hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06326008, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2023-002, briefTitle: Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Long-term Adverse events (AEs), secondaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: The persistence of CD19/CD22 CAR T cells., secondaryOutcomes measure: The Maximum concentration (Cmax) of CD19/CD22 CAR T cells., secondaryOutcomes measure: The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06325995, orgStudyIdInfo id: Changhai HHHospital, briefTitle: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2030-10-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer., conditionsModule conditions: Localized Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Conventional radiation therapy, interventions name: Hypofractionated radiation therapy, outcomesModule primaryOutcomes measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events, secondaryOutcomes measure: 5-year progression-free survival (PFS), secondaryOutcomes measure: quality of life (QoL), secondaryOutcomes measure: medical expenses, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Prostate cancer-specific survival, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Huojun Zhang, M.D., role: CONTACT, phone: +8613311732399, email: chyyzhj@163.com, contacts name: Huojun Zhang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06325982, orgStudyIdInfo id: BYFFL-01, briefTitle: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Fujian Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world., conditionsModule conditions: Radiation Injuries, conditions: Rectal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Triethanolamine cream, outcomesModule primaryOutcomes measure: Occurrence time of acute and chronic radiation rectal injury, primaryOutcomes measure: Evaluation of acute and chronic radiation rectal injury, secondaryOutcomes measure: Clinical symptom assessment, secondaryOutcomes measure: Quality of life assessment assessed by IBDQ, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06325969, orgStudyIdInfo id: PCOS Immune, briefTitle: PCOS Patients Immune Status Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-03-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shanghai 10th People's Hospital, class: OTHER, descriptionModule briefSummary: In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients., conditionsModule conditions: Polycystic Ovary Syndrom, conditions: Metformin, conditions: Immune Function, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Detect the immune function of peripheral blood samples, outcomesModule primaryOutcomes measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., primaryOutcomes measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., secondaryOutcomes measure: Homeostasis model assessment of insulin resistance, secondaryOutcomes measure: body mass index, secondaryOutcomes measure: menstrual frequency, secondaryOutcomes measure: fasting glucose, secondaryOutcomes measure: fasting insulin, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: LDL-c, secondaryOutcomes measure: total testosterone, secondaryOutcomes measure: free testosterone, secondaryOutcomes measure: Sex hormone-binding globulin, secondaryOutcomes measure: Androstenedione, secondaryOutcomes measure: Dehydroepiandrosterone, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Shanghai Tenth People's Hospital, status: RECRUITING, city: Shanghai, zip: 200072, country: China, contacts name: Manna Zhang, Doctor, role: CONTACT, phone: +86-021-66301004, email: mannazhang@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06325956, orgStudyIdInfo id: Immune status and metformin, briefTitle: PCOS Immune Function Predicts Metformin Efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shanghai 10th People's Hospital, class: OTHER, descriptionModule briefSummary: In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function., conditionsModule conditions: Polycystic Ovary Syndrome, conditions: Metformin, conditions: Immune Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., primaryOutcomes measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., secondaryOutcomes measure: Homeostasis model assessment of insulin resistance, secondaryOutcomes measure: body mass index, secondaryOutcomes measure: menstrual frequency, secondaryOutcomes measure: fasting glucose, secondaryOutcomes measure: fasting insulin, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: LDL-c, secondaryOutcomes measure: total testosterone, secondaryOutcomes measure: free testosterone, secondaryOutcomes measure: Sex hormone-binding globulin, secondaryOutcomes measure: Androstenedione, secondaryOutcomes measure: Dehydroepiandrosterone, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Shanghai Tenth People's Hospital, status: RECRUITING, city: Shanghai, zip: 200072, country: China, contacts name: Manna Zhang, Doctor, role: CONTACT, phone: 86-21-66301004, email: mannazhang@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06325930, orgStudyIdInfo id: RIV-HU6-105, briefTitle: A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Rivus Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-HU6, outcomesModule primaryOutcomes measure: To assess the mass balance, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pharmaron Clinical Pharmacology Center (CPC), status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Kristin Satterfield, MD, PhD, role: CONTACT, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06325917, orgStudyIdInfo id: 101271-5, briefTitle: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic, acronym: DSMES, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, descriptionModule briefSummary: Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two arms parallel randomized controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: what's app ongoing support, interventions name: usual care, outcomesModule primaryOutcomes measure: glycemic control, secondaryOutcomes measure: diabetes self management behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Jordan, city: Amman, zip: 11942, country: Jordan, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False
protocolSection identificationModule nctId: NCT06325904, orgStudyIdInfo id: 9138930, briefTitle: Uniportal VATS Versus Chest Tube for Early Empyema, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Minia University, class: OTHER, descriptionModule briefSummary: This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost., conditionsModule conditions: Empyema, Pleural, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Uniportal VATS, interventions name: Tube thoracostomy, outcomesModule primaryOutcomes measure: Need for further management, primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Minia University, city: Minya, zip: 61111, country: Egypt, geoPoint lat: 28.10988, lon: 30.7503, hasResults: False
protocolSection identificationModule nctId: NCT06325891, orgStudyIdInfo id: RP025, briefTitle: Microbiota in Gastric Cancer by Gastric Mucosal Brushing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, descriptionModule briefSummary: Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Gastric mucosal brusing, interventions name: Gastric mucosal biopsy, outcomesModule primaryOutcomes measure: Microbiome analysis using gastric mucosal brushing, secondaryOutcomes measure: Microbiome analysis using gastric mucosal biopsy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Chulalongkorn Memorial Hospital, status: RECRUITING, city: Bangkok, zip: 10330, country: Thailand, contacts name: Rapat Pittayanon, MD, role: CONTACT, phone: +66813132112, email: rapat125@gmail.com, contacts name: Thanrada Vimonsuntirungsri, role: CONTACT, phone: +66853356240, email: aa_choc@docchula.com, geoPoint lat: 13.75398, lon: 100.50144, locations facility: King Chulalongkorn memorial hospital, status: RECRUITING, city: Bangkok, zip: 10330, country: Thailand, contacts name: Thanrada Vimonsuntirungsri, MD, role: CONTACT, phone: +66853356240, email: aa_choc@docchula.com, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
protocolSection identificationModule nctId: NCT06325878, orgStudyIdInfo id: NEU2-OSS-2022-001, briefTitle: Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, acronym: GEARCIDP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange), conditionsModule conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 3500, type: ESTIMATED, armsInterventionsModule interventions name: Genome-wide association study, outcomesModule primaryOutcomes measure: single nucleotide polymorphisms (SNPs), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, country: Italy, contacts name: Eduardo Nobile Orazio, Prof, role: CONTACT, email: eduardo.nobile@unimi.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False