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protocolSection identificationModule nctId: NCT06351059, orgStudyIdInfo id: UE-0083, briefTitle: Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Schulthess Klinik, class: OTHER, collaborators name: Ecole Polytechnique Fédérale de Lausanne, descriptionModule briefSummary: The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress., conditionsModule conditions: Osteoarthritis, Knee, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: InModi acoustic emission analysis, outcomesModule primaryOutcomes measure: acoustic emissions, primaryOutcomes measure: kinematic data, primaryOutcomes measure: MRI / MOAKS, primaryOutcomes measure: EOS / leg alignment, primaryOutcomes measure: PROMS, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schulthess Klinik, city: Zürich, state: ZH, zip: 8008, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06351046, orgStudyIdInfo id: NCT05178082_WP3, briefTitle: Preventive Interventions for Chronic Pain Worsening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: The Novo Nordic Foundation, descriptionModule briefSummary: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck., conditionsModule conditions: Chronic Non-Cancer Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention., primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: The statistical analysis of the data will be blinded, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Online Mindfullness Based Stress Reduction Program, interventions name: Virtual Reality-based Pain Self-management program, outcomesModule primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pain intensity and interference in daily activities, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Pain acceptance, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Use of medication, secondaryOutcomes measure: Use of healthcare system, secondaryOutcomes measure: Number of absent days at work, otherOutcomes measure: Satisfaction with the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06351033, orgStudyIdInfo id: ADP_012023, briefTitle: Ozonized Oil as Dietary Supplement in Macular Degeneration, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Alba Di Pardo, class: OTHER, descriptionModule briefSummary: Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression., conditionsModule conditions: Maculopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High ozonide (HOO) ozonated oil, outcomesModule primaryOutcomes measure: evaluation of any slowing down of the maculopathy, primaryOutcomes measure: evaluation of any slowing down of the maculopathy, primaryOutcomes measure: evaluation of any slowing down of the maculopathy, primaryOutcomes measure: evaluation of any slowing down of the maculopathy and closure of the study, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Neuromed, city: Pozzilli, country: Italy, geoPoint lat: 41.51142, lon: 14.06252, hasResults: False
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protocolSection identificationModule nctId: NCT06351020, orgStudyIdInfo id: LM302-03-101, briefTitle: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-08-10, completionDateStruct date: 2026-12-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: LaNova Medicines Zhejiang Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy, conditionsModule conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: experimental arm:LM-302 control arm:Apatinib or Irinotecan, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: LM-302, interventions name: Apatinib, interventions name: Irinotecan, outcomesModule primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: AE and SAE, secondaryOutcomes measure: Evaluate the immunogenicity of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06351007, orgStudyIdInfo id: NMM-4650-23-24-1, briefTitle: Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK), acronym: EPAK, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-19, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, class: OTHER, descriptionModule briefSummary: A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups., conditionsModule conditions: Chronic Kidney Disease, conditions: Predialysis, conditions: Peritoneal Dialysis, conditions: Hemodialysis, conditions: Educational Activities, conditions: Adherence, conditions: Nutritional Status, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional education and psychological intervention, interventions name: Standard care, outcomesModule primaryOutcomes measure: Patients´ dietary attitude, primaryOutcomes measure: Dietary adherence, primaryOutcomes measure: Nutritional knowledge, secondaryOutcomes measure: Muscle status, secondaryOutcomes measure: Muscle functionality, secondaryOutcomes measure: Nutritional status of predialysis patients, secondaryOutcomes measure: Nutritional status of dialysis patients, secondaryOutcomes measure: Patients´ quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, status: RECRUITING, city: Mexico City, zip: 14080, country: Mexico, contacts name: Ximena Atilano Carsi, PhD, role: CONTACT, phone: 00 52 55 56 17 65 42, email: [email protected], geoPoint lat: 19.42847, lon: -99.12766, hasResults: False
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protocolSection identificationModule nctId: NCT06350994, orgStudyIdInfo id: APHP230625, secondaryIdInfos id: IDRCB 2023-A01957-38, type: OTHER, domain: ANSM, briefTitle: Early Assessment of Cardiac Function After Treatment With CAR-T Cells, acronym: Cardio CAR-T, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5)., conditionsModule conditions: Car T- Cell, conditions: Hematologic Malignancy, conditions: Acute Lymphoblastic Leukemia, conditions: Lymphoma, B-Cell, conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity, secondaryOutcomes measure: Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations, secondaryOutcomes measure: Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Critical care medicine department, city: Paris, zip: 75012, country: France, contacts name: Jérémie JOFFRE, MD, PhD, role: CONTACT, phone: +33 1 49 28 21 45, email: [email protected], contacts name: Hafid AIT-OUFELLA, Professor, role: CONTACT, phone: +33 1 49 28 21 45, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06350981, orgStudyIdInfo id: FORE813, briefTitle: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Foundation for Orthopaedic Research and Education, class: OTHER, collaborators name: Pacira Pharmaceuticals, Inc, descriptionModule briefSummary: The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores., conditionsModule conditions: Back Pain, conditions: Surgery-Complications, conditions: Narcotic Use, conditions: Physical Stress, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Exparel, interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion., secondaryOutcomes measure: Total Postsurgical opioid consumption, secondaryOutcomes measure: Time to discharge, secondaryOutcomes measure: Time to ambulation, secondaryOutcomes measure: Maximum ambulated distance, secondaryOutcomes measure: Numeric Rating Pain Scale (Physical Therapy), secondaryOutcomes measure: Numeric Rating Pain Scale, secondaryOutcomes measure: Oswestry Disability Index (ODI), secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation for Orthopaedic Research and Education, city: Tampa, state: Florida, zip: 33607, country: United States, contacts name: Deborah H Warren, role: CONTACT, phone: 813-910-3688, email: [email protected], geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06350968, orgStudyIdInfo id: MEC-2023-0151, secondaryIdInfos id: 10200012110003, type: OTHER_GRANT, domain: ZonMw, briefTitle: Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord, acronym: INDEED, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Maasstad Hospital, collaborators name: Spijkenisse Medical Center, collaborators name: Franciscus &Vlietland, collaborators name: IJsselland, collaborators name: Ikazia Hospital, Rotterdam, collaborators name: Van Weel-Bethesda hospital, collaborators name: Albert Schweitzer Hospital, collaborators name: Beatrix hospital, descriptionModule briefSummary: The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?Healthcare providers and patients are asked to use the module and share their experiences with it., conditionsModule conditions: Oncology, conditions: Advance Care Planning, conditions: Implementation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Implementation outcome, secondaryOutcomes measure: Intervention outcome, secondaryOutcomes measure: Implementation outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Joica Benschop, status: RECRUITING, city: Rotterdam, zip: 3023TB, country: Netherlands, contacts name: Joica Benschop, MSc, role: CONTACT, phone: +31622586583, email: [email protected], contacts name: Wendy Oldenmenger, PhD, role: CONTACT, phone: +31651072608, email: [email protected], geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06350955, orgStudyIdInfo id: 2022-01389, briefTitle: IV Iron-induced Hypophosphatemia After RYGB, acronym: IVORY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Lucie Favre, class: OTHER, descriptionModule briefSummary: The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®)., conditionsModule conditions: Hypophosphatemia, conditions: Roux-en-Y Gastric Bypass, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Iron isomaltoside, interventions name: Iron Carboxymaltose, outcomesModule primaryOutcomes measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06350942, orgStudyIdInfo id: 1451_01/BVNTW-VNCSKTE, briefTitle: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-09, primaryCompletionDateStruct date: 2020-12, completionDateStruct date: 2024-02, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: National Children's Hospital, Vietnam, class: OTHER, collaborators name: Vinmec Research Institute of Stem Cell and Gene Technology, descriptionModule briefSummary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children., conditionsModule conditions: Ureteral Duplication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU), outcomesModule primaryOutcomes measure: Mean operating time, primaryOutcomes measure: Intraoperative complications, primaryOutcomes measure: Conversion to open, primaryOutcomes measure: Early postoperative complications, primaryOutcomes measure: Median length of hospital stays, primaryOutcomes measure: Mean UPM renal pelvis' APD, primaryOutcomes measure: Mean SFU of UPM renal pelvis, primaryOutcomes measure: Mean UPM ureter's diameter, primaryOutcomes measure: Mean UPM DRF, primaryOutcomes measure: Mean DRF of operated side, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: The National Hospital of Pediatrics, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Vinmec Research Institute of Stem Cell and Gene Technology, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
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protocolSection identificationModule nctId: NCT06350929, orgStudyIdInfo id: RC31/24/0017, briefTitle: Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients, acronym: NORAFLOW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction., conditionsModule conditions: Hypotension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac output monitoring by the Starling™ SV Sebac®, outcomesModule primaryOutcomes measure: Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction., secondaryOutcomes measure: Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus., secondaryOutcomes measure: Evaluation of the impact of the norepinephrine bolus on blood pressure correction., secondaryOutcomes measure: Evaluation of the impact of the norepinephrine bolus on heart rate., secondaryOutcomes measure: Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Toulouse Rangueil, city: Toulouse, zip: 31400, country: France, contacts name: François LABASTE, Dr, role: CONTACT, phone: 0561322822, phoneExt: +33, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06350916, orgStudyIdInfo id: IRB00082594, secondaryIdInfos id: LCI-GI-CRC-SEAMLESS-2020, type: OTHER, domain: Atrium Health, briefTitle: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-28, primaryCompletionDateStruct date: 2021-07-30, completionDateStruct date: 2021-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Atrium Health Levine Cancer Institute, descriptionModule briefSummary: The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery., conditionsModule conditions: Colorectal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: SeamlessMD® Mobile Application, outcomesModule primaryOutcomes measure: Perioperative ERAS metric completion rate, primaryOutcomes measure: Postoperative hospital length of stay, primaryOutcomes measure: Postoperative complications, primaryOutcomes measure: 30-day readmission, secondaryOutcomes measure: Postoperative Opioid Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Levine Cancer Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, geoPoint lat: 35.22709, lon: -80.84313, hasResults: False
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protocolSection identificationModule nctId: NCT06350903, orgStudyIdInfo id: ICM 2024-3356, briefTitle: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging, acronym: SWEET-HEART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Matthieu Pelletier-Galarneau, MD MSc, class: OTHER, descriptionModule briefSummary: The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies., conditionsModule conditions: Myocardial Suppression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Fast + High-fat low-carbohydrate diet, interventions name: Fast + Empagliflozin, outcomesModule primaryOutcomes measure: Levels of serum Beta-hydroxybutyrate (BHB) mmol/L, secondaryOutcomes measure: Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L, secondaryOutcomes measure: Proportions of glycemia levels (mmol/L) <3.5 mmol/L, secondaryOutcomes measure: Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350890, orgStudyIdInfo id: HTD1801.PCT105, briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: HighTide Biopharma Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone., conditionsModule conditions: T2DM (Type 2 Diabetes Mellitus), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 405, type: ESTIMATED, armsInterventionsModule interventions name: HTD1801, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary Endpoint: Mean Change in HbA1c, secondaryOutcomes measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose, secondaryOutcomes measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose, secondaryOutcomes measure: DB Phase: Proportion of patients achieving HbA1c <7.0%, secondaryOutcomes measure: DB Phase: Proportion of patients achieving HbA1c <6.5%, secondaryOutcomes measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR), secondaryOutcomes measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C), otherOutcomes measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c, otherOutcomes measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose, otherOutcomes measure: OLE Phase: Proportion of patients achieving HbA1c <7.0%, otherOutcomes measure: OLE Phase: Proportion of patients achieving HbA1c <6.5%, otherOutcomes measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR), otherOutcomes measure: OLE Phase: Mean Change in LDL-C, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuancheng People's Hospital, status: RECRUITING, city: Xuancheng, state: Anhui, country: China, geoPoint lat: 25.40949, lon: 116.3841, locations facility: Beijing Pinggu Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fuwai Hospital, CAMS & PUMC, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Huizhou Municipal Central Hospital, status: RECRUITING, city: Huizhou, state: Guangdong, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Shenzhen People's Hospital, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Liuzhou People's Hospital, status: RECRUITING, city: Liuzhou, state: Guangxi, country: China, locations facility: Cangzhou Central Hospital, status: RECRUITING, city: Cangzhou, state: Hebei, country: China, geoPoint lat: 38.31667, lon: 116.86667, locations facility: Handan First Hospital, status: RECRUITING, city: Handan, state: Hebei, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: Hengshui People's Hospital (Harrison International Peace Hospital), status: RECRUITING, city: Hengshui, state: Hebei, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Hebei Petro China Center Hospital, status: RECRUITING, city: Langfang, state: Hebei, country: China, geoPoint lat: 39.50972, lon: 116.69472, locations facility: The First Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Fourth Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, state: Heilongjiang, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: The Third Affiliated Hospital of Qiqihar Medical College, status: RECRUITING, city: Qiqihar, state: Heilongjiang, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), status: RECRUITING, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan), status: RECRUITING, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Nanyang Medical College, status: RECRUITING, city: Nanyang, state: Henan, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Zhumadian Central Hospital, status: RECRUITING, city: Zhumadian, state: Henan, country: China, geoPoint lat: 32.97944, lon: 114.02944, locations facility: Huangshi Central Hospital, status: RECRUITING, city: Huangshi, state: Hubei, country: China, geoPoint lat: 30.24706, lon: 115.04814, locations facility: Jingzhou Central Hospital, status: RECRUITING, city: Jingzhou, state: Hubei, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The First People's Hospital of Changde City, status: RECRUITING, city: Changde, state: Hunan, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, state: Hunan, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Baotou City Central Hospital, status: RECRUITING, city: Baotou, state: Inner Mongolia, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Inner Mongolia Autonomous Region People's Hospital, status: RECRUITING, city: Hohhot, state: Inner Mongolia, country: China, geoPoint lat: 40.81056, lon: 111.65222, locations facility: The First People's Hospital of Changzhou, status: RECRUITING, city: Changzhou, state: Jiangsu, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Huai'an First People's Hospital, status: RECRUITING, city: Huai'an, state: Jiangsu, country: China, geoPoint lat: 33.50389, lon: 119.14417, locations facility: The Second People's Hospital of Lianyungang, status: RECRUITING, city: Lianyungang, state: Jiangsu, country: China, geoPoint lat: 34.59845, lon: 119.21556, locations facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing Jiangning Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Sir Run Run Hospital Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, state: Jiangsu, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Pingxiang People's Hospital, status: RECRUITING, city: Pingxiang, state: Jiangxi, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: The Second Norman Bethune Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Tonghua Central Hospital, status: RECRUITING, city: Tonghua, state: Jilin, country: China, geoPoint lat: 41.71972, lon: 125.92639, locations facility: Panjin Liaohe Oilfield Gem Flower Hospital, status: RECRUITING, city: Panjin, state: Liaoning, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: The Sixth People's Hospital of Shenyang, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Qinghai Provincial People's Hospital, status: RECRUITING, city: Xining, state: Qinghai, country: China, geoPoint lat: 36.62554, lon: 101.75739, locations facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, status: RECRUITING, city: Xianyang, state: Shaanxi, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Liaocheng People's Hospital, status: RECRUITING, city: Liaocheng, state: Shandong, country: China, geoPoint lat: 36.45596, lon: 115.97766, locations facility: Shanghai East Hospital of Tongji University, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Third People's Hospital of Datong, status: RECRUITING, city: Datong, state: Shanxi, country: China, geoPoint lat: 40.09361, lon: 113.29139, locations facility: Yuncheng Central Hospital, status: RECRUITING, city: Yuncheng, state: Shanxi, country: China, geoPoint lat: 35.02306, lon: 110.99278, locations facility: People's Hospital of Tianjin, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First People's Hospital of Kashgar, status: RECRUITING, city: Kashgar, state: Xinjiang, country: China, geoPoint lat: 39.47066, lon: 75.98951, locations facility: The Second Affiliated Hospital of Kunming Medical University, status: RECRUITING, city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, state: Zhejiang, country: China, geoPoint lat: 30.8703, lon: 120.0933, hasResults: False
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protocolSection identificationModule nctId: NCT06350877, orgStudyIdInfo id: PA RCT, briefTitle: 1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, descriptionModule briefSummary: Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?Trial participants will be randomly assigned to one of the following groups:1. 1:1 physical activity training;2. Group-based physical activity training consisting of small 5-8 person groups; or3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes., conditionsModule conditions: Physical Activity, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A 3-arm parallel Randomized Controlled Trial (RCT) assessing the immediate (post-intervention) and short-term (1-month) impact of the experimental arms (1:1 physical activity delivery and group-based physical activity delivery) compared to a 10-week control arm (wait-list control) will be conducted. A parallel arm design will be implemented, whereby participants will be randomized to a study arm and each study arm will be allocated a different intervention. The protocol adheres to CONSORT guidelines and SPIRIT recommendations for reporting of clinical trial protocols., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Following completion of the baseline assessment (T1), students will be randomly assigned to an experimental arm or the control arm by a program coordinator for the study. To prevent care provider bias, the physical activity coaches will remain blind to the purpose of group allocation and hypotheses of the study. Research Randomizer (www.randomizer.org) will be used to allocate participants into three equal groups using a blocked design (with an allocation ratio of 1:1:1)., whoMasked: CARE_PROVIDER, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: Physical Activity Intervention, outcomesModule primaryOutcomes measure: Depression, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Psychological distress, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Social Connectedness, secondaryOutcomes measure: Physical Activity Behaviour, secondaryOutcomes measure: Intervention Reach, secondaryOutcomes measure: Therapeutic Alliance, secondaryOutcomes measure: Intervention Satisfaction, secondaryOutcomes measure: Coach Perceptions, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Toronto, Mental Health and Physical Activity Research Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5S 2W6, country: Canada, contacts name: Melissa L deJonge, Msc, role: CONTACT, phone: 9059739414, email: [email protected], contacts name: Catherine M Sabiston, PhD, role: CONTACT, phone: 416-978-5837, email: [email protected], contacts name: Melissa L deJonge, Msc, role: SUB_INVESTIGATOR, contacts name: Delaney E Thibodeau, Msc, role: SUB_INVESTIGATOR, contacts name: Sandra Yeun, PhD, role: SUB_INVESTIGATOR, contacts name: Luc Simard, role: SUB_INVESTIGATOR, contacts name: Catherine M Sabiston, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06350864, orgStudyIdInfo id: FMASU R11/2024, briefTitle: HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) ., conditionsModule conditions: Upper Gastrointestinal Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, randomized, comparative, controlled clinical trial study, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible., whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: High-flow nasal cannula (HFNC), interventions name: Conventional nasal oxygen therapy (COT), interventions name: Upper gastrointestinal endoscopy (UGE) including gastroscopy, interventions name: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA), outcomesModule primaryOutcomes measure: Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure., secondaryOutcomes measure: The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses, secondaryOutcomes measure: Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes, secondaryOutcomes measure: Clinically significant hypoxia, secondaryOutcomes measure: Sedation related adverse effects (SRAEs), secondaryOutcomes measure: Procedure-related adverse events (PRAEs), otherOutcomes measure: Endoscopy procedure time, otherOutcomes measure: Anesthetic time, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University-Faculty of Medicine, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Ahmed M Mohamed, MD, role: CONTACT, phone: 002 01121318459, email: [email protected], contacts name: Wessam Z Selima, MD, role: CONTACT, phone: 002 01001958858, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06350851, orgStudyIdInfo id: BA161WP1, briefTitle: Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination, acronym: Obi1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Bioaster, class: OTHER, descriptionModule briefSummary: Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs., conditionsModule conditions: Onchocerciasis, conditions: Loiasis, conditions: Mansonelliasis, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Biological samples collection (blood drawing + feces), outcomesModule primaryOutcomes measure: Evaluation of the performance of the prototype diagnostic test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Higher Institute for Scientific and Medical Research, city: Yaounde, zip: 5797, country: Cameroon, contacts name: Joseph KAMGNO, role: CONTACT, phone: +237 6 75 06 91 58, email: [email protected], contacts name: Joseph KAMGNO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 3.86667, lon: 11.51667, hasResults: False
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protocolSection identificationModule nctId: NCT06350838, orgStudyIdInfo id: KN-BCG-I, briefTitle: Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2023-02-13, completionDateStruct date: 2023-02-13, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Chengdu CoenBiotech Co., Ltd, class: INDUSTRY, collaborators name: Hunan Cancer Hospital, descriptionModule briefSummary: Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC), conditionsModule conditions: Non-muscular Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: BCG for Therapeutic Use, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events;, primaryOutcomes measure: Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT)., primaryOutcomes measure: Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count., primaryOutcomes measure: Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT)., primaryOutcomes measure: Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count., primaryOutcomes measure: Effects on vital signs,such as temperature., primaryOutcomes measure: Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram., primaryOutcomes measure: Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure., primaryOutcomes measure: Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function., secondaryOutcomes measure: Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG)., secondaryOutcomes measure: Shedding condition of the test drug in urine., secondaryOutcomes measure: To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 415000, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06350825, orgStudyIdInfo id: 2023-SR-543, briefTitle: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP), conditionsModule conditions: Metastatic Prostate Cancer, conditions: Therapy, Directly Observed, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Cytoreductive prostatectomy or brachytherapy, interventions name: ADT+second-generation antiandrogens ± chemotherapy, outcomesModule primaryOutcomes measure: rPFS, secondaryOutcomes measure: Safety of CRP in mHSPC patients, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Shangqian Wang, M.D., role: CONTACT, phone: 13770561625, email: [email protected], contacts name: Lixin Hua, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2024-03-20, uploadDate: 2024-03-20T11:18, filename: Prot_ICF_000.pdf, size: 125657, hasResults: False
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protocolSection identificationModule nctId: NCT06350812, orgStudyIdInfo id: PB119110, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-04-29, completionDateStruct date: 2025-04-29, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: PegBio Co., Ltd., class: OTHER, descriptionModule briefSummary: The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: PB-119, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Effectiveness index, secondaryOutcomes measure: Effectiveness index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350799, orgStudyIdInfo id: 01741, briefTitle: Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-03-14, primaryCompletionDateStruct date: 2021-05-27, completionDateStruct date: 2023-04-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: VA Puget Sound Health Care System, class: FED, collaborators name: Public Health - Seattle and King County, collaborators name: University of Washington, descriptionModule briefSummary: We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys., conditionsModule conditions: COPD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 9, type: ACTUAL, outcomesModule primaryOutcomes measure: Acceptability, Appropriateness, Feasibility, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Puget Sound Health Care System, city: Seattle, state: Washington, zip: 98108, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06350786, orgStudyIdInfo id: ROM Study, secondaryIdInfos id: PZ00P1_201972, type: OTHER_GRANT, domain: Swiss National Science Foundation, briefTitle: Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain, acronym: ROM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cosima Locher, class: OTHER, collaborators name: Brown University, collaborators name: University of Basel, descriptionModule briefSummary: This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group., conditionsModule conditions: Chronic Non-cancer Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: P-Dragees blue Lichtenstein, Placebo dragees, interventions name: Control group (EM), outcomesModule primaryOutcomes measure: Daily opioid consumption (MED):, secondaryOutcomes measure: Subjective opioid withdrawal symptoms, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Pain disability, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Pain Opioid Analgesics Beliefs Scale - Cancer, secondaryOutcomes measure: Treatment Expectancy, secondaryOutcomes measure: Placebo pill count, secondaryOutcomes measure: Opioid adherence, otherOutcomes measure: Rationale credibility, otherOutcomes measure: Placebo understanding, otherOutcomes measure: Patient Provider Connection, otherOutcomes measure: Medication history, otherOutcomes measure: Primary treating physicians' acceptability of the OLP approach:, otherOutcomes measure: Primary treating physicians' treatment expectancies, otherOutcomes measure: Qualitative Outcomes, otherOutcomes measure: Safety Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350773, orgStudyIdInfo id: FMBSUREC/06122022/ Zaher, briefTitle: Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Beni-Suef University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group., conditionsModule conditions: Group 2 Pulmonary Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: tadalafil 20 mg then 40 mg if tolerated, outcomesModule primaryOutcomes measure: Functional capacity of the patients, primaryOutcomes measure: heart failure symptoms, secondaryOutcomes measure: right ventricular function, secondaryOutcomes measure: right ventricular function, secondaryOutcomes measure: right ventricular function, secondaryOutcomes measure: right ventricular function, secondaryOutcomes measure: right ventricular function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beni Suef University, status: RECRUITING, city: Cairo, state: Beni Suef, zip: 62511, country: Egypt, contacts name: Hesham Boshra Mahmoud, Doctorate, role: CONTACT, phone: 201001402250, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06350760, orgStudyIdInfo id: UJA_PROCARE-I+, briefTitle: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules, acronym: PROCARE-I+, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Jaén, class: OTHER, collaborators name: Universidad Miguel Hernandez de Elche, collaborators name: University Rovira i Virgili, collaborators name: University of Miami, descriptionModule briefSummary: PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty., conditionsModule conditions: Anxiety Disorders and Symptoms, conditions: Depressive Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Active control condition, interventions name: PROCARE-I+ 8-session, outcomesModule primaryOutcomes measure: Self-reported anxiety and mood symptomatology, primaryOutcomes measure: Factors associated with adolescents' mental health, primaryOutcomes measure: Resilience measure, primaryOutcomes measure: Health-related quality of life, primaryOutcomes measure: Absence of emotional disorders, secondaryOutcomes measure: Economic evaluations, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Emotional regulation, otherOutcomes measure: Bullying, otherOutcomes measure: Expressed Emotion, otherOutcomes measure: Ecoanxiety, otherOutcomes measure: Exam anxiety, otherOutcomes measure: Videogames addiction, otherOutcomes measure: Smartphone addiction, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universidad Miguel Hernández, status: RECRUITING, city: Elche, state: Alicante, zip: 03202, country: Spain, contacts name: José Antonio Piqueras, Ph. D., role: CONTACT, phone: 966658343, email: [email protected], contacts name: José Antonio Piqueras, Ph. D., role: SUB_INVESTIGATOR, geoPoint lat: 38.26218, lon: -0.70107, locations facility: University of Jaén, status: RECRUITING, city: Jaén, state: Jaen, zip: 23071, country: Spain, contacts name: Luis Joaquín García-López, Ph. D., role: CONTACT, phone: 953213412, email: [email protected], contacts name: Luis Joaquín García-López, Ph. D., role: PRINCIPAL_INVESTIGATOR, contacts name: José Antonio Muela-Martínez, Ph. D., role: PRINCIPAL_INVESTIGATOR, contacts name: Lourdes Espinosa-Fernández, Ph. D., role: PRINCIPAL_INVESTIGATOR, contacts name: Laura Zafra-Palomino, Ph. D. stud, role: PRINCIPAL_INVESTIGATOR, contacts name: David Jiménez-Vázquez, Ph. D. stud, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.76922, lon: -3.79028, locations facility: Universitat Rovira i Virgili, status: RECRUITING, city: Tarragona, zip: 43003, country: Spain, contacts name: Josefa Canals, M.D., role: CONTACT, phone: 977257895, email: [email protected], contacts name: Josefa Canals, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 41.11667, lon: 1.25, hasResults: False
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protocolSection identificationModule nctId: NCT06350747, orgStudyIdInfo id: CelalBayarU-SBF-OT-02, briefTitle: The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pretest-posttest with control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Laughter Yoga, outcomesModule primaryOutcomes measure: Perceived Stress Scale, primaryOutcomes measure: Jenkins Sleep Scale, primaryOutcomes measure: Maslach Burnout Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, status: RECRUITING, city: Manisa, zip: 45060, country: Turkey, contacts name: Özge Topsakal, PhD, role: CONTACT, phone: 05549165599, email: [email protected], geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
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protocolSection identificationModule nctId: NCT06350734, orgStudyIdInfo id: 18-004675, secondaryIdInfos id: NCI-2024-00973, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 18-004675, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-10-12, primaryCompletionDateStruct date: 2029-01-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study evaluates the effect of bladder cancer treatment on quality of life., conditionsModule conditions: Stage 0a Bladder Cancer AJCC v8, conditions: Stage 0is Bladder Cancer AJCC v8, conditions: Stage I Bladder Cancer AJCC v8, conditions: Stage II Bladder Cancer AJCC v8, conditions: Stage IIIA Bladder Cancer AJCC v8, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 704, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Change in quality of life outcomes - PROMIS-29, primaryOutcomes measure: Change in quality of life outcomes - Bladder Cancer Index, primaryOutcomes measure: Patient level characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Mark D. Tyson, M.D., M.P.H., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Paul R. Young, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Matthew T. Gettman, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06350721, orgStudyIdInfo id: DizzyVR, briefTitle: Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR, acronym: DizzyVR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Universidad Loyola Andalucia, class: OTHER, collaborators name: University of Seville, collaborators name: Universitat Politècnica de València, collaborators name: Universidad de Zaragoza, descriptionModule briefSummary: The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. The main questions it aims to answer are:* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.* To detect and record possible adverse events due to the use of DizzyVR.* To examine the degree of adherence of the participants to the intervention.* To know the average success rate of the different games in each session.* To evaluate the average difficulty levels overcome throughout the intervention.* To know the usability and satisfaction with the system reported by participants and therapists.Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR., conditionsModule conditions: Vestibular Disorder, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: DizzyVR, outcomesModule primaryOutcomes measure: Retention rate of participants, primaryOutcomes measure: User Satisfaction Evaluation Questionnaire (USEQ), primaryOutcomes measure: Register of risk and number of adverse events experimented by the stakeholders, primaryOutcomes measure: Adherence rate, primaryOutcomes measure: Dropout rates, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06350708, orgStudyIdInfo id: 2024-18304-33663, secondaryIdInfos id: 336664, type: OTHER, domain: Integrated Research Application System (IRAS), briefTitle: Virtual Reality (VR) Paediatric Tracheostomy Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-10, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children., conditionsModule conditions: Educational Study, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality (VR) tracheostomy educational tool, outcomesModule primaryOutcomes measure: Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed), secondaryOutcomes measure: Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank., secondaryOutcomes measure: Participant satisfaction measured using a bespoke data collection tool., secondaryOutcomes measure: Virtual Reality Sickness, secondaryOutcomes measure: Usability using the validated system usability scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Manchester, city: Manchester, state: Greater Manchester, zip: M13 9PL, country: United Kingdom, contacts name: Jonathan R Abbas, MBChB, role: CONTACT, email: [email protected], geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
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protocolSection identificationModule nctId: NCT06350695, orgStudyIdInfo id: HP-00103478, secondaryIdInfos id: 1R21AG080424-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21AG080424-01, briefTitle: The ROle of Compression StocKings in Heart Failure Patients, acronym: ROCK-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months., conditionsModule conditions: Heart Failure，Congestive, conditions: Leg Edema, conditions: Venous Insufficiency, conditions: Venous Ulcers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective randomized-control 1:1 single blind study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: low grade compression stockings (10-15 mmHg), interventions name: high grade compression stockings (20-30 mmHg), outcomesModule primaryOutcomes measure: Incidence of adverse events., primaryOutcomes measure: Change in symptoms of heart failure., primaryOutcomes measure: Change in kidney function., secondaryOutcomes measure: Change in venous reflux., secondaryOutcomes measure: Change in C Class from the CEAP classification for venous insufficiency., secondaryOutcomes measure: Mobility of the patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Maryland, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Rydica Newton, Research Coordinator, role: CONTACT, phone: 410-706-3941, email: [email protected], contacts name: Kim Nordstrom, role: CONTACT, email: [email protected], contacts name: Rafael S Cires-Drouet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06350682, orgStudyIdInfo id: HP-00107323, briefTitle: Resilient HIV Implementation Science With SGM Youths Using Evidence, acronym: RISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, collaborators name: University of Florida, descriptionModule briefSummary: The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group., conditionsModule conditions: Hiv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: HealthMPowerment (HMP), outcomesModule primaryOutcomes measure: PrEP initiation for HIV seronegative seropositive, primaryOutcomes measure: Viral load suppression for HIV, primaryOutcomes measure: RE-AIM, secondaryOutcomes measure: HIV testing cascade, secondaryOutcomes measure: PrEP continuum, secondaryOutcomes measure: HIV care and treatment continuum, secondaryOutcomes measure: Implementation effectiveness, eligibilityModule sex: MALE, minimumAge: 15 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06350669, orgStudyIdInfo id: 9576-22-SMC, briefTitle: App-supported Vestibular Rehabilitation (RCT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Haifa, class: OTHER, collaborators name: Sheba Medical Center, collaborators name: Ben-Gurion University of the Negev, descriptionModule briefSummary: A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes, conditionsModule conditions: Vestibular Disorder, conditions: Vestibular Diseases, conditions: Vestibular Abnormality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Vestibular rehabilitation phone application, outcomesModule primaryOutcomes measure: Adherence measures, primaryOutcomes measure: Timed up and go (TUG), secondaryOutcomes measure: Demographics and medical history intake, secondaryOutcomes measure: Vestibular functions- physical examination, secondaryOutcomes measure: Oculomotor functions- physical examination, secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Dizziness Handicap Inventory (DHI), secondaryOutcomes measure: Activities-specific Balance Confidence Scale (ABC), secondaryOutcomes measure: Dynamic Gait Index (DGI), secondaryOutcomes measure: 10-Meters Walk Test (10MWT), secondaryOutcomes measure: 2-Minute Walk Test (2MWT), secondaryOutcomes measure: Dynamic Visual Acuity (DVA), secondaryOutcomes measure: Video Head Impulse Test (vHIT), secondaryOutcomes measure: Suppression Head Impulse Test (SHIMP), secondaryOutcomes measure: Exercise difficulty levels and symptoms severity, secondaryOutcomes measure: Cognitive reserve index questionnaire (CRIQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheba Medical Center, city: Ramat Gan, country: Israel, contacts name: Yoav Gimmon, PT, Ph.D, role: CONTACT, email: [email protected], contacts name: Amit Wolfovitz, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Shelly Levy-Tzedek, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Liran Kalderon, M.Sc.PT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08227, lon: 34.81065, hasResults: False
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protocolSection identificationModule nctId: NCT06350656, orgStudyIdInfo id: IRBN282022/CHUSTE, briefTitle: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2), acronym: EC2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-31, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box., conditionsModule conditions: Cerebrospinal; Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Clinical data collection, interventions name: Therapeutic data collection, interventions name: IntraCranial Pression (ICP) values collection, outcomesModule primaryOutcomes measure: Intracranial pressure (mmHg), secondaryOutcomes measure: Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CENTRE HOSPITALIER Charponnay, status: RECRUITING, city: Chaponnay, zip: 69970, country: France, contacts name: PIERRE-HENRI MURGAT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.63097, lon: 4.94299, locations facility: CENTRE HOSPITALIER UNIVERSITAIRE Grenoble, status: RECRUITING, city: Grenoble, zip: 38000, country: France, contacts name: JEAN FRANCOIS PAYEN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, locations facility: HOPITAL NORD La Tronche, status: RECRUITING, city: La Tronche, zip: 38170, country: France, contacts name: KEVIN LAGARDE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.20429, lon: 5.73645, locations facility: APHP, status: RECRUITING, city: Paris, zip: 75010, country: France, contacts name: SAMUEL GAUGUIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hopital Lariboisiere - Ahph, status: RECRUITING, city: Paris, zip: 75010, country: France, contacts name: JEROME CARTAILLIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CENTRE HOSPITALIER UNIVERSITAIRE Rennes, status: RECRUITING, city: Rennes, zip: 35000, country: France, contacts name: YOANN LAUNEY, MD PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne, status: RECRUITING, city: Saint-Étienne, zip: 42055, country: France, contacts name: CLEMENT MAGAND, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06350643, orgStudyIdInfo id: 287064, secondaryIdInfos id: P50MD017319-03S1, type: NIH, link: https://reporter.nih.gov/quickSearch/P50MD017319-03S1, briefTitle: The Black Health Block Quit and Screen Project, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Arkansas, class: OTHER, collaborators name: Virginia Commonwealth University, collaborators name: Coalition for a Tobacco Free Arkansas, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), collaborators name: National Medical Association, descriptionModule briefSummary: The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities.The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes., conditionsModule conditions: Knowledge, conditions: Attitudes, conditions: Behavioral Intention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Black Health Block Culturally Tailored training, interventions name: Health Disparities and Lung Cancer Screening training, outcomesModule primaryOutcomes measure: Familiarity with treatment guidelines for tobacco and nicotine treatment, primaryOutcomes measure: Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation, primaryOutcomes measure: Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients, primaryOutcomes measure: Provider Perceptions about patient barriers to smoking cessation, primaryOutcomes measure: Behavioral intentions to screen and advise patients about smoking cessation, primaryOutcomes measure: Familiarity with lung cancer screening guidelines, primaryOutcomes measure: Knowledge about low dose computed tomography for lung cancer screening, primaryOutcomes measure: Perceptions about shared decision-making for low dose computed tomography for lung cancer screening, primaryOutcomes measure: Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening, primaryOutcomes measure: Provider Perceptions about patient barriers to get screened for lung cancer, primaryOutcomes measure: Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography, secondaryOutcomes measure: Diversity of enrolled healthcare providers, secondaryOutcomes measure: Retention: Percent of providers complete the training after enrolling, secondaryOutcomes measure: Adherence to completing training modules: Percent of modules completed, secondaryOutcomes measure: Preferences regarding training, secondaryOutcomes measure: Satisfaction with training, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Commonwealth Univesity, city: Richmond, state: Virginia, zip: 23284, country: United States, contacts name: Mignonne Guy, PhD, role: CONTACT, phone: 804-828-1731, email: [email protected], contacts name: Mignonne Guy, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06350630, orgStudyIdInfo id: 20PH284, secondaryIdInfos id: 2024-512653-25-00, type: CTIS, briefTitle: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study, acronym: QUIgAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, collaborators name: Ministry of Health, France, descriptionModule briefSummary: immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study., conditionsModule conditions: IgA Nephropathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind trial randomized, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 334, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine Oral Tablet, interventions name: Placebo oral tablet, outcomesModule primaryOutcomes measure: Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: GFR, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: GFR, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: end stage renal disease (GFR< 15mL/min/1.73m²), secondaryOutcomes measure: death, secondaryOutcomes measure: adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Gabriel Montpied, city: Clermont-Ferrand, zip: 63000, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Hospices Civils de Lyon, city: Lyon, zip: 69437, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: AP-HM Hôpital de la Conception, city: Marseille, zip: 13385, country: France, contacts name: Thomas ROBERT, MD, role: CONTACT, phone: 0662426166, phoneExt: +33, email: [email protected], geoPoint lat: 43.29551, lon: 5.38958, locations facility: APHP Hôpital Bichat, city: Paris, zip: 75018, country: France, contacts name: Eric DAUGAS, PU-PH, role: CONTACT, phone: 0140257101, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital de Tenon, city: Paris, zip: 75020, country: France, contacts name: Khalil EL KAROUI, PU-PH, role: CONTACT, phone: 0156016317, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Lyon Sud, city: Pierre-Bénite, zip: 69495, country: France, contacts name: Sarah MEZAACHE, MD, role: CONTACT, phone: 0478863712, phoneExt: +33, email: [email protected], geoPoint lat: 45.7009, lon: 4.82511, locations facility: CHU de Saint-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Nicolas MAILLARD, MD, role: CONTACT, phone: 0477828127, phoneExt: +33, email: [email protected], contacts name: Carine LABRUYERE, role: CONTACT, phone: 0477120469, phoneExt: +33, email: [email protected], geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06350617, orgStudyIdInfo id: 2023-12-028, briefTitle: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: National Research Foundation of Korea, collaborators name: Ministry of Food and Drug Safety, Korea, collaborators name: Seoul National University Hospital, collaborators name: Bucheon St. Mary's Hospital, collaborators name: Saint Vincent's Hospital, Korea, collaborators name: Severance Hospital, collaborators name: Kumoh National Institute of Technology, collaborators name: NEUROPHET, descriptionModule briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves., conditionsModule conditions: Parkinson's Disease and Parkinsonism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High-Frequency, ipsilateral M1, interventions name: High-Frequency, bilateral M1, interventions name: High-Frequency, Lt. DLPFC, interventions name: High-Frequency, bilateral M1, outcomesModule primaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III, secondaryOutcomes measure: Differences of MDS-UPDRS, Part III, secondaryOutcomes measure: Differences of New Freezing of Gait Questionnaire (FoG-Q), secondaryOutcomes measure: Differences of New Freezing of Gait Questionnaire (FoG-Q), secondaryOutcomes measure: Differences of Digit span Test, secondaryOutcomes measure: Differences of Digit span Test, secondaryOutcomes measure: Differences of Trail making Test, secondaryOutcomes measure: Differences of Trail making Test, secondaryOutcomes measure: Differences of Gait lab parameter (Gait speed), secondaryOutcomes measure: Differences of Gait lab parameter (Gait speed), secondaryOutcomes measure: Differences of Gait lab parameter (Stride length), secondaryOutcomes measure: Differences of Gait lab parameter (Stride length), secondaryOutcomes measure: Differences of Gait lab parameter (Step count), secondaryOutcomes measure: Differences of Gait lab parameter (Step count), secondaryOutcomes measure: Differences of Gait lab parameter (Cadence), secondaryOutcomes measure: Differences of Gait lab parameter (Cadence), secondaryOutcomes measure: Differences of Gait lab parameter (Swing ratio), secondaryOutcomes measure: Differences of Gait lab parameter (Swing ratio), secondaryOutcomes measure: Differences of Gait lab parameter (Stride time), secondaryOutcomes measure: Differences of Gait lab parameter (Stride time), secondaryOutcomes measure: Differences of Gait lab parameter (Pressure distribution), secondaryOutcomes measure: Differences of Gait lab parameter (Pressure distribution), eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Won Hyuk Chang, PhD, role: CONTACT, phone: +82-2-3410-6068, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06350604, orgStudyIdInfo id: PRO-2023-355, briefTitle: Project WHADE: A Partner-Based Physical Activity Program for Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Rowan University, class: OTHER, descriptionModule briefSummary: This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change., conditionsModule conditions: Hypertension, conditions: Type 2 Diabetes, conditions: Metabolic Syndrome, conditions: Smoking, conditions: High Cholesterol, conditions: PreDiabetes, conditions: Prehypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants receive the same intervention, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Project WHADE: A Partner-Based Physical Activity Program for Women, outcomesModule primaryOutcomes measure: Frequency of partner communication, primaryOutcomes measure: Satisfaction with partner communication, secondaryOutcomes measure: Physical activity behavior - steps, secondaryOutcomes measure: Physical activity behavior - active minutes, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rowan University, status: RECRUITING, city: Glassboro, state: New Jersey, zip: 08028, country: United States, contacts name: Sofia Gular, B.A., role: CONTACT, phone: 856-256-4872, email: [email protected], contacts name: Danielle Arigo, Ph.D., role: CONTACT, phone: 8562564500, phoneExt: 53775, email: [email protected], geoPoint lat: 39.70289, lon: -75.11184, hasResults: False
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protocolSection identificationModule nctId: NCT06350591, orgStudyIdInfo id: 6038674, briefTitle: Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Queen's University, class: OTHER, descriptionModule briefSummary: Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training\]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy., conditionsModule conditions: Healthy, conditions: Skeletal Muscle Atrophy, conditions: Skeletal Muscle Hypertrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel, within-subject design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Immobilization, interventions name: Resistance training, outcomesModule primaryOutcomes measure: Changes in average rates of muscle synthesis, primaryOutcomes measure: Dynamic proteomic profiling, secondaryOutcomes measure: Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression, secondaryOutcomes measure: Muscle torque, secondaryOutcomes measure: Quadriceps skeletal muscle volume, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: School of Kinesiology and Health Studies, status: RECRUITING, city: Kingston, state: Ontario, zip: K7L 3N6, country: Canada, contacts name: Chris McGlory, PhD, role: CONTACT, phone: 6135336000, phoneExt: 75410, email: [email protected], contacts name: Kristine Boileau, BSc, role: CONTACT, email: [email protected], contacts name: Chris McGlory, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.22976, lon: -76.48101, hasResults: False
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protocolSection identificationModule nctId: NCT06350578, orgStudyIdInfo id: BUHOOTH-D-23-00073, briefTitle: A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Primary Health Care Corporation, Qatar, class: OTHER_GOV, descriptionModule briefSummary: This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries., conditionsModule conditions: Dental Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A binary outcome non-inferiority randomized trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single-blind, whoMasked: CARE_PROVIDER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Hall Crown Technique, interventions name: Conventional SSC Technique, outcomesModule primaryOutcomes measure: Restoration survival at 12 months, primaryOutcomes measure: Occlusal vertical dimension (OVD) resolution, primaryOutcomes measure: Tooth survival, primaryOutcomes measure: Procedural time, secondaryOutcomes measure: Participant's cooperation, secondaryOutcomes measure: Participant's pain perception, secondaryOutcomes measure: Treatment perceptions and opinions of the parents, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Primary Healthcare Corporation, status: RECRUITING, city: Doha, country: Qatar, contacts name: Research Section, role: CONTACT, phone: +97444069917, email: [email protected], geoPoint lat: 25.28545, lon: 51.53096, hasResults: False
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protocolSection identificationModule nctId: NCT06350565, orgStudyIdInfo id: DEX20240104, briefTitle: A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus., conditionsModule conditions: Respiratory Distress Syndrome of Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Respiratory distress syndrome, primaryOutcomes measure: PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ, primaryOutcomes measure: Pharmacodynamics, primaryOutcomes measure: Measurability indicators, primaryOutcomes measure: Blood biochemistry findings in newborns, primaryOutcomes measure: DEX potential safety marker test, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350552, orgStudyIdInfo id: PA224ES-1-03, briefTitle: Prevalence of Postural Abnormalities in Dialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Pardis Specialized Wellness Institute, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate and compare the prevalence of forward head, hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients?Participants will answer 2 questionnaires and will do some functional tests., conditionsModule conditions: End Stage Renal Disease, conditions: Hemodialysis Complication, conditions: Peritoneal Dialysis Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Prevalence of thoracic hyper kyphosis, primaryOutcomes measure: Prevalence of forward head, secondaryOutcomes measure: Balance level, secondaryOutcomes measure: Cardiopulmonary function's level, secondaryOutcomes measure: Fall risk level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Khorshid Dialysis Center, city: Isfahan, country: Iran, Islamic Republic of, geoPoint lat: 32.65246, lon: 51.67462, hasResults: False
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protocolSection identificationModule nctId: NCT06350539, orgStudyIdInfo id: 10-007, briefTitle: Personalized Models for Cancer Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2034-02-15, completionDateStruct date: 2034-02-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: New York Stem Cell Foundation Research Institute, class: OTHER, collaborators name: Stevens Institute of Technology, descriptionModule briefSummary: The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Biological Sample Collection, outcomesModule primaryOutcomes measure: Implement organoid culture technologies., primaryOutcomes measure: Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking., primaryOutcomes measure: Establish functional testing using organoid cultures alone or in combination with additional cell types., primaryOutcomes measure: Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer., primaryOutcomes measure: Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs., primaryOutcomes measure: Develop stem cells from individual patient samples to study tumor evolution., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New York Stem Cell Foundation Research Institute, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Becca Wood, role: CONTACT, phone: 212-927-1801, email: [email protected], contacts name: Lisa Voltolina, role: CONTACT, phone: 6462133911, email: [email protected], contacts name: Laura Andres-Martin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06350526, orgStudyIdInfo id: PULMHEMA, briefTitle: Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: New Valley University, class: OTHER, descriptionModule briefSummary: Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians, conditionsModule conditions: Hematologic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Complete Blood Count, interventions name: C-reactive protein, interventions name: O2 saturation, interventions name: Serum ferritin and D-dimer, interventions name: Liver and renal function tests, interventions name: Lactate dehydrogenase, interventions name: coronavirus (SARS-CoV-2) swab, interventions name: CT chest, outcomesModule primaryOutcomes measure: Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases, secondaryOutcomes measure: Number of patients who developed complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350513, orgStudyIdInfo id: NecmettinE, briefTitle: The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-09-25, completionDateStruct date: 2025-02-25, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Selverhan Yurttutan, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Child, Only, conditions: Anxiety, conditions: Fear, conditions: Nurse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Group (Experiment-Control) Randomized Controlled Experimental, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Animation movie, story book, outcomesModule primaryOutcomes measure: State Anxiety Inventory for Children (STAI-C), primaryOutcomes measure: State Anxiety Inventory for Children (STAI-C), primaryOutcomes measure: State Anxiety Inventory for Children (STAI-C), secondaryOutcomes measure: Children's Fear Scale, secondaryOutcomes measure: Children's Fear Scale, secondaryOutcomes measure: Children's Fear Scale, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Semra Köse, city: Konya, state: Meram, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, locations facility: Necmettin Erbakan Üniversity, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06350500, orgStudyIdInfo id: I-3858823, briefTitle: A Patient Navigation Program for Addressing Disparities in Breast Cancer Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients., conditionsModule conditions: Breast Carcinoma, conditions: Breast Ductal Carcinoma in Situ, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Patient Navigation, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Enrollment rate, primaryOutcomes measure: Reasons for refusal, primaryOutcomes measure: Retention Rate, primaryOutcomes measure: Reasons for discontinuation, secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30), secondaryOutcomes measure: Social Determinates of health, secondaryOutcomes measure: Barriers to care, secondaryOutcomes measure: Use of supportive services, secondaryOutcomes measure: Patient Satisfaction survey, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350487, orgStudyIdInfo id: SMC2024-01-089-003, briefTitle: The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction, acronym: ENRICH-PEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF)., conditionsModule conditions: Heart Failure, Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, open label, single center, randomized controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Change in peak oxygen consumption (VO2), secondaryOutcomes measure: Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope), secondaryOutcomes measure: Change in Left atrial volume index (LAVI) before and after maximal exercise, secondaryOutcomes measure: Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise, secondaryOutcomes measure: Change in Left ventricular mass index (LVMI) before and after maximal exercise, secondaryOutcomes measure: Change in LV wall thickness before and after maximal exercise, secondaryOutcomes measure: Change in LV global longitudinal strain before and after maximal exercise, secondaryOutcomes measure: Change in LA strain before and after maximal exercise, secondaryOutcomes measure: Change in right ventricular (RV) free wall strain before and after maximal exercise, secondaryOutcomes measure: Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS), secondaryOutcomes measure: Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level, secondaryOutcomes measure: Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise, secondaryOutcomes measure: Change in serum iron, secondaryOutcomes measure: Change in ferritin, secondaryOutcomes measure: Change in total iron binding capacity, secondaryOutcomes measure: Change in hemoglobin, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Hospitalization for heart failure, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Jeong Hoon Yang, MD, PhD, role: CONTACT, phone: 82-2-3410-3419, email: [email protected], contacts name: David Hong, MD, role: CONTACT, phone: 82-2-3410-3419, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06350474, orgStudyIdInfo id: SIMPLIFY-IP-19 Dnase, briefTitle: Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study, acronym: SIMPLIFY-DN, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-25, primaryCompletionDateStruct date: 2022-07-11, completionDateStruct date: 2022-07-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nicole Hamblett, class: OTHER, collaborators name: Cystic Fibrosis Foundation, collaborators name: Dartmouth-Hitchcock Medical Center, collaborators name: University of Washington, descriptionModule briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use.The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI.This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCTXXXXXXX (will add once available)., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 477, type: ACTUAL, armsInterventionsModule interventions name: Discontinuation of dornase alfa (Dnase), interventions name: Continuation of dornase alfa (Dnase), outcomesModule primaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in LCI 2.5 From Baseline to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2, secondaryOutcomes measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6, secondaryOutcomes measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6, secondaryOutcomes measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms, secondaryOutcomes measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Providence Alaska Medical Center, city: Anchorage, state: Alaska, zip: 99508, country: United States, geoPoint lat: 61.21806, lon: -149.90028, locations facility: Tucson Cystic Fibrosis Center, city: Tucson, state: Arizona, zip: 85724, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Arkansas Children's Hospital, city: Little Rock, state: Arkansas, zip: 72202, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Miller Children's and Women's Hospital Long Beach, city: Long Beach, state: California, zip: 90806, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: CHOC Children's Hospital, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Stanford University Medical Center, city: Palo Alto, state: California, zip: 94304, country: United States, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Rady Children's Hospital and Health Center at the University of California San Diego, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco - Adult Center, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of California, San Francisco - Peds Center, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale University School of Medicine, city: New Haven, state: Connecticut, zip: 06520, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Nemours Children's Clinic - Jacksonville, city: Jacksonville, state: Florida, zip: 32207, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Central Florida Pulmonary Group, city: Orlando, state: Florida, zip: 32803, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: The Nemours Children's Clinic - Orlando, city: Orlando, state: Florida, zip: 32827, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Nemours Children's Clinic - Pensacola, city: Pensacola, state: Florida, zip: 32514, country: United States, geoPoint lat: 30.42131, lon: -87.21691, locations facility: All Children's Hospital, city: Saint Petersburg, state: Florida, zip: 33701, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Tampa General Hospital, city: Tampa, state: Florida, zip: 33606, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Emory University, city: Atlanta, state: Georgia, zip: 30324, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Saint Luke's Cystic Fibrosis Center of Idaho, city: Boise, state: Idaho, zip: 83702, country: United States, geoPoint lat: 43.6135, lon: -116.20345, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: OSF Saint Francis Medical Center, city: Peoria, state: Illinois, zip: 61637, country: United States, geoPoint lat: 40.69365, lon: -89.58899, locations facility: Riley Hospital for Children, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: University of Iowa, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40506, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Louisville, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Tulane University, city: Metairie, state: Louisiana, zip: 70001, country: United States, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Maine Medical Partners Pediatric Specialty Care, city: Portland, state: Maine, zip: 04102, country: United States, geoPoint lat: 43.66147, lon: -70.25533, locations facility: John Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21205, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, Michigan Medicine, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Wayne State University Harper University Hospital, city: Detroit, state: Michigan, zip: 48201, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Corewell Health Helen DeVos, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: Children's Hospitals and Clinics of Minnesota, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: The Minnesota Cystic Fibrosis Center, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Children's Mercy Kansas City, city: Kansas City, state: Missouri, zip: 64108, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Billings Clinic, city: Billings, state: Montana, zip: 59101, country: United States, geoPoint lat: 45.78329, lon: -108.50069, locations facility: Dartmouth Hitchcock Medical Center, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, geoPoint lat: 43.64229, lon: -72.25176, locations facility: Monmouth Medical Center, city: Eatontown, state: New Jersey, zip: 07724, country: United States, geoPoint lat: 40.29622, lon: -74.05097, locations facility: Morristown Medical Center, city: Morristown, state: New Jersey, zip: 07960, country: United States, geoPoint lat: 40.79677, lon: -74.48154, locations facility: Rutgers - Robert Wood Johnson Medical School, city: New Brunswick, state: New Jersey, zip: 08903, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Cohen Children's Medical Center of New York, city: New Hyde Park, state: New York, zip: 11042, country: United States, geoPoint lat: 40.7351, lon: -73.68791, locations facility: Beth Israel Medical Center, city: New York, state: New York, zip: 10003, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Lenox Hill Hospital Cystic Fibrosis Center, city: New York, state: New York, zip: 10028, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University Cystic Fibrosis Program, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Rochester Medical Center Strong Memorial, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: SUNY Upstate Medical University, city: Syracuse, state: New York, zip: 13210, country: United States, geoPoint lat: 43.04812, lon: -76.14742, locations facility: New York Medical College at Westchester Medical Center, city: Valhalla, state: New York, zip: 10595, country: United States, geoPoint lat: 41.07482, lon: -73.77513, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Atrium Health Wake Forest Baptist, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Children's Hospital Medical Center of Akron, city: Akron, state: Ohio, zip: 44308, country: United States, geoPoint lat: 41.08144, lon: -81.51901, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, city: Cleveland, state: Ohio, zip: 44146, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Cleveland Clinic Cystic Fibrosis Program, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43205, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Dayton Children's Hospital, city: Dayton, state: Ohio, zip: 45404, country: United States, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Oregon Health & Sciences University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Hershey Medical Center Pennsylvania State University, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, geoPoint lat: 40.28592, lon: -76.65025, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Dell Children's Medical Center of Central Texas, city: Austin, state: Texas, zip: 78723, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: University of Texas Southwestern / Children's Health, city: Dallas, state: Texas, zip: 75207, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Texas Southwestern, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Cook Children's Medical Center, city: Fort Worth, state: Texas, zip: 76104, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: University of Texas Health Center at Tyler, city: Tyler, state: Texas, zip: 75708, country: United States, geoPoint lat: 32.35126, lon: -95.30106, locations facility: Primary Children's Cystic Fibrosis Center, city: Salt Lake City, state: Utah, zip: 84113, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: University of Vermont Medical Center, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22904, country: United States, geoPoint lat: 38.02931, lon: -78.47668, locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23219, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: University of Washington Medical Center, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Providence Medical Group, Cystic Fibrosis Center, city: Spokane, state: Washington, zip: 99204, country: United States, geoPoint lat: 47.65966, lon: -117.42908, locations facility: West Virginia University - Morgantown, city: Morgantown, state: West Virginia, zip: 26506, country: United States, geoPoint lat: 39.62953, lon: -79.9559, locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, locations facility: Children's Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, locations facility: Froedtert & Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
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protocolSection identificationModule nctId: NCT06350461, orgStudyIdInfo id: SIMPLIFY-IP-19 HS, briefTitle: Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study, acronym: SIMPLIFY-HS, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-25, primaryCompletionDateStruct date: 2022-07-11, completionDateStruct date: 2022-07-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nicole Hamblett, class: OTHER, collaborators name: Cystic Fibrosis Foundation, collaborators name: Dartmouth-Hitchcock Medical Center, collaborators name: University of Washington, descriptionModule briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available)., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 370, type: ACTUAL, armsInterventionsModule interventions name: Discontinuation of hypertonic saline (HS), interventions name: Continuation of hypertonic saline (HS), outcomesModule primaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in LCI 2.5 From Baseline to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2, secondaryOutcomes measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6, secondaryOutcomes measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6, secondaryOutcomes measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms, secondaryOutcomes measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Providence Alaska Medical Center, city: Anchorage, state: Alaska, zip: 99508, country: United States, geoPoint lat: 61.21806, lon: -149.90028, locations facility: Tucson Cystic Fibrosis Center, city: Tucson, state: Arizona, zip: 85724, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Arkansas Children's Hospital, city: Little Rock, state: Arkansas, zip: 72202, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Miller Children's and Women's Hospital Long Beach, city: Long Beach, state: California, zip: 90806, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: CHOC Children's Hospital, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Stanford University Medical Center, city: Palo Alto, state: California, zip: 94304, country: United States, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Rady Children's Hospital and Health Center at the University of California San Diego, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco - Adult Center, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of California, San Francisco - Peds Center, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale University School of Medicine, city: New Haven, state: Connecticut, zip: 06520, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Nemours Children's Clinic - Jacksonville, city: Jacksonville, state: Florida, zip: 32207, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Central Florida Pulmonary Group, city: Orlando, state: Florida, zip: 32803, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: The Nemours Children's Clinic - Orlando, city: Orlando, state: Florida, zip: 32827, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Nemours Children's Clinic - Pensacola, city: Pensacola, state: Florida, zip: 32514, country: United States, geoPoint lat: 30.42131, lon: -87.21691, locations facility: All Children's Hospital, city: Saint Petersburg, state: Florida, zip: 33701, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Tampa General Hospital, city: Tampa, state: Florida, zip: 33606, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Emory University, city: Atlanta, state: Georgia, zip: 30324, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Saint Luke's Cystic Fibrosis Center of Idaho, city: Boise, state: Idaho, zip: 83702, country: United States, geoPoint lat: 43.6135, lon: -116.20345, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: OSF Saint Francis Medical Center, city: Peoria, state: Illinois, zip: 61637, country: United States, geoPoint lat: 40.69365, lon: -89.58899, locations facility: Riley Hospital for Children, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: University of Iowa, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40506, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Louisville, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Tulane University, city: Metairie, state: Louisiana, zip: 70001, country: United States, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Maine Medical Partners Pediatric Specialty Care, city: Portland, state: Maine, zip: 04102, country: United States, geoPoint lat: 43.66147, lon: -70.25533, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, Michigan Medicine, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Wayne State University Harper University Hospital, city: Detroit, state: Michigan, zip: 48201, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Corewell Health Helen DeVos, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: Children's Hospitals and Clinics of Minnesota, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: The Minnesota Cystic Fibrosis Center, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Children's Mercy Kansas City, city: Kansas City, state: Missouri, zip: 64108, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Billings Clinic, city: Billings, state: Montana, zip: 59101, country: United States, geoPoint lat: 45.78329, lon: -108.50069, locations facility: Dartmouth Hitchcock Medical Center, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, geoPoint lat: 43.64229, lon: -72.25176, locations facility: Monmouth Medical Center, city: Eatontown, state: New Jersey, zip: 07724, country: United States, geoPoint lat: 40.29622, lon: -74.05097, locations facility: Morristown Medical Center, city: Morristown, state: New Jersey, zip: 07960, country: United States, geoPoint lat: 40.79677, lon: -74.48154, locations facility: Rutgers - Robert Wood Johnson Medical School, city: New Brunswick, state: New Jersey, zip: 08903, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Cohen Children's Medical Center of New York, city: New Hyde Park, state: New York, zip: 11042, country: United States, geoPoint lat: 40.7351, lon: -73.68791, locations facility: Beth Israel Medical Center, city: New York, state: New York, zip: 10003, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Lenox Hill Hospital Cystic Fibrosis Center, city: New York, state: New York, zip: 10028, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University Cystic Fibrosis Program, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Rochester Medical Center Strong Memorial, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: SUNY Upstate Medical University, city: Syracuse, state: New York, zip: 13210, country: United States, geoPoint lat: 43.04812, lon: -76.14742, locations facility: New York Medical College at Westchester Medical Center, city: Valhalla, state: New York, zip: 10595, country: United States, geoPoint lat: 41.07482, lon: -73.77513, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Atrium Health Wake Forest Baptist, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Children's Hospital Medical Center of Akron, city: Akron, state: Ohio, zip: 44308, country: United States, geoPoint lat: 41.08144, lon: -81.51901, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, city: Cleveland, state: Ohio, zip: 44146, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Cleveland Clinic Cystic Fibrosis Program, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43205, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Dayton Children's Hospital, city: Dayton, state: Ohio, zip: 45404, country: United States, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Oregon Health & Sciences University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Hershey Medical Center Pennsylvania State University, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, geoPoint lat: 40.28592, lon: -76.65025, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Dell Children's Medical Center of Central Texas, city: Austin, state: Texas, zip: 78723, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: University of Texas Southwestern / Children's Health, city: Dallas, state: Texas, zip: 75207, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Texas Southwestern, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Cook Children's Medical Center, city: Fort Worth, state: Texas, zip: 76104, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: University of Texas Health Center at Tyler, city: Tyler, state: Texas, zip: 75708, country: United States, geoPoint lat: 32.35126, lon: -95.30106, locations facility: Primary Children's Cystic Fibrosis Center, city: Salt Lake City, state: Utah, zip: 84113, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: University of Vermont Medical Center, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22904, country: United States, geoPoint lat: 38.02931, lon: -78.47668, locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23219, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: University of Washington Medical Center, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Providence Medical Group, Cystic Fibrosis Clinic, city: Spokane, state: Washington, zip: 99204, country: United States, geoPoint lat: 47.65966, lon: -117.42908, locations facility: West Virginia University - Morgantown, city: Morgantown, state: West Virginia, zip: 26506, country: United States, geoPoint lat: 39.62953, lon: -79.9559, locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, locations facility: Children's Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, locations facility: Froedtert & Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
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protocolSection identificationModule nctId: NCT06350448, orgStudyIdInfo id: WMT-CN-RH, briefTitle: Washed Microbiota Transplantation for Rhinitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-08-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis., conditionsModule conditions: Rhinitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Washed Microbiota Transplantation, outcomesModule primaryOutcomes measure: Changes in the reflective total nasal symptom score (rTNSS), secondaryOutcomes measure: Changes in the combined symptoms and medication score (CSMS), secondaryOutcomes measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score, secondaryOutcomes measure: Changes in the single reflective nasal symptoms score, secondaryOutcomes measure: Specific IgE, secondaryOutcomes measure: Inflammatory factors, secondaryOutcomes measure: Flow cytometric analysis of lymphocyte clusters, secondaryOutcomes measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210011, country: China, contacts name: Faming Zhang, MD,PhD, role: CONTACT, phone: 086-25-58509883, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06350435, orgStudyIdInfo id: CUHK 2023.569, briefTitle: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Pamela Youde Nethersole Eastern Hospital, descriptionModule briefSummary: Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia., conditionsModule conditions: Metatarsalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Prefabricated foot orthoses (PFO) with metatarsal pads, interventions name: Prefabricated foot orthoses (PFO) without metatarsal pads, outcomesModule primaryOutcomes measure: Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale, secondaryOutcomes measure: Foot and Ankle Outcome Score, secondaryOutcomes measure: Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamela Youde Nethersole Eastern Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06350422, orgStudyIdInfo id: Microgravity-ChinaPLAGH, briefTitle: Neuroimage Genome Study of Neuroplasticity Associated With Microgravity, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment., conditionsModule conditions: Microgravity, conditions: Neuroplasticity, conditions: MRI, conditions: Repeatable Battery for the Assessment of Neuropsychological Status, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Head-Down tilt Bed Rest test, outcomesModule primaryOutcomes measure: Local brain functional activity, primaryOutcomes measure: Brain functional connectivity, primaryOutcomes measure: Brain structure - Morphology, primaryOutcomes measure: Brain fiber bundle and brain Diffusion index, primaryOutcomes measure: Brain blood flow, primaryOutcomes measure: Imaging indexes and clinical scale scores, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06350409, orgStudyIdInfo id: CTN-0146, secondaryIdInfos id: UG1DA015831-22S4, type: NIH, link: https://reporter.nih.gov/quickSearch/UG1DA015831-22S4, briefTitle: Adolescent Outcomes of Post-operative Opioid EXposure, acronym: APEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-10, primaryCompletionDateStruct date: 2026-09-10, completionDateStruct date: 2026-10-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sharon Levy, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations., conditionsModule conditions: Opioid Use Disorder, conditions: Pain, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery., primaryOutcomes measure: Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery., primaryOutcomes measure: Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery., primaryOutcomes measure: Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery., primaryOutcomes measure: Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston Childrens Hopsital - Division of Addiction Medicine, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Melissa Brogna, MSW, role: CONTACT, phone: 857-218-4311, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06350396, orgStudyIdInfo id: CPLTRDDM2024, briefTitle: pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Changping Laboratory, class: OTHER, descriptionModule briefSummary: This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression., conditionsModule conditions: Treatment Resistant Depression, conditions: Major Depressive Disorder, 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: 270, type: ESTIMATED, armsInterventionsModule interventions name: active rTMS treatment, interventions name: sham rTMS treatment, outcomesModule primaryOutcomes measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment, secondaryOutcomes measure: Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS), secondaryOutcomes measure: Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17), secondaryOutcomes measure: Changes in the MADRS from baseline to each visit, secondaryOutcomes measure: Changes in the HAMD-17 from baseline to each visit, secondaryOutcomes measure: cognitive change in Digit Symbol Substitution Test (DSST), secondaryOutcomes measure: cognitive change in continuous performance test (CPT), secondaryOutcomes measure: cognitive change in Trail-Making Test (TMT), secondaryOutcomes measure: cognitive change in Digit Span Test (DST), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hebei Mental Health Center, city: Hebei, state: Baoding, country: China, contacts name: Lili Zhang, role: CONTACT, locations facility: West China Hospital, Sichuan University, city: Chengdu, country: China, contacts name: Qiyong Gong, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Inner Mongolia Mental Health Center, city: Hohhot, country: China, contacts name: Dongsheng Lv, role: CONTACT, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Shandong Daizhuang Hospital, city: Jining, country: China, contacts name: Zhonggang Wang, role: CONTACT, geoPoint lat: 35.405, lon: 116.58139, locations facility: The Second Affiliated Hospital of Xinxiang Medical University, city: Xinxiang, country: China, contacts name: Yongfeng Yang, role: CONTACT, geoPoint lat: 35.19033, lon: 113.80151, hasResults: False
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protocolSection identificationModule nctId: NCT06350383, orgStudyIdInfo id: K01TW011775, type: NIH, link: https://reporter.nih.gov/quickSearch/K01TW011775, briefTitle: Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-01-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, collaborators name: Drexel University, collaborators name: Africa Mental Health Research and Training Foundation, descriptionModule briefSummary: The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic., conditionsModule conditions: Violence, Domestic, conditions: Psychological Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-arm, parallel-group design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants will not be told which arm they have been randomized to. Additionally, to reduce contamination, community health volunteers (CHVs) will either carry out assessment or intervention, not both. Assessors will not be told to which arm participants they are assessing have been assigned., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: WINGS+PM+, interventions name: PM+-only, outcomesModule primaryOutcomes measure: World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument, secondaryOutcomes measure: Receipt of violence services, secondaryOutcomes measure: Domestic Violence Coping Self-efficacy Scale (DVCSE), secondaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Safety Behavior Checklist, secondaryOutcomes measure: Psychological distress (GHQ-12), secondaryOutcomes measure: Functioning (WHODAS 2.0), secondaryOutcomes measure: Short form of the Posttraumatic Stress Disorder Checklist (PCL-5), secondaryOutcomes measure: Personalized outcomes (PSYCHLOPS), otherOutcomes measure: Quality control/intervention fidelity, otherOutcomes measure: Facilitator Satisfaction and ease of intervention delivery (EBPAS-36), otherOutcomes measure: Adverse events, otherOutcomes measure: Participant satisfaction with intervention, otherOutcomes measure: Number of participants in attendance at sessions, otherOutcomes measure: Retention Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350370, orgStudyIdInfo id: NCC3489, briefTitle: Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: Natural orifice specimen extraction, outcomesModule primaryOutcomes measure: Rate of short-term complication, secondaryOutcomes measure: Operative duration, secondaryOutcomes measure: Intraoperative blood loss, secondaryOutcomes measure: Time to first flatus after surgery, secondaryOutcomes measure: Time to first stool after surgery, secondaryOutcomes measure: Length of stay after surgery, secondaryOutcomes measure: 3-year disease free survival, secondaryOutcomes measure: 3-year overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 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: Xishan Wang, role: CONTACT, phone: 13261967603, email: [email protected], contacts name: Mingguang Zhang, role: CONTACT, phone: +8613261967603, email: [email protected], contacts name: Xishan Wang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06350357, orgStudyIdInfo id: 2024B014, briefTitle: Conventional Clipping Versus Punching Closure, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ningbo No. 1 Hospital, class: OTHER, descriptionModule briefSummary: Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method., conditionsModule conditions: the Rate of Complete Closure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: punching closure, interventions name: Conventional clipping, outcomesModule primaryOutcomes measure: Completely closed, secondaryOutcomes measure: delayed hemorrhage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ningbo first hospital, status: RECRUITING, city: Ningbo, state: Zhejiang, country: China, contacts name: Lei Xu, role: CONTACT, phone: +86-13486659126, email: [email protected], geoPoint lat: 29.87819, lon: 121.54945, hasResults: False
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protocolSection identificationModule nctId: NCT06350344, orgStudyIdInfo id: HZKY-PJ-2024-8-2, briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management, acronym: SmaVTE-COR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Navy General Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE., conditionsModule conditions: Venous Thromboembolism, conditions: Digital Health, conditions: Health Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 2353, type: ESTIMATED, armsInterventionsModule interventions name: mobile venous thromboembolism application (mVTEA), outcomesModule primaryOutcomes measure: VTE-related composite event, secondaryOutcomes measure: VTE-KAP questionnaire score, secondaryOutcomes measure: Generic quality of life, secondaryOutcomes measure: VTE events, secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: VTE-related hospitalization, secondaryOutcomes measure: New-onset of atrial fibrillation or atrial flutter, secondaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sixth Medical Center of Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100048, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06350331, orgStudyIdInfo id: HZKY-PJ-2024-8-1, briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management, acronym: SmaVTE-RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Navy General Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE., conditionsModule conditions: Venous Thromboembolism, conditions: Digital Health, conditions: Health Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: mobile venous thromboembolism application (mVTEA), outcomesModule primaryOutcomes measure: VTE-KAP questionnaire score, secondaryOutcomes measure: Knowledge, attitude, and practice scores in the VTE-KAP questionnaire, secondaryOutcomes measure: Generic quality of life, secondaryOutcomes measure: VTE events, secondaryOutcomes measure: Chronic thromboembolic pulmonary hypertension (CTEPH), secondaryOutcomes measure: Chronic thromboembolic pulmonary disease (CTEPD), secondaryOutcomes measure: Post-pulmonary embolism syndrome (PPES), secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: VTE-related hospitalization, secondaryOutcomes measure: VTE-related rehospitalization, secondaryOutcomes measure: New-onset of atrial fibrillation or atrial flutter, secondaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sixth Medical Center of Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100048, country: China, contacts name: ZHI-GENG JIN, Doctor, role: CONTACT, phone: 8615801402223, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06350318, orgStudyIdInfo id: MCC-22005, briefTitle: Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: BeiGene, Ltd., descriptionModule briefSummary: The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas)., conditionsModule conditions: Follicular Lymphoma, conditions: Marginal Zone Lymphoma, conditions: B-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Zanubrutinib, interventions name: Rituximab, outcomesModule primaryOutcomes measure: Overall Response Rate: Cohort A, primaryOutcomes measure: Overall Response Rate: Cohort B, secondaryOutcomes measure: Efficacy of Zanubrutinib and Rituximab, secondaryOutcomes measure: Safety and tolerability of combination Zanubrutinib and Rituximab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Richard Corona, role: CONTACT, phone: 813-745-3465, email: [email protected], contacts name: Sameh Gaballa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06350305, orgStudyIdInfo id: Screening for high-risk COPD, briefTitle: Screening for High-risk Chronic Obstructive Pulmonary Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Henan University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD)., conditionsModule conditions: High-risk COPD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3600, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire survey, outcomesModule primaryOutcomes measure: COPD screening questionnaire from Terrassa (EGARPOC), primaryOutcomes measure: COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE), primaryOutcomes measure: COPD Assessment Test (CAT), primaryOutcomes measure: COPD screening questionnaire (COPD-Q), primaryOutcomes measure: chronic obstructive pulmonary disease diagnostic questionnaire (CDQ), primaryOutcomes measure: modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ), primaryOutcomes measure: Simple screening questionnaire, primaryOutcomes measure: lung function questionnaire (LFQ), primaryOutcomes measure: chronic obstructive pulmonary disease screening questionnaire (COPD-SQ), primaryOutcomes measure: chronic obstructive pulmonary disease population screener questionnaire (COPD-PS), primaryOutcomes measure: Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS), primaryOutcomes measure: Standardised Scale of Physical Fitness in Chinese Medicine, primaryOutcomes measure: Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Henan University of Chinese Medicine, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: yang Xie, doctor, role: CONTACT, phone: 0371-66248624, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06350292, orgStudyIdInfo id: 0161464, briefTitle: SLEEP-COPE: Sleep Intervention for Oppositional Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, descriptionModule briefSummary: Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents., conditionsModule conditions: Insomnia Chronic, conditions: Oppositional Defiant Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: SLEEP: COPE, outcomesModule primaryOutcomes measure: Child Daily Sleep Diaries, primaryOutcomes measure: Parent Daily Sleep Diaries, secondaryOutcomes measure: Child Actigraphy, secondaryOutcomes measure: Parent Actigraphy, secondaryOutcomes measure: Child Salivary Cortisol, secondaryOutcomes measure: Child Hair Cortisol, secondaryOutcomes measure: The Revised Childhood Anxiety and Depression Scale, secondaryOutcomes measure: PROMIS Child Sleep Disturbance, secondaryOutcomes measure: Alabama Parenting Questionnaire, secondaryOutcomes measure: Perceived Stress Scale, secondaryOutcomes measure: Child Disruptive Behavior Disorders Checklist, secondaryOutcomes measure: Beck Depression Inventory-II, secondaryOutcomes measure: State-Trait Anxiety Inventory, secondaryOutcomes measure: PROMIS Adult Sleep Disturbance, secondaryOutcomes measure: Pediatric Sleep Questionnaire, secondaryOutcomes measure: Epworth Sleepiness Scale, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350279, orgStudyIdInfo id: HSK39297-101, briefTitle: A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-25, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Haisco Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: HSK39297, outcomesModule primaryOutcomes measure: The number and severity of treatment emergent adverse events (TEAEs) ., secondaryOutcomes measure: AUC, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: AP change, secondaryOutcomes measure: Bb, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Tongren Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Laichun Lu, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06350266, orgStudyIdInfo id: 2024-0183, briefTitle: Informing Low-acuity Emergency Department Patients of Non-emergent Resources, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Geisinger Clinic, class: OTHER, descriptionModule briefSummary: The goal of this campaign is to reduce unnecessary ED visits/encourage patients with low acuity visits to follow up with an appropriate provider and/or to seek care outside of the ED in the future. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will include one or more calls to action that make patients aware of other Geisinger resources and avenues through which they can seek care outside of the ED. These may include, but are not limited to, walk-in urgent care, virtual urgent care, PCP appointments, and/or other ways in which to contact Geisinger. We will measure whether ED use differs across patients in different outreach conditions. We will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions., conditionsModule conditions: Emergency Service, Hospital, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: Patients will be aware of their own messages but not of messages sent to other patients or in other arms., enrollmentInfo count: 8300, type: ESTIMATED, armsInterventionsModule interventions name: Information about healthcare resources, outcomesModule primaryOutcomes measure: Return to ED, otherOutcomes measure: PCP appointment scheduled, otherOutcomes measure: PCP visit, otherOutcomes measure: Telehealth appointment scheduled, otherOutcomes measure: Telehealth appointment attended, otherOutcomes measure: Urgent care visit, otherOutcomes measure: Call made to PCP, otherOutcomes measure: Any of the suggested actions taken, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350253, orgStudyIdInfo id: 22-X-187, briefTitle: Comparison Of Measured To Predicted Resting Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ohio University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry., conditionsModule conditions: Body Weight, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Metabolic cart, interventions name: MedGem, interventions name: BIA, outcomesModule primaryOutcomes measure: Resting metabolic rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ohio University Exercise Physiology Lab, status: RECRUITING, city: Athens, state: Ohio, zip: 45701, country: United States, contacts name: Angela Hillman, PhD, role: CONTACT, phone: 740-593-0153, email: [email protected], geoPoint lat: 39.32924, lon: -82.10126, hasResults: False
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protocolSection identificationModule nctId: NCT06350240, orgStudyIdInfo id: KUzunAkkaya, briefTitle: Effects of Textured Insoles and Exercise in Children With Joint Hypermobility, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, collaborators name: TÜBİTAK, descriptionModule briefSummary: Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children., conditionsModule conditions: Child, Only, conditions: Joint Laxity, conditions: Exercise, conditions: Textured Insoles, 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: Exercise, interventions name: Exercise+texture insoles, outcomesModule primaryOutcomes measure: Tactile sense, primaryOutcomes measure: Foot load distribution, primaryOutcomes measure: Balance, secondaryOutcomes measure: Foot posture, secondaryOutcomes measure: Quality of life assessment, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Kamile Uzun Akkaya, Phd, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06350227, orgStudyIdInfo id: WestChinaSU, briefTitle: Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: West China Second University Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts., conditionsModule conditions: Ovarian Cyst Benign, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: the absorbable hemostat and suture, interventions name: electrocoagulation and suture, interventions name: suture, outcomesModule primaryOutcomes measure: Antral Follicle Count (AFC), secondaryOutcomes measure: Anti-Mullerian hormone (AMH), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Second University Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Yanru Long, role: CONTACT, phone: 86-13550169017, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06350214, orgStudyIdInfo id: #2005-06; #2011-17; #2018-01, briefTitle: Physical Activity and Nutrition in Cancer Survivors, statusModule overallStatus: COMPLETED, startDateStruct date: 2007-01-01, primaryCompletionDateStruct date: 2018-12-31, completionDateStruct date: 2018-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors., conditionsModule conditions: Cancer, conditions: Nutrition, Healthy, conditions: Physical Inactivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3100, type: ACTUAL, armsInterventionsModule interventions name: physical activity and nutrition assessment, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Cause-specific mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06350201, orgStudyIdInfo id: KY2024.0124.02, briefTitle: Machine Learning-based Classification of Symptom Clusters and Online CBT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Wuhan Mental Health Centre, class: OTHER, descriptionModule briefSummary: To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents., conditionsModule conditions: Depression and Anxiety Symptom, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: cognitive behavior therapy, interventions name: control group, outcomesModule primaryOutcomes measure: The Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: 7-tiem Generalized Anxiety Disorder Scale,GAD-.7, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06350188, orgStudyIdInfo id: ECM#2024-506, briefTitle: Efficacy of Kinesiotape on Treatment of Nonspecific Cardiac Chest Pain, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-06-22, completionDateStruct date: 2024-07-22, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: purpose of the study To investigate the effect of Kinesio-tape on treatment of nonspecific cardiac chest pain, conditionsModule conditions: Nonspecific Cardiac Chest Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: experimental, interventions name: traditional, outcomesModule primaryOutcomes measure: PAIN USING VIISUSL ANALOGE SCALE, secondaryOutcomes measure: PERSSURE PAIN THRESHOLD, otherOutcomes measure: SHOULDER RANGE OF MOTION, otherOutcomes measure: shoulder pain and disability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Huda Badr Abd Elhamed, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06350175, orgStudyIdInfo id: 2212697123, briefTitle: Emergency Department Management of Tobacco Use Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: West Virginia University, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy., conditionsModule conditions: Tobacco Use Disorder, conditions: Tobacco Use Cessation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Nicotine Replacement Therapy Agent, interventions name: West Virginia Quit Line, outcomesModule primaryOutcomes measure: Percentage of Continued Abstinence Rate (2 weeks), primaryOutcomes measure: Percentage of Continued Abstinence Rate (1 month), primaryOutcomes measure: Percentage of Continued Abstinence Rate (3 months), primaryOutcomes measure: Patient Health Questionnaire 2 (Baseline), primaryOutcomes measure: Patient Health Questionnaire 2 (3 months from baseline), primaryOutcomes measure: Heaviness of Smoking Index (Baseline), primaryOutcomes measure: Heaviness of Smoking Index (3 months from baseline), primaryOutcomes measure: Richmond Test (Baseline), primaryOutcomes measure: Richmond Test (3 months from baseline), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West Virginia University, city: Morgantown, state: West Virginia, zip: 26505, country: United States, geoPoint lat: 39.62953, lon: -79.9559, hasResults: False
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protocolSection identificationModule nctId: NCT06350162, orgStudyIdInfo id: ASTRUM-LC12, briefTitle: Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer ., conditionsModule conditions: Extensive Stage Lung Small Cell Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, interventions name: Chest Radiation, outcomesModule primaryOutcomes measure: 1-year Progression-free survival rate, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), otherOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, country: China, contacts name: jing Qin, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06350149, orgStudyIdInfo id: STUDY00004637, secondaryIdInfos id: 1R21DK128731-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21DK128731-01A1, briefTitle: A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are:* Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible.* What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CFParticipants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Sugar Sweetened Beverages (SSB), interventions name: Hi GI, interventions name: Lo GI, outcomesModule primaryOutcomes measure: Recruitment Rate, primaryOutcomes measure: Refusal Rate, primaryOutcomes measure: Investigator Fidelity, primaryOutcomes measure: Participant Fidelity, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Retention Rates, primaryOutcomes measure: Recruitment, secondaryOutcomes measure: Change in plasma Cysteine (Cys), secondaryOutcomes measure: Change in plasma Cystine (CySS), secondaryOutcomes measure: Change in plasma Glutathione (GSH), secondaryOutcomes measure: Change in plasma Glutathione Disulfide (GSSG), secondaryOutcomes measure: Change in redox potentials (EhCys/ CySS and EhGSH/GSSG), secondaryOutcomes measure: Insulinogenic index, secondaryOutcomes measure: Whole body insulin sensitivity index (WBISI-Matsuda), secondaryOutcomes measure: Disposition Index, secondaryOutcomes measure: Change in plasma Eh Cys/CySS, secondaryOutcomes measure: Change in incremental glucose AUC, secondaryOutcomes measure: Changes in Plasma insulin, secondaryOutcomes measure: Changes in Plasma C-peptide, secondaryOutcomes measure: Changes in Plasma Glucagon, secondaryOutcomes measure: Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1), secondaryOutcomes measure: Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Center for Advanced Pediatrics: Emory Healthcare, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30329, country: United States, contacts name: Tanicia Daley, MD, role: CONTACT, phone: 404-785-5437, email: [email protected], contacts name: Arlene Stecenko, MD, role: CONTACT, phone: 404-727-1460, email: [email protected], contacts name: Tanicia Daley, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jessica Alvarez, PhD, role: SUB_INVESTIGATOR, contacts name: Arlene Stecenko, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06350136, orgStudyIdInfo id: 2024/05-37, briefTitle: The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Firat University, class: OTHER, descriptionModule briefSummary: This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field., conditionsModule conditions: With Tele-Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: With Tele-Nursing, outcomesModule primaryOutcomes measure: Hill-Bone Hypertension Treatment Compliance Scale, primaryOutcomes measure: Self-Care Management Scale in Chronic Diseases;, primaryOutcomes measure: Psychological Impact of Earthquake Scale:, primaryOutcomes measure: Earthquake Stress Coping Strategies Scale, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350123, orgStudyIdInfo id: D6405C00002, briefTitle: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease., acronym: MIRO-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-01-13, completionDateStruct date: 2026-01-13, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD., conditionsModule conditions: Chronic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin, outcomesModule primaryOutcomes measure: Relative change in UACR from baseline to Week 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: San Carlos, state: California, zip: 94070, country: United States, geoPoint lat: 37.50716, lon: -122.26052, locations facility: Research Site, city: Waterbury, state: Connecticut, zip: 06708, country: United States, geoPoint lat: 41.55815, lon: -73.0515, locations facility: Research Site, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Site, city: Salt Lake City, state: Utah, zip: 84124, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Research Site, city: Norfolk, state: Virginia, zip: 23504, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: Research Site, city: Linz, zip: 4021, country: Austria, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Research Site, city: St. Pölten, zip: 3100, country: Austria, geoPoint lat: 48.2, lon: 15.63333, locations facility: Research Site, city: Vienna, zip: A-1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wels, zip: 4600, country: Austria, geoPoint lat: 48.16667, lon: 14.03333, locations facility: Research Site, city: Wien, zip: 1030, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wien, zip: 1130, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wien, zip: 1190, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Burgas, zip: 8018, country: Bulgaria, geoPoint lat: 42.50606, lon: 27.46781, locations facility: Research Site, city: Dobrich, zip: 9300, country: Bulgaria, geoPoint lat: 43.56667, lon: 27.83333, locations facility: Research Site, city: Pleven, zip: 5800, country: Bulgaria, geoPoint lat: 43.41667, lon: 24.61667, locations facility: Research Site, city: Plovdiv, zip: 4000, country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, city: Sofia, zip: 1680, country: Bulgaria, geoPoint lat: 42.69751, lon: 23.32415, locations facility: Research Site, city: London, state: Ontario, zip: N6A 5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, city: Waterloo, state: Ontario, zip: N2T 0C1, country: Canada, geoPoint lat: 43.4668, lon: -80.51639, locations facility: Research Site, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Quebec, zip: G1R 2J6, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, city: Bari, zip: 70124, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Research Site, city: Bologna, zip: 40138, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Research Site, city: Genoa, zip: 16132, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Research Site, city: Parma, zip: 43126, country: Italy, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Research Site, city: Pavia, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Research Site, city: Ipoh, zip: 30990, country: Malaysia, geoPoint lat: 4.5841, lon: 101.0829, locations facility: Research Site, city: Kota Bahru, zip: 15586, country: Malaysia, geoPoint lat: 6.13328, lon: 102.2386, locations facility: Research Site, city: Kuala Lumpur, zip: 59100, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, locations facility: Research Site, city: Białystok, zip: 15-481, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Research Site, city: Gdańsk, zip: 80-546, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Research Site, city: Grodzisk Mazowiecki, zip: 05-825, country: Poland, geoPoint lat: 52.10387, lon: 20.6337, locations facility: Research Site, city: Leżajsk, zip: 37-300, country: Poland, geoPoint lat: 50.26257, lon: 22.41932, locations facility: Research Site, city: Ruda Śląska, zip: 41-709, country: Poland, geoPoint lat: 50.2584, lon: 18.85632, locations facility: Research Site, city: Szczecin, zip: 70-111, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: Research Site, city: Warszawa, zip: 02-798, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, city: Łódź, zip: 92-213, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, city: Żywiec, zip: 34-300, country: Poland, geoPoint lat: 49.68529, lon: 19.19243, locations facility: Research Site, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Barcelona, zip: 8035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Cordoba, zip: 14004, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Research Site, city: Palma de Mallorca, zip: 07010, country: Spain, geoPoint lat: 39.56939, lon: 2.65024, locations facility: Research Site, city: Sevilla, zip: 41013, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Research Site, city: Valencia, zip: 46026, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Research Site, city: Kaohsiung, zip: 80756, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, city: New Taipei City, zip: 220, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, locations facility: Research Site, city: Taichung, zip: 40201, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, city: Tainan, zip: 710, country: Taiwan, geoPoint lat: 22.99083, lon: 120.21333, locations facility: Research Site, city: Taipei City, zip: 110, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei City, zip: 11217, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 11490, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06350110, orgStudyIdInfo id: ESBI202492, briefTitle: Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE), acronym: BAH242, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-10, primaryCompletionDateStruct date: 2025-12-10, completionDateStruct date: 2025-12-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Essen Biotech, class: OTHER, descriptionModule briefSummary: This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate., conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Lupus Nephritis, conditions: Autoimmune Diseases, conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, conditions: Granulomatous Polyangiitis, conditions: Microscopic Polyangiitis, conditions: Systemic Sclerosis, conditions: Idiopathic Inflammatory Myopathies, conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group AssignmentPatients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD19 and BCMA CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for the CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells.Monitoring and Follow-up:Following the CAR-T cell infusion, patients will be subjected to rigorous monitoring to assess safety and treatment response., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group., enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: CD19- BCMA CAR-T cells, outcomesModule primaryOutcomes measure: Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells, secondaryOutcomes measure: Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: District one hospital, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06350097, orgStudyIdInfo id: D516NC00001, briefTitle: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer, acronym: TROPION-Lung14, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-16, primaryCompletionDateStruct date: 2028-03-21, completionDateStruct date: 2032-05-25, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet) monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.Study details include:1. The study duration will be event-driven, with an estimated duration of approximately 9 years.2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.3. The visit frequency will be every 3 weeks during the treatment period.Note: Participants on osimertinib treatment (osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression, IP discontinuation or primary PFS DCO. Participants who are receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 582, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib, interventions name: Datopotamab Deruxtecan, outcomesModule primaryOutcomes measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants., secondaryOutcomes measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of OS in all randomised participants., secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on CNS metastases in participants with CNS metastases at baseline, secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants., secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of ORR in all randomised participants with measurable disease at baseline., secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline., secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases, secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants, secondaryOutcomes measure: To assess the PK of osimertinib and Datopotamab Deruxtecan, secondaryOutcomes measure: To investigate the immunogenicity of Datopotamab Deruxtecan, secondaryOutcomes measure: To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples, secondaryOutcomes measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Clayton, zip: 3168, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Research Site, city: Kogarah, zip: 2217, country: Australia, geoPoint lat: -33.98333, lon: 151.11667, locations facility: Research Site, city: Changchun, zip: 130000, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Research Site, city: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, city: Jinan, zip: 250021, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Research Site, city: Jinan, zip: 250117, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Research Site, city: Kunming, zip: 650118, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Research Site, city: Linhai, zip: 318000, country: China, geoPoint lat: 28.85535, lon: 121.14469, locations facility: Research Site, city: Shanghai, zip: 200030, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, city: Seoul, zip: 06351, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 120-752, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Taipei City, zip: 106, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06350084, orgStudyIdInfo id: 2023/381, briefTitle: Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection., conditionsModule conditions: Pain, Acute, conditions: Newborn, conditions: Crying, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Mother's Touch, interventions name: Nurse's Therapeutic Touch, outcomesModule primaryOutcomes measure: NIPS (Neonatal Infant Pain Scale), secondaryOutcomes measure: Crying times, secondaryOutcomes measure: Processing time, eligibilityModule sex: ALL, minimumAge: 2 Days, maximumAge: 4 Days, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: [email protected], contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False
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protocolSection identificationModule nctId: NCT06350071, orgStudyIdInfo id: 2023/06, briefTitle: Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection., conditionsModule conditions: Pain, Acute, conditions: Newborns, conditions: Crying, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Kangaroo Care, interventions name: Swaddling, outcomesModule primaryOutcomes measure: NIPS (Neonatal Infant Pain Scale), secondaryOutcomes measure: Crying times, secondaryOutcomes measure: Processing time, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 4 Days, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: [email protected], contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False
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protocolSection identificationModule nctId: NCT06350058, orgStudyIdInfo id: 202012005, briefTitle: Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-08-03, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 375, type: ACTUAL, armsInterventionsModule interventions name: Inactivated rotavirus vaccine (low dose), interventions name: Inactivated rotavirus vaccine (high dose), interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence rate of AE, primaryOutcomes measure: Incidence rate of SAE, eligibilityModule sex: ALL, minimumAge: 6 Weeks, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hebei Provincial Center for Disease Control and Prevention, city: Shijiangzhuang, state: Hebei, zip: 050021, country: China, geoPoint lat: 34.61038, lon: 113.58554, hasResults: False
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protocolSection identificationModule nctId: NCT06350045, orgStudyIdInfo id: supra 11th puncture PCNL, briefTitle: High Supracostal Versus Subcostal Puncture in Adult PCNL, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one, conditionsModule conditions: Urolithiasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: closed envelop, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ACTUAL, armsInterventionsModule interventions name: PCNL, outcomesModule primaryOutcomes measure: Rate of complications, primaryOutcomes measure: Stone free rate, secondaryOutcomes measure: duration of Hospital stay., secondaryOutcomes measure: Operative time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University Hospital, city: Assiut, zip: 11751, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06350032, orgStudyIdInfo id: TREPaed, secondaryIdInfos id: 2023-505082-91-00, type: CTIS, briefTitle: Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: AOP Orphan Pharmaceuticals AG, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is:• if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either treatment-naïve or have been previously treated with commercially available parenteral treprostinil formulations.Participants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week)., conditionsModule conditions: Pulmonary Arterial Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: preservative-free parenteral treprostinil, outcomesModule primaryOutcomes measure: Frequency and seriousness of adverse events and adverse drug reactions, otherOutcomes measure: Change from baseline in quality of Life (QoL), otherOutcomes measure: Change from baseline in 6-minute walk distance (6MWD), otherOutcomes measure: Change from baseline in World Health Organization Functional Class (WHO FC), otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - RA/RV enlargement, otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - RV systolic dysfunction, otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - RV/LV end-systolic ratio (PSAX), otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - tricuspid annular plane systolic excursion (TAPSE), otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - S/D ratio (TR jet), otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - Pulmonary Artery Acceleration Time (PAAT), otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - pericardial effusion, otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - eccentricity index, otherOutcomes measure: Change from baseline in echocardiography (ECHO) parameters - acceleration time, otherOutcomes measure: Change from baseline in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, otherOutcomes measure: Treprostinil plasma concentration, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Medizinische Universität Wien, city: Vienna, zip: 1090, country: Austria, contacts name: Sulaimi Albinni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Necker-Enfants Malades Hospital, Paris, city: Paris, zip: 75015, country: France, contacts name: Damien Bonnet, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Gottsegen National Cardiovascular Center, city: Budapest, zip: H-1096, country: Hungary, contacts name: Laszlo Ablonczy, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Ramón y Cajal University Hospital, city: Madrid, zip: 28034, country: Spain, contacts name: Maria J del Cerro, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06350019, orgStudyIdInfo id: 26379996/91, briefTitle: Vascular Effects of Penil revascularızatıon, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01-01, primaryCompletionDateStruct date: 2014-08-15, completionDateStruct date: 2014-12-25, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated., conditionsModule conditions: Erectile Dysfunction, conditions: Erectile Dysfunction Due to Arterial Disease, conditions: Erectile Dysfunction Due to Venous Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Penile revascularızation, outcomesModule primaryOutcomes measure: The importance of resistive index in evaluating the postoperative success of penile revascularization, eligibilityModule sex: MALE, minimumAge: 23 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06350006, orgStudyIdInfo id: SHR-A1904-301, briefTitle: SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Hengrui Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study consists of two research phases:Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors., conditionsModule conditions: Cldn18.2-positive Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two phases, IB-A for dose escalation and IB-B for efficacy extension. The Phase III multi-center, randomized controlled, double-blind study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 924, type: ESTIMATED, armsInterventionsModule interventions name: SHR-A1904; Adebrelimab, interventions name: SHR-A1904; CAPOX; Adebrelimab, outcomesModule primaryOutcomes measure: Incidence and severity of AE, primaryOutcomes measure: Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximal Tolerable Dose (MTD), primaryOutcomes measure: Phase III Recommended Dose (RP3D), primaryOutcomes measure: Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria, secondaryOutcomes measure: SHR-A1904 toxin binding antibody, secondaryOutcomes measure: SHR-A1904 Total antibody, secondaryOutcomes measure: Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb), secondaryOutcomes measure: Expression level of CLDN18.2 in tumor tissues, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence and severity of AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Ruihua Xu, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06349993, orgStudyIdInfo id: pd003, briefTitle: Digital Intervention for Depression and Anxiety in Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Adai Technology (Beijing) Co., Ltd., class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.Participants will be asked to engage with the digital intervention platform for a period of two months., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Digital Intervention, interventions name: Health Education, outcomesModule primaryOutcomes measure: Hamilton Depression Rating Scale, primaryOutcomes measure: Hamilton Anxiety Rating Scale, secondaryOutcomes measure: ADHD(attention deficit hyperactivity disorder) Rating Scale-IV, secondaryOutcomes measure: PHQ-9 (Patient Health Questionnaire-9), secondaryOutcomes measure: GAD-7 (Generalized Anxiety Disorder-7), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Liqun Zhang, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06349980, orgStudyIdInfo id: HLX53-HCC201, briefTitle: A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-02-10, completionDateStruct date: 2027-02-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: HLX53 (1000mg), interventions name: HLX53 (2000mg), interventions name: HLX10, interventions name: HLX04, interventions name: Placebo, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349967, orgStudyIdInfo id: WCH-2023-1592, briefTitle: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 59, type: ESTIMATED, armsInterventionsModule interventions name: Nab-paclitaxel Combined With Cadonilimab (AK104), outcomesModule primaryOutcomes measure: overall response rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349954, orgStudyIdInfo id: BFHHZS20240064, briefTitle: Effectiveness and Safety of Single-session Endoscopic Stone Extraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction., conditionsModule conditions: Choledocholithiasis With Acute Cholangitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All patients will be randomly allocated into single-session group or two-session group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: single-session ERCP, interventions name: two-session ERCP, outcomesModule primaryOutcomes measure: Success rate of complete stone removal, primaryOutcomes measure: ERCP-related complication rate, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Hospital expenses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Wei Jiang, role: CONTACT, phone: 18663186116, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349941, orgStudyIdInfo id: STU-2023-0745, briefTitle: Telemedicine in Rural Patients With Heart Failure, acronym: RURAL-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Movn app, outcomesModule primaryOutcomes measure: Physical activity levels, primaryOutcomes measure: Quality of life using KCCQ score, secondaryOutcomes measure: Enrollment rate, secondaryOutcomes measure: Loss to follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06349928, orgStudyIdInfo id: MASF_Dancers01, briefTitle: "The Show Must go on" : The Experience of Injuries Among Dancers: Fears, Thoughts, and Beliefs. A Qualitative Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Siena, class: OTHER, descriptionModule briefSummary: This qualitative, cross-sectional study aims at describing the experience of Italian dancers with injury.Dancers face a high risk of sustaining one or more injuries during their career (87-94%), which may lead to physical, psychological, and socioeconomic consequences affecting dancer's lives and careers both short and long-term.Dancers report fearing injury and its consequences and believing in the existence of a stigma around injury and injured colleagues; many of them also try to self-manage pain and delay reporting injuries to healthcare professionals, possibly making its outcomes worse.This study will collect data from dancers via focus groups and individual interviews, investigating dancers' experiences, thoughts, and beliefs about injury. Records from the interviews will be transcribed ad verbatim and analyzed using the framework method to synthetize the data and highlight the most meaningful content.Understanding dancers' thoughts and behaviors regarding past or possible future injuries may be beneficial in improving treatment efficacy and designing adequate education and prevention strategies. It may also help raise awareness of dancers' complex and unique needs, and the importance of having accessible, specialized professionals around dance companies and schools., conditionsModule conditions: Injuries, conditions: Dancing, conditions: Injury;Sports, conditions: Stress, Psychological, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Focus group or interview, outcomesModule primaryOutcomes measure: Experience and perception of injury amongst dancers, secondaryOutcomes measure: Understanding of injury prevention and pain management amongst dancers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349915, orgStudyIdInfo id: 2023-15217, briefTitle: A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents, acronym: SWEEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Albert Einstein College of Medicine, class: OTHER, collaborators name: American Foundation for Suicide Prevention, collaborators name: Yeshiva University, descriptionModule briefSummary: Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, NY. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents., conditionsModule conditions: Suicide, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP), outcomesModule primaryOutcomes measure: Suicidal Thoughts, secondaryOutcomes measure: Suicidal Urge Resistance, secondaryOutcomes measure: Social Connectedness, secondaryOutcomes measure: Optimism, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Intervention Acceptability, otherOutcomes measure: Emotions, otherOutcomes measure: Treatment Readiness, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349902, orgStudyIdInfo id: Pro00077561, briefTitle: Re-link HCV in Substance-Use Telemedicine Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: trueNorth Medical Centres, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach., conditionsModule conditions: Hepatitis C, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Re-Link, outcomesModule primaryOutcomes measure: number of patients identified as having diagnosed but untreated HCV, primaryOutcomes measure: percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care, secondaryOutcomes measure: treatment initiation rates, secondaryOutcomes measure: treatment completion dates, secondaryOutcomes measure: cure rates, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: trueNorth Medical Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5B 2A5, country: Canada, contacts name: Hannah O'Reilly, BSc, role: CONTACT, phone: 8888783563, phoneExt: 6452, email: [email protected], contacts role: CONTACT, phoneExt: Cavacuiti, email: [email protected], contacts name: Chris Cavacuiti, BA, MD, MHSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06349889, orgStudyIdInfo id: MA-NPC-II-004, briefTitle: Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, collaborators name: Nanfang Hospital, Southern Medical University, collaborators name: West China Hospital, descriptionModule briefSummary: This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC)., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Nasopharyngeal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, outcomesModule primaryOutcomes measure: Failure-free survival (FFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Distant metastasis-free survival (DMFS), secondaryOutcomes measure: Locoregional recurrence-free survival (LRRFS), secondaryOutcomes measure: Adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Quality of life (QoL), secondaryOutcomes measure: Failure-free survival (FFS) within different subgroups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jian Guan, M.D., role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Lei Liu, M.D., role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06349876, orgStudyIdInfo id: SUEZ MED - IRB Approval NO: 6, briefTitle: Cholecystectomy in Patients With Silent Common Bile Duct Stones, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2023-07-15, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Suez University, class: OTHER, descriptionModule briefSummary: Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones, conditionsModule conditions: Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: laparoscopic cholecystectomy, outcomesModule primaryOutcomes measure: number of patients developed jaundice post cholecystectomy, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Qeft Teatching Hospital, city: Qinā, country: Egypt, geoPoint lat: 26.16418, lon: 32.72671, locations facility: Qena Faculty of Medicine, city: Qinā, country: Egypt, geoPoint lat: 26.16418, lon: 32.72671, locations facility: Suez Faculty of Medicine, city: Suez, zip: 43221, country: Egypt, geoPoint lat: 29.97371, lon: 32.52627, hasResults: False
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protocolSection identificationModule nctId: NCT06349863, orgStudyIdInfo id: W23.225, briefTitle: Dutch CHolEcystitis Snapshot Study, acronym: Dutch-CHESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: St. Antonius Hospital, class: OTHER, collaborators name: St. Antonius Onderzoeksfonds, collaborators name: Dutch Snapshot Research Group, collaborators name: Nederlandse Leverpatientenvereniging, descriptionModule briefSummary: Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands., conditionsModule conditions: Cholecystitis, conditions: Cholecystitis; Gallstone, conditions: Cholecystitis; Choledocholithiasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Total hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349850, orgStudyIdInfo id: Soh-Med-24-03-06MS, briefTitle: Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes, conditionsModule conditions: Diabetic Kidney Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: serum uric acid level to plasma HDL-c level ratio (UHR), outcomesModule primaryOutcomes measure: Uric acid to HDL-c ratio (UHR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349837, orgStudyIdInfo id: ECLIPSE-02, briefTitle: Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Low Dose Radiotherapy, interventions name: Stereotactic Ablative Radiotherapy, outcomesModule primaryOutcomes measure: Dose Limiting Toxicities, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349824, orgStudyIdInfo id: 004AEstb/EC/01/2022, briefTitle: Dextrose, Steroid, PRP: Choosing the Right Injection for CRS Relief; a RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Sheikh Zayed Medical College, class: OTHER_GOV, descriptionModule briefSummary: USG guided injections to relieve carpal tunnel syndrome with dextrose water or steroid or PRP, conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: injection Dextrose water, interventions name: USG machine, outcomesModule primaryOutcomes measure: VAS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheikh Zayed Medical College, city: Rahim yar khan, state: Punjab, zip: 64200, country: Pakistan, geoPoint lat: 28.41987, lon: 70.30345, hasResults: False
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protocolSection identificationModule nctId: NCT06349811, orgStudyIdInfo id: BL-M05D1-101, briefTitle: A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BL-M05D1, outcomesModule primaryOutcomes measure: Phase Ia: Dose limiting toxicity (DLT), primaryOutcomes measure: Phase Ia: Maximum tolerated dose (MTD), primaryOutcomes measure: Phase Ib: Recommended Phase II Dose (RP2D), secondaryOutcomes measure: Treatment-Emergent Adverse Event (TEAE), secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: CL (Clearance), secondaryOutcomes measure: Ctrough, secondaryOutcomes measure: ADA (anti-drug antibody), secondaryOutcomes measure: Phase Ib: Objective Response Rate (ORR), secondaryOutcomes measure: Phase Ib: Disease Control Rate (DCR), secondaryOutcomes measure: Phase Ib: Duration of Response (DOR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349798, orgStudyIdInfo id: DR200177, briefTitle: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO), acronym: NEFARTHRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University Hospital, Tours, class: OTHER, descriptionModule briefSummary: NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).Patients will be followed during 6 months., conditionsModule conditions: Total Hip Arthroplasty, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Patient, investigator and outcome assessor will be blind., A nurse anesthetist who will not be involved in the follow up of the patient will receive the kit and prepare the syringes., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Nefopam, interventions name: Nefopam, interventions name: NaCl 0.9%, outcomesModule primaryOutcomes measure: Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU)., secondaryOutcomes measure: Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge., secondaryOutcomes measure: Time to return to walking., secondaryOutcomes measure: Time to leave room., secondaryOutcomes measure: Time to climb stairs., secondaryOutcomes measure: Length of stay., secondaryOutcomes measure: Time to abandon canes/crutches., secondaryOutcomes measure: Opioid analgesic consumption between days 1 and 5 or at hospital discharge, secondaryOutcomes measure: Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire., secondaryOutcomes measure: Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present)., secondaryOutcomes measure: Incidence of all serious AEs during patient follow-up and non-serious AEs., secondaryOutcomes measure: Incidence of patients with morphine side effects, secondaryOutcomes measure: Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anaesthesia - Intensive care, city: Angers, zip: 49933, country: France, contacts name: Emmanuel RINEAU, MD, role: CONTACT, phone: 02 41 35 39 51, phoneExt: +33, email: [email protected], contacts name: Emmanuel RINEAU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Anaesthesia - Intensive care, city: Blois, zip: 41016, country: France, contacts name: Raphaël DARMON, MD, role: CONTACT, phone: 02 54 55 66 33, phoneExt: +33, email: [email protected], contacts name: Raphaël DARMON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.58333, lon: 1.33333, locations facility: Anaesthesia - Intensive care, city: Chartres, zip: 28018, country: France, contacts name: Elias CHADDOUK, MD, role: CONTACT, phone: 02 37 30 30 30, phoneExt: +33, email: [email protected], contacts name: Elias CHADDOUK, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.44685, lon: 1.48925, locations facility: Anaesthesia - Intensive care, city: Nantes, zip: 44000, country: France, contacts name: Raphaël CINOTTI, MD, role: CONTACT, phone: 02 53 48 22 30, phoneExt: +33, email: [email protected], contacts name: Raphaël CINOTTI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Anaesthesia - Intensive care, city: Orléans, zip: 45067, country: France, contacts name: Léa PARCOT, MD, role: CONTACT, phone: 02 38 22 97 17, phoneExt: +33, email: [email protected], contacts name: Léa PARCOT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Anaesthesia - Intensive care, city: Poitiers, zip: 86021, country: France, contacts name: Denis FRASCA, MD, role: CONTACT, phone: 05 49 44 38 95, phoneExt: +33, email: [email protected], contacts name: Denis FRASCA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Anesthesia - intensive care, city: Tours, zip: 37044, country: France, contacts name: Francis REMERAND, MD, role: CONTACT, phone: 02 47 47 84 80, phoneExt: +33, email: [email protected], contacts name: Francis REMERAND, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False
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protocolSection identificationModule nctId: NCT06349785, orgStudyIdInfo id: P.T.REC/012/003858, briefTitle: Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients, acronym: MHI, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: New Ismailia National University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old, conditionsModule conditions: Mechanical Ventilation Complication, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: using sealed envelopes,, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: rehabilitation of mechanically ventilated patients, interventions name: supportive care, outcomesModule primaryOutcomes measure: change the respiratory functions, primaryOutcomes measure: change the respiratory mechanics, primaryOutcomes measure: change the bronchospasm, primaryOutcomes measure: change the amount of ventilation, secondaryOutcomes measure: decreasing the amount of secretions, secondaryOutcomes measure: weaning from mechanical ventilator, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: College of Medicine, city: Ismailia, zip: 41522, country: Egypt, geoPoint lat: 30.60427, lon: 32.27225, hasResults: False
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protocolSection identificationModule nctId: NCT06349772, orgStudyIdInfo id: FY2024-203, briefTitle: Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Texas Tech University Health Sciences Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only., conditionsModule conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Zynrelef, interventions name: Exparel, outcomesModule primaryOutcomes measure: postoperative pain score, secondaryOutcomes measure: Total postoperative opioid use, secondaryOutcomes measure: Proportion of total rescue medication use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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