hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06298292, orgStudyIdInfo id: ZerominisCT01, briefTitle: Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies, acronym: ZeroMinisMR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: metaX Institut fuer Diatetik GmbH, class: INDUSTRY, collaborators name: Birmingham Women's and Children's NHS Foundation Trust, collaborators name: Great Ormond Street Hospital for Children NHS Foundation Trust, descriptionModule briefSummary: The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years., conditionsModule conditions: Tyrosinemia, Type I, conditions: Tyrosinemia, Type II, conditions: Tyrosinemia, Type III, conditions: Alkaptonuria, conditions: Homocystine; Metabolic Disorder, conditions: MSUD (Maple Syrup Urine Disease), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Zero minis (range of protein substitutes in tablet form), outcomesModule primaryOutcomes measure: Daily compliance, secondaryOutcomes measure: Treatment-Emergent tolerability, secondaryOutcomes measure: Patient Acceptability, secondaryOutcomes measure: Metabolic control, secondaryOutcomes measure: Incidence of study product emergent events., eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298266, orgStudyIdInfo id: GD2H-XYK-001, briefTitle: To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Guangdong Second Provincial General Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma, conditionsModule conditions: Relapsed or Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: infusion of GPRC5D-CD19 CAR T injection, outcomesModule primaryOutcomes measure: Objective Response Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Second Provincial General Hospital, city: Guangzhou, state: Guangdong, zip: 510317, country: China, contacts name: Qing Zhang, role: CONTACT, phone: +862089169186, email: zhqing@vip.163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06298253, orgStudyIdInfo id: 2024P000832, briefTitle: Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2, acronym: BeWell, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries., conditionsModule conditions: Food Insecurity, conditions: Implementation Science, conditions: Diet, Healthy, conditions: Behavioral Economics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3750, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral economics-enhanced SWAP implementation, interventions name: Basic SWAP implementation, outcomesModule primaryOutcomes measure: Pantry SWAP implementation, primaryOutcomes measure: Percent items (by weight) ordered by pantry that are labeled green or red, primaryOutcomes measure: Percent of pantry clients' selected food that is green or red, primaryOutcomes measure: Client dietary quality score, secondaryOutcomes measure: Skin carotenoid level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298214, orgStudyIdInfo id: RP-23-019, briefTitle: Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester, acronym: Her Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Elizabeth F Sutton, PhD, class: OTHER, collaborators name: Donaghue Medical Research Foundation, descriptionModule briefSummary: The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.The main question\[s\] the study aims to answer are:* Can the Her Health program increase access to healthcare in the first year postpartum?* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby., conditionsModule conditions: Postpartum, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Her Health Program, outcomesModule primaryOutcomes measure: Postpartum visit attendance, secondaryOutcomes measure: Medical trust, secondaryOutcomes measure: Health literacy, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Healthcare costs, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Woman's Hospital, city: Baton Rouge, state: Louisiana, zip: 70817, country: United States, geoPoint lat: 30.45075, lon: -91.15455, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-05, uploadDate: 2024-02-02T12:19, filename: Prot_SAP_000.pdf, size: 458232, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-06, uploadDate: 2024-02-02T12:21, filename: ICF_001.pdf, size: 188057, hasResults: False
protocolSection identificationModule nctId: NCT06298188, orgStudyIdInfo id: RisaKids, briefTitle: Risankizumab in Children With Crohn's Disease (RisaKids), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Shaare Zedek Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Risankizumab, outcomesModule primaryOutcomes measure: Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298175, orgStudyIdInfo id: 2021-157, briefTitle: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-15, primaryCompletionDateStruct date: 2021-04-15, completionDateStruct date: 2021-08-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks., conditionsModule conditions: Chronic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre-post test, randomized controlled study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Self management training, outcomesModule primaryOutcomes measure: Self-Control Self-Management Scale (SCMS), secondaryOutcomes measure: Cognitive Emotion Regulation Questionnaire (CERQ), secondaryOutcomes measure: The Occupational Balance Questionnaire (OBQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saglik Bilimleri Universitesi, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06298162, orgStudyIdInfo id: 2018-1279, briefTitle: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass, acronym: MRI pouch, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-25, primaryCompletionDateStruct date: 2020-02-01, completionDateStruct date: 2020-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Rijnstate Hospital, class: OTHER, descriptionModule briefSummary: A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Gastric Bypass, conditions: Obesity, Morbid, conditions: Pouch Emptying, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: 2 years after RYGB, no intervention. MRI measurement. Observational., outcomesModule primaryOutcomes measure: Pouch emptying rate measured with MRI, secondaryOutcomes measure: subjective ratings of fullness, secondaryOutcomes measure: subjective ratings of wellbeing, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yonta Burgh, city: Arnhem, zip: 6815 AD, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, hasResults: False
protocolSection identificationModule nctId: NCT06298149, orgStudyIdInfo id: 2023-650-EXEMPT, secondaryIdInfos id: 1U54CA280812-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1U54CA280812-01, briefTitle: Reach Through Equitable Implementation of Turtle Island Tales, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Montana State University, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: University of Utah, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts., conditionsModule conditions: Obesity, Childhood, conditions: Obesity, conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Turtle Island Tales, outcomesModule primaryOutcomes measure: 20-item Family Nutrition and Physical Activity Survey, secondaryOutcomes measure: Food insecurity screener, secondaryOutcomes measure: Mental Health screening, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montana State University, city: Bozeman, state: Montana, zip: 59717, country: United States, geoPoint lat: 45.67965, lon: -111.03856, hasResults: False
protocolSection identificationModule nctId: NCT06298136, orgStudyIdInfo id: 15610923, briefTitle: The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder, acronym: MindADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness-based intervention, interventions name: child behavior management, outcomesModule primaryOutcomes measure: Child ADHD symptoms, secondaryOutcomes measure: Parent depressive symptoms, secondaryOutcomes measure: Parent anxiety symptoms, secondaryOutcomes measure: Parent sleep quality, secondaryOutcomes measure: Parent well-being, secondaryOutcomes measure: Child executive functioning, secondaryOutcomes measure: Parental Stress, secondaryOutcomes measure: Expressed emotion, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Herman Hay Ming Lo, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Christine Wing Tung Yeung, MSsc, role: CONTACT, phone: +85266279904, email: wing-tung.yeung@polyu.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06298123, orgStudyIdInfo id: adjuvant-03, briefTitle: Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Chen Xiaoping, class: OTHER, descriptionModule briefSummary: The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Adjuvant Immunotherapy, conditions: Checkpoint Inhibitor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 304, type: ACTUAL, armsInterventionsModule interventions name: Anti-PD-1 monoclonal antibody, outcomesModule primaryOutcomes measure: Recurrence-Free Survival (RFS), secondaryOutcomes measure: Overall Survival (OS), otherOutcomes measure: Imaging data (enhanced CT and MRI） and histopathology data, if available., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06298110, orgStudyIdInfo id: PRP in Abdominal hysterectomy, briefTitle: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2024-09-25, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy., conditionsModule conditions: Wound Heal, conditions: Abdominal Wound, conditions: PRP, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Platelets Rich plasma of the same patient, outcomesModule primaryOutcomes measure: changes in wound healing, secondaryOutcomes measure: Vancouver scar scale changes, secondaryOutcomes measure: Visual Analog Scale changes, secondaryOutcomes measure: Hospital readmission, secondaryOutcomes measure: Infection, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False