hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06282198, orgStudyIdInfo id: UCHCEU-13/02/24, briefTitle: Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses, acronym: IMU-DFM, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cardenal Herrera University, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses., conditionsModule conditions: Distal Femoral Musculoskeletal Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Gait Symmetry index measured in percentage (%), secondaryOutcomes measure: Sagittal range of movement of the knee measured with a goniometer, secondaryOutcomes measure: Muscular strength, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad CEU Cardenal Herrera, status: RECRUITING, city: Valencia, country: Spain, contacts name: JF Lisón, PhD, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
protocolSection identificationModule nctId: NCT06282172, orgStudyIdInfo id: BTL-785_CTUS1600, briefTitle: Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-25, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-12-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: BTL Industries Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat., conditionsModule conditions: Fat Burn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Treatment with BTL-785-7, outcomesModule primaryOutcomes measure: Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue., secondaryOutcomes measure: Investigation of post-treatment adipocyte apoptosis, secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, secondaryOutcomes measure: Comfort Evaluation Assessed by Therapy Comfort Questionnaire, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schweiger Dermatology PC, Research Division, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, hasResults: False
protocolSection identificationModule nctId: NCT06282159, orgStudyIdInfo id: DNTH103-MG-201, briefTitle: A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC), acronym: MAGIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Dianthus Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG)., conditionsModule conditions: Myasthenia Gravis, Generalized, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: DNTH103, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)], primaryOutcomes measure: Incidence, severity, and relationship of adverse events of special interest (AESI), primaryOutcomes measure: Number of participants with changes from baseline in ECG parameters, primaryOutcomes measure: Number of participants with changes in clinical laboratory values over time, secondaryOutcomes measure: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score, secondaryOutcomes measure: Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score, secondaryOutcomes measure: Serum concentrations of DNTH103, secondaryOutcomes measure: Change from baseline in complement total blood test (CH50), secondaryOutcomes measure: Antidrug antibody (ADA) levels against DNTH103, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bradenton Research Center, status: RECRUITING, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Gloria Carlbert, role: CONTACT, email: gloriacarlbert@bradentonresearch.com, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Texas Neurology, status: RECRUITING, city: Dallas, state: Texas, zip: 75206, country: United States, contacts name: Haley Rucker, role: CONTACT, email: hrucker@texasneurology.com, geoPoint lat: 32.78306, lon: -96.80667, locations facility: West Texas Neurology Clinic, status: RECRUITING, city: Lubbock, state: Texas, zip: 79414, country: United States, contacts name: Christie Long, role: CONTACT, email: research@westtexasneurologyclinic.com, geoPoint lat: 33.57786, lon: -101.85517, hasResults: False
protocolSection identificationModule nctId: NCT06282120, orgStudyIdInfo id: CSPC-DNY-BTC, briefTitle: Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-05, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, collaborators name: CSPC Ouyi Pharmaceutical Co., Ltd., descriptionModule briefSummary: The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer., conditionsModule conditions: Metastatic Biliary Tract Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy, outcomesModule primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1, secondaryOutcomes measure: EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Cancer Hospital Airport Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Huikai Li, Doctor, role: CONTACT, phone: 18622228639, email: vianvianvip@163.com, contacts name: Xihao Zhang, Master, role: CONTACT, phone: 15510801035, email: zxh15510801035@163.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06282094, orgStudyIdInfo id: LUX, briefTitle: ViSiGi LUX Bariatric Sizing and Calibration System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Boehringer Labs LLC, class: INDUSTRY, descriptionModule briefSummary: This study investigates the new ViSiGi LUX., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Physician Feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: WellSpan, status: RECRUITING, city: York, state: Pennsylvania, zip: 17405, country: United States, contacts name: Faiz Shariff, role: CONTACT, geoPoint lat: 39.9626, lon: -76.72774, hasResults: False
protocolSection identificationModule nctId: NCT06282068, orgStudyIdInfo id: CS2-23178, briefTitle: AI Determine Malignancy of GGO on Chest CT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Chung Shan Medical University, class: OTHER, descriptionModule briefSummary: Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment.Study Design Collect CT images of untreated lung nodules 4-30mm in size that are scheduled for surgery. No limits on age, gender, disease type, with image resolution \<2.5mm. AI and clinicians will judge nodule characteristics separately. Surgical resection followed by comparison with pathology reports will evaluate diagnostic accuracy.Study Procedures A double-blinded method will be used. AI and physicians will record nodules as likely benign or malignant separately. After surgical resection, the lesions will undergo pathological staging and the diagnostic accuracy of both groups will be compared.Expected Results Compare the diagnostic accuracy of AI and clinicians to improve AI training quality, achieve early diagnosis and treatment goals, and provide patients with better medical care quality.Monitoring Method AI and clinicians will read separately, adhering to shared decision making without affecting patient access to diagnosis and treatment.Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software, conditionsModule conditions: Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: AI computer-aided detection software, outcomesModule primaryOutcomes measure: The accuricy of the diagnostic power., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung Shan Medical University Hospital, city: Taichung, state: South, zip: 402, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06282055, orgStudyIdInfo id: TIMES, briefTitle: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes, acronym: TIMES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: DCB Research AG, class: OTHER, descriptionModule briefSummary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle, secondaryOutcomes measure: Total daily Insulin dose throughout the menstrual cycle, secondaryOutcomes measure: Coefficient of glucose variability throughout the menstrual cycle, secondaryOutcomes measure: Estimated insulin sensitivity throughout the menstrual cycle, secondaryOutcomes measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle, secondaryOutcomes measure: Correlations between insulin sensitivity trajectories and confounders, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06282016, orgStudyIdInfo id: BKR-2024-001, briefTitle: Risk Factors for Neuroendocrine Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Bavarian Cancer Registry, class: OTHER_GOV, collaborators name: Bavarian Association of Statutory Health Insurance Accredited Physicians, descriptionModule briefSummary: Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors., conditionsModule conditions: Neuroendocrine Neoplasm of Lung, conditions: Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 7200, type: ESTIMATED, armsInterventionsModule interventions name: Case-control study (no intervention), outcomesModule primaryOutcomes measure: Depression/Persistent mood disorder, primaryOutcomes measure: Obesity, primaryOutcomes measure: Metabolic syndrome, primaryOutcomes measure: Previous malignant neoplasm, primaryOutcomes measure: Alcohol buse, primaryOutcomes measure: Diabetes, primaryOutcomes measure: Ulcerative colitis, primaryOutcomes measure: Crohn disease, primaryOutcomes measure: Allergic rhinitis, primaryOutcomes measure: Asthma, secondaryOutcomes measure: Area deprivation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06281990, orgStudyIdInfo id: BAUN-SBF-PO-01, briefTitle: Education and Information for Bariatric Surgery Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2024-01-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Balikesir University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs., conditionsModule conditions: Bariatric Surgeries, conditions: Education of Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups in the research: control and intervention groups., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded)., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Data collection form, primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: State-Trait Anxiety Inventory (STAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pınar Ongün, city: Balıkesir, zip: 38000, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False
protocolSection identificationModule nctId: NCT06281977, orgStudyIdInfo id: ES613, briefTitle: Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm, acronym: SEDATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-03-12, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ottawa Heart Institute Research Corporation, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit., conditionsModule conditions: Ventricular Tachycardia, conditions: Ventricular Arrhythmias, conditions: Ventricular Fibrillation, conditions: Recurrent Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Normal saline, outcomesModule primaryOutcomes measure: The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation., secondaryOutcomes measure: All-cause in-hospital death, secondaryOutcomes measure: Ventricular arrhythmia requiring treatment after study drug initiation, secondaryOutcomes measure: Resuscitated cardiac arrest after study drug initiation, secondaryOutcomes measure: Renal failure requiring new initiation of renal replacement therapy after study drug initiation, secondaryOutcomes measure: Intubation following study drug initiation, secondaryOutcomes measure: Length of stay in the intensive care unit, secondaryOutcomes measure: Length of stay in hospital, secondaryOutcomes measure: Need for mechanical circulatory support device after study drug initiation, secondaryOutcomes measure: Ventricular Arrhythmia requiring treatment only during active study drug treatment, secondaryOutcomes measure: Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False