hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06386159, orgStudyIdInfo id: 2023-1178, briefTitle: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application., conditionsModule conditions: Post-extubation Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Electrical vagus nerve stimulation, outcomesModule primaryOutcomes measure: functional oral intake scale（FOIS）, primaryOutcomes measure: standardized Swallowing Assessment（SSA）, secondaryOutcomes measure: Rate of total oral feeding after the intervention, secondaryOutcomes measure: Duration of Enteral Nutrition Tube Indwelling, secondaryOutcomes measure: Rate of Re-intubation after Endotracheal Intubation, secondaryOutcomes measure: Incidence of aspiration within one week after extubation, secondaryOutcomes measure: The incidence of aspiration pneumonia within one week after extubation, secondaryOutcomes measure: Inflammation-related indicators: serum C-reactive protein (CRP), secondaryOutcomes measure: Inflammation-related indicators: serum interleukin-6 (IL-6), secondaryOutcomes measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh), secondaryOutcomes measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1), secondaryOutcomes measure: Days of ICU hospitalization, secondaryOutcomes measure: Total days of hospitalization, secondaryOutcomes measure: In-hospital survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Feng Xiuqin, status: RECRUITING, city: Hangzhou, zip: 310000, country: China, contacts name: Feng Feng, Xiuqin, role: CONTACT, phone: 13757119151, email: fengxiuqin@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06386146, orgStudyIdInfo id: JAB-30355-1001, briefTitle: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Jacobio Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation., conditionsModule conditions: Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: JAB-30355, interventions name: JAB-30355, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Time to reach the observed maximum (peak) concentration (Tmax), secondaryOutcomes measure: Terminal half-life (t1/2), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386120, orgStudyIdInfo id: 2024-z033, briefTitle: Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care., conditionsModule conditions: Lung Contusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PEEP setting strategy, outcomesModule primaryOutcomes measure: ventilation blood flow ratio, secondaryOutcomes measure: oxygenation index, secondaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: Mechanical ventilation-free from day 1 to 28, secondaryOutcomes measure: Length of ICU stay, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: The rate of successful weaning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386094, orgStudyIdInfo id: INT/IEC/2023/SPL-902, briefTitle: Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2025-08-15, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS), septic shock., heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality., conditionsModule conditions: NAFLD, conditions: Cardiac Disease, conditions: Fatty Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiographic assessment, outcomesModule primaryOutcomes measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease, secondaryOutcomes measure: Presence of myocardial abnormalities in CCM dysfunction, secondaryOutcomes measure: Presence of perfusion abnormalities in CCM dysfunction, secondaryOutcomes measure: All cause mortality in NAFLD, secondaryOutcomes measure: Cardiac event related mortality in NAFLD, secondaryOutcomes measure: To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Madhumita Premkumar, status: RECRUITING, city: Chandigarh, zip: 160012, country: India, contacts name: Dr. Madhumita Premkumar, MD, role: CONTACT, phone: +9101722754777, email: drmadhumitap@gmail.com, geoPoint lat: 30.73629, lon: 76.7884, hasResults: False
protocolSection identificationModule nctId: NCT06386081, orgStudyIdInfo id: AC18/00031, briefTitle: Dietary Intervention in Food Allergy, acronym: AC18/00031, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, class: OTHER, descriptionModule briefSummary: The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples., conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Treatment will be blinded to the participants and research team., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ACTUAL, armsInterventionsModule interventions name: Citrus pectin with low DE, interventions name: Apple pectin with high DE, interventions name: Placebo, outcomesModule primaryOutcomes measure: Clinical efficacy of pectin dietary intervention in nsLTP allergic patients, secondaryOutcomes measure: Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention, secondaryOutcomes measure: Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention, secondaryOutcomes measure: Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention, secondaryOutcomes measure: Changes in Pru p 3-specific basophil activation induced by pectin intervention, secondaryOutcomes measure: Changes induced in the taxonomic diversity of gut microbiota, secondaryOutcomes measure: Changes in feaces metabolome induced by pectin dietary intervention, secondaryOutcomes measure: Changes in serum metabolome induced by the pectin dietary intervention, secondaryOutcomes measure: Epigenomic changes induced by the pectin dietary intervention, secondaryOutcomes measure: Pectin safety profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Regional Universitario de Málaga, city: Malaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, hasResults: False
protocolSection identificationModule nctId: NCT06386055, orgStudyIdInfo id: STUDY00007545, briefTitle: Air Pollution and Physical Activity: A Randomized Controlled Trial, acronym: PARC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, descriptionModule briefSummary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study., conditionsModule conditions: Physical Inactivity, conditions: Pollution; Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Active exercise, outcomesModule primaryOutcomes measure: blood pressure, secondaryOutcomes measure: Self-report questionnaire, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University at Buffalo, city: Buffalo, state: New York, zip: 14214, country: United States, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
protocolSection identificationModule nctId: NCT06386029, orgStudyIdInfo id: STUDY24010191, briefTitle: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:1. Is the Power Down feasible for caregivers to do each night?2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?, conditionsModule conditions: Autism, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot, non-blinded intervention trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Power Down bedtime manipulation, outcomesModule primaryOutcomes measure: Recruitment rates of participants through the trial, primaryOutcomes measure: Retention rates of participants through the trial, primaryOutcomes measure: Caregiver reported acceptability, secondaryOutcomes measure: Treatment adherence, secondaryOutcomes measure: Data collection rates- Questionnaires, secondaryOutcomes measure: Data collection rates- Daily diaries, secondaryOutcomes measure: Data collection rates- Wearing the actigraphy watch, secondaryOutcomes measure: Credibility/Expectancy Questionnaire, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Amy G Hartman, PhD, role: CONTACT, phone: 614-989-6303, email: agh38@pitt.edu, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
protocolSection identificationModule nctId: NCT06386016, orgStudyIdInfo id: Stethoscope study, briefTitle: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Xiao-dong Zhuang, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention., conditionsModule conditions: Valvular Heart Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: artificial intelligence-based stethoscope, outcomesModule primaryOutcomes measure: valvular heart disease, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Sun Yat-Sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Xiaodong Zhuang, PhD, role: CONTACT, phone: +86 13760755035, email: zhuangxd3@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06386003, orgStudyIdInfo id: 23-230, briefTitle: Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, collaborators name: Toronto Metropolitan University, collaborators name: University of Ottawa, descriptionModule briefSummary: This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD)., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: PTSD, conditions: Chronic PTSD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Feasibility and tolerability, secondaryOutcomes measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score, secondaryOutcomes measure: Posttraumatic stress disorder Checklist-5 (PCL-5), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder Scale, 7-item (GAD-7), secondaryOutcomes measure: Dissociative Experiences Scale II (DES-II), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: World Health Organization Well-Being Index, 5-item (WHO-5), secondaryOutcomes measure: Quality of relationships inventory (QRI), secondaryOutcomes measure: Inventory of psychosocial functioning (IPF), secondaryOutcomes measure: Posttraumatic Maladaptive Beliefs Scale (PMBS), secondaryOutcomes measure: Brief Experiential Avoidance Questionnaire (BEAQ), secondaryOutcomes measure: 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24), secondaryOutcomes measure: Working Alliance Inventory- Short Form (WAI-SF), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF), secondaryOutcomes measure: Self-Compassion Scale-Short Form (SCS-SF), secondaryOutcomes measure: Psychological Insight Questionnaire (PIQ), secondaryOutcomes measure: Emotional Breakthrough Inventory (EBI), secondaryOutcomes measure: Altered States of Consciousness Rating Scale (ASC), secondaryOutcomes measure: Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ), otherOutcomes measure: Effect on digital physiological passive data collected through the use of a wearable device, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Michael's Hospital, Unity Health Toronto, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06385990, orgStudyIdInfo id: 2024ks01, briefTitle: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-29, completionDateStruct date: 2027-03-29, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hunan Cancer Hospital, class: OTHER, descriptionModule briefSummary: This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles., conditionsModule conditions: Triple Negative Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: UTD1, outcomesModule primaryOutcomes measure: 2-year disease-free survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Invasive Disease free survival (iDFS), secondaryOutcomes measure: Distant Disease-free Survival (DDFS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Quchang Ouyang, status: RECRUITING, city: Changsha, state: Hunan, zip: 410083, country: China, contacts name: Quchang Ouyang, role: CONTACT, phone: 8673189762161, email: oyqc1969@126.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False