hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06386328, orgStudyIdInfo id: A129_03FDI2317, briefTitle: A Clinical Trial to Evaluate the Food Effect of CKD-378, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-06-03, completionDateStruct date: 2024-06-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Chong Kun Dang Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: A clinical trial to evaluate the food effect of CKD-378, conditionsModule conditions: Type II Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CKD-378, QD, PO, outcomesModule primaryOutcomes measure: AUCt of CKD-378, primaryOutcomes measure: Cmax of CKD-378, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386302, orgStudyIdInfo id: CSIIT-A36, briefTitle: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy., conditionsModule conditions: AML, conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule interventions name: Chidamide, interventions name: Venetoclax, interventions name: azacitidine, outcomesModule primaryOutcomes measure: Composite complete remission rate, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: MRD response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386289, orgStudyIdInfo id: CNV202202, briefTitle: Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke, acronym: SPLENDID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cerenovus, Part of DePuy Synthes Products, Inc., class: INDUSTRY, descriptionModule briefSummary: The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 172, type: ESTIMATED, armsInterventionsModule interventions name: Cereglide 92, outcomesModule primaryOutcomes measure: First pass reperfusion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Iowa Hospital & Clinics, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: JFK Medical Center, city: Edison, state: New Jersey, zip: 08820, country: United States, geoPoint lat: 40.51872, lon: -74.4121, locations facility: Westchester Medical Center, city: Valhalla, state: New York, zip: 10595, country: United States, geoPoint lat: 41.07482, lon: -73.77513, locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84132, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: West Virginia University, city: Morgantown, state: West Virginia, zip: 26506, country: United States, geoPoint lat: 39.62953, lon: -79.9559, hasResults: False
protocolSection identificationModule nctId: NCT06386276, orgStudyIdInfo id: 00025986, briefTitle: Surgical TReatment of Women With Deep ENDometriosis, acronym: TrEnd, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A., class: OTHER, descriptionModule briefSummary: TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes., conditionsModule conditions: Deep Endometriosis, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Colorectal bowel resection, outcomesModule primaryOutcomes measure: To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection, primaryOutcomes measure: To assess the rate of complications, primaryOutcomes measure: To assess the rate of conversion to open surgery, primaryOutcomes measure: To assess the rate of endometriosis-free bowel resection margins, primaryOutcomes measure: To assess the rate of recurrence, secondaryOutcomes measure: To assess the intraoperative blood loss, secondaryOutcomes measure: To assess the operating time, secondaryOutcomes measure: To assess the gastrointestinal function recovery, secondaryOutcomes measure: To assess the duration of hospital stay, secondaryOutcomes measure: To assess the reproductive outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Casa Di Cura Malzoni Villa Platani Spa, status: RECRUITING, city: Avellino, state: Campania, zip: 83100, country: Italy, contacts name: Francesca Falcone, MD, role: CONTACT, email: francesca.falcone3@icloud.com, contacts name: Mario Malzoni, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Falcone, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.91494, lon: 14.79103, hasResults: False
protocolSection identificationModule nctId: NCT06386263, orgStudyIdInfo id: D9673R00032, briefTitle: HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada, acronym: HER-TEMPO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-04-04, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings., conditionsModule conditions: Unresectable Breast Cancer, conditions: Metastatic Breast Cancer, conditions: HER2-low Expressing Breast Cancer, conditions: HER2-positive Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab deruxtecan, outcomesModule primaryOutcomes measure: Early treatment discontinuation rates, primaryOutcomes measure: Dose modifications, secondaryOutcomes measure: Real world time to treatment discontinuation (rwTTD), secondaryOutcomes measure: Reasons for treatment discontinuations, secondaryOutcomes measure: Median treatment duration and dose intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NavieGo Patient ProgramsLtd & Affiliate, city: Oakville, state: Ontario, zip: L6H 1A7, country: Canada, geoPoint lat: 43.45011, lon: -79.68292, hasResults: False
protocolSection identificationModule nctId: NCT06386250, orgStudyIdInfo id: 0005, briefTitle: Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy, acronym: Painseverity, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-05, primaryCompletionDateStruct date: 2020-01-06, completionDateStruct date: 2020-01-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy, conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C), primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: regional block, interventions name: Caudal block, interventions name: Epidural, outcomesModule primaryOutcomes measure: Postoperative pain intensity, otherOutcomes measure: postoperative pain intesity, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Muhammad Sharif, city: Lahore, state: Punjab, zip: 53711, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06386237, orgStudyIdInfo id: UVienna_NDNL_1, briefTitle: Nutritional Modulation of Cognition and Brain Activity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, collaborators name: Medical University of Vienna, descriptionModule briefSummary: The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants., conditionsModule conditions: Nutrition, Healthy, conditions: Cognitive Change, conditions: Brain Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios), outcomesModule primaryOutcomes measure: Changes in cognition/behavior I, primaryOutcomes measure: Changes in cognition/behavior II, primaryOutcomes measure: Changes in brain activity, secondaryOutcomes measure: Changes in metabolic parameters I, secondaryOutcomes measure: Changes in metabolic parameters II, secondaryOutcomes measure: Changes in metabolic parameters III, secondaryOutcomes measure: Changes in metabolic parameters IV, secondaryOutcomes measure: Changes in subjective affective state, secondaryOutcomes measure: Changes in experienced hunger, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Stefan Schulreich, Prof. Dr., role: CONTACT, phone: +4314277, phoneExt: 54960, email: stefan.schulreich@univie.ac.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06386211, orgStudyIdInfo id: BDR17228, secondaryIdInfos id: BDR17228, type: OTHER, domain: Sanofi Identifier, briefTitle: Bioavailability Study of Magne-B6 New Formulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Opella Healthcare Group SAS, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: MAGNE-B6 Oral Solution, interventions name: MAGNE-B6 New Formulation Tablet, outcomesModule primaryOutcomes measure: Maximal Observed Concentration (Cmax) of Magnesium in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma, primaryOutcomes measure: Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma, primaryOutcomes measure: Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma, primaryOutcomes measure: Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma, primaryOutcomes measure: Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma, primaryOutcomes measure: Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine, secondaryOutcomes measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386198, orgStudyIdInfo id: 23-40699, briefTitle: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients, acronym: HEAL-Tx:ToC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: American Society of Transplantation, descriptionModule briefSummary: The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM., conditionsModule conditions: Liver Transplant; Complications, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Health Advocate, outcomesModule primaryOutcomes measure: Changes in patient experience, secondaryOutcomes measure: Change in medication adherence using MLVI, secondaryOutcomes measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources., secondaryOutcomes measure: A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94158, country: United States, contacts name: Emily Stekol, role: CONTACT, phone: 415-502-3190, email: emily.stekol@ucsf.edu, contacts name: Sharad Wadhwani, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Children's Healthcare of Atlanta, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30345, country: United States, contacts name: Nitika Gupta, role: CONTACT, contacts name: Nitika Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
protocolSection identificationModule nctId: NCT06386185, orgStudyIdInfo id: DRAPE, briefTitle: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography, acronym: DRAPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Royal United Hospitals Bath NHS Foundation Trust, class: OTHER, collaborators name: Sheffield Teaching Hospitals NHS Foundation Trust, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: Golden Jubilee National Hospital, collaborators name: Papworth Hospital NHS Foundation Trust, collaborators name: University of Bath, descriptionModule briefSummary: The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.The main questions it aims to answer are:Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?, conditionsModule conditions: Pulmonary Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Electrocardiogram, interventions name: Transthoracic echocardiogram, interventions name: Right heart catheter, outcomesModule primaryOutcomes measure: Distinguish between patients with and without pulmonary hypertension, primaryOutcomes measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension, secondaryOutcomes measure: Assess the impact of the severity of pulmonary hypertension, secondaryOutcomes measure: Assess the impact of additional ECG markers on existing PH probability stratification, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal United Hospital NHS Foundation Trust, city: Bath, state: Banes, zip: BA1 3NG, country: United Kingdom, geoPoint lat: 51.3751, lon: -2.36172, locations facility: Golden Jubilee Hospital, city: Glasgow, state: Lanarkshire, zip: G81 4DY, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Sheffield Teaching Hospitals NHS Foundation Trust, city: Sheffield, state: South Yorkshire, zip: S10 2JF, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Royal Papworth Hospital, city: Cambridge, zip: CB2 0AY, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: Royal Free NHS Foundation Trust, city: London, zip: NW3 2QG, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False