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protocolSection identificationModule nctId: NCT06382272, orgStudyIdInfo id: IRB23-2027, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False

protocolSection identificationModule nctId: NCT06382259, orgStudyIdInfo id: H24-Acute-Movement-Breaks, briefTitle: The Acute Effect of Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: McMaster University, descriptionModule briefSummary: To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Movement breaks, outcomesModule primaryOutcomes measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring, secondaryOutcomes measure: Time in range determined using continuous glucose monitoring, secondaryOutcomes measure: Time above range determined using continuous glucose monitoring, secondaryOutcomes measure: Time below range determined using continuous glucose monitoring, secondaryOutcomes measure: Glycemic variability determined using continuous glucose monitoring, secondaryOutcomes measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382246, orgStudyIdInfo id: H24-Acute-ExSnacks, briefTitle: The Acute Effect of "Exercise Snacks" on Glycemic Responses in Individuals With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: McMaster University, descriptionModule briefSummary: To conduct a randomized crossover trial to determine the acute impact of exercise snacks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized controlled crossover design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Exercise snacks, outcomesModule primaryOutcomes measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring, secondaryOutcomes measure: Time in range determined using continuous glucose monitoring, secondaryOutcomes measure: Time above range determined using continuous glucose monitoring, secondaryOutcomes measure: Time below range determined using continuous glucose monitoring, secondaryOutcomes measure: Glycemic variability determined using continuous glucose monitoring, secondaryOutcomes measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382233, orgStudyIdInfo id: PRO-FUTURE project, briefTitle: The PRO-FUTURE Project, acronym: PRO-FUTURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2028-01-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Campania "Luigi Vanvitelli", class: OTHER, collaborators name: University of Milan, collaborators name: A.O.R.N. Santobono-Pausilipon, collaborators name: University of Modena and Reggio Emilia, collaborators name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, descriptionModule briefSummary: The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are:* Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies?* Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis?, conditionsModule conditions: Ureteropelvic Junction Obstruction, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Identification of Diagnostic Biomarkers, outcomesModule primaryOutcomes measure: Urine Biomarkers, primaryOutcomes measure: Blood Biomarkers, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Univeristà degli Studi della Campania Luigi Vanvitelli, status: RECRUITING, city: Naples, state: Campania, zip: 80138, country: Italy, contacts name: Pierluigi Marzuillo, role: CONTACT, contacts name: Pierluigi Marzuillo, role: PRINCIPAL_INVESTIGATOR, contacts name: Paolo Montaldo, role: PRINCIPAL_INVESTIGATOR, contacts name: Carmine Noviello, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfonso Papparella, role: SUB_INVESTIGATOR, contacts name: Stefano Guarino, role: SUB_INVESTIGATOR, contacts name: Anna Di Sessa, role: SUB_INVESTIGATOR, contacts name: Grazia Cirillo, role: SUB_INVESTIGATOR, contacts name: Giusy Capasso, role: SUB_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Department of Clinical Sciences and Community Health, University of Milano, status: ACTIVE_NOT_RECRUITING, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, country: Italy, contacts name: Giovanni Montini, role: CONTACT, contacts name: Giovanni Montini, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfredo Berrettini, role: PRINCIPAL_INVESTIGATOR, contacts name: Michele Gnech, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, status: RECRUITING, city: Modena, country: Italy, contacts name: Giovanni Grandi, role: CONTACT, contacts name: Giovanni Grandi, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefano Puliatti, role: SUB_INVESTIGATOR, geoPoint lat: 44.64783, lon: 10.92539, locations facility: AORN Santobono-Pausilipon, status: RECRUITING, city: Naples, country: Italy, contacts name: Giovanni Di Iorio, role: CONTACT, contacts name: Giovanni Di Iorio, role: PRINCIPAL_INVESTIGATOR, contacts name: Agnese Roberti, role: SUB_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False

protocolSection identificationModule nctId: NCT06382220, orgStudyIdInfo id: R550, briefTitle: Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-07-25, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fayoum University Hospital, class: OTHER, descriptionModule briefSummary: Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications .Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade.Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration,The aim of this studyTo compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people., conditionsModule conditions: Recruitment, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacain, outcomesModule primaryOutcomes measure: The rate of occurrence of hypotension, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fayoum University hospital, status: RECRUITING, city: Fayoum, state: Faiyum Governorate, zip: 63514, country: Egypt, contacts name: Mohamed A Hamed, MD, role: CONTACT, phone: 01118560065, phoneExt: 02, email: mah07@fayoum.edu.eg, contacts name: Mahdy A Abdelhady, MD, role: CONTACT, phone: 0120363256, phoneExt: 02, email: maa45@fayoum.edu.eg, geoPoint lat: 29.30995, lon: 30.8418, hasResults: False

protocolSection identificationModule nctId: NCT06382207, orgStudyIdInfo id: HM20029298, briefTitle: Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, collaborators name: Eko Devices, Inc., descriptionModule briefSummary: When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room., conditionsModule conditions: Tachyarrhythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This proof-of-concept study will enroll infants, defined as individuals \<1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients \<10 kg in a clinic and home setting., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Eko Duo electronic stethoscope, interventions name: CORE 500 electronic stethoscope, outcomesModule primaryOutcomes measure: Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500, primaryOutcomes measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500, primaryOutcomes measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500, primaryOutcomes measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only, eligibilityModule sex: ALL, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False

protocolSection identificationModule nctId: NCT06382194, orgStudyIdInfo id: STUDY00014522, secondaryIdInfos id: 1R21AG076362-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21AG076362-01, briefTitle: Decision Making Tool for Firearm Storage, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage., conditionsModule conditions: Dementia, Mild, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Decision aid, outcomesModule primaryOutcomes measure: Firearm storage (adapted from the National Firearm Survey), secondaryOutcomes measure: Low-Literacy Decisional Conflict Scale, secondaryOutcomes measure: Knowledge Questionnaire, secondaryOutcomes measure: Feasibility of intervention delivery, secondaryOutcomes measure: Acceptability of Intervention Measure, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98104, country: United States, contacts name: Rachel Ross, MPH, role: CONTACT, phone: 509-596-1438, email: rross4@uw.edu, contacts name: Elizabeth A Phelan, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laura Prater, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06382181, orgStudyIdInfo id: 2023- ENFPOD-2621979, secondaryIdInfos id: Silvia Corchón Arreche, type: OTHER, domain: University of Valencia, secondaryIdInfos id: Omar Cauli, type: OTHER, domain: University of Valencia, briefTitle: A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise)., conditionsModule conditions: Loneliness, conditions: Mental Health Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were assigned to three groups in parallel for the duration of the study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Music therapy for community-dwelling individuals with unwanted loneliness, interventions name: Health education for community-dwelling individuals with unwanted loneliness, interventions name: Physical exercise for community-dwelling individuals with unwanted loneliness, outcomesModule primaryOutcomes measure: Score on the Jong Gierveld Loneliness Scale, secondaryOutcomes measure: Score on Goldberg Anxiety and Depression Scale, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Vanessa Ibáñez del Valle, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06382168, orgStudyIdInfo id: D19-11186, briefTitle: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Delta-Fly Pharma, Inc., class: INDUSTRY, descriptionModule briefSummary: This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants., conditionsModule conditions: Leukemia, Myeloid, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: DFP-10917, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Number of patients with dose-limiting toxicities assessed by CTCAE v5.0., primaryOutcomes measure: Number of patients with treatment-related adverse events assessed by CTCAE v5.0., primaryOutcomes measure: Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period)., secondaryOutcomes measure: The proportion of patients who achieve complete remission., secondaryOutcomes measure: The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery., secondaryOutcomes measure: The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state., secondaryOutcomes measure: Overall survival., secondaryOutcomes measure: Progression-free survival., secondaryOutcomes measure: Maximum concentration of DFP-10917., secondaryOutcomes measure: Area under the curve of DFP-10917., otherOutcomes measure: Volume of distribution of DFP-10917., otherOutcomes measure: Clearance of DFP-10917., otherOutcomes measure: Time to maximum concentration of venetoclax., otherOutcomes measure: Maximum concentration of venetoclax., otherOutcomes measure: Elimination half-life of venetoclax., otherOutcomes measure: Area under the curve of venetoclax., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCI Chao Family Comprehensive Cancer Center, city: Orange, state: California, zip: 92868, country: United States, contacts name: Kiran Naqvi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Timothy Pardee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Simmons Cancer Center: UT Southwestern, city: Dallas, state: Texas, zip: 75235, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Vermont Cancer Center, city: Burlington, state: Vermont, zip: 05401, country: United States, contacts name: Diego Adrianzen Herrer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Virginia Cancer Center, city: Charlottesville, state: Virginia, zip: 22911, country: United States, contacts name: Michael Keng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False

protocolSection identificationModule nctId: NCT06382155, orgStudyIdInfo id: 111-210, briefTitle: A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2036-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: BioMarin Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS)., conditionsModule conditions: Idiopathic Short Stature, 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: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vosoritide Injection, interventions name: Human Growth Hormone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Annualized Growth Velocity (AGV), primaryOutcomes measure: Change from baseline in height, primaryOutcomes measure: Change from baseline in height Z-score, secondaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: Change from baseline in AGV Z-score (average stature reference), secondaryOutcomes measure: Change from baseline in height, secondaryOutcomes measure: Change from baseline in height Z score, secondaryOutcomes measure: Change from baseline at prespecified timepoints in urine cyclic guanine monophosphate (cGMP), secondaryOutcomes measure: Change from baseline at pre-specified timepoints in serum collagen X marker (CXM), secondaryOutcomes measure: Change from baseline in bone age minus chronological age at pre-specified timepoints, secondaryOutcomes measure: Change from baseline in total body (less head) bone mineral density (BMD) Z-score, secondaryOutcomes measure: Change from baseline in lumbar spine BMD Z-score, secondaryOutcomes measure: Change from baseline in total body (less head) bone mineral content (BMC), secondaryOutcomes measure: Change from baseline in lumbar spine BMC, secondaryOutcomes measure: Maximum concentration (Cmax) of vosoritide in plasma, secondaryOutcomes measure: Area under the plasma vosoritide concentration time-curve from time 0 to infinity (AUC0-∞), secondaryOutcomes measure: Area under the plasma vosoritide concentration time-curve from time 0 to the last measurable concentration (AUC0-t), secondaryOutcomes measure: Elimination half-life of vosoritide (t½), secondaryOutcomes measure: Apparent clearance of vosoritide, secondaryOutcomes measure: Apparent volume of distribution of vosoritide based upon the terminal phase (Vz/F), secondaryOutcomes measure: Time vosoritide is present at maximum concentration (Tmax), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, hasResults: False

protocolSection identificationModule nctId: NCT06382142, orgStudyIdInfo id: BL-B01D1-307, briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure., conditionsModule conditions: Triple-Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 436, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Eribulin, interventions name: Vinorelbine, interventions name: Gemcitabine, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, country: China, contacts name: Jiong Wu, role: CONTACT, contacts name: Jiong Wu, role: PRINCIPAL_INVESTIGATOR, contacts name: Jian Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06382129, orgStudyIdInfo id: BL-B01D1-302, briefTitle: A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 558, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, city: Beijing, state: Beijing, country: China, contacts name: Jie Wang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06382116, orgStudyIdInfo id: BL-B01D1-301, briefTitle: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Pemetrexed+Cisplatin or Carboplatin, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, country: China, contacts name: Li Zhang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06382103, orgStudyIdInfo id: B2024-108R, briefTitle: Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2026-05-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ctDNA monitoring, interventions name: Plasma proteomic analysis, outcomesModule primaryOutcomes measure: Correlation between ctDNA level and recurrence-free survival (RFS), primaryOutcomes measure: Correlation between specific plasma protein expression level and recurrence-free survival (RFS), secondaryOutcomes measure: Correlation between tumor mutation numbers and recurrence-free survival (RFS), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 180 Fenglin Road, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06382090, orgStudyIdInfo id: PamukkaleU-SBE-BB-01, briefTitle: Premenstrual Syndrome and Laughter Yoga, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2025-05-24, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined., conditionsModule conditions: Premenstrual Syndrome, conditions: Laughter, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups: comparative experiment and control, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Laughter yoga, outcomesModule primaryOutcomes measure: Premenstrual Symptom Scale, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False

protocolSection identificationModule nctId: NCT06382077, orgStudyIdInfo id: CPSP5502, briefTitle: Chronic Post Surgical Pain-Cardiac, acronym: CPSP-Cardiac, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-04-25, completionDateStruct date: 2025-10-25, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors., conditionsModule conditions: Chronic Post-surgical Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1176, type: ESTIMATED, outcomesModule primaryOutcomes measure: The incidence of chronic postsurgical pain, secondaryOutcomes measure: Postoperative opioid consumption in the first 24 hours, secondaryOutcomes measure: Postoperative pain scores, secondaryOutcomes measure: The incidences of postoperative nausea and vomiting, secondaryOutcomes measure: The number of patients with side effects and complications, secondaryOutcomes measure: Time to extubation, secondaryOutcomes measure: Length of stay in the intensive care unit, secondaryOutcomes measure: Length of stay in the hospital, secondaryOutcomes measure: Chronic pain status at 3 and 6 months, secondaryOutcomes measure: Psychological assessment, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Postoperative complications at 3 and 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayis University, city: Samsun, state: Atakum, zip: 55139, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, locations facility: Istanbul University, city: Istanbul, country: Turkey, contacts name: Zerrin Sungur, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Marmara University, city: Istanbul, country: Turkey, contacts name: Alper Kararmaz, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Burhan Dost, city: Samsun, zip: 55270, country: Turkey, contacts name: BURHAN DOST, role: CONTACT, phone: 05327042493, email: burhandost@hotmail.com, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False

protocolSection identificationModule nctId: NCT06382064, orgStudyIdInfo id: 2024H0089, briefTitle: Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Biweekly replacement contact lenses, interventions name: One week replacement contact lenses, outcomesModule primaryOutcomes measure: Subjective assessment of lens wear experience, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University College of Optometry, city: Columbus, state: Ohio, zip: 43210, country: United States, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06382051, orgStudyIdInfo id: CAIN457ACA06, briefTitle: Modifying PEST for Psoriatic Arthritis Screening, acronym: ScreenX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-28, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status., conditionsModule conditions: Plaque Psoriasis, conditions: Psoriatic Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 502, type: ESTIMATED, armsInterventionsModule interventions name: PEST Screening group, outcomesModule primaryOutcomes measure: Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs, secondaryOutcomes measure: Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist, secondaryOutcomes measure: Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist, secondaryOutcomes measure: Proportion of patients with a false positive score between each group, secondaryOutcomes measure: Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests, secondaryOutcomes measure: Patient acceptability/user experience of the PEST+2 questionnaire, secondaryOutcomes measure: Administration of dermatologist quantitative surveys, secondaryOutcomes measure: Qualitative interview with selected dermatologists, secondaryOutcomes measure: Intervention Appropriateness Measure (IAM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382038, orgStudyIdInfo id: HZKY-PJ-2024-19, briefTitle: Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism, acronym: SmaPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, 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 pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE., conditionsModule conditions: Venous Thromboembolism, conditions: Pulmonary Thromboembolisms, conditions: Clinical Decision Support Systems, conditions: Digital Health, 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: 3078, type: ESTIMATED, armsInterventionsModule interventions name: mobile venous thromboembolism application (mVTEA), outcomesModule primaryOutcomes measure: VTE-related composite event, secondaryOutcomes measure: Patient satisfaction with anticoagulant treatment, secondaryOutcomes measure: Generic quality of life, secondaryOutcomes measure: Recurrent VTE, secondaryOutcomes measure: Chronic thromboembolic pulmonary hypertension (CTEPH), secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: VTE-related hospitalization, 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

protocolSection identificationModule nctId: NCT06382025, orgStudyIdInfo id: Alkinstorybook, briefTitle: Preoperative Information With Storybook for Pediatric Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-03-09, primaryCompletionDateStruct date: 2020-02-20, completionDateStruct date: 2020-05-29, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period., conditionsModule conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 168, type: ACTUAL, armsInterventionsModule interventions name: showing cartoons -storybook, interventions name: showing cartoons - standard, outcomesModule primaryOutcomes measure: preoperative anxiety scale, primaryOutcomes measure: State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents, primaryOutcomes measure: Children's Hospital of Eastern Ontario Pain (CHEOP) Scale, primaryOutcomes measure: Pediatric Anesthesia Emergence Delirium (PAED) scale, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Trakya University, city: Edirne, state: Edi̇rne, zip: 22030, country: Turkey, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False

protocolSection identificationModule nctId: NCT06382012, orgStudyIdInfo id: 2024-15703, briefTitle: Antiemetic Fosaprepitant To Remedy Nausea and Vomiting, acronym: AFTR NV RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, descriptionModule briefSummary: The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration., conditionsModule conditions: Nausea and Vomiting, conditions: Nausea, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Fosaprepitant 150 mg, interventions name: Ondansetron 4 mg, outcomesModule primaryOutcomes measure: Sustained Relief from NV, secondaryOutcomes measure: Severity of Nausea, secondaryOutcomes measure: Need for rescue antiemetic medication, secondaryOutcomes measure: Medication Preference, secondaryOutcomes measure: Functional disability, secondaryOutcomes measure: Vomiting, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Fluid Treatment, secondaryOutcomes measure: Mean Fluid Volume, secondaryOutcomes measure: Length of Stay, secondaryOutcomes measure: QTc Interval (QT interval corrected for heart rate), secondaryOutcomes measure: Revisit Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center (Montefiore and Weiler EDs), city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Mustfa K Manzur, MD, role: CONTACT, phone: 718-920-6626, email: mmanzur@montefiore.org, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False

protocolSection identificationModule nctId: NCT06381999, orgStudyIdInfo id: M602011083, briefTitle: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool, acronym: I-REFER, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2024-02-26, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Merz Therapeutics GmbH, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool., conditionsModule conditions: Post-stroke Spasticity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 73, type: ACTUAL, outcomesModule primaryOutcomes measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral, secondaryOutcomes measure: Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gailtal-Klinik, city: Hermagor, zip: 9620, country: Austria, geoPoint lat: 46.62722, lon: 13.36722, hasResults: False

protocolSection identificationModule nctId: NCT06381986, orgStudyIdInfo id: SHJ002-SJP2, briefTitle: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sunhawk Vision Biotech, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA., conditionsModule conditions: Corneal Erosion, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-Blinded, Parallel, Vehicle-Controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-Blinded, Parallel, Vehicle-Controlled, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: SHJ002, interventions name: Vehicle, outcomesModule primaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score, secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score, secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS), secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical Chung-Ho Memorial Hospital, city: Kaohsiung, zip: 807, country: Taiwan, contacts name: Shiuh-Liang Hsu, MD, role: CONTACT, phone: +886-73121101, email: shiuhlianghsu@gmail.com, contacts name: Shiuh-Liang Hsu, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Li-Yi Chiu, MD, role: SUB_INVESTIGATOR, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False

protocolSection identificationModule nctId: NCT06381973, orgStudyIdInfo id: ELTGOL, briefTitle: Ventilation Distribution in COPD Patients During Breathing Exercises, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: William Poncin, PT, PhD, class: OTHER, descriptionModule briefSummary: ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ELTGOL_Physio, interventions name: ELTGOL_Auto, interventions name: PEP, interventions name: 1L-Tidal-Breathing, interventions name: Spontaneous Breathing, outcomesModule primaryOutcomes measure: Impedance variation using Electrical Impedance Tomography, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cliniques universitaires Saint-Luc, status: RECRUITING, city: Brussels, state: Brussels Capital, zip: 1200, country: Belgium, contacts name: William Poncin, role: CONTACT, phone: +320470592032, phoneExt: +320470592032, email: william.poncin@uclouvain.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False

protocolSection identificationModule nctId: NCT06381960, orgStudyIdInfo id: 2022LJ014, briefTitle: Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jianhui Tian, class: OTHER, descriptionModule briefSummary: To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil., conditionsModule conditions: Lung Cancer, 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: 356, type: ESTIMATED, armsInterventionsModule interventions name: Fuzheng Quxie Recipe, outcomesModule primaryOutcomes measure: Disease-free survival, DFS, secondaryOutcomes measure: Overall survival,OS, secondaryOutcomes measure: Minimal residual disease, MRD, secondaryOutcomes measure: Circulating Tumour Cell Assay, secondaryOutcomes measure: Chinese Medicine Symptom Score, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Immunological indicators, secondaryOutcomes measure: Tumour marker, secondaryOutcomes measure: Peripheral blood systemic immunoinflammatory index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Changning, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, locations facility: Shanghai General Hospital, status: RECRUITING, city: Hongkou, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: 18762866303, email: 1183596839@qq.com, locations facility: Shanghai Traditional Chinese Medicine-Integrated Hospital, status: RECRUITING, city: Hongkou, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, locations facility: Shanghai Municipal Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Jing'an, state: Shanghai, zip: 200071, country: China, contacts name: Tianhui Tian, Professor, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, Dr, role: CONTACT, phone: 18762866303, email: 1183596839@qq.com, locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Yangpu, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-12-21, uploadDate: 2024-04-18T10:13, filename: Prot_000.pdf, size: 825047, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-12-21, uploadDate: 2024-04-18T10:14, filename: ICF_001.pdf, size: 151196, hasResults: False

protocolSection identificationModule nctId: NCT06381947, orgStudyIdInfo id: 19092023, briefTitle: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients, acronym: BESAFE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Salerno, class: OTHER, descriptionModule briefSummary: Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels.The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients., conditionsModule conditions: Dyslipidemias, conditions: Statin Adverse Reaction, conditions: Cardiovascular Diseases, conditions: Lipid Metabolism Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is an investigator-initiated, phase 4, open-label, multicentre, 2-way crossover trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe, interventions name: Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe, outcomesModule primaryOutcomes measure: Mean percentage change in LDL-C after 12 weeks of treatment, secondaryOutcomes measure: Mean absolute change from baseline to week 12 in low-density lipoprotein cholesterol, secondaryOutcomes measure: Percentage of patients reaching the recommended LDL-C target, secondaryOutcomes measure: Changes in plasmatic levels of total cholesterol after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of HDL cholesterol after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of non-HDL cholesterol after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of fasting glucose after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of glycated haemoglobin after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of fasting insulinemia after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of HOMA index after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of hs-CRP after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of lipoprotein(a) after 12 weeks of treatment, secondaryOutcomes measure: Changes in plasmatic levels of apolipoprotein B after 12 weeks of treatment, secondaryOutcomes measure: Changes in PCSK9 serum levels before starting the treatment and after 12 weeks of treatment, secondaryOutcomes measure: Number of participants with abnormal uric acid level, abnormal AST/ALT level, ALT or AST >3x ULN, and/or unexplained creatine kinase (CK) >3x ULN, secondaryOutcomes measure: The number and type of adverse events, secondaryOutcomes measure: MACE at 12 and 28 weeks, secondaryOutcomes measure: Rehospitalization at 12 and 28 weeks, secondaryOutcomes measure: Death at 12 and 28 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-02, uploadDate: 2024-04-08T09:09, filename: Prot_SAP_000.pdf, size: 452473, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-05-02, uploadDate: 2024-04-08T09:09, filename: ICF_001.pdf, size: 193521, hasResults: False

protocolSection identificationModule nctId: NCT06381934, orgStudyIdInfo id: 2024-00335; kt23ChristCrain4, briefTitle: Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments., conditionsModule conditions: Thiazide Associated Hyponatremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: aSID/ChU Guided Therapy, outcomesModule primaryOutcomes measure: Serum Sodium Level, secondaryOutcomes measure: Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels, secondaryOutcomes measure: Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels, secondaryOutcomes measure: Diagnostic performance analyses of: aSID and ChU, secondaryOutcomes measure: Diagnostic performance analyses of: aSID measured in blood gas analysis, secondaryOutcomes measure: Diagnostic performance analyses of: clinical volume status assessment, secondaryOutcomes measure: Diagnostic performance analyses of: not-invasive instrumental volume status assessment, secondaryOutcomes measure: Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, city: Basel, zip: 4031, country: Switzerland, contacts name: Laura Potasso, Dr. med. sc., role: CONTACT, phone: +41 61 328 58 76, email: laura.potasso@usb.ch, contacts name: Mirjam Christ-Crain, Prof. Dr. med., role: CONTACT, phone: +41 61 328 70 80, email: mirjam.christ-crain@usb.ch, contacts name: Laura Potasso, Dr. med. sc., role: PRINCIPAL_INVESTIGATOR, contacts name: Mirjam Christ-Crain, Prof. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False

protocolSection identificationModule nctId: NCT06381921, orgStudyIdInfo id: B2023-0046, briefTitle: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain, acronym: OIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-05-01, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, collaborators name: Yale University, descriptionModule briefSummary: The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial., conditionsModule conditions: Abdominal Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled ambulatory trial, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: IBS-PPSM intervention, outcomesModule primaryOutcomes measure: Pain intensity and interference, primaryOutcomes measure: IBS-related symptoms, primaryOutcomes measure: Electrodermal activity (EDA), primaryOutcomes measure: Electrocardiogram (ECG), primaryOutcomes measure: Electromyogram (EMG), primaryOutcomes measure: Objective integrated multimodal electrophysiological index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06381908, orgStudyIdInfo id: 1-10-72-19-24, briefTitle: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity, acronym: CHO-EX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: University Ghent, descriptionModule briefSummary: The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The study is labelled as a single-blinded study because the investigators are blinded to the group allocation (the group allocation and diet handling is managed by a researcher not involved in other aspects of the data collection or processing). The participants are not informed about their allocated condition, however, it is conceivably possible for them to recognize this based on the food provided. However, the direction of the hypothesis will not be evident to the participants. Moreover, we include questionnaires before the post-tests related to their perceived diet allocation and their perception of the effect of the diet on the test assessments., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Calorie-restriction with low carbohydrate, interventions name: Calorie-restriction with moderate carbohydrate, outcomesModule primaryOutcomes measure: Time to exhaustion, primaryOutcomes measure: Sprint performance, primaryOutcomes measure: Exercise tolerance, primaryOutcomes measure: Muscle glycogen levels, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Maximal fat oxidation capacity, secondaryOutcomes measure: Muscle metabolic enzyme activity, secondaryOutcomes measure: Blood lipid profile, secondaryOutcomes measure: Continuous glucose levels, secondaryOutcomes measure: Fasting blood glucose and insulin, secondaryOutcomes measure: Long-term glycemic control (HbAc1), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Section for Sport Science, Department of Public Health, Aarhus University, status: RECRUITING, city: Aarhus C, zip: 8000, country: Denmark, contacts name: Mette Hansen, PhD, role: CONTACT, phone: +4551666551, email: mhan@ph.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False

protocolSection identificationModule nctId: NCT06381895, orgStudyIdInfo id: SYSKY-2023-467-01, briefTitle: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated., conditionsModule conditions: Bladder Cancer, conditions: Radiomics, conditions: Immunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1200, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Tumour-infiltrating lymphocytes (TIL), secondaryOutcomes measure: overall survival, secondaryOutcomes measure: cancer-specific survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06381882, orgStudyIdInfo id: MiPac, briefTitle: The Role of the Human Microbiome in Patients After Pancreatic Resection., acronym: MiPac, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: St. Antonius Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients., conditionsModule conditions: Pancreas Cancer, conditions: Pancreas Neoplasm, conditions: Pancreas Adenocarcinoma, conditions: Periampullary Cancer, conditions: Periampullary Carcinoma, conditions: Microbial Colonization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pancreatic resection, outcomesModule primaryOutcomes measure: Risk stratification postoperative complications, secondaryOutcomes measure: Long time oncological outcomes - site of recurrence, secondaryOutcomes measure: Long time oncological outcomes - disease free survival, secondaryOutcomes measure: Long time oncological outcomes - overall survival, secondaryOutcomes measure: Complications neoadjuvant chemotherapy, secondaryOutcomes measure: Complications adjuvant chemotherapy, secondaryOutcomes measure: Response to neoadjuvant chemotherapy, secondaryOutcomes measure: Complications bile duct drainage, secondaryOutcomes measure: Postoperative endocrine insufficiency, secondaryOutcomes measure: Postoperative exocrine insufficiency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381869, orgStudyIdInfo id: CRNHA 2018-2, briefTitle: Bioavailability of Pea Protein in Young and Old Volunteers, acronym: NUTRALYS, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-10, primaryCompletionDateStruct date: 2019-06-13, completionDateStruct date: 2019-06-13, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Roquette Freres, class: INDUSTRY, collaborators name: CRNH Auvergne, collaborators name: Université d'Auvergne, descriptionModule briefSummary: The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal., conditionsModule conditions: Healthy Male Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Pea protein (NUTRALYS ® S85 plus) in water, interventions name: Pea protein (NUTRALYS ® S85 plus) within meal, interventions name: Whey protein in water, interventions name: Whey protein within meal, outcomesModule primaryOutcomes measure: Leucine blood concentration, secondaryOutcomes measure: Essential amino acids blood concentration (µmol/L), secondaryOutcomes measure: Non essential amino acid blood concentration (µmol/L), secondaryOutcomes measure: Blood glucose concentration (g/L), secondaryOutcomes measure: Blood insulin concentration (μIU/ml), secondaryOutcomes measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l), secondaryOutcomes measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne, city: Clermont-Ferrand, zip: 63009, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False

protocolSection identificationModule nctId: NCT06381856, orgStudyIdInfo id: EPM_2024-00227-01, briefTitle: Improving Participation of Autistic Children and Adolescents in the Habilitation Process, acronym: IMPAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Region Örebro County, class: OTHER, descriptionModule briefSummary: This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre., conditionsModule conditions: Autism Spectrum Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The child's involvement, secondaryOutcomes measure: The Mental Health Continuum - Short Form, secondaryOutcomes measure: The "Your child's strengths, abilities and special needs"-questionnaire., secondaryOutcomes measure: The collaboration with the neuropsychiatric team questionnaire, secondaryOutcomes measure: Cantril ladder, otherOutcomes measure: Individual interviews, otherOutcomes measure: Type and number of goals in the childrens' individual habilitation plans, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Health Care Research Center, city: Örebro, zip: 70182, country: Sweden, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False

protocolSection identificationModule nctId: NCT06381843, orgStudyIdInfo id: WSKCT004, briefTitle: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2023-03-29, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: WestVac Biopharma Co., Ltd., class: INDUSTRY, collaborators name: West China Hospital, descriptionModule briefSummary: A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated., conditionsModule conditions: COVID-19, conditions: SARS-CoV-2 Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Recombinant COVID-19 Vaccine (Sf9 Cell), interventions name: COVID-19 Vaccine (Vero Cell), Inactivated, outcomesModule primaryOutcomes measure: Incidence of adverse drug reactions (ADRs), primaryOutcomes measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain, primaryOutcomes measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant, secondaryOutcomes measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain, secondaryOutcomes measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant, secondaryOutcomes measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain, secondaryOutcomes measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant, secondaryOutcomes measure: GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False

protocolSection identificationModule nctId: NCT06381830, orgStudyIdInfo id: ASCT+CART, briefTitle: Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, collaborators name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, collaborators name: Suzhou Hongci Hematology Hospital, Suzhou, China, descriptionModule briefSummary: The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma., conditionsModule conditions: Lymphoma, B-Cell, conditions: Autologous Stem Cell Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Apheresis, interventions name: Autologous Stem Cell Transplantation, interventions name: CAR-T Cell Therapy, outcomesModule primaryOutcomes measure: Overall Response Rate (ORR), primaryOutcomes measure: Progression-free Survival（PFS）, secondaryOutcomes measure: Duration of Response(DOR), secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Overall Survival（OS）, secondaryOutcomes measure: Adverse events profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Caixia Li, M.D., role: CONTACT, phone: +86 512 67781856, email: licaixia@suda.edu.cn, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False

protocolSection identificationModule nctId: NCT06381817, orgStudyIdInfo id: 2024112, briefTitle: Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, collaborators name: Children's Hospital of Soochow University, collaborators name: Ruijin Hospital, collaborators name: Nanfang Hospital, Southern Medical University, collaborators name: Fujian Medical University Union Hospital, collaborators name: First Affiliated Hospital Xi'an Jiaotong University, collaborators name: Wuhan Union Hospital, China, collaborators name: Zhejiang University, descriptionModule briefSummary: The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion., conditionsModule conditions: Acute T Cell Lymphoblastic Leukemia, conditions: Haploidentical Hematopoietic Stem Cell Transplantation, conditions: Cord Blood, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Haplo-cord HCT, interventions name: Haplo-HCT, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Cumulative incidence of relapse, secondaryOutcomes measure: Non-relapse mortality, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Yang XU, role: CONTACT, phone: 86+051267781850, email: xuyang1020@126.com, contacts name: Yang Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False

protocolSection identificationModule nctId: NCT06381804, orgStudyIdInfo id: 24YL9001, briefTitle: Effect of Shotblocker and Palm Stimulator, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: shotblocker, interventions name: palm stimulator, outcomesModule primaryOutcomes measure: Visual analog scale (VAS) pain Scale score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Necmettin Erbakan University, status: RECRUITING, city: Meram, country: Turkey, contacts name: Gülden Basit, role: CONTACT, phone: (0 332) 320 40 29, email: guldenbasit@gmail.com, contacts role: CONTACT, phone: (0 332) 320 40 29, contacts name: Merve Öz, role: SUB_INVESTIGATOR, geoPoint lat: 37.82985, lon: 32.46777, hasResults: False

protocolSection identificationModule nctId: NCT06381791, orgStudyIdInfo id: PRO00036811, briefTitle: CBD for Pain Following Orthopedic Shoulder Surgery, acronym: CBD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.Participants will:* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.* Complete two short surveys. Once before surgery and once after.* Have bloodwork tested after surgery, conditionsModule conditions: Shoulder Osteoarthritis, conditions: Rotator Cuff Injuries, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Epidiolex, interventions name: Placebo oral solution, outcomesModule primaryOutcomes measure: Primary - Pain Journal, secondaryOutcomes measure: Survey Data, secondaryOutcomes measure: Pain Disability Index (PDI), secondaryOutcomes measure: Pain, Enjoyment, General Activity (PEG) Scale, secondaryOutcomes measure: Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Houston Methodist Hospital, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Haley M Goble, MHA, CRCC, role: CONTACT, phone: 713-441-3930, email: hmgoble@houstonmethodist.org, contacts name: Patrick C McCulloch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06381778, orgStudyIdInfo id: 112006-E, briefTitle: Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Far Eastern Memorial Hospital, class: OTHER, descriptionModule briefSummary: Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan., conditionsModule conditions: Hypertrophic Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 2600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Death, secondaryOutcomes measure: CV death, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Far Eastern Memorial Hospital, status: RECRUITING, city: New Taipei City, zip: 220, country: Taiwan, contacts name: Yen-Wen Wu, MD, PhD, role: CONTACT, phone: 886-2-8966-7000, phoneExt: 1090, email: wuyw0502@gmail.com, contacts name: Yen-Wen Wu, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False

protocolSection identificationModule nctId: NCT06381765, orgStudyIdInfo id: Serratus-Pectointercostal, briefTitle: Serratus Plane Block and Pectointercostal Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cukurova University, class: OTHER, descriptionModule briefSummary: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Serratus plane bock and pectointercostal block, outcomesModule primaryOutcomes measure: postoperative morphine consumption, primaryOutcomes measure: postoperative visual analog scale scores, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381752, orgStudyIdInfo id: CPMvsPT, briefTitle: Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-25, primaryCompletionDateStruct date: 2020-03-31, completionDateStruct date: 2020-03-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Johannes Gutenberg University Mainz, class: OTHER, descriptionModule briefSummary: Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes., conditionsModule conditions: Total Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 175, type: ACTUAL, armsInterventionsModule interventions name: Continuous passive motion, interventions name: standard rehabilitation, outcomesModule primaryOutcomes measure: Staffelstein Score, secondaryOutcomes measure: Oxford Knee Score (OKS), secondaryOutcomes measure: Range of motion (ROM), secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Return to work, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitaetsmedizin der JGU Mainz, city: Mainz, state: Rheinland-Pfalz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, hasResults: False

protocolSection identificationModule nctId: NCT06381739, orgStudyIdInfo id: M011, briefTitle: A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol, acronym: AeroVax, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine).To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs.During follow-up participants will:* visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination* report their symptoms for 24 weeks after getting the vaccine.In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy)., conditionsModule conditions: COVID-19 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: ChAd-triCoV/Mac, interventions name: Control, outcomesModule primaryOutcomes measure: Antigen specific T cell responses in blood., primaryOutcomes measure: Antigen specific T cell responses in bronchoalveolar lavage (BAL)., primaryOutcomes measure: Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine., secondaryOutcomes measure: Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR), secondaryOutcomes measure: CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood., secondaryOutcomes measure: Neutralizing and total antibody levels in BAL and blood, secondaryOutcomes measure: Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely., secondaryOutcomes measure: Tissue-resident memory surface marker expression airway T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences Centre, city: Hamilton, state: Ontario, zip: L8S 4K1, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False

protocolSection identificationModule nctId: NCT06381726, orgStudyIdInfo id: Progetto AIRC IG-2022 ID 27184, briefTitle: Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2028-02-28, completionDateStruct date: 2028-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Milan, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR.Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity.Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.Expected Results1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.2. Identify demographic, clinical and imaging variables associated with functional reorganization.3. Describe the gain induced by up-front treatment.4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment.Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history., conditionsModule conditions: Glioma, conditions: Glioma, Malignant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients immediately candidate for resection will be assessed neurologically, neuropsychologically and by functional MRI. Extent of resection will be assessed on \<48hrs and 2-month MRI. Neurological and neuropsychological assessment will be performed during regular follow-up. Patients not requiring an adjuvant treatment according to tumor board meeting will be submitted to functional MRI at 4-8 and 12 months from surgery. Patients not immediately eligible for resection will be submitted to biopsy for histomolecular definition. Patients not requiring radiation therapy will be submitted to neurological, neuropsychological, and functional MRI evaluation. Upon clinical context, patients will undergo motor rehabilitation and/or chemotherapy. After 3-6 months, patients will undergo functional MRI and evaluated for surgery. Neurological and neuropsychological evaluation will be performed at treatment initiation, every month during treatment, at admission for surgery and 1 month after surgery., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Resting State Functional Magnetic Resonance Imaging (rs-fMRI), interventions name: Up-front Motor Rehabilitation, interventions name: Up-front Chemotherapy, outcomesModule primaryOutcomes measure: Muscle power, primaryOutcomes measure: Motor praxia, secondaryOutcomes measure: Comprehensive neuropsychological assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale Galeazzi Sant'Ambrogio, status: RECRUITING, city: Milan, state: Lombardy, zip: 20157, country: Italy, contacts name: Lorenzo Bello, MD, role: CONTACT, phone: 0039-340-217-1453, email: lorenzo.bello@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06381713, orgStudyIdInfo id: ONZ-2024-0158, briefTitle: Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, collaborators name: Research Foundation Flanders, descriptionModule briefSummary: Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders., conditionsModule conditions: Cleft Palate Children, conditions: Speech Therapy, conditions: Speech Disorders in Children, conditions: Cleft Lip and Palate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: High intensive combined phonetic-phonological intervention, interventions name: Low intensive combined phonetic-phonological intervention, outcomesModule primaryOutcomes measure: Consonant proficiency, primaryOutcomes measure: Incremental cost-utility ratio, primaryOutcomes measure: Incremental cost-effectiveness ratio, secondaryOutcomes measure: Intelligibility in Context, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Speech Function, secondaryOutcomes measure: Speech Distress, secondaryOutcomes measure: Communication attitudes of children aged 4 and 5 years, secondaryOutcomes measure: Communication attitudes of children aged 6 years and older, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381700, orgStudyIdInfo id: DF CO2405/0014 (P), briefTitle: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children:, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Malaya, class: OTHER, descriptionModule briefSummary: The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?3. Is the MySmile app easy to use by secondary school children?4. Is the MySmile app acceptable to use from the perspective of secondary school children?Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours., conditionsModule conditions: Oral Disease, conditions: Gingival Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 303, type: ESTIMATED, armsInterventionsModule interventions name: MySmile app, interventions name: Control, outcomesModule primaryOutcomes measure: The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972, primaryOutcomes measure: The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963, secondaryOutcomes measure: The mean increment of oral health knowledge, attitude and practice using validated questionnaires., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Muhammad Hamidie bin Saari, city: Kuala Lumpur, state: Wilayah Persukutuan Kuala Lumpur, zip: 50480, country: Malaysia, contacts name: Zamros Yuzadi Mohd Yusof, PHD, role: CONTACT, contacts name: Zamros Yuzadi Mohd Yusof, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marhazlinda Jamaludin, Master, role: PRINCIPAL_INVESTIGATOR, contacts name: Unaizah Hanum Obaidellah, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nazirah Ab Mumin, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False

protocolSection identificationModule nctId: NCT06381687, orgStudyIdInfo id: 2023-3118978, secondaryIdInfos id: PID2022-141095NB-I00, type: OTHER_GRANT, domain: Spanish Ministry of Science, Innovation and Universities, briefTitle: A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol), acronym: MOVIMUSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education., conditionsModule conditions: Fundamental Motor Skills, conditions: Physical Activity, conditions: Music Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The allocation of ECECs to the intervention versus control group will be randomised in a blinded procedure at the end of the first year, following the baseline assessment. Once ECEC centres meeting the selection criteria are identified, they will be randomised to one of the trial arms., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: A multi-component, multi-level programme (MoviMusi), outcomesModule primaryOutcomes measure: Physical activity, primaryOutcomes measure: Sleep time, primaryOutcomes measure: Motor skills, primaryOutcomes measure: Musical skills, primaryOutcomes measure: Sedentary time, secondaryOutcomes measure: For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities., secondaryOutcomes measure: For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play., secondaryOutcomes measure: For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution., secondaryOutcomes measure: For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program., secondaryOutcomes measure: For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children., secondaryOutcomes measure: For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home., secondaryOutcomes measure: For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm, secondaryOutcomes measure: For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment., secondaryOutcomes measure: For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children., eligibilityModule sex: ALL, minimumAge: 14 Months, maximumAge: 22 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Valencia, status: RECRUITING, city: Valencia, state: Comunidad Valenciana, zip: 46021, country: Spain, contacts name: Vladimir Martínez-Bello, Ph.D., role: CONTACT, phone: 34961625473, email: vladimir.martinez@uv.es, contacts name: María del Mar Bernabé-Villodre, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Herminia Vega-Perona, Ms.Sc., role: SUB_INVESTIGATOR, contacts name: José Díaz-Barahona, Ph.D., role: SUB_INVESTIGATOR, contacts name: Yolanda Cabrera García-Ochoa, Ph.D., role: SUB_INVESTIGATOR, contacts name: Sandra Molines-Borrás, Ph.D., role: SUB_INVESTIGATOR, contacts name: Felipe Gertrudix, Ph. D., role: SUB_INVESTIGATOR, contacts name: Juan Carlos Montoya-Rubio, Ph. D., role: SUB_INVESTIGATOR, contacts name: María Ángeles Fernández-Vilar, Ph. D., role: SUB_INVESTIGATOR, contacts name: José Manuel Azorín, Ph. D., role: SUB_INVESTIGATOR, contacts name: Nataliya Filenko, Ph. D., role: SUB_INVESTIGATOR, contacts name: Daniel Martínez-Bello, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ángela Martínez, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06381674, orgStudyIdInfo id: OHSU: 25890, secondaryIdInfos id: HT9425-23-1-0845, type: OTHER_GRANT, domain: Department of Defense, briefTitle: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation, acronym: SuBTyPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy., conditionsModule conditions: Mild Traumatic Brain Injury, Concussion, conditions: Rehabilitation, conditions: Balance Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback, interventions name: Vestibular therapy for mTBI, outcomesModule primaryOutcomes measure: Patient Global Impression of Change (PGIC), secondaryOutcomes measure: Concussion Clinical Profiles Screening (CP Screening), secondaryOutcomes measure: Dizziness Handicap Index (DHI), secondaryOutcomes measure: Quality of Life After Brain Injury (QOLIBRI), secondaryOutcomes measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Headache Impact Test (HIT-6), secondaryOutcomes measure: Insomnia Severity Index (ISI), secondaryOutcomes measure: Neck Disability Index (NDI), secondaryOutcomes measure: Convergence Insufficiency Symptom Survey (CISS), secondaryOutcomes measure: Vertigo Symptom Scale (VSS), secondaryOutcomes measure: Concussion Symptom Subtypes Inventory (CSSI), secondaryOutcomes measure: Automated Neuropsychological Assessment Metric (ANAM), secondaryOutcomes measure: Dynamic Visual Acuity ( DVA-Clinical), secondaryOutcomes measure: Ocular Motor Function Tests, secondaryOutcomes measure: Video Head Impulse Test (vHIT), secondaryOutcomes measure: Functional Gait Assessment (FGA), secondaryOutcomes measure: Complex Turning Course (CTC), secondaryOutcomes measure: Modified Balance Error Scoring System (mBESS), secondaryOutcomes measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB), secondaryOutcomes measure: Instrumented One Minute Walk (Single and Dual Task), secondaryOutcomes measure: Hybrid Assessment of Mobility (HAM-4), secondaryOutcomes measure: Tandem Gait (Single and Dual Task), secondaryOutcomes measure: Vestibular Ocular Motor Screening (VOMS), secondaryOutcomes measure: Central Sensorimotor Integration Testing (CSMI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239-3098, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Fort Sam Houston, city: San Antonio, state: Texas, zip: 78234, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84112, country: United States, geoPoint lat: 40.76078, lon: -111.89105, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and ICF, date: 2024-02-13, uploadDate: 2024-03-07T11:25, filename: Prot_SAP_ICF_000.pdf, size: 1554413, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan: Updated Statistical Analysis Document, date: 2024-04-02, uploadDate: 2024-04-04T19:41, filename: SAP_001.pdf, size: 112584, hasResults: False

protocolSection identificationModule nctId: NCT06381661, orgStudyIdInfo id: APHP240385, briefTitle: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial, acronym: PALETTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-04-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2032-04-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context., conditionsModule conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization will concern 3 specific domains (immunomodulation, coagulation, and corticosteroids); in each domain, patients will be randomly allocated between control (standard of care) and 1-4 experimental treatments using parallell arms, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Tocilizumab, interventions name: Baricitinib, interventions name: Anakinra, interventions name: Hydrocortisone, interventions name: Hydrocortisone and fludrocortisone, interventions name: Heparin, interventions name: Low molecular weight heparin, interventions name: Recombinant humanThrombomodulin( rhTM), interventions name: Sivelestat, interventions name: Fresh frozen plasma, interventions name: Usual care, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Number of patients with persistent life-supportive therapies, secondaryOutcomes measure: Composite of the two primary outcomes, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of hospital free days, secondaryOutcomes measure: Number of hospital free days, secondaryOutcomes measure: Time to recover walking, secondaryOutcomes measure: Time to resume previous social and professional activities, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Quality of life score for adults assessed by SF-36, secondaryOutcomes measure: Quality of life score for adults assessed by EQ-5D-5L, secondaryOutcomes measure: Quality of life score for children assessed by FFS, secondaryOutcomes measure: Number of adverse events, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new sepsis episodes, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of new unscheduled hospitalizations, secondaryOutcomes measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems, eligibilityModule sex: ALL, minimumAge: 37 Weeks, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381648, orgStudyIdInfo id: 23228/LyMIC, briefTitle: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC), acronym: LyMIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2026-06-18, completionDateStruct date: 2026-06-18, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients., conditionsModule conditions: Cholangiocarcinoma, conditions: Cholangiocarcinoma, Intrahepatic, conditions: Cholangiocarcinoma Resectable, conditions: Cholangiocarcinoma; Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma), outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Takayuki Noma, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, status: RECRUITING, city: Hokkaido, state: Sapporo, zip: 060-8648, country: Japan, contacts name: Akinobu Taketomi, PhD, role: CONTACT, email: akinobutaketomi@yahoo.co.jp, contacts name: Kazuki Wakizaka, PhD, role: SUB_INVESTIGATOR, contacts name: Akinobu Taketomi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, status: RECRUITING, city: Fukuoka, zip: 812-8582, country: Japan, contacts name: Masaki Mori, PhD, role: CONTACT, email: m_mori@surg2.med.kyushu-u.ac.jp, contacts name: Masaki Mori, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Takeo Toshima, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: Department of Surgery, Tokushima University, status: RECRUITING, city: Tokushima, zip: 770-8503, country: Japan, contacts name: Mitsuo Shimada, PhD, role: CONTACT, email: mitsuo.shimada@tokushima-u.ac.jp, contacts name: Yuma Wada, PhD, role: SUB_INVESTIGATOR, contacts name: Takayuki Noma, MD, role: SUB_INVESTIGATOR, contacts name: Yuji Morine, PhD, role: SUB_INVESTIGATOR, contacts name: Tetsuya Ikemoto, PhD, role: SUB_INVESTIGATOR, contacts name: Yu Saito, PhD, role: SUB_INVESTIGATOR, contacts name: Mitsuo Shimada, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.06667, lon: 134.56667, hasResults: False

protocolSection identificationModule nctId: NCT06381635, orgStudyIdInfo id: FD-BUE-REC: IRB000124920, briefTitle: Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients.The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis?2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy., conditionsModule conditions: Radiation Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Manuka honey mixed with aloe vera gel, outcomesModule primaryOutcomes measure: Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis, secondaryOutcomes measure: the level of salivary transforming growth factor beta 1, secondaryOutcomes measure: the level of salivary Epidermal Growth factor (EGF), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ain shams University, status: RECRUITING, city: Cairo, zip: 11565, country: Egypt, contacts name: hani wlliam, MD, role: CONTACT, phone: +20 0001000093885, email: ethicscommittee.fdasurec@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Fatma E.Sayed, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Fatma E. Hassanein, PHD, role: CONTACT, phone: +201000093885, email: fatmahassanein@dent.asu.edu.eg, contacts name: Asma Abou Bakr, role: CONTACT, email: Asmaa.Aboubakr@bue.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06381622, orgStudyIdInfo id: CTA no: 2023-510028-63-00, briefTitle: Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-09-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nordsjaellands Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery., conditionsModule conditions: Nerve Block, conditions: Anesthesia, Local, conditions: Forearm Fracture, conditions: Surgery, conditions: Brachial Plexus Block, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Ropivacaine 0.5% Injectable Solution, interventions name: Lidocaine epinephrine, interventions name: Ropivacaine 0.75% Injectable Solution, outcomesModule primaryOutcomes measure: Total time to breakthrough pain, secondaryOutcomes measure: The onset of sensory block, secondaryOutcomes measure: Total duration of sensory blockade, secondaryOutcomes measure: Total duration of motor blockade, secondaryOutcomes measure: Degree of motor blockade, otherOutcomes measure: Pain intensity at pain breakthrough, otherOutcomes measure: Duration of maximum pain intensity after the blockade has ended, otherOutcomes measure: Occurence of adverse events (AE) and serious adverse events (SAE), otherOutcomes measure: Failed blockade, otherOutcomes measure: The patient's experience of the treatment (patient satisfaction), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nordsjælland Hospital, status: RECRUITING, city: Hillerød, zip: 3400, country: Denmark, contacts name: Lars H Lundstrøm, PhD, role: CONTACT, phone: 48296512, phoneExt: 45, email: lars.hyldborg.lundstroem.02@regionh.dk, contacts name: Christian Rothe, PhD, role: CONTACT, phone: 48297459, phoneExt: 45, email: christian.rothe@regionh.dk, geoPoint lat: 55.92791, lon: 12.30081, hasResults: False

protocolSection identificationModule nctId: NCT06381609, orgStudyIdInfo id: 69HCL22_0901, briefTitle: Peer Support in Alcohol Dependence, acronym: PEERSIAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-11-01, completionDateStruct date: 2027-11-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 626, type: ESTIMATED, armsInterventionsModule interventions name: Quality life questionnaire AQoLS, interventions name: Quality life questionnaire Euroqol EQ-5D-5L, interventions name: Peer support consultations, outcomesModule primaryOutcomes measure: Unplanned cessation of care at 6 months, secondaryOutcomes measure: Number of unfulfilled consultations, secondaryOutcomes measure: Euroqol-5D-5L questionnaire score, secondaryOutcomes measure: Difference in costs (in euros), secondaryOutcomes measure: Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5), secondaryOutcomes measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score, secondaryOutcomes measure: average number of standard drinks declared per week, secondaryOutcomes measure: Alcohol Quality of Life Scale (AQoLS) score, secondaryOutcomes measure: State-Trait Anxiety Inventory (STAI-Y) score, secondaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score, secondaryOutcomes measure: Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score, secondaryOutcomes measure: type of opioid use, secondaryOutcomes measure: frequency of opioid use, secondaryOutcomes measure: type of psychostimulant use, secondaryOutcomes measure: frequency of psychostimulant use, secondaryOutcomes measure: Fagerström test score, secondaryOutcomes measure: Health Care Satisfaction Questionnaire (HCSQ) score, secondaryOutcomes measure: Number of hospitalisations, secondaryOutcomes measure: Service organization description, secondaryOutcomes measure: Description of type of support and missions performed by Peer Support, secondaryOutcomes measure: Acceptability of Intervention Measure (AIM) score, secondaryOutcomes measure: AIM score, secondaryOutcomes measure: Adoption of intervention, secondaryOutcomes measure: Intervention fidelity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH Le Vinatier, city: Bron, zip: 69500, country: France, contacts name: Monique GUENIN, MD-PhD, role: CONTACT, phone: +33 4 37 91 55 55, email: monique.guenin@ch-le-vinatier.fr, contacts name: Monique GUENIN, MD-PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital Beaujon, city: Clichy, zip: 92110, country: France, contacts name: Delphine MOISAN, MD-PhD, role: CONTACT, phone: +33 1 40 87 58 82, email: delphine.moisan@aphp.fr, contacts name: Delphine MOISAN, MD-PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.90018, lon: 2.30952, locations facility: GH Nord, Hospices Civils de Lyon, city: Lyon, zip: 69004, country: France, contacts name: Benjamin ROLLAND, Professor, role: CONTACT, contacts name: Benjamin ROLLAND, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: François BAILLY, MD-PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: CHS St Anne, city: Paris, zip: 75014, country: France, contacts name: Clément VANSTEENE, MD-PhD, role: CONTACT, contacts name: Clément, role: CONTACT, contacts name: VANSTEENE, MD-PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bichat Hospital, city: Paris, zip: 75018, country: France, contacts name: Pierre-Alexis GEOFFROY, MD-PhD, role: CONTACT, phone: +33 1 40 25 82 60, email: pierrealexis.geoffroy@aphp.fr, contacts name: Pierre-Alexis GEOFFROY, MD-PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06381596, orgStudyIdInfo id: 2023-1715, secondaryIdInfos id: A536000, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/OPHTHAL&VIS SCI/GEN, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 3/6/2024, type: OTHER, domain: UW- Madison, briefTitle: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration, acronym: FPF in AMD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophyParticipants will undergo FPF imaging using the OcuMet Beacon system., conditionsModule conditions: Geographic Atrophy, conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: OcuMet Beacon, outcomesModule primaryOutcomes measure: Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon, secondaryOutcomes measure: Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement, secondaryOutcomes measure: Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology and Visual Sciences, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Amy Remm, role: CONTACT, phone: 608-262-3377, email: amy.remm@wisc.edu, contacts name: Mihai Mititelu, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06381583, orgStudyIdInfo id: 23228/EMERALD, briefTitle: A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma, acronym: EMERALD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2026-06-18, completionDateStruct date: 2026-06-18, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses., conditionsModule conditions: Esophagus Cancer, conditions: Esophageal Cancer Stage, conditions: Esophageal Cancer, conditions: Esophageal Neoplasms, conditions: Esophagus Adenocarcinoma, conditions: Esophagus, Barrett, conditions: Barrett Esophagus, conditions: Barrett Adenocarcinoma, conditions: Barrett Epithelium, conditions: Barretts Esophagus With Dysplasia, conditions: Barrett's Esophagus Without Dysplasia, conditions: Barretts Esophagus With High Grade Dysplasia, conditions: Barretts Esophagus With Low Grade Dysplasia, conditions: Barrett Esophagus, Long-Segment, conditions: Barrett's Esophagus With Dysplasia, Unspecified, conditions: Barrett's Esophagus With Esophagitis, conditions: Gastroesophageal Reflux, conditions: Reflux Disease, conditions: Esophageal Adenocarcinoma, conditions: Esophageal Dysplasia, conditions: Esophageal Neoplasms Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia), outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alessandro Mannucci, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False

protocolSection identificationModule nctId: NCT06381570, orgStudyIdInfo id: VICTORY/OZM-138, briefTitle: Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas, acronym: VICTORY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-03-21, completionDateStruct date: 2029-03-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Daniel Morgenstern, class: OTHER, collaborators name: The Hospital for Sick Children, descriptionModule briefSummary: This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.The study will be conducted in two sequential phases:Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later, conditionsModule conditions: Low-grade Glioma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: Tovorafenib, outcomesModule primaryOutcomes measure: MTD/RP2D, primaryOutcomes measure: Safety and Tolerability, primaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Pharmacokinetics (Cmax vinblastine and tovorafenib), secondaryOutcomes measure: Pharmacokinetics (AUC of vinblastine and tovorafenib), secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Clinical Benefit rate, eligibilityModule sex: ALL, minimumAge: 0 Weeks, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The Hospital for Sick Children, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1X8, country: Canada, contacts name: Nirav Thacker, role: CONTACT, phone: 6137377600, phoneExt: 6525, email: nthacker@cheo.on.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06381557, orgStudyIdInfo id: YRPG-PMS-ZYJN-RCT-2022-01, briefTitle: Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules, acronym: CRF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Qiang Fu, class: OTHER, collaborators name: Yangtze River Pharmaceutical Group Co., Ltd., descriptionModule briefSummary: Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer., conditionsModule conditions: Cancer-related Fatigue, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Zhengyuan Capsules, interventions name: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder, outcomesModule primaryOutcomes measure: Fatigue degree with the Brief Fatigue Inventory（BFI）, secondaryOutcomes measure: Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）, secondaryOutcomes measure: Fatigue degree with the MD Anderson Symptom Inventory（MDASI）, secondaryOutcomes measure: Change of patients' functional status with Karnofsky performance status (KPS), secondaryOutcomes measure: Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）, otherOutcomes measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381544, orgStudyIdInfo id: fbu_nurs_elmali_002, briefTitle: The Effect of Aromatherapy Use in Nursing Skills Training, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-02-19, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fenerbahce University, class: OTHER, descriptionModule briefSummary: Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.RESEARCH HYPOTHESES:H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.H1: Aromatherapy reduces the anxiety experienced by students during skills training.H2: Aromatherapy has a positive effect on students' learning nursing skills., conditionsModule conditions: Nursing Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ACTUAL, armsInterventionsModule interventions name: Aromatherapy application, outcomesModule primaryOutcomes measure: Difference between skill learning of students in the aromatherapy group and the control group, secondaryOutcomes measure: Difference between anxiety levels of students in the aromatherapy group and the control group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fenerbahce University, city: Istanbul, state: Atasehir, zip: 34758, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Fenerbahce University, city: Ataşehir, state: Istanbul, zip: 34758, country: Turkey, geoPoint lat: 40.9833, lon: 29.1167, hasResults: False

protocolSection identificationModule nctId: NCT06381531, orgStudyIdInfo id: 4410, briefTitle: Tracing Brain Tumors Through Deep Time, acronym: TRACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2027-06-10, completionDateStruct date: 2027-06-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Tata Memorial Centre, class: OTHER, collaborators name: Indian Statistical Institute, Kolkata, descriptionModule briefSummary: Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology., conditionsModule conditions: Brain Tumor, conditions: Oncology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Imaging with CT and MRI, outcomesModule primaryOutcomes measure: Age-based density maps of brain tumor location, secondaryOutcomes measure: Anthropometric analysis of skulls, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tata Memorial Hospital, city: Mumbai, state: Maharashtra, zip: 400012, country: India, contacts name: Dr Archya Dasgupta, MD, role: CONTACT, geoPoint lat: 19.07283, lon: 72.88261, hasResults: False

protocolSection identificationModule nctId: NCT06381518, orgStudyIdInfo id: Z2023165, briefTitle: Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease, acronym: SHUFFLE, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Zuyderland Medisch Centrum, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch., conditionsModule conditions: IBD, conditions: Infliximab, conditions: Crohn Disease, conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Switch to SC CT-P13., outcomesModule primaryOutcomes measure: Area under the curve (AUC) at steady state, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Time expenditure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zuyderland Medical Centre, city: Sittard, country: Netherlands, geoPoint lat: 50.99833, lon: 5.86944, hasResults: False

protocolSection identificationModule nctId: NCT06381505, orgStudyIdInfo id: STUDY02002103, briefTitle: RetracTOR/ Retractor for Image Guided Trans-Oral Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ryan J. Halter, class: OTHER, collaborators name: Dartmouth College, descriptionModule briefSummary: This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients., conditionsModule conditions: Oral Cavity Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dartmouth-Hitchcock Medical Center, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, contacts name: Joseph Paydarfar, MD, role: CONTACT, phone: 603-650-8123, email: joseph.a.paydarfar@hitchcock.org, geoPoint lat: 43.64229, lon: -72.25176, hasResults: False

protocolSection identificationModule nctId: NCT06381492, orgStudyIdInfo id: 2024-0057, secondaryIdInfos id: A536130, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/ORTHO&REHAB/PHYS THER, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 11/20/2023, type: OTHER, domain: UW- Madison, briefTitle: Quantifying Patellar Tendon Microstructure Using DTI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.Participants will:* undergo MRI and ultrasound imaging* perform knee function test* complete questionnaires, conditionsModule conditions: Patellar Tendinopathy, conditions: Anterior Cruciate Ligament Reconstruction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: Ultrasound (US), outcomesModule primaryOutcomes measure: Compare scalar parameters of known patellar tendon pathology to the contralateral tendon, primaryOutcomes measure: Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Wisconsin - Madison, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Maria Flory, role: CONTACT, phone: 608-262-8652, email: flory@ortho.wisc.edu, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06381479, orgStudyIdInfo id: B031, briefTitle: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National Taiwan Sport University, class: OTHER, collaborators name: Bened Biomedical Co., Ltd., descriptionModule briefSummary: There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period., conditionsModule conditions: Stress, conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: probiotics, interventions name: placebo, outcomesModule primaryOutcomes measure: Cortisol, secondaryOutcomes measure: Perceived Stress Scale (PSS), secondaryOutcomes measure: Job Stress Scale, secondaryOutcomes measure: Overwork Survey, secondaryOutcomes measure: Insomnia Severity index (ISI), secondaryOutcomes measure: The State Trait Anxiety Inventory (STAI), secondaryOutcomes measure: Depression Anxiety Stress Scales (DASS-42), secondaryOutcomes measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16, secondaryOutcomes measure: VAS-GI, secondaryOutcomes measure: Patient Global Impression scales of Improvement rated by patient, PGI-C, secondaryOutcomes measure: Serotonin, secondaryOutcomes measure: GABA, secondaryOutcomes measure: Norepinephrine, secondaryOutcomes measure: Immunoglobulin A, IgA, secondaryOutcomes measure: adrenocorticotropic hormone, ACTH, secondaryOutcomes measure: Total Antioxidant Capacity, TAC, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Graduate Institute of Sports Science, National Taiwan Sport University, status: RECRUITING, city: Taoyuan, zip: 33301, country: Taiwan, contacts name: Chi-Chang Huang, PI, role: CONTACT, phone: +88633283201, phoneExt: 2409, email: john5523@ntsu.edu.tw, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06381466, orgStudyIdInfo id: D7250C00001, briefTitle: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants., conditionsModule conditions: Dilated Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: AZD0233, interventions name: AZD0233 Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233, secondaryOutcomes measure: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233, secondaryOutcomes measure: Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233, secondaryOutcomes measure: Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233, secondaryOutcomes measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233, secondaryOutcomes measure: Terminal elimination half-life (t1/2) of AZD0233, secondaryOutcomes measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233, secondaryOutcomes measure: Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233, secondaryOutcomes measure: Terminal rate constant (λz) of AZD0233, secondaryOutcomes measure: Accumulation ratio for Cmax (Rac Cmax) of AZD0233, secondaryOutcomes measure: Accumulation ratio for AUC (Rac AUC) of AZD0233, secondaryOutcomes measure: Renal clearance (CLR) of AZD0233, secondaryOutcomes measure: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233, secondaryOutcomes measure: Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233, secondaryOutcomes measure: Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False

protocolSection identificationModule nctId: NCT06381453, orgStudyIdInfo id: 23-5037, briefTitle: Belimumab in Autoimmune Hepatitis, acronym: BELief, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\<2x ULN \& corticosteroids at a dose of \</= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH., conditionsModule conditions: Autoimmune Hepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Belimumab Auto-Injector [Benlysta], outcomesModule primaryOutcomes measure: To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH, secondaryOutcomes measure: To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden, secondaryOutcomes measure: To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden, secondaryOutcomes measure: To see the effects of treatment with Belimumab on AIH disease activity and treatment burden, secondaryOutcomes measure: To measure the effects of Belimumab on markers of AIH disease activity, secondaryOutcomes measure: To evaluate the effects of Belimumab on markers of AIH disease activity, secondaryOutcomes measure: To outline the effects of Belimumab on Patient Reported Outcomes (PRO), secondaryOutcomes measure: To assess the effects of Belimumab on Patient Reported Outcomes (PRO), secondaryOutcomes measure: To measure the effects of Belimumab on Patient Reported Outcomes (PRO), secondaryOutcomes measure: To evaluate the safety of Belimumab in patients with autoimmune hepatitis, secondaryOutcomes measure: To assess the safety of Belimumab in patients with autoimmune hepatitis, secondaryOutcomes measure: Safety and Tolerability, secondaryOutcomes measure: To report the safety of Belimumab in patients with autoimmune hepatitis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381440, orgStudyIdInfo id: PROGR-EX_MNESYS, briefTitle: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability, acronym: PROGR-EX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, collaborators name: Universita di Verona, collaborators name: Università degli Studi di Ferrara, descriptionModule briefSummary: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lokomat device (Hocoma AG, Volketswil, Switzerland)., interventions name: Conventional walking training, outcomesModule primaryOutcomes measure: Walking function, secondaryOutcomes measure: Mobility, secondaryOutcomes measure: Walking endurance, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Spasticity, secondaryOutcomes measure: Perceived quality of life, secondaryOutcomes measure: Perceived walking ability, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Adaptation to medical condition, secondaryOutcomes measure: Coping strategies, secondaryOutcomes measure: Muscle oxygen consumption, secondaryOutcomes measure: Hemodynamic cortical activation, secondaryOutcomes measure: Electrical brain activity, secondaryOutcomes measure: miRNA expression, secondaryOutcomes measure: Acceptability of robot intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, status: RECRUITING, city: Ferrara, state: Emilia Romagna, zip: 44124, country: Italy, contacts name: Sofia Straudi, MD, PhD, role: CONTACT, phone: 0532236185, email: s.straudi@ospfe.it, contacts name: Sofia Straudi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Fabio Manfredini, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nicola Lamberti, PhD, role: SUB_INVESTIGATOR, contacts name: Andrea Baroni, PhD, role: SUB_INVESTIGATOR, contacts name: Giulia Fregna, MSc, role: SUB_INVESTIGATOR, contacts name: Michela Rimondini, PhD, role: SUB_INVESTIGATOR, contacts name: Marialuisa Gandolfi, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Luigi Zerbinati, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.83804, lon: 11.62057, hasResults: False

protocolSection identificationModule nctId: NCT06381427, orgStudyIdInfo id: 01NVF22109, briefTitle: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure, acronym: PeriOP-CARE HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, collaborators name: Deutsche Luft und Raumfahrt, descriptionModule briefSummary: Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1057, type: ESTIMATED, armsInterventionsModule interventions name: Interdisciplinary decision-making for perioperative care, outcomesModule primaryOutcomes measure: combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation, secondaryOutcomes measure: Incidence of acute kidney injury, secondaryOutcomes measure: Incidence of any, treatable, suspected, or confirmed bacterial infection, secondaryOutcomes measure: Incidence of cardiac decompensation, secondaryOutcomes measure: Incidence of re-hospitalization, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Incidence of myocardial infarction (STEMI, NSTEMI), secondaryOutcomes measure: Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS), secondaryOutcomes measure: Quality of life assessed using PHQ-9, secondaryOutcomes measure: Quality of life assessed using GAD-7, otherOutcomes measure: Utilization of services and costs, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg, city: Gießen, zip: 35390, country: Germany, contacts name: Michael Sander, PhD, role: CONTACT, phone: +4964198544401, contacts name: Birgit Aßmus, PHD, role: CONTACT, geoPoint lat: 50.58727, lon: 8.67554, hasResults: False

protocolSection identificationModule nctId: NCT06381414, orgStudyIdInfo id: ChildhoodEarlyOralAging, briefTitle: Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Nove de Julho, class: OTHER, descriptionModule briefSummary: The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05., conditionsModule conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 183, type: ESTIMATED, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: Assessment of Tooth Wear and Dental Management, primaryOutcomes measure: Presence of Enamel Defects, primaryOutcomes measure: Vertical Dimension of Occlusion, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Nove de Julho University, city: São Paulo, state: SP, zip: 03155-000, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False

protocolSection identificationModule nctId: NCT06381401, orgStudyIdInfo id: MS-492-2023, briefTitle: Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious complications.The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline)., conditionsModule conditions: Surgical Field Visualization, Acute Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: bupivacaine 0.25%, interventions name: bupivacaine 0.125%, outcomesModule primaryOutcomes measure: The total consumption of IV glyceryl trinitrate (GTN), secondaryOutcomes measure: Fentanyl consumption, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative hospital stay, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381388, orgStudyIdInfo id: NL86587.041.24, briefTitle: Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke, acronym: InterAct, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jord Vink, class: OTHER, descriptionModule briefSummary: Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.Study design: A prospective, open-label within-subject intervention studyStudy population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: cTBS, outcomesModule primaryOutcomes measure: Interhemispheric inhibition (IHI), secondaryOutcomes measure: Ipsilesional resting motor threshold (RMT), secondaryOutcomes measure: Contralesional resting motor threshold (RMT), secondaryOutcomes measure: TMS interference, secondaryOutcomes measure: Intracortical inhibition (ICI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: De Hoogstraat Revalidatie, city: Utrecht, country: Netherlands, contacts name: Anne Visser-Meily, MD, PhD, role: CONTACT, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False

protocolSection identificationModule nctId: NCT06381375, orgStudyIdInfo id: 24-2-2024, briefTitle: Drug-drug Interactions With Anti-tuberculous Drugs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients., conditionsModule conditions: Drug-drug Interaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Anti Tuberculosis Drug, outcomesModule primaryOutcomes measure: Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients, primaryOutcomes measure: 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events)., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Omnia Azmy Nabeh, status: RECRUITING, city: Cairo, zip: 11562, country: Egypt, contacts name: Omnia Azmy Nabeh, MD, role: CONTACT, phone: 01066969673, email: omnia.azmy@kasralainy.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06381362, orgStudyIdInfo id: IGOMIPS, briefTitle: Italian Registry of Minimally Invasive Pancreatic Surgery, acronym: IGOMIPS, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-02-28, primaryCompletionDateStruct date: 2029-02-28, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Associazione Italiana per lo Studio del Pancreas, class: OTHER, descriptionModule briefSummary: Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes, conditionsModule conditions: Pancreatic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2300, type: ESTIMATED, armsInterventionsModule interventions name: Minimally invasive pancreatic surgery, outcomesModule primaryOutcomes measure: Postoperative short-term outcomes, primaryOutcomes measure: Long-term oncological outcomes, secondaryOutcomes measure: Rate of cases that after a minimally invasive approach had to be converted to and open approach, secondaryOutcomes measure: Surgeon learning curve, secondaryOutcomes measure: Surgeon learning curve, secondaryOutcomes measure: Surgeon learning curve, secondaryOutcomes measure: Surgeon learning curve, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Giovanni Capretti, status: RECRUITING, city: Milan, country: Italy, contacts name: Giovanni Capretti, Dr., role: CONTACT, phone: +390282247646, email: giovanni.capretti@hunimed.eu, contacts name: Alessandro Zerbi, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Capretti, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06381349, orgStudyIdInfo id: GPOEM-GEMS, briefTitle: Predicting Outcomes of GPOEM Using Gastric Electrical Mapping, acronym: GPOEM-GEMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Chris Varghese, class: OTHER, descriptionModule briefSummary: Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months., conditionsModule conditions: Gastroparesis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Gastric Alimetry test, outcomesModule primaryOutcomes measure: Gastroparesis Cardinal Symptom Index (GCSI), secondaryOutcomes measure: Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL), secondaryOutcomes measure: EQ-5D scores, secondaryOutcomes measure: Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM), secondaryOutcomes measure: Patient Health Questionnaire - 8 (PHQ-8), secondaryOutcomes measure: Generalized Anxiety Disorder 7-item (GAD-7), secondaryOutcomes measure: Perceived Stress Scale 4 (PSS-4), secondaryOutcomes measure: Brief Illness Perception Questionnaire-Revised, secondaryOutcomes measure: Alimetry® Gut-Brain Wellbeing (AGBW), secondaryOutcomes measure: Work Productivity and Activity Impairment (WPAI), otherOutcomes measure: Change in Gastric Alimetry Phenotype, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06381336, orgStudyIdInfo id: TRAKSILVER2022, briefTitle: A Digital Home-Based Physiotherapy Program for Active Aging, acronym: TRAK, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-23, primaryCompletionDateStruct date: 2022-11-07, completionDateStruct date: 2022-11-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Trak Health Solutions S.L., class: INDUSTRY, collaborators name: Basque Health Service, collaborators name: University of the Basque Country (UPV/EHU), descriptionModule briefSummary: This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity., conditionsModule conditions: Frail Elderly Syndrome, conditions: Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: TRAK-SILVER platform, outcomesModule primaryOutcomes measure: Short Physical Performance Battery (SPPB, primaryOutcomes measure: Gait Speed, primaryOutcomes measure: Timed Up and Go Test, primaryOutcomes measure: 6-minute walk test (6MWT), primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Number of steps count, primaryOutcomes measure: Geriatric Depression Scale-15 (GDS), primaryOutcomes measure: De Jong Gierveld Loneliness Scale (JGLS), primaryOutcomes measure: Quality of life (QoL) questionnaire, otherOutcomes measure: Client Satisfaction Questionnaire (CSQ), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Social Center of Orio (Zahartzaroa), city: Orio, state: Basque Country, zip: 20810, country: Spain, geoPoint lat: 43.2787, lon: -2.12537, hasResults: False

protocolSection identificationModule nctId: NCT06381323, orgStudyIdInfo id: PA2024, briefTitle: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism., conditionsModule conditions: Primary Aldosteronism, conditions: Finerenone, conditions: Mineralocorticoid Receptor Antagonist, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Finerenone, outcomesModule primaryOutcomes measure: 24h systolic BP drop value, secondaryOutcomes measure: The change of diastolic BP from the baseline level after Finerenone treatment, secondaryOutcomes measure: Hypertension remission rate, secondaryOutcomes measure: Change of serum potassium level, secondaryOutcomes measure: Change of plasma renin activity, secondaryOutcomes measure: Change of ARR, secondaryOutcomes measure: Change of UACR, secondaryOutcomes measure: Change of eGFR, otherOutcomes measure: Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Dalong Zhu, MD,PhD, role: CONTACT, phone: 86-25-83-105302, email: zhudalong@nju.edu.cn, contacts name: Ping Li, MD,PhD, role: CONTACT, phone: 86-25-83-105302, email: li78321@yeah.net, contacts name: Dalong Zhu, MD,PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ping Li, MD,PhD, role: SUB_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06381310, orgStudyIdInfo id: 202310077DINB, briefTitle: Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, collaborators name: National Taiwan University Hospital Bei-Hu Branch, descriptionModule briefSummary: Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis, which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care., conditionsModule conditions: Successful Cannulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: asus-handheld-ultrasound LU710L, outcomesModule primaryOutcomes measure: cannulation success rate, secondaryOutcomes measure: cannulation satisfaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital Bei-Hu Branch, status: RECRUITING, city: Taipei City, country: Taiwan, contacts name: Tsuei-Wun Chang, role: CONTACT, phone: 886-23717101, phoneExt: 218501, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06381297, orgStudyIdInfo id: OndokusMU, secondaryIdInfos id: Ondokuz Mayıs University, type: REGISTRY, domain: Clinical research ethics committee, briefTitle: Speech in Noise Discrimination Skills in Multiple Sclerosis Patients., statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-09, primaryCompletionDateStruct date: 2023-03-23, completionDateStruct date: 2023-04-23, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Asuman Kucukoner, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.The main questions it aims to answer are:Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated., conditionsModule conditions: Multiple Sclerosis-Relapsing-Remitting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Multiple sclerosis patient group and healthy control group., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Hearing test, interventions name: Speech in noise discrimination test, interventions name: Montreal Cognitive Assessment Scale, interventions name: Symbol Number Modalities Test (SDMT), outcomesModule primaryOutcomes measure: Pure tone Audiometry Test, primaryOutcomes measure: Speech Audiometry, primaryOutcomes measure: Speech Discrimination in Noise Test, primaryOutcomes measure: Otoacoustic Emission Test, primaryOutcomes measure: Contralateral Suppression Test, secondaryOutcomes measure: Montreal Cognitive Assessment Scale, secondaryOutcomes measure: Symbol Digit Modalities Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ondokuz Mayıs University, city: Samsun, zip: 55300, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False

protocolSection identificationModule nctId: NCT06381284, orgStudyIdInfo id: MG-001, briefTitle: Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-05-27, completionDateStruct date: 2025-05-27, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: ZS Associates, class: INDUSTRY, collaborators name: University of California, San Francisco, descriptionModule briefSummary: This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG)., conditionsModule conditions: Myasthenia Gravis, conditions: Neuromuscular Manifestations, conditions: Neuromuscular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Social media recruitment, interventions name: Self-Assessment, interventions name: Follow-up, outcomesModule primaryOutcomes measure: Social media recruitment feasibility, secondaryOutcomes measure: MG Exercise Assessment Tool validity, otherOutcomes measure: Time to diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ZS Associates, status: RECRUITING, city: Evanston, state: Illinois, zip: 60201, country: United States, contacts name: Ananda V Pandurangadu, MD, role: CONTACT, phone: 1-847-448-1001, email: support@unearthrootcause.com, contacts name: Ananda Vishnu Pandurangadu, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pritikanta Paul, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.04114, lon: -87.69006, hasResults: False

protocolSection identificationModule nctId: NCT06381271, orgStudyIdInfo id: TRUST TAVR Registry, briefTitle: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-10-30, primaryCompletionDateStruct date: 2034-10, completionDateStruct date: 2034-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected, conditionsModule conditions: Aortic Valve Regurgitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Transcatheter aortic valve replacement, outcomesModule primaryOutcomes measure: Combined clinical efficacy outcomes, secondaryOutcomes measure: Combined early safety and clinical efficacy outcomes, secondaryOutcomes measure: Rate of technical success, secondaryOutcomes measure: Rate of device success, secondaryOutcomes measure: Combined clinical efficacy outcomes, secondaryOutcomes measure: Rate of all-cause mortality, secondaryOutcomes measure: Valve-related long-term clinical efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shannxi, zip: 710032, country: China, contacts name: Rutao Wang, M.D., Ph.D., role: CONTACT, phone: +86-15091095796, email: rutaowang@qq.com, contacts name: Ruining Zhang, BSc, role: CONTACT, phone: +86-15802990370, email: ruining-zhang@qq.com, contacts name: Ling Tao, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False

protocolSection identificationModule nctId: NCT06381258, orgStudyIdInfo id: SDF, briefTitle: Fetal Cardiac Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies., conditionsModule conditions: Fetal Growth Retardation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Cardiac systolic function, secondaryOutcomes measure: Cardiac diastolic function, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06381245, orgStudyIdInfo id: KB/265/2023, briefTitle: First-time Ablation of Atrial Fibrillation Registry, acronym: DIPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers., conditionsModule conditions: Atrial Fibrillation, conditions: Arrhythmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: PPG-based remote heart rhythm/rate monitoring, interventions name: ECG-based remote heart rhythm/rate monitoring, interventions name: Transthoracic and transesophageal echocardiography examination, interventions name: Liver ultrasound examination, interventions name: Rotational angiography with three-dimensional reconstruction, interventions name: Blood-derived biomarker analysis, interventions name: Mobile health-based spirometry, outcomesModule primaryOutcomes measure: Late AF recurrence, secondaryOutcomes measure: Late recurrence of AF or atrial tachycardia or atrial flutter, secondaryOutcomes measure: Early recurrence of AF, secondaryOutcomes measure: Early recurrence of AF or atrial tachycardia or atrial flutter, secondaryOutcomes measure: Time to AF recurrence and the impact of early recurrence on late AF recurrence, secondaryOutcomes measure: The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring, secondaryOutcomes measure: Progression or regression of AF, secondaryOutcomes measure: Modification of treatment, including antiarrhythmic treatment, secondaryOutcomes measure: AF-related quality of life and symptoms, secondaryOutcomes measure: Periprocedural complications, secondaryOutcomes measure: Heart rate variability and rate, secondaryOutcomes measure: Blood biomarker levels, secondaryOutcomes measure: Ablation procedure parameters, secondaryOutcomes measure: Cardiac remodelling, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Warsaw, status: RECRUITING, city: Warsaw, country: Poland, contacts name: Monika Gawałko, MD, PhD, role: CONTACT, phone: 22 599 19 58, phoneExt: +48, email: monika.gawalko@wum.edu.pl, contacts name: Monika Gawałko, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Paweł Balsam, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Piotr Lodziński, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Michał Marchel, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Michał Peller, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Bartosz Krzowski, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Cezary Maciejewski, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Maria Boszko, MD, role: SUB_INVESTIGATOR, contacts name: Michał Gawlik, MD, role: SUB_INVESTIGATOR, contacts name: Karolina Mitrzak, MD, role: SUB_INVESTIGATOR, contacts name: Alicja Skrobucha, MD, role: SUB_INVESTIGATOR, contacts name: Mateusz Wawrzeńczyk, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False

protocolSection identificationModule nctId: NCT06381232, orgStudyIdInfo id: VIOME-001, briefTitle: Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-07-23, primaryCompletionDateStruct date: 2028-07-23, completionDateStruct date: 2028-07-23, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Viome, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease., conditionsModule conditions: General Health, conditions: Wellness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Molecular Determinants of Health and Disease, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Viome Life Sciences, status: RECRUITING, city: Bothell, state: Washington, zip: 98011, country: United States, contacts name: Momchilo Vuyisich, role: CONTACT, phone: 425-300-6933, email: studies@viome.com, geoPoint lat: 47.76232, lon: -122.2054, hasResults: False

protocolSection identificationModule nctId: NCT06381219, orgStudyIdInfo id: s67001, briefTitle: Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE., conditionsModule conditions: Eosinophilic Esophagitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Implementation of cow's milk in decreasingly heated forms, interventions name: Implementation of hen's egg in decreasingly heated forms, outcomesModule primaryOutcomes measure: Maintained remission of EoE, secondaryOutcomes measure: Maintained remission only in step 1 of the diet, secondaryOutcomes measure: Association of remission with circulating IgG4 levels, secondaryOutcomes measure: Association of remission with IgG4 levels on biopsy, secondaryOutcomes measure: In vitro B cell test to mimic B cell activation after stimulation, secondaryOutcomes measure: Correlation between QoL and remission, secondaryOutcomes measure: Associated atopy, secondaryOutcomes measure: Associated food allergies, eligibilityModule sex: ALL, minimumAge: 12 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: UZ Leuven Gasthuisberg, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Dominique Bullens, Prof. Dr., role: CONTACT, phone: 0032 16 34 38 01, email: dominique.bullens@kuleuven.be, contacts name: Marleen Jannis, role: CONTACT, phone: 0032 16 34 38 01, email: marleen.jannis@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-07-05, uploadDate: 2023-10-25T10:35, filename: Prot_000.pdf, size: 696874, hasResults: False

protocolSection identificationModule nctId: NCT06381206, orgStudyIdInfo id: No 475, briefTitle: Silodosin in Management of Lower Ureteral Stones, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-20, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2023-10-25, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Syrian Private University, class: OTHER, descriptionModule briefSummary: This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin., conditionsModule conditions: Stone, Kidney, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Silodosin, outcomesModule primaryOutcomes measure: Stone expulsion (yes), primaryOutcomes measure: Stone expulsion (no), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damascus university, city: Damascus, zip: 1, country: Syrian Arab Republic, geoPoint lat: 33.5102, lon: 36.29128, hasResults: False

protocolSection identificationModule nctId: NCT06381193, orgStudyIdInfo id: ESTR-01-2022, briefTitle: Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2023-07-10, completionDateStruct date: 2023-07-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centros de Investigación de Nutrición y Salud, class: OTHER, collaborators name: Nutribiotica, descriptionModule briefSummary: The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.* To evaluate the stool consistency after 8 weeks (Bristol scale).* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.Participants are randomized into the following groups:* Group A: 20 assigned to probiotic + placebo* Group B: 20 assigned to prebiotic + placebo* Group C: 20 assigned to probiotic + prebiotic* Group D: 20 assigned to the placebo + placeboParticipants took 4 units of product per day (2 of each assigned product) for 2 months., conditionsModule conditions: Functional Constipation, 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: 80, type: ACTUAL, armsInterventionsModule interventions name: Probiotic, interventions name: Prebiotic, interventions name: Probiotic + Prebiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation., secondaryOutcomes measure: To evaluate the stool consistency (Bristol scale)., secondaryOutcomes measure: To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20), secondaryOutcomes measure: To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA), city: Madrid, zip: 28036, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06381180, orgStudyIdInfo id: Warrior CARE: CBH, briefTitle: Warrior CARE: Cannabis Behavioral Health, acronym: CBH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, descriptionModule briefSummary: This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Cannabis Use, conditions: Suicide, conditions: Veterans, conditions: Marijuana, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Tetrahydrocannabinol, interventions name: Cannabidiol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment., primaryOutcomes measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment, primaryOutcomes measure: Assessing Suicidality over time using the C-SSRS assessment., primaryOutcomes measure: Assessing Suicidality throughout the study using the SBQ-R assessment., primaryOutcomes measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires., secondaryOutcomes measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire., secondaryOutcomes measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment., secondaryOutcomes measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires., secondaryOutcomes measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments., secondaryOutcomes measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales., secondaryOutcomes measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires., secondaryOutcomes measure: Assess demographics using a self-report assessment, secondaryOutcomes measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments., secondaryOutcomes measure: Assess smoking habits and history using the FTND assessment, secondaryOutcomes measure: Assess general health and history pre- and post-treatment using the SF-36 assessment., secondaryOutcomes measure: Assess healthcare utilization throughout the study., secondaryOutcomes measure: Assess pain pre- and post-treatment using the BPI assessment., secondaryOutcomes measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire., secondaryOutcomes measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire., secondaryOutcomes measure: Assess substance use throughout the study using the TLFB assessment., secondaryOutcomes measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks, secondaryOutcomes measure: Assess physiological measures throughout the study as a safety check, secondaryOutcomes measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD., eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wayne State University, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: Nareen Sadik, B.S., role: CONTACT, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False

protocolSection identificationModule nctId: NCT06381167, orgStudyIdInfo id: Endoscopic decompression, briefTitle: Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis., conditionsModule conditions: Lumbar Spinal Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic Decompressive Laminectomy, outcomesModule primaryOutcomes measure: Oswestry Disability Index ODI scores for low back pain and neuropathic pain, secondaryOutcomes measure: visual analog scale (VAS) score for low back and lower extremity radiating pain, secondaryOutcomes measure: European Quality of Life-5 Dimensions (EQ-5D) score, secondaryOutcomes measure: painDETECT score, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381154, orgStudyIdInfo id: MC230404, secondaryIdInfos id: NCI-2024-03078, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-009036, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230404, type: OTHER, domain: Mayo Clinic, secondaryIdInfos id: P01CA084203, type: NIH, link: https://reporter.nih.gov/quickSearch/P01CA084203, secondaryIdInfos id: P30CA015083, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA015083, briefTitle: Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2029-07-04, completionDateStruct date: 2029-07-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer., conditionsModule conditions: Locally Advanced Pancreatic Adenocarcinoma, conditions: Metastatic Pancreatic Adenocarcinoma, conditions: Stage II Pancreatic Cancer AJCC v8, conditions: Stage III Pancreatic Cancer AJCC v8, conditions: Stage IV Pancreatic Cancer AJCC v8, conditions: Unresectable Pancreatic Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Endoscopic Ultrasound, interventions name: Fluorouracil, interventions name: Irinotecan, interventions name: Leucovorin, interventions name: Lymph Node Biopsy, interventions name: Magnetic Resonance Imaging, interventions name: Oxaliplatin, interventions name: Pembrolizumab, interventions name: Photodynamic Therapy, interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, interventions name: Verteporfin, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Vinay Chandrasekhara, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False

protocolSection identificationModule nctId: NCT06381141, orgStudyIdInfo id: CLN-619-002, briefTitle: A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cullinan Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma, conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CLN-619, outcomesModule primaryOutcomes measure: Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance, primaryOutcomes measure: Incidence of Dose-Limiting toxicity (DLTs), primaryOutcomes measure: Best Overall Response (BOR) per patient, primaryOutcomes measure: Overall Response Rate (ORR), primaryOutcomes measure: Duration of Response (DoR), primaryOutcomes measure: Clinical Benefit Rate (CBR), primaryOutcomes measure: Progression Free Survival (PFS), primaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381128, orgStudyIdInfo id: CAA by CT in children with CHD, briefTitle: Coronary Arteries Anomalies by CT in Children With CHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction., conditionsModule conditions: Cardiac Congenital Defects, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac CT, outcomesModule primaryOutcomes measure: Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381115, orgStudyIdInfo id: 23-006685, briefTitle: App-Based Optimization of Long-Term CPAP Adherence and Quality of Life, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: Arizona State University (ASU), descriptionModule briefSummary: The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: SleepWell24 Application, outcomesModule primaryOutcomes measure: CPAP Adoption, primaryOutcomes measure: Change in Quality of Life, secondaryOutcomes measure: Change in sleep time, secondaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in sedentary time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, city: Scottsdale, state: Arizona, zip: 85259, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False

protocolSection identificationModule nctId: NCT06381102, orgStudyIdInfo id: 20240134, briefTitle: Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-13, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Miami, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: transcutaneous auricular vagus nerve stimulation 30/30, interventions name: transcutaneous auricular vagus nerve stimulation 10/10, outcomesModule primaryOutcomes measure: Tolerability measured by tolerability questionnaire, primaryOutcomes measure: Tolerability measured by self-report, secondaryOutcomes measure: Change in heart rate variability (HRV), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Gabriel Gonzalez, DPT, role: CONTACT, phone: 305-243-8117, email: gxg651@miami.edu, contacts name: Marlon Wong, PT, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Gabriel Gonzalez, DPT, role: SUB_INVESTIGATOR, contacts name: Jessica Bolanos, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False

protocolSection identificationModule nctId: NCT06381089, orgStudyIdInfo id: VNS004, briefTitle: Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients, acronym: ERRVNS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-07-10, completionDateStruct date: 2024-08-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: SEFA HAKTAN HATIK, class: OTHER, descriptionModule briefSummary: This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p\<0.05 level., conditionsModule conditions: Ischemic Stroke, conditions: Vagus Nerve Stimulation, conditions: Robotic Rehabilitation, conditions: Autonomic Nervous System, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Robotic Rehabilitation, interventions name: Transcutaneous Auricular Vagal Nerve Stimulation, outcomesModule primaryOutcomes measure: Numerical Pain Rating Scale, primaryOutcomes measure: Stroke Specific Quality of Life Scale, primaryOutcomes measure: 10 Meter Walk Test, primaryOutcomes measure: Fugl-Meyer Assessment Lower Extremity, primaryOutcomes measure: Modified Ashworth Scale, primaryOutcomes measure: Electromyography, primaryOutcomes measure: Autonomic Nervous System, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381076, orgStudyIdInfo id: IRB202400087, briefTitle: Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey., conditionsModule conditions: Chronic Kidney Disease 5D, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized comparator-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Liposomal curcumin, interventions name: Food colorant, outcomesModule primaryOutcomes measure: high-sensitivity C-reactive protein, secondaryOutcomes measure: Advanced glycation end products, secondaryOutcomes measure: fatty acid byproduct - 4-hydroxynon-enal, secondaryOutcomes measure: fatty acid byproduct - malondialdehyde, secondaryOutcomes measure: fatty acid byproduct - 8-F2 isoprostanes, secondaryOutcomes measure: Klotho, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381063, orgStudyIdInfo id: PI2023_843_0152, briefTitle: Non-steroidal Anti-inflammatory in Cardiac Surgery, acronym: KETOPAIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, collaborators name: University Hospital, Rouen, collaborators name: University Hospital, Lille, descriptionModule briefSummary: Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication., conditionsModule conditions: Acute Postoperative Pain, conditions: Non-steroidal Anti-inflammatory Drugs, conditions: Cardiac Surgery, conditions: Pain Intensity, conditions: Multimodal Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 238, type: ESTIMATED, armsInterventionsModule interventions name: pain management, interventions name: ketoprofen, interventions name: PLacebo, outcomesModule primaryOutcomes measure: reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery, primaryOutcomes measure: NSAIDs reduce postoperative at rest at 24 hours from the end of surgery, secondaryOutcomes measure: Change in pain trajectory during the first 7 days after cardiac surgery, secondaryOutcomes measure: Change in cumulative opioid within 48 hours after surgery, secondaryOutcomes measure: Change in pulmonary postoperative complications within 7 days after surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens Picardie, status: RECRUITING, city: Amiens, country: France, contacts name: Osama ABOU ARAB, role: CONTACT, email: abouarab.osama@chu-amiens.fr, contacts name: Emmanuel BESNIER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mouhamed MOUSSA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False

protocolSection identificationModule nctId: NCT06381050, orgStudyIdInfo id: SHR-7631-101, briefTitle: The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Suzhou Suncadia Biopharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: SHR-7631, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD), primaryOutcomes measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0), secondaryOutcomes measure: PK parameter: Tmax, secondaryOutcomes measure: PK parameter: Cmax, secondaryOutcomes measure: PK parameter: AUC0-t, secondaryOutcomes measure: PK parameter: AUC0-∞, secondaryOutcomes measure: PK parameter: t1/2, secondaryOutcomes measure: PK parameter: MRT (mean residence time), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06381037, orgStudyIdInfo id: PID2021-127986OB-I00, briefTitle: Quality of Life and Psychological Strengths of Older People, acronym: QUALIFRAG, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: CEU San Pablo University, class: OTHER, descriptionModule briefSummary: As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors., conditionsModule conditions: Quality of Life, conditions: Skills, Coping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Quantitative, observational and longitudinal study with three measurements (pre-intervention, post-intervention and monitoring)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: "How to improve your strengths and quality of life"., outcomesModule primaryOutcomes measure: Quality of life, primaryOutcomes measure: Psychological wellbeing, primaryOutcomes measure: Loneliness, primaryOutcomes measure: Anxiety and depression Anxiety and depression, primaryOutcomes measure: Gratitude, primaryOutcomes measure: Experiential acceptance, primaryOutcomes measure: Resilience, primaryOutcomes measure: Family functioning, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Pablo CEU University (Campus Montepríncipe), status: RECRUITING, city: Alcorcón, state: Madrid, zip: 28925, country: Spain, contacts name: Leyre Galarraga Cristóbal, role: CONTACT, phone: 913724700, phoneExt: 14607, email: leyre.galarragacristobal@ceu.es, contacts name: Gema Pérez Rojo, role: CONTACT, phone: 913724700, phoneExt: 14999, email: gema.perezrojo@ceu.es, geoPoint lat: 40.34582, lon: -3.82487, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-12-01, uploadDate: 2023-12-11T03:43, filename: SAP_000.pdf, size: 70923, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-01, uploadDate: 2023-12-11T03:42, filename: ICF_001.pdf, size: 71559, hasResults: False

protocolSection identificationModule nctId: NCT06381024, orgStudyIdInfo id: 2022 A02702-41, briefTitle: A Study of Telemonitoring in Cancer Patients, acronym: MINERVA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-04, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Bligny, class: OTHER, collaborators name: Exystat, collaborators name: Cureety, collaborators name: Pharmaspecific, collaborators name: ProPens, descriptionModule briefSummary: The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:* In-person care alone (Standard of care group).* In-person care with Cureety telemonitoring (Standard of care with Cureety group).Participants will:* be monitored with digital application Cureety (Standard of care with Cureety group)* fill out quality of life questionnaire (baseline, 2 months, 4 months)* fill out satisfaction questionnaire (2 months, 4 months)* have the ongoing and incoming phone calls logged (duration and type), conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:* In-person care alone (Standard of care group).* In-person care with telemonitoring (Standard of care with Cureety group).The randomization will be stratified by:• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: remote patient monitoring, outcomesModule primaryOutcomes measure: Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment, secondaryOutcomes measure: Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment, secondaryOutcomes measure: Numbers of telephone calls during the first 4 months of cancer treatment in subgroups, secondaryOutcomes measure: Hospital-free survival rate, secondaryOutcomes measure: Quality of life at 2 and 4 months after initiation of cancer treatment., secondaryOutcomes measure: Patient satisfaction with the healthcare provided, secondaryOutcomes measure: CH Bligny staff satisfaction with the healthcare provided, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Bligny, status: RECRUITING, city: Briis-sous-Forges, zip: 91640, country: France, contacts name: Ingrid Alexandre, MD, role: CONTACT, phone: +33169263138, email: i.alexandre@chbligny.fr, contacts name: Ingrid Alexandre, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.62399, lon: 2.12112, hasResults: False

protocolSection identificationModule nctId: NCT06381011, orgStudyIdInfo id: BEUFTR-4, briefTitle: Local Vibration in Cervical Radiculopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Bitlis Eren University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy., conditionsModule conditions: Cervical Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Local Vibration, outcomesModule primaryOutcomes measure: Neck Pain, primaryOutcomes measure: Upper Limb Pain, primaryOutcomes measure: Paresthesia, secondaryOutcomes measure: Cervical Range of Motion, secondaryOutcomes measure: The Change in the Pressure Pain Threshold of the Upper Trapezius, secondaryOutcomes measure: The Change in the Viscoelastic Properties of the Upper Trapezius, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bitlis Eren University, city: Bitlis, state: Merkez, zip: 13000, country: Turkey, contacts name: Ömer Dursun, Asst. Prof., role: CONTACT, phone: 5426088687, phoneExt: +90, email: fztomrdrsn@gmail.com, contacts name: Erhan Dincer, M.Sc., role: CONTACT, phone: 5442543857, phoneExt: +90, email: fzterhan@hotmail.com, geoPoint lat: 38.40115, lon: 42.10784, hasResults: False

protocolSection identificationModule nctId: NCT06380998, orgStudyIdInfo id: EPCPHCFAPAEWPSPSWAG, briefTitle: Effects of Petroleum Compounds on Psychological Health and Cognitive Functions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity., conditionsModule conditions: Cognitive Deterioration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: whey protien, outcomesModule primaryOutcomes measure: Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut, primaryOutcomes measure: To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers, primaryOutcomes measure: To explore the role of supplements with whey protein in ameliorating these effects, secondaryOutcomes measure: To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, city: Assiut, state: Assiut University, zip: 71515, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False

protocolSection identificationModule nctId: NCT06380985, orgStudyIdInfo id: NURA-009-23F, secondaryIdInfos id: 1I01CX002715-01A1, type: OTHER_GRANT, domain: Clinical Science Research & Development, briefTitle: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury, acronym: TABM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI., conditionsModule conditions: Alcohol Use Disorder, conditions: Mild-Moderate Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition, interventions name: Sham Condition, outcomesModule primaryOutcomes measure: Percent of Heavy Drinking Days, secondaryOutcomes measure: Cue-induced fMRI BOLD-signal craving activation contrasts, otherOutcomes measure: Cognitive flexibility, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Francisco VA Medical Center, San Francisco, CA, city: San Francisco, state: California, zip: 94121-1563, country: United States, contacts name: David L Pennington, role: CONTACT, phone: 415-221-4810, phoneExt: 24504, email: david.pennington2@va.gov, contacts name: Yim Fan Wong, BS, role: CONTACT, phone: (415) 221-4810, phoneExt: 22329, email: yimfan.wong@va.gov, contacts name: David L Pennington, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False