hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06384118, orgStudyIdInfo id: YZUHL20220047, briefTitle: Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-01-17, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Yating Liu, class: OTHER, descriptionModule briefSummary: From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Hypoglycemia, conditions: Health Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study, outcomesModule primaryOutcomes measure: The hypoglycemic coping style, secondaryOutcomes measure: hypoglycemic fear behavioral, secondaryOutcomes measure: Hypoglycemia fear worry, secondaryOutcomes measure: Level of health information access behavior, secondaryOutcomes measure: Level of health beliefs, secondaryOutcomes measure: Level of diabetes knowledge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ya ting Liu, city: Yangzhou, state: 未选择, country: China, geoPoint lat: 32.39722, lon: 119.43583, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-08-01, uploadDate: 2024-04-16T10:45, filename: Prot_SAP_000.pdf, size: 233766, hasResults: False
protocolSection identificationModule nctId: NCT06384105, orgStudyIdInfo id: PRDE1, briefTitle: Study of the Patient Radiation Dose During Five Endourological Procedures, acronym: PRDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2024-12-18, completionDateStruct date: 2024-12-18, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, descriptionModule briefSummary: In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study., conditionsModule conditions: Radiation Exposure, conditions: Urolithiasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 870, type: ESTIMATED, armsInterventionsModule interventions name: frames per second, outcomesModule primaryOutcomes measure: Dose limit, secondaryOutcomes measure: Difference in PRD, secondaryOutcomes measure: PRD different centres, secondaryOutcomes measure: PRD difference complicated cases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AZ Klina, status: RECRUITING, city: Brasschaat, state: Antwerp, zip: 2930, country: Belgium, contacts name: Vincent De Coninck, MD, role: CONTACT, phone: +32 3 650 50 56, phoneExt: +32, email: vincent.de.coninck@klina.be, geoPoint lat: 51.2912, lon: 4.49182, locations facility: UZA, status: RECRUITING, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, contacts name: Stefan De Wachter, MD, role: CONTACT, phone: +32 3 821 33 68, phoneExt: +32, email: stefan.de.wachter@uza.be, geoPoint lat: 51.15662, lon: 4.44504, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-06, uploadDate: 2024-04-22T15:53, filename: ICF_000.pdf, size: 735146, hasResults: False
protocolSection identificationModule nctId: NCT06384092, orgStudyIdInfo id: NB240005-NB-V, briefTitle: Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-03-13, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NovoBliss Research Pvt Ltd, class: OTHER, descriptionModule briefSummary: The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population., conditionsModule conditions: Skin Pigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Proof of science/concept, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Test Sun Protection Cream, interventions name: Benchmark Sun Protection Cream, outcomesModule primaryOutcomes measure: Changes in Melanine index using instrumental assessment, primaryOutcomes measure: Change in erythema index using instrumental assessment, secondaryOutcomes measure: Change in skin erythema/dryness/wrinkles and oedema using draize scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: NovoBliss Research Pvt Ltd, city: Gandhinagar, state: Gujarat, zip: 382421, country: India, geoPoint lat: 23.21667, lon: 72.68333, hasResults: False
protocolSection identificationModule nctId: NCT06384079, orgStudyIdInfo id: STU00219828, briefTitle: Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2030-11, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery., conditionsModule conditions: Ureteral Stricture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Antegrade and retrograde pyelogram, outcomesModule primaryOutcomes measure: Ureteral stricture length measured by antegrade or retrograde pyelogram, secondaryOutcomes measure: Ureteral Stricture Quality will be graded as either narrowed or obliterated segment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Emily Ji, role: CONTACT, phone: 312-695-8146, email: emily.ji@nm.org, contacts name: Ziho Lee, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-25, uploadDate: 2024-03-01T13:40, filename: Prot_000.pdf, size: 140931, hasResults: False
protocolSection identificationModule nctId: NCT06384066, orgStudyIdInfo id: STU00219774, briefTitle: Mobile Health Application to Improve Patient Satisfaction After Urethroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: Create a custom urethroplasty mobile application that will guide patients through through the surgical process., conditionsModule conditions: Urethral Stricture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: GetWell Mobile Application, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Improve patient satisfaction, education and reported outcomes, primaryOutcomes measure: Change in rate of patient phone calls and messages, primaryOutcomes measure: Rate of emergency department visits, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-04, uploadDate: 2024-03-01T13:15, filename: Prot_000.pdf, size: 9077970, hasResults: False
protocolSection identificationModule nctId: NCT06384053, orgStudyIdInfo id: SAHARA Trial, briefTitle: Skin Cancer and Hyperthermia and Radiotherapy, acronym: SAHARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Kantonsspital Winterthur KSW, class: OTHER, collaborators name: Luzerner Kantonsspital, descriptionModule briefSummary: The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC)., conditionsModule conditions: Basal Cell Carcinoma, conditions: Squamous Cell Carcinoma Skin, conditions: Non-melanoma Skin Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, interventions name: Radiotherapy (RT), outcomesModule primaryOutcomes measure: Local control, secondaryOutcomes measure: Analysis, secondaryOutcomes measure: Late toxicities, secondaryOutcomes measure: Quality of life assessment, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kantonsspital Winterthur, city: Winterthur, state: Kanton Zuerich, zip: 8401, country: Switzerland, geoPoint lat: 47.50564, lon: 8.72413, locations facility: Luzerner Kantonsspital, city: Luzern, zip: 6000, country: Switzerland, contacts name: Winfried Arnold, MD, role: CONTACT, geoPoint lat: 47.05048, lon: 8.30635, hasResults: False
protocolSection identificationModule nctId: NCT06384040, orgStudyIdInfo id: GR-2019-12370692, briefTitle: Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment, acronym: IMPRESA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-09-04, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, collaborators name: Istituto Ortopedico Rizzoli, descriptionModule briefSummary: Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: platelet-rich plasma knee injection, outcomesModule primaryOutcomes measure: knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression, secondaryOutcomes measure: To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, state: Milano, zip: 20089, country: Italy, contacts name: Berardo Di Matteo, role: CONTACT, phone: 02 82241, email: reumatologia@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
protocolSection identificationModule nctId: NCT06384001, orgStudyIdInfo id: STUDY00004032, briefTitle: Meditation for Older Adults With Chronic Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Florida State University, class: OTHER, descriptionModule briefSummary: This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA)., conditionsModule conditions: Chronic Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Active MBM, interventions name: Sham MBM, outcomesModule primaryOutcomes measure: Change in pain intensity and interference, secondaryOutcomes measure: Change in pain sensitivities, secondaryOutcomes measure: Change in pain modulation, secondaryOutcomes measure: Change in chronic pain self-efficacy, secondaryOutcomes measure: Change in anxiety, secondaryOutcomes measure: Change in cognitive complaints, secondaryOutcomes measure: Change in depression, secondaryOutcomes measure: Change in fatigue, secondaryOutcomes measure: Change in sleep disturbance, secondaryOutcomes measure: Change in pain-related cortical response, secondaryOutcomes measure: Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut, secondaryOutcomes measure: Chang in inflammatory cytokines, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06383975, orgStudyIdInfo id: CIV-24-01-045634, briefTitle: VEin of MArshall Ethanolization vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF, acronym: VEMAPULSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Sebastien Knecht, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.The main question the trial aims to answer is:• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?Participants will:* Undergo an ablation with either the new or the standard technique* Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up* Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit* Record their heart rhythm at home every week* Complete a questionnaire 3, 6, 9 and 12 months after the procedure, conditionsModule conditions: Persistent Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed field ablation with posterior wall isolation, interventions name: Radiofrequency ablation and vein of Marshall ethanolization, outcomesModule primaryOutcomes measure: Atrial tachyarrhythmia recurrence within 12 months, secondaryOutcomes measure: Safety and procedural related adverse event, secondaryOutcomes measure: Duration of the ablation procedure, secondaryOutcomes measure: Fluoroscopy time, secondaryOutcomes measure: Fluoroscopy dose, secondaryOutcomes measure: Effect of the procedure on quality of life, secondaryOutcomes measure: Incidence of repeat ablation, secondaryOutcomes measure: Unscheduled visits and hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AZ Sint-Jan Brugge AV, city: Brugge, zip: 8000, country: Belgium, contacts name: Emma Christiaen, role: CONTACT, email: emma.christiaen@azsintjan.be, contacts name: Sébastien Knecht, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.20892, lon: 3.22424, hasResults: False
protocolSection identificationModule nctId: NCT06383962, orgStudyIdInfo id: CP 21-001-UK02, briefTitle: Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2029-09-01, completionDateStruct date: 2034-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Synergy Spine Solutions, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease., conditionsModule conditions: Cervical Degenerative Disc Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Synergy cervical spine disc replacement, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Device Related or Device Procedure Related Adverse Events, secondaryOutcomes measure: Neck and Arm Pain Measurement, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Motor and Sensory Function in the Arm, secondaryOutcomes measure: Nurick's Criteria, secondaryOutcomes measure: Odom's criteria, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Orthopaedic Hospital, city: Birmingham, country: United Kingdom, contacts name: Sam Papadopoullos, role: CONTACT, email: sam.papadopoullos@nhs.net, contacts name: Timothy Knight, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Shahnawaz Haleem, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False