hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06267261, orgStudyIdInfo id: KOL-001, briefTitle: Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-07, primaryCompletionDateStruct date: 2021-08-23, completionDateStruct date: 2021-10-25, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Alyatec, class: INDUSTRY, collaborators name: Medicom, descriptionModule briefSummary: There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs., conditionsModule conditions: Allergic Asthma, conditions: Allergic Rhinitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: KOLMI® surgical face mask (OP-Air), outcomesModule primaryOutcomes measure: Time to early asthma response (EAR), secondaryOutcomes measure: Frequency of EAR and late asthma response (LAR), secondaryOutcomes measure: Severity of EAR and LAR, secondaryOutcomes measure: Nasal Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ALYATEC, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
protocolSection identificationModule nctId: NCT06267248, orgStudyIdInfo id: T05100, briefTitle: Spine Registration Using 3D-Scanning, acronym: BWH, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Advanced Scanners Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period., conditionsModule conditions: Spine Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Optical 3D Scanner, outcomesModule primaryOutcomes measure: Spine Registration, secondaryOutcomes measure: Vertebral Shift Measurement, secondaryOutcomes measure: Determination Of Bony Exposure Requirements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mass General Bringham, Hale Building for Transformative Medicine, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06267235, orgStudyIdInfo id: lowprotein, briefTitle: Dietary Protein Restriction and Health, acronym: LOWPRO, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2020-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: The incidence of type 2 diabetes worldwide has increased significantly over the past decades, which is associated with changing dietary habits and physical inactivity. According to the diet, so far there has been a great focus on the quality of carbohydrates and fat in relation to metabolic health, while the importance of protein has been neglected. The Danes' average protein intake is 1.5 g/kg/day, which is at the high end of the recommendations (0.8-1.5 g/kg/day) from the Nordic Nutrition Recommendations (NNR 2023). Recent studies in rodents have shown that protein restriction has positive effects on health, including improved glucose and insulin homeostasis and reduced fat mass, while a high intake of protein has a negative effect on insulin sensitivity. Previously the investigators have shown, in healthy young men, that consuming a diet low in protein (0.9 g/kg/day), compared to the participants usual diet (1.5 g/kg/day), over 7 days, resulted in an increased insulin sensitivity as well as a marked increase in the plasma fibroblast growth factor 21 (FGF21) concentration. The increased insulin sensitivity is thought to be mediated by the increase in plasma FGF21 concentration. However, the effect is not yet fully understood. It is also not clear whether the increase in plasma FGF21 concentration, as well as the mentioned metabolic effects on insulin and glucose homeostasis, will take place if the participants are kept weight stable on a eucaloric diet., conditionsModule conditions: Protein, conditions: Healthy, conditions: Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Longitudinal study changing diet during the intervention 5 weeks restricted dietary protein + 5 weeks habitual dietary protein consumption, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: Dietary protein restriction, outcomesModule primaryOutcomes measure: Energy balance, primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Adipose tissue proteomics, secondaryOutcomes measure: Plasma FGF21, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06267222, orgStudyIdInfo id: SCATDCS23, briefTitle: Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Laura Alice Santos Oliveira, class: OTHER, collaborators name: Federal Institute of Rio de Janeiro, descriptionModule briefSummary: The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:* If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.* If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions.  * Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges.  * Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6)., conditionsModule conditions: SCA, conditions: Postural Balance, conditions: Gait Ataxia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a pragmatic clinical trial that will be carried out using the CONSORT-Pragmatic Trials (Zwarenstein et al., 2008)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: THE INVESTIGATOR NOT BE INFORMED ABOUT THE TREATMENT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises, outcomesModule primaryOutcomes measure: Postural control, primaryOutcomes measure: Mobility, primaryOutcomes measure: Gait performance, secondaryOutcomes measure: The subjective experience of the participants regarding the protocol., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Fontes Baptista, city: Rio de Janeiro, state: RJ, zip: 21032-060, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, hasResults: False
protocolSection identificationModule nctId: NCT06267209, orgStudyIdInfo id: He-Modulation, briefTitle: Conditioned Pain Modulation in Patients With Hemophilia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-03-03, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables, conditionsModule conditions: Hemophilia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Observational group, outcomesModule primaryOutcomes measure: Assess the Conditioned Pain Modulation Index, secondaryOutcomes measure: Assess the kinesiophobia with Tampa Scale of Kinesiophofia, secondaryOutcomes measure: Assess the catastrophizing with Pain catastrophizing scale, secondaryOutcomes measure: Assess the catastrophizing with State-Trait Anxiety Inventory, secondaryOutcomes measure: Assess the joint damage with Haemophilia Joint Health Score, secondaryOutcomes measure: Assess the joint pain with visual analog scale, secondaryOutcomes measure: Assess the pressure pain threshold with pressure algometer, secondaryOutcomes measure: Assess the functional capacity with the 6-Minute Walking test, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Oviedo, city: Oviedo, state: Asturias, zip: 33006, country: Spain, contacts name: Rubén Cuesta-Barriuso, PhD, role: CONTACT, geoPoint lat: 43.36029, lon: -5.84476, hasResults: False
protocolSection identificationModule nctId: NCT06267196, orgStudyIdInfo id: CemilTascıogluERHO-AYAN, briefTitle: The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety, acronym: stressball, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-03-02, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, class: OTHER, descriptionModule briefSummary: The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels, conditionsModule conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: The use of a stress ball, outcomesModule primaryOutcomes measure: stress ball and anxiety, primaryOutcomes measure: stress ball and pain, secondaryOutcomes measure: Stress ball and blood pressure, secondaryOutcomes measure: Stress ball and pulse, secondaryOutcomes measure: Stress ball and saturation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Özge Sayın Ayan, status: NOT_YET_RECRUITING, city: Istanbul, state: Eyup, zip: 34065, country: Turkey, contacts name: özge sayın, role: CONTACT, phone: +905332965628, email: ozgesayinayan@gmail.com, contacts name: volkan özen, role: CONTACT, phone: +905309276094, email: vozen81@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Prof.Dr.Cemil Tascioglu City Hospital, status: RECRUITING, city: Istanbul, state: Şişli, zip: 34360, country: Turkey, contacts name: özge sayın ayan, role: CONTACT, phone: +905332965628, email: ozgesayinayan@gmail.com, contacts name: volkan özen, role: CONTACT, phone: +905309276094, email: vozen81@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06267183, orgStudyIdInfo id: SV001-101, briefTitle: A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Shanghai Synvida Biotechnology Co.,Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: SV001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Peak time（Tmax）, secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: half-life（T1/2）, secondaryOutcomes measure: Immunogenicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Xuhui District Central Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Qian Chen, role: CONTACT, phone: 0086-021-54036058, email: qchen@shxh-centerlab.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06267170, orgStudyIdInfo id: SCLC-RWS-001, briefTitle: A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer, acronym: SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2025-02-25, completionDateStruct date: 2026-02-25, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy, conditionsModule conditions: SCLC,Extensive Stage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, outcomesModule primaryOutcomes measure: Safety (Occurrence of ≥ Grade 3 AE), secondaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: DCR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06267144, orgStudyIdInfo id: 23K237-001, briefTitle: Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-17, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab plus chemotherapy, outcomesModule primaryOutcomes measure: Event free survival(EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease-Control Rate (DCR), secondaryOutcomes measure: Pathological complete response rate（PCR）, secondaryOutcomes measure: Major pathological response rate (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital Of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Ma Kewei, role: CONTACT, phone: 0431-88782222, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
protocolSection identificationModule nctId: NCT06267131, orgStudyIdInfo id: IRB 22-1286, briefTitle: Transcutaneous Pulse Oximetry Brain Monitoring Study (US), acronym: T-POT US, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cyban Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain., conditionsModule conditions: Acute Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single center prospective observational cohort study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Brain Pulse Oximeter, outcomesModule primaryOutcomes measure: Agreement of the brain oximeter levels compared with invasive ICP levels, secondaryOutcomes measure: Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform, secondaryOutcomes measure: Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, Neurological Institute, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Catherine Hassett, DO, role: CONTACT, phone: 216-445-1385, email: HASSETC@ccf.org, contacts name: Joao Gomes, MD, role: CONTACT, phone: 216-445-1385, email: GOMESJ@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False