hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06364566, orgStudyIdInfo id: time-exploring, briefTitle: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-10-15, primaryCompletionDateStruct date: 2016-10-15, completionDateStruct date: 2019-10-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use, conditionsModule conditions: Time, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 303, type: ACTUAL, armsInterventionsModule interventions name: Neoadjuvant chemradiotherapy, interventions name: Minimally invasive esophagectomy, outcomesModule primaryOutcomes measure: The overall survival of the overall population, primaryOutcomes measure: The Disease-Free survival of the overall population, primaryOutcomes measure: The overall survival of the non-PCR population, primaryOutcomes measure: The Disease-Free survival of the non-PCR population, primaryOutcomes measure: The overall survival of the PCR population, primaryOutcomes measure: The Disease-Free survival of the PCR population, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital Affiliated to Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2021-10-15, uploadDate: 2024-04-10T05:47, filename: SAP_000.pdf, size: 119312, hasResults: False
protocolSection identificationModule nctId: NCT06364553, orgStudyIdInfo id: NL86416.078.24, briefTitle: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study, acronym: ENTRANCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia., conditionsModule conditions: Oesophageal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Esophageal self-expandable metal stent, outcomesModule primaryOutcomes measure: Complication: incidence of perforation, primaryOutcomes measure: Complication: incidence of hemorrhage, primaryOutcomes measure: Complication: incidence of fistula formation, primaryOutcomes measure: Complication: incidence of gastroesophageal reflux, primaryOutcomes measure: Complication: incidence of stent migration, primaryOutcomes measure: Efficacy: clinical outcome, primaryOutcomes measure: Efficacy: incidence of patients receiving technical successful stent placement, secondaryOutcomes measure: Incidence of recurrent dysphagia, secondaryOutcomes measure: Pain related to esophageal stent (placement), secondaryOutcomes measure: Overall survival, otherOutcomes measure: Patient characteristic: age, otherOutcomes measure: Patient characteristic: gender, otherOutcomes measure: Patient characteristic: tumor location, otherOutcomes measure: Patient characteristic: tumor histology, otherOutcomes measure: Stent characteristic: length of the stent, otherOutcomes measure: Stent characteristic: diameter of the stent, otherOutcomes measure: Patient characteristic: prior radiotherapy, otherOutcomes measure: Patient characteristic: prior chemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06364527, orgStudyIdInfo id: ADH-BSA-02-23, briefTitle: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: CoheroHealth, class: INDUSTRY, collaborators name: Aptar Digital Health, collaborators name: Lindus Health, descriptionModule briefSummary: The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines., conditionsModule conditions: Asthma Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: Aptar Digital Health respiratory disease management platform, outcomesModule primaryOutcomes measure: Asthma Control Questionnaire - 5 scores, secondaryOutcomes measure: Mini-Asthma Quality of Life Questionnaire, secondaryOutcomes measure: Rescue medication usage, secondaryOutcomes measure: Inhaled corticosteroid steroid daily adherence, otherOutcomes measure: Step-up from inhaled corticosteroids to biologics, otherOutcomes measure: Asthma related oral corticosteroids utilization and associated cost, otherOutcomes measure: Asthma related accident and emergency department visits and associated cost, otherOutcomes measure: Asthma related unscheduled outpatient clinic visits and associated cost, otherOutcomes measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost, otherOutcomes measure: Computer System Usability Questionnaire, otherOutcomes measure: Semi-structured interviews using the 2019 Rudin et al study, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364514, orgStudyIdInfo id: IRB-P00047313, briefTitle: PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability., conditionsModule conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Stability Assessment, outcomesModule primaryOutcomes measure: Proportion of eligible patients who consent to participate in the intervention, primaryOutcomes measure: Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation, secondaryOutcomes measure: Median days of antibiotics received for patients in the intervention group as well as from historical control group, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364501, orgStudyIdInfo id: KH801, briefTitle: Phase 1 Trial of KH801, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Beijing Kanghong Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection.This study is expected to include a total of approximately 17-42 participants., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: KH801, outcomesModule primaryOutcomes measure: MTD, primaryOutcomes measure: DLT, primaryOutcomes measure: RP2D, secondaryOutcomes measure: AE, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: CL, secondaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: anti-drug antibody (ADA), otherOutcomes measure: Objective Response Rate（ORR）, otherOutcomes measure: Disease Control Rate (DCR), otherOutcomes measure: Duration of Response (DOR), otherOutcomes measure: Median Progression-Free Survival (mPFS), otherOutcomes measure: Overall Survival（OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital, city: Peking, state: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, contacts name: Lin Shen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: ErWei Song, role: CONTACT, phone: 18982182468, email: 022516@cnkh.com, contacts name: ErWei Song, role: PRINCIPAL_INVESTIGATOR, contacts name: Junyan Wu, role: PRINCIPAL_INVESTIGATOR, contacts name: Herui Yao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Central Hospital Affiliated To Shandong First Medical University, city: Jinan, state: Shandong, country: China, contacts name: Meili Sun, role: CONTACT, contacts name: Meili Sun, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Rutie Yin, role: CONTACT, contacts name: Rutie Yin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06364475, orgStudyIdInfo id: BezmialemVU-TF-AÖ-1, briefTitle: Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2022-07-01, completionDateStruct date: 2022-09-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 137, type: ACTUAL, armsInterventionsModule interventions name: 16:8 Time-Restricted Intermittent Fasting Group, interventions name: Energy-Restricted Six-Meal Group, outcomesModule primaryOutcomes measure: Weight measured in kilogram, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Waist-to-height ratio (WHtR), secondaryOutcomes measure: Waist circumference in centimetres, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul Sabri Artam Vakfi Family Medicine Center, city: İ̇stanbul, zip: 34473, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06364462, orgStudyIdInfo id: ZLRK202301, briefTitle: Precise Evaluation Criteria for Histological Regression of NASH Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-09, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements., conditionsModule conditions: NASH, conditions: Liver Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: lifestyle intervention, outcomesModule primaryOutcomes measure: Regression of NASH fibrosis, secondaryOutcomes measure: Dynamic changes of liver stiffness measurements (LSM), secondaryOutcomes measure: Dynamic changes of CAP, secondaryOutcomes measure: Dynamic changes of MRE, secondaryOutcomes measure: Dynamic changes of MRI-PDFF, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Incidence of liver-related events, secondaryOutcomes measure: Incidence of extrahepatic related events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364449, orgStudyIdInfo id: 202309052RIND, briefTitle: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-13, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort., conditionsModule conditions: Decision Tree Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: predicted AV access choices, secondaryOutcomes measure: to determine factors affecting clinical use of the targeted AV access over a variable timeframe, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Chih-Yang Chan, MD Phd, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06364436, orgStudyIdInfo id: AksarayU1, briefTitle: Distant Reiki Therapy on Postpartum Period Fatigue and Depression, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Aksaray University, class: OTHER, descriptionModule briefSummary: This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression., conditionsModule conditions: PostPartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Reiki energy therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale for Fatigue (VAS-F), primaryOutcomes measure: Edinburgh Postnatal Depression Scale (EPDS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aksaray University, city: Aksaray, state: Merkez, country: Turkey, geoPoint lat: 38.37255, lon: 34.02537, hasResults: False
protocolSection identificationModule nctId: NCT06364397, orgStudyIdInfo id: ESPRIT202403, briefTitle: Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis, acronym: ESPRIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, collaborators name: Peking Union Medical College Hospital, collaborators name: First People's Hospital of Hangzhou, descriptionModule briefSummary: The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography (ERCP) works to treat idiopathic recurrent pancreatitis (IRAP) in adults. It also clarify the efficacy of ERCP in the diagnosis of IRAP. The main questions it aims to answer are:Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients? Does ERCP contribute to identify the etiology of IRAP patients?Participants will be randomly allocated to receive ERCP (pancreatic sphincterotomy and pancreatic stent placement) or conservative treatment and be followed for 1 year., conditionsModule conditions: Recurrent Acute Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: ERCP, interventions name: Health education and conservative management of clinical routines, outcomesModule primaryOutcomes measure: Recurrence rate of AP, secondaryOutcomes measure: Ratio of reduced AP episodes, secondaryOutcomes measure: Proportion of patients with reduced AP episodes, secondaryOutcomes measure: Severity of AP, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Evaluation of psychological condition, secondaryOutcomes measure: Proportion of patients diagnosed by ERCP., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai Hospital, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False