hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06364215, orgStudyIdInfo id: 2024P000883, briefTitle: Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation, acronym: (SMILE-AF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF)., conditionsModule conditions: Atrial Fibrillation Paroxysmal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary Vein Isolation alone, interventions name: Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation, outcomesModule primaryOutcomes measure: Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period., primaryOutcomes measure: The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure., secondaryOutcomes measure: Freedom from atrial arrhythmias medication, secondaryOutcomes measure: Procedural time, secondaryOutcomes measure: Procedure-related Recurrencies, secondaryOutcomes measure: Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT)., secondaryOutcomes measure: Use of amiodarone, secondaryOutcomes measure: Complications., secondaryOutcomes measure: fluoroscopy time., secondaryOutcomes measure: Pulsed field ablation (PFA) applications during procedure., secondaryOutcomes measure: first-pass pulmonary vein isolation (PVI)., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Obadah Aloum, MD, role: CONTACT, phone: 617-525-7047, contacts name: Fernando Moreno, role: CONTACT, phone: 6175257047, contacts name: Jorge E Romero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06364202, orgStudyIdInfo id: 1928368, briefTitle: Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Augusta University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels.Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels, conditionsModule conditions: Sleep, conditions: Body Composition, conditions: Blood Pressure, conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Peanut Butter, outcomesModule primaryOutcomes measure: Body composition, primaryOutcomes measure: Body composition, primaryOutcomes measure: Sleep, primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Physical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Augusta University, city: Augusta, state: Georgia, zip: 30909, country: United States, geoPoint lat: 33.47097, lon: -81.97484, hasResults: False
protocolSection identificationModule nctId: NCT06364176, orgStudyIdInfo id: STUDY00149479, briefTitle: Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Losartan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Sweat chloride, secondaryOutcomes measure: Lung function - absolute, secondaryOutcomes measure: Lung function - relative, secondaryOutcomes measure: Transforming growth factor (TGF)-beta1 - airway, secondaryOutcomes measure: TGF-beta1 - systemic, secondaryOutcomes measure: Inflammatory mediators - airway, secondaryOutcomes measure: Inflammatory mediators - systemic, secondaryOutcomes measure: CFQ-R, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, 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: Charles Bengtson, MD, MSc, role: CONTACT, phone: 913-588-6000, contacts name: Carolina Aguiar, role: CONTACT, phone: 9139459295, contacts name: Matthias Salathe, M.D., role: SUB_INVESTIGATOR, contacts name: Andreas Schmid, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
protocolSection identificationModule nctId: NCT06364150, orgStudyIdInfo id: MAGIC6, briefTitle: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction, acronym: MAGICcell6, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Seoul National Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction"., conditionsModule conditions: Acute Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single arm, open label interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Autologous Peripheral Blood Stem Cell injection, outcomesModule primaryOutcomes measure: Left ventricular systolic function, secondaryOutcomes measure: Regional wall motion score index, secondaryOutcomes measure: B-natriuretic peptide level, secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Target lesion Revascularization, secondaryOutcomes measure: Readmssion, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: non-Target lesion Revascularization, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364137, orgStudyIdInfo id: 73203, briefTitle: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: MainSquare Co. (dba 'Teleo'), descriptionModule briefSummary: The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences., conditionsModule conditions: Anxiety Disorders, conditions: Mood Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Teleo, interventions name: Standard videoconferencing, outcomesModule primaryOutcomes measure: PRIME-O Video Coding Score, secondaryOutcomes measure: My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores, secondaryOutcomes measure: My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores, secondaryOutcomes measure: Attendance during Psychotherapy Sessions, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False
protocolSection identificationModule nctId: NCT06364111, orgStudyIdInfo id: Vibrabot Capsule, briefTitle: Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-06-14, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Tsinghua Chang Gung Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule., conditionsModule conditions: Chronic Functional Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Vibrabot capsule, interventions name: polyethylene glycol, outcomesModule primaryOutcomes measure: The proportions of responders to the three therapies during the treatment period., secondaryOutcomes measure: Evaluation of intestinal motility, secondaryOutcomes measure: Assessment of neurotransmitters in peripheral blood, secondaryOutcomes measure: Assessment of changes in intestinal flora, secondaryOutcomes measure: Evaluation of the treatment cycle of Vibrabot Capsules, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: XuanJiang, status: RECRUITING, city: Beijing, state: Beijing, zip: 102218, country: China, contacts name: Xuan Jiang, professor, role: CONTACT, phone: 13671006525, email: jxa01998@btch.edu.cn, contacts name: Jinzhe Liu, physician, role: CONTACT, phone: 18810831618, email: ljza02528@btch.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06364098, orgStudyIdInfo id: prevention of PPH, briefTitle: Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Study design:A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.Population of study:192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 192, type: ACTUAL, armsInterventionsModule interventions name: Misoprostol, outcomesModule primaryOutcomes measure: The amount of blood loss, secondaryOutcomes measure: Changes in hematocrit values in both groups after delivery, secondaryOutcomes measure: Changes in Hemoglobin level measured by gm/dl in both groups after delivery, otherOutcomes measure: Incidence of side effects of study medications, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, Kasr Alainy, city: Cairo, state: Al Manyal, zip: 11956, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06364085, orgStudyIdInfo id: DBS2024, briefTitle: Enhancing Epilepsy Management With Precision Deep Brain Stimulation, acronym: EPI-BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Nova Scotia Health Authority, class: OTHER, descriptionModule briefSummary: The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study., conditionsModule conditions: Epilepsy, Drug Resistant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Neuromodulation programming, outcomesModule primaryOutcomes measure: Seizure reduction, secondaryOutcomes measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy, secondaryOutcomes measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy, secondaryOutcomes measure: Change in anxiety score on Anxiety General Anxiety Disorder-7, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Elizabeth Health Science Centre, city: Halifax, state: Nova Scotia, zip: B3H 3A7, country: Canada, contacts name: Lutz Weise, role: CONTACT, geoPoint lat: 44.64533, lon: -63.57239, hasResults: False
protocolSection identificationModule nctId: NCT06364072, orgStudyIdInfo id: PDC 01-0202, secondaryIdInfos id: 2023-504023-63-00, type: CTIS, briefTitle: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cessatech A/S, class: INDUSTRY, descriptionModule briefSummary: The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: CT001, outcomesModule primaryOutcomes measure: To assess the safety and tolerability, primaryOutcomes measure: To evaluate the analgesic effect, secondaryOutcomes measure: To assess medication errors, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364059, orgStudyIdInfo id: aSDH-TT, briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Military University Hospital, Prague, descriptionModule briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes., conditionsModule conditions: Acute Subdural Hematoma, conditions: Acquired Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Decompressive craniectomy with evacuation of subdural hematoma, outcomesModule primaryOutcomes measure: Level of consciousness at time of injury, primaryOutcomes measure: Initial size of subdural hematoma, primaryOutcomes measure: Initial midline shift, primaryOutcomes measure: Chronic use of anti-clotting medication, primaryOutcomes measure: Trauma severity analyzed using Injury Severity Score (ISS)., primaryOutcomes measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II), primaryOutcomes measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC)., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months., secondaryOutcomes measure: Number of revisions., secondaryOutcomes measure: Time from injury to surgery., secondaryOutcomes measure: Time of operation., secondaryOutcomes measure: The need for reversal of the effects of anticoagulants., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military University Hospital Prague, city: Praha, zip: 16209, country: Czechia, contacts name: Michal Soták, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: michal.sotak@uvn.cz, contacts name: Tomáš Tyll, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: tomas.tyll@uvn.cz, contacts name: Tomáš Tyll, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False