hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06308159, orgStudyIdInfo id: LT02-101, briefTitle: An Open-label Study of a Gene Therapy Product in Beta-Thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Lantu Biopharma, class: INDUSTRY, descriptionModule briefSummary: This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem Cells (HSCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Vebeglogene autotemcel, outcomesModule primaryOutcomes measure: Time and duration of the subject's hemoglobin (Hb)≥9.0 g/dL without receiving red blood cell infusion, secondaryOutcomes measure: The prevalence and severity of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: The reduction of red blood cells (RBCs) transfusion requirement after product infusion compared to previous transfusion records, secondaryOutcomes measure: Number of days required to achieve successful neutrophil and platelet engraftment, secondaryOutcomes measure: Vector copy number (VCN) in peripheral blood over time, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06308146, orgStudyIdInfo id: S21-1249496, briefTitle: Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-21, primaryCompletionDateStruct date: 2022-10-11, completionDateStruct date: 2022-10-11, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kerry Group P.L.C, class: INDUSTRY, collaborators name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc., descriptionModule briefSummary: A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks., conditionsModule conditions: Functional Bloating, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to receive either the probiotic or placebo. Study products (i.e., TP and placebo) will be dispensed by the site as per the randomization scheme at the study visits., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: To minimize bias, the sponsor representatives involved in the study, the investigator, the participants, and any healthcare professionals or site personnel involved in participant management or outcome assessment remained blinded to interventional assignments, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Bacillus subtilis ATCC 122264, interventions name: Placebo, outcomesModule primaryOutcomes measure: Effect on intestinal gas symptoms and quality of life, secondaryOutcomes measure: Effect on intestinal gas symptoms and quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Apex Trials, city: Guelph, state: Ontario, zip: N1G 0B4, country: Canada, geoPoint lat: 43.54594, lon: -80.25599, hasResults: False
protocolSection identificationModule nctId: NCT06308133, orgStudyIdInfo id: CD34+CE_2023, briefTitle: Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency, acronym: CD34+CE_2023, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: All procedures performed during the study will comply with current clinical practice, international and national guidelines. Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection (cMNC) system with Spectra Optia (Terumo BCT), specifically the biological and clinical factors affecting the procedure efficiency., conditionsModule conditions: Optimize PBSC Harvest Through Automated Buffy Coat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 113, type: ACTUAL, armsInterventionsModule interventions name: apheresis procedure, outcomesModule primaryOutcomes measure: measured by statistical correlation, primaryOutcomes measure: Correlation of clinical, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, city: Milan, state: Milano, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-10, uploadDate: 2024-03-06T12:44, filename: Prot_SAP_000.pdf, size: 378344, hasResults: False
protocolSection identificationModule nctId: NCT06308120, orgStudyIdInfo id: ISI-IONCN-002, briefTitle: A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB, acronym: ARTICULAtE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Intuitive Surgical, class: INDUSTRY, collaborators name: Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd, descriptionModule briefSummary: Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules., conditionsModule conditions: Pulmonary Nodule, Solitary, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Stratified, randomized controlled trial with parallel group assignment, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Pathologist reviewing biopsy results will be blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 354, type: ESTIMATED, armsInterventionsModule interventions name: Ion Endoluminal System, interventions name: superDimension Navigation System and Accessories, outcomesModule primaryOutcomes measure: Diagnostic Yield, secondaryOutcomes measure: Sensitivity for malignancy of biopsy obtained samples, secondaryOutcomes measure: Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization, secondaryOutcomes measure: Incidence of intraoperative severe airway bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Jiyuan Sun, M.D., role: CONTACT, contacts name: Jiyuan Sun, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Yuanlin Song, M.D., role: CONTACT, contacts name: Yuanlin Song, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Dan Liu, role: CONTACT, contacts name: Dan Liu, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06308107, orgStudyIdInfo id: IRB00433127, briefTitle: Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery., conditionsModule conditions: Myocardial Stunning, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: IV Diazoxide, outcomesModule primaryOutcomes measure: Safety as assessed by mean change in blood pressure, primaryOutcomes measure: Safety as assessed by change in blood glucose levels, primaryOutcomes measure: Safety as assessed by incidence of adverse events, secondaryOutcomes measure: Efficacy as assessed by change in ejection fraction, secondaryOutcomes measure: Efficacy as assessed by use of mechanical circulatory support, secondaryOutcomes measure: Efficacy as assessed by change in Vasoactive Inotropic Score (VIS), secondaryOutcomes measure: Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06308094, orgStudyIdInfo id: IRB00429859, briefTitle: 320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: Two independent blinded trained readers will detect, interpret and quantify interstitial fibrosis using CT images, to ascertain intra- and inter-observer variability. The readers will determine the region of interest (ROI), myocardial and blood pool attenuation values in the pre-contrast and 5 minutes delayed acquisition., enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: CT, outcomesModule primaryOutcomes measure: Recurrence of Atrial Fibrillation, primaryOutcomes measure: Occurrence of ER visits, hospitalizations for cardiovascular causes, secondaryOutcomes measure: Change in Ejection Fraction, secondaryOutcomes measure: Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308068, orgStudyIdInfo id: BE24-002, briefTitle: Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-30, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-08-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions, conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Diacerein 50 mg Capsule, outcomesModule primaryOutcomes measure: Bioequivalence based on Cmax period, primaryOutcomes measure: Bioequivalence based on AUC parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308055, orgStudyIdInfo id: 2022-R01, briefTitle: Abiomed Impella RT-DAQ - Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Abiomed Inc., class: INDUSTRY, descriptionModule briefSummary: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition, conditionsModule conditions: Cardiogenic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Data Acquisition, outcomesModule primaryOutcomes measure: Collection of hemodynamic parameters (Cardiac Output in l/min), primaryOutcomes measure: Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg), primaryOutcomes measure: Collection of hemodynamic parameters (Mixed Venous Saturation in %), primaryOutcomes measure: Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ), secondaryOutcomes measure: Rate of Patient Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308042, orgStudyIdInfo id: 2024/5558, briefTitle: Remote Evaluation in Patients With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-29, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 30 second sit and stand test, outcomesModule primaryOutcomes measure: 30 second sit and stand test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308016, orgStudyIdInfo id: 25/IRE/23, briefTitle: Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, descriptionModule briefSummary: Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria., conditionsModule conditions: Laryngeal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Identification of risk factors, secondaryOutcomes measure: Stratify patients, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Raul Pellini, MD, role: CONTACT, phone: ND, email: raul.pellini@ifo.it, contacts name: Francesco Mazzola, Doctor, role: CONTACT, phone: 06 5266 4485, email: francesco.mazzola@ifo.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06308003, orgStudyIdInfo id: PTA CONF, briefTitle: Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The study is, in accordance with current legislation, definable as monocentric Prospective Observational.The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.adult patients who will undergo surgery of hip arthroplasty.Patients will undergo:Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit., conditionsModule conditions: Hip Arthropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Anterior hip arthroplasty, outcomesModule primaryOutcomes measure: The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico San Siro, status: RECRUITING, city: Milan, country: Italy, contacts name: Elena Cittera, role: CONTACT, phone: 0283502224, email: elena.cittera@grupposandonato.it, contacts name: Alberto Ventura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False