hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06347198, orgStudyIdInfo id: 20230807-02, briefTitle: Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, collaborators name: Huazhong University of Science and Technology, descriptionModule briefSummary: This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fruquintinib, interventions name: Sintilimab, interventions name: Inulin, outcomesModule primaryOutcomes measure: Intestinal microbiota diversity, abundance and taxonomic information, primaryOutcomes measure: adverse events, secondaryOutcomes measure: Objective remission rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of remission (DOR), secondaryOutcomes measure: Concentration of various serum metabolites, secondaryOutcomes measure: Concentration of various plasma Cytokine Changes, secondaryOutcomes measure: Frequency of peripheral blood lymphocyte, otherOutcomes measure: Correlation between dietary fiber intake and progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Min Jin, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Min Jin, role: CONTACT, phone: 18807108606, email: minjin86@126.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06347172, orgStudyIdInfo id: 2024p000278, secondaryIdInfos id: U54AG063546, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG063546, briefTitle: Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Brown University, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified., conditionsModule conditions: Alzheimer Disease, conditions: Mild Cognitive Impairment, conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Nudge Intervention, outcomesModule primaryOutcomes measure: Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information, secondaryOutcomes measure: Number of nudges that fire as intended: Fidelity, secondaryOutcomes measure: Discontinuation or prescribed reduction in medication, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06347159, orgStudyIdInfo id: EDG-7500-102, briefTitle: A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Edgewise Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy., conditionsModule conditions: Hypertrophic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: EDG-7500, interventions name: EDG-7500, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: Change from baseline in left ventricular outflow tract (LVOT) gradient, secondaryOutcomes measure: Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine), status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Edgewise Therapeutics, Inc., role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
protocolSection identificationModule nctId: NCT06347146, orgStudyIdInfo id: R01HD112323, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD112323, secondaryIdInfos id: R01HD112323, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD112323, briefTitle: Bridges2Scale: Testing Implementation Strategies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect., conditionsModule conditions: HIV/AIDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: Financial Literacy Training (FLT) workshops, interventions name: Mentorship, interventions name: Income Generation Activity (IGA), interventions name: Youth Development Accounts (YDA), outcomesModule primaryOutcomes measure: Intervention Fidelity, primaryOutcomes measure: HIV prevalence, secondaryOutcomes measure: Sexual risk-taking behavior, secondaryOutcomes measure: Economic stability, secondaryOutcomes measure: School attainment, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Proportion of adolescents living with HIV who are virally suppressed, secondaryOutcomes measure: Proportion of HIV negative adolescents who use PrEP, secondaryOutcomes measure: Hopelessness, secondaryOutcomes measure: Self-Esteem, secondaryOutcomes measure: Self-concept, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06347107, orgStudyIdInfo id: S67215, briefTitle: Robotic Subretinal tPA Injection Study, acronym: RoTIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: DORC Dutch Ophthalmic Research Center International BV, descriptionModule briefSummary: In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:* The robotic stabilizer (prototype - FAMHP approval received)* 41G subretinal needle (CE marked - used within label)* Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review., conditionsModule conditions: Subretinal Hemorrhage, conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Investigator-initiated, academic, mono-center, prospective, interventional case study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Robotic subretinal tPA injection, outcomesModule primaryOutcomes measure: Percentage of patients with succesful subretinal insertion of the robot-held 41G needle, primaryOutcomes measure: Percentage of patients with stable subretinal position of the needle for at least 3 minutes., secondaryOutcomes measure: Device-related adverse events, secondaryOutcomes measure: Functional outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Peter Stalmans, MD PhD, role: CONTACT, email: peter.stalmans@uzleuven.be, contacts name: Ivo De Clerck, MD, role: CONTACT, email: ivo.declerck@uzleuven.be, contacts name: Ivo De Clerck, MD, role: SUB_INVESTIGATOR, contacts name: Peter Stalmans, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
protocolSection identificationModule nctId: NCT06347081, orgStudyIdInfo id: P.T.REC/012/00449, briefTitle: Effect of Nd-YAG Laser on Hypertrophic Scar, acronym: Nd-YAG, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures., conditionsModule conditions: Hypertrophic Scar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one treatment one control group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Nd- YAG laser at 532nm wavelength, outcomesModule primaryOutcomes measure: hypertrophic scar maturation, primaryOutcomes measure: hypertrophic scar volume, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, city: Cairo, zip: 12613, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06347068, orgStudyIdInfo id: LCCC2128-ATL, briefTitle: Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, collaborators name: Bellicum Pharmaceuticals, descriptionModule briefSummary: This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC)., conditionsModule conditions: Breast Cancer, conditions: Relapse, conditions: Resistant Cancer, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: iC9-CAR.B7-H3 T Cell Therapy, interventions name: cyclophosphamide, interventions name: fludarabine, outcomesModule primaryOutcomes measure: Toxicity: NCI-CTCAE, primaryOutcomes measure: Toxicity: Cytokine Release Syndrome (CRS), primaryOutcomes measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS), secondaryOutcomes measure: The recommended phase 2 dose (RP2D) NCI-CTCAE v5., secondaryOutcomes measure: The recommended phase 2 dose (RP2D) CRS Grading, secondaryOutcomes measure: The recommended phase 2 dose (RP2D), secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Duration of Response (DOR), eligibilityModule sex: ALL, minimumAge: 18 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: Catherine Cheng, role: CONTACT, phone: 919-445-4208, email: catherine_cheng@med.unc.edu, contacts name: E. Claire Dees, MD, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06347055, orgStudyIdInfo id: 403690, briefTitle: NeuroControl of Nicotine Dependence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2030-03-25, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Missouri-Columbia, class: OTHER, descriptionModule briefSummary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours., conditionsModule conditions: Nicotine Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Repetitive Transcranial Magnetic Stimulation (rTMS), outcomesModule primaryOutcomes measure: Acute effects of cTBS on cognitive control, secondaryOutcomes measure: Exploratory: Acute effects of cTBS on fMRI brain response, otherOutcomes measure: Safety and Tolerability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06347042, orgStudyIdInfo id: 012/004897, briefTitle: Effect of Qigong on Sleep Quality in Fibromyalgia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: qigong exercise + routine medical treatment +Anti-inflammatory diet, interventions name: routine medical treatment +Anti-inflammatory diet only, outcomesModule primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Heart Rate variability, secondaryOutcomes measure: Quality of Life o measure the quality of life of patients with problems found fibromyalgia., secondaryOutcomes measure: pain self-administered questionnaire, secondaryOutcomes measure: Fatigue :prevalence and severity of fatigue, secondaryOutcomes measure: Depression and Anxiety assess Depression and Anxiety, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical therapy Cairo University, city: Cairo, state: Giza, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06346990, orgStudyIdInfo id: Faculty 2023-2024-2-2, briefTitle: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-14, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Applied Science Private University, class: OTHER, descriptionModule briefSummary: This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Artery Bypass Graft Surgery, conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Holy Quran Recital, outcomesModule primaryOutcomes measure: Delirium, secondaryOutcomes measure: Length of stay-ICU, secondaryOutcomes measure: Length of stay-hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False