hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06307613, orgStudyIdInfo id: ARGX-113-2301, secondaryIdInfos id: 2023-509197-35-00, type: CTIS, briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod PH20 SC, interventions name: Placebo PH20 SC, outcomesModule primaryOutcomes measure: Percentage of participants who were proptosis responders, secondaryOutcomes measure: Change in proptosis measurement in the study eye from baseline, secondaryOutcomes measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline, secondaryOutcomes measure: Percentage of participants with a resolution of diplopia (responders), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Clinical Research, status: RECRUITING, city: Coral Springs, state: Florida, zip: 33067, country: United States, contacts name: Shailesh Gupta, MD, role: CONTACT, phone: 857-350-4834, email: clinicaltrials@argenx.com, geoPoint lat: 26.27119, lon: -80.2706, hasResults: False
protocolSection identificationModule nctId: NCT06307600, orgStudyIdInfo id: BHCT-RD06-03, briefTitle: The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia., conditionsModule conditions: B Lymphoblastic Leukemia/Lymphoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: RD06-03 cell injection, outcomesModule primaryOutcomes measure: Dose-limiting toxicity, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230036, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
protocolSection identificationModule nctId: NCT06307561, orgStudyIdInfo id: GGurzoglu, briefTitle: The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Acıbadem Atunizade Hospital, class: OTHER, descriptionModule briefSummary: Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia., conditionsModule conditions: Secondary Dystonia, conditions: Cerebral Palsy, Mixed, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ACTUAL, outcomesModule primaryOutcomes measure: The Barry-Albright Dystonia Scale (BADS), primaryOutcomes measure: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), primaryOutcomes measure: The Care and Comfort Hypertonicity Questionnaire (CCHQ), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Acıbadem Altunizade Hospital, city: Istanbul, state: Altunizade, zip: 34662, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06307522, orgStudyIdInfo id: MRG24ALC, briefTitle: MRG-001 in Patients With Alcoholic Hepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: MedRegen LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH)., conditionsModule conditions: Alcoholic Hepatitis, conditions: Acute Alcoholic Hepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: MRG-001, outcomesModule primaryOutcomes measure: Assessment of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Pharmacokinetic Response, secondaryOutcomes measure: Pharmacodynamic Response, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06307496, orgStudyIdInfo id: Pro00133913, briefTitle: VIDeOS for Smoking Cessation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: Alliance NCORP Research Base Cancer Control Program, descriptionModule briefSummary: The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial., conditionsModule conditions: Cancer, conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Smoking cessation intervention, interventions name: Informational intervention, outcomesModule primaryOutcomes measure: Acceptability, primaryOutcomes measure: Feasibility, primaryOutcomes measure: Retention Rates, secondaryOutcomes measure: Changes in knowledge about quitting smoking, secondaryOutcomes measure: Changes in smoking behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06307483, orgStudyIdInfo id: 20240108, briefTitle: Dose-effect Relationship of Tai Chi on Health Promotion in Different Age Groups, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-25, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2023-11-25, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Beijing Sport University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases., conditionsModule conditions: Sleep Disorder, conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Cognitive Impairment, conditions: Metabolic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 499, type: ACTUAL, armsInterventionsModule interventions name: Taichi group, interventions name: Exercise group, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Heart rate variability (HRV), primaryOutcomes measure: Flow-mediated dilation (FMD), primaryOutcomes measure: Cardiac Output (CO), primaryOutcomes measure: Intima-Media Thickness (IMT), primaryOutcomes measure: The Berg Balance Scale（BBS）, primaryOutcomes measure: The 30-s Chair Stand Test, primaryOutcomes measure: Lower limb muscle strength test, secondaryOutcomes measure: Body Fat Percentage, secondaryOutcomes measure: Finger-Ring Test, secondaryOutcomes measure: Hand Grip Strength, secondaryOutcomes measure: Upper and Lower Body Flexibility, secondaryOutcomes measure: The SARC-F scale, secondaryOutcomes measure: Shape Trail Test (STT), secondaryOutcomes measure: 1-back Task more-odd shifting Task Stroop Task, secondaryOutcomes measure: Timed Up and Go, secondaryOutcomes measure: Close-eyed stepping in place, secondaryOutcomes measure: Single-leg stance with eyes closed, secondaryOutcomes measure: Ankle-Brachial Index (ABI), secondaryOutcomes measure: Short-Physical Performance Battery (SPPB), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Blood pressure variability (BPV), secondaryOutcomes measure: HUR Labs Balance Software Suite, secondaryOutcomes measure: E/A ratio, secondaryOutcomes measure: Star Excursion Balance Test apparatus（SEBT）, secondaryOutcomes measure: Montreal Cognitive Assessment(MoCA), secondaryOutcomes measure: Brachial-ankle pulse wave velocity (BaPWV), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Sport University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06307470, orgStudyIdInfo id: 276879, briefTitle: Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Arkansas, class: OTHER, collaborators name: Intimate Pathways Center for Sexual Health, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:1. What is the feasibility of this intervention in an online, private setting?2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time., conditionsModule conditions: Women's Health: Neoplasm of Breast, conditions: Menopause, Premature, conditions: Body Image, conditions: Sexual Dysfunction, conditions: Cancer, Breast, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience), outcomesModule primaryOutcomes measure: Vulvovaginal Symptoms Questionnaire (VSQ), primaryOutcomes measure: Body Image Scale, primaryOutcomes measure: Female Sexual Functioning Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06307444, orgStudyIdInfo id: stellate block and ESP block, briefTitle: Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions., conditionsModule conditions: Acute Herpes Zoster Pain Managment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-Guided Stellate Ganglion Block, interventions name: T2 T3 (High Thorathic) ESP Block, outcomesModule primaryOutcomes measure: reduction of a numeric rating scale (NRS) pain score, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06307405, orgStudyIdInfo id: WJP2023, briefTitle: The Value of mNGS in Diagnosis of Pulmonary Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Yunfeng Hou, class: OTHER, descriptionModule briefSummary: Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis., conditionsModule conditions: Pulmonary Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: next generation sequencing, outcomesModule primaryOutcomes measure: Etiological detection rates of two detection techniques, secondaryOutcomes measure: Consistency of detection results of two detection techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06307379, orgStudyIdInfo id: EC 23022, briefTitle: Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures, acronym: BRONCHOPROEM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Vitaz, class: OTHER, descriptionModule briefSummary: 'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce., conditionsModule conditions: Bronchial Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Procedure-related dyspnea scale (VAS), primaryOutcomes measure: Procedure-related pain scale (VAS), primaryOutcomes measure: Procedure related cough scale (VAS), primaryOutcomes measure: General patient satisfaction, secondaryOutcomes measure: Procedure-related complications:, secondaryOutcomes measure: Sedation-related complications, secondaryOutcomes measure: Diagnostic yield, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VITAZ, status: RECRUITING, city: Sint-Niklaas, country: Belgium, contacts name: Jonas Yserbyt, role: CONTACT, email: jonas.yserbyt@vitaz.be, geoPoint lat: 51.16509, lon: 4.1437, hasResults: False
protocolSection identificationModule nctId: NCT06307366, orgStudyIdInfo id: ErasmusMC10365, briefTitle: Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research, acronym: PANDAcc, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research., conditionsModule conditions: Mental Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: No intervention will be used, outcomesModule primaryOutcomes measure: Themes around the topics (related to perceptions and experiences) explored., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, city: Rotterdam, state: Zuid-Holland, zip: 3000CB, country: Netherlands, contacts name: Lisanne AE van Houtum, PhD, role: CONTACT, phone: +31107037005, email: l.vanhoutum@erasmusmc.nl, contacts name: Hilmar H Bijma, MD, PhD, role: CONTACT, phone: +31107036109, email: h.bijma@erasmusmc.nl, contacts name: Hilmar H Bijma, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Neeltje EM van Haren, PhD, role: SUB_INVESTIGATOR, contacts name: Lisanne AE van Houtum, PhD, role: SUB_INVESTIGATOR, contacts name: Eline MP Poels, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False