hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06360367, orgStudyIdInfo id: 2023-00060, briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-10-22, completionDateStruct date: 2024-10-22, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Hawaii, class: OTHER, collaborators name: United States Department of Agriculture (USDA), collaborators name: Pennington Biomedical Research Center, descriptionModule briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY., conditionsModule conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: HI-FLY Curriculum, interventions name: HI-FLY Curriculum + PortionSize Ed app, outcomesModule primaryOutcomes measure: Feasibility- Study enrollment, primaryOutcomes measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses, primaryOutcomes measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores, primaryOutcomes measure: Acceptability- PortionSize Ed app usage data, primaryOutcomes measure: Acceptability- Reason for study drop out, primaryOutcomes measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score, primaryOutcomes measure: Efficacy- Change in HEI-2020 component scores, primaryOutcomes measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey, primaryOutcomes measure: Feasibility- Study Attrition, secondaryOutcomes measure: Change in body weight, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Hawaii at Manoa, status: RECRUITING, city: Honolulu, state: Hawaii, zip: 96822, country: United States, contacts name: Chloe P Lozano, PhD, role: CONTACT, phone: 808-956-7095, email: cpanizza@hawaii.edu, geoPoint lat: 21.30694, lon: -157.85833, hasResults: False
protocolSection identificationModule nctId: NCT06360354, orgStudyIdInfo id: 20230223, briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers., conditionsModule conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 282, type: ESTIMATED, armsInterventionsModule interventions name: AMG 193, interventions name: Gemcitabine, interventions name: Nab-paclitaxel, interventions name: Cisplatin, interventions name: Pembrolizumab, interventions name: Modified FOLFIRINOX, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT), primaryOutcomes measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE), primaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAE), secondaryOutcomes measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), secondaryOutcomes measure: Disease Control (DC) per RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) per RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR) per RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) per RECIST v1.1, secondaryOutcomes measure: Progression-free Survival (PFS) per RECIST v1.1, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of AMG193, secondaryOutcomes measure: Time to Maximum Plasma Concentration (tmax) of AMG193, secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope National Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False
protocolSection identificationModule nctId: NCT06360341, orgStudyIdInfo id: 202301946, briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes., conditionsModule conditions: Low Back Pain, Mechanical, conditions: Acute Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Emergency Department Digital Pain Self-Management Intervention (EDPSI), interventions name: Routine Discharge Care, outcomesModule primaryOutcomes measure: Improving Self-Management Health Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health Shand's Adult Emergency Department, city: Gainesville, state: Florida, zip: 32608, country: United States, contacts name: Alexandria A Carey, MSN, MBA-HC, role: CONTACT, phone: 661-607-1702, email: alexandria.carey@ufl.edu, contacts name: Angela R Starkweather, PhD, role: CONTACT, phone: (352) 273-6323, email: a.starkweather@ufl.edu, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False
protocolSection identificationModule nctId: NCT06360315, orgStudyIdInfo id: 202201265, briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure., conditionsModule conditions: Chronic Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Incentive letter for pneumococcal vaccination to the patient and to the GP, outcomesModule primaryOutcomes measure: 1-year Pneumococcus vaccination rate, secondaryOutcomes measure: 1-year all-cause hospital admission rate, secondaryOutcomes measure: 1-year specific hospital admission rate, secondaryOutcomes measure: 1-year all-cause mortality rate, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montpellier University Hospital, city: Montpellier, zip: 34090, country: France, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
protocolSection identificationModule nctId: NCT06360289, orgStudyIdInfo id: ALN-TTR-NT-003, briefTitle: Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alnylam Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy., conditionsModule conditions: Hereditary Amyloidosis, Transthyretin-Related, conditions: Asymptomatic Carrier State, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Standard of Care, outcomesModule primaryOutcomes measure: NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline, primaryOutcomes measure: Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy, secondaryOutcomes measure: Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline, secondaryOutcomes measure: Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy, secondaryOutcomes measure: Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases, secondaryOutcomes measure: Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants, secondaryOutcomes measure: Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP), city: Paris, state: Île-de-France, zip: 94270, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06360276, orgStudyIdInfo id: 14012021, briefTitle: Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-14, primaryCompletionDateStruct date: 2022-08-02, completionDateStruct date: 2022-08-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.Hypotheses for research:1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping., conditionsModule conditions: Fatigue, conditions: Coping Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Seated Exercises, interventions name: Psychoeducational Rehabilitation, interventions name: Routine Care, outcomesModule primaryOutcomes measure: Piper Fatigue Scale, primaryOutcomes measure: Mini-Mental Adjustment to Cancer Scale, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Nursing, city: Alexandria, zip: 56321, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
protocolSection identificationModule nctId: NCT06360263, orgStudyIdInfo id: #1-6/2023, briefTitle: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-11, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Esraa Salem Kamal, class: OTHER, descriptionModule briefSummary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement., conditionsModule conditions: Bone Loss, Alveolar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Densah bur in combination with activated plasma albumin gel, outcomesModule primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Implant stability, primaryOutcomes measure: Vertical bone height gain, primaryOutcomes measure: Bone density around implant, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Alexandria University, status: RECRUITING, city: Alexandria, country: Egypt, contacts name: Esraa S Kamal, BDS, role: CONTACT, phone: 106 054 3345, phoneExt: +20, email: esraasalemkamal@gmail.com, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
protocolSection identificationModule nctId: NCT06360250, orgStudyIdInfo id: B2001-F20220601, briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Changchun BCHT Biotechnology Co., class: INDUSTRY, collaborators name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, collaborators name: Anning City First People's Hospital, descriptionModule briefSummary: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation, conditionsModule conditions: Clostridium Tetanus, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, interventions name: Tetanus human immunoglobulin (HTIG), interventions name: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo, interventions name: Adsorbed tetanus vaccine (TT), outcomesModule primaryOutcomes measure: Safety evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: Immunogenicity evaluation index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360237, orgStudyIdInfo id: ISIS 678354, briefTitle: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS), statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ionis Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS)., conditionsModule conditions: Familial Chylomicronemia Syndrome, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: Olezarsen, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360224, orgStudyIdInfo id: CASES, briefTitle: Collect Flow and Ultrasound Images of Coronary Bypass Grafts, acronym: CASES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2029-05-15, completionDateStruct date: 2029-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Medistim ASA, class: INDUSTRY, descriptionModule briefSummary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG)., conditionsModule conditions: Cardiac Bypass Surgery (CABG), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes, outcomesModule primaryOutcomes measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False