hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06311201, orgStudyIdInfo id: P.T.REC/012/004256, briefTitle: Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2024-01-26, completionDateStruct date: 2024-01-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women., conditionsModule conditions: Diastasis Recti, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Abdominal belt, interventions name: Pilates exercises, outcomesModule primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction, primaryOutcomes measure: Assessment of trunk flexion strength, primaryOutcomes measure: Assessment of static trunk flexion endurance, secondaryOutcomes measure: Assessment of functional status, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06311188, orgStudyIdInfo id: HUM00240243, secondaryIdInfos id: 1R21MD016940-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21MD016940-01A1, briefTitle: Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention., conditionsModule conditions: Stress, conditions: Trauma, conditions: PTSD, conditions: HPA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: ITR Healing intervention, outcomesModule primaryOutcomes measure: PTSD Screen, primaryOutcomes measure: PTSD Checklist, secondaryOutcomes measure: Stress Psychosocial, secondaryOutcomes measure: Stress Physiological, secondaryOutcomes measure: Parent/Caregiver-Child Relationship, secondaryOutcomes measure: Five Facet Mindfulness Questionnaire (FFMQ), secondaryOutcomes measure: Recidivism, secondaryOutcomes measure: Personal Agency, secondaryOutcomes measure: Racial Identity, secondaryOutcomes measure: Parenting Stress, otherOutcomes measure: MoCA screen, otherOutcomes measure: CESD - Depression screen, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06311149, orgStudyIdInfo id: 479/2023/Oss/AOUFe, briefTitle: Multicenter Evaluation of Patients Using LATITUDE Monitoring System, acronym: Multitude, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2043-12-31, completionDateStruct date: 2043-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle., conditionsModule conditions: Cardiovascular Diseases, conditions: Arrhythmias, Cardiac, conditions: Heart Failure, conditions: Sudden Cardiac Death, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Device therapy, secondaryOutcomes measure: Device-related complications, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria di Ferrara, status: RECRUITING, city: Ferrara, zip: 44124, country: Italy, contacts name: Matteo Bertini, MD, PhD, role: CONTACT, email: brtmtt2@unife.it, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Policlinico Federico II, status: RECRUITING, city: Napoli, country: Italy, contacts name: Antonio Rapacciuolo, role: CONTACT, email: antonio.rapacciuolo@unina.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
protocolSection identificationModule nctId: NCT06311123, orgStudyIdInfo id: ISR IM047-059, briefTitle: Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration., conditionsModule conditions: Ulcerative Colitis, conditions: Ulcerative Colitis Chronic Moderate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: difference in leukocyte subsets, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92093-006, country: United States, contacts name: Jesus Rivera-Nieves, MD, role: CONTACT, phone: 858-534-5495, email: jriveran@ucsd.edu, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06311110, orgStudyIdInfo id: #BC-11326 AM04, briefTitle: Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-02-08, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC)., conditionsModule conditions: Developmental Coordination Disorder, conditions: Lower Urinary Tract Symptoms, conditions: Bowel Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, interventions name: Developmental Coordination Disorder Questionnaire, interventions name: Questionnaire concerning impaired toilettraining and comorbities, outcomesModule primaryOutcomes measure: Impaired toilet training, primaryOutcomes measure: Daytime incontinence, primaryOutcomes measure: Enuresis, primaryOutcomes measure: Fecal incontinence, secondaryOutcomes measure: Toilet training difficulties, secondaryOutcomes measure: General bladder and bowel dysfunction, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ghent University Hospital/Ghent University, city: Ghent, state: East Flanders, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
protocolSection identificationModule nctId: NCT06311084, orgStudyIdInfo id: 310211, briefTitle: IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People, acronym: IMAG2, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-25, primaryCompletionDateStruct date: 2023-11-09, completionDateStruct date: 2024-01-23, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK.Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents.Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions., conditionsModule conditions: Self Injurious Behavior, conditions: Adolescent Behavior Problem, conditions: Child Behavior Problem, conditions: Mental Health Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open ended feasibility and acceptability of novel blended digital psychological intervention, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Imaginator 2.0, outcomesModule primaryOutcomes measure: Attrition, primaryOutcomes measure: Treatment adherence, primaryOutcomes measure: Scores on User Experience Questionnaire, secondaryOutcomes measure: Number of self harm episodes over 3 months, otherOutcomes measure: Craving Experiences Questionnaire, otherOutcomes measure: Difficulties in Emotion Regulation Scale, otherOutcomes measure: Depression, Anxiety, Stress Scale, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West London NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-04-04, uploadDate: 2024-02-16T12:11, filename: Prot_000.pdf, size: 1958833, hasResults: False
protocolSection identificationModule nctId: NCT06311071, orgStudyIdInfo id: IR.SUMS.MED.REC.1401.200, briefTitle: The Predictive Value of Coronary Artery Calcium Score, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shiraz University of Medical Sciences, class: OTHER, descriptionModule briefSummary: In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients, conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 498, type: ACTUAL, armsInterventionsModule interventions name: calcium score, interventions name: Invasive coronary angiography, outcomesModule primaryOutcomes measure: coronary artery disease, primaryOutcomes measure: coronary calcium score, secondaryOutcomes measure: cardiovascular risk score, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Javad Kojuri, city: Shiraz, state: Fars, zip: 7134814336, country: Iran, Islamic Republic of, geoPoint lat: 29.61031, lon: 52.53113, hasResults: False
protocolSection identificationModule nctId: NCT06311058, orgStudyIdInfo id: PRO00032531, briefTitle: Protein Supplementation After ACL Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy., conditionsModule conditions: ACL Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects are randomized to 1 of 3 intervention groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: This is a double-blinded randomized controlled trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Whey protein isolate, interventions name: Protein + BAA, interventions name: Placebo, outcomesModule primaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Houston Methodist, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Haley Goble, MHA, role: CONTACT, phone: 713-441-3930, email: hmgoble@houstonmethodist.org, contacts name: Robert A Jack, MD, role: SUB_INVESTIGATOR, contacts name: Patrick C McCulloch, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: David M Lintner, MD, role: SUB_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06311032, orgStudyIdInfo id: 22-01227, briefTitle: Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2023-06-28, completionDateStruct date: 2023-07-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas., conditionsModule conditions: Surgery Risk Assessment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of Decisions to Stop Surveillance Imaging, primaryOutcomes measure: Number of Decisions to Continue Surveillance Imaging, 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: NCT06310993, orgStudyIdInfo id: STH22549, briefTitle: Exercise to Boost Immunity in Advanced Cancer, acronym: BICEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sheffield Teaching Hospitals NHS Foundation Trust, class: OTHER, collaborators name: University of Sheffield, collaborators name: Sheffield Hallam University, descriptionModule briefSummary: The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression, conditionsModule conditions: Mesothelioma; Lung, conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Primary Outcome Measure, secondaryOutcomes measure: Secondary outcome 1, secondaryOutcomes measure: Secondary Outcome 2, secondaryOutcomes measure: Secondary Outcome 3, secondaryOutcomes measure: Secondary Outcome 4, secondaryOutcomes measure: Secondary Outcome 5, secondaryOutcomes measure: Secondary Outcome 6, secondaryOutcomes measure: Secondary Outcome 7, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Research Centre at Weston Park Hospital, city: Sheffield, state: England, zip: S1O 2SJ, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Sheffield Hallam University, city: Sheffield, state: South Yorkshire, zip: S10 2BP, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False
protocolSection identificationModule nctId: NCT06310980, orgStudyIdInfo id: SMARTPEN, briefTitle: Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor., acronym: SMARTPEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Giulio Frontino, class: OTHER, descriptionModule briefSummary: The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: smartpen, outcomesModule primaryOutcomes measure: Time in range, secondaryOutcomes measure: time below range, secondaryOutcomes measure: time above range, secondaryOutcomes measure: coefficient of variation (CV), secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: ITSRQ, secondaryOutcomes measure: DIDS, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False