hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06364930, orgStudyIdInfo id: SGLT2i_HBV Study, briefTitle: SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2030-10-31, completionDateStruct date: 2031-03-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo)., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 412, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo 10mg Tab, outcomesModule primaryOutcomes measure: The primary endpoint is liver complications, secondaryOutcomes measure: Cardiovascular complications, secondaryOutcomes measure: change in liver stiffness measurement, secondaryOutcomes measure: change anthropometric parameters, secondaryOutcomes measure: change anthropometric parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Angel ML Chim, MSc, role: CONTACT, phone: 26324205, email: angelchim@cuhk.edu.hk, contacts name: Grace LH Wong, MD, role: CONTACT, phone: +85235053538, email: wonglaihung@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06364917, orgStudyIdInfo id: IRB-300012781 (UAB2432), briefTitle: DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2027-01-30, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pemetrexed, interventions name: Nivolumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens, secondaryOutcomes measure: Efficacy Evaluation, secondaryOutcomes measure: Correlation Analysis, otherOutcomes measure: Progression-Free Survival (PFS), otherOutcomes measure: Median Overall Survival (OS), otherOutcomes measure: Tolerability Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Margaret Thomas, MPH, role: CONTACT, email: margaretannthomas@uabmc.edu, contacts name: Aakash Desai, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maya Khalil, MD, role: SUB_INVESTIGATOR, contacts name: Yanish Boumber, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
protocolSection identificationModule nctId: NCT06364865, orgStudyIdInfo id: 2022-04, briefTitle: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study, acronym: AE05ML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Teleflex, class: INDUSTRY, descriptionModule briefSummary: This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback., conditionsModule conditions: Gall Bladder Disease, conditions: Bile Duct Diseases, conditions: Acute Cholecystitis, conditions: Kidney, conditions: Liver, conditions: Appendix, conditions: Spleen Disease, conditions: Prostate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 161, type: ESTIMATED, armsInterventionsModule interventions name: laparoscopic procedure, outcomesModule primaryOutcomes measure: Evaluating the safety of AE05ML, primaryOutcomes measure: Evaluating the performance of AE05ML, secondaryOutcomes measure: Evaluating device performance characteristics, secondaryOutcomes measure: Evaluating operator reported feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364852, orgStudyIdInfo id: LY007C1101, briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL, acronym: r/r B-NHL, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-25, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, collaborators name: The First Affiliated Hospital with Nanjing Medical University, collaborators name: Shanghai Longyao Biotechnology Inc., Ltd., descriptionModule briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research, conditionsModule conditions: B-NHL, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: LY007, outcomesModule primaryOutcomes measure: Maximum tolerated dose or clinically recommended dose;, primaryOutcomes measure: Dose limiting toxicity, primaryOutcomes measure: Adverse Events, Serious Adverse Events, Adverse Events of Particular Concern, Including cytokine release syndrome, neurotoxicity,physical examination, vital signs, ECOG score, ECG, laboratory testing, etc., secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PD aspect, secondaryOutcomes measure: therapeutic effect, secondaryOutcomes measure: Anti LY007 antibody, secondaryOutcomes measure: The titer of human anti mouse antibody, otherOutcomes measure: Exploratory study endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Weili Zhao, MD, role: CONTACT, phone: 13512112076, phoneExt: 610707, email: zwl_trial@163.com, contacts name: Zixun Yan, MD, role: CONTACT, phone: +8613482056727, phoneExt: 610707, email: yanzixun125@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06364839, orgStudyIdInfo id: CT2024-ZJU-OBS7, briefTitle: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-03-23, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Xiao Xu, class: OTHER, descriptionModule briefSummary: Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively., conditionsModule conditions: Hepatocellular Carcinoma, Non-cirrhotic Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions, outcomesModule primaryOutcomes measure: Postoperative complications were evaluated by postoperative imaging and serological examination, primaryOutcomes measure: The overall survival rate was evaluated by follow-up investigation and outpatient review, primaryOutcomes measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiao Xu, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06364826, orgStudyIdInfo id: NPC-202403, briefTitle: Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-04-22, completionDateStruct date: 2026-04-22, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab, bevacizumab, gemcitabine, interventions name: IMRT, outcomesModule primaryOutcomes measure: 3-year Event-free survival rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: adverse events(AEs), otherOutcomes measure: biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06364800, orgStudyIdInfo id: GDT-001-07-02, briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2026-04-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, collaborators name: Chinese Academy of Medical Sciences, collaborators name: Beijing GD Initiative Cell Therapy Technology Co., Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody.Hepatocellular Carcinoma, conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: γδ T cells, interventions name: PD-1 monoclonal antibody, interventions name: targeted drugs, outcomesModule primaryOutcomes measure: Safety evaluation: Incidence of Adverse events (AEs), primaryOutcomes measure: Safety evaluation: Dose limited toxicity (DLTs), primaryOutcomes measure: Efficacy evaluation: Objective Response Rate(ORR), primaryOutcomes measure: Efficacy evaluation: Duration of Response(DOR), primaryOutcomes measure: Efficacy evaluation: Progress Free Survival(PFS), primaryOutcomes measure: Efficacy evaluation: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364787, orgStudyIdInfo id: GDT-001-07-01, briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2026-04-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, collaborators name: Chinese Academy of Medical Sciences, collaborators name: Beijing GD Initiative Cell Therapy Technology Co., Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of patients with hepatocellular carcinoma., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: γδ T cells, interventions name: Targeted drugs, interventions name: PD-1 monoclonal antibody, outcomesModule primaryOutcomes measure: Safety evaluation: Incidence of Adverse events (AEs), primaryOutcomes measure: Safety evaluation: Dose limited toxicity (DLTs), primaryOutcomes measure: Safety evaluation: Maximum-tolerated dose (MTD), primaryOutcomes measure: Efficacy evaluation: Objective Response Rate(ORR), primaryOutcomes measure: Efficacy evaluation: Duration of Response(DOR), primaryOutcomes measure: Efficacy evaluation: Progress Free Survival(PFS), primaryOutcomes measure: Efficacy evaluation: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364774, orgStudyIdInfo id: 22-020309, briefTitle: ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Philadelphia, class: OTHER, descriptionModule briefSummary: The main goal of this study is to find out if the blood disorder called transfusion-dependent beta thalassemia can be safely treated by modifying blood stem cells. This is done by collecting blood stem cells from the subject, modifying those cells, adding a healthy beta globin gene, and then giving them back to the subject. It is hoped that these modified cells will decrease the need for blood transfusions. The gene modified blood stem cells are called CHOP-ALS20 ("study drug"). This experimental gene therapy has not been tried on human beings before and is not FDA approved., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm pilot, phase I/II study of 12 subjects., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ALS20, outcomesModule primaryOutcomes measure: Neutrophil Engraftment, primaryOutcomes measure: Platelet Engraftment, primaryOutcomes measure: Overall Survival at 2 years, primaryOutcomes measure: Incidence of transplant related mortality, primaryOutcomes measure: Incidence of Graft Versus Host Disease, primaryOutcomes measure: Incidence of Vector-Derived Replication Competent Lentivirus, primaryOutcomes measure: Insertional Oncogenesis, primaryOutcomes measure: Clonal Predominance, primaryOutcomes measure: maintain total hemoglobin level of 9.0 g/dL or higher, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Janet Kwiatkowski, MD, role: CONTACT, phone: 215-590-5286, email: kwiatkowski@chop.edu, contacts name: Jaladhikumar Patel, role: CONTACT, phone: 267-426-5602, email: patelj23@chop.edu, contacts name: Janet Kwiatkowski, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
protocolSection identificationModule nctId: NCT06364761, orgStudyIdInfo id: 24103_BIL_EDOF, briefTitle: Assesment of Intermediate Vision After BIL Cataract Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.Participants will:* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)* Have to fill in 2 questionnaires about visual functioning and spectacle independanceResearchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens ., conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Bag in the lens cataract surgery, outcomesModule primaryOutcomes measure: Intermediate vision, secondaryOutcomes measure: Near vision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False