hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06288282, orgStudyIdInfo id: STUDY-23-01287, briefTitle: Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants., conditionsModule conditions: Chronic Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Screener and Opioid Assessment for patients with pain revised (SOAPPR), primaryOutcomes measure: Current Opioid misuse measure (COMM) surveys, secondaryOutcomes measure: Pain Intensity with Brief Pain inventory (BPI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Pain management centers, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06288269, orgStudyIdInfo id: PhrapokklaoHospital, briefTitle: Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Phrapokklao Hospital,Thailand, class: OTHER, descriptionModule briefSummary: The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled., conditionsModule conditions: Stroke, conditions: Hypertension, conditions: Type2diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 291, type: ACTUAL, armsInterventionsModule interventions name: Severity of Stroke and 1 year survival, outcomesModule primaryOutcomes measure: Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42), primaryOutcomes measure: 1 year survival death, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trat Provincial Public Health Office, city: Trat, zip: 23000, country: Thailand, geoPoint lat: 12.24364, lon: 102.51514, hasResults: False
protocolSection identificationModule nctId: NCT06288256, orgStudyIdInfo id: STUDY-22-01390, briefTitle: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts., conditionsModule conditions: Lumbar Spine Pathology, conditions: Elective Spine Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Current Opioid Misuse Measure (COMM) Score, secondaryOutcomes measure: Numerical Rating Scale (NRS) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Spine Center, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06288243, orgStudyIdInfo id: Samatya, briefTitle: Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-01, primaryCompletionDateStruct date: 2019-05-28, completionDateStruct date: 2019-05-29, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality.Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively., conditionsModule conditions: Stroke, Acute, conditions: Swallowing Disorder, conditions: Cognitive Impairment, conditions: Stroke, conditions: Movement Disorders, conditions: Dysphagia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 97, type: ACTUAL, armsInterventionsModule interventions name: Clinician-observed assessment tests, outcomesModule primaryOutcomes measure: The Correlation Between Swallowing Skills and Cognitive Status, primaryOutcomes measure: The Correlation Between Swallowing Skills and Functionality, secondaryOutcomes measure: The relationship between stroke risk factors and swallowing skills, secondaryOutcomes measure: The relationship between demographic informations and swallowing skills, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 92 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06288230, orgStudyIdInfo id: LT01-101, briefTitle: An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Lantu Biopharma, class: INDUSTRY, descriptionModule briefSummary: This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients., conditionsModule conditions: Spinal Muscular Atrophy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: vesemnogene lantuparvovec, outcomesModule primaryOutcomes measure: Numbers of participants with adverse events (AEs), serious adverse events (SAEs), secondaryOutcomes measure: Change from baseline in hours of daily ventilation support and motor function, secondaryOutcomes measure: Change from baseline in ambulatory function, secondaryOutcomes measure: Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06288217, orgStudyIdInfo id: NS-CIP-001, briefTitle: Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NeuraStasis, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study., conditionsModule conditions: Stroke, Ischemic, conditions: Upper Extremity Paresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation), interventions name: Upper Limb Rehabilitation, interventions name: Sham Stimulation, outcomesModule primaryOutcomes measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change, secondaryOutcomes measure: Action Research Arm Test (ARAT) Average Change, secondaryOutcomes measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %, secondaryOutcomes measure: Proportion of subjects completing all pre-specified treatment doses, secondaryOutcomes measure: Subject Questionnaire on Device Usage, secondaryOutcomes measure: Therapist Questionnaire on Device Usage, secondaryOutcomes measure: Serious adverse device effects (SADE) rate at 24 hours post-therapy session, secondaryOutcomes measure: Stroke impact scale (SIS) Summative Score Average Change, secondaryOutcomes measure: Analysis of the number of stimulations per therapy session, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Sean Savitz, MD, role: CONTACT, phone: 713-500-7083, email: Sean.I.Savitz@uth.tmc.edu, contacts name: Emily Stevens, OTR, role: CONTACT, phone: 713-500-7914, email: emily.a.stevens@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06288204, orgStudyIdInfo id: Denise Mafra16, briefTitle: Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, collaborators name: Rio de Janeiro State Research Supporting Foundation (FAPERJ), collaborators name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., descriptionModule briefSummary: This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months., conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule interventions name: Propolis + Royal Jelly, interventions name: Royal Jelly, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in inflammation, oxidative stress, primaryOutcomes measure: Change in intestinal microbiota, secondaryOutcomes measure: Change in senescence biomarkers, secondaryOutcomes measure: Change in uremic toxins, otherOutcomes measure: Change in adhesion molecules, otherOutcomes measure: Change in blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denise Mafra, city: Rio de Janeiro, state: RJ, zip: 22260050, country: Brazil, contacts name: Denise Mafra, phd, role: CONTACT, phone: 21985683003, email: dmafra30@gmail.com, geoPoint lat: -22.90278, lon: -43.2075, hasResults: False
protocolSection identificationModule nctId: NCT06288191, orgStudyIdInfo id: MIA2023/490, secondaryIdInfos id: CA224-1065, type: OTHER, domain: Bristol-Myers Squibb, briefTitle: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2036-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Melanoma Institute Australia, class: OTHER, collaborators name: Bristol-Myers Squibb, descriptionModule briefSummary: The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival., conditionsModule conditions: Cutaneous Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label, single arm, single centre, clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination, outcomesModule primaryOutcomes measure: Pathological complete response rate, secondaryOutcomes measure: Pathological near pathological response (near pCR), partial response (pPR) and pathological non-response (pNR) rate, secondaryOutcomes measure: Toxicity and tolerability of neoadjuvant immunotherapy and surgery, secondaryOutcomes measure: Objective response rate to neoadjuvant therapy, secondaryOutcomes measure: Metabolic response rate to neoadjuvant immunotherapy, secondaryOutcomes measure: Recurrence-free survival, secondaryOutcomes measure: Disease progression rate, secondaryOutcomes measure: Event-free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Patient reported quality of life (QLQ-C30), secondaryOutcomes measure: Patient reported quality of life (EQ-5L-5D), secondaryOutcomes measure: Study treatment completion rate and the causes of any missed treatments, secondaryOutcomes measure: De-escalation of adjuvant radiotherapy., otherOutcomes measure: Identification of tissue and blood biomarkers of response / resistance, otherOutcomes measure: Profile of the gut microbiome from faecal samples and relationship to response and toxicities., otherOutcomes measure: The pathological response to RECIST, immune related response criteria and PERCIST response, otherOutcomes measure: Assessment of the response to neoadjuvant using the immune-related response criteria (irRC) and correlate the assessment with the RECIST 1.1 response at each timepoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06288178, orgStudyIdInfo id: 2022/18, briefTitle: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations, acronym: Obesity, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2023-01-20, completionDateStruct date: 2023-02-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels., conditionsModule conditions: Obesity, conditions: Glycemic Index, conditions: Blood Glucose, conditions: Bread, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 103, type: ACTUAL, armsInterventionsModule interventions name: Bread consumption, outcomesModule primaryOutcomes measure: One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption., secondaryOutcomes measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Avrasya University, city: Trabzon, zip: 61000, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, hasResults: False
protocolSection identificationModule nctId: NCT06288165, orgStudyIdInfo id: CopperHealthCentre2, briefTitle: Lower Silesia Sinus Reducer Registry, acronym: LSSRR, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-11, primaryCompletionDateStruct date: 2027-05-11, completionDateStruct date: 2027-05-11, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Regional Cardiology Center, The Copper Health Centre (MCZ),, class: OTHER, descriptionModule briefSummary: Lower Silesia Sinus Reducer Registry is a, single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation ., conditionsModule conditions: Safety Issues, conditions: Efficacy, Self, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Coronary Sinus Reducer Implantation, outcomesModule primaryOutcomes measure: The Clinical success - reduction of angina symptoms, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Change in potential aerobic capacity and endurance - The six minute walking test (6MWT), secondaryOutcomes measure: Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, The Copper Health Centre (MCZ), status: RECRUITING, city: Lubin, state: Lower Silesia, zip: 59-300, country: Poland, contacts name: Adrian Włodarczak, M.D; Ph.D.Assoc Prof., role: CONTACT, phone: +48768460300, email: wlodarczak.adrian@gmail.com, contacts name: Szymon Włodarczak, MD, role: CONTACT, phone: +4876 846 03 00, email: wlodarczak.szy@gmail.com, geoPoint lat: 51.40089, lon: 16.20149, locations facility: Cardiac Department of Copper Health Center, status: RECRUITING, city: Lubin, state: Lower Silesia, zip: 59301, country: Poland, contacts name: Adrian Włodarczak, Prof, role: CONTACT, phone: 76 846 03 00, phoneExt: 0048, email: wlodarczak.adrian@gmail.com, contacts name: Szymon Włodarczak, MD, role: CONTACT, phone: 76 846 03 00, phoneExt: 0048, email: wlodarczak.szy@gmail.com, contacts name: Piotr Rola, Ph D; MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.40089, lon: 16.20149, hasResults: False