hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06388629, orgStudyIdInfo id: M064-066 Rev 00, briefTitle: Epicardial Access Study With Rook, acronym: EASY-R, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-17, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Circa Scientific, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure., conditionsModule conditions: Arrythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, non-randomized, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Rook Epicardial Access Kit, outcomesModule primaryOutcomes measure: Successful Epicardial Access, secondaryOutcomes measure: Speed of Access, secondaryOutcomes measure: Rate of Use Errors, otherOutcomes measure: Rate of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Na Homolce Hospital, status: RECRUITING, city: Prague, zip: 15030, country: Czechia, contacts name: Petr Neuzil, MD, PhD, role: CONTACT, phone: +420257272211, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
protocolSection identificationModule nctId: NCT06388616, orgStudyIdInfo id: D6402C00013, briefTitle: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group., conditionsModule conditions: Hepatic Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study.All subjects will receive the study intervention:* Cohort 1 will enroll 8 participants with mild hepatic impairment* Cohort 2 will enroll 8 participants with moderate hepatic impairment* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Balcinrenone, outcomesModule primaryOutcomes measure: Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast), primaryOutcomes measure: Area under plasma concentration-time curve from zero to infinity (AUCinf), primaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]), secondaryOutcomes measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings, secondaryOutcomes measure: Number of participants with abnormal laboratory tests results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Hialeah, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Site, city: Orlando, state: Florida, zip: 32809, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Research Site, city: San Antonio, state: Texas, zip: 78215, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06388564, orgStudyIdInfo id: INCA34176-254, secondaryIdInfos id: 2022-502168-19-00, type: REGISTRY, domain: EU CT Number, briefTitle: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-08, primaryCompletionDateStruct date: 2027-03-05, completionDateStruct date: 2028-09-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD., conditionsModule conditions: Chronic Graft-versus-host-disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Axatilimab, interventions name: Ruxolitinib, interventions name: Corticosteroids, outcomesModule primaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score, secondaryOutcomes measure: Best overall response in the first 6 months, secondaryOutcomes measure: OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD., secondaryOutcomes measure: Proportion of participants who remain corticosteroid-free, secondaryOutcomes measure: Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD., secondaryOutcomes measure: Failure-free Survival (FFS), secondaryOutcomes measure: Axatilimab pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Ruxolitinib PK in Plasma, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388551, orgStudyIdInfo id: LY03017/CT-CHN-101, briefTitle: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Luye Pharma Group Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects., conditionsModule conditions: Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis, conditions: Negative Symptoms of Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: LY03017, interventions name: LY03017-Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Maximum observed concentration (Cmax) of LPM526000133 in plasma, secondaryOutcomes measure: Time to maximum observed concentration (Tmax) of LPM526000133 in plasma, secondaryOutcomes measure: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma, secondaryOutcomes measure: Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, country: China, contacts name: Huafang Li, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06388525, orgStudyIdInfo id: PostERCPLC, briefTitle: Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2020-01-01, completionDateStruct date: 2020-01-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kanuni Sultan Suleyman Training and Research Hospital, class: OTHER, descriptionModule briefSummary: In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use), conditionsModule conditions: Endoscopic Retrograde Cholangiopancreatography, conditions: ERCP-Laparoscopic Cholecystectomy Interval, conditions: Number of Preoperative ERCPs, conditions: Stone Extraction Status in ERCP Procedures, conditions: Biliary Stents, conditions: Mechanical Lithotripsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 426, type: ACTUAL, armsInterventionsModule interventions name: Endoscopic Retrograde Cholangiopancreatography, outcomesModule primaryOutcomes measure: Conversion to open, primaryOutcomes measure: Subtotal Cholecystectomy, primaryOutcomes measure: Postoperative Complications, primaryOutcomes measure: Adhesion levels, primaryOutcomes measure: Operative time, primaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06388512, orgStudyIdInfo id: STUDY00160044, briefTitle: iMRI Prone Positioning Frame Design Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, collaborators name: Continuum Educational Technologies, descriptionModule briefSummary: The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device., conditionsModule conditions: Epilepsy, conditions: Pulmonary Embolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: prototype prone positioning device, outcomesModule primaryOutcomes measure: Number of devices that meet functional requirements, primaryOutcomes measure: Number of devices that are damaged during use, secondaryOutcomes measure: Number of patients with skin complications, secondaryOutcomes measure: Number of patients with thromboembolic complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Andrew Guillotte, MD, role: CONTACT, phone: 309-648-7036, email: aguillotte@kumc.edu, contacts name: Anand Dharia, MD, role: SUB_INVESTIGATOR, contacts name: Jennifer Cheng, MD, role: SUB_INVESTIGATOR, contacts name: Michael Kinsman, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Christopher Miller, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
protocolSection identificationModule nctId: NCT06388499, orgStudyIdInfo id: GOIPG/2022/1854, briefTitle: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-07-22, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Limerick, class: OTHER, descriptionModule briefSummary: This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions., conditionsModule conditions: Chronic Conditions, Multiple, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TECC (Telerehabilitation and Exercise for Chronic Conditions), outcomesModule primaryOutcomes measure: Recruitment rate assessed by number of participants recruited during recruitment period., primaryOutcomes measure: Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments., primaryOutcomes measure: Adherence rate assessed by the attendance at synchronous group exercise sessions, primaryOutcomes measure: Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8), primaryOutcomes measure: Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS), primaryOutcomes measure: Adverse events assessed via self-report questionnaire, primaryOutcomes measure: Intervention acceptability as assessed by qualitative feedback from participants via focus groups, secondaryOutcomes measure: Physical function assessed by the 30-second chair stand test (30CST)., secondaryOutcomes measure: Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir, status: RECRUITING, city: Tipperary, country: Ireland, contacts name: Niamh Julian, BSc, role: CONTACT, geoPoint lat: 52.47333, lon: -8.15583, hasResults: False
protocolSection identificationModule nctId: NCT06388486, orgStudyIdInfo id: UMCGoettingen9/9/16, briefTitle: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy, acronym: CitDip, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-01, primaryCompletionDateStruct date: 2022-03-09, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Medical Center Goettingen, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry., conditionsModule conditions: Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ACTUAL, armsInterventionsModule interventions name: Psychotherapy, outcomesModule primaryOutcomes measure: Change in depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06388473, orgStudyIdInfo id: NMRR-20-2188-56086 IIR, briefTitle: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting, acronym: iScreenMen, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-14, primaryCompletionDateStruct date: 2021-06-06, completionDateStruct date: 2021-06-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Malaya, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months., conditionsModule conditions: Men's Health Screening, conditions: Implementation, conditions: Web-based Application, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 101, type: ACTUAL, armsInterventionsModule interventions name: Tailored implementation intervention, outcomesModule primaryOutcomes measure: Reach, primaryOutcomes measure: Reach, primaryOutcomes measure: Adoption of ScreenMen using qualitative methods, primaryOutcomes measure: Implementation of ScreenMen using qualitative methods, primaryOutcomes measure: Maintenance of ScreenMen using qualitative methods, secondaryOutcomes measure: Impact of COVID-19 on the clinic using qualitative methods, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinik Kesihatan Cheras Baru, city: Kuala Lumpur, zip: 56100, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False
protocolSection identificationModule nctId: NCT06388460, orgStudyIdInfo id: STUDY00001015, secondaryIdInfos id: R01HL169229, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL169229, briefTitle: Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14., conditionsModule conditions: Childhood Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Asthma Link, interventions name: Enhanced Usual Care, outcomesModule primaryOutcomes measure: Improving Asthma Symptoms, secondaryOutcomes measure: Improving Medication Adherence, secondaryOutcomes measure: Improving Healthcare Utilization, secondaryOutcomes measure: Reducing Parental Lost Workdays, secondaryOutcomes measure: Reducing School Absences, secondaryOutcomes measure: Improving Quality of Life, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Massachusetts Chan Medical School, status: RECRUITING, city: Worcester, state: Massachusetts, zip: 01655, country: United States, contacts name: Michelle Spano, role: CONTACT, phone: 508-856-2990, email: michelle.spano@umassmed.edu, contacts name: MIchelle Trivedi, MD MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.26259, lon: -71.80229, hasResults: False