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protocolSection identificationModule nctId: NCT06265233, orgStudyIdInfo id: 69668, briefTitle: ERP Plus Improv Group Therapy for OCD (IMPROVE Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The goal of this study is to pilot test a novel group therapy intervention for adults with OCD., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Group Improv sessions, interventions name: Group Exposure and Response Prevention (ERP) Therapy, outcomesModule primaryOutcomes measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), secondaryOutcomes measure: Change in Intolerance of Uncertainty Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 401 Quarry, status: RECRUITING, city: Stanford, state: California, zip: 94304, country: United States, contacts name: Study Team, role: CONTACT, phone: 650-723-4095, email: ocdresearch@stanford.edu, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False

protocolSection identificationModule nctId: NCT06265220, orgStudyIdInfo id: AB-101-03, briefTitle: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Artiva Biotherapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches.The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.Patients may receive up to 2 cycles of treatment spaced 24 weeks apart., conditionsModule conditions: Lupus Nephritis - WHO Class III, conditions: Lupus Nephritis - WHO Class IV, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: AB-101, interventions name: Cyclophosphamide, interventions name: Fludarabine, interventions name: Rituximab, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events, primaryOutcomes measure: AB-101 Clinical Activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92121, country: United States, contacts name: Bosco Trinh, role: CONTACT, contacts name: Bethany Karl, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False

protocolSection identificationModule nctId: NCT06265207, orgStudyIdInfo id: ArdahanU-Simsekli-DS-02, briefTitle: The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ardahan University, class: OTHER, collaborators name: Kafkas University, descriptionModule briefSummary: In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine., conditionsModule conditions: Mammography, conditions: Early Diagnosis of Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single Blind Parallel Group Randomized Controlled Trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Since the researcher will be conducting the research, blinding will not be possible, and separate consent forms were prepared for the experimental and control groups, without specifying which group they were in, and it was planned to blind the participants in this way. In addition, in order to prevent statistical bias, it is planned to prevent bias in data analysis by coding the data as first group and second group, rather than experimental and control group, when entering the data into SPSS, and by not giving information about which group is the experiment and which is the control group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality, interventions name: routine maintenance, outcomesModule primaryOutcomes measure: Visual Comparison Scale, primaryOutcomes measure: State Anxiety Inventory, primaryOutcomes measure: Satisfaction Evaluation Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265194, orgStudyIdInfo id: ZAT2024, briefTitle: Effect of EMDR in the Treatment of Fibromyalgia, acronym: EMDR, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2018-01-01, completionDateStruct date: 2018-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Academy of Therapeutic Sciences, Turkey, class: OTHER, descriptionModule briefSummary: The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.The main questions it aims to answer are:* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?, conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants do not have the knowledge of group interventions., whoMasked: PARTICIPANT, enrollmentInfo count: 79, type: ACTUAL, armsInterventionsModule interventions name: EMDR, interventions name: TAU, outcomesModule primaryOutcomes measure: Fibromyalgia Impact Questionnaire (FIQ), primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Trauma Symptom Checklist-40 (TSC-40), secondaryOutcomes measure: Beck Depression Inventory (BDI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06265181, orgStudyIdInfo id: AIBU-SBF-SK-04, briefTitle: The Effect of Diabetes Coaching on Distress and Diabetes Self-Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental and control group., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: When the researcher evaluates the participant according to the inclusion criteria, written consent will be obtained from the participant and pre-evaluation forms will be applied when compliance with the criteria is achieved. Afterwards, the participant's group will be notified to the researcher by the independent researcher and randomization will be carried out. With this; Data entries will be made by an independent researcher as group A and group B, without writing the group names. Until the data analysis and reporting is completed, the statistician will be blinded to which group is the intervention and which group is the control., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes coaching, outcomesModule primaryOutcomes measure: Type 2 Diabetes Self-Management Scale, secondaryOutcomes measure: Diabetes Distress Scale, secondaryOutcomes measure: HbA1c Monitoring Form, secondaryOutcomes measure: Introductory Features Form, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265168, orgStudyIdInfo id: req-2023-01512; am23Sutter3, briefTitle: Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients, acronym: COMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient., conditionsModule conditions: Coma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Simulation, outcomesModule primaryOutcomes measure: To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient., secondaryOutcomes measure: Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient, secondaryOutcomes measure: Participants' self-evaluation of their performance in hindsight, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, country: Switzerland, contacts name: Prof. Dr. Sutter, role: CONTACT, contacts name: Liliane Nueesch, role: CONTACT, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False

protocolSection identificationModule nctId: NCT06265155, orgStudyIdInfo id: SuzhouMHAnhui, briefTitle: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Anzhi Li, class: OTHER, descriptionModule briefSummary: Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke., conditionsModule conditions: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 302, type: ESTIMATED, outcomesModule primaryOutcomes measure: RR values for exposure during the risk period versus exposure in the past year for each trigger, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suzhou Hospital Anhui Medical University, status: RECRUITING, city: Suzhou, state: Anhui, zip: 234000, country: China, contacts name: Anzhi Li, B.S., role: CONTACT, phone: +8615903860581, email: 365819805@qq.com, contacts name: Zhengfei Ma, M.D., role: CONTACT, phone: 13866586362, email: Zhengfeima@126.com, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False

protocolSection identificationModule nctId: NCT06265142, orgStudyIdInfo id: MoH/CSR/23/26368, briefTitle: Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, descriptionModule briefSummary: Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.Patient Population: young infants from 0 to 6 months of ageIntervention: There will be two groups:1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.Outcome: Contamination rate and feasibility of both urine sampling techniques, conditionsModule conditions: Urinary Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B, after collecting urine by CCU, we recommend to collect another sample by catheterization to guide the management and antibiotic choice., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The statistician who will analyze the data will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bladder catheterization, interventions name: clean catch urine via bladder massage technique, outcomesModule primaryOutcomes measure: Urine culture contamination rate, primaryOutcomes measure: Parental satisfaction questionnaire, secondaryOutcomes measure: duration of the procedure, secondaryOutcomes measure: Pain score, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 6 Months, stdAges: CHILD, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-01, uploadDate: 2024-02-14T09:44, filename: Prot_000.pdf, size: 662911, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-01, uploadDate: 2024-02-14T09:45, filename: ICF_001.pdf, size: 128074, hasResults: False

protocolSection identificationModule nctId: NCT06265129, orgStudyIdInfo id: R.23.12.2429, briefTitle: The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Obstructive sleep apnea syndrome (OSAS) is characterized by recurrent episodes of obstructive events (apnea and hypopnea) and intermittent hypoxia, which in turn contributes to the systemic inflammation that underlies this disease and its consequences (Ryan et al 2009, Gileles-Hillel et al 2014). This systemic inflammation leads to endothelial dysfunction, which contributes to the pathogenesis of cardiovascular complications in OSAS, in addition to the exposure to risk factors, such as male gender, older age, obesity, and lack of exercise (Lorenzi Filho et al 2010). Some red blood cells (RBC) and platelets indices have emerged as inflammatory biomarkers in various diseases (Tertemiz et al 2016) The severity of OSA is significantly associated with increase hematocrit, even after controlling for possible confounding variables. However, nocturnal hypoxemia in OSA does not usually lead to clinical polycythemia (Choi et al 2006). In patients referred with a clinical diagnosis of OSAS, RDW may be a marker for the severity of the condition. As RDW is usually included in a complete blood count, it could provide an inexpensive tool for triaging OSAS patients for polysomnography evaluation (Sökücü et al 2012). The hematological indices white blood cell count (WBC), neutrophil count, lymphocyte count, mean platelet volume (MPV), platelet distribution width (PDW), and red blood cell distribution width (RDW) have been proposed as alternative markers to those normally used clinically, e.g., interleukin-6 (IL6) and C-reactive protein, to evaluate the burden of inflammation in OSAS (Wu et al 2018), conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Complete blood picture (done in the morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW), outcomesModule primaryOutcomes measure: Red Blood Cells Indices, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tamer Awad Elsayed, city: Mansoura, state: Dakhlia, zip: 050, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False

protocolSection identificationModule nctId: NCT06265116, orgStudyIdInfo id: A0801024 CD, briefTitle: One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2027-01-23, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period., conditionsModule conditions: Dental Caries Class II, conditions: Marginal Integrity of Composite Restorations With Universal Adhesives, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: One-step universal adhesive, outcomesModule primaryOutcomes measure: Percentage of functional and biological properties for each group, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Omar Abd El-Fattah Abd El-Maksoud, status: RECRUITING, city: Mansoura, state: Dakahlia, zip: 35516, country: Egypt, contacts name: Omar A Abd El-Maksoud, role: CONTACT, phone: 01024366555, email: omarabdelfata7.92@gmail.com, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False

protocolSection identificationModule nctId: NCT06265103, orgStudyIdInfo id: 20190407, briefTitle: Epilepsy Learning Healthcare System (ELHS), acronym: ELHS, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-03-20, primaryCompletionDateStruct date: 2099-02-14, completionDateStruct date: 2099-02-14, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Epilepsy Foundation of America, class: OTHER, descriptionModule briefSummary: The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care., conditionsModule conditions: Epilepsy, conditions: Seizure Disorder, conditions: Neurologic Disorder, conditions: Rare Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Clinical care and quality improvement, outcomesModule primaryOutcomes measure: Seizure Frequency, primaryOutcomes measure: Seizure Freedom, primaryOutcomes measure: Quality of Life documentation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barrow Neurological Institute Comprehensive Epilepsy Center, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85013, country: United States, contacts name: Malinda Brooks-Busch, MPH, role: CONTACT, phone: 602-406-3443, email: Malinda.Brooks-Busch@dignityhealth.org, contacts name: Sue Herman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: University of Southern California, status: RECRUITING, city: Los Angeles, state: California, zip: 90032, country: United States, contacts name: Alissa Maier, MPH, role: CONTACT, phone: 937-545-2627, email: Alissa.Maier@med.usc.edu, contacts name: Christi Heck, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Epilepsy Foundation, status: RECRUITING, city: Bowie, state: Maryland, zip: 20716, country: United States, contacts name: Kathleen Farrell, MB BCh BAO, role: CONTACT, phone: 732-832-5983, email: kfarrell@efa.org, contacts name: Saniya Griffin, role: CONTACT, email: elhs@efa.org, contacts name: Brandy Fureman, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.94278, lon: -76.73028, locations facility: Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH), status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Jason Raymond Smith, role: CONTACT, phone: 617-726-3311, email: JSMITH114@PARTNERS.ORG, contacts name: Daniel Hoch, MD, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Beth Israel Deaconess Medical Center's Comprehensive Epilepsy Program, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Jennifer Sabbagh, role: CONTACT, phone: 617-975-8545, email: jsabbagh@bidmc.harvard.edu, contacts name: Bernard Chang, M.D., M.M.Sc., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC), status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Naima Griffin, role: CONTACT, phone: 513-636-9933, email: naima.griffin@cchmc.org, contacts name: Katie Holland, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: University of Cincinnati Gardner Neuroscience Institute Epilepsy Center, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45267, country: United States, contacts name: Lucy Mendoza, CCRP, role: CONTACT, phone: 513-558-3020, email: mendozlc@UCMAIL.UC.EDU, contacts name: David Ficker, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Penn State Hershey, status: NOT_YET_RECRUITING, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Jessica Beiler, MPH,CCRC, role: CONTACT, phone: 717-531-5656, email: jbeiler@pennstatehealth.psu.edu, contacts name: William Trescher, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.28592, lon: -76.65025, locations facility: Children's Hospital of Philadelphia (CHOP), status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Nicholas Abend, role: CONTACT, email: abend@email.chop.edu, contacts name: Nicholas Abend, MD, MSCE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: UT Southwestern Children's Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75063, country: United States, contacts name: Bonnie Jenkins, LCSW, role: CONTACT, phone: 214-456-0614, email: bonnie.jenkins@childrens.com, contacts name: Deepa Sirsi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False

protocolSection identificationModule nctId: NCT06265090, orgStudyIdInfo id: F.P.T 2307017, briefTitle: Effect of Lumbar Stabilization Exercises Combined With Ball and Balloon Exercise in Treatment of Chronic Non-specific Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2022-12-20, completionDateStruct date: 2023-01-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: \[Background\] Low back pain occurs when a poor lifestyle weakens the muscular strength of the waist and excessive loads on and tensions of the muscles create pain. Mediating muscle weakening to stabilize the trunk is an important aspect in the recovery of body function in patients with LBP \[Purpose\], this study was conducted to investigate the effect of core stability exercises combined with ball and balloon exercises on chronic non-specific low back pain. \[Subjects and Methods\] a sixty patient of chronic non-specific low back pain were randomly assigned into two groups, group (A) received core stability exercises combined with ball and balloon exercises and group (B) received core stability exercises, these exercises were performed for three times a week for four weeks. Pain was assessed by visual analogue scale (VAS). Spinal function was measured by Arabic Oswestery Disability Index (AODI) and pulmonary function was assessed by pulmonary function test including forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV) and peak expiratory flow (PEF) before and after the study.Keywords: core stability exercises, ball and balloon exercises, chronic non-specific low back pain, conditionsModule conditions: Chronic Mechanical Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from April 2023 to October 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.Subjects:Seventy male and female physiotherapy students have chronic non-specific low back pain will be chosen from faculty of physical therapy, delta university for science and technology.The local ethics committee approved this study (Delta University for science and technology, faculty of Physical Therapy, Ethics committee F.P.T 2307017)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: the participants were selected randomly without their knowledge about in experimental or control group the assessor was for assessment only and the therapist was for treatment only, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: therapeutic exercises, interventions name: exercises, outcomesModule primaryOutcomes measure: visual analogue score, secondaryOutcomes measure: forced expiratory volume in the first second (FEV1) in liters, secondaryOutcomes measure: forced vital capacity (FVC) in liters, secondaryOutcomes measure: FVC/FEV1 ratio, secondaryOutcomes measure: maximum voluntary ventilation (MVV), secondaryOutcomes measure: peak expiratory flow (PEF) in liter/min, otherOutcomes measure: Arabic Oswestery Disability Index (AODI) for functional assessment, otherOutcomes measure: weight, otherOutcomes measure: age, otherOutcomes measure: height, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Delta University For Science and Technology, city: Al Manşūrah, state: Gamasah, zip: 11152, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False

protocolSection identificationModule nctId: NCT06265077, orgStudyIdInfo id: 2023-199, briefTitle: Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Noha Mansour, class: OTHER, descriptionModule briefSummary: No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain., conditionsModule conditions: Breast Cancer, conditions: Filgrastim Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: famotidine and loratadine, outcomesModule primaryOutcomes measure: The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06265064, orgStudyIdInfo id: KhonKaenUniversity, briefTitle: STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-11, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.The main question\[s\] it aims to answer are:* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?* Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.Participants who undergoing to elective surgery under general anesthesia will* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)* In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.If there is a comparison group:Researchers will compare obese patients with/without high STOP bang score \>=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference \> 42 cm, Thyromental distance \< 6 cm)to prediction difficult mask ventilation, conditionsModule conditions: Obesity, conditions: OSA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 278, type: ACTUAL, armsInterventionsModule interventions name: STOP-Bang score >= 3 with factors predicting difficult intubation, outcomesModule primaryOutcomes measure: Difficult mask ventilation, secondaryOutcomes measure: Resipiratory complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KhonKaen University, city: Nai Muang, state: Khonkaen, zip: +66, country: Thailand, geoPoint lat: 15.17901, lon: 100.1282, hasResults: False

protocolSection identificationModule nctId: NCT06265051, orgStudyIdInfo id: 100939, briefTitle: Tirofiban After Successful MT Recanalization in AIS, acronym: ATTRACTION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Xiang Luo, class: OTHER, collaborators name: Wuhan Central Hospital, collaborators name: Wuhan University, collaborators name: Renmin Hospital of Wuhan University, collaborators name: Second Affiliated Hospital of Soochow University, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: Wuhan Hospital of Traditional Chinese Medicine, collaborators name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, collaborators name: Huangshi Central Hospital, China, collaborators name: The First Affiliated Hospital of Yangtze University, collaborators name: The Fifth Hospital of Wuhan, collaborators name: Wuhan Puren Hospital, collaborators name: Xiangyang No.1 People's Hospital, collaborators name: Xianning Central Hospital, collaborators name: Wuhan Hanyang Hospital, collaborators name: Wuhan Third Hospital, collaborators name: Yichang Central People's Hospital, collaborators name: Affiliated Hospital of Chengde Medical University, collaborators name: Beijing Tiantan Hospital, collaborators name: Nanyang Central Hospital, collaborators name: Jingzhou Central Hospital, collaborators name: Taihe Hospital, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, descriptionModule briefSummary: Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset., conditionsModule conditions: Acute Ischemic Stroke, conditions: Vessel Occlusion, 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: 1360, type: ESTIMATED, armsInterventionsModule interventions name: Tirofiban, interventions name: Saline placebo, outcomesModule primaryOutcomes measure: Proportion of patients functionally independent (mRS score 0 to 2) at 90 days, primaryOutcomes measure: Number of participants with symptomatic intracranial hemorrhage, secondaryOutcomes measure: Modified ranking scale (mRS), secondaryOutcomes measure: Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1), secondaryOutcomes measure: Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3), secondaryOutcomes measure: Number of participants with improvement of neurological function, secondaryOutcomes measure: Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L), secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Proportion of intracranial hemorrhage of any type, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265038, orgStudyIdInfo id: SANAT-CAGE-2022, briefTitle: Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.* To evaluate if implantation causes significant increase quality of life of the patients.* To evaluate if using the device can be considered as safe overall., conditionsModule conditions: Degenerative Instability, conditions: Spondylolisthesis, conditions: Post-discectomy Syndrome, conditions: Post-traumatic Instability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: ReSpace TiCell Cage, outcomesModule primaryOutcomes measure: CT imaging_1 - cumulative fusion rate, primaryOutcomes measure: CT imaging_2 - fusion status, secondaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: Oswestry Disability Index (ODI), otherOutcomes measure: AE and ADE, otherOutcomes measure: Complications, otherOutcomes measure: Surgical revisions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Center for Spinal Disorders, status: RECRUITING, city: Budapest, state: Pest, zip: 1126, country: Hungary, contacts name: Aron Lazary, MD, PhD, role: CONTACT, phone: +36118877900, phoneExt: 5671, email: lazary.aron@gmail.com, geoPoint lat: 47.49801, lon: 19.03991, hasResults: False

protocolSection identificationModule nctId: NCT06265025, orgStudyIdInfo id: GM103-CT-101, briefTitle: GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2028-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: GeneMedicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:, conditionsModule conditions: Head and Neck Cancer, conditions: Malignant Melanoma, conditions: Colorectal Cancer, conditions: Renal Cell Carcinoma, conditions: Cervical Cancer, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Dose escalation and dose expansion, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: GM103 (Part A), interventions name: GM103 (Part B), interventions name: GM103 and Pembrolizumab (Part C), outcomesModule primaryOutcomes measure: Percentage of patients with DLTs by cohorts, primaryOutcomes measure: Percentage of patients with DLTs, primaryOutcomes measure: Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR defined as the proportion of patients whose BOR was CR, PR and SD, secondaryOutcomes measure: Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death, secondaryOutcomes measure: Incidence of GM103 detection, secondaryOutcomes measure: Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: NOT_YET_RECRUITING, city: Goyang-si, state: Gyeonggi-do, zip: 10408, country: Korea, Republic of, contacts name: WY Choi, role: CONTACT, geoPoint lat: 37.65639, lon: 126.835, locations facility: Korea University Anam Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, contacts name: SH Lee, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hanyang University Seoul Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 04763, country: Korea, Republic of, contacts name: MS Chung, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, Yonsei University Health System, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: JY Lee, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06265012, orgStudyIdInfo id: PHV01-C-101, briefTitle: Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects, acronym: PHV01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2024-09-16, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Public Health Vaccines LLC, class: INDUSTRY, collaborators name: Biomedical Advanced Research and Development Authority, descriptionModule briefSummary: This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:* Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?* What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days., conditionsModule conditions: Marburg Virus Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Single-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: PHV01, interventions name: Placebo, outcomesModule primaryOutcomes measure: Solicited Adverse Events (AEs), primaryOutcomes measure: Unsolicited AEs, primaryOutcomes measure: Other AEs, primaryOutcomes measure: Immunogenicity, Antibodies (Ab), primaryOutcomes measure: Immunogenicity, Neutralizing antibodies (NEUT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: CenExel RCA, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, contacts name: Terry Piedra, role: CONTACT, phone: 305-596-3125, email: t.piedra@cenexel.com, contacts name: Amanda Gonzalez, role: CONTACT, phone: 813-817-7984, email: amanda.gonzalez@cenexel.com, contacts name: Craig Shapiro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.0112, lon: -80.14949, hasResults: False

protocolSection identificationModule nctId: NCT06264999, orgStudyIdInfo id: 427976, briefTitle: Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Smith & Nephew, Inc., descriptionModule briefSummary: The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.The main questions it aims to answer are:Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform* Gait analysis* Stair performance test* CT based Micromotion analysis of the implant micromovement, conditionsModule conditions: Arthritis Knee, conditions: Arthroplasty, conditions: Gait Analysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Journey II CR, interventions name: Journey II XR, outcomesModule primaryOutcomes measure: Preferred walking speed (meter/minute) after surgery, primaryOutcomes measure: CT-RSA measured maximum total point of motion(MTPM), secondaryOutcomes measure: evaluation of max walking speed(m/minute), secondaryOutcomes measure: stride length(cm), secondaryOutcomes measure: step length in mid stance phase (cm), secondaryOutcomes measure: single leg support time(s), secondaryOutcomes measure: double-leg support time(s), secondaryOutcomes measure: stair performance(s), secondaryOutcomes measure: Rating pain using NRS (Numeric Rating Scale)., secondaryOutcomes measure: KOOS-PS (Knee Injury and Osteoarthritis Outcome score), secondaryOutcomes measure: Clinical evaluation of range of motion ., secondaryOutcomes measure: Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L),, secondaryOutcomes measure: IKSS (International Knee Society System knee and function score), secondaryOutcomes measure: FJS-12 (Forgotten Joint score), secondaryOutcomes measure: Clinical evaluation of Anteroposterior stability., secondaryOutcomes measure: Clinical evaluation of Mediolateral stability., otherOutcomes measure: A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º, otherOutcomes measure: Presence of eminence fractures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St.Olavs Hospital, city: Trondheim, state: Trøndelag, zip: 7006, country: Norway, contacts name: Anders Sjøstrøm, MD, role: CONTACT, phone: +4772575241, email: anders.sjostrom@stolav.no, contacts name: Siri Bjørgen Winther, PhD, role: SUB_INVESTIGATOR, contacts name: Sølvi Liabekk Selli, role: SUB_INVESTIGATOR, geoPoint lat: 63.43049, lon: 10.39506, hasResults: False

protocolSection identificationModule nctId: NCT06264986, orgStudyIdInfo id: 2023-09-02, briefTitle: The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-13, primaryCompletionDateStruct date: 2024-02-21, completionDateStruct date: 2024-02-21, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Blanca Roman-Viñas, MD, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery., conditionsModule conditions: Muscle Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, placebo-controlled, randomised trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Ashwagandha, interventions name: Placebo, outcomesModule primaryOutcomes measure: Increased lower body muscle strength, primaryOutcomes measure: Increased maximum voluntary muscle strength, primaryOutcomes measure: Increased upper body muscle strength and explosiveness, primaryOutcomes measure: Improved overall muscle strength, secondaryOutcomes measure: Improved perception of wellbeing, secondaryOutcomes measure: Improved perception of recovery, eligibilityModule sex: FEMALE, minimumAge: 17 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Club Esportiu Seagull, city: Badalona, state: Barcelona, zip: 08917, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False

protocolSection identificationModule nctId: NCT06264973, orgStudyIdInfo id: NL9318, briefTitle: Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy, acronym: MaDyCo, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy., conditionsModule conditions: Preterm Birth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum, secondaryOutcomes measure: Maternal age, secondaryOutcomes measure: Fetal sex, secondaryOutcomes measure: Maternal weight/BMI, secondaryOutcomes measure: Number of fetus, secondaryOutcomes measure: Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more, secondaryOutcomes measure: PE by urine measurement of protein-creatinine ratio, secondaryOutcomes measure: Oestradiol concentration in serum, secondaryOutcomes measure: Cord blood and neonatal blood, otherOutcomes measure: CYP3A4 level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, status: RECRUITING, city: Rotterdam, state: Zuid Holland, zip: 3015GD, country: Netherlands, contacts name: Sam Schoenmakers, MD, PhD, role: CONTACT, phone: +31107037439, email: s.schoenmakers@erasmusmc.nl, contacts name: Emma Ronde-Salminen, MD, role: CONTACT, phone: 0031683997312, email: e.ronde@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False

protocolSection identificationModule nctId: NCT06264960, orgStudyIdInfo id: E10208771, briefTitle: The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-15, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-10-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ulku Gunes, class: OTHER, descriptionModule briefSummary: Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines., conditionsModule conditions: Procedural Pain, conditions: Procedural Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This single-center, single-blind, randomized controlled trial was conducted in Izmir, Turkey, from July 2021 to July 2022. Participants were randomly assigned to one of three groups: intervention 1 (music), intervention 2 (breathing exercises), or control (standard care), in a 1:1:1 ratio., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The nurse responsible for conducting all measurements, including pain and anxiety assessments using the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI), was not part of the research team.The nurse, being independent and not aware of the participants' group assignments, helps to ensure that the assessments are conducted impartially, without knowledge of which intervention each participant received., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 512, type: ACTUAL, armsInterventionsModule interventions name: Music therapy, interventions name: Breathing exercise, outcomesModule primaryOutcomes measure: State-Trait Anxiety Inventory, primaryOutcomes measure: Visual Analog Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University, city: Bornova, state: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, locations facility: Ülkü Güneş, city: Bornova, state: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, hasResults: False

protocolSection identificationModule nctId: NCT06264947, orgStudyIdInfo id: CMUH112-REC2-141, briefTitle: Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again., conditionsModule conditions: Age-related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: laser acupuncture, interventions name: sham laser acupuncture, outcomesModule primaryOutcomes measure: BCVA (Best Corrected Visual Acuity), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Medical University Hospital, city: Taichung, zip: 404, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False

protocolSection identificationModule nctId: NCT06264934, orgStudyIdInfo id: DiCECT, briefTitle: An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner, acronym: DiCECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Zedsen Limited, class: INDUSTRY, collaborators name: Imperial College Healthcare NHS Trust, descriptionModule briefSummary: The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:1. Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner., conditionsModule conditions: Breast Cancer, conditions: Benign Breast Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Breast scan using the Z-scanner, interventions name: Breast scan using the Z-scanner, outcomesModule primaryOutcomes measure: Measurement of complex permittivity of breast tissue components, secondaryOutcomes measure: Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion), otherOutcomes measure: Repeatability of the Z-scanner, otherOutcomes measure: Reproducibility of the Z-scanner, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Lesley Honeyfield, role: CONTACT, contacts name: Adrian Lim, role: PRINCIPAL_INVESTIGATOR, contacts name: Deborah Cunningham, role: SUB_INVESTIGATOR, contacts name: Sylvie Flais, role: SUB_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06264921, orgStudyIdInfo id: NKT3447-101, briefTitle: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: NiKang Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D)., conditionsModule conditions: Solid Tumor, conditions: Solid Tumor, Adult, conditions: Advanced Solid Tumor, conditions: Metastatic Tumor, conditions: Ovarian Cancer, conditions: Ovarian Neoplasms, conditions: Ovarian Carcinoma, conditions: Metastatic Ovarian Carcinoma, conditions: Endometrial Cancer, conditions: Endometrial Neoplasms, conditions: Endometrial Diseases, conditions: Metastatic Endometrial Cancer, conditions: Metastatic Endometrial Carcinoma, conditions: Advanced Endometrial Carcinoma, conditions: Advanced Ovarian Carcinoma, conditions: Gastric Cancer, conditions: Advanced Gastric Carcinoma, conditions: Metastatic Gastric Cancer, conditions: Metastatic Gastric Carcinoma, conditions: Small-cell Lung Cancer, conditions: Small Cell Lung Carcinoma, conditions: Triple Negative Breast Cancer, conditions: Triple Negative Breast Neoplasms, conditions: Platinum-resistant Ovarian Cancer, conditions: Platinum-refractory Ovarian Carcinoma, conditions: CCNE1 Amplification, conditions: Hormone Receptor Negative Breast Carcinoma, conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, conditions: Progesterone-receptor-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Dose Escalation and Dose Expansion, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomized for the Expansion Phase, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: NKT3447, outcomesModule primaryOutcomes measure: Number of Participants with Dose Limiting Toxicity (DLT) events, primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Number of Participants with Adverse Events, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) of NKT3447, secondaryOutcomes measure: Time to maximum observed plasma concentration of NKT3447 (Tmax), secondaryOutcomes measure: Observed trough concentration of NKT3447 (Ctrough), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC0-t) of NKT3447, secondaryOutcomes measure: Apparent clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (V/F), secondaryOutcomes measure: Half-life (t1/2), secondaryOutcomes measure: Accumulation ratio (AR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sarah Cannon Research Institute at HealthONE, status: RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: Kelly Mozzetta, role: CONTACT, contacts name: Gerald Falchook, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: AdventHealth Cancer Institute, status: RECRUITING, city: Celebration, state: Florida, zip: 34747, country: United States, contacts name: Heather Osorio, role: CONTACT, email: Heather.Osorio@AdventHealth.com, contacts name: Karolina Kilowski, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.32529, lon: -81.53313, locations facility: The Gabrail Pharmacology Phase 1 Research Center, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, contacts name: Carrie Smith, role: CONTACT, email: csmith@gabrailcancercenter.com, contacts name: Nashat Y Gabrail, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Texas Oncology-Austin Midtown NEXT Oncology, status: RECRUITING, city: Austin, state: Texas, zip: 78758, country: United States, contacts name: Erica Torres, role: CONTACT, phone: 210-610-5205, email: etorres@nextoncology.com, contacts name: Andrae Vandross, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.26715, lon: -97.74306, locations facility: START Mountain Region, status: RECRUITING, city: West Valley City, state: Utah, zip: 84119, country: United States, contacts name: Marie Asay, role: CONTACT, phone: 801-907-4770, email: marie.asay@startthecure.com, contacts name: Justin A Call, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.69161, lon: -112.00105, hasResults: False

protocolSection identificationModule nctId: NCT06264908, orgStudyIdInfo id: 20240125-010-000, briefTitle: An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis, acronym: OASIS-H, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Dr Iris Tang Yan Ki, class: OTHER, collaborators name: Hospital Authority, Hong Kong, descriptionModule briefSummary: The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups., conditionsModule conditions: Hand Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients will be randomized into early intervention and routine clinical care (control) group. Patients in control group will crossover to receive the intervention at week 26., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Integrated self-management programme, outcomesModule primaryOutcomes measure: Change in Pain visual analogue scale (VAS), secondaryOutcomes measure: Change in pain Visual Analogue Scale (VAS), secondaryOutcomes measure: Change in Functional index hand osteoarthritis (FIHOA), secondaryOutcomes measure: Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score, secondaryOutcomes measure: Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1, secondaryOutcomes measure: Change in Short-form 36 items health survey, secondaryOutcomes measure: Change in hand grip strength, secondaryOutcomes measure: Change in hand dexterity measurement, secondaryOutcomes measure: Radiographic changes, otherOutcomes measure: Adverse events, otherOutcomes measure: Use of rescue pain medication, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264895, orgStudyIdInfo id: Trinity College Dublin 211202, briefTitle: Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction., acronym: LEAP-W, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, descriptionModule briefSummary: Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population., conditionsModule conditions: Social Exclusion, conditions: Chronic Disease, conditions: Physical Disability, conditions: Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single -arm longitudinal cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Hand grip dynamometry, secondaryOutcomes measure: Limb circumference, secondaryOutcomes measure: 10 Metre Walk Test, secondaryOutcomes measure: 2 Minute Walk Test, secondaryOutcomes measure: The Chair Stand Test, secondaryOutcomes measure: Single Leg Stance Test, secondaryOutcomes measure: Numerical Rating Scale (NRS), secondaryOutcomes measure: Clinical Frailty Scale (CFS), secondaryOutcomes measure: SHARE-Frailty Instrument (FI), secondaryOutcomes measure: Mini Nutritional Assessment (MNA), secondaryOutcomes measure: Short Form-12 V2, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264882, orgStudyIdInfo id: 23-1518, secondaryIdInfos id: U54AG062319, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG062319, briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function, acronym: LILAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-05-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen., conditionsModule conditions: Menopause, conditions: Estrogen Deficiency, conditions: Aging, conditions: Adiposity, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Degarelix, interventions name: Transdermal Estradiol Patch, interventions name: Transdermal Placebo Patch, outcomesModule primaryOutcomes measure: Brachial artery flow mediated dilation (FMD), secondaryOutcomes measure: Visceral fat area (VFA), otherOutcomes measure: Subcutaneous fat area, otherOutcomes measure: Tryptophan-Kynurenine metabolites, otherOutcomes measure: Body composition - mass, otherOutcomes measure: Body composition - bone, otherOutcomes measure: Oxidized LDL, otherOutcomes measure: Total antioxidant status, otherOutcomes measure: Pro-inflammatory cytokines, otherOutcomes measure: Blood lipids and lipoproteins, otherOutcomes measure: Blood glucose, otherOutcomes measure: Insulin, otherOutcomes measure: Adipokines, otherOutcomes measure: Physical activity levels, otherOutcomes measure: Endothelial cell protein measures, otherOutcomes measure: Ex vivo serum exposure studies, otherOutcomes measure: Cerebrovascular function, otherOutcomes measure: Arterial Stiffness, otherOutcomes measure: Carotid artery stiffness, otherOutcomes measure: Blood pressure, otherOutcomes measure: Self reported sleep quality, otherOutcomes measure: Cognitive function, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06264869, orgStudyIdInfo id: 141123, briefTitle: Interdental Guided Creeping Technique, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft., conditionsModule conditions: Interdental Papilla Recession, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG), interventions name: Interdental guided creeping technique (IGCT) and collagen membrane (CM), outcomesModule primaryOutcomes measure: Black triangle height, secondaryOutcomes measure: Percentage of interdental papillary fill, secondaryOutcomes measure: Papillary gain, black triangle reduction, secondaryOutcomes measure: Papillary height, attached gingiva width, secondaryOutcomes measure: Pocket depth, clinical attachment level, keratinized tissue thickness, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Gingival index, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Patient Reported Outcome, secondaryOutcomes measure: Patient Reported Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264856, orgStudyIdInfo id: 202210096RIND, briefTitle: Bronchoscopy for Thoracic Trauma Patients, statusModule overallStatus: SUSPENDED, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes., conditionsModule conditions: Chest Trauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: bronchoscopic sputum suction, interventions name: negative pressure aspiration suction, outcomesModule primaryOutcomes measure: Rate of pneumonia, secondaryOutcomes measure: Intensive Care Unit admission interval, secondaryOutcomes measure: admission interval, secondaryOutcomes measure: tracheostomy rate, secondaryOutcomes measure: intubation rate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Traumatology, National Taiwain University Hospital, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch, city: Taipei, zip: 100; 300; 640; 280, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06264843, orgStudyIdInfo id: 724, briefTitle: Peripheral Bypass Trial for Completion Control, acronym: PATENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Medistim ASA, class: INDUSTRY, descriptionModule briefSummary: The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle, conditionsModule conditions: Chronic Limb-Threatening Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Medistim MiraQ system with TTFM and L15 HFUS probes, outcomesModule primaryOutcomes measure: Primary graft patency rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264830, orgStudyIdInfo id: 202307103DIPC, briefTitle: 3D Visualization System in Highly Myopic Cataract Operation, acronym: 3D-HiMCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes., conditionsModule conditions: Cataract, conditions: High Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Alcon-NGENUITY®(NG)-system, interventions name: Standard cataract operation, outcomesModule primaryOutcomes measure: Number of times of Microscopic focus adjustment, measured by counting from the video recordings, primaryOutcomes measure: Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope, primaryOutcomes measure: Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope, secondaryOutcomes measure: Total operation time, secondaryOutcomes measure: Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion), secondaryOutcomes measure: Number of Participants with intraoperative complication, secondaryOutcomes measure: Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment), secondaryOutcomes measure: Number of Participants with post-operative complication, secondaryOutcomes measure: Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology, National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, contacts name: Tzyy-Chang Ho, MD, role: CONTACT, phone: 886-2-23123456, phoneExt: 62579, email: hotc@ntuh.gov.tw, contacts name: Cheng-Yung Lee, MD, role: CONTACT, phone: 886-2-23123456, phoneExt: 65190, email: G05875@hch.gov.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06264817, orgStudyIdInfo id: EC 48 LyberT, briefTitle: Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema., acronym: LyberT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Thuasne, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema, conditionsModule conditions: Lymphedema of Upper Limb, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, multi-center, interventional, controlled-randomized, single blinded study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MOBIDERM Autofit Armsleeve, interventions name: Compressive bandaging, outcomesModule primaryOutcomes measure: Volume excess variation, secondaryOutcomes measure: Resource consumption, secondaryOutcomes measure: Resource consumption, secondaryOutcomes measure: Resource consumption, secondaryOutcomes measure: Lymphedema related Quality of life (QoL), secondaryOutcomes measure: Doctors' opinion on improving the patient's health condition, secondaryOutcomes measure: Patient's opinion on Global Impression of Change, secondaryOutcomes measure: Satisfaction about the device, secondaryOutcomes measure: The safety, secondaryOutcomes measure: Compliance to treatment, secondaryOutcomes measure: General quality of life (QoL), secondaryOutcomes measure: Skin elasticity, secondaryOutcomes measure: Ttissue induration, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pinar BORMAN, city: Ankara, country: Turkey, contacts name: Pinar BORMAN, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06264804, orgStudyIdInfo id: [2023] No. 86, briefTitle: Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Yifeng Yu, class: OTHER, descriptionModule briefSummary: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss., conditionsModule conditions: Refractive Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identify risk factors for progressive suction loss, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yuyifeng, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330008, country: China, contacts name: yifeng Yu, Doctorate, role: CONTACT, phone: +8613979180258, email: 171018170@qq.com, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False

protocolSection identificationModule nctId: NCT06264791, orgStudyIdInfo id: STUDY00018516, secondaryIdInfos id: K99AA030591, type: NIH, link: https://reporter.nih.gov/quickSearch/K99AA030591, briefTitle: Stress-motivated Alcohol Use as a Value-based Decision-making Process, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:* Does psychological stress affect the decision to consume (more) alcohol?* How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations)., conditionsModule conditions: Psychological Stress, conditions: Alcohol Intoxication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Stress, interventions name: Alcohol, outcomesModule primaryOutcomes measure: Proportion of choices for alcoholic over non-alcoholic drinks., eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Jonas Dora, PhD, role: CONTACT, phone: 206-741-6330, email: jdora@uw.edu, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06264778, orgStudyIdInfo id: 2023013, briefTitle: Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Shandong University, class: OTHER, descriptionModule briefSummary: This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients., conditionsModule conditions: Ameloblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dabrafenib, outcomesModule primaryOutcomes measure: objective response rate, secondaryOutcomes measure: Relapse-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264765, orgStudyIdInfo id: 22-12-23, briefTitle: Scalp Block -Craniotomi, acronym: scalp block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended., conditionsModule conditions: Hemodynamic Instability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized double blinding, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Blind patients and postoperative follow-ups will not know which group the patient is in the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: scalp block, interventions name: Incisional infiltration, outcomesModule primaryOutcomes measure: opioid consumption, secondaryOutcomes measure: The Numeric Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ferdi Gülaştı, status: RECRUITING, city: Aydın, zip: 09020, country: Turkey, contacts name: Ferdi Gülaştı, role: CONTACT, email: ferdigulasti@gmail.com, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False

protocolSection identificationModule nctId: NCT06264752, orgStudyIdInfo id: STUDY20120008, secondaryIdInfos id: R01DK121730, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK121730, briefTitle: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury, acronym: MEnD-AKI, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: University of Florida, collaborators name: University of Pittsburgh Medical Center, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults., conditionsModule conditions: Acute Kidney Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 39 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Statisticians performing the analysis will be blinded to the treatment allocation.The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 625, type: ESTIMATED, armsInterventionsModule interventions name: Level A, interventions name: Level B, interventions name: Passive Alert, outcomesModule primaryOutcomes measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30), secondaryOutcomes measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge, secondaryOutcomes measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3, secondaryOutcomes measure: Nephrotoxic burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Altoona, city: Altoona, state: Pennsylvania, zip: 16601, country: United States, geoPoint lat: 40.51868, lon: -78.39474, locations facility: UPMC Horizon, city: Farrell, state: Pennsylvania, zip: 16121, country: United States, geoPoint lat: 41.21228, lon: -80.49674, locations facility: UPMC McKeesport, city: McKeesport, state: Pennsylvania, zip: 15132, country: United States, geoPoint lat: 40.34785, lon: -79.86422, locations facility: UPMC Jameson, city: New Castle, state: Pennsylvania, zip: 16105, country: United States, geoPoint lat: 41.00367, lon: -80.34701, locations facility: UPMC Magee, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Presbyterian/Montefiore, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Shadyside, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Williamsport, city: Williamsport, state: Pennsylvania, zip: 17701, country: United States, geoPoint lat: 41.24119, lon: -77.00108, hasResults: False

protocolSection identificationModule nctId: NCT06264739, orgStudyIdInfo id: 22-12-23/2, briefTitle: Erector Spinae Block -Dexmedetomidine, acronym: esp -dex, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain., conditionsModule conditions: Postoperative Acute Pain, conditions: Opioid Consumption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized double blinding, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Blindness patients and those who follow up after surgery will not know which group is in the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: esp Dexmedetomidine (dekstomid), interventions name: esp remifentanyl (ultiva), outcomesModule primaryOutcomes measure: opioid consumption, secondaryOutcomes measure: The Numeric Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ferdi Gülaştı, status: RECRUITING, city: Aydın, zip: 09020, country: Turkey, contacts name: Ferdi Gülaştı, role: CONTACT, email: ferdigulasti@gmail.com, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False

protocolSection identificationModule nctId: NCT06264726, orgStudyIdInfo id: 23-0254, secondaryIdInfos id: R01HL150909, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL150909, briefTitle: CommunityRx-Cardiovascular Disease, acronym: CRx-CVD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-03-12, completionDateStruct date: 2025-03-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:• What is the effectiveness of community resource information on patient self-efficacy to use community resources?Participants will be given:* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.* Access to a community resource navigator for support with using the HealtheRx upon request* 2 text messages with reminders about the HealtheRx and access to the community resource navigator, conditionsModule conditions: Cardiovascular Diseases, conditions: Self Efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 325, type: ESTIMATED, armsInterventionsModule interventions name: HealtheRx, outcomesModule primaryOutcomes measure: Change in participant self-efficacy for finding community resources, secondaryOutcomes measure: Change in participant knowledge of community resources, secondaryOutcomes measure: Change in participant utilization of community resources, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OIC Family Medical Center - Fairview, status: RECRUITING, city: Rocky Mount, state: North Carolina, zip: 27801, country: United States, contacts name: Jesslyn Pope, role: CONTACT, email: jpope@oicone.org, geoPoint lat: 35.93821, lon: -77.79053, locations facility: OIC Family Medical Center - Happy Hill, status: RECRUITING, city: Rocky Mount, state: North Carolina, zip: 27804, country: United States, contacts name: Jesslyn Pope, role: CONTACT, email: jpope@oicone.org, geoPoint lat: 35.93821, lon: -77.79053, hasResults: False

protocolSection identificationModule nctId: NCT06264713, orgStudyIdInfo id: CE/2023_041, briefTitle: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback, acronym: IRENE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S. Fondazione Santa Lucia, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests., conditionsModule conditions: Neglect, Hemispatial, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Immersive Virtual Reality, interventions name: Sham Immersive Virtual Reality, outcomesModule primaryOutcomes measure: Changes in the Behavioural Inattention Test, secondaryOutcomes measure: Changes in the Copying drawings with or without programming elements, secondaryOutcomes measure: Changes in the Barrage Test, secondaryOutcomes measure: Changes in the Wundt Justrow area illusion test, secondaryOutcomes measure: Changes in the Kessler Foundation Neglect Assessment Process, secondaryOutcomes measure: Changes in the Stroke Specific Quality of Life Scale, secondaryOutcomes measure: Changes in the Fugl-Meyer Assessment scale, secondaryOutcomes measure: Changes in reaction time e time of fixation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Santa Lucia Foundation, status: RECRUITING, city: Rome, state: Lazio, zip: 00142, country: Italy, contacts name: Valeria Verna, MSc, role: CONTACT, phone: 0651501907, contacts name: Valeria Verna, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Marco Tramontano, PhD, role: SUB_INVESTIGATOR, contacts name: Alex Martino Cinnera, PhD, role: SUB_INVESTIGATOR, contacts name: Viviana Betti, PhD, role: SUB_INVESTIGATOR, contacts name: Matteo Marucci, PhD, role: SUB_INVESTIGATOR, contacts name: Luisa Magnotti, BSc, role: SUB_INVESTIGATOR, contacts name: Alessandro Matano, MSc, role: SUB_INVESTIGATOR, contacts name: Aurora Tavernese, MSc, role: SUB_INVESTIGATOR, contacts name: Paolucci Stefano, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06264700, orgStudyIdInfo id: STUDY00003303, secondaryIdInfos id: R44HL169085, type: NIH, link: https://reporter.nih.gov/quickSearch/R44HL169085, briefTitle: Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness, acronym: ADHERE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, collaborators name: Ann & Robert H Lurie Children's Hospital of Chicago, collaborators name: Hasbro Children's Hospital, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: After completing a one to three-month run-in period, participants will be randomized to receive six months of either VDOT or attention control. All participants will then complete six months of ongoing monitoring during which VDOT patients will receive intermittent communication to encourage adherence and both groups will continue to use their electronic adherence monitors., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The investigators will be blinded to prevent the possibility of any differential treatment that could affect the ability of the study team to evaluate the impact of VDOT on hydroxyurea adherence. As such, a statistician will create a randomization model and study staff will facilitate communication with participants as well as between participants and the VDOT team., whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Video Directly Observed Therapy (VDOT), interventions name: Health Reminder Tip Alerts, outcomesModule primaryOutcomes measure: Retention Rate, primaryOutcomes measure: Sustained Engagement, primaryOutcomes measure: Electronic Adherence, secondaryOutcomes measure: Pediatric SCD Medication Self-Management Questionnaire, secondaryOutcomes measure: Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations, secondaryOutcomes measure: Laboratory Studies (i.e. MCV, HbF), secondaryOutcomes measure: Treatment Satisfaction, secondaryOutcomes measure: Participant Satisfaction, eligibilityModule sex: ALL, minimumAge: 11 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lurie Children's Hospital, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Sherif Badawy, MD, role: CONTACT, phone: 312-227-4836, email: sbadawy@luriechildrens.org, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Hasbro Children's Hospital, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Patrick McGann, MD, PhD, role: CONTACT, phone: 617-519-9555, email: patrick_mcgann@brown.edu, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False

protocolSection identificationModule nctId: NCT06264687, orgStudyIdInfo id: HepcidinIVIron, briefTitle: Hepcidin After Intravenous Iron Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Pierre-Alexandre Krayenbühl, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration., conditionsModule conditions: Iron Deficiency (Without Anemia), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, outcomesModule primaryOutcomes measure: Serum Hepcidin Change, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06264674, orgStudyIdInfo id: CLI-05993AB6-03, secondaryIdInfos id: 2023-503333-22-00, type: OTHER, domain: EMA CTIS, briefTitle: Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos), acronym: TRECOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2025-09-18, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Chiesi Farmaceutici S.p.A., class: INDUSTRY, descriptionModule briefSummary: The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 790, type: ESTIMATED, armsInterventionsModule interventions name: CHF5993 200/6/12.5 μg pMDI HFA-152a, interventions name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a, outcomesModule primaryOutcomes measure: Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1), secondaryOutcomes measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period, secondaryOutcomes measure: Percentage of days without intake of rescue medication., secondaryOutcomes measure: Change in the average daily use of rescue medication., secondaryOutcomes measure: Change on the average daily asthma symptoms., secondaryOutcomes measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs)., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital, status: RECRUITING, city: Manchester, zip: M23 9QZ, country: United Kingdom, contacts name: Dave Singh, MD, role: CONTACT, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False

protocolSection identificationModule nctId: NCT06264661, orgStudyIdInfo id: HJM 006/22-R, briefTitle: Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-08, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2022-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás, class: OTHER, descriptionModule briefSummary: Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia, outcomesModule primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Glycosylated hemoglobin, primaryOutcomes measure: Quality of life, primaryOutcomes measure: Insomnia, secondaryOutcomes measure: Gene expression analysis of CLOCK, secondaryOutcomes measure: Gene expression analysis of BMAL1, secondaryOutcomes measure: Gene expression analysis of PER1, secondaryOutcomes measure: Gene expression analysis of PER2, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás, city: Cdmx, state: México, zip: 11360, country: Mexico, hasResults: False

protocolSection identificationModule nctId: NCT06264648, orgStudyIdInfo id: AIBU-FTR-OOP-04, briefTitle: Investigation of Palpation Pressure Sensitivity, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2023-06-16, completionDateStruct date: 2023-10-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again., conditionsModule conditions: Sensitivity Training Groups, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 groups of physiotherapists with different fields of experience were attended to study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ACTUAL, armsInterventionsModule interventions name: Pressure sensitivity education, outcomesModule primaryOutcomes measure: Measurement Palpation Pressure with Digital Scale, primaryOutcomes measure: Measurement Palpation Pressure with Digital Scale, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University, city: Bolu, zip: 14300, country: Turkey, geoPoint lat: 40.73583, lon: 31.60611, hasResults: False

protocolSection identificationModule nctId: NCT06264635, orgStudyIdInfo id: HS26227, briefTitle: Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Platelet-Rich-Plasma, interventions name: Saline, outcomesModule primaryOutcomes measure: International Index of Erectile Function (IIEF), secondaryOutcomes measure: Adverse Events, eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Men's Health Clinic, city: Winnipeg, state: Manitoba, zip: R3K 1M3, country: Canada, contacts name: Premal Patel, MD, role: CONTACT, phone: 2042214476, email: ppatel5@hsc.mb.ca, contacts name: Jainik Shah, BFSc, role: CONTACT, phone: 6477721737, email: shahj4@myumanitoba.ca, geoPoint lat: 49.8844, lon: -97.14704, hasResults: False

protocolSection identificationModule nctId: NCT06264622, orgStudyIdInfo id: CEIC-2996, briefTitle: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension, acronym: GARDOSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Universitat de Lleida, class: OTHER, collaborators name: Pharmactive Biotech Products S.L.U, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner* If the changes in lipid profile are in a dose-response mannerParticipants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks, conditionsModule conditions: Hypertension, 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: 180, type: ESTIMATED, armsInterventionsModule interventions name: Low dose, interventions name: High dose, interventions name: Placebo, outcomesModule primaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Blood Lipid Profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Lleida, status: RECRUITING, city: Lleida, zip: 25198, country: Spain, contacts name: Jose Serrano, PhD, role: CONTACT, phone: 973702408, email: josecarlos.serrano@udl.cat, contacts name: Manuel Portero, PhD, role: CONTACT, phone: 973702408, email: manuel.portero@udl.cat, geoPoint lat: 41.61674, lon: 0.62218, hasResults: False

protocolSection identificationModule nctId: NCT06264609, orgStudyIdInfo id: 91026, briefTitle: Precision Medicine Approach for Osteoporosis - Follow Up Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hartmut Malluche, MD, class: OTHER, descriptionModule briefSummary: Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Alendronate, interventions name: Teriparatide, interventions name: Alendronate, outcomesModule primaryOutcomes measure: Percent change in bone loss, secondaryOutcomes measure: Percent change in Bone Mass Density at the hip, otherOutcomes measure: Trabecular bone score (TBS), eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40536, country: United States, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False

protocolSection identificationModule nctId: NCT06264596, orgStudyIdInfo id: 2310-72, briefTitle: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: The Guthrie Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery., conditionsModule conditions: Intraoperative Bleeding, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Concealed irrigation bags, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Epinephrine, interventions name: Normal Saline irrigation fluid, outcomesModule primaryOutcomes measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale, primaryOutcomes measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Robert Packer Hospital, city: Sayre, state: Pennsylvania, zip: 18840, country: United States, contacts name: Wonyong Lee, MD, role: CONTACT, phone: 570-887-4882, email: Wonyong.Lee@guthrie.org, contacts name: Wonyong Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.97896, lon: -76.5155, hasResults: False

protocolSection identificationModule nctId: NCT06264583, orgStudyIdInfo id: IN-DE-980-6998, briefTitle: HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bonn, class: OTHER, collaborators name: Swiss HIV Cohort Study, collaborators name: ICONA Cohort, collaborators name: Amsterdam UMC, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: King's College London, collaborators name: University Hospital of Cologne, collaborators name: Goethe University, collaborators name: Heinrich-Heine University, Duesseldorf, collaborators name: University Hospital, Essen, collaborators name: ICH Hamburg, collaborators name: Praxiszentrum Hohenstaufenring Köln, collaborators name: Sorbonne University, collaborators name: Henri Mondor University Hospital, collaborators name: Hospital Universitario Infanta Leonor, collaborators name: Hospital General Universitario Gregorio Marañon, collaborators name: GEPCOI (Portuguese Group of Coinfection), descriptionModule briefSummary: The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing. 1. Evaluation of former screening of HDV by assessing existing data at study sites. 2. Determination of the HDV prevalence in European PLWH and HBV coinfection.2. Setting up a database of all PLWH with HBV/HDV coinfection 1. Analysis of transmission risk factors for HDV coinfection 2. Asses the rate of HDV positive patients with ongoing HDV replication. 3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results., conditionsModule conditions: Hepatitis D, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: HDV screening, outcomesModule primaryOutcomes measure: HDV prevalence in HIV/HBV coinfection, secondaryOutcomes measure: Degree of liver disease in pateints with HIV/HBV/HDV triple infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bonn, city: Bonn, state: NRW, zip: 53127, country: Germany, contacts name: Jürgen Rockstroh, role: CONTACT, phone: +491716575969, email: juergen.rockstroh@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-31, uploadDate: 2024-02-09T03:56, filename: Prot_000.pdf, size: 798649, hasResults: False

protocolSection identificationModule nctId: NCT06264570, orgStudyIdInfo id: SW007, briefTitle: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels., acronym: PERBIO-HC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results., conditionsModule conditions: Hyperhomocysteinemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: B-TMG supplementation, interventions name: B-SAM supplementation, interventions name: B-TMG placebo, interventions name: B-SAM placebo, outcomesModule primaryOutcomes measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l., secondaryOutcomes measure: change in the level of very low density lipoproteins, secondaryOutcomes measure: change of anxiety when using dietary supplements accessed by the Spielberg scale, secondaryOutcomes measure: change of depression when using dietary supplements by the Becks scale, secondaryOutcomes measure: occurrence of major cardiovascular events during follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, status: RECRUITING, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, contacts name: Andrei AV Ponomarenko, MD, role: CONTACT, phone: +79628316017, email: dayshadoff@gmail.com, contacts name: Elena EI Krykova, role: CONTACT, phone: +79133825952, email: krukova_ei@cnmt.ru, contacts name: Eugene EA Pokushalov, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrei AV Ponomarenko, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False

protocolSection identificationModule nctId: NCT06264557, orgStudyIdInfo id: RW-MCI-01, secondaryIdInfos id: ROWAN, type: OTHER, domain: ROWAN, briefTitle: Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment, acronym: SB-DEX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Rowan, class: INDUSTRY, descriptionModule briefSummary: Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment, conditionsModule conditions: Mild Cognitive Impairment, conditions: MCI, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: SB-100, interventions name: Educational book, outcomesModule primaryOutcomes measure: K-RBANS, secondaryOutcomes measure: K-RBANS, secondaryOutcomes measure: K-MMSE-2, secondaryOutcomes measure: CDR-SB, secondaryOutcomes measure: K-IADL, secondaryOutcomes measure: PRMQ, secondaryOutcomes measure: GDS-15, secondaryOutcomes measure: QOL-AD, secondaryOutcomes measure: ADAS-Cog14, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hanyang University Guri Hospital, status: RECRUITING, city: Guri-si, state: Gyeonggi-do, zip: 11923, country: Korea, Republic of, contacts name: Hojin Choi, PI, role: CONTACT, geoPoint lat: 37.5986, lon: 127.1394, locations facility: Inje University Haeundae Paik Hospital, status: RECRUITING, city: Busan, country: Korea, Republic of, contacts name: Jinse Park, PI, role: CONTACT, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Inha University Hospital, status: RECRUITING, city: Incheon, zip: 22332, country: Korea, Republic of, contacts name: Hyewon Yoon, PI, role: CONTACT, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Gachon University Gil Medical Center, status: RECRUITING, city: Incheon, country: Korea, Republic of, contacts name: Kee Hyung Park, PI, role: CONTACT, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Chonnam National University Hospital, status: RECRUITING, city: Kwangju, country: Korea, Republic of, contacts name: Soo Hyun Cho, PI, role: CONTACT, geoPoint lat: 36.9122, lon: 127.1279, locations facility: Ewha Womans University Seoul Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ji Young Yun, PI, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hanyang University Seoul Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Jin Seok Park, PI, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Koera University Guro Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Chi Kyung Kim, PI, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Anam Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Chan Nyoung Leee, PI, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: The Catholic University of Korea, Seoul St. Mary's Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Dong Woo Kang, PI, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ajou University Hospital, status: RECRUITING, city: Suwon, country: Korea, Republic of, contacts name: Sun Min Lee, PI, role: CONTACT, geoPoint lat: 37.29111, lon: 127.00889, locations facility: The Catholic University of Korea, St. Vincent's Hospital, status: RECRUITING, city: Suwon, country: Korea, Republic of, contacts name: Yoo Hyun Um, PI, role: CONTACT, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False

protocolSection identificationModule nctId: NCT06264544, orgStudyIdInfo id: SW006, briefTitle: Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism, acronym: ZEST-PREP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach., conditionsModule conditions: Thyrotoxicosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: zinc, selenium, and L-tyrosine in SEPP1, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False

protocolSection identificationModule nctId: NCT06264531, orgStudyIdInfo id: JDS_2023_12, briefTitle: Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations, acronym: BevacizuMAV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Fondation Ophtalmologique Adolphe de Rothschild, class: NETWORK, descriptionModule briefSummary: Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs., conditionsModule conditions: Cerebral AV Malformation, 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: 54, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06264518, orgStudyIdInfo id: 56168915, briefTitle: An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Clinical study participation has historically been heavily biased toward specific demographics.Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of patients who decide to enroll in a traumatic brain injury clinical trial, primaryOutcomes measure: Rate of patients who remain in traumatic brain injury clinical trial to trial completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T11:16, filename: ICF_000.pdf, size: 79118, hasResults: False

protocolSection identificationModule nctId: NCT06264505, orgStudyIdInfo id: 55955210, briefTitle: Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion., conditionsModule conditions: Soft Tissue Sarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients in soft tissue sarcoma clinical research, primaryOutcomes measure: Number of soft tissue sarcoma study participants who maintain involvement until study finish, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T10:34, filename: ICF_000.pdf, size: 80606, hasResults: False

protocolSection identificationModule nctId: NCT06264492, orgStudyIdInfo id: 55777205, briefTitle: Delving Into Participation Trends of Scleroderma Clinical Trials, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma., conditionsModule conditions: Scleroderma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients in clinical research for scleroderma, primaryOutcomes measure: Number of scleroderma study participants who stay committed until clinical study wraps up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T10:51, filename: ICF_000.pdf, size: 71611, hasResults: False

protocolSection identificationModule nctId: NCT06264479, orgStudyIdInfo id: PEAR-TREE2, briefTitle: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2, acronym: PEAR-TREE2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ourotech, Inc., class: INDUSTRY, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: Cambridge University Hospitals NHS Trust, collaborators name: East & North Herts NHS Trust, collaborators name: Imperial College Healthcare NHS Trust, descriptionModule briefSummary: Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival)., conditionsModule conditions: Kidney Cancer, conditions: Renal Cell Cancer Metastatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, outcomesModule primaryOutcomes measure: Objective Response Rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Complete Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Deep Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Durable Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: PFS prediction accuracy, otherOutcomes measure: Culture success rate, otherOutcomes measure: Hazard ratio by biomarker group, otherOutcomes measure: OS prediction accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Addenbrooke's Hospital, city: Cambridge, state: Cambridgeshire, zip: CB2 0QQ, country: United Kingdom, contacts name: Kate Fife, role: CONTACT, geoPoint lat: 52.2, lon: 0.11667, locations facility: Mount Vernon Cancer Centre, city: London, zip: HA6 2RN, country: United Kingdom, contacts name: Anand Sharma, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, zip: W6 8RF, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Free NHS Foundation Trust, city: London, country: United Kingdom, contacts name: Ekaterini Boleti, MD PhD MRCP, role: CONTACT, phone: 020 7830 2396, phoneExt: 34476, geoPoint lat: 51.50853, lon: -0.12574, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-28, uploadDate: 2023-07-28T07:18, filename: Prot_SAP_000.pdf, size: 424039, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-28, uploadDate: 2023-07-28T07:19, filename: ICF_001.pdf, size: 197013, hasResults: False

protocolSection identificationModule nctId: NCT06264466, orgStudyIdInfo id: IECED-010112023, briefTitle: Safety and Efficacy of a Novel Flexible Bipolar in POEM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Instituto Ecuatoriano de Enfermedades Digestivas, class: OTHER, descriptionModule briefSummary: Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively., conditionsModule conditions: Esophageal Achalasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: interventional trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: POEM with Speedboat Ultraslim, outcomesModule primaryOutcomes measure: Technical success of procedure, primaryOutcomes measure: Clinical success of procedure, primaryOutcomes measure: Frequency of adverse events attributable to the procedure, secondaryOutcomes measure: Rate of Gastroesophageal reflux disease, secondaryOutcomes measure: Assessment of Gastroesophageal reflux disease severity, secondaryOutcomes measure: Change in health-related quality of life after POEM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), status: RECRUITING, city: Guayaquil, state: Guayas, zip: 090505, country: Ecuador, contacts name: Carlos Robles-Medranda, MD FASGE, role: CONTACT, phone: +593989158865, email: carlosoakm@yahoo.es, contacts role: CONTACT, email: carlosoakm@yahoo.es, contacts name: Carlos Robles-Medranda, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Michel Kahaleh, MD, role: SUB_INVESTIGATOR, contacts name: Eduardo Albeniz, MD, role: SUB_INVESTIGATOR, contacts name: Juan Alcivar-Vasquez, MD, role: SUB_INVESTIGATOR, contacts name: Maria Egas-Izquierdo, MD, role: SUB_INVESTIGATOR, contacts name: Jorge Baquerizo-Burgos, MD, role: SUB_INVESTIGATOR, contacts name: Domenica Cunto, MD, role: SUB_INVESTIGATOR, contacts name: Miguel Puga-Tejada, MD, role: SUB_INVESTIGATOR, contacts name: Martha Arevalo-Mora, MD, role: SUB_INVESTIGATOR, contacts name: Raquel Del Valle, MD, role: SUB_INVESTIGATOR, contacts name: Hannah Pitanga-Lukashok, MD, role: SUB_INVESTIGATOR, geoPoint lat: -2.20584, lon: -79.90795, hasResults: False

protocolSection identificationModule nctId: NCT06264453, orgStudyIdInfo id: KH-001-D201, briefTitle: A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-08-23, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: HysensBio Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity., conditionsModule conditions: Dentin Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 171, type: ESTIMATED, armsInterventionsModule interventions name: KH001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Schiff sensitivity score, secondaryOutcomes measure: Change from baseline in a Schiff sensitivity score, secondaryOutcomes measure: Change from baseline in a Tactile threshold, secondaryOutcomes measure: Change from baseline in Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264440, orgStudyIdInfo id: 283HV104, briefTitle: A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Biogen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: BIIB122, interventions name: Rabeprazole, outcomesModule primaryOutcomes measure: Maximum Observed Concentration (Cmax) of BIIB122, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PPD Development, LP, city: Austin, state: Texas, zip: 78744, country: United States, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False

protocolSection identificationModule nctId: NCT06264427, orgStudyIdInfo id: KVUG - 2022 - 10, briefTitle: Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Steno Diabetes Center Greenland, class: OTHER, collaborators name: Zealand University Hospital, collaborators name: University of Copenhagen, descriptionModule briefSummary: The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.The main questions it aims to answer are:* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?* What is the prevalence of sleep apnea among high-risk individuals in Greenland?* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?Participants will:* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation* Blood samples for full genome sequencing, conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Obesity, Morbid, conditions: Obstructive Sleep Apnea, conditions: MODY, conditions: Diabetic Retinopathy, conditions: Diabetic Neuropathies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will be examined with whole genom sequencing, and diabetes treatment will be accommodated their diabetic fenotype.'For the intervention, participants will be screened for obstructive sleep apnea (OSA). Participants with signs of OSA will be offered treatment with Continuos Positive Airway Pressure., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Whole genome sequencing, interventions name: VAGUS, interventions name: NightOwl, interventions name: CPAP, outcomesModule primaryOutcomes measure: Number of participants with MODY diabetes and their complication status, primaryOutcomes measure: Number of participants with diabetic complication, primaryOutcomes measure: Number of participants with obstructive sleep apnea, secondaryOutcomes measure: CPAP compliance in Greenlandic patients, secondaryOutcomes measure: CPAP treatment effect on quality of life measured with the World Health Organization Well-being Index (WHO-5)., secondaryOutcomes measure: CPAP treatment effect on daytime sleepiness measured with the functional outcome of sleep questionnaire (FOSQ-10)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Greenland, Queen Ingrids Hospital, status: RECRUITING, city: Nuuk, state: Sermersooq, zip: 3900, country: Greenland, contacts name: Mads Mose Jensen, MD., role: CONTACT, phone: +299 34 46 23, email: MMSN@peqqik.gl, contacts name: Marit Eika Jørgensen, Md. Ph.d, role: CONTACT, phone: 34 43 24, email: MAEJ@peqqik.gl, geoPoint lat: 64.18347, lon: -51.72157, hasResults: False

protocolSection identificationModule nctId: NCT06264414, orgStudyIdInfo id: DTT106-III-0123, briefTitle: Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia, acronym: AUSTRÁLIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-02, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: EMS, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia, conditionsModule conditions: Prostatic Hyperplasia, Benign, conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: DTT106, interventions name: Dutasteride-Tamsulosin, outcomesModule primaryOutcomes measure: Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline., secondaryOutcomes measure: Change in maximum urinary flow rate (Qmax), secondaryOutcomes measure: Decrease in post-void residual volume (PVR), secondaryOutcomes measure: Improvement in urinary symptoms., secondaryOutcomes measure: Improvement in urinary emptying symptoms, secondaryOutcomes measure: Improvement in urinary storage symptoms., secondaryOutcomes measure: Improvement in the participant's quality of life in relation to their urinary condition, secondaryOutcomes measure: Improvement in the participant's sexual function, secondaryOutcomes measure: Improvement in the participant's orgasmic function., secondaryOutcomes measure: Effectiveness of the treatment in improving the participant's sexual desire, secondaryOutcomes measure: Effectiveness in improving the participant's satisfaction with sexual relations, secondaryOutcomes measure: Overall satisfaction of the participant regarding their sex life., eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: EMS, city: Hortolândia, state: São Paulo, country: Brazil, geoPoint lat: -22.85833, lon: -47.22, hasResults: False

protocolSection identificationModule nctId: NCT06264401, orgStudyIdInfo id: menopausal with osteoporsis, briefTitle: Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population., conditionsModule conditions: Postmenopausal Osteoporosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: intervention: medication the experimental and control groups received (Alendronate) 70 mg 1 tab every week for 4 months.treatment exercises the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program which include 5 min warming up and 5 min cooling down at the end of the session each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 min including 10 min warming up and 10 min cooling down in form of stretching., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Alendronate, interventions name: treatment exercises, outcomesModule primaryOutcomes measure: Dual-energy x-ray absorptiometry, primaryOutcomes measure: Oswestry Disability Index, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of physical therapy, Cairo university, city: Giza, zip: 12662, country: Egypt, contacts name: Nermeen Abd El Aziem, phd, role: CONTACT, phone: 01025016087, email: nermeenshaaban93o@yahoo.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06264388, orgStudyIdInfo id: 20231234, secondaryIdInfos id: R21CA282543, type: NIH, link: https://reporter.nih.gov/quickSearch/R21CA282543, briefTitle: DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2034-05-01, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ashish Shah, class: OTHER, collaborators name: Denovo Biopharma LLC, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled., conditionsModule conditions: High Grade Glioma, conditions: Anaplastic Astrocytoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: DB107-RRV, interventions name: DB107-FC, outcomesModule primaryOutcomes measure: Progression Free Survival, primaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria, secondaryOutcomes measure: Number of Treatment Related Toxicities, secondaryOutcomes measure: Durable Response Rate (DRR), secondaryOutcomes measure: Durable Clinical Benefit Rate (DCBR), secondaryOutcomes measure: Duration of Durable Response Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami Hospital, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Leonela Wright, MSN, RN, role: CONTACT, phone: 305-243-0864, email: lxw612@med.miami.edu, contacts name: Ashish Shah, MD, role: CONTACT, phone: 305-243-6946, email: ashah@med.miami.edu, contacts name: Ashish Shah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False

protocolSection identificationModule nctId: NCT06264375, orgStudyIdInfo id: E-SPORT, briefTitle: Effect of a Specific and General Physical Exercise Intervention on Gaming and E-Sport Performance, acronym: E-SPORT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-04-19, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Universitaet Innsbruck, class: OTHER, descriptionModule briefSummary: The goal of this randomized control intervention study is to test the effect of i) a specific physical training for e-sport and ii) a general physical training on e-sport performance, compared to iii) not training physically at all.Participants are gamers and e-athletes who play at least \>2hours peer week. The main questions it aims to answer are:* Does physical training have an effect on e-sport related abilities (hand grip strength, reaction, anticipation)* Does the training of specific elements, which aim at these abilities "out-game", transfer on the actual skills needed using a keyboard and mouseParticipants will be randomly - but mediated by hours of playing per week - distributed in 1 of 3 groups.* Group 1 will 3 times per week for 30 minutes perform a specific physical training with focus on abilities needed in e-sport (grip strength, reaction, anticipation) over a timespan of 8 weeks.* Group 2 will perform a similar physical training (load, intensity) to Group 1, but without specific elements.* Group 3 will serve as control group without any training.Researchers will compare Group 1, Group 2 and Groups 3 to see if the different trainings (Group 1 and Group 2) have different effect on e-sport performance and if no training (Group 3) differs in e-sport performance development., conditionsModule conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 8 weeks of intervention, where Group 1 does a specific physical training, Group 2 a general physical training and Group 3 who does not train., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Data is collected and afterwards anonymized during the pre- and post measurement and during the intervention using a weekly questionnaire (activity level, gaming time), enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule interventions name: Physical exercise, outcomesModule primaryOutcomes measure: Grip Strength (Out-Game), primaryOutcomes measure: Reaction Time (Out-Game), primaryOutcomes measure: Anticipation (Out-Game), primaryOutcomes measure: Whole Body Fitness, primaryOutcomes measure: Gaming Performance - Accuracy/Speed and Anticipation, secondaryOutcomes measure: Well-being after training, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Sport Science, city: Innsbruck, state: Tyrol, zip: 6020, country: Austria, geoPoint lat: 47.26266, lon: 11.39454, hasResults: False

protocolSection identificationModule nctId: NCT06264362, orgStudyIdInfo id: K23AG081547, type: NIH, link: https://reporter.nih.gov/quickSearch/K23AG081547, secondaryIdInfos id: 1K23AG081547-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23AG081547-01, briefTitle: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Drexel University, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.In Part 1 - The investigators are inviting the following people to participate in an interview:1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.In Part 2 - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.Please contact us for any questions., conditionsModule conditions: Pain, Chronic, conditions: Dementia, Mild, conditions: Mobility Limitation, conditions: Physical Disability, conditions: Osteo Arthritis Knee, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: In Phase 1, 15 dyads and 15 clinicians will be interviewed (a dyad equals one person living with mild to very mild dementia and their care partner) to inform design of the intervention. In Phase 2, 20 people living with mild to very mild dementia will be treated with the new intervention. Their care partners may be involved in treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Tailored Physical Activity Program, outcomesModule primaryOutcomes measure: Program parameters, primaryOutcomes measure: Program parameters, primaryOutcomes measure: Feasibility of Intervention Measure, primaryOutcomes measure: Perception of program, secondaryOutcomes measure: Numeric Pain Score, secondaryOutcomes measure: Zarit Burden Interview-Short Form, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Drexel University, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Annalisa Na, PT, PhD, role: CONTACT, phone: 267-359-5889, email: an838@drexel.edu, contacts name: Ben Senderling, MS, role: CONTACT, phone: 2679800425, email: bms422@drexel.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False

protocolSection identificationModule nctId: NCT06264349, orgStudyIdInfo id: 05102023, briefTitle: Women and Maternity: Development of a Nutritional Education Project, acronym: MATER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood., conditionsModule conditions: Pregnancy, conditions: Lactation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Quasi-experimental - controlled, non-randomized pilot study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lifestyle Educational Intervention, outcomesModule primaryOutcomes measure: Gestational weight gain management, secondaryOutcomes measure: Nutritional aspects evaluation during pregnancy and lactation, secondaryOutcomes measure: Physical activity evaluation during pregnancy and lactation, secondaryOutcomes measure: Smoking habits during pregnancy and lactation, secondaryOutcomes measure: Maternal attitude towards infant feeding., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264336, orgStudyIdInfo id: UIC AHS Pilot 2024, briefTitle: Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: treadmill training, outcomesModule primaryOutcomes measure: Symptomatic fatigue, primaryOutcomes measure: Walking speed, primaryOutcomes measure: Corticomotor excitability, secondaryOutcomes measure: Fatigue impact, secondaryOutcomes measure: Walking endurance, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Visual processing speed, secondaryOutcomes measure: Verbal learning and memory, otherOutcomes measure: Spatial walking symmetry, otherOutcomes measure: Temporal walking symmetry, otherOutcomes measure: Community ambulation, otherOutcomes measure: Interhemispheric inhibition, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Brice T Cleland, PhD, role: CONTACT, phone: 312-996-9056, email: bcleland@uic.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False

protocolSection identificationModule nctId: NCT06264323, orgStudyIdInfo id: UI-5487, briefTitle: Incidence of Acute Injuries in Boxing, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-09-01, primaryCompletionDateStruct date: 2018-05-30, completionDateStruct date: 2018-11-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Iceland, class: OTHER, descriptionModule briefSummary: A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks., conditionsModule conditions: Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 74, type: ACTUAL, outcomesModule primaryOutcomes measure: Questionnaire, primaryOutcomes measure: Sport Concussion Assessment Tool 3rd Edition (SCAT3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Iceland, city: Reykjavík, zip: 102, country: Iceland, geoPoint lat: 64.13548, lon: -21.89541, hasResults: False

protocolSection identificationModule nctId: NCT06264310, orgStudyIdInfo id: R2R01-WHF-201, briefTitle: To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: River 2 Renal Corp., class: INDUSTRY, collaborators name: International HealthCare, LLC, descriptionModule briefSummary: This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF), conditionsModule conditions: Heart Failure, conditions: Worsening Heart Failure (WHF), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomly assigned to one of four cohorts. Three groups will receive R2R01, and one group will receive placebo., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Treatment of all cohorts will be double-blind (all patients, study staff, investigators and Sponsor). Site pharmacist is unblinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: R2R01, outcomesModule primaryOutcomes measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0., primaryOutcomes measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0., secondaryOutcomes measure: Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30., secondaryOutcomes measure: Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30., secondaryOutcomes measure: Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up., secondaryOutcomes measure: Number of patients with an event of: WHF-induced SDAC or other outpatient clinic visits requiring additional intensification of the therapy/IV loop diuretics using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30., secondaryOutcomes measure: Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eastern Shore Research Institute, city: Fairhope, state: Alabama, zip: 36532, country: United States, geoPoint lat: 30.52297, lon: -87.90333, locations facility: C&R Research Services USA, Inc., city: Cape Coral, state: Florida, zip: 33904, country: United States, geoPoint lat: 26.56285, lon: -81.94953, locations facility: Nature Coast Clinical Research, city: Inverness, state: Florida, zip: 34452, country: United States, geoPoint lat: 28.83582, lon: -82.33037, locations facility: Jacksonville Center for Clinical Research, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Amavita Research Services, LLC, city: Miami, state: Florida, zip: 33137, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False

protocolSection identificationModule nctId: NCT06264297, orgStudyIdInfo id: 01-22-270-111, briefTitle: High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial, acronym: Radiofrequency, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de Terrassa, class: OTHER, descriptionModule briefSummary: The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain., conditionsModule conditions: Pulsed Radiofrequency, conditions: Lumbar Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency, outcomesModule primaryOutcomes measure: OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE, secondaryOutcomes measure: DN4 - QUESTIONNAIRE, secondaryOutcomes measure: Visual Numeric Scale, secondaryOutcomes measure: Categorical scale, secondaryOutcomes measure: patient global impression of improvement (pgi-i) score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consorci Sanitari de Terrassa, status: RECRUITING, city: Terrassa, state: Barcelona, zip: 08227, country: Spain, contacts name: Maria Martinez Garcia, role: CONTACT, phone: +34650528215, email: mariamartinezgarcia@gmail.com, contacts role: CONTACT, email: mariamartinezgarcia@gmail.com, contacts name: maria Martinez Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.56667, lon: 2.01667, hasResults: False

protocolSection identificationModule nctId: NCT06264284, orgStudyIdInfo id: 2023PI163, briefTitle: Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-19, primaryCompletionDateStruct date: 2023-07-19, completionDateStruct date: 2023-07-19, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.This study occurred in a Level 3 Maternity Ward., conditionsModule conditions: Anesthesia Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: epidural anesthesia, interventions name: general anesthesia, outcomesModule primaryOutcomes measure: To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanowski, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False

protocolSection identificationModule nctId: NCT06264271, orgStudyIdInfo id: GIP-22-NL-06-203, briefTitle: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: General University Hospital, Prague, descriptionModule briefSummary: The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 329, type: ACTUAL, armsInterventionsModule interventions name: structured nutrition intervention, outcomesModule primaryOutcomes measure: difference in HbA1c, secondaryOutcomes measure: differences in time in range, secondaryOutcomes measure: differences in time below range, secondaryOutcomes measure: differences in time above range, secondaryOutcomes measure: differences in coefficient of variation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charles University, city: Prague, zip: 12808, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False

protocolSection identificationModule nctId: NCT06264258, orgStudyIdInfo id: STUDY2023_00000285, briefTitle: Game-based Pediatric Diabetes Education, acronym: DVx-T1D, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Carnegie Mellon University, class: OTHER, collaborators name: University of Pittsburgh, descriptionModule briefSummary: The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Behavior, Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 participants (40 in each arm) of 6-12 years old youth with type 1 diabetes (T1D).The investigators will quantify the impact of the mobile game app vs. standard care on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters), physical activity levels and food choices of children (measured using food logs and surveys).The study will also assess changes in children's knowledge about the measured outcomes and investigate the feasibility and acceptability of game adoption and the barriers and challenges faced by patients, families and clinicians., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: DVx-T1D™ app, outcomesModule primaryOutcomes measure: Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention, primaryOutcomes measure: Change in glucose average and variability, secondaryOutcomes measure: Changes in the quality of food consumption, secondaryOutcomes measure: Change in game play patterns over time, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: UPMC Children's Hospital of Pittsburgh, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, contacts name: Neha Sudhir, role: CONTACT, email: sudhirn2@upmc.edu, contacts name: Ingrid Libman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False

protocolSection identificationModule nctId: NCT06264245, orgStudyIdInfo id: 2022-126, secondaryIdInfos id: 2023-A00985-40, type: OTHER, domain: ID RCB, briefTitle: Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects, acronym: COMPRESSED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Institut Pasteur, class: INDUSTRY, collaborators name: Institut de l'Audition, descriptionModule briefSummary: The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :* be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,* be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity., conditionsModule conditions: Auditory Perception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Audiological profile, interventions name: Hearing self-assessments, interventions name: Objective and subjective audiological tests, interventions name: Self-assessment of exposure sound quality, outcomesModule primaryOutcomes measure: Hearing assessments of participants exposed to manipulated sounds after and before exposure, secondaryOutcomes measure: Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure,, secondaryOutcomes measure: Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds., secondaryOutcomes measure: Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli, secondaryOutcomes measure: Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure., secondaryOutcomes measure: Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haute Ecole Léonard De Vinci, city: Bruxelles, country: Belgium, contacts name: Patrick Vereheyden, MD, role: CONTACT, phone: + 32 2 793 41 43, email: Patrick.Verheyden@vinci.be, geoPoint lat: 50.85045, lon: 4.34878, locations facility: CEntre de Recherche et d'Innovation en Audiologie Humaine, city: Paris, zip: 75015, country: France, contacts name: Paul Avan, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06264232, orgStudyIdInfo id: AT ELANA 841P-BER-302-19, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False

protocolSection identificationModule nctId: NCT06264219, orgStudyIdInfo id: H-24002284, briefTitle: Restoration of the Gut Microbiome After Cesarean Section, acronym: RestoreGut, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Professor Klaus Bønnelykke, class: OTHER, descriptionModule briefSummary: This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section., conditionsModule conditions: Microbial Colonization, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Microbiome restoration - FMT, interventions name: Microbiome restoration - FVT, interventions name: Placebo, interventions name: Vaginal birth, untreated control, outcomesModule primaryOutcomes measure: Microbial development trajectory, secondaryOutcomes measure: Microbial development trajectory, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copsac, DBAC, city: Gentofte, state: Copenhagen, zip: 2820, country: Denmark, geoPoint lat: 55.74903, lon: 12.54601, locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Hanne Hegaard, Professor, role: CONTACT, phone: +45 27583632, email: Hanne.Kristine.Hegaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False

protocolSection identificationModule nctId: NCT06264206, orgStudyIdInfo id: CALLA_IVF_KIR, briefTitle: Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Calla IVF Center, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment., conditionsModule conditions: Immunomodulatory Drugs, conditions: Killer-cell Immunoglobulin-like Receptors (KIRs), conditions: KIR Alleles (KIR AA), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Killer-cell immunoglobulin-like receptors (KIRs) testing, outcomesModule primaryOutcomes measure: the incidence of immune cause of recurrent implantation failure, primaryOutcomes measure: the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA, secondaryOutcomes measure: comparation between the pregnancy rates in KIR AA group and KIR Bx group, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Calla Ivf Center, city: Oradea, state: Bihior, zip: 410103, country: Romania, geoPoint lat: 47.0458, lon: 21.91833, hasResults: False

protocolSection identificationModule nctId: NCT06264193, orgStudyIdInfo id: Rowers, briefTitle: The Impact of Hypoxia on the Biochemical and Morphological Parameters of Blood in Rowers., acronym: IHOBMPBR, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-11-30, primaryCompletionDateStruct date: 2014-12-21, completionDateStruct date: 2014-12-21, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that 18 days of the LH-TL method does not significantly increase the level of EPO and VEGF in rowers. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables., conditionsModule conditions: Hypoxia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The hypoxic group included rowers participating in sports training and the LH-TL method, hypoxic rooms (FiO2=14.5%, corresponds to an altitude of 3000 meters). And the control group participating only in sports training and living in normoxic rooms, at the same sports camp., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: hypoxia, outcomesModule primaryOutcomes measure: Erythropoietin (EPO) mlU/ml, primaryOutcomes measure: vascular endothelial growth factor (VEGF) mlU/ml, secondaryOutcomes measure: creatine kinase (CK) ng/ml, secondaryOutcomes measure: Hs C-Reactive Protein (hsCRP) mg/L, secondaryOutcomes measure: hemoglobin (Hb)g/dL, secondaryOutcomes measure: hematocrit (Htc)%, secondaryOutcomes measure: red blood cells (RBC)mln/mm3, secondaryOutcomes measure: white blood cells (WBC)10 3/µL, secondaryOutcomes measure: reticulocytes (Ret)‰, secondaryOutcomes measure: SpO2 - oxygen saturation (%), secondaryOutcomes measure: bpm - beats per minute(%), eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264180, orgStudyIdInfo id: RP1-104, briefTitle: VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2034-08-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Replimune Inc., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy., conditionsModule conditions: Advanced Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Vusolimogene Oderparepvec, interventions name: Nivolumab, interventions name: Nivolumab + Relatlimab, interventions name: Pembrolizumab, interventions name: Single-agent chemotherapy, outcomesModule primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264167, orgStudyIdInfo id: NODE, briefTitle: NODE (groiN ultrasOunD cancEr), acronym: NODE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Queensland Centre for Gynaecological Cancer, class: OTHER_GOV, collaborators name: Royal Brisbane and Women's Hospital, descriptionModule briefSummary: This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months., conditionsModule conditions: Vulvar Cancer Stage Ib, conditions: Vulvar Cancer Stage II, conditions: Lymph Node Metastasis, conditions: Groin Node, conditions: Ultrasound Therapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility trial, open label, three-group, randomised clinical trial30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High-resolution bilateral groin ultrasound surveillance, outcomesModule primaryOutcomes measure: Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months., secondaryOutcomes measure: Utility of tumour mutations to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of circulating tumour DNA to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of plasma to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of serum to determine positive lymph node metastasis., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Andrew's War Memorial Hospital, city: Brisbane, state: Queensland, zip: 4000, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Andreas Obermair, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, locations facility: Royal Brisbane and Women's Hospital, city: Brisbane, state: Queensland, zip: 4029, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Avalon Knott, role: CONTACT, phone: 07 3346 5073, email: a.knott@uq.edu.au, contacts name: Andrea Garrett, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False

protocolSection identificationModule nctId: NCT06264154, orgStudyIdInfo id: 854051, secondaryIdInfos id: R01CA287474-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA287474-01, briefTitle: The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms., conditionsModule conditions: Smoking, conditions: Tobacco Use, conditions: Cigarette Smoking, conditions: E-Cig Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: E-cigarettes, outcomesModule primaryOutcomes measure: Cigarette Consumption, primaryOutcomes measure: Cigarette Smoking Behavior, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06264141, orgStudyIdInfo id: NONS-RARS-01, briefTitle: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis, acronym: NONS-RARS-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Sanotize Research and Development corp., class: INDUSTRY, descriptionModule briefSummary: A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy., conditionsModule conditions: Recurrent Acute Rhinosinusitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-week therapy of NONS vs Placebo (saline nasal spray) initiated immediately after the onset of a new RARS episode to assess the acceleration to clinical success (cured/much-improved symptoms), lack of use of INCS (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide-releasing solution (NORS) platform therapy., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: A blinded participant number will be assigned to each randomized participant. Site staff/ physician will then dispense a kit labelled with the authorization number generated during randomization to the individual participant. No study investigators, associates performing assessments or participants will be aware of the study medication in the assigned treatments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: Nitric Oxide Releasing Solution, interventions name: Nasal spray with isotonic saline, outcomesModule primaryOutcomes measure: Primary endpoint is the time to sinus symptoms resolution, secondaryOutcomes measure: Time (days) to full recovery from sinusitis (participant reported), secondaryOutcomes measure: Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success), secondaryOutcomes measure: Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure, secondaryOutcomes measure: Time (days) to initiation of INCS, secondaryOutcomes measure: Proportion of participants requiring INCS, secondaryOutcomes measure: Proportion of participants requiring rescue oral ATBs, secondaryOutcomes measure: Proportion of participants recovered from sinusitis, secondaryOutcomes measure: Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs, secondaryOutcomes measure: Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22, secondaryOutcomes measure: Tolerability and safety of NONS, secondaryOutcomes measure: Proportion of participants with clinically significant changes from baseline in vital signs, secondaryOutcomes measure: Proportion of participants with clinically significant changes from baseline in laboratory parameters, secondaryOutcomes measure: Number of participants with clinically significant changes from Baseline in physical examinations, otherOutcomes measure: Number of ATB courses required as a rescue treatment, otherOutcomes measure: Time (days) to the initiation of NSAIDs, otherOutcomes measure: Proportion of participants requiring NSAIDs, otherOutcomes measure: Time (days) to each symptom being cured or much improved, otherOutcomes measure: Proportion of participants being cured or much improved for each symptom, otherOutcomes measure: Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Okanegan Clinical Trials, status: RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, contacts name: Cora Withers, role: CONTACT, phone: 250-862-8141, email: cora@oktrials.ca, contacts name: Colleen Maytham, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site), status: RECRUITING, city: Richmond, state: British Columbia, zip: V6V 2L1, country: Canada, contacts role: CONTACT, phone: 604-373-4954, contacts name: Colleen Maytham, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.17003, lon: -123.13683, locations facility: Cliantha Research, status: RECRUITING, city: Mississauga, state: Ontario, zip: L4W 1V7, country: Canada, contacts name: Patricia Couroux, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5789, lon: -79.6583, locations facility: Clinical Research of Ontario, status: NOT_YET_RECRUITING, city: Scarborough, state: Ontario, zip: M1S 4T7, country: Canada, contacts name: Jemilat Smith, role: CONTACT, phone: 18002474525, phoneExt: 1, email: jemilatsmith@gmail.com, geoPoint lat: 43.77223, lon: -79.25666, locations facility: Intermed Groupe Santé, status: RECRUITING, city: Chicoutimi, state: Quebec, zip: G7H 7Y8, country: Canada, contacts name: Nancu Lavoie, role: CONTACT, phone: 418-602-6620, email: n.lavoie@intermedgs.ca, contacts name: Doria Grimard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.41963, lon: -71.06369, locations facility: Alpha Recherche Clinique LeBourneuf, status: RECRUITING, city: Québec City, state: Quebec, zip: G2J 0C4, country: Canada, contacts name: Amélie Boulay, role: CONTACT, phone: 418.704.1112, email: aboulay@alpha-recherche.ca, contacts name: Anne-Marie Beaulieu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Alpha Recherche Clinique Val-Belair, status: RECRUITING, city: Québec City, state: Quebec, zip: G3K 2P8, country: Canada, contacts name: Jessica M. M. Petit, role: CONTACT, phone: 418.847.1112, email: jpetit@alpha-recherche.ca, contacts name: Melanie Gauvin, role: CONTACT, email: mgauvin@alpha-recherche.ca, contacts name: Camille Walsh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False

protocolSection identificationModule nctId: NCT06264128, orgStudyIdInfo id: TheraPAP Comfort, briefTitle: TPAP for Comfort in OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: SleepRes Inc., class: INDUSTRY, descriptionModule briefSummary: TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will undergo the same therapy combinations. CPAP (Continuous Positive Airway Pressure) and 2 level of TPAP (TheraPAP - novel CPAP approach pressure is reduced below therapy pressure from inspiration through mid exhalation specifically for comfort) will be assessed against each other in a round robin both backward and forward (6 total binary comparisons) for 2 levels of baseline pressure., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: There is no specific intent to mask although participants will be naive to CPAP-type therapy, but they will be able to feel the difference., enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: TPAP, interventions name: CPAP, outcomesModule primaryOutcomes measure: CPAP v TPAP Patient Preference via Visual Analog Scale, secondaryOutcomes measure: TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SleepCenters of Middle Tennessee, status: RECRUITING, city: Murfreesboro, state: Tennessee, zip: 37129, country: United States, contacts name: Craig Salazar, role: CONTACT, phone: 615-893-4896, email: csalazar@sleepcenterinfo.com, contacts name: WIlliam H Noah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.84562, lon: -86.39027, hasResults: False

protocolSection identificationModule nctId: NCT06264115, orgStudyIdInfo id: Soh-Med-24-01-05MS, briefTitle: Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy, conditionsModule conditions: Cholecystitis, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopic Cholecystectomy, outcomesModule primaryOutcomes measure: Postoperative pain score, secondaryOutcomes measure: Operative time, secondaryOutcomes measure: length of hospital stay, otherOutcomes measure: Total postoperative morphine consumption, otherOutcomes measure: Time of first analgesic, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False

protocolSection identificationModule nctId: NCT06264102, orgStudyIdInfo id: 2024/1/1, briefTitle: Influence of Dalcroze Eurhythmics on Pains in Older Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-11, primaryCompletionDateStruct date: 2019-03-08, completionDateStruct date: 2019-07-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain., conditionsModule conditions: Back Pain, conditions: Headache, conditions: Leg Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: Physical exercise program, outcomesModule primaryOutcomes measure: Pain levels before exercise program, secondaryOutcomes measure: Results of pain levels after exercise program, eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Poznan University of Physical Education, city: Poznań, state: Wielkopolska, zip: 61-871, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False

protocolSection identificationModule nctId: NCT06264089, orgStudyIdInfo id: 202015, briefTitle: Effects of Preservation Rhinoplasty Nasal Valve Angle and Area, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-06, primaryCompletionDateStruct date: 2023-08-30, completionDateStruct date: 2023-08-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Yuzuncu Yıl University, class: OTHER, descriptionModule briefSummary: The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery., conditionsModule conditions: Nasal Obstruction, Bilateral, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Preservation Rhinoplasty Nasal Valve Angle and Area, outcomesModule primaryOutcomes measure: Nasal Obstruction Symptom Evaluation Scale (NOSE), secondaryOutcomes measure: Reformatted coronal Computed tomography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yaser Said Cetin, city: Van, zip: 65080, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False

protocolSection identificationModule nctId: NCT06264076, orgStudyIdInfo id: 686340, secondaryIdInfos id: CIV-NO-23-09-043976, type: OTHER, domain: Eudamed CIV ID, briefTitle: Ligament Balancing in Total Knee Arthroplasty, acronym: BLIS-TKA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: Vestre Viken Hospital Trust, descriptionModule briefSummary: The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital., conditionsModule conditions: Ligament; Laxity, Knee, conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-group, non-blind, interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Non-blind, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: A novel instrument for ligament balancing in total knee arthroplasty, outcomesModule primaryOutcomes measure: Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?, secondaryOutcomes measure: MCL-lengthening in millimeters after ligament balancing using the novel instrument, secondaryOutcomes measure: Demographic information - height (cm) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - weight (kg) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - age (years) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing., secondaryOutcomes measure: Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing., secondaryOutcomes measure: Patient reported outcome measures (PROM) using EQ-5D-5L, secondaryOutcomes measure: Patient reported outcome measures (PROM) using FJS-12, secondaryOutcomes measure: Patient reported outcome measures (PROM) using KOOS-12, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baerum Hospital, Vestre Viken Hospital Trust, city: Bærums Verk, state: Viken, zip: 1346, country: Norway, contacts name: Jarle Vik, MD, role: CONTACT, phone: 004793844926, email: jarle.vik@vestreviken.no, geoPoint lat: 59.94148, lon: 10.50273, locations facility: Oslo University Hospital, Ullevaal, city: Oslo, zip: 0450, country: Norway, contacts name: Lars HW Engseth, MD, role: CONTACT, phone: 004741254136, email: laengs@ous-hf.no, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False

protocolSection identificationModule nctId: NCT06264063, orgStudyIdInfo id: D-DIST, briefTitle: Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia, acronym: D-DIST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2025-10-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions., conditionsModule conditions: Dystonia, conditions: Neurologic Disorder, conditions: NEUROSCIENCE, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: control group, interventions name: experimental group, interventions name: EEG power in alpha band, outcomesModule primaryOutcomes measure: montreal cognitive assessment, primaryOutcomes measure: Beck depression inventory, secondaryOutcomes measure: EEG power in alpha band, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi Bonino Pulejo, status: RECRUITING, city: Messina, zip: 98124, country: Italy, contacts name: Caterina Formica, PhD, PSY, role: CONTACT, phone: +3909060128185, email: katia.formica@irccsme.it, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False

protocolSection identificationModule nctId: NCT06264050, orgStudyIdInfo id: 2023.04, briefTitle: Psychological Support Group and Its Effects on Mood, Anxiety and Coping, acronym: SUPPORT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2004-01-08, primaryCompletionDateStruct date: 2024-09-08, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS San Camillo, Venezia, Italy, class: OTHER, descriptionModule briefSummary: The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital.It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group.The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity)., conditionsModule conditions: Coping Strategies, conditions: Anxiety, conditions: Nurse-Patient Relations, conditions: Psychological, conditions: Mood Depressed, conditions: Rehabilitation, conditions: Neurologic Manifestations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pre post study on a single cohort, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: evalutaion scales, outcomesModule primaryOutcomes measure: The State-Trait Anxiety Inventory (STAI) Y2, primaryOutcomes measure: The Beck Depression Inventory II (BDI-II), primaryOutcomes measure: The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), primaryOutcomes measure: The Coping Orientations to Problem Experienced NVI - 25, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06264037, orgStudyIdInfo id: 2023.03, secondaryIdInfos id: Studio 1574 /IRCCS San Camillo, type: OTHER, domain: CESC di Venezia e IRCSS San Camillo, briefTitle: The Experience in Neurorehabilitation Setting: a Qualitative Study, acronym: NURSEXPERIENCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-12-08, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS San Camillo, Venezia, Italy, class: OTHER, descriptionModule briefSummary: In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson\&#39;s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method., conditionsModule conditions: Rehabilitation, conditions: Neurologic Disorder, conditions: Stroke, conditions: Parkinson Disease, conditions: Multiple Sclerosis, conditions: Neurosurgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: semi structured interview, outcomesModule primaryOutcomes measure: narrative contents, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alberto Camuccio, status: RECRUITING, city: Venezia, zip: 30126, country: Italy, contacts name: Alberto Camuccio, doctor, role: CONTACT, phone: +39412207516, email: alberto.camuccio@hsancamillo.it, contacts name: Enrico Dal Pozzo, doctor, role: CONTACT, phone: +39412207111, email: enrico.dalpozzo@hsancamillo.it, geoPoint lat: 45.43713, lon: 12.33265, locations facility: IRCCS San Camillo Department of Neurorehabilitation, Venezia, status: RECRUITING, city: Venezia, zip: 30126, country: Italy, contacts name: Alberto Camuccio, doctor, role: CONTACT, phone: +39412207516, email: alberto.camuccio@hsancamillo.it, contacts name: Enrico Dal Pozzo, doctor, role: CONTACT, phone: +39412207111, email: enrico.dalpozzo@hsancamillo.it, geoPoint lat: 45.43713, lon: 12.33265, locations facility: IRCCS San Camillo Venezia, status: RECRUITING, city: Venezia, zip: 30126, country: Italy, contacts name: Alberto Camuccio, doctor, role: CONTACT, phone: +39412207516, email: alberto.camuccio@hsancamillo.it, contacts name: Enrico Dal Pozzo, doctor, role: CONTACT, phone: +39412207111, email: enrico.dalpozzo@hsancamillo.it, geoPoint lat: 45.43713, lon: 12.33265, hasResults: False

protocolSection identificationModule nctId: NCT06264024, orgStudyIdInfo id: 519516, briefTitle: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2034-02-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe., conditionsModule conditions: Keratoconus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: Corneal collagen cross linking (CXL), interventions name: Transepithelial phototherapeutic keratectomy (t-PTK), outcomesModule primaryOutcomes measure: Visual acuity, primaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Risk of progression, secondaryOutcomes measure: Depth of demarcation line (OCT), secondaryOutcomes measure: Depth of demarcation line (confocal microscopy), secondaryOutcomes measure: Patient reported outcome measure (PROMs), secondaryOutcomes measure: Patient reported outcome measure (PROMs), secondaryOutcomes measure: Patient reported outcome measure (PROMs), secondaryOutcomes measure: Patient reported pain after surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophhtalmology, University of Oslo, status: RECRUITING, city: Oslo, country: Norway, contacts name: Olav Kristianslund, MD, PhD, role: CONTACT, email: olakri@ous-hf.no, contacts name: Bjarne L Thorbjørnsen, MD, role: CONTACT, email: uxtbja@ous-hf.no, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False

protocolSection identificationModule nctId: NCT06264011, orgStudyIdInfo id: 2023B0044, briefTitle: Discrimination and Religious Experiences of Adult Muslimahs in Salaat, acronym: DREAMS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: This goal of this clinical trial is to examine the effects of the Muslim prayer (salaat) on physiological arousal among Muslim women. This study aims to measure EEG and HRV during the salaat performance among Muslim women. Using EEG as a measure of physiological relaxation, HRV will be utilized as a measure of stress experienced by Muslim women whose prayer have been understudied in research on the salaat. Thus, the main questions it aims to answer are 1) whether salaat performed by Muslim women influences physiological relaxation similar to what is seen by men, and 2) Evaluate health-related correlates of perceived discrimination among Muslim women.Participants will complete 15 questionnaires. Participants will be connected to a Heart Rate Variability (HRV) monitor as well as a 32-electrode EEG cap. After the baseline data are obtained, all participants will complete both conditions (salaat and counting) but the order of participation in conditions will be randomly assigned. The resting period will again occur between conditions and at the end of the second condition.All participants will pray the Duha prayer, an optional superogatory prayer that typically occurs in the early morning, to control for differences in timing and duration of prayer. The Duha is completed between the dawn and noon prayers and consists of four cycles of prayer as well as Qur'an recitation and supplication throughout the four positions. The salaat condition includes four cycles with four different positions during each cycle (standing with bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and sitting again). The counting condition will include the same physical component as the salaat condition. This will include 4 cycles of movement through the four different positions (i.e., standing, bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and a final sitting position in cycles two and four (see Figure 2)). Apart from not including the final sitting position, cycles one and three are identical to cycles two and four (see Figure 2). The counting condition will include replacing Qur'anic recitation and subsequent supplications throughout the prayer by counting "one one-thousand, two one-thousand, three one-thousand, etc." throughout the duration of time typically required to perform the full salaat. During the standing position, counting can last for approximately 30-60 seconds in line with the previous study by Doufesh and colleagues (2012). Thus, the first three cycles of prayer will require approximately 77 seconds each while the final cycle will require around 97 seconds based on the estimates by Doufesh and colleagues (2012), for a total of approximately five and a half minutes. To ensure that participant duration during the counting condition is, on average, equivalent to the salaat condition, an audio recording will be provided with counting aloud during each position. The duration of the counting in the audio recording will be an average of the duration of each position as found in Doufesh and colleagues (2012). A bell sound will be used to indicate when participants should change to the next position. After performance of each condition, participants will return to a comfortable seated position. Participants will complete a questionnaire to rate their mental focus in the condition. Blood pressure will be measured at the end of each condition. While at rest, assessment of blood pressure, HRV, and EEG will be obtained from participants for 5 minutes between each condition and at the end of the study., conditionsModule conditions: Stress, Psychological, conditions: Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There is one intervention (i.e., the prayer condition) and one control condition (i.e., the counting condition)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: This study uses a cross-sectional, repeated measures, crossover design. All participants will complete both conditions of the study but will be randomized to start in either the salaat or counting conditions., whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Salaat, interventions name: Sham comparator, outcomesModule primaryOutcomes measure: Relative power alpha, primaryOutcomes measure: High frequency heart rate variability (HF-HRV), primaryOutcomes measure: The Body Perception Questionnaire Body Awareness Very Short Form (BPQ-VSF), secondaryOutcomes measure: The SF 36-Item Health Survey (SF-36), secondaryOutcomes measure: Modified International Physical Activity Questionnaire - Short Form (IPAQ-SF), secondaryOutcomes measure: Health Care Discrimination Scale (HCDS; Martin, 2015), secondaryOutcomes measure: Perceived Religious Discrimination Scale (PRDS; Rippy & Newman, 2008), secondaryOutcomes measure: The Internalized Islamophobia Scale, secondaryOutcomes measure: Muslim Identification Scale (MIS; Verkuyten, 2007), secondaryOutcomes measure: Brief Religious COPE, secondaryOutcomes measure: Salaat Frequency Scale, secondaryOutcomes measure: The Salaat Index, secondaryOutcomes measure: Hijab Frequency Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Ohio State University, status: RECRUITING, city: Columbus, state: Ohio, zip: 43016, country: United States, contacts name: Ihsan Rodriguez, MS, role: CONTACT, phone: 505-463-5297, email: Rodriguez.919@osu.edu, contacts name: Charles Emery, PhD, role: CONTACT, phone: 43210, email: emery.33@osu.edu, contacts name: Charles Emery, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ihsan Rodriguez, MS, role: SUB_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06263998, orgStudyIdInfo id: HUC1-394, briefTitle: Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2025-11-28, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Huons Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults., conditionsModule conditions: Xerophthalmia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: NCP112, interventions name: NCP112 Placebo, outcomesModule primaryOutcomes measure: Treatment-Emergent Adverse Events, secondaryOutcomes measure: Evaluation of pharmacokinetic profile, secondaryOutcomes measure: Evaluation of pharmacokinetic profile, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06263985, orgStudyIdInfo id: 20214133, briefTitle: Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-02, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Michigan Institution of Women's Health PC, class: OTHER, collaborators name: Coloplast A/S, descriptionModule briefSummary: The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:* Is the leading edge of the prolapse above the hymen* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure., conditionsModule conditions: Pelvic Organ Prolapse, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Axis Dermis biologic mesh repair for pelvic organ prolapse, outcomesModule primaryOutcomes measure: Improvement in function, primaryOutcomes measure: Improvement in Anatomy, secondaryOutcomes measure: Assess complications or untoward side effects., eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Urogynecology of Michigan, city: Dearborn, state: Michigan, zip: 48124, country: United States, geoPoint lat: 42.32226, lon: -83.17631, hasResults: False

protocolSection identificationModule nctId: NCT06263972, orgStudyIdInfo id: 0168-21EMC, briefTitle: Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: HaEmek Medical Center, Israel, class: OTHER, collaborators name: Technion, Israel Institute of Technology, collaborators name: Rambam Health Care Campus, descriptionModule briefSummary: The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks., conditionsModule conditions: Fibromyalgia, conditions: Electric Shock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Direct Stimulation Prefrontal Cortex, interventions name: Shame cortex stimulation, interventions name: Direct Stimulation to Motor Cortex, interventions name: erobic physical activity, outcomesModule primaryOutcomes measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale., primaryOutcomes measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score., primaryOutcomes measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score., primaryOutcomes measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06263959, orgStudyIdInfo id: GST-HG131-II-01, briefTitle: A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-29, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Fujian Akeylink Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B, conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: GST-HG131, interventions name: Placebo to match GST-HG131, outcomesModule primaryOutcomes measure: Change from Baseline in HBsAg levels, secondaryOutcomes measure: Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fifth Medical Center of Chinese PLA General Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Tang Yanan, role: CONTACT, phone: +8613585734994, email: annie_tyn@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06263946, orgStudyIdInfo id: WS10337, briefTitle: Essilor® Stellest® Lenses Multicentre European Study (SLOMES), acronym: SLOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Essilor International, class: INDUSTRY, descriptionModule briefSummary: The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: multicentre, European, prospective, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Essilor® Stellest® spectacle lenses, outcomesModule primaryOutcomes measure: Change in cycloplegic axial length, primaryOutcomes measure: Change in cycloplegic autorefraction, secondaryOutcomes measure: Change in refraction progression centile, secondaryOutcomes measure: Change in cycloplegic axial length, secondaryOutcomes measure: Change in cycloplegic autorefraction, secondaryOutcomes measure: Change in refraction, secondaryOutcomes measure: Change in axial length, secondaryOutcomes measure: Change in choroidal thickness, secondaryOutcomes measure: Change in refraction, secondaryOutcomes measure: Change in axial length vs atropine, secondaryOutcomes measure: Change in choroidal thickness, secondaryOutcomes measure: Change in Paediatric Refractive Error Profile (PREP-2) score, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department, status: RECRUITING, city: Paris, zip: 75019, country: France, contacts name: Ramin Tadayoni, Professor, role: CONTACT, email: rtadayoni@for.paris, contacts name: Ramin Tadayoni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Centre for Eye Research Ireland (CERI) - TU DUBLIN, status: RECRUITING, city: Dublin, zip: D07 H6K8, country: Ireland, contacts name: Ian Flitcroft, Professor, role: CONTACT, email: ian.flitcroft@tudublin.ie, contacts name: James LOUGHMAN, Professor, role: CONTACT, phone: +353868589593, email: james.loughman@tudublin.ie, contacts name: Ian Flitcroft, Pr., role: PRINCIPAL_INVESTIGATOR, contacts name: James Loughman, Pr., role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Erasmus Medical Center, status: NOT_YET_RECRUITING, city: Rotterdam, zip: 3015, country: Netherlands, contacts name: Caroline Klaver, Professor, role: CONTACT, email: c.c.w.klaver@erasmusmc.nl, contacts name: Jan Roelof Polling, role: CONTACT, phone: 010-7040704, email: j.polling@erasmusmc.nl, contacts name: Caroline Klaver, role: PRINCIPAL_INVESTIGATOR, contacts name: Jan Roelof Polling, role: SUB_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False