hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06359639, orgStudyIdInfo id: USM/JEPeM/KK/23080645, briefTitle: Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Michelle Choong Poh Kin, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling., conditionsModule conditions: Breakup Distress, conditions: Posttraumatic Growth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive restructuring, interventions name: Supportive counselling, outcomesModule primaryOutcomes measure: Breakup distress, primaryOutcomes measure: Posttraumatic growth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359626, orgStudyIdInfo id: YHP2205, briefTitle: Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-09, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2024-07-24, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Yuhan Corporation, class: INDUSTRY, descriptionModule briefSummary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: two-way crossover, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: YHP2205, interventions name: YHR2401, outcomesModule primaryOutcomes measure: Area under the plasma drug concentration-time curve [AUCt], primaryOutcomes measure: Maximum plasma concentration [Cmax], secondaryOutcomes measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf], secondaryOutcomes measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf], secondaryOutcomes measure: Time of peak concentration [Tmax], secondaryOutcomes measure: Terminal phase of half-life [t1/2], eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359613, orgStudyIdInfo id: 029/IRC/BMR, briefTitle: Efficacy Assessment of Gluten Free Cupcakes, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-03, primaryCompletionDateStruct date: 2019-12-15, completionDateStruct date: 2020-01-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Veterinary and Animal Sciences, Lahore - Pakistan, class: OTHER, descriptionModule briefSummary: Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ)., conditionsModule conditions: Celiac Disease in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: nutrient rich food product, interventions name: food product, outcomesModule primaryOutcomes measure: Body Weight, primaryOutcomes measure: Height of the patients, primaryOutcomes measure: Mid upper Arm Circumference (MUAC), primaryOutcomes measure: Body Mass Index (BMI), primaryOutcomes measure: Complete Blood Count (CBC), primaryOutcomes measure: Total Protein, primaryOutcomes measure: Lipid Profile, primaryOutcomes measure: Liver Enzymes, primaryOutcomes measure: Serum Electrolytes, secondaryOutcomes measure: Gastrointestinal Symptoms, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: UVAS, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06359587, orgStudyIdInfo id: H22-03005, briefTitle: Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia, acronym: RePORT-BC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: Providence Health & Services, collaborators name: Vancouver Coastal Health, collaborators name: Fraser Health, collaborators name: Interior Health, collaborators name: Northern Hospital, Australia, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Island Health, descriptionModule briefSummary: The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention., conditionsModule conditions: Hospital Acquired Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Intervention Arm (Intervention Bundle Implementation):This arm involves the time periods where hospital units are actively receiving the intervention bundle, including healthcare provider (HCP) and patient engagement tools.Control Arm (No Intervention Bundle Implementation):This arm represents the time periods when the hospital units do not receive the intervention bundle. This time period is the control period. Each hospital will contribute to intervention and control period data., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 700000, type: ESTIMATED, armsInterventionsModule interventions name: Laboratory test overuse (LTO) Bundle, outcomesModule primaryOutcomes measure: Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle, secondaryOutcomes measure: Change in number of total laboratory tests ordered per patient-day with the LTO bundle, secondaryOutcomes measure: Rate of hospital re-admissions and mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359574, orgStudyIdInfo id: IRB-24-0209, briefTitle: Core Competency Model for Corrections, acronym: CCM-C, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Charlotte, class: OTHER, collaborators name: North Carolina Department of Adult Corrections, collaborators name: North Carolina Department of Health and Human Services, descriptionModule briefSummary: The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders., conditionsModule conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Core Competency Model for Corrections (CCM-C) Self-Directed Violence Prevention Training, outcomesModule primaryOutcomes measure: Feasibility, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Appropriateness, primaryOutcomes measure: Usability, secondaryOutcomes measure: Perceived self-directed violence prevention skills, secondaryOutcomes measure: Willingness to intervene with a suicidal person, secondaryOutcomes measure: Beliefs about incarcerated persons engaging in self-directed violence, secondaryOutcomes measure: Self-directed violence prevention knowledge, secondaryOutcomes measure: Perceived importance of training, otherOutcomes measure: Compassion fatigue: Job burnout, otherOutcomes measure: Compassion fatigue: Traumatic stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: North Carolina Department of Adult Corrections, city: Raleigh, state: North Carolina, zip: 27699, country: United States, geoPoint lat: 35.7721, lon: -78.63861, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-14, uploadDate: 2024-03-20T14:21, filename: ICF_000.pdf, size: 256435, hasResults: False
protocolSection identificationModule nctId: NCT06359561, orgStudyIdInfo id: 2023-2201 - Cervical lead, briefTitle: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients With Cervical Lead Placement, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Rijnstate Hospital, class: OTHER, collaborators name: Saluda Medical Pty Ltd, descriptionModule briefSummary: This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement., conditionsModule conditions: Chronic Pain Syndrome, conditions: Multi Focal Pain, conditions: Failed Neck Surgery Syndrome, conditions: Polyneuropathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: cervical lead placement, outcomesModule primaryOutcomes measure: Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS), secondaryOutcomes measure: Pain distribution using Patient Reported Dermatomal Coverage Map, secondaryOutcomes measure: Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire, secondaryOutcomes measure: Pain-related medication intake., secondaryOutcomes measure: Programming parameters., secondaryOutcomes measure: Programming parameters., secondaryOutcomes measure: Evaluate stimulation sensation (awareness and quality), secondaryOutcomes measure: Evaluate stimulation coverage in pain region(s), secondaryOutcomes measure: Posture Change Measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rijnstate Hospital, city: Arnhem, state: Gelderland, zip: 6815AD, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, hasResults: False
protocolSection identificationModule nctId: NCT06359535, orgStudyIdInfo id: HSK21542-IIT-02, briefTitle: An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-11-06, completionDateStruct date: 2024-11-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mengchang Yang, class: OTHER, descriptionModule briefSummary: This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored., conditionsModule conditions: Nausea and Vomiting, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HSK21542, interventions name: Placebo, outcomesModule primaryOutcomes measure: Total direct medical costs, direct non-medical costs, indirect costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Mengchang Yang, Doctor, role: CONTACT, phone: +8618140049936, email: ymc681@126.com, contacts name: Mengchang Yang, role: PRINCIPAL_INVESTIGATOR, contacts name: Yu He, role: SUB_INVESTIGATOR, contacts name: Mengxia Lan, role: SUB_INVESTIGATOR, contacts name: Ai Wei, role: SUB_INVESTIGATOR, contacts name: Lina Yang, role: SUB_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06359522, orgStudyIdInfo id: 22.0334, briefTitle: PDA Occlusion Using NIRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-18, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, collaborators name: Norton Healthcare, descriptionModule briefSummary: Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy., conditionsModule conditions: Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: NIRS monitor, outcomesModule primaryOutcomes measure: Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings., primaryOutcomes measure: Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol., secondaryOutcomes measure: Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment., eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Norton Children's Hospital, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Scott D Duncan, MD, role: CONTACT, phone: 502-629-5283, email: scottd.duncan@louisville.edu, contacts name: Janice E. Sullivan, MD, role: CONTACT, phone: 502-629-5283, email: sully@louisville.edu, contacts name: Joshua D Kurtz, MD, role: SUB_INVESTIGATOR, contacts name: Joshua Lee, MD, role: SUB_INVESTIGATOR, contacts name: John N Juneau, MD, role: SUB_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
protocolSection identificationModule nctId: NCT06359509, orgStudyIdInfo id: SYS6020-001, briefTitle: Study of SYS6020 in BCMA-positive Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2032-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: BCMA Targeted CAR T-cells, outcomesModule primaryOutcomes measure: Incidence of adverse events (AEs), primaryOutcomes measure: Dose limiting toxicities (DLTs), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Percentage of subjects who achieved complete response or strict complete response (CR/sCR), secondaryOutcomes measure: Percentage of subjects who achieved very good partial response (VGPR) and higher response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06359496, orgStudyIdInfo id: CT2024-ZJU-OBS8, briefTitle: Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05., conditionsModule conditions: Zhejiang University, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: No intervention factor, outcomesModule primaryOutcomes measure: Postoperative complications were evaluated by postoperative imaging reports and serological indicators, primaryOutcomes measure: The survival rate of each group was evaluated by follow-up survey and K-M curve, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiao Xu, city: Hangzhou, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False