hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06389656, orgStudyIdInfo id: 1K23DK135791-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23DK135791-01, briefTitle: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes, acronym: SWIFT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Miriam Hospital, class: OTHER, descriptionModule briefSummary: Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention., conditionsModule conditions: Body Weight, conditions: Weight Bias, conditions: Weight Stigma, conditions: Weight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Weight Management, interventions name: Weight Bias Internalization, outcomesModule primaryOutcomes measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM), primaryOutcomes measure: In depth qualitative feedback from teens regarding intervention acceptability and feasibility, primaryOutcomes measure: Attendance rates at intervention sessions, primaryOutcomes measure: Retention rate for intervention sessions, secondaryOutcomes measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M), secondaryOutcomes measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ), secondaryOutcomes measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS), secondaryOutcomes measure: Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS), secondaryOutcomes measure: Anthropometrics, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Miriam Hospital, status: RECRUITING, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Katherine Darling, PhD, role: CONTACT, phone: 401-793-8688, email: katherine_darling@brown.edu, contacts name: Andrea M Grenga, BA, role: CONTACT, phone: 401-793-8997, email: agrenga@lifespan.org, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False
protocolSection identificationModule nctId: NCT06389643, orgStudyIdInfo id: 11/WIM/2021, briefTitle: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-19, primaryCompletionDateStruct date: 2022-09-14, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Military Institute od Medicine National Research Institute, class: OTHER, descriptionModule briefSummary: Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC), conditionsModule conditions: Aphakia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Four-point scleral fixation of Akreos AO60 IOL, interventions name: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique, outcomesModule primaryOutcomes measure: BCVA, primaryOutcomes measure: RE, primaryOutcomes measure: ECC, secondaryOutcomes measure: Number of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military Institute of Medicine - National Research Institute, city: Warsaw, zip: 04-141, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
protocolSection identificationModule nctId: NCT06389630, orgStudyIdInfo id: 0012, briefTitle: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills, acronym: EETDTMSSİS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2025-01-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kocaeli Sağlık ve Teknoloji Üniversitesi, class: OTHER, descriptionModule briefSummary: Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.Purpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.Design: A pretest-posttest two-group, quasi-experimental design will be used in the study., conditionsModule conditions: Complication of Injection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: video-assisted training group, interventions name: low fidelity simulation model group, outcomesModule primaryOutcomes measure: subcutaneous injection skills, primaryOutcomes measure: ecchymosis, primaryOutcomes measure: hematoma, primaryOutcomes measure: lipoarthrrophy, primaryOutcomes measure: lipohypertrophy, primaryOutcomes measure: pain, primaryOutcomes measure: blood glucose level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06389617, orgStudyIdInfo id: USM/JEPeM/KK/24010061, briefTitle: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hospital Universiti Sains Malaysia, class: OTHER, descriptionModule briefSummary: To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant, conditionsModule conditions: End Stage Renal Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone, outcomesModule primaryOutcomes measure: To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg, primaryOutcomes measure: To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg, secondaryOutcomes measure: To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06389604, orgStudyIdInfo id: NL86367.068.24, briefTitle: Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience, acronym: Prep4heat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast., conditionsModule conditions: Body Temperature Changes, conditions: Heat Exposure, conditions: Heat Stress, conditions: Hyperthermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Non-randomized, within subject experiemental trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: No blinding due to nature of intervention, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Heat acclimation, outcomesModule primaryOutcomes measure: Core temperature, secondaryOutcomes measure: Skin temperature, secondaryOutcomes measure: Sweat rate, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Skin blood flow, secondaryOutcomes measure: Energy expenditure, secondaryOutcomes measure: Substrate oxidation, secondaryOutcomes measure: Plasma metabolites, secondaryOutcomes measure: Brain blood flow, secondaryOutcomes measure: Flow-mediated dilation, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06389591, orgStudyIdInfo id: OCR44973, briefTitle: RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma., conditionsModule conditions: Recurrent Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1), interventions name: RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2), outcomesModule primaryOutcomes measure: Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines, primaryOutcomes measure: Incidence of investigational treatment related toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health, city: Gainesville, state: Florida, zip: 32608, country: United States, contacts name: Marcia Hodik, role: CONTACT, phone: 352-273-9000, email: marcia.hodik@neurosurgery.ufl.edu, contacts name: Ashley Ghiaseddin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False
protocolSection identificationModule nctId: NCT06389578, orgStudyIdInfo id: HZNP-TEP-103, briefTitle: A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-14, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-09-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Horizon Therapeutics USA, Inc., class: INDUSTRY, descriptionModule briefSummary: The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Teprotumumab, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab, primaryOutcomes measure: PK: Maximum Serum Concentration (Cmax) of Teprotumumab, primaryOutcomes measure: Number of Participants With Adverse Events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bascom Palmer Eye Institute - University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Barnes Jewish Hospital Washington University, city: Saint Louis, state: Missouri, zip: 63108, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Neuro-Eye Clinical Trials, city: Bellaire, state: Texas, zip: 77401, country: United States, geoPoint lat: 29.70579, lon: -95.45883, hasResults: False
protocolSection identificationModule nctId: NCT06389565, orgStudyIdInfo id: 2024p000857, briefTitle: Pilot Randomized Clinical Trial of Change My Story, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: University of Ibadan, descriptionModule briefSummary: Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress., conditionsModule conditions: Hiv, conditions: Depression, conditions: Psychological Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Problem Solving Therapy, interventions name: Change My Story, outcomesModule primaryOutcomes measure: Engagement, primaryOutcomes measure: Satisfaction, primaryOutcomes measure: Feasibility 1, primaryOutcomes measure: Feasibility 2, primaryOutcomes measure: Feasibility 3, primaryOutcomes measure: Feasibility 4, primaryOutcomes measure: Feasibility 5, primaryOutcomes measure: Feasibility 6, primaryOutcomes measure: Feasibility 7, primaryOutcomes measure: Acceptability 1, primaryOutcomes measure: Acceptability 2, primaryOutcomes measure: Acceptability 3, primaryOutcomes measure: Acceptability 4, primaryOutcomes measure: Acceptability 5, secondaryOutcomes measure: Remission of depression., secondaryOutcomes measure: Remission of psychological distress., secondaryOutcomes measure: ART adherence, secondaryOutcomes measure: Viral suppression, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06389552, orgStudyIdInfo id: IN_CTP_N01, briefTitle: Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: HK inno.N Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery., conditionsModule conditions: Adjuvant Chemotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul ST. Mary's Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Myung-Ah Lee, role: CONTACT, contacts name: Myung-Ah Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06389539, orgStudyIdInfo id: Pro00070958, briefTitle: Synbiotic to Attenuate Resorption of the Skeleton, acronym: STARS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hebrew SeniorLife, class: OTHER, collaborators name: Solarea Bio, Inc, collaborators name: Beth Israel Deaconess Medical Center, collaborators name: Tufts University, collaborators name: MaineHealth, descriptionModule briefSummary: This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women., conditionsModule conditions: Osteoporosis, conditions: Inflammation, conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: Study staff involved in participants' outcome assessments will be masked to the intervention assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: SBD111 medical food, interventions name: Placebo, outcomesModule primaryOutcomes measure: Lumbar spine BMD (g/cm2), secondaryOutcomes measure: Vertebral compressive strength (N), secondaryOutcomes measure: volumetric BMD, secondaryOutcomes measure: C-terminal cross-linked telopeptide of type I collagen (β-CTX), secondaryOutcomes measure: Procollagen Type I Intact N-terminal Propeptide (P1NP), eligibilityModule sex: FEMALE, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hebrew SeniorLife, city: Roslindale, state: Massachusetts, zip: 02131, country: United States, contacts name: Kathryn Tasker, role: CONTACT, phone: 617-971-5351, email: KathyTasker@hsl.harvard.edu, geoPoint lat: 42.29121, lon: -71.1245, hasResults: False