hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06340815, orgStudyIdInfo id: VAR-2022-02, briefTitle: Varian ProBeam Proton Therapy System Clinical Trial (Shandong), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-20, primaryCompletionDateStruct date: 2023-03-08, completionDateStruct date: 2023-03-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Varian, a Siemens Healthineers Company, class: INDUSTRY, descriptionModule briefSummary: This study is prospective, single-center, single-arm objective performance criteria.This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration., conditionsModule conditions: Tumor, Solid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Radiation: Proton Therapy System (ProBeam), outcomesModule primaryOutcomes measure: Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion, primaryOutcomes measure: Safety evaluation: Incidence of Acute radiation injury, primaryOutcomes measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sophia Shao, city: Shanghai, zip: 230001, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06340802, orgStudyIdInfo id: SYG001, briefTitle: A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl, acronym: AURORA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Synergia Medical, class: INDUSTRY, descriptionModule briefSummary: This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM., conditionsModule conditions: Drug Resistant Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: VNS Treatment, outcomesModule primaryOutcomes measure: Treatment emergent adverse events, primaryOutcomes measure: Procedure and/or device related adverse events, secondaryOutcomes measure: Device-related treatment emergent adverse events, secondaryOutcomes measure: Device deficiencies, secondaryOutcomes measure: Procedural Success, secondaryOutcomes measure: Change in seizure frequency, secondaryOutcomes measure: Proportion of responders, secondaryOutcomes measure: Change in seizure severity, secondaryOutcomes measure: Change in quality of life, secondaryOutcomes measure: Changed in mood, secondaryOutcomes measure: Usability, otherOutcomes measure: Exploratory Endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06340776, orgStudyIdInfo id: 81321, briefTitle: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-15, primaryCompletionDateStruct date: 2023-06-20, completionDateStruct date: 2023-09-28, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection., conditionsModule conditions: Pain Management, conditions: Hysterectomy, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Acupressure groupThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery.Control group:The control group was evaluated for two days without any application., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Acupressure, outcomesModule primaryOutcomes measure: the score of nausea, vomiting and retching experiences, primaryOutcomes measure: gas output and stool formation of the participants, primaryOutcomes measure: postoperative pain, secondaryOutcomes measure: Systolic Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Diastolic blood pressure, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yeliz Yildirim Varişoğlu, city: Istanbul, state: Beykoz, zip: 34413, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06340763, orgStudyIdInfo id: ABT-CIP-10466, secondaryIdInfos id: CRD_1058, type: OTHER, domain: Abbott, briefTitle: JETi Hong Kong Post Market Study (PMS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Abbott Medical Devices, class: INDUSTRY, descriptionModule briefSummary: The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure., conditionsModule conditions: Peripheral Artery Thrombosis, conditions: Peripheral Venous Thrombosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: JETi Hydrodynamic Thrombectomy System, outcomesModule primaryOutcomes measure: For Arterial Subjects: Clot removal grade for each JETi-treated vessel, primaryOutcomes measure: For Arterial Subjects: Composite of JETi-related major adverse events (MAEs), primaryOutcomes measure: For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score (limb basis)., primaryOutcomes measure: For Venous Subjects: Composite of JETi-related major adverse events (MAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, city: Hong Kong, country: Hong Kong, contacts name: Guangming TAN, Prof., role: CONTACT, phone: +852 3505 2211, contacts name: Guangming TAN, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06340750, orgStudyIdInfo id: LMY-920-003, briefTitle: BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Luminary Therapeutics, class: INDUSTRY, collaborators name: Nationwide Children, descriptionModule briefSummary: This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: LMY-920, outcomesModule primaryOutcomes measure: Safety of the Treatment, primaryOutcomes measure: Recommended Phase 2 Dose (RP2D), secondaryOutcomes measure: Efficacy of the Treatment: SELENA-SLEDAI, secondaryOutcomes measure: Efficacy of the Treatment: BILAG, secondaryOutcomes measure: Efficacy of the Treatment: PGA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06340737, orgStudyIdInfo id: IRB-73394, briefTitle: AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2031-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: The Leukemia and Lymphoma Society, descriptionModule briefSummary: This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion., conditionsModule conditions: Follicular Lymphoma, conditions: Mantle Cell Lymphoma, conditions: Hairy Cell Leukemia, conditions: Lymphoplasmacytic Lymphoma, conditions: Burkitt Lymphoma, conditions: Marginal Zone Lymphoma, conditions: Waldenstrom Macroglobulinemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: CD22CART Infusion, outcomesModule primaryOutcomes measure: Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort., primaryOutcomes measure: Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), primaryOutcomes measure: Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL), secondaryOutcomes measure: Evaluate Progression Free Survival (PFS), secondaryOutcomes measure: Evaluate Overall Survival (OS), secondaryOutcomes measure: Evaluate Duration of Response (DOR), secondaryOutcomes measure: Assess the response rate in adults with relapsed/refractory Hairy cell leukemia (HCL), Lymphoplasmacytic lymphoma (Waldenstrom macroglobulemia) (WM), Burkitt lymphoma (BL), and Marginal Zone lymphoma (MZL)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, status: RECRUITING, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Kelly Chyan, role: CONTACT, phone: 650-625-8130, email: kchyan@stanford.edu, contacts name: Matthew Frank, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False
protocolSection identificationModule nctId: NCT06340724, orgStudyIdInfo id: KY20240123-08, briefTitle: Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail., conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vonoprazan, interventions name: Amoxicillin, interventions name: Banxiaxiexin decotion, outcomesModule primaryOutcomes measure: Change from Baseline in functional dyspepsia symptoms at 6 weeks, primaryOutcomes measure: Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks, secondaryOutcomes measure: Adverse reactions that occur after taking medication, secondaryOutcomes measure: Patients' drug compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospitai, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: Wenjuan Wei, Doctorate, role: CONTACT, phone: +8618851009006, email: wjwei.hf@hotmail.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06340711, orgStudyIdInfo id: 23-06026219, briefTitle: Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, collaborators name: Oncolys BioPharma Inc, descriptionModule briefSummary: The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections., conditionsModule conditions: Esophageal Adenocarcinoma, conditions: Gastric Adenocarcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: OBP-301, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Overall response rate as assessed by the RECIST v1.1, primaryOutcomes measure: Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, primaryOutcomes measure: Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital, city: New York, state: New York, zip: 10065, country: United States, contacts name: Casey Owens, role: CONTACT, email: cdo4001@med.cornell.edu, contacts name: Manish Shah, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06340685, orgStudyIdInfo id: STUDY23050042, secondaryIdInfos id: UX007-IST236, type: OTHER_GRANT, domain: Ultragenyx Pharmaceutical Inc., briefTitle: Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Jirair Krikor Bedoyan, class: OTHER, collaborators name: Ultragenyx Pharmaceutical Inc, descriptionModule briefSummary: This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency., conditionsModule conditions: Pyruvate Dehydrogenase Complex Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Triheptanoin, outcomesModule primaryOutcomes measure: Number of participants who report side-effects related to gastrointestinal (GI) distress, primaryOutcomes measure: Normalization of biochemical markers of disease (lactate), primaryOutcomes measure: Normalization of biochemical markers of disease (pyruvate), primaryOutcomes measure: Normalization of biochemical markers of disease (β-hydroxybutyrate level), primaryOutcomes measure: Normalization of biochemical markers of disease (Alanine/Leucine ratio), primaryOutcomes measure: Normalization of biochemical markers of disease (Alanine/Lysine ratio), primaryOutcomes measure: Normalization of biochemical markers of disease (Alanine/Proline ratio), primaryOutcomes measure: More efficacious seizure control, primaryOutcomes measure: More efficacious metabolic control, primaryOutcomes measure: More efficacious disease control, secondaryOutcomes measure: Improved quality of life, secondaryOutcomes measure: Improved long-term maintenance and tolerance of diet, secondaryOutcomes measure: Improved quality of life, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: UPMC Children's Hospital of Pittsburgh, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, contacts name: Danielle Black, MPH, role: CONTACT, phone: 412-692-6893, email: danielle.black@chp.edu, contacts name: Jirair Bedoyan, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False