hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06285643, orgStudyIdInfo id: ASK-PD5-CS201, briefTitle: A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD), acronym: REGENERATE-PD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Asklepios Biopharmaceutical, Inc., class: INDUSTRY, collaborators name: Bayer, descriptionModule briefSummary: The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 87, type: ESTIMATED, armsInterventionsModule interventions name: AAV2-GDNF Gene therapy, interventions name: Control Surgery, outcomesModule primaryOutcomes measure: Motor symptoms-MDS-UPDRS parts 2 and 3, primaryOutcomes measure: PD Motor Diary Non-Motor symptoms-MDS-UPDRS part1, primaryOutcomes measure: PDQ39 Levodopa Equivalent Daily Dose, secondaryOutcomes measure: Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary, secondaryOutcomes measure: Change from baseline in the MDS-UPDRS part 1 and PDQ-39, secondaryOutcomes measure: Change in Levodopa equivalent daily dose, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06285617, orgStudyIdInfo id: 2022GDRC016, briefTitle: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis, acronym: SAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Xinqiao Hospital of Chongqing, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group., conditionsModule conditions: Subacute Thyroiditis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prednisone, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: 1-week predisone+1-week celecoxib, interventions name: 6-weeks predisone, outcomesModule primaryOutcomes measure: The difference in efficacy between the two groups at the completion., secondaryOutcomes measure: Thyroid function, secondaryOutcomes measure: Total cholesterol (TC), secondaryOutcomes measure: Triglycerides (TG), secondaryOutcomes measure: Systolic blood pressure (SBP), secondaryOutcomes measure: Diastolic blood pressure (DBP), secondaryOutcomes measure: Parathyroid hormone (PTH), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06285604, orgStudyIdInfo id: IRB-20230398-R, briefTitle: Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Women's Hospital School Of Medicine Zhejiang University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.* To provide objective basis for clinical rational use of blood in the selection of blood products.Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators., conditionsModule conditions: Neonatal Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Blood transfusion, outcomesModule primaryOutcomes measure: Clinical efficacy of different red blood cell products transfusion in anemic neonates, primaryOutcomes measure: The changes of inflammatory response before and after transfusion in anemic neonates, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Women's Hospital School of Medicine Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06285578, orgStudyIdInfo id: MOST 107-2410-H-277-003, briefTitle: Effects of Probiotic and HIIT in Obese Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2019-01-31, completionDateStruct date: 2019-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Taipei, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women., conditionsModule conditions: Cardiorespiratory Fitness, conditions: Metabolism, conditions: Anthropometry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Probiotics supplementation, interventions name: HIIT training, interventions name: Placebo supplementation, outcomesModule primaryOutcomes measure: Height, primaryOutcomes measure: Body weight, primaryOutcomes measure: Body mass index (BMI), primaryOutcomes measure: Body fat percentage, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Hip circumference, primaryOutcomes measure: Maximum oxygen uptake (VO2max), primaryOutcomes measure: Time to exhaustion (TTE), primaryOutcomes measure: Running economy (RE), primaryOutcomes measure: Fasting blood glucose (FBG), primaryOutcomes measure: Total cholesterol (TC), primaryOutcomes measure: Triglyceride (TG), primaryOutcomes measure: High-density lipoprotein cholesterol (HDL-C), primaryOutcomes measure: Low-density lipoprotein cholesterol (LDL-C), secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Bone mineral density (BMD), secondaryOutcomes measure: Caloric intake, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Taipei, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06285552, orgStudyIdInfo id: 4792/0842, briefTitle: Evaluation of the Comprehensive Family Support Program (PAIF), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, collaborators name: Gobierno de Cantabria, collaborators name: Loyola University, collaborators name: University of Jaen, descriptionModule briefSummary: The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program., conditionsModule conditions: Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be assigned to the manualized program according to the inclusion criteria. The comparison group will be composed of families in areas where the intervention is not available but with similar sociodemographic characteristics., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Positive parenting PAIF program, outcomesModule primaryOutcomes measure: Perception of the parental role, primaryOutcomes measure: Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation), primaryOutcomes measure: Parenting practices (Overreactivity and Laxness), secondaryOutcomes measure: Satisfaction with the intervention, secondaryOutcomes measure: Children adjustment, secondaryOutcomes measure: Social support, secondaryOutcomes measure: Satisfaction with Family Life, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consejería de Inclusión Social, Juventud, Familias E Igualdad, status: RECRUITING, city: Santander, state: Cantabria, zip: 39004, country: Spain, contacts name: JOSÉ ANGEL RODRÍGUEZ, role: CONTACT, phone: 942 207 756, email: rodriguez_ja@cantabria.es, geoPoint lat: 43.46472, lon: -3.80444, hasResults: False
protocolSection identificationModule nctId: NCT06285526, orgStudyIdInfo id: 2023/0046/OB, secondaryIdInfos id: 2023-A00350-45, type: REGISTRY, domain: French Minister, briefTitle: Glycocalyx Monitoring in Major Abdominal Surgery, acronym: GLYCOCHIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-05, primaryCompletionDateStruct date: 2024-07-05, completionDateStruct date: 2025-01-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters., conditionsModule conditions: Major Abdominal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy, interventions name: Cephalic DuodenoPancreatectomy, outcomesModule primaryOutcomes measure: Glycocalyx thickness, secondaryOutcomes measure: Glycocalyx thickness and a biological marker of tissue hypoperfusion, secondaryOutcomes measure: Glycocalyx thickness and a biological marker of tissue hypoxia, secondaryOutcomes measure: Blood cell velocity and macrocirculatory function, secondaryOutcomes measure: Perfused capillary density and macrocirculatory function, secondaryOutcomes measure: Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rouen University Hospital, status: RECRUITING, city: Rouen, zip: 76000, country: France, contacts name: DEMAILLY Zoé, MD, role: CONTACT, phone: 02 32 88 24 40, phoneExt: +33, email: Zoe.Demailly@chu-rouen.fr, contacts name: Thomas CLAVIER, MD, role: CONTACT, phone: 02 32 88 82 92, phoneExt: +33, email: Thomas.Clavier@chu-rouen.fr, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False
protocolSection identificationModule nctId: NCT06285513, orgStudyIdInfo id: 2021/387/OB, secondaryIdInfos id: 2023-A00503-42, type: REGISTRY, domain: Frecnh Ministry, briefTitle: Cardiovascular Metabolic Remodeling in Shock, acronym: METASHOCK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved., conditionsModule conditions: Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac ultrasound, outcomesModule primaryOutcomes measure: Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Rouen, city: Rouen, country: France, contacts name: Grégoire JOLLY, MD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False
protocolSection identificationModule nctId: NCT06285500, orgStudyIdInfo id: UNIQUE, secondaryIdInfos id: 23-5095, type: OTHER, domain: University Health Network, briefTitle: Umbrella Study for Single Patient Treatments in Oncology, acronym: UNIQUE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments., conditionsModule conditions: Advanced Cancer, conditions: Rare Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Patient-specific treatments, outcomesModule primaryOutcomes measure: Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Progression-free survival rate, secondaryOutcomes measure: Number of participants with adverse events as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, Princess Margaret Cancer Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Amit Oza, Dr., role: CONTACT, phone: 416 946 4450, email: amit.oza@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06285487, orgStudyIdInfo id: 23-1600, briefTitle: Depression in Youth Onset Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes., conditionsModule conditions: Type 2 Diabetes, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Group Program, outcomesModule primaryOutcomes measure: Acceptability of IPT-T2D, primaryOutcomes measure: Depression Changes, primaryOutcomes measure: Changes in Glycemic Control, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
protocolSection identificationModule nctId: NCT06285461, orgStudyIdInfo id: T2566/2023, briefTitle: Food Intake, Endocrine Factors and Brown Fat, acronym: FoodBAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Turku University Hospital, class: OTHER_GOV, collaborators name: University of Turku, descriptionModule briefSummary: This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis)., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This will be a crossover study in which participants undergo two postprandial test days with meals with high- or low-hedonic reward and two weeks of washout between interventions., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Non-palatable meal, interventions name: Palatable meal, outcomesModule primaryOutcomes measure: Brown adipose tissue metabolism, primaryOutcomes measure: Changes in gut peptides, primaryOutcomes measure: Differences in μ-opioid receptors in the human brain, secondaryOutcomes measure: Energy expenditure/Meal-induced thermogenesis, secondaryOutcomes measure: Visual Analogue scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Turku PET Centre, status: RECRUITING, city: Turku, zip: 20520, country: Finland, contacts name: Kirsi A Virtanen, role: CONTACT, phone: +358407626564, email: kianvi@utu.fi, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
protocolSection identificationModule nctId: NCT06285448, orgStudyIdInfo id: A24-028, briefTitle: Feasibility of Lecanemab Registry and Clinical Outcome Measures, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners., conditionsModule conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lecanemab, outcomesModule primaryOutcomes measure: Feasibility of enrollment, primaryOutcomes measure: Feasibility of completing visits, primaryOutcomes measure: Qualitative experience at 3 months, primaryOutcomes measure: Qualitative experience at 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HealthPartners Neuroscience Center, city: Saint Paul, state: Minnesota, zip: 55130, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False