hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06280274, orgStudyIdInfo id: STUDY00025798, briefTitle: Metformin Use in Patients Undergoing Total Joint Replacement Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial., conditionsModule conditions: Hyperglycemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Rate of participant enrollment, primaryOutcomes measure: Rate of appropriate study drug administration, primaryOutcomes measure: Rate of participant adherence to trial intervention per protocol, primaryOutcomes measure: Rate of participant retention to 90-day follow up, secondaryOutcomes measure: Perioperative glycemic variability, secondaryOutcomes measure: Sliding scale insulin utilization, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: 90-day Rate of surgical site infection, secondaryOutcomes measure: 90-day Rate of periprosthetic joint infection, secondaryOutcomes measure: 90-day Rate of mortality, secondaryOutcomes measure: 90-day rate of readmission, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Ryland Kagan, role: CONTACT, phone: 503-494-5649, email: kagan@ohsu.edu, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
protocolSection identificationModule nctId: NCT06280261, orgStudyIdInfo id: GO20/296, briefTitle: The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-27, primaryCompletionDateStruct date: 2020-09-01, completionDateStruct date: 2020-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents., conditionsModule conditions: Psychological Well-Being, conditions: Caregiver Burden, conditions: Life Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: PROSPECTIVE, enrollmentInfo count: 156, type: ACTUAL, armsInterventionsModule interventions name: parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire, outcomesModule primaryOutcomes measure: Rosenberg Self-Esteem Scale, primaryOutcomes measure: Stait trait anxiety inventory, primaryOutcomes measure: Strenghts and difficulties questionnaire, primaryOutcomes measure: Zarit burden scale, primaryOutcomes measure: Parenting stress index, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Sihhiye, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-10-20, uploadDate: 2024-02-19T08:48, filename: Prot_SAP_000.pdf, size: 288978, hasResults: False
protocolSection identificationModule nctId: NCT06280248, orgStudyIdInfo id: EUS in pancreatic fluid, briefTitle: EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice \[Lin et al., 2014\]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:* Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.* Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed., conditionsModule conditions: Pancreas Pseudocyst, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst, outcomesModule primaryOutcomes measure: Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06280222, orgStudyIdInfo id: VR FOR ANXIETY-HMO-CTIL, briefTitle: The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation., acronym: VRFORANXIETY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level ., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: The VR instrument - Oculus Quest 2, outcomesModule primaryOutcomes measure: Vital signs, primaryOutcomes measure: Vital signs, primaryOutcomes measure: VAS (visual-analogue scale), primaryOutcomes measure: State and Trait Anxiety (STAI) Score, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hadassah mound scopus IVF unit, status: RECRUITING, city: Jerusalem, country: Israel, contacts name: Anat Hershko-Klement, M.D, role: CONTACT, phone: +972549170084, email: anat.klement@gmail.com, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
protocolSection identificationModule nctId: NCT06280209, orgStudyIdInfo id: 351-201, secondaryIdInfos id: 2023-506737-30-00, type: OTHER, domain: EU CT, briefTitle: A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: BioMarin Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: BMN 351, outcomesModule primaryOutcomes measure: To evaluate and safety and tolerability of single and multiple doses of BMN 351 (incidence, severity, and dose-relationship of adverse effects and changes in laboratory parameters)., secondaryOutcomes measure: Pharmacokinetics (PK) concentration of BMN 351 in plasma, urine and muscle approximately every 8 weeks for up to 48 weeks., otherOutcomes measure: To evaluate the immune response to BMN 351., otherOutcomes measure: To evaluate the effect of BMN 351 on physical function., otherOutcomes measure: To evaluate the effect of BMN 351 on physical function., otherOutcomes measure: Change from baseline in dystrophin expression measured by Liquid chromatography-mass spectrometry (LC-MS)., eligibilityModule sex: MALE, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Sant Joan de Deu, status: RECRUITING, city: Barcelona, zip: 08950, country: Spain, contacts name: Soraya Peralta, role: CONTACT, phone: +34 673200068, email: soraya.peralta@sjd.es, contacts name: Andres Nascimento, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Viamed Santa Angela De la Cruz, status: RECRUITING, city: Sevilla, zip: 41013, country: Spain, contacts name: Carmen Silva, role: CONTACT, phone: +34 669393637, email: tuautorapreferida@gmail.com, contacts name: Marcos Madruga-Garrido, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Great Ormond Street Hospital NHS Foundation Trust, status: RECRUITING, city: London, zip: WC1N 3JH, country: United Kingdom, contacts name: Marta Zancolli, role: CONTACT, phone: +44 (0)20 7905 2188, email: marta.zancolli@gosh.nhs.uk, contacts name: Giovanni Baranello, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06280196, orgStudyIdInfo id: BAT-3306-002-CR, briefTitle: A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-15, primaryCompletionDateStruct date: 2027-07-30, completionDateStruct date: 2028-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Bio-Thera Solutions, class: INDUSTRY, descriptionModule briefSummary: To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind, randomized, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 676, type: ESTIMATED, armsInterventionsModule interventions name: BAT3306, interventions name: EU-Keytruda®, interventions name: US-Keytruda®, interventions name: Pemetrexed, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: clinical equivalence, secondaryOutcomes measure: safety of BAT3306-AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06280183, orgStudyIdInfo id: 323132, briefTitle: Functional Inspiratory Muscle Training in Obese Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, collaborators name: Istanbul Galata University, descriptionModule briefSummary: In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, single-blind study three arm study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The assessor will be blind to the group allocation, and participants will be blind to group allocation, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Functional Inspiratory Muscle Training, interventions name: Aerobic+Resistive Exercise Traning, outcomesModule primaryOutcomes measure: Respiratory Muscle Strength, primaryOutcomes measure: Incremental load test (Respiratory Muscle Endurance), primaryOutcomes measure: Forced expiratory volume 1st second (Respiratory Function), primaryOutcomes measure: Forced vital capacity (Respiratory Function), secondaryOutcomes measure: Comorbidity Assessment, secondaryOutcomes measure: Physical Activity Assessment, secondaryOutcomes measure: Edmonton Obesity Staging System (EOSS), secondaryOutcomes measure: Functional Capacity, secondaryOutcomes measure: Peripheral Muscle Strength, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body fat-muscle ratios, secondaryOutcomes measure: Glucose profile, secondaryOutcomes measure: Lipid profile, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06280157, orgStudyIdInfo id: MVX0007, secondaryIdInfos id: 332126, type: OTHER, domain: IRAS, briefTitle: A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Minervax ApS, class: OTHER, collaborators name: Simbec-Orion Group, descriptionModule briefSummary: The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination., conditionsModule conditions: Group B Streptococcus Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: GBS-NN/NN2, outcomesModule primaryOutcomes measure: Antibody Concentration Specific for GBS-NN and GBS-NN2, primaryOutcomes measure: Antibody Responses Specific to AlpCN, RibN, Alp1N and Alp2-3N, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Simbec-Orion Clinical Pharmacology, city: Merthyr Tydfil, state: Pentrebach Merthyr Tydfil CF48 4DR, country: United Kingdom, geoPoint lat: 51.74794, lon: -3.37779, hasResults: False
protocolSection identificationModule nctId: NCT06280144, orgStudyIdInfo id: PF20230428, briefTitle: Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-22, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Changchun BCHT Biotechnology Co., class: INDUSTRY, collaborators name: Hu Bei province Center for Disease control and prevention, collaborators name: The Inner Mongolia Autonomous Region Center for Disease Control and Prevention, descriptionModule briefSummary: To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine., conditionsModule conditions: Influenza Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 6080, type: ESTIMATED, armsInterventionsModule interventions name: Influenza Vaccine, Live, Nasal, Freeze-dried, interventions name: Sterile water for inhalation, outcomesModule primaryOutcomes measure: Primary influenza protective effect endpoint, primaryOutcomes measure: Primary influenza protective effect endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Safety, secondaryOutcomes measure: Study on detoxification, otherOutcomes measure: Protective effect of COVID-19 cases., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations status: RECRUITING, city: Chi Feng, state: Inner Mongolia Autonomous Region, zip: 024000, country: China, contacts name: Xiaoling Tian, role: CONTACT, phone: 13848710296, email: txlingok@126.com, hasResults: False
protocolSection identificationModule nctId: NCT06280131, orgStudyIdInfo id: multiple sclerosis and pulse, briefTitle: The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate, conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: to evaluate efficacy of a pulse therapy on clinical outcome, secondaryOutcomes measure: clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional, secondaryOutcomes measure: clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False