hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06312709, orgStudyIdInfo id: STUDY00021288, secondaryIdInfos id: K23HL159240, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL159240, briefTitle: teleABLE to Reduce Post-Stroke Sedentary Behavior, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.Participants in this study will:* Complete questionnaires at Weeks 1, 8, and 24* Wear an activPAL monitor at Weeks 1, 8, and 24* Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)* Complete an interview at Week 24, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement), interventions name: Health Education, outcomesModule primaryOutcomes measure: Between-group difference in change scores on health-related quality of life, primaryOutcomes measure: Between-group difference in change in sedentary behavior, secondaryOutcomes measure: Between-group difference in change in sedentary behavior, secondaryOutcomes measure: Between-group difference in change scores on health-related quality of life, otherOutcomes measure: Between-group difference in change in step count, otherOutcomes measure: Between-group difference in change in step count, otherOutcomes measure: Between-group difference in change in total activity retention, otherOutcomes measure: Between-group difference in change in total activity retention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: School of Kinesiology, University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, contacts name: Karli Jahnke, MOT, OTR/L, role: CONTACT, phone: 612-626-4046, email: dwell@umn.edu, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False
protocolSection identificationModule nctId: NCT06312683, orgStudyIdInfo id: 23-2111, briefTitle: Rifaximin for the Secondary Prevention of Recurrent Pouchitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Bausch Health Americas, Inc., descriptionModule briefSummary: Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis., conditionsModule conditions: Pouchitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Rifaximin 550 MG Oral Tablet [XIFAXAN], outcomesModule primaryOutcomes measure: Percentage of Participants Who Develop Recurrent Pouchitis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Mikki Sandridge, role: CONTACT, phone: 919-843-3873, email: mikki_sandridge@med.unc.edu, contacts name: Edward Barnes, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06312657, orgStudyIdInfo id: 81971, briefTitle: Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice, acronym: BED(In)(44), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-03-28, completionDateStruct date: 2026-03-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Joshua A. Lile, Ph.D., class: OTHER, descriptionModule briefSummary: The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Drug Cue, interventions name: Money, interventions name: Withdrawal, outcomesModule primaryOutcomes measure: Task choices, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06312644, orgStudyIdInfo id: D9289C00007, briefTitle: Study of Ultomiris® (Ravulizumab) Safety in Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2033-10-21, completionDateStruct date: 2033-10-21, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Alexion Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk., conditionsModule conditions: Ultomiris-exposed Pregnant/ Postpartum, conditions: Pregnancy, conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH), conditions: Atypical Hemolytic Uremic Syndrome (aHUS), conditions: Generalized Myasthenia Gravis (gMG), conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ultomiris, outcomesModule primaryOutcomes measure: Number of Pregnancy Complications, primaryOutcomes measure: Number of Maternal Complications, primaryOutcomes measure: Fetal/Infant Outcomes, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06312618, orgStudyIdInfo id: FMASU MD292/2023, briefTitle: Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane., conditionsModule conditions: Emergence Agitation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: the overall incidence of postoperative Emergence Agitation, secondaryOutcomes measure: Vital signs change., secondaryOutcomes measure: Vital signs change., secondaryOutcomes measure: Vital signs change., secondaryOutcomes measure: Proportion of patients with adverse events in the PACU, secondaryOutcomes measure: Proportion of patients with Post Operative Nausea and Vomiting (PONV), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06312605, orgStudyIdInfo id: 230620, briefTitle: The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question\[s\] it aims to answer are:* Pigment recurrence after one year.* Patient satisfaction and histological response of tissues.Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen.Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each., conditionsModule conditions: Gingival Pigmentation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All participants receive surgical depigmentation then either vitamin C is applied following 2 regimens, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Coding of the groups, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Injectable applied vitamin C, interventions name: Topical applied Vitamin C, interventions name: Surgical depigmentation only, outcomesModule primaryOutcomes measure: Pigmentation scores, primaryOutcomes measure: Assessment of pigment surface area (SA), primaryOutcomes measure: Assessment of pigment intensity in terms of mean darkness value (MDV), secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Histological response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty AinShams University, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06312566, orgStudyIdInfo id: EP0231, briefTitle: A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-10-25, completionDateStruct date: 2024-10-25, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: UCB Biopharma SRL, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants., conditionsModule conditions: Healthy Study Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: brivaracetam (BRV) tablet, interventions name: brivaracetam (BRV) dry syrup, outcomesModule primaryOutcomes measure: Maximum plasma concentration at steady state [Cmax(ss)] after multiple doses of brivaracetam, primaryOutcomes measure: Area under the curve during a dosing interval at steady state [AUC(tau)] after multiple doses of brivaracetam, secondaryOutcomes measure: Percentage of study participants with treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs), secondaryOutcomes measure: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ep0231 001, status: RECRUITING, city: Sumida- Ku, state: Tokyo, country: Japan, hasResults: False
protocolSection identificationModule nctId: NCT06312553, orgStudyIdInfo id: IRB-300012515, secondaryIdInfos id: P50MD017338, type: NIH, link: https://reporter.nih.gov/quickSearch/P50MD017338, briefTitle: Remotely Delivered Mindfulness-Based Diabetes Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring, interventions name: Standard Diabetes Self Management Education, outcomesModule primaryOutcomes measure: Feasibility: percentage of screened participants who are eligible, primaryOutcomes measure: Feasibility: percentage of eligible participants who enroll, primaryOutcomes measure: Feasibility: ability to randomize participants to study arms, primaryOutcomes measure: Feasibility: distribution of participants by demographics, primaryOutcomes measure: Feasibility: percentage of sessions attended, primaryOutcomes measure: Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities., primaryOutcomes measure: Feasibility: barriers to participation in intervention sessions or completing study activities at home, primaryOutcomes measure: Feasibility: reasons for dropping out, primaryOutcomes measure: Feasibility: overall study retention, primaryOutcomes measure: Acceptability, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06312540, orgStudyIdInfo id: PERSONA, secondaryIdInfos id: 15397/2018, type: OTHER_GRANT, domain: Tuscany Region - Bando FAS, briefTitle: PERSonalized rObotic NeurorehAbilitation for Stroke Survivors, acronym: PERSONA, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-02, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero, Universitaria Pisana, class: OTHER, collaborators name: Fondazione Don Carlo Gnocchi Onlus, collaborators name: Scuola Superiore Sant'Anna di Pisa, descriptionModule briefSummary: The aim is to carry out a first clinical study, to expand existing knowledge about the neurophysiological mechanisms underlying post-stroke recovery. The information acquired during this phase will be used as building blocks to develop customized protocols. Understanding the mechanisms underlying stroke-induced motor deficits and motor recovery is mandatory to improve clinicians; ability to guide the repair of the affected neural structures. The motor system comprises a network of cortical and subcortical areas interacting via excitatory and inhibitory circuits, thereby governing motor behaviour. Stroke lesions cause neural dysfunction both at the lesion site and in remote brain regions. Abnormal interactions among cortical regions within the motor network contribute to the motor impairment after stroke. Longitudinal analysis of neural activity and connectivity can help to understand the pathophysiology mechanisms underlying functional impairment and recovery after stroke. Analysis of the data will try to extract biomarkers of plasticity and recovery that will be used to design customized therapeutic interventions., conditionsModule conditions: Stroke Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Brain activity, primaryOutcomes measure: Functional evaluation, secondaryOutcomes measure: Clinical scale, secondaryOutcomes measure: Spasticity assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOUPisana, status: RECRUITING, city: Pisa, state: Pi, zip: 56124, country: Italy, contacts name: Stefania Dalise, Medical, role: CONTACT, phone: 001 050 994282, email: stefania.dalise@ao-pisa.toscana.it, contacts name: Stefania Dalise, Medical, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
protocolSection identificationModule nctId: NCT06312527, orgStudyIdInfo id: TUH Mepiform TKA, briefTitle: Mepiform in Simultaneous Bilateral TKA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this RCT is comparing efficacy of silicone dressing in scar preventing after simultaneous bilateral total knee arthroplasty.The main question\[s\] it aims to answer are:* Does silicone dressing can prevent scar formation after total knee arthroplasty?* Does silicone dressing have similar functional outcomes and complications after total knee arthroplasty? Participants will apply silicone dressing after wound healed and apply for 10 weeks. Researchers will compare to the other side that is no intervention., conditionsModule conditions: Scar Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Silicone dressing, outcomesModule primaryOutcomes measure: Vancouver Scar Scale, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Forgotten joint score, secondaryOutcomes measure: modified WOMAC score, secondaryOutcomes measure: Scar pain, secondaryOutcomes measure: Scar itching, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University, city: Khlong luang, state: Pathum Thani, zip: 12120, country: Thailand, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False