hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06283212, orgStudyIdInfo id: ETX-DS-005, briefTitle: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome, acronym: UK Only, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Encoded Therapeutics, class: INDUSTRY, descriptionModule briefSummary: EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design., conditionsModule conditions: Dravet Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: ETX101, outcomesModule primaryOutcomes measure: Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome., primaryOutcomes measure: Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52., secondaryOutcomes measure: Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures., secondaryOutcomes measure: Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 47 Months, stdAges: CHILD, contactsLocationsModule locations facility: Queen Elizabeth Hospital, status: RECRUITING, city: Glasgow, zip: G51 4TF, country: United Kingdom, contacts name: Patricia Clark, role: CONTACT, phone: 0141 232 7600, email: Patricia.Clark2@ggc.scot.nhs.uk, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Great Ormond Street Hospital, status: NOT_YET_RECRUITING, city: London, zip: WC1N3JH, country: United Kingdom, contacts name: Helen Cross, MD, role: CONTACT, email: helen.cross10@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Sheffield Children's Hospital, status: NOT_YET_RECRUITING, city: Sheffield, zip: S10 2TH, country: United Kingdom, contacts name: Research Team, role: CONTACT, email: research.sheffchild@nhs.net, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False
protocolSection identificationModule nctId: NCT06283199, orgStudyIdInfo id: ORL-ORT-025, briefTitle: Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-06, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month., conditionsModule conditions: Musculoskeletal Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Difference in pain level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, country: Italy, contacts name: Alessandro Di Martino, MD, role: CONTACT, phone: 0039 051 6366567, email: alessandro.dimartino@ior.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: EOC - Orthopaedics and Traumatology Service, status: RECRUITING, city: Lugano, zip: 6900, country: Switzerland, contacts name: Christian Candrian, Prof.Dr.med, role: CONTACT, phone: +41 (0) 91 811 61 23, email: christian.candrian@eoc.ch, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
protocolSection identificationModule nctId: NCT06283186, orgStudyIdInfo id: CSEULS-PI-004/2024, briefTitle: Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centro Universitario La Salle, class: OTHER, descriptionModule briefSummary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise, interventions name: Aerobic exercise, outcomesModule primaryOutcomes measure: Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ), secondaryOutcomes measure: Fatigue Assessment Scale (FAS), secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Rate of perceived exertion (RPE), secondaryOutcomes measure: Physical Activity Readiness Questionnaire (PAR-Q), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: CSEU LaSalle, status: RECRUITING, city: Madrid, zip: 28023, country: Spain, contacts name: Álvaro Reina-Varona, MSc, role: CONTACT, phone: 0034 + 649001863, email: alvaroreina93@gmail.com, contacts name: Álvaro Reina-Varona, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
protocolSection identificationModule nctId: NCT06283173, orgStudyIdInfo id: 23-401, briefTitle: HRIPT for Collagen Dressing, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-22, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Covalon Technologies Inc., class: INDUSTRY, collaborators name: ALS Beauty and Personal Care, descriptionModule briefSummary: The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site., conditionsModule conditions: Skin Sensitisation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ACTUAL, armsInterventionsModule interventions name: ColActive Plus Collagen Matrix Dressing, outcomesModule primaryOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, primaryOutcomes measure: Skin irritation reaction using Berger and Bowman scale, otherOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, otherOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ALS Beauty and Personal Care, city: Torrance, state: California, zip: 90501, country: United States, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False
protocolSection identificationModule nctId: NCT06283160, orgStudyIdInfo id: 2023/834, briefTitle: Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy, acronym: PROMETHEE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling)., conditionsModule conditions: Pancreatic Fistula, conditions: Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Besançon, status: RECRUITING, city: Besançon, zip: 25000, country: France, contacts name: Alexandre Doussot, MD, PhD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, hasResults: False
protocolSection identificationModule nctId: NCT06283147, orgStudyIdInfo id: 2023.530, briefTitle: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):1. RAMP Knee-OA group2. Usual care groupOutcomes will be measured at baseline, week 16, week 32, and week 52., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: Risk assessment and Management Programme - Knee Osteoarthritis, outcomesModule primaryOutcomes measure: Knee pain, secondaryOutcomes measure: Physical Function, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Lower limb muscle mass, secondaryOutcomes measure: Level of physical activity, secondaryOutcomes measure: Self-Management efficacy, secondaryOutcomes measure: Level of Anxiety, secondaryOutcomes measure: Level of Depression, secondaryOutcomes measure: Insomnia, secondaryOutcomes measure: Loneliness, secondaryOutcomes measure: Health related Quality of Life, secondaryOutcomes measure: Demographic data, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lek Yuen GOPC, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Cheryl Fung, role: CONTACT, phone: 26095050, phoneExt: +852, email: cheryllcfung@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06283134, orgStudyIdInfo id: BJCT-CMU1H-02, briefTitle: A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, collaborators name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd, descriptionModule briefSummary: This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: BioTTT001 hepatic artery infusion, interventions name: toripalimab, interventions name: regorafenib, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: MTD, secondaryOutcomes measure: Overall survival(OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Plasma adenovirus (ADV) copies, secondaryOutcomes measure: ADV copies in various sites, secondaryOutcomes measure: Serum IL-12 level, secondaryOutcomes measure: Serum neutralizing antibody level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06283121, orgStudyIdInfo id: BJCT-CMU1H-01, briefTitle: A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, collaborators name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd, descriptionModule briefSummary: This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer., conditionsModule conditions: Gastric Cancer, Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BioTTT001 intraperitoneal infusion, interventions name: SOX regimen, interventions name: toripalimab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06283108, orgStudyIdInfo id: 23-1183, briefTitle: Gurney Journey: Virtual Reality Distraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Colorado, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program., conditionsModule conditions: Dental Caries in Children, conditions: Dental Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience), interventions name: Standard Child Life Preparation and Support, outcomesModule primaryOutcomes measure: Induction Compliance Checklist, primaryOutcomes measure: modified Yale Preoperative Anxiety Scale, secondaryOutcomes measure: The Pediatric Behavioral Induction Assessment, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Colorado, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Claire Simonsen, BA, role: CONTACT, phone: 720-777-5313, email: claire.simonsen@childrenscolorado.org, contacts name: Joseph Albietz, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jennifer Staab, MS, role: SUB_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
protocolSection identificationModule nctId: NCT06283095, orgStudyIdInfo id: OSA, briefTitle: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: ET Zarief, class: OTHER, descriptionModule briefSummary: The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS., conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: expansion palatoplasty, outcomesModule primaryOutcomes measure: Evaluation the outcome of expansion palatoplasty in management of OSAS., secondaryOutcomes measure: Expansion palatoplasty in Obstructive sleep apnea patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASSUIT, status: RECRUITING, city: Assuit, zip: 1, country: Egypt, contacts name: Enas T Zarief, physician, role: CONTACT, phone: 01226270800, email: enas.tharwat23@gmail.com, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False