hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06385041, orgStudyIdInfo id: BE-2-83, briefTitle: Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-12, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Vitalija Stonkuvienė, class: OTHER, descriptionModule briefSummary: The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation., conditionsModule conditions: Frailty Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group 1, interventions name: Intervention group 2, outcomesModule primaryOutcomes measure: Collecting data from the medical history, primaryOutcomes measure: Frailty level by Edmonton frail scale score, primaryOutcomes measure: Fear of Falling by Falls Efficacy Scale International; FES-I)., primaryOutcomes measure: Quality of life by EuroQoL FiveDimensionsEQ-5D-5L., primaryOutcomes measure: Motivation by Multidimensional Health Locus of Control scale, primaryOutcomes measure: Change from baseline functional capacity by six minutes walking test (6MWT), primaryOutcomes measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB), primaryOutcomes measure: Change from baseline muscular strength by one repetition maximum test (1RM), primaryOutcomes measure: Change from baseline grip strength by hydraulic hand dinanometer, primaryOutcomes measure: Change from baseline balance parameters by Biodex Balance System SD, primaryOutcomes measure: Change from baseline stance and gait parameters by Zebris Medical GmbH, secondaryOutcomes measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt), secondaryOutcomes measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva, status: RECRUITING, city: Kaunas, country: Lithuania, contacts name: Vitalija Stonkuvienė, role: CONTACT, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False
protocolSection identificationModule nctId: NCT06385028, orgStudyIdInfo id: 20230213_PIANISSIMO, briefTitle: Physical Activity Promotion in Osteoarthritis Patients, acronym: PIANISSIMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Luxembourg Institute of Health, class: OTHER_GOV, collaborators name: Œuvre Nationale de Secours Grande Duchesse Charlotte, descriptionModule briefSummary: The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week., conditionsModule conditions: Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pilot feasibility study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity promotion, outcomesModule primaryOutcomes measure: Weekly number of connections to the application over time, primaryOutcomes measure: Response rate to the weekly questionnaires over time, secondaryOutcomes measure: Evolution of physical activity metrics, secondaryOutcomes measure: influence of pain on physical activity practice, secondaryOutcomes measure: influence of physical activity on pain report, otherOutcomes measure: long-term evolution of daily steps, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Luxembourg Institute of Health, city: Strassen, zip: 1445, country: Luxembourg, geoPoint lat: 49.62056, lon: 6.07333, hasResults: False
protocolSection identificationModule nctId: NCT06385002, orgStudyIdInfo id: 2024-0158, briefTitle: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Pusan National University Yangsan Hospital, class: OTHER, descriptionModule briefSummary: Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone., conditionsModule conditions: Gynecological Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam, outcomesModule primaryOutcomes measure: time to emergence, primaryOutcomes measure: time to tracheal extubation, secondaryOutcomes measure: usage of vasopressors, secondaryOutcomes measure: severity of cough, secondaryOutcomes measure: time to discharge from the recovery room, secondaryOutcomes measure: postoperative pain scores, secondaryOutcomes measure: scores for postoperative nausea and vomiting, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06384989, orgStudyIdInfo id: MinnesotaHealthSolutions_LL, briefTitle: Safety-Enhancing Motor Vehicle Child Safety Seat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Minnesota HealthSolutions, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design., conditionsModule conditions: Motor Vehicle Injury, conditions: Safety Issues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Child restraint system with load leg feature, outcomesModule primaryOutcomes measure: Correct use of load leg, primaryOutcomes measure: Load leg error types, secondaryOutcomes measure: Other installation errors, secondaryOutcomes measure: Opinion on load leg design and instructions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Julie Mansfield, PhD, role: CONTACT, phone: 614-366-2101, email: julie.mansfield@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06384976, orgStudyIdInfo id: KYV101-007, briefTitle: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Kyverna Therapeutics, class: INDUSTRY, descriptionModule briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis, conditionsModule conditions: Multiple Sclerosis, Primary Progressive, conditions: Multiple Sclerosis, Secondary Progressive, conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: KYV-101, interventions name: Standard lymphodepletion regimen, interventions name: Anti-CD20 mAB, outcomesModule primaryOutcomes measure: To evaluate efficacy of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To characterize the safety and tolerability of KYV-101, secondaryOutcomes measure: To evaluate efficacy of KYV-101, secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To characterize the Pharmacodynamics (PD), secondaryOutcomes measure: To characterize the Pharmacodynamics (PD), secondaryOutcomes measure: To evaluate the immunogenicity (humoral response) of KYV-101, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06384963, orgStudyIdInfo id: Cer22/02, briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF, acronym: RSA-PACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ceryx Medical Australia, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability, interventions name: Monotonic right atrial overdrive pacing, outcomesModule primaryOutcomes measure: Number of arrhythmia episodes per patient during pacing, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Waikato Hospital, city: Hamilton, zip: 3240, country: New Zealand, contacts name: Martin Stiles, MB ChB, role: CONTACT, phone: +64 07 957 6080, email: martin.stiles@waikatodhb.health.nz, contacts name: Kelly Henderson, BSc, role: CONTACT, phone: +64 0272564243, phoneExt: 25015, email: Kelly.Henderson@waikatodhb.health.nz, geoPoint lat: -37.78333, lon: 175.28333, hasResults: False
protocolSection identificationModule nctId: NCT06384937, orgStudyIdInfo id: GCA-PRO-2022-001-01, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06384924, orgStudyIdInfo id: SBU-RAMAN-SKINCANCER, briefTitle: Raman Spectroscopy and Skin Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Renee Cattell, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:-Can Raman Spectroscopy help figure out how far a tumor spreads?This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin., conditionsModule conditions: Skin Cancer, conditions: Basal Cell Carcinoma, conditions: Squamous Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Raman Spectroscopy handheld probe (EmVision, FL, USA), interventions name: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA), outcomesModule primaryOutcomes measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin., secondaryOutcomes measure: Compare the size of clinically defined margin and Raman-defined margin, secondaryOutcomes measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stony Brook Hospital, city: Stony Brook, state: New York, zip: 11794, country: United States, contacts name: Renee Cattell, PhD, role: CONTACT, email: renee.cattell@stonybrookmedicine.edu, contacts name: Renee Cattell, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False
protocolSection identificationModule nctId: NCT06384911, orgStudyIdInfo id: STUDY00004543, briefTitle: InvesT1D: Promoting Adolescent Investment in Diabetes Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Harvard Pilgrim Health Care, descriptionModule briefSummary: The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Financial Incentives Program, outcomesModule primaryOutcomes measure: Time In Range, secondaryOutcomes measure: Time Above Range, secondaryOutcomes measure: Time Below Range, secondaryOutcomes measure: Hemoglobin A1c (HbA1c), secondaryOutcomes measure: Diabetes Distress, secondaryOutcomes measure: Diabetes Family Conflict, secondaryOutcomes measure: Adolescent Quality of Life, secondaryOutcomes measure: Caregiver Quality of Life, secondaryOutcomes measure: Diabetic Ketoacidosis, secondaryOutcomes measure: Severe Hypoglycemia, secondaryOutcomes measure: Insulin Adminstration, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06384885, orgStudyIdInfo id: 2024-079, briefTitle: Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes, acronym: SIPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Rocky Vista University, LLC, class: OTHER, descriptionModule briefSummary: Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality., conditionsModule conditions: Swimming Induced Pulmonary Edema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Lung ultrasound, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Vista University, status: RECRUITING, city: Parker, state: Colorado, zip: 80012, country: United States, contacts name: Kathryn A Vidlock, MD, role: CONTACT, phone: 651-226-1642, email: kvidlock@rvu.edu, contacts name: Brady Patterson, role: PRINCIPAL_INVESTIGATOR, contacts name: Harrison Steins, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.5186, lon: -104.76136, hasResults: False
protocolSection identificationModule nctId: NCT06384859, orgStudyIdInfo id: Pending, briefTitle: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.Participants will:* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score, conditionsModule conditions: Insertional Achilles Tendinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: ESWT, interventions name: PRP, outcomesModule primaryOutcomes measure: VAS, secondaryOutcomes measure: VAS-FA, secondaryOutcomes measure: FFI, secondaryOutcomes measure: FAAM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ramathibodi hospital, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, contacts name: Prapan Wongrungrote, MD, role: CONTACT, phone: +66 0810688654, email: prapanw197@gmail.com, contacts name: Sukij Laohajaroensombat, MD, role: CONTACT, phone: +66 022011589, email: sukij.lah@mahidol.ac.th, geoPoint lat: 13.759, lon: 100.53358, hasResults: False