hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06295432, orgStudyIdInfo id: DZ2022E0001, briefTitle: A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Dizal Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: DZD9008+AZD4205, outcomesModule primaryOutcomes measure: Part A: incidence of DLT, ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial People'S Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Zhen Wang, role: CONTACT, phone: 020-83827812, email: wangzhen@gdph.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06295406, orgStudyIdInfo id: 21C310, briefTitle: Reading Ability in Childhood Obesity, acronym: Lettura_evOB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory., conditionsModule conditions: Obesity, Childhood, conditions: Obesity, Adolescent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological assessment, outcomesModule primaryOutcomes measure: Raw score at the neuropsychological assessment, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, status: RECRUITING, city: Piancavallo, state: VCO, zip: 28824, country: Italy, contacts name: Federica Scarpina, PhD, role: CONTACT, phone: +39032351, phoneExt: 4003, email: f.scarpina@auxologico.it, hasResults: False
protocolSection identificationModule nctId: NCT06295393, orgStudyIdInfo id: 20-0229-CCMC, briefTitle: Renin Angiotensin Aldosterone System In Septic Kids, acronym: RISK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Northwell Health, class: OTHER, descriptionModule briefSummary: Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups., conditionsModule conditions: Sepsis, conditions: Acute Kidney Injury Due to Sepsis, conditions: Acute Kidney Injury (Nontraumatic), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Difference in serum renin in sepsis, secondaryOutcomes measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury, secondaryOutcomes measure: Septic induced kidney injury will be associated with alterations in renal blood flow, secondaryOutcomes measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients, secondaryOutcomes measure: Changes in the components of the RAAS over the first three days in sepsis, secondaryOutcomes measure: Changes in renal blood flow on Ultrasound in Sepsis, secondaryOutcomes measure: Renal blood flow and RAAS in sepsis, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cohen Children's Medical Center, status: RECRUITING, city: New Hyde Park, state: New York, zip: 11004, country: United States, contacts name: Grace Fisler, MD, role: CONTACT, email: gfisler@northwell.edu, contacts name: Shannon A Moriarty, role: CONTACT, phone: 631-834-0984, email: smoriarty2@northwell.edu, geoPoint lat: 40.7351, lon: -73.68791, hasResults: False
protocolSection identificationModule nctId: NCT06295380, orgStudyIdInfo id: CarenAmp, briefTitle: Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase)., conditionsModule conditions: Lower Limb Amputation Knee, conditions: Injuries, conditions: Biomechanical Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Virtual environment practiced on the Caren, interventions name: Conventional physiotherapy, outcomesModule primaryOutcomes measure: Kinematic data, primaryOutcomes measure: Kinetic data, primaryOutcomes measure: Electromyography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi, city: Messina, state: Sicily, zip: 98124, country: Italy, contacts name: Rocco Salvatore Calabrò, MD, role: CONTACT, phone: 09060128179, phoneExt: +39, email: roccos.calabro@irccsme.it, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False
protocolSection identificationModule nctId: NCT06295354, orgStudyIdInfo id: 2024-17062, briefTitle: Early Variations in Immune Aging, acronym: EVIA-NL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: Background:Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.Study design:A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between., conditionsModule conditions: Aging, conditions: Aging Well, conditions: Immuno Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, we just study 'aging', outcomesModule primaryOutcomes measure: Immunological function, primaryOutcomes measure: Immunological Aging Score, primaryOutcomes measure: Biological Aging Score, primaryOutcomes measure: Metagenomics, primaryOutcomes measure: Genetics and epigenetics, primaryOutcomes measure: Clinical events, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06295341, orgStudyIdInfo id: 01C312, briefTitle: Short Stature and Psychological Well-being, acronym: PSICOSHORT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA., conditionsModule conditions: Short Stature, conditions: Short; Stature, Psychosocial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human growth hormone (only for children with growth hormone deficiency), outcomesModule primaryOutcomes measure: Psychological well-being through the Psychological Well-Being Scales (PWB), primaryOutcomes measure: Psychological distress through the Depression Anxiety Stress Scale (DASS-21), primaryOutcomes measure: Quality of life through the Quality of Life in Short Stature Youth (QoLISSY),, primaryOutcomes measure: Skills and problems through the Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Behavioral problems through the Child Behaviour Checklist for Children (CBCL), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Alessandro Sartorio, MD, role: CONTACT, phone: +390261911, phoneExt: 2426, email: sartorio@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06295315, orgStudyIdInfo id: 01C310, briefTitle: Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome, acronym: PROPSICOPWS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated., conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, outcomesModule primaryOutcomes measure: Psychological well-being through the Psychological General Well-Being Index (PGWBI), primaryOutcomes measure: Perception of life quality through the 36-Item Short Form Survey (SF-36), primaryOutcomes measure: Mental distress through the Symptom Checklist-90-R (SCL-90-R), secondaryOutcomes measure: Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21), secondaryOutcomes measure: Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version)., secondaryOutcomes measure: Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, site Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, contacts name: Alessandro Sartorio, MD, role: CONTACT, phone: +390261911, phoneExt: 2426, email: sartorio@auxologico.it, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
protocolSection identificationModule nctId: NCT06295302, orgStudyIdInfo id: RFCU-IIa-202308, briefTitle: A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hubei Biological Medicine Industrial Technology Institute Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated., conditionsModule conditions: Chronic Spontaneous Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HWH486, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7), secondaryOutcomes measure: Change in Hive Severity Score (HSS) over a 7-day period (HSS7), secondaryOutcomes measure: Change in Itch Severity Score (ISS) over a 7-day period (ISS7), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital,Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Bioethics Committee of West China Hospital, role: CONTACT, phone: +86 28 8512 3237, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06295289, orgStudyIdInfo id: ZRKY-2023-04, briefTitle: Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2024-12-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period., conditionsModule conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Hybrid Closed-loop Insulin Delivery System, interventions name: Insulin pump, outcomesModule primaryOutcomes measure: TIR, secondaryOutcomes measure: TAR, secondaryOutcomes measure: TBR, secondaryOutcomes measure: MBG, otherOutcomes measure: postoperative infection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Xuefeng Yu, role: CONTACT, phone: 02783662883, email: xfyu188@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06295276, orgStudyIdInfo id: HSOsnabruck, briefTitle: Effect of Teletherapy-supported Training on Nursing Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Hochschule Osnabruck, class: OTHER, descriptionModule briefSummary: Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale, conditionsModule conditions: Low Back Pain, conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel comparative randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Allocation concealment:The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality., enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: teletherapy-guided exercise programme, interventions name: Waiting list/control intervention, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Oswestry Disability Index (ODI), primaryOutcomes measure: NRS Numeric rating scale for pain, secondaryOutcomes measure: Short-Form: SF 36-Quality of life, secondaryOutcomes measure: Global rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Diakonie Pflege Schule, status: RECRUITING, city: Osnabrück, state: Niedersachsen, zip: 49078, country: Germany, contacts name: Roland Simon, BScPTc, role: CONTACT, phone: 05068932755, email: helmut.simon@hs-osnabrueck.de, geoPoint lat: 52.27264, lon: 8.0498, hasResults: False