hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06305442, orgStudyIdInfo id: PR-24031, briefTitle: Microbiota Directed Food for Children With Moderate Acute Malnutrition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Washington University School of Medicine, descriptionModule briefSummary: Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF., conditionsModule conditions: Moderate Acute Malnutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, randomized, parallel group, clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Microbiota-Directed Food, interventions name: Ready-to-Use Supplementary Food, outcomesModule primaryOutcomes measure: Mean change in Weight-for-Length Z-score (WLZ), secondaryOutcomes measure: Microbial community repair, secondaryOutcomes measure: Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden), secondaryOutcomes measure: Mean change in Weight-for-Age Z-score (WAZ), secondaryOutcomes measure: Mean change in Length-for-Age Z-score (LAZ), secondaryOutcomes measure: Mean change in body composition (% body fat mass and % fat-free mass), secondaryOutcomes measure: Bayley Scales of early childhood development (cognitive, motor, language development), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Mirpur Study site, city: Dhaka, country: Bangladesh, contacts name: Dr. Jinat Alam, MPH, MBBS, role: CONTACT, phone: +8801676742255, email: jinat.alam@icddrb.com, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
protocolSection identificationModule nctId: NCT06305429, orgStudyIdInfo id: HABITE, briefTitle: Encouraging Positive Parenting Habits, acronym: HABITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: D'Or Institute for Research and Education, class: OTHER, collaborators name: Okinawa Institute of Science and Technology Graduate University, descriptionModule briefSummary: This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open, single-group trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HabitE (effective parenting habit) program (in Brazilian Portuguese), outcomesModule primaryOutcomes measure: Number of videos viewed, primaryOutcomes measure: Percentage of completed daily ratings, primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Parent-rated child's difficulties with daily transitions, secondaryOutcomes measure: Parent-rated child's impairment related to transition difficulties, secondaryOutcomes measure: Inconsistent parenting, secondaryOutcomes measure: Use of physical control, secondaryOutcomes measure: Hostility toward child, secondaryOutcomes measure: Parent Stress, otherOutcomes measure: ADHD symptoms, otherOutcomes measure: ODD symptoms, otherOutcomes measure: Irritability, otherOutcomes measure: Proactive parenting, otherOutcomes measure: Use of positive reinforcement, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06305403, orgStudyIdInfo id: VEXUS1, briefTitle: VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2025-05-18, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined., conditionsModule conditions: Sepsis, conditions: Acute Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: serum creatinin level, outcomesModule primaryOutcomes measure: ngal, primaryOutcomes measure: VEXUS, secondaryOutcomes measure: MORTALİTY, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305390, orgStudyIdInfo id: 2022-003905-31, briefTitle: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer., acronym: RF2021-1237227, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa., conditionsModule conditions: Clinical Suspicion of Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 167, type: ESTIMATED, armsInterventionsModule interventions name: PET/MRI, outcomesModule primaryOutcomes measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa), secondaryOutcomes measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele, status: RECRUITING, city: Milano, zip: 20132, country: Italy, contacts name: Maria Picchio, MD, role: CONTACT, phone: 02-26436117, email: Picchio.maria@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06305377, orgStudyIdInfo id: DESPED-T1 study, briefTitle: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Giulio Frontino, class: OTHER, descriptionModule briefSummary: The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Tandem Control IQ, outcomesModule primaryOutcomes measure: Glucometric data, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305364, orgStudyIdInfo id: CL-1001, briefTitle: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Jubaan Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance., conditionsModule conditions: Colorectal Neoplasms, conditions: Gastrointestinal Microbiome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, maskingDescription: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score., enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Gixam, outcomesModule primaryOutcomes measure: Primary Safety Endpoint - Number of device related adverse events and serious adverse events, primaryOutcomes measure: Primary Efficacy Endpoint - Gixam's diagnostic accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westside GI, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Theodore Bortz, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NewYork-Presbyterian / Columbia University Irving Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Elissa Lynch, role: CONTACT, contacts name: Daniel Freedberg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06305351, orgStudyIdInfo id: K-757 P008, briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-07, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kallyope Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM), conditionsModule conditions: Obesity, conditions: Type 2 Diabetes Mellitus (T2DM), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: K-757 and K-833 QD, interventions name: K-757 and K-833 BID, interventions name: Matching placebo to K-757 and K-833 QD, interventions name: Matching placebo to K-757 and K-833 BID, outcomesModule primaryOutcomes measure: Proportion of participants who experienced 1 or more treatment-emergent AEs, primaryOutcomes measure: Proportion of participants who discontinued study medication due to an AE, secondaryOutcomes measure: Area under the concentration-time curve [AUC] of plasma K-757, secondaryOutcomes measure: AUC of plasma K-833, secondaryOutcomes measure: Maximum concentration [Cmax] of plasma K-757, secondaryOutcomes measure: Cmax of plasma K-833, secondaryOutcomes measure: Time of maximum concentration [Tmax] of plasma K-757, secondaryOutcomes measure: Tmax of plasma K-833, secondaryOutcomes measure: Clearance [Cl] of plasma K-757, secondaryOutcomes measure: Cl of plasma K-833, secondaryOutcomes measure: Volume of distribution at steady-state [Vdss] of plasma K-757, secondaryOutcomes measure: Vdss of plasma K-833, secondaryOutcomes measure: Half-life [t1/2] of plasma K-757, secondaryOutcomes measure: t1/2 of plasma K-833, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: QPS Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33143, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
protocolSection identificationModule nctId: NCT06305312, orgStudyIdInfo id: HCI166685, secondaryIdInfos id: 1R01CA282409-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01CA282409-01, briefTitle: Community Services Navigation to Advance Health Equity in Breast Cancer Screening, acronym: B-SINCERE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1450, type: ESTIMATED, armsInterventionsModule interventions name: Community Service Navigation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener, primaryOutcomes measure: Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Elissa Ozanne, PhD, role: CONTACT, phone: 801-213-4130, email: Elissa.Ozanne@hsc.utah.edu, contacts name: Tracy Onega, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
protocolSection identificationModule nctId: NCT06305299, orgStudyIdInfo id: LCCC2152-ATL, briefTitle: Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy., conditionsModule conditions: Ovary Neoplasm, conditions: Ovarian Cancer, conditions: Epithelial Ovarian Cancer, conditions: Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: iC9-CAR.B7-H3 T cells, 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), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: The disease control rate (DCR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lineberger Comprehensive Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Caroline Babinec, role: CONTACT, email: Caroline_babinec@med.unc.edu, contacts name: Linda Van Le, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False