hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06298071, orgStudyIdInfo id: SIBP-R002-Ib, briefTitle: A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute Of Biological Products, class: INDUSTRY, collaborators name: First Affiliated Hospital Bengbu Medical College, collaborators name: The First Affiliated Hospital of Henan University of Science and Technology, collaborators name: Chengdu Fifth People's Hospital, descriptionModule briefSummary: To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials., conditionsModule conditions: Gout, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: According to the sequence from low-dose group to high-dose group, there are 12 participants in each group, totaling 36 participants., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: SIBP-R002, interventions name: SIBP-R002, interventions name: SIBP-R002, interventions name: Methotrexate, outcomesModule primaryOutcomes measure: AE(Adverse Events), primaryOutcomes measure: SAE(Serious Adverse Events), primaryOutcomes measure: AUC(Area Under The Plasma Concentration Versus Time Curve), primaryOutcomes measure: Cmax(Peak Plasma Concentration), primaryOutcomes measure: Tmax(Peak Time), primaryOutcomes measure: T ½ (Terminal elimination half-life), primaryOutcomes measure: CL (Clearance Rate), primaryOutcomes measure: ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody), primaryOutcomes measure: NAb (Anti-PEG-uricase Neutralizing Antibody), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, status: RECRUITING, city: Bengbu, state: Anhui, country: China, contacts name: Huan Zhou, Master, role: CONTACT, phone: 86-13665527160, email: zhouhuanbest@hotmail.com, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False
protocolSection identificationModule nctId: NCT06298058, orgStudyIdInfo id: SIBP-A13-I, briefTitle: A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute Of Biological Products, class: INDUSTRY, collaborators name: Shanghai Pulmonary Hospital, Shanghai, China, descriptionModule briefSummary: To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D)., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is an open, multi-dose increasing single and multiple dose study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: SIBP-A13 formulation for injection, outcomesModule primaryOutcomes measure: AE (Adverse Events), primaryOutcomes measure: SAE (Serious Adverse Events), primaryOutcomes measure: AUC (Area Under The Plasma Concentration Versus Time Curve), primaryOutcomes measure: Cmax (Peak Plasma Concentration), primaryOutcomes measure: Tmax (Peak Time), primaryOutcomes measure: T ½ (Terminal elimination half-life), primaryOutcomes measure: CL (Clearance Rate), secondaryOutcomes measure: ORR (Objective Response Rate), secondaryOutcomes measure: DCR (Disease control rate), secondaryOutcomes measure: PFS (Progression-free survival), secondaryOutcomes measure: OS (overall survival), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298045, orgStudyIdInfo id: DIM-06790-002, briefTitle: Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Servier Affaires Médicales, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only., conditionsModule conditions: Stable Angina, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Assessment of angina symptoms via the summary score of SAQ-7, secondaryOutcomes measure: CCS angina grading post-inclusion, secondaryOutcomes measure: Tolerance ( Adverse Events), secondaryOutcomes measure: Tolerance ( Serious Adverse Events), secondaryOutcomes measure: Adherence to the antianginal treatment combination under evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thera Card Srl, status: RECRUITING, city: Braşov, zip: 500091, country: Romania, contacts name: Zara Cornelia, Dr, role: CONTACT, phone: +40723733774, email: cornelia.zara@theracardia.ro, geoPoint lat: 45.64861, lon: 25.60613, hasResults: False
protocolSection identificationModule nctId: NCT06297993, orgStudyIdInfo id: WIND-PSC-01, briefTitle: Adult Patients With Primary Sclerosing Cholangitis, acronym: WIND-PSC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2031-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Arbor Research Collaborative for Health, class: OTHER, descriptionModule briefSummary: Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC., conditionsModule conditions: PSC, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Develop interventional clinical trial external control using clinical and biomarker data., secondaryOutcomes measure: Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data., secondaryOutcomes measure: Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schiff Center for Liver Diseases / University of Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Cynthia Levy, MD, role: CONTACT, phone: 306-243-4615, email: clevy@med.miami.edu, contacts name: Cynthia Levy, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
protocolSection identificationModule nctId: NCT06297980, orgStudyIdInfo id: 23-1513, briefTitle: Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes, acronym: MERIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: The Leona M. and Harry B. Helmsley Charitable Trust, descriptionModule briefSummary: The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity., conditionsModule conditions: Type 1 Diabetes, conditions: Hypoglycemia, conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus, conditions: Menstruation Disturbances, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Personalized modifications to treatment to address menstrual cycle effects on glycemia, outcomesModule primaryOutcomes measure: Glucose time in range, primaryOutcomes measure: Glucose standard deviation, secondaryOutcomes measure: Mean glucose (mg/dL) pre-exercise, secondaryOutcomes measure: Mean glucose (mg/dL) while exercising, secondaryOutcomes measure: Mean glucose (mg/dL) over 24 hours after exercise, secondaryOutcomes measure: Glucose standard deviation, secondaryOutcomes measure: Glucose standard deviation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: JANET K SNELL-BERGEON, PhD, role: CONTACT, phone: 303-724-6762, email: Janet.Snell-Bergeon@cuanschutz.edu, contacts name: Catherine Chartier-Logan, MPH, role: CONTACT, phone: 3037247505, email: Catherine.Chartier-Logan@cuanschutz.edu, contacts name: Sarit Polsky, MD, role: SUB_INVESTIGATOR, contacts name: Cristy Geno, PhD, role: SUB_INVESTIGATOR, contacts name: Bryan Bergman, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Pyle, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
protocolSection identificationModule nctId: NCT06297967, orgStudyIdInfo id: CSAPG-33, briefTitle: Acetic Acid 2% Solution for Skin Ulcers, acronym: ECA-AA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment., conditionsModule conditions: Ulcer, Skin, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Acetic Acid, interventions name: Prontosan, outcomesModule primaryOutcomes measure: Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment, secondaryOutcomes measure: Percentage of participants with ulcer healing at 4 weeks from the start of treatment., secondaryOutcomes measure: Percentage of participants with ulcer healing at 12 weeks from the start of treatment., secondaryOutcomes measure: Time (days) to ulcer healing from the start of treatment., secondaryOutcomes measure: Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale., secondaryOutcomes measure: Number of adverse reactions associated with the treatment, collected from the medical record., secondaryOutcomes measure: The healthcare expenditure associated with each branch of the study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consorci Sanitari Alt'Pènedes i Garraf, city: Barcelona, state: Cataluña, zip: 08810, country: Spain, contacts name: Marta De Vicente, role: CONTACT, phone: +34 938931616, email: mdevicente@csapg.cat, contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960025, phoneExt: 43197, email: recerca@csapg.cat, contacts name: Marta De Vicente, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06297915, orgStudyIdInfo id: 2022/08-45, briefTitle: Infusion Treatments of Chronic Peripheral Neuropathic Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-17, primaryCompletionDateStruct date: 2023-05-10, completionDateStruct date: 2023-08-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment., conditionsModule conditions: Neuropathic Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Ketamine, interventions name: Lidocain, outcomesModule primaryOutcomes measure: Neuropathic Pain Scale, primaryOutcomes measure: Pain Rating Scale, secondaryOutcomes measure: Quality of Life Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Cankaya, zip: 06360, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06297876, orgStudyIdInfo id: H00023815, briefTitle: COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-19, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts, conditionsModule conditions: Vaccine Hesitancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other., whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Storytelling, interventions name: Learn More (Active Comparator), outcomesModule primaryOutcomes measure: Change in Vaccine Hesitancy, secondaryOutcomes measure: Vaccine Uptake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Massachusetts Chan Medical School, status: RECRUITING, city: Worcester, state: Massachusetts, zip: 01605, country: United States, contacts name: Sarah Forrester, PhD, role: CONTACT, phone: 508-856-8338, email: sarah.forrester@umassmed.edu, contacts name: Jeroan Allison, MD, role: CONTACT, phone: 5088568993, email: jeroanallison@umassed.edu, geoPoint lat: 42.26259, lon: -71.80229, hasResults: False
protocolSection identificationModule nctId: NCT06297837, orgStudyIdInfo id: LHS0205, briefTitle: ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing), acronym: ADAPT-AST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Liverpool University Hospitals NHS Foundation Trust, class: OTHER_GOV, descriptionModule briefSummary: The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:* Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?* Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient?Participants in this study will not be receiving treatments. The study will involve:Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs.Assessing whether it can help save money and resources in the lab and pharmacy., conditionsModule conditions: Urinary Tract Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The number of antimicrobial susceptibility results that 'should' spur action by a clinician on, secondaryOutcomes measure: The number of days until a result that 'should' spur action by a clinician, secondaryOutcomes measure: The number of antimicrobial susceptibility results that 'could' spur action by a clinician on, secondaryOutcomes measure: The number of days until a result that 'could' spur action by a clinician, secondaryOutcomes measure: The projected health economic cost per specimen, including laboratory (e.g., consumable cost) and patient (e.g., drug toxicity, clinical failure) measures., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-10-03, uploadDate: 2023-11-16T04:00, filename: Prot_ICF_000.pdf, size: 2230025, hasResults: False