hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06326021 id: BJGBYY-IIT-LCYJ-2024-004 briefTitle: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia overallStatus: RECRUITING date: 2024-04-11 date: 2026-06-15 date: 2026-12-30 date: 2024-03-22 date: 2024-04-16 name: Beijing GoBroad Hospital class: OTHER briefSummary: This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\*10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\*10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases. conditions: Refractory/Relapsed Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: autologous FL-33 CAR T therapy name: prior-HSCT donor-derived FL-33 CAR T therapy measure: Dose-limiting toxicity(DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective Response Rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: The persistence of FL-33 CAR T cells sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BeijingGoBroadH status: RECRUITING city: Beijing country: China name: Tengyu Wang role: CONTACT phone: 18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06326008 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2026-06-30 date: 2024-03-22 date: 2024-03-27 name: Beijing GoBroad Hospital class: OTHER 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. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy measure: Dose-limiting toxicity (DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective response rate(ORR) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Overall survival (OS) measure: The persistence of CD19/CD22 CAR T cells. measure: The Maximum concentration (Cmax) of CD19/CD22 CAR T cells. measure: The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells. sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06325995 id: Changhai HHHospital briefTitle: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2025-10-01 date: 2030-10-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER 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.
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. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: Conventional radiation therapy name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: 5-year progression-free survival (PFS) measure: quality of life (QoL) measure: medical expenses measure: Overall survival (OS) measure: Prostate cancer-specific survival sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06325982 id: BYFFL-01 briefTitle: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: Fujian Cancer Hospital class: OTHER_GOV 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. conditions: Radiation Injuries conditions: Rectal Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Triethanolamine cream measure: Occurrence time of acute and chronic radiation rectal injury measure: Evaluation of acute and chronic radiation rectal injury measure: Clinical symptom assessment measure: Quality of life assessment assessed by IBDQ sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06325969 id: PCOS Immune briefTitle: PCOS Patients Immune Status Evaluation overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-03-08 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER 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. conditions: Polycystic Ovary Syndrom conditions: Metformin conditions: Immune Function studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Detect the immune function of peripheral blood samples measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: +86-021-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06325956 id: Immune status and metformin briefTitle: PCOS Immune Function Predicts Metformin Efficacy overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-07-01 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER 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. conditions: Polycystic Ovary Syndrome conditions: Metformin conditions: Immune Function studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Metformin measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: 86-21-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06325943 id: CIDPRIT briefTitle: Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: CIDPRIT overallStatus: COMPLETED date: 2019-04-01 date: 2023-05-30 date: 2023-11-30 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER name: Ospedale Mondino di Pavia name: University of Turin, Italy name: Istituto Neurologico Carlo Besta di Milano name: San Raffaele University Hospital, Italy name: Università di Messina name: Universita degli Studi di Genova name: Istituto Di Ricerche Farmacologiche Mario Negri name: Università di Napoli Federico II briefSummary: Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.
Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization. conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 37 type: ACTUAL name: Rituximab name: Placebo measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability measure: Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: treatment suspension measure: time to worsening measure: Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state measure: motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment measure: clinical form measure: response to rituximab in patients with antinerve antibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas city: Rozzano country: Italy lat: 45.38193 lon: 9.1559 hasResults: False
nctId: NCT06325930 id: RIV-HU6-105 briefTitle: A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 overallStatus: RECRUITING date: 2024-03-26 date: 2024-05-22 date: 2024-05-22 date: 2024-03-22 date: 2024-04-17 name: Rivus Pharmaceuticals, Inc. class: INDUSTRY 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. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C]-HU6 measure: To assess the mass balance sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Pharmaron Clinical Pharmacology Center (CPC) status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Kristin Satterfield, MD, PhD role: CONTACT lat: 39.29038 lon: -76.61219 hasResults: False
nctId: NCT06325917 id: 101271-5 briefTitle: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic acronym: DSMES overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2024-07-01 date: 2024-07-30 date: 2024-03-22 date: 2024-03-22 name: University of Jordan class: OTHER 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.
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. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ACTUAL name: what's app ongoing support name: usual care measure: glycemic control measure: diabetes self management behaviors sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jordan city: Amman zip: 11942 country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False
nctId: NCT06325904 id: 9138930 briefTitle: Uniportal VATS Versus Chest Tube for Early Empyema overallStatus: COMPLETED date: 2021-03-01 date: 2023-06-01 date: 2023-12-01 date: 2024-03-22 date: 2024-03-25 name: Minia University class: OTHER 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. conditions: Empyema, Pleural studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Uniportal VATS name: Tube thoracostomy measure: Need for further management measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Minia University city: Minya zip: 61111 country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False
nctId: NCT06325891 id: RP025 briefTitle: Microbiota in Gastric Cancer by Gastric Mucosal Brushing overallStatus: RECRUITING date: 2024-02-01 date: 2025-03-31 date: 2025-05-31 date: 2024-03-22 date: 2024-03-22 name: King Chulalongkorn Memorial Hospital class: OTHER 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. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Gastric mucosal brusing name: Gastric mucosal biopsy measure: Microbiome analysis using gastric mucosal brushing measure: Microbiome analysis using gastric mucosal biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Rapat Pittayanon, MD role: CONTACT phone: +66813132112 email: rapat125@gmail.com name: Thanrada Vimonsuntirungsri role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 facility: King Chulalongkorn memorial hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Thanrada Vimonsuntirungsri, MD role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 hasResults: False
nctId: NCT06325878 id: NEU2-OSS-2022-001 briefTitle: Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: GEARCIDP overallStatus: RECRUITING date: 2022-11-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER 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) conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 3500 type: ESTIMATED name: Genome-wide association study measure: single nucleotide polymorphisms (SNPs) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas status: RECRUITING city: Rozzano country: Italy name: Eduardo Nobile Orazio, Prof role: CONTACT email: eduardo.nobile@unimi.it lat: 45.38193 lon: 9.1559 hasResults: False