hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06322823, orgStudyIdInfo id: 2010.432, briefTitle: Direct Thawing of Vitrified Human Blastocyst, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide., conditionsModule conditions: IVF, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ACTUAL, armsInterventionsModule interventions name: direct thawing, interventions name: Vitrification, outcomesModule primaryOutcomes measure: blastocysts survival rate, secondaryOutcomes measure: ferilization rate, secondaryOutcomes measure: pregnancy rate, secondaryOutcomes measure: live birth rate, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: David Yiu Leung Chan, city: Hong Kong, zip: 000000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06322810, orgStudyIdInfo id: ESP vs. PIFB, briefTitle: ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].The main questions it aims to answer are:* Does ESPB provide superior analgesia than PIFB* Do patients who receive ESPB have better recovery outcomes, conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Erector spinae plane block (ESPB), interventions name: Pecto-intercostal fascial plane blok (PIFB), outcomesModule primaryOutcomes measure: 48hr opioid consumption, secondaryOutcomes measure: Postoperative static pain scores-Day 1, secondaryOutcomes measure: Postoperative static pain scores-Day 2, secondaryOutcomes measure: Postoperative dynamic pain scores-Day 1, secondaryOutcomes measure: Postoperative dynamic pain scores-Day 2, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 1, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 2, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 3, secondaryOutcomes measure: QoL15 (pre-op), secondaryOutcomes measure: QoL15 (POD3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 407, country: Taiwan, contacts name: Yi-Ting Chang, MD, role: CONTACT, phone: (+886)4-23592525, phoneExt: 4101, email: taco@vghtc.gov.tw, contacts name: Yi-Ting Chang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06322784, orgStudyIdInfo id: LiJingjing, briefTitle: DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shenzhen People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are:* To verify the effect of dietary fiber supplementation on reducing the level of inflammation;* To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis.The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made, conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental group=1,Control Group=2,, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Researchers set blinding to reduce implementation bias, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Oat bran (dietary fiber), outcomesModule primaryOutcomes measure: Disease activity score, primaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Compliance of oat bran, secondaryOutcomes measure: Inflammatory indicators :TNF- α, secondaryOutcomes measure: Inflammatory indicators:IL-6, secondaryOutcomes measure: Inflammatory indicators :IL-10, secondaryOutcomes measure: Inflammatory indicators: ESR, secondaryOutcomes measure: Inflammatory indicators :CRP, secondaryOutcomes measure: gut flora, secondaryOutcomes measure: Adjustment of anti rheumatic drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jingjing Li, city: Shenzhen, state: Guangdong, zip: 518000, country: China, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False
protocolSection identificationModule nctId: NCT06322771, orgStudyIdInfo id: APHP240376, briefTitle: Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal, acronym: RANSPRE-refus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate., conditionsModule conditions: Pregnancy Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 830, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Factors associated with women's refusal, secondaryOutcomes measure: Number of acceptations, secondaryOutcomes measure: Number of refusals, secondaryOutcomes measure: Demographic characteristics, secondaryOutcomes measure: Questionnaire "acceptance", secondaryOutcomes measure: Questionnaire "refusal", eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Port-Royal Maternity, status: RECRUITING, city: Paris, state: IDF, zip: 75014, country: France, contacts name: Yoann Athiel, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06322745, orgStudyIdInfo id: 1986, briefTitle: Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy., conditionsModule conditions: Renal Tumor, conditions: Renal Malignant Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized prospective comparative study. Two-arm parallel assignment:First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy, interventions name: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy, outcomesModule primaryOutcomes measure: Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping)., primaryOutcomes measure: Suture time and operative time in minutes, primaryOutcomes measure: Intraoperative number of sutures for renorraphy, primaryOutcomes measure: Intraoperative Blood loss, primaryOutcomes measure: Blood transfusion rate, primaryOutcomes measure: Renal function: serum creatinine, primaryOutcomes measure: Renal function: estimated GFR (eGFR), primaryOutcomes measure: Transforming growth factor beta (TGF-β) urine level, primaryOutcomes measure: Monocyte chemoattractant protein (MCP-1) urine level, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Post operative pain, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Urology Department, Al-Azhar University Hospitals, status: RECRUITING, city: Cairo, zip: 11511, country: Egypt, contacts name: Malakah Mohammed, Secretary, role: CONTACT, phone: +20225107222, email: urologydepartment@azhar.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06322732, orgStudyIdInfo id: APHP191125, briefTitle: Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care, acronym: OptiNeoCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.Perinatal asphyxia is a serious and often unexpected pathology, requiring urgent multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of technical expertise and care coordination. Because of its rarity and complexity, it may be subject to suboptimal care.The aim of this study is to provide feedback within the center itself, coupled in 1/3 of cases with a confidential investigation into the search for and understanding of suboptimal care.Primary endpoint:Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia., conditionsModule conditions: Perinatal Asphyxia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: sub-optimal perinatal care, secondaryOutcomes measure: Frequency of suboptimal care, secondaryOutcomes measure: Relationship, secondaryOutcomes measure: Outcome, secondaryOutcomes measure: Characteristics of suboptimal care, secondaryOutcomes measure: Determinantes of suboptimal care, secondaryOutcomes measure: Ad-hoc survey, eligibilityModule sex: ALL, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322706, orgStudyIdInfo id: ABSK021-105, briefTitle: A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Abbisko Therapeutics Co, Ltd, class: INDUSTRY, descriptionModule briefSummary: Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects, conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ABSK021, interventions name: Omeprazole, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: tmax, primaryOutcomes measure: AUC0-∞, primaryOutcomes measure: AUClast, secondaryOutcomes measure: AE, secondaryOutcomes measure: SAE, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: ECG QT Interval, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vz/F, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322667, orgStudyIdInfo id: BAN2401-J081-401, briefTitle: A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-22, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Eisai Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab., conditionsModule conditions: Alzheimer's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H), primaryOutcomes measure: Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA, secondaryOutcomes measure: Number of Participants With Infusion Related Reaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eisai trial site 2, status: RECRUITING, city: Hiroshima, country: Japan, geoPoint lat: 34.4, lon: 132.45, locations facility: Eisai trial site 3, status: RECRUITING, city: Kyoto, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Eisai trial site 1, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False
protocolSection identificationModule nctId: NCT06322641, orgStudyIdInfo id: DAS-8092, secondaryIdInfos id: U1111-1303-3089, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-04-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD), conditionsModule conditions: Atherosclerotic Cardiovascular Disease (ASCVD), conditions: Chronic Kidney Disease (CKD), conditions: Systemic Inflammation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: No treatment given, outcomesModule primaryOutcomes measure: Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KJT Group, Inc., city: Rochester, state: New York, zip: 14623, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
protocolSection identificationModule nctId: NCT06322628, orgStudyIdInfo id: VSA006-2001, briefTitle: A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Visirna Therapeutics HK Limited, class: INDUSTRY, descriptionModule briefSummary: Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients., conditionsModule conditions: Nash, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: VSA006, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH, primaryOutcomes measure: Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis, secondaryOutcomes measure: Compared with placebo, the percentage change in serum alanine aminotransferase (ALT), secondaryOutcomes measure: Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline, secondaryOutcomes measure: Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline, secondaryOutcomes measure: Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI), secondaryOutcomes measure: Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis, secondaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006, secondaryOutcomes measure: Maximum observed concentration (Cmax) of VSA006, secondaryOutcomes measure: Time of maximum concentration of VSA006 (Tmax), secondaryOutcomes measure: Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006, secondaryOutcomes measure: anti-drug antibodies (ADAs) of VSA006, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False