SPECT), secondaryOutcomes measure: Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections., secondaryOutcomes measure: Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections., secondaryOutcomes measure: Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections, secondaryOutcomes measure: Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TomskNRMC, city: Tomsk, country: Russian Federation, geoPoint lat: 56.49771, lon: 84.97437, hasResults: False

protocolSection identificationModule nctId: NCT06386640, orgStudyIdInfo id: 0784, briefTitle: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure, acronym: FIT-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-27, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Leicester, class: OTHER, descriptionModule briefSummary: Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach, conditionsModule conditions: Chronic Heart Failure, conditions: Frailty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Development, outcomesModule primaryOutcomes measure: Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF, primaryOutcomes measure: Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF, primaryOutcomes measure: Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration, primaryOutcomes measure: Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Glenfield Hospital, status: RECRUITING, city: Leicester, country: United Kingdom, contacts name: Shirley Sze, role: CONTACT, email: kyss1@leicester.ac.uk, geoPoint lat: 52.6386, lon: -1.13169, hasResults: False

protocolSection identificationModule nctId: NCT06386627, orgStudyIdInfo id: Skoltech-CNBR3, secondaryIdInfos id: 21-75-30024, type: OTHER_GRANT, domain: Russian Science Foundation, briefTitle: Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Skolkovo Institute of Science and Technology, class: OTHER, collaborators name: Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia, descriptionModule briefSummary: The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. We recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, we also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Stimulus response task, interventions name: Transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Atypical shape of lateralized readiness potential, secondaryOutcomes measure: Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skolkovo Institute of Science and Technology (Skoltech), city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False

protocolSection identificationModule nctId: NCT06386614, orgStudyIdInfo id: BDNF, briefTitle: Effects of TDCS of the Frontal Lobe on Cognitive Function and BDNF in PSCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Dalian Medical University, class: OTHER, descriptionModule briefSummary: The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:* \[Search for effective treatments of cognitive impairment after stroke\]* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Routine treatment, interventions name: Transcranial Direct Current Stimulation, outcomesModule primaryOutcomes measure: BDNF, secondaryOutcomes measure: Cognitive function level, secondaryOutcomes measure: Executive function level, secondaryOutcomes measure: Memory function level, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University, status: COMPLETED, city: DaLian, state: Liaoning, zip: 116021, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Lily, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116021, country: China, contacts name: Yang Tu, role: CONTACT, phone: 18875214238, email: 715700399@qq.com, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False

protocolSection identificationModule nctId: NCT06386601, orgStudyIdInfo id: 2024-15804, briefTitle: Surgical Ergonomics Education During Minimally Invasive Gynecologic Skills Training, acronym: SEE MIGS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are:* Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury?* Will the participants feel that learning and practicing such lessons helps to avoid injury while at work?Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved.Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills.There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working.Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed., conditionsModule conditions: Work-related Injury, conditions: Work Related Upper Limb Disorder, conditions: Surgery, conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified into junior residents (1st and 2nd year) and senior residents (3rd and 4th year) and then randomized to the intervention group or control group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ergonomics Knowledge, interventions name: Ergonomics Feedback/Guided Practice, outcomesModule primaryOutcomes measure: Number of participants that would recommend incorporating surgical ergonomics lecture/module as a permanent part of the didactic curriculum., primaryOutcomes measure: Number of participants that would recommend incorporating surgical ergonomics hands-on skills session with feedback and guided practice on surgical ergonomics as a permanent part of the didactic curriculum., primaryOutcomes measure: Change from baseline in surgical ergonomic knowledge score over two sessions, primaryOutcomes measure: Change from baseline in surgical ergonomic practice based on rapid upper limb assessment (RULA) score over two sessions, primaryOutcomes measure: Change from baseline in surgical ergonomic practice based on rapid entire body assessment (REBA) score over two sessions, primaryOutcomes measure: Change from baseline in surgical ergonomic practice based on revised hand strain index (RHSI) score over two sessions, secondaryOutcomes measure: Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice., secondaryOutcomes measure: Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice., secondaryOutcomes measure: Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice, secondaryOutcomes measure: Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center, city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Alexandria Connor, MD, role: CONTACT, phone: 859-512-4053, email: alconnor@montefiore.org, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False

protocolSection identificationModule nctId: NCT06386588, orgStudyIdInfo id: 2024P000610, briefTitle: The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Closed loop auditory stimulation during sleep, outcomesModule primaryOutcomes measure: Changes in sleep physiology, primaryOutcomes measure: Changes in functional connectivity of the hippocampus and thalamus, primaryOutcomes measure: Changes in hippocampal activation during motor sequence task (MST), primaryOutcomes measure: Changes in hippocampal microstructural integrity, secondaryOutcomes measure: Greater gains in typing speed over rest breaks during MST training (micro-offline gains), secondaryOutcomes measure: Sleep dependent memory consolidation (SDMC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Dara Manoach, PhD, role: CONTACT, phone: 617-724-6148, email: manoachlab@gmail.com, contacts name: Lindsey Jones, MS, role: CONTACT, phone: 617-702-2368, email: manoachlab@gmail.com, contacts name: Dara Manoach, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, hasResults: False

protocolSection identificationModule nctId: NCT06386575, orgStudyIdInfo id: suprainguinal, briefTitle: Suprainguinal Fascia Iliaca Block in Knee Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Konya City Hospital, class: OTHER, descriptionModule briefSummary: Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia., conditionsModule conditions: Analgesia, conditions: Anesthesia, Local, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Suprainguinal fascia iliaca block will be applied to the patients at the end of the surgery., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: control group; Patients who received physiological saline, interventions name: suprainguinal fascia block; Patients receiving local anesthetic, outcomesModule primaryOutcomes measure: quality of recovery-15T, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386562, orgStudyIdInfo id: 2023-07489-01, briefTitle: Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: The goal of this pilot randomized controlled trial is to learn about effects and experiences of an internet-based parenting program for parents of children and adolescents with behavioral problems (e.g., aggressive or defiant behavior).The main questions the study aims to answer are:* What are the preliminary effects of the internet-based parenting program?* What is the level of parents' engagement in the parenting program?* How do parents perceive the program?Families will be randomized to a version of an internet-based parenting program with support provided from family guides (psychologists) through chat messages in the program, or to the same internet-based parenting program with additional phone/digital support-meetings. Parents will answer quantitative measurements questions before, during, and after treatment. Parents will also be asked to participate in a qualitative interview after the program. Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support., conditionsModule conditions: Child Behavior Problem, conditions: Disruptive Behavior, conditions: Oppositional Defiant Disorder, conditions: Conduct Problems, conditions: Parent-Child Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program, interventions name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support, outcomesModule primaryOutcomes measure: Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale)., primaryOutcomes measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale, primaryOutcomes measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale, secondaryOutcomes measure: Mean change from baseline in child wellbeing on the KIDSCREEN-10, secondaryOutcomes measure: Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire, secondaryOutcomes measure: Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale, secondaryOutcomes measure: Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale, secondaryOutcomes measure: Mean change in family warmth, secondaryOutcomes measure: Mean change in family conflicts, secondaryOutcomes measure: Mean change in parental satisfaction with the week, secondaryOutcomes measure: Parental experiences of the internet-based parenting program explored through qualitative interviews, secondaryOutcomes measure: Parental experiences of each module in the internet-based parenting program, secondaryOutcomes measure: Parental experiences of the whole internet-based parenting program, secondaryOutcomes measure: Parental use of the internet-based parenting program: homework tasks, exercises, secondaryOutcomes measure: Parental use of the internet-based parenting program: time spent working with the program, secondaryOutcomes measure: Parental use of the internet-based parenting program: drop out rate, otherOutcomes measure: Background information, otherOutcomes measure: Working alone or with partner in the parenting program, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386549, orgStudyIdInfo id: HSEARS20220424001, briefTitle: Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-14, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: LIAO Peng, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?* Is tele-rehabilitation more effective in improving scar management in children with burns injuries?* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries?, conditionsModule conditions: Burns, conditions: Tele-rehabilitation, conditions: Scar, conditions: Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: tele-rehabilitation, outcomesModule primaryOutcomes measure: The scars of children with burns, primaryOutcomes measure: The quality and outcomes of care for burn children, secondaryOutcomes measure: psychological stress of caregvers, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hongkong Poly Uiniversity, status: RECRUITING, city: Hong Kong, country: China, contacts name: Fu Jinfeng, role: CONTACT, phone: +8613987695500, email: fujinfeng@etyy.cn, geoPoint lat: 22.39407, lon: 114.13737, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-05-31, uploadDate: 2024-04-17T21:22, filename: ICF_000.pdf, size: 59989, hasResults: False

protocolSection identificationModule nctId: NCT06386536, orgStudyIdInfo id: 2023-1796, briefTitle: Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Sylvie Nadeau, class: OTHER, descriptionModule briefSummary: This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype.The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike., conditionsModule conditions: Aging, conditions: Mobility Limitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A single-subject reversal study design (A-B) will be used. During the A and B phases, the participants will undergo training with either the VI-TRIVEL or a conventional stationary bike., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Intelligent stationary bike, interventions name: Conventional stationary bilke, outcomesModule primaryOutcomes measure: Walking ability and functional capacity, primaryOutcomes measure: Leg strength and endurance, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Quality of life, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: L'Institut de réadaptation Gingras-Lindsay-de-Montréal, status: RECRUITING, city: Montréal, state: Quebec, zip: H3S 2J4, country: Canada, contacts name: Sylvie Nadeau, PhD, role: CONTACT, phone: 5143436111, phoneExt: 12253, email: sylvie.nadeau@umontreal.ca, contacts name: Roua Walha, PhD, role: CONTACT, phone: 8199195095, email: roua.walha@umontreal.ca, contacts name: Sylvie Nadeau, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Roua Walha, PhD, role: SUB_INVESTIGATOR, contacts name: Julie Soulard, PhD, role: SUB_INVESTIGATOR, contacts name: Cyril Duclos, PhD, role: SUB_INVESTIGATOR, contacts name: Nicolas Berryman, PhD, role: SUB_INVESTIGATOR, contacts name: Elaine Deguise, PhD, role: SUB_INVESTIGATOR, contacts name: Claudine Auger, PhD, role: SUB_INVESTIGATOR, contacts name: Dahlia Kairy, PhD, role: SUB_INVESTIGATOR, contacts name: David Labbé, PhD, role: SUB_INVESTIGATOR, contacts name: Rachid Aissaoui, PhD, role: SUB_INVESTIGATOR, contacts name: Gabriel Moisan, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False

protocolSection identificationModule nctId: NCT06386523, orgStudyIdInfo id: 23-AOI-03, briefTitle: Standardization of a New Psychophysical Olfactory Test, TODA2, acronym: TODA-STAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-05-23, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st, conditionsModule conditions: Patients Without an Olfactory Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Passage of olfactory tests, outcomesModule primaryOutcomes measure: Passage of olfactory tests:, primaryOutcomes measure: Passage of olfactory tests:, primaryOutcomes measure: Passage of olfactory tests:, secondaryOutcomes measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test, secondaryOutcomes measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386510, orgStudyIdInfo id: 2025-5517, briefTitle: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke, acronym: CN-NINM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, descriptionModule briefSummary: Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicentered stratified randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Strength training, interventions name: Cranial nerve non-invasive neuromodulation, outcomesModule primaryOutcomes measure: Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale, primaryOutcomes measure: Change in UL functional performance on the Wolf Motor Function Test, primaryOutcomes measure: Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres., secondaryOutcomes measure: Change in participants' subjective real life functional UL performance on the Motor Activity Log, secondaryOutcomes measure: Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension, secondaryOutcomes measure: Change in resting motor threshold of the affected and unaffected FDI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital, city: Laval, state: Quebec, zip: H7V 1R2, country: Canada, contacts name: Marie-Helene Boudrias, PhD, role: CONTACT, phone: 514-398-5457, email: mh.boudrias@mcgill.ca, contacts name: Marie-Helene Boudrias, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.56995, lon: -73.692, locations facility: Centre de recherche sur le vieillissement, city: Sherbrooke, state: Quebec, zip: J1H 4C4, country: Canada, contacts name: Marie-Helene Milot, PhD, role: CONTACT, phone: 819-780-2220, phoneExt: 45277, email: marie-helene.milot@usherbrooke.ca, contacts name: Maureen Ahiatsi, MsC, role: CONTACT, phone: 819-780-2220, phoneExt: 45691, email: maureen.rudy.sandra.ahiatsi@usherbrooke.ca, geoPoint lat: 45.40008, lon: -71.89908, locations facility: CIRRIS, city: Québec, zip: G1M2S8, country: Canada, contacts name: Andréanne Blanchette, PhD, role: CONTACT, phone: 418-529-9141, phoneExt: 46896, email: andreanne.blanchette@fmed.ulaval.ca, contacts name: Andréanne Blanchette, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False

protocolSection identificationModule nctId: NCT06386497, orgStudyIdInfo id: 2023-D0100, briefTitle: Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease, acronym: Somnomat Casa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: ETH Zurich, descriptionModule briefSummary: This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Nocturnal translational vestibular stimulation, outcomesModule primaryOutcomes measure: Evaluation of acceptability and feasibility, primaryOutcomes measure: Evaluation of acceptability and feasibility, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2), secondaryOutcomes measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2), secondaryOutcomes measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2), secondaryOutcomes measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2), secondaryOutcomes measure: Restless Legs Syndrome Rating Scale (IRLS), secondaryOutcomes measure: Restless Legs Syndrome Rating Scale (IRLS), secondaryOutcomes measure: Restless Legs Syndrome Rating Scale (IRLS), secondaryOutcomes measure: Restless Legs Syndrome Rating Scale (IRLS), secondaryOutcomes measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), secondaryOutcomes measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), secondaryOutcomes measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), secondaryOutcomes measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), secondaryOutcomes measure: Parkinson's disease quality of life questionnaire (PDQ-39), secondaryOutcomes measure: Parkinson's disease quality of life questionnaire (PDQ-39), secondaryOutcomes measure: Parkinson's disease quality of life questionnaire (PDQ-39), secondaryOutcomes measure: Parkinson's disease quality of life questionnaire (PDQ-39), secondaryOutcomes measure: Patients' Global Impression of Severity Scale (PGIS), secondaryOutcomes measure: Patients' Global Impression of Change Scale (PGICS), secondaryOutcomes measure: Patients' Global Impression of Change Scale (PGICS), secondaryOutcomes measure: Patients' Global Impression of Change Scale (PGICS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Insel Gruppe AG, University Hospital Bern, city: Bern, zip: 3010, country: Switzerland, geoPoint lat: 46.94809, lon: 7.44744, locations facility: ETH Zurich, Sensory-Motor Systems Lab, IRIS, city: Zürich, zip: 8092, country: Switzerland, contacts name: Robert Riener, Prof., role: CONTACT, phone: 44 632 66 79, phoneExt: +41, email: robert.riener@hest.ethz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False

protocolSection identificationModule nctId: NCT06386484, orgStudyIdInfo id: 2019-05463, briefTitle: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-02, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight., conditionsModule conditions: Repetitive Head Impact, conditions: Selective Head and Neck Cooling, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PolarCap System, outcomesModule primaryOutcomes measure: Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight., secondaryOutcomes measure: Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden, status: RECRUITING, city: Lund, state: Skane, zip: 22100, country: Sweden, contacts name: Ali Al-husseini, MD, Medical doctor, PhD stud, role: CONTACT, phone: +46707267261, email: Ali.al-husseini@med.lu.se, contacts name: Ali Al-husseini, role: SUB_INVESTIGATOR, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False

protocolSection identificationModule nctId: NCT06386471, orgStudyIdInfo id: 24093, briefTitle: Personalized GI Motility Responses to Diet, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-06-12, completionDateStruct date: 2025-06-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, descriptionModule briefSummary: The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses., conditionsModule conditions: Nutritional and Metabolic Diseases, conditions: Gastrointestinal Dysfunction, conditions: Cardiovascular Diseases, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, controlled, crossover, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Appearance, flavor, and texture of whole grain vs refined bread could not be masked, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Whole grain rye bread, interventions name: Refined grain rye bread, outcomesModule primaryOutcomes measure: Gastrointestinal Pressure (mmHg), primaryOutcomes measure: Luminal pH (pH units), primaryOutcomes measure: Temperature (degrees celcius), primaryOutcomes measure: Gastrointestinal Transit Time (hours:minutes), primaryOutcomes measure: Blood Glucose, primaryOutcomes measure: Triglycerides, primaryOutcomes measure: Total Cholesterol, primaryOutcomes measure: HDL cholesterol, primaryOutcomes measure: LDL cholesterol, primaryOutcomes measure: Lipopolysaccharide Binding Protein, secondaryOutcomes measure: Microbiome, secondaryOutcomes measure: Metabolomics, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 63 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Illinois at Urbana-Champaign, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Brett R Loman, PhD, RD, role: CONTACT, contacts name: Brett R Loman, PhD, RD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.11059, lon: -88.20727, hasResults: False

protocolSection identificationModule nctId: NCT06386458, orgStudyIdInfo id: AT-01, briefTitle: Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-08, primaryCompletionDateStruct date: 2023-05-09, completionDateStruct date: 2023-05-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hangzhou NOYA MedTech Co. Ltm., class: INDUSTRY, descriptionModule briefSummary: This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups., conditionsModule conditions: Heart Diseases, conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 177, type: ACTUAL, armsInterventionsModule interventions name: AThrough radiofrequency transseptal puncture system, interventions name: Traditional mechanical transseptal puncture needle, outcomesModule primaryOutcomes measure: Transseptal puncture success rate., secondaryOutcomes measure: Initial transseptal puncture success rate., secondaryOutcomes measure: Time required to successfully complete the transseptal puncture., secondaryOutcomes measure: Number of attempts needed to successfully complete the transseptal puncture., secondaryOutcomes measure: Ratio of atrial septal puncture failures that cross over to the opposite group., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The 7th People's Hospital of Zhengzhou, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital with Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Tianjin Chest Hospital, city: Tianjin, state: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Ningbo University, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False

protocolSection identificationModule nctId: NCT06386445, orgStudyIdInfo id: XJTU1AF-CRF-2023-XK013, briefTitle: Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications., conditionsModule conditions: Stem Cell Transplant Complications, conditions: Acute Graft Versus Host Disease, conditions: Acute Kidney Injury, conditions: Major Adverse Cardiac Events, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Serum metabolomics sequencing, outcomesModule primaryOutcomes measure: acute graft versus host disease, secondaryOutcomes measure: acute kidney injury, secondaryOutcomes measure: major adverse cardiac events, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386432, orgStudyIdInfo id: RG1124189, secondaryIdInfos id: NCI-2024-02453, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: RG1124189, type: OTHER, domain: Fred Hutch/University of Washington Cancer Consortium, secondaryIdInfos id: U54CA132381, type: NIH, link: https://reporter.nih.gov/quickSearch/U54CA132381, briefTitle: EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Fred Hutchinson Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: National Cancer Institute Center to Reduce Cancer Health Disparities, collaborators name: New Mexico State University, descriptionModule briefSummary: This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking., conditionsModule conditions: Cigarette Smoking-Related Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Smartphone App-delivered Smoking Cessation Intervention, interventions name: Smartphone App-delivered Smoking Cessation Intervention, interventions name: Health Promotion and Education, interventions name: Health Promotion and Education, interventions name: Biospecimen Collection, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Participant satisfaction, primaryOutcomes measure: Number of logins to the assigned application, secondaryOutcomes measure: Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products, secondaryOutcomes measure: Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products, secondaryOutcomes measure: Self-reported 30-day PPA from all nicotine/tobacco products, secondaryOutcomes measure: Biochemically confirmed 30-day PPA from all nicotine/tobacco products, secondaryOutcomes measure: Self-reported 7-day PPA from cigarette smoking, secondaryOutcomes measure: Self-reported 30-day PPA from cigarette smoking, secondaryOutcomes measure: Change in Contemplation Ladder scores, secondaryOutcomes measure: Change in acceptance of tobacco-use triggers, secondaryOutcomes measure: Change in values-guided action, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fred Hutch/University of Washington Cancer Consortium, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Jaimee Heffner, role: CONTACT, phone: 206-667-7314, email: jheffner@fredhutch.org, contacts name: Jaimee Heffner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06386419, orgStudyIdInfo id: CKJX839A1IN03, briefTitle: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-08-08, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium., conditionsModule conditions: Primary Hypercholesterolemia, conditions: Mixed Dyslipidemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: open label assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: inclisiran, outcomesModule primaryOutcomes measure: Incidence and type of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Mean change in LDL-C from baseline to Day 300., secondaryOutcomes measure: Proportion of the participants with ≥50% LDL-C reduction on Day 300, secondaryOutcomes measure: Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk, secondaryOutcomes measure: Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386406, orgStudyIdInfo id: ORL-ORT-040, briefTitle: This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain, acronym: TAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life., conditionsModule conditions: Plantar Fascitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: TAP insole, outcomesModule primaryOutcomes measure: Change in pain severity according to visual analog scale, secondaryOutcomes measure: Change in pain severity according to visual analog scale, secondaryOutcomes measure: Subjective functional recovery based on the Foot Function Index (FFI) score [, secondaryOutcomes measure: Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ), secondaryOutcomes measure: Patient satisfaction on a 0-10 numeric rating scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: EOC, status: RECRUITING, city: Lugano, zip: 6900, country: Switzerland, contacts name: Martin Riegger, Dr.med, role: CONTACT, phone: +41 (0) 91 811 70 29, email: RicercaOrtopedia.ORL@eoc.ch, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False

protocolSection identificationModule nctId: NCT06386393, orgStudyIdInfo id: HHSP233201500048I-75P00120F370, briefTitle: Survey on Where Parents Look for and Find Information and How They Use Information When Selecting Child Care, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National Opinion Research Center, class: OTHER, collaborators name: Office of Planning, Research & Evaluation, collaborators name: Urban Institute, descriptionModule briefSummary: The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is contracting with NORC at the University of Chicago to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to make CCEE selections. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts. This study is part of the Consumer Education and Parental Choice in Early Care and Education (CEPC) project.The study will select a nationally representative sample from NORC's probability-based AmeriSpeak panel. The AmeriSpeak panel provides sample coverage of approximately 97 percent of the U.S. population. It currently contains 48,900 panel members age 13 and over residing in over 40,000 households. U.S. households are randomly selected with a known, non-zero probability from the NORC National Frame, and then recruited by mail, telephone, and by field interviewers face-to-face. NORC's in-person recruitment enhances representativeness for young adults, lower socio-economic households, non-internet households, and other households that are typically hard to reach for statistical surveys of the population.The survey respondents are AmeriSpeak panelists of at least 18 years of age who have indicated that they have a young child in the household (under the age of 6 years, but not in kindergarten). If a household has two or more panel members who reside in a household with a young child, one will be selected at random to complete the survey, with preference given to parents/legal guardians. Selected panelists will be asked questions to confirm eligibility for the survey, including that the household has at least one child under the age of 6 but not in kindergarten. The study is designed to include parents and legal guardians across race/ethnicity, education level, and gender from the full spectrum of geographic locations. To include families who may not have English as a preferred language, a Spanish version of the survey will be provided. The survey will include parents and legal guardians using many kinds of CCEE and those who use parental care only to see if there are differences in how information is used depending on care type. In addition, the study will include understudied subgroups, such as parents who speak a language other than English, to help inform consumer education efforts. The survey is intended to produce findings that are generalizable to the larger population of parents with children under the age of 6, but not in kindergarten., conditionsModule conditions: Searching for and Selecting Child Care in the US, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2196, type: ESTIMATED, outcomesModule primaryOutcomes measure: Primary sources of information about child care, primaryOutcomes measure: How parents assess the people, places, or things that may offer CCEE information, primaryOutcomes measure: What types of CCEE related information parents look for, primaryOutcomes measure: Information about the last time parents made a decision about CCEE and what information they tried to learn about at that time, secondaryOutcomes measure: Characteristics and experiences of the household and types of CCEE being used, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NORC at the University of Chicago, city: Chicago, state: Illinois, zip: 60603, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False

protocolSection identificationModule nctId: NCT06386380, orgStudyIdInfo id: IRE-4906, briefTitle: Adversity and Its Association With the Development and Expression of Rheumatic Diseases, acronym: RD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran, class: OTHER, descriptionModule briefSummary: Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.With this background, we wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness., conditionsModule conditions: RhA - Rheumatoid Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Rheumatic diseases Mistreatment Scale (RDMS), interventions name: Routine assessment of patient index data 3 (RAPID-3), interventions name: Health Assessment Questionnaire (HAQ), interventions name: WHOQOL-BREF, interventions name: Depression, Anxiety and Stress Scale (DASS-21), interventions name: Brief Resilient Coping Scale, interventions name: Expression of CDKN2A /p16INK4a, interventions name: Immunophenotype of leukocyte subpopulations, interventions name: Telomere length, interventions name: Cellular senescence, outcomesModule primaryOutcomes measure: Adversity and senescence in patients with rheumatoid arthritis, secondaryOutcomes measure: Eexpression of the p16INK4a gene in CD3+, secondaryOutcomes measure: Telomere length, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386367, orgStudyIdInfo id: MHNO-001, briefTitle: Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Myanmar Health Network Organization, class: OTHER, collaborators name: Chulalongkorn University, collaborators name: Ministry of Health and Sports, Myanmar, descriptionModule briefSummary: Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable., conditionsModule conditions: Buddhist Monks, conditions: Health Education, conditions: Malaria, conditions: Monastery-based, conditions: Myanmar, conditions: Preventive Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 501, type: ACTUAL, armsInterventionsModule interventions name: Monastery-based health education by Buddhist monks, outcomesModule primaryOutcomes measure: Malaria knowledge and preventive practices, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Myanmar Health Network Organization, city: Yangon, zip: 11091, country: Myanmar, geoPoint lat: 16.80528, lon: 96.15611, hasResults: False

protocolSection identificationModule nctId: NCT06386354, orgStudyIdInfo id: 2023-464-1, briefTitle: Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications, acronym: Porcerito, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Dr. Negrin University Hospital, class: OTHER, descriptionModule briefSummary: The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient., conditionsModule conditions: Postoperative Neuromuscular Block, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Train-of-four, outcomesModule primaryOutcomes measure: Residual Neuromuscular Block, primaryOutcomes measure: Residual Neuromuscular Block, secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ángel Becerra, city: Las Palmas De Gran Canaria, state: Las Palmas, zip: 35019, country: Spain, geoPoint lat: 28.09973, lon: -15.41343, hasResults: False

protocolSection identificationModule nctId: NCT06386341, orgStudyIdInfo id: W23.154, briefTitle: QoL in OSA patiënts Treated With MMA Surgery., acronym: QOMAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-02, primaryCompletionDateStruct date: 2026-08-02, completionDateStruct date: 2026-08-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Diakonessenhuis, Utrecht, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.The main question it aims to answer is:Does MMA surgery in OSA patiënts improve their quality of life?Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure., conditionsModule conditions: Sleep Apnea, Obstructive, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Maxillomandibular Advancement Surgery, outcomesModule primaryOutcomes measure: SF-36, secondaryOutcomes measure: OHIP-14, secondaryOutcomes measure: ESS, secondaryOutcomes measure: FOSQ, secondaryOutcomes measure: EQ-5D-3L, secondaryOutcomes measure: OQLQ, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diakonessenhuis, status: RECRUITING, city: Utrecht, zip: 3582KE, country: Netherlands, contacts name: Susanne Leij, role: CONTACT, phone: 088-250 6172, email: sleij@diakhuis.nl, contacts name: Maurits de Ruiter, MD, DDS, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Haya Al-Bayyati, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False

protocolSection identificationModule nctId: NCT06386328, orgStudyIdInfo id: A129_03FDI2317, briefTitle: A Clinical Trial to Evaluate the Food Effect of CKD-378, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-06-03, completionDateStruct date: 2024-06-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Chong Kun Dang Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: A clinical trial to evaluate the food effect of CKD-378, conditionsModule conditions: Type II Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CKD-378, QD, PO, outcomesModule primaryOutcomes measure: AUCt of CKD-378, primaryOutcomes measure: Cmax of CKD-378, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386315, orgStudyIdInfo id: MC230808, secondaryIdInfos id: NCI-2024-03242, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-010273, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230808, type: OTHER, domain: Mayo Clinic, briefTitle: Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma., conditionsModule conditions: Indolent B-Cell Non-Hodgkin Lymphoma, conditions: Recurrent Indolent B-Cell Non-Hodgkin Lymphoma, conditions: Refractory Indolent B-Cell Non-Hodgkin Lymphoma, conditions: Recurrent Indolent Non-Hodgkin Lymphoma, conditions: Refractory Indolent Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, interventions name: Endoscopic Procedure, interventions name: Involved-site Radiation Therapy (3 Fractions), interventions name: Involved-site Radiation Therapy (12 Fractions), interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Incidence of grade 2 or higher acute adverse events (AEs), secondaryOutcomes measure: Response rate, secondaryOutcomes measure: Time to progression rate, secondaryOutcomes measure: Patient reported quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: William G. Rule, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Bradford S. Hoppe, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Scott C. Lester, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False

protocolSection identificationModule nctId: NCT06386302, orgStudyIdInfo id: CSIIT-A36, briefTitle: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy., conditionsModule conditions: AML, conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule interventions name: Chidamide, interventions name: Venetoclax, interventions name: azacitidine, outcomesModule primaryOutcomes measure: Composite complete remission rate, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: MRD response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386289, orgStudyIdInfo id: CNV202202, briefTitle: Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke, acronym: SPLENDID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cerenovus, Part of DePuy Synthes Products, Inc., class: INDUSTRY, descriptionModule briefSummary: The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 172, type: ESTIMATED, armsInterventionsModule interventions name: Cereglide 92, outcomesModule primaryOutcomes measure: First pass reperfusion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Iowa Hospital & Clinics, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: JFK Medical Center, city: Edison, state: New Jersey, zip: 08820, country: United States, geoPoint lat: 40.51872, lon: -74.4121, locations facility: Westchester Medical Center, city: Valhalla, state: New York, zip: 10595, country: United States, geoPoint lat: 41.07482, lon: -73.77513, locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84132, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: West Virginia University, city: Morgantown, state: West Virginia, zip: 26506, country: United States, geoPoint lat: 39.62953, lon: -79.9559, hasResults: False

protocolSection identificationModule nctId: NCT06386276, orgStudyIdInfo id: 00025986, briefTitle: Surgical TReatment of Women With Deep ENDometriosis, acronym: TrEnd, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A., class: OTHER, descriptionModule briefSummary: TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes., conditionsModule conditions: Deep Endometriosis, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Colorectal bowel resection, outcomesModule primaryOutcomes measure: To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection, primaryOutcomes measure: To assess the rate of complications, primaryOutcomes measure: To assess the rate of conversion to open surgery, primaryOutcomes measure: To assess the rate of endometriosis-free bowel resection margins, primaryOutcomes measure: To assess the rate of recurrence, secondaryOutcomes measure: To assess the intraoperative blood loss, secondaryOutcomes measure: To assess the operating time, secondaryOutcomes measure: To assess the gastrointestinal function recovery, secondaryOutcomes measure: To assess the duration of hospital stay, secondaryOutcomes measure: To assess the reproductive outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Casa Di Cura Malzoni Villa Platani Spa, status: RECRUITING, city: Avellino, state: Campania, zip: 83100, country: Italy, contacts name: Francesca Falcone, MD, role: CONTACT, email: francesca.falcone3@icloud.com, contacts name: Mario Malzoni, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Falcone, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.91494, lon: 14.79103, hasResults: False

protocolSection identificationModule nctId: NCT06386263, orgStudyIdInfo id: D9673R00032, briefTitle: HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada, acronym: HER-TEMPO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-04-04, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings., conditionsModule conditions: Unresectable Breast Cancer, conditions: Metastatic Breast Cancer, conditions: HER2-low Expressing Breast Cancer, conditions: HER2-positive Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab deruxtecan, outcomesModule primaryOutcomes measure: Early treatment discontinuation rates, primaryOutcomes measure: Dose modifications, secondaryOutcomes measure: Real world time to treatment discontinuation (rwTTD), secondaryOutcomes measure: Reasons for treatment discontinuations, secondaryOutcomes measure: Median treatment duration and dose intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NavieGo Patient ProgramsLtd & Affiliate, city: Oakville, state: Ontario, zip: L6H 1A7, country: Canada, geoPoint lat: 43.45011, lon: -79.68292, hasResults: False

protocolSection identificationModule nctId: NCT06386250, orgStudyIdInfo id: 0005, briefTitle: Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy, acronym: Painseverity, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-05, primaryCompletionDateStruct date: 2020-01-06, completionDateStruct date: 2020-01-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy, conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C), primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: regional block, interventions name: Caudal block, interventions name: Epidural, outcomesModule primaryOutcomes measure: Postoperative pain intensity, otherOutcomes measure: postoperative pain intesity, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Muhammad Sharif, city: Lahore, state: Punjab, zip: 53711, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False

protocolSection identificationModule nctId: NCT06386237, orgStudyIdInfo id: UVienna_NDNL_1, briefTitle: Nutritional Modulation of Cognition and Brain Activity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, collaborators name: Medical University of Vienna, descriptionModule briefSummary: The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants., conditionsModule conditions: Nutrition, Healthy, conditions: Cognitive Change, conditions: Brain Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios), outcomesModule primaryOutcomes measure: Changes in cognition/behavior I, primaryOutcomes measure: Changes in cognition/behavior II, primaryOutcomes measure: Changes in brain activity, secondaryOutcomes measure: Changes in metabolic parameters I, secondaryOutcomes measure: Changes in metabolic parameters II, secondaryOutcomes measure: Changes in metabolic parameters III, secondaryOutcomes measure: Changes in metabolic parameters IV, secondaryOutcomes measure: Changes in subjective affective state, secondaryOutcomes measure: Changes in experienced hunger, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Stefan Schulreich, Prof. Dr., role: CONTACT, phone: +4314277, phoneExt: 54960, email: stefan.schulreich@univie.ac.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False

protocolSection identificationModule nctId: NCT06386224, orgStudyIdInfo id: 1R01DK137520-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DK137520-01, briefTitle: Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain, acronym: IMPACT-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: University of Kentucky, descriptionModule briefSummary: Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community., conditionsModule conditions: Pancreatitis, conditions: Chronic Pancreatitis, conditions: Acute Recurrent Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Participants are not informed of their condition assignment and both receive online programs for chronic pancreatitis. Investigators are blinded \& masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Internet-delivered pain self-management (CBT Condition), interventions name: Education Program, outcomesModule primaryOutcomes measure: Change in pain severity and pain interference, secondaryOutcomes measure: Change in disease-specific pain, secondaryOutcomes measure: Change in physical functioning, secondaryOutcomes measure: Change in psychological functioning, secondaryOutcomes measure: Change in pain catastrophizing, secondaryOutcomes measure: Change in sleep disturbance, secondaryOutcomes measure: Change in disease specific health-related quality of life, secondaryOutcomes measure: Change in patient global impression of change, secondaryOutcomes measure: Change in opioid use, secondaryOutcomes measure: Treatment acceptability, secondaryOutcomes measure: Change in substance use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Tonya Palermo, PhD, role: CONTACT, phone: 206-884-4208, email: tonya.palermo@seattlechildrens.org, contacts name: Tonya M Palermo, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06386211, orgStudyIdInfo id: BDR17228, secondaryIdInfos id: BDR17228, type: OTHER, domain: Sanofi Identifier, briefTitle: Bioavailability Study of Magne-B6 New Formulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Opella Healthcare Group SAS, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: MAGNE-B6 Oral Solution, interventions name: MAGNE-B6 New Formulation Tablet, outcomesModule primaryOutcomes measure: Maximal Observed Concentration (Cmax) of Magnesium in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma, primaryOutcomes measure: Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma, primaryOutcomes measure: Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma, primaryOutcomes measure: Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma, primaryOutcomes measure: Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine, secondaryOutcomes measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06386198, orgStudyIdInfo id: 23-40699, briefTitle: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients, acronym: HEAL-Tx:ToC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: American Society of Transplantation, descriptionModule briefSummary: The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM., conditionsModule conditions: Liver Transplant; Complications, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Health Advocate, outcomesModule primaryOutcomes measure: Changes in patient experience, secondaryOutcomes measure: Change in medication adherence using MLVI, secondaryOutcomes measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources., secondaryOutcomes measure: A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94158, country: United States, contacts name: Emily Stekol, role: CONTACT, phone: 415-502-3190, email: emily.stekol@ucsf.edu, contacts name: Sharad Wadhwani, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Children's Healthcare of Atlanta, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30345, country: United States, contacts name: Nitika Gupta, role: CONTACT, contacts name: Nitika Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06386185, orgStudyIdInfo id: DRAPE, briefTitle: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography, acronym: DRAPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Royal United Hospitals Bath NHS Foundation Trust, class: OTHER, collaborators name: Sheffield Teaching Hospitals NHS Foundation Trust, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: Golden Jubilee National Hospital, collaborators name: Papworth Hospital NHS Foundation Trust, collaborators name: University of Bath, descriptionModule briefSummary: The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.The main questions it aims to answer are:Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?, conditionsModule conditions: Pulmonary Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Electrocardiogram, interventions name: Transthoracic echocardiogram, interventions name: Right heart catheter, outcomesModule primaryOutcomes measure: Distinguish between patients with and without pulmonary hypertension, primaryOutcomes measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension, secondaryOutcomes measure: Assess the impact of the severity of pulmonary hypertension, secondaryOutcomes measure: Assess the impact of additional ECG markers on existing PH probability stratification, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal United Hospital NHS Foundation Trust, city: Bath, state: Banes, zip: BA1 3NG, country: United Kingdom, geoPoint lat: 51.3751, lon: -2.36172, locations facility: Golden Jubilee Hospital, city: Glasgow, state: Lanarkshire, zip: G81 4DY, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Sheffield Teaching Hospitals NHS Foundation Trust, city: Sheffield, state: South Yorkshire, zip: S10 2JF, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Royal Papworth Hospital, city: Cambridge, zip: CB2 0AY, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: Royal Free NHS Foundation Trust, city: London, zip: NW3 2QG, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False