hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06385249, orgStudyIdInfo id: NAV-0012, briefTitle: An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wellspect HealthCare, class: INDUSTRY, descriptionModule briefSummary: The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents., conditionsModule conditions: Bowel Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Navina Mini, outcomesModule primaryOutcomes measure: Overall patient satisfaction, secondaryOutcomes measure: Incomplete bowel emptying, secondaryOutcomes measure: Episodes of fecal incontinence, secondaryOutcomes measure: Level of independence, secondaryOutcomes measure: Perception of handling of the device, secondaryOutcomes measure: Safety outcome, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset, status: RECRUITING, city: Linköping, country: Sweden, contacts name: Peter Wide, role: CONTACT, phone: +46101031341, email: Peter.Wide@regionostergotland.se, contacts name: Jenny Axelsson, role: CONTACT, phone: +46101032432, email: jenny.axelsson@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False
protocolSection identificationModule nctId: NCT06385223, orgStudyIdInfo id: DSRB 2023/00680, briefTitle: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Institute of Mental Health, Singapore, class: OTHER, collaborators name: National University of Singapore, descriptionModule briefSummary: The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression., conditionsModule conditions: Depression, 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: 70, type: ESTIMATED, armsInterventionsModule interventions name: Beam F3 targeted accelerated iTBS, interventions name: Individualized connectome-guided accelerated iTBS, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale, secondaryOutcomes measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report), secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: EQ-5D (EuroQol), secondaryOutcomes measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF), otherOutcomes measure: TMS induced changes in resting-fMRI functional connectivity, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385210, orgStudyIdInfo id: 22SM7855, briefTitle: Barriers to Routine Surgical Video Recording, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery., conditionsModule conditions: Minimally Invasive Surgery, conditions: Laparoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Semi structured interviews, outcomesModule primaryOutcomes measure: Stakeholder perceived barriers to surgical video recording, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery and Cancer, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06385197, orgStudyIdInfo id: 170886-HMO-CTIL, briefTitle: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: App randomizing dosing regimen, outcomesModule primaryOutcomes measure: safety assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hadassah Medical Center, city: Jerusalem, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
protocolSection identificationModule nctId: NCT06385184, orgStudyIdInfo id: NCR234859, briefTitle: Social & QoL Behaviors in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Gregory Wallace, class: OTHER, descriptionModule briefSummary: Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Subjective Quality of Life, primaryOutcomes measure: Social Behavior, primaryOutcomes measure: Activities of Daily Living, primaryOutcomes measure: Mental Health, primaryOutcomes measure: Cognition, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The George Washington University, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20052, country: United States, contacts name: Gregory Wallace, PhD, role: CONTACT, phone: 202-994-8285, email: ladn@gwu.edu, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False
protocolSection identificationModule nctId: NCT06385171, orgStudyIdInfo id: FFA-BTX-1, briefTitle: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2027-01-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Global Aesthetics LLC, class: OTHER, descriptionModule briefSummary: A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable., conditionsModule conditions: Wrinkle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin type A, outcomesModule primaryOutcomes measure: Change in facial wrinkles and Lines, primaryOutcomes measure: Facial Appearance, primaryOutcomes measure: Assessment of Wrinkle Severity, secondaryOutcomes measure: Assessment of Skin Reaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Global Aesthetics LLC, city: Cisco, state: Texas, zip: 76437, country: United States, geoPoint lat: 32.38819, lon: -98.97923, locations facility: Global Aesthetics LLC, city: Lubbock, state: Texas, zip: 79413, country: United States, contacts name: Otis Scroggins, BS, CNA, role: CONTACT, phone: 806-370-7428, email: fakefaceaesthetics@gmail.com, geoPoint lat: 33.57786, lon: -101.85517, hasResults: False
protocolSection identificationModule nctId: NCT06385145, orgStudyIdInfo id: GenSci004-107, briefTitle: A Bioavailability Study of Two Different PEG-rhGH Preparations., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2024-07-13, completionDateStruct date: 2024-12-26, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations., conditionsModule conditions: Pediatric Growth Hormone Deficiency (PGHD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: PEG-rhGH with new preparation (T), interventions name: PEG-rhGH with present preparation (R), outcomesModule primaryOutcomes measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Safety and tolerability (Number of participants with treatment-related adverse events), secondaryOutcomes measure: Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation, secondaryOutcomes measure: Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation, secondaryOutcomes measure: Anti-drug antibody (Number of Participants with positive ADA), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, Doctor, role: CONTACT, phone: +862860212136, email: yongxlan@126.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06385119, orgStudyIdInfo id: F8394-101, briefTitle: A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-11-25, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fore Biotherapeutics, class: INDUSTRY, descriptionModule briefSummary: The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine:* The effect of food on the single dose PK of plixorafenib administered with cobicistat.* The effect of cobicistat administration on the single dose PK of plixorafenib.* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Plixorafenib, interventions name: Cobicistat, outcomesModule primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)., primaryOutcomes measure: AUC from time 0 extrapolated to infinity (AUC0-inf)., primaryOutcomes measure: Maximum observed plasma concentration (Cmax)., primaryOutcomes measure: Time to maximum observed plasma concentration (Tmax)., primaryOutcomes measure: Terminal elimination rate constant (Kel)., primaryOutcomes measure: Terminal phase half-life (t1/2)., primaryOutcomes measure: Apparent oral clearance (CL/F)., primaryOutcomes measure: Apparent volume of distribution (Vd/F)., primaryOutcomes measure: Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z)., secondaryOutcomes measure: Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae)., secondaryOutcomes measure: Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: PPD - Austin Research Unit, city: Austin, state: Texas, zip: 78744, country: United States, contacts name: Kristie Miller, MD, role: CONTACT, phone: 877-362-2608, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False
protocolSection identificationModule nctId: NCT06385106, orgStudyIdInfo id: rTMS in AD, briefTitle: Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD)., conditionsModule conditions: Alzheimer Disease, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: Real repetitive transcranial magnetic stimulation, interventions name: Sham repetitive transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Cognitive funtion, primaryOutcomes measure: Sleep parameters, secondaryOutcomes measure: glymphatic system, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385080, orgStudyIdInfo id: 61186372HNC2002, briefTitle: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer, acronym: OrigAMI-4, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-17, completionDateStruct date: 2026-07-17, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Research & Development, LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel., conditionsModule conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: Amivantamab, interventions name: Pembrolizumab, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: Cohorts 1, 2, and 3B: Objective Response Rate, primaryOutcomes measure: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT), primaryOutcomes measure: Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity, secondaryOutcomes measure: Cohorts 1, 2, and 3B: Duration of Response (DoR), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Progression-free Survival (PFS), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Overall Survival (OS), secondaryOutcomes measure: Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity, secondaryOutcomes measure: Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab, secondaryOutcomes measure: Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab, secondaryOutcomes measure: Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab, secondaryOutcomes measure: Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab, secondaryOutcomes measure: Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab, secondaryOutcomes measure: Cohort 1: Accumulation Ratio (R) of Amivantamab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
protocolSection identificationModule nctId: NCT06385067, orgStudyIdInfo id: JW-PM-DCB-2024, briefTitle: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: JW Medical Systems Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Biolimus Coated Coronary Artery Balloon Dilation Catheter, outcomesModule primaryOutcomes measure: Target lesion failure rate (TLF), secondaryOutcomes measure: Interventional success rate, secondaryOutcomes measure: Device-related cardiovascular clinical composite endpoint, secondaryOutcomes measure: Patient-related cardiovascular clinical composite endpoint, secondaryOutcomes measure: Major adverse cardiac events (MACEs), secondaryOutcomes measure: Incidence of thrombotic events as defined by ARC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False