hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06306508, orgStudyIdInfo id: HUvbayraktaroglu, briefTitle: Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-02-16, completionDateStruct date: 2025-02-16, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study., conditionsModule conditions: Cystic Fibrosis, conditions: Cystic Fibrosis in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Modified shuttle walk test (MST), secondaryOutcomes measure: Forced expiratory volume at one second (FEV1), secondaryOutcomes measure: Forced vital capacity (FVC), secondaryOutcomes measure: Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC), secondaryOutcomes measure: Peak expiratory flow (PEF), secondaryOutcomes measure: Maximum inspiratory pressure (MIP), secondaryOutcomes measure: Maximum expiratory pressure (MEP), secondaryOutcomes measure: Physical Activity Questionnaire for Children (PAQ-C), secondaryOutcomes measure: Munich physical fitness test (MFT), secondaryOutcomes measure: Quadriceps strength, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Cystic Fibrosis Questionnaire Revised (CFQ-R), secondaryOutcomes measure: Parental Attitude Scale (PAS), secondaryOutcomes measure: Parent Attitude Scale, secondaryOutcomes measure: Perceived Social Support Scale (PSS), secondaryOutcomes measure: Breathlessness Beliefs Questionnaire (BBQ), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Haliç University, status: RECRUITING, city: Istanbul, state: Eyup, zip: 34060, country: Turkey, contacts name: Vildan Bayraktaroglu, PT, MSc, role: CONTACT, phone: (0212) 924 24 44, email: vildanbayraktaroglu@halic.edu.tr, contacts name: Seda Saka, PT, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06306482, orgStudyIdInfo id: SBA 23/390, briefTitle: Determination of Posture in Patients With Restrictive and Obstructive Lung Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-03-07, completionDateStruct date: 2026-03-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease., conditionsModule conditions: Lung Diseases, Obstructive, conditions: Lung Diseases, conditions: Postural; Defect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of horizontal alignment of the head anterior view, primaryOutcomes measure: Evaluation of horizontal alignment of the trunk anterior view, primaryOutcomes measure: Evaluation of horizontal alignment of the head lateral view, primaryOutcomes measure: Evaluation of vertical alignment of the head lateral view, primaryOutcomes measure: Evaluation of horizontal alignment of the trunk lateral view, primaryOutcomes measure: Evaluation of vertical alignment of the trunk lateral view, primaryOutcomes measure: Evaluation of horizontal asymmetry trunk in posterior view, primaryOutcomes measure: Evaluation of scapulae, primaryOutcomes measure: Posture, secondaryOutcomes measure: Functional exercise capacity, secondaryOutcomes measure: Respiratory Muscle Strength, secondaryOutcomes measure: Lung function, secondaryOutcomes measure: Dyspnea, secondaryOutcomes measure: Peripheral muscle strength, secondaryOutcomes measure: Lower extremity capacity, secondaryOutcomes measure: Energy expenditure, secondaryOutcomes measure: Balance and Fall risk, secondaryOutcomes measure: Tightness of muscle, secondaryOutcomes measure: Severity of disease for patients with COPD, secondaryOutcomes measure: Severity of disease for patients with bronchiectasis, secondaryOutcomes measure: Diffusion capacity for patients with diffuse parenchymal lung diseases, secondaryOutcomes measure: Symptoms for patients with COPD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aynur Demirel, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Hacettepe University, city: Ankara, zip: 06100, country: Turkey, contacts name: Aynur Demirel, role: CONTACT, phone: +905545295057, phoneExt: 178, email: aynur.demirel@hacettepe.edu.tr, contacts name: hidaye yamikan, role: CONTACT, phone: +905349898724, email: hidaye.yamikan@hacettepe.edu.tr, contacts name: hidaye yamikan, role: SUB_INVESTIGATOR, contacts name: irem seleoglu, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06306469, orgStudyIdInfo id: PHRI-2022-1001, briefTitle: Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-02, primaryCompletionDateStruct date: 2022-07-09, completionDateStruct date: 2024-01-11, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Pranic Healing Research Institute, class: OTHER, descriptionModule briefSummary: The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Meditation practice, outcomesModule primaryOutcomes measure: Assessing the changes in gut and oral microbiome profile of the participants during retreat, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pranic Healing Research Institute, city: Lyndhurst, state: New Jersey, zip: 07071, country: United States, geoPoint lat: 40.81204, lon: -74.12431, hasResults: False
protocolSection identificationModule nctId: NCT06306456, orgStudyIdInfo id: GH21C201, briefTitle: A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, descriptionModule briefSummary: This study, including phase Ib, phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations., conditionsModule conditions: Non-Small Cell Lung Cancer With EGFR Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: GH21+Osimertinib, outcomesModule primaryOutcomes measure: Number of participants with dose limiting toxicities, primaryOutcomes measure: Number of participants with adverse events, primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of response (DCR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Time to achieve Cmax (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Caicun Zhou, Doctorate, role: CONTACT, phone: 021-65115006, email: caicunzhoudr@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06306443, orgStudyIdInfo id: 20235453, briefTitle: Buprenorphine for Individuals in Jail, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Friends Research Institute, Inc., class: OTHER, descriptionModule briefSummary: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: open label randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: extended-release buprenorphine (XR-B), outcomesModule primaryOutcomes measure: urine toxicology, primaryOutcomes measure: days of opioid use, primaryOutcomes measure: time to opioid relapse, secondaryOutcomes measure: retention in buprenorphine treatment, secondaryOutcomes measure: urine toxicology for other illicit substance use, secondaryOutcomes measure: days of illicit substance use, secondaryOutcomes measure: overdose events, secondaryOutcomes measure: PROMIS Patient-Reported Outcomes Measurement Information System - physical health, secondaryOutcomes measure: PROMIS Patient-Reported Outcomes Measurement Information System - mental health, secondaryOutcomes measure: HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score, secondaryOutcomes measure: HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score, secondaryOutcomes measure: criminal activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Friends Research Institute, city: Baltimore, state: Maryland, zip: 21201, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Baltimore Central Booking & Intake Center, city: Baltimore, state: Maryland, zip: 21202, country: United States, contacts name: Michael Gordon, DPA, role: CONTACT, phone: 410-837-3977, phoneExt: 251, email: mgordon@friendsresearch.org, contacts name: Thomas R Blue, PhD, role: CONTACT, phone: 4108373977, email: tblue@friendsresearch.org, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06306430, orgStudyIdInfo id: uLAM TB FIA, briefTitle: Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis, acronym: uLAMTBFIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU)., conditionsModule conditions: Tuberculosis, conditions: Diagnoses Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: STANDARDTM F TB LAM FIA, outcomesModule primaryOutcomes measure: Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay, secondaryOutcomes measure: Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emerging Bacterial Pathogens Unit, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306417, orgStudyIdInfo id: PKUTH TCM, briefTitle: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-28, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients., conditionsModule conditions: Polycystic Ovary Syndrome (PCOS), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: lifestyle intervention, interventions name: acupuncture, interventions name: Sham acupuncture, outcomesModule primaryOutcomes measure: HOMA-IR, secondaryOutcomes measure: Hirsutism(FG score >4）, acne and early alopecia, secondaryOutcomes measure: AUC insulin, secondaryOutcomes measure: Follicle stimulating hormone (FSH), secondaryOutcomes measure: luteinizing hormone (LH), secondaryOutcomes measure: Progestin (P), secondaryOutcomes measure: Estrogen (E2), secondaryOutcomes measure: Prolactin (PRL), secondaryOutcomes measure: Androgen(T), secondaryOutcomes measure: Anti-mullerian hormone (AMH), secondaryOutcomes measure: Sex hormone-binding globulin (SHBG), secondaryOutcomes measure: Free testosterone index (FAI), secondaryOutcomes measure: total cholesterol, secondaryOutcomes measure: triglycerides, secondaryOutcomes measure: high density lipoprotein (HDL), secondaryOutcomes measure: low density lipoprotein (LDL), secondaryOutcomes measure: Bile acidomics, secondaryOutcomes measure: Metagenomics and 16S rDNA sequencing analysis, secondaryOutcomes measure: short form-36 (SF36), secondaryOutcomes measure: Self-Rating Anxiety Scale (SAS), secondaryOutcomes measure: Self-Rating Depress Scale (SDS), secondaryOutcomes measure: polycystic ovary syndrome questionnaire, PCOSQ, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Fat%, secondaryOutcomes measure: waist to hip ratio(WHR), secondaryOutcomes measure: glycosylated hemoglobin level, secondaryOutcomes measure: ovarian size, secondaryOutcomes measure: number of follicles, secondaryOutcomes measure: uterine size, secondaryOutcomes measure: endometrial thickness, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University third hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Haolin Zhang, PHD, role: CONTACT, phone: +8615611963539, email: zoe@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06306391, orgStudyIdInfo id: IMIMFCTL/NLX_1, briefTitle: Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Parc de Salut Mar, class: OTHER, collaborators name: Food and Drug Administration (FDA), descriptionModule briefSummary: This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Intravenous naloxone, interventions name: Intranasal naloxone, outcomesModule primaryOutcomes measure: Effects of naloxone on heart rate (HR)., primaryOutcomes measure: Effects of naloxone on systolic and diastolic blood pressure (BP)., secondaryOutcomes measure: Effects of naloxone on plasma cortisol at visit 1 and visit 4., otherOutcomes measure: Adverse effects., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: IMIM (Hospital del Mar Medical Research Institute), status: RECRUITING, city: Barcelona, zip: 08003, country: Spain, contacts name: Rafael De la Torre Fornell, PharmD, PhD, role: CONTACT, phone: 00343160780, phoneExt: 1780, email: rtorre@imim.es, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06306378, orgStudyIdInfo id: XJTU1AF2023LSK-481, briefTitle: The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, collaborators name: Xi'an TCM Hospital of Encephalopathy, descriptionModule briefSummary: Research background and project basisAutism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.Research purposeExploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: social memory levels and spindle levels, outcomesModule primaryOutcomes measure: Recognition accuracy, primaryOutcomes measure: Response delay time, primaryOutcomes measure: Sleep spindle density, primaryOutcomes measure: Sleep spindle average duration, primaryOutcomes measure: Sleep spindle amplitude, primaryOutcomes measure: Sleep spindle frequency, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Afflicated Hospital Xian Jiaotong University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710061, country: China, contacts name: Yan Li, MD., PhD., role: CONTACT, phone: 13720418610, email: liyanxjtu@xjtu.edu.cn, contacts name: Dongqi Cui, PhD., role: CONTACT, phone: 18501059233, email: 18501059233@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False