hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06309147, orgStudyIdInfo id: ALX-923-107, briefTitle: A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Allyx Therapeutics, class: INDUSTRY, collaborators name: Michael J. Fox Foundation for Parkinson's Research, descriptionModule briefSummary: A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, parallel, 3-arm, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Matching placebo, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: BMS-9894923, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling, otherOutcomes measure: To evaluate changes in α-synuclein, otherOutcomes measure: Change from baseline dopamine transporter, otherOutcomes measure: Assess changes in motor function, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke Clinical Research Institute, status: RECRUITING, city: Durham, state: North Carolina, zip: 27701, country: United States, contacts name: Alexis Schuettke, role: CONTACT, phone: 919-668-2842, email: alexis.schuettke@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
protocolSection identificationModule nctId: NCT06309108, orgStudyIdInfo id: 2022/68-04, secondaryIdInfos id: İUC, type: OTHER, domain: İUC, briefTitle: Bariatric Surgery and Patient Education, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2022-05-02, completionDateStruct date: 2023-07-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Obesity is a disease that poses a health risk and is increasing worldwide. Bariatric surgery is the most effective method used in the treatment of obesity. Preoperative health education for bariatric surgery patients is important to support surgery. There is not enough nursing research in the literature regarding training patients with two different materials before bariatric surgery. The purpose of the randomized controlled experimental study designed in light of this information was to determine the effect of education given to patients with two different materials before bariatric surgery on early complications. The rates of the study were determined by randomizing trial I, trial II, and control treatment in 66 rooms that met the interval and study screening criteria offered between May 2022 and June 2023 in the general surgery service of a university hospital. Data from the research; was collected with the Veria Total Form, Autar Risk Assessment Scale, Apfel Risk Score, Visual Comparison Scale-VAS (Visual Analog Scale-VAS), Training Satisfaction Survey, and Complication Monitoring Form. In the first face-to-face meeting in the experimental groups, we were given training by the researcher with the removable Training Booklet I and Training Booklet II and were monitored until discharge. No control group training was given., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Education, conditions: Patient Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In our study, patients who would undergo bariatric surgery were selected randomly., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Education Booklet, interventions name: Augmented Reality Group, outcomesModule primaryOutcomes measure: Veria Total Form for sociodemographic features, secondaryOutcomes measure: Autar Risk Assessment Scale for DVT, otherOutcomes measure: Apfel Risk Score for nausea and vomiting, otherOutcomes measure: Visual Analog Scale-VAS for pain, otherOutcomes measure: Training Satisfaction Survey, otherOutcomes measure: Complication Monitoring Form to determine whether complications develop, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul University- Cerrahpasa Instutite Graduate Studies, city: İstanbul, state: Avcılar, zip: 34320, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06309082, orgStudyIdInfo id: DFU, briefTitle: Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows:* What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging?* Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds.Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds., conditionsModule conditions: Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: H-CEUS score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital the First Affiliated Hospital, city: Wenzhou, state: Zhejiang, zip: 325006, country: China, contacts name: Shihao Xu, role: CONTACT, phone: 13857766918, email: dcxshvip@wmu.edu.cn, contacts name: Shihao Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
protocolSection identificationModule nctId: NCT06309069, orgStudyIdInfo id: LOCAL/2024/TP-01, secondaryIdInfos id: IRB 24.01.01, type: OTHER, domain: CHU de Nîmes, briefTitle: Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort, acronym: CCE Cohorte, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics., conditionsModule conditions: Calcified Cerebral Embolism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 79, type: ESTIMATED, armsInterventionsModule interventions name: None, purely observational study, outcomesModule primaryOutcomes measure: Calcified aortic brachiocephalic, primaryOutcomes measure: cardiovascular risk, primaryOutcomes measure: history of stroke, primaryOutcomes measure: Population, primaryOutcomes measure: Population, primaryOutcomes measure: history of surgical/endovascular cardiovascular intervention, primaryOutcomes measure: NIHSS, primaryOutcomes measure: calcified aortic arch, primaryOutcomes measure: calcified carotid, primaryOutcomes measure: atherosclerotic plaques, primaryOutcomes measure: calcified aortic valves, primaryOutcomes measure: calcified mitral valves, primaryOutcomes measure: CCE diameter, primaryOutcomes measure: density, primaryOutcomes measure: involved cerebral artery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nîmes, city: Nîmes, zip: 30029, country: France, contacts name: Teodora PARVU, role: CONTACT, phone: +33466685008, email: teodora.parvu@chu-nimes.fr, geoPoint lat: 43.83333, lon: 4.35, hasResults: False
protocolSection identificationModule nctId: NCT06309043, orgStudyIdInfo id: HLX05-001, briefTitle: A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts., conditionsModule conditions: EGFR Overexpression, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 268, type: ESTIMATED, armsInterventionsModule interventions name: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection, outcomesModule primaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: CL, secondaryOutcomes measure: λz, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06309030, orgStudyIdInfo id: ZRJY2023-QM21, briefTitle: Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Liu Longxiao, class: OTHER, descriptionModule briefSummary: The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Bushen quhan zhiwang decoction, interventions name: Bushen quhan zhiwang decoction placebo, outcomesModule primaryOutcomes measure: disease activity score derivative for 28 joints (DAS28), secondaryOutcomes measure: patient reported outcomes（PRO）, secondaryOutcomes measure: visual analogue scale for pain, secondaryOutcomes measure: withdrawl mechanical threshold, secondaryOutcomes measure: erythrocyte sedimentation Rate（ESR）, secondaryOutcomes measure: C-reactive protein（CRP）, secondaryOutcomes measure: TCM symptom score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06309017, orgStudyIdInfo id: 23-01243, briefTitle: Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition specialist, interventions name: Ensure Surgery Immunonutrition shakes, outcomesModule primaryOutcomes measure: Length of hospital stay, primaryOutcomes measure: Proportion of patients who experienced postoperative major complications, secondaryOutcomes measure: Proportion of patients who participated in a nutritional intervention program before surgery, secondaryOutcomes measure: Proportion of patients who participated in a nutritional intervention program after surgery, secondaryOutcomes measure: Number of nutritional shakes completed, secondaryOutcomes measure: Percentage of nutritional shakes completed overall, secondaryOutcomes measure: Percentage of nutritional shakes completed pre-surgery, secondaryOutcomes measure: Percentage of nutritional shakes completed post-surgery, secondaryOutcomes measure: Proportion of patients who experienced any postoperative complications, secondaryOutcomes measure: Proportion of patients with 30 day readmission, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06309004, orgStudyIdInfo id: 2023-00741a, briefTitle: Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction, acronym: iACTforDGBI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention, conditionsModule conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Focus group interviews, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06308991, orgStudyIdInfo id: IDU-SBF-SD-01, briefTitle: Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Izmir Democracy University, class: OTHER, descriptionModule briefSummary: The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants., conditionsModule conditions: Endotracheal Aspiration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Yakson touch, interventions name: Gentle Human Touch, interventions name: Routine care, outcomesModule primaryOutcomes measure: Neonatal Pain Agitation and Sedation Scale (N-PASS), primaryOutcomes measure: Change in Oxygen saturation, primaryOutcomes measure: Change in Heart rate, secondaryOutcomes measure: COMFORTneo Scale, eligibilityModule sex: ALL, minimumAge: 26 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Izmir Democracy University, city: Karabağlar, state: Izmir, zip: 35140, country: Turkey, geoPoint lat: 38.37396, lon: 27.1352, hasResults: False
protocolSection identificationModule nctId: NCT06308939, orgStudyIdInfo id: IRB-2024-198, briefTitle: Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: Eribulin, interventions name: Sintilimab, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Duration of Overall Response(DoR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: adverse event(AE), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: zhejiangCH, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Ying Xi Shao, doctor, role: CONTACT, phone: 15824113524, email: 15824113524@163.com, contacts name: Jia Xiao Wang, doctor, role: CONTACT, contacts name: Jia Xiao Wang, doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False