hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06334744, orgStudyIdInfo id: COVAR, briefTitle: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-17, primaryCompletionDateStruct date: 2023-01-08, completionDateStruct date: 2023-06-08, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, descriptionModule briefSummary: To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine., conditionsModule conditions: Oncologic Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, outcomesModule primaryOutcomes measure: Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same., secondaryOutcomes measure: Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine, secondaryOutcomes measure: Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine., secondaryOutcomes measure: Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine., secondaryOutcomes measure: Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs San Matteo Pavia, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
protocolSection identificationModule nctId: NCT06334731, orgStudyIdInfo id: 045.PHA.2021.D, briefTitle: Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of third generation cephalosporin-resistant bacteria (3GCRB), secondaryOutcomes measure: Incidence of ESBLPE, secondaryOutcomes measure: Incidence of CRB, secondaryOutcomes measure: Incidence of other pathogens, secondaryOutcomes measure: Incidence of nosocomial infections, secondaryOutcomes measure: Incidence of clinical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Dallas Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75203, country: United States, contacts name: Matthew Crotty, PharmD, role: CONTACT, phone: 214-941-2400, email: matthewcrotty@mhd.com, contacts name: Matthew Crotty, PharmD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
protocolSection identificationModule nctId: NCT06334692, orgStudyIdInfo id: BLINDER, briefTitle: Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome, acronym: BLINDER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN)., conditionsModule conditions: Nephrotic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa)., outcomesModule primaryOutcomes measure: Levels of circulating anti-nephrin autoantibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò, city: Ranica, state: BG, zip: 24020, country: Italy, contacts name: Federica Casiraghi, PhD, role: CONTACT, phone: +3903545351, email: federica.casiraghi@marionegri.it, geoPoint lat: 45.72328, lon: 9.71335, hasResults: False
protocolSection identificationModule nctId: NCT06334666, orgStudyIdInfo id: SI 172/2024, briefTitle: The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks., conditionsModule conditions: Daily Step Count, conditions: MASLD, conditions: BMI, conditions: Metabolic Syndrome, conditions: NAFLD, conditions: Insulin Resistance, conditions: Genetic Polymorphism, conditions: Cardiovascular Disease (CVD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Encourage using pedometer, outcomesModule primaryOutcomes measure: To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior., secondaryOutcomes measure: To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments., secondaryOutcomes measure: To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06334653, orgStudyIdInfo id: H-23069670, briefTitle: Exercise-regulated Organ Crosstalk, Influence of IL-6, acronym: EVEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Helga Ellingsgaard, class: OTHER, descriptionModule briefSummary: Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise., conditionsModule conditions: Healthy Volunteers Only, conditions: Energy Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: exercise, outcomesModule primaryOutcomes measure: Whole body substrate kinetics., primaryOutcomes measure: Tissue specific utilization and production of substrates., primaryOutcomes measure: IL-6 regulation of protein synthesis and degradation., primaryOutcomes measure: Number of EVs from muscle, liver, and brain., primaryOutcomes measure: Size of EVs from muscle, liver, and brain., primaryOutcomes measure: EVs from muscle, liver, and brain., primaryOutcomes measure: Influence of exercise on EV number., primaryOutcomes measure: Influence of exercise on EV size, primaryOutcomes measure: Influence of exercise on EV content., primaryOutcomes measure: Tissue specific proteomic content of EVs., secondaryOutcomes measure: Lactate., secondaryOutcomes measure: Pyruvate., secondaryOutcomes measure: Keto acids., secondaryOutcomes measure: Ketone bodies., secondaryOutcomes measure: Influence of IL-6 on fatty acid oxidation rates., secondaryOutcomes measure: Influence of IL-6 on insulin., secondaryOutcomes measure: Influence of IL-6 on glucagon., secondaryOutcomes measure: Influence of IL-6 on epinephrine., secondaryOutcomes measure: Influence of IL-6 on norepinephrine., secondaryOutcomes measure: IL-6 levels., secondaryOutcomes measure: Influence of IL-6 on substrate usage., secondaryOutcomes measure: Influence of IL-6 on perceived exertion., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, state: Capital Region, zip: 2100, country: Denmark, contacts name: Helga Ellingsgaard, PhD, role: CONTACT, phone: +4535457544, email: helga.ellingsgaard@regionh.dk, contacts name: Peter S Plomgaard, MD PhD, role: CONTACT, phone: +4535457544, email: Peter.Plomgaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06334640, orgStudyIdInfo id: 37C302, briefTitle: Sleeping Quality and Chronic Ocular Diseases, acronym: SONNO-OCU, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2025-10-17, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: To assess the impact of sleep quality on chronic eyes diseases, conditionsModule conditions: Sleep Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: Three questionaires, outcomesModule primaryOutcomes measure: Proportion of sleep disorders in patients and healthy volunteers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Paolo Milani, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06334627, orgStudyIdInfo id: ENREACH, briefTitle: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania, acronym: EN-REACH, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-05-03, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: London School of Hygiene and Tropical Medicine, class: OTHER, collaborators name: International Centre for Diarrhoeal Disease Research, Bangladesh, collaborators name: Golden Community, Nepal, collaborators name: Muhimbili University of Health and Allied Sciences, collaborators name: University of Glasgow, descriptionModule briefSummary: The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:* What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?* What is the feasibility and accessibility of a parent group intervention for these children?Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development., conditionsModule conditions: Child Development, conditions: Child Development Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1651, type: ACTUAL, armsInterventionsModule interventions name: Pre-Primary Intervention, outcomesModule primaryOutcomes measure: Measuring Early Learning Quality and Outcomes (MELQO Tool), primaryOutcomes measure: The Pediatric Evaluation of Disability Inventory, secondaryOutcomes measure: Washington Group Questionnaire, secondaryOutcomes measure: The Wechsler Preschool & Primary Scale of Intelligence, secondaryOutcomes measure: Pre-school Register, secondaryOutcomes measure: Mental Health Questionnaire, secondaryOutcomes measure: Pediatric Quality of Life Inventory (PEDSQL Tool), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: International Centre for Diarrheal Disease Research, Bangladesh, city: Dhaka, country: Bangladesh, geoPoint lat: 23.7104, lon: 90.40744, locations facility: Golden Community, city: Lalitpur, country: Nepal, geoPoint lat: 27.67658, lon: 85.31417, locations facility: Muhimbili University of Health and Allied Sciences, city: Dar Es Salaam, country: Tanzania, geoPoint lat: -6.82349, lon: 39.26951, hasResults: False
protocolSection identificationModule nctId: NCT06334614, orgStudyIdInfo id: IIT_iReach, briefTitle: iReach: a Rehabilitative Medical Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-08, primaryCompletionDateStruct date: 2025-05-08, completionDateStruct date: 2025-12-08, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Italiano di Tecnologia, class: OTHER, descriptionModule briefSummary: The broad goal of this clinical trial is to demonstrate whether a one-month rehabilitative training with our medical device, iReach, can promote the recovery of spatial and sensorimotor abilities and the cortical reorganization process in children with visual impairment between 3 and 36 months of age., conditionsModule conditions: Blindness, conditions: Visual Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participant masking because the clinical trial involves infants, whoMasked: PARTICIPANT, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: iReach, outcomesModule primaryOutcomes measure: Incidence of Device Adverse Events, secondaryOutcomes measure: Change in motor skills after training with iReach medical device, secondaryOutcomes measure: Perceptual responses to multisensory stimuli, secondaryOutcomes measure: Change in motor abilities following the rehabilitation with the iReach medical device, secondaryOutcomes measure: Variation in the power of the cortical activity following the rehabilitation with the iReach medical device, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 36 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06334601, orgStudyIdInfo id: 09C333, briefTitle: Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness, acronym: Muscle-OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Tests of upper airway collapsibility and muscle responsiveness., outcomesModule primaryOutcomes measure: Upper airway collapsibility, primaryOutcomes measure: Upper airway muscle responsiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Elisa Perger, MD, role: CONTACT, phone: +390261911, phoneExt: 2705, email: e.perger@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06334588, orgStudyIdInfo id: APHP240105, secondaryIdInfos id: 2023-A02668-37, type: REGISTRY, domain: ID-RCB, briefTitle: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study, acronym: ECLAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: Eye-tracking, interventions name: Clinical Scales, interventions name: Research of genetic anomalies, outcomesModule primaryOutcomes measure: Rest cerebral blood flow (CBF), secondaryOutcomes measure: Measurements of white matter microstructure - fractional anisotropy, secondaryOutcomes measure: Measurements of white matter microstructure - mean diffusivity, secondaryOutcomes measure: Measurements of white matter microstructure - radial diffusivity, secondaryOutcomes measure: Measurements of white matter microstructure - axial diffusivity, secondaryOutcomes measure: Measurements of resting state functional connectivity, secondaryOutcomes measure: Correlation between social perception and multimodal brain imaging, secondaryOutcomes measure: Correlation between clinical severity and multimodal brain imaging, secondaryOutcomes measure: Imaging abnormalities associated with known genetic mutations, secondaryOutcomes measure: Social perception abnormalities associated with known genetic mutations, secondaryOutcomes measure: Anatomic changes over time - study of developmental trajectory, secondaryOutcomes measure: Social perception changes over time - study of developmental trajectory, secondaryOutcomes measure: Brain imaging in young children associated with ASD, secondaryOutcomes measure: Early data on social perception, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Nathalie BODDAERT, MD, PhD, role: CONTACT, phone: +33 1.71.39.65.30, email: nathalie.boddaert@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False