hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06360562, orgStudyIdInfo id: 2020P002418, briefTitle: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM), statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-15, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-04-25, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality., conditionsModule conditions: Mood Disorders, conditions: Anxiety Disorders, conditions: Psychotic Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Resilience Training, outcomesModule primaryOutcomes measure: Discomfort with Others, primaryOutcomes measure: Intervention Feasibility and Acceptability, primaryOutcomes measure: Penn Emotion Recognition Test, primaryOutcomes measure: Stop Distance Paradigm, secondaryOutcomes measure: Beck Depression Inventory, secondaryOutcomes measure: Spielberger State-Trait Anxiety Inventory, secondaryOutcomes measure: Prodromal Questionnaire- Brief, secondaryOutcomes measure: Connor-Davidson Resilience Scale, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Daphne J Holt, MD, PhD, role: CONTACT, phone: 617-726-7618, email: dholt@mgh.harvard.edu, contacts name: Nicole DeTore, PhD, role: CONTACT, phone: 617-726-2065, email: ndetore@mgh.harvard.edu, geoPoint lat: 42.37787, lon: -71.062, hasResults: False
protocolSection identificationModule nctId: NCT06360536, orgStudyIdInfo id: IRB-300012634, secondaryIdInfos id: P50MD017338, type: NIH, link: https://reporter.nih.gov/quickSearch/P50MD017338, briefTitle: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women, acronym: OVERCOME-IT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program., conditionsModule conditions: Overweight or Obesity, conditions: Prediabetes or Diabetes, conditions: Prehypertension (Elevated Blood Pressure) or Hypertension, conditions: Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Resistance Training, outcomesModule primaryOutcomes measure: Feasibility of recruitment, primaryOutcomes measure: Feasibility of retention, primaryOutcomes measure: Intervention adherence, secondaryOutcomes measure: Change in resistance training behaviors, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in HbA1C, secondaryOutcomes measure: Change in body composition, secondaryOutcomes measure: Change in handgrip strength, secondaryOutcomes measure: Change in the number of chair stands, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Jackie Grant, role: CONTACT, phone: 205-975-7108, email: jroche@uabmc.edu, contacts name: Amber Kinsey, role: CONTACT, phone: 205-934-9851, email: akinsey@uabmc.edu, contacts name: Amber W Kinsey, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
protocolSection identificationModule nctId: NCT06360523, orgStudyIdInfo id: CRE-2024.141, briefTitle: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-07-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: AI modal, outcomesModule primaryOutcomes measure: Prostate Cancer detection rate of ISUP grade group ≥2, secondaryOutcomes measure: Diagnosis of any grade of prostate cancer, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06360510, orgStudyIdInfo id: 44, briefTitle: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-05, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS)., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: %5 dextrose injection, interventions name: betamethasone injection, outcomesModule primaryOutcomes measure: vas, secondaryOutcomes measure: boston carpal tunnel syndrome questionnaire, secondaryOutcomes measure: median nerve cross sectional area, secondaryOutcomes measure: tinnel test positivity, secondaryOutcomes measure: phalen test positivity, secondaryOutcomes measure: duruöz hand index, secondaryOutcomes measure: global evaluation of treatment outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06360497, orgStudyIdInfo id: 202206090070, briefTitle: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2022-10-09, completionDateStruct date: 2022-10-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Normal University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory., conditionsModule conditions: MM Group, conditions: LKCM Group, conditions: Waitlist Group, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 152, type: ACTUAL, armsInterventionsModule interventions name: mindfulness meditation intervention and loving-kindness and compassion meditation intervention, outcomesModule primaryOutcomes measure: The Depression Anxiety Stress Scale, primaryOutcomes measure: The Philadelphia Mindfulness Scale, primaryOutcomes measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire, secondaryOutcomes measure: The Emotional Word Lists, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 56 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xianglong Zeng, city: Beijing, state: Beijing, zip: 100875, country: China, geoPoint lat: 39.9075, lon: 116.39723, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-27, uploadDate: 2024-03-27T06:37, filename: Prot_SAP_000.pdf, size: 125410, hasResults: False
protocolSection identificationModule nctId: NCT06360484, orgStudyIdInfo id: PrevelanceHDVSudan, briefTitle: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-09-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: National Center for Gastroentestinal and Liver Disease, class: OTHER, descriptionModule briefSummary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG, conditionsModule conditions: Hepatitis B, conditions: Hepatitis D, conditions: Viral Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: investigations for Hepatitis D virus, outcomesModule primaryOutcomes measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases., eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Center for Gastrointestinal and Liver Diseases, city: Khartoum, zip: 15004, country: Sudan, geoPoint lat: 15.55177, lon: 32.53241, hasResults: False
protocolSection identificationModule nctId: NCT06360471, orgStudyIdInfo id: FS-FMC, briefTitle: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2032-10-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.Statistical analysis of the data will be performed., conditionsModule conditions: Fertility Issues, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule interventions name: fertility preservation, outcomesModule primaryOutcomes measure: 5-year cumulative live birth rate, secondaryOutcomes measure: Ovarian function(AMH levels), secondaryOutcomes measure: Ovarian function(AFC counts), secondaryOutcomes measure: Newborn malformation rate, secondaryOutcomes measure: Tumor recurrence rate, secondaryOutcomes measure: Tumor survival rate, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Xiang Ma, MD. PHD, role: CONTACT, phone: +8618001581878, email: sxmaxiang@126.com, contacts name: Nan Lu, role: CONTACT, phone: +8615950476023, email: nancylu1993@126.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06360458, orgStudyIdInfo id: MRCTA,ECFAH of FMU[2024]368, briefTitle: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Wan-Jin Chen, class: OTHER, descriptionModule briefSummary: The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 735, type: ESTIMATED, armsInterventionsModule interventions name: Methylprednisolone, outcomesModule primaryOutcomes measure: Mortality at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360445, orgStudyIdInfo id: HD1912BE202201, briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-26, primaryCompletionDateStruct date: 2022-08-21, completionDateStruct date: 2022-08-21, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: CSPC Ouyi Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 2-period Crossover Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Olaparib Tablet test formulation 100mg, interventions name: Olaparib Tablet reference formulation 100mg, interventions name: Olaparib Tablet test formulation 150mg, interventions name: Olaparib Tablet reference formulation 150mg, outcomesModule primaryOutcomes measure: Cmax Description: Maximum observed plasma concentration, primaryOutcomes measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time, primaryOutcomes measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration, secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Apparent total body clearance (Cl/F), secondaryOutcomes measure: Apparent volume of distribution (V/F), secondaryOutcomes measure: Number of participants with Adverse Events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06360406, orgStudyIdInfo id: D1346R00009, briefTitle: Real-World Treatment Study of Koselugo (Selumetinib), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-09-30, completionDateStruct date: 2031-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.This study will provide information on the Korean patient population that is treated with the study drug., conditionsModule conditions: Neurofibromatosis 1, conditions: Neurofibroma, Plexiform, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Adverse events (AEs) rate, primaryOutcomes measure: Physeal dysplasia occurance rate, secondaryOutcomes measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360380, orgStudyIdInfo id: AQP-CLP-004, briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System, acronym: REFORM-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-03, primaryCompletionDateStruct date: 2024-11-03, completionDateStruct date: 2024-12-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AquaPass Medical Ltd., class: INDUSTRY, descriptionModule briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.Patients will wear a lightweight suit that helps remove excess fluids through their sweat.We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.Participants will select if to be treated at their home or in the outpatient clinic., conditionsModule conditions: Chronic Heart Failure, conditions: CKD Stage 3, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: AquaPass System, outcomesModule primaryOutcomes measure: AquaPass Performance Evaluation, secondaryOutcomes measure: AquaPass Safety Evaluation, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False