hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06271447, orgStudyIdInfo id: 2023-21-705, briefTitle: Answerability and Minimal Clinical Significance of the Pain Questionnaires, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation., conditionsModule conditions: Chronic Low-back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Traditional therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Fear-Avoidance Beliefs Questionnaire, primaryOutcomes measure: Tampa Scale for Kinesiophobia, primaryOutcomes measure: The Pain Catastrophizing Scale, primaryOutcomes measure: The Perceived Global Impact, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif Esma Safran, status: RECRUITING, city: Istanbul, state: None Selected, zip: 34752, country: Turkey, contacts name: Elif E Safran, asst. prof., role: CONTACT, phone: 500 4047, phoneExt: 216, email: elif.bayraktar@acibadem.edu.tr, contacts name: Nuray N Alaca, assoc. prof., role: CONTACT, phone: 500 4184, phoneExt: Safran, email: elifesmabayraktar@hotmail.com, contacts name: Elif E Safran, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Irmak I Çavuşoğlu, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Nuray N Alaca, assoc. prof., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06271434, orgStudyIdInfo id: Olej z kryla/jelita, briefTitle: Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-23, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.Hypotesis:The krill oil will infleunce the gut barier integrity., conditionsModule conditions: Endothelial Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All competitors will be randomly divided into two groups (double-blind):A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.B. control (n = 15) receiving placebo. The supplementation period will be six weeks., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Triple, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: THYROX (Atlantic krill oil, interventions name: Placebo, outcomesModule primaryOutcomes measure: I-FABP (intestinal fatty acid binding protein), primaryOutcomes measure: CLDN-3, primaryOutcomes measure: LBP (lipopolysaccharide binding protein), primaryOutcomes measure: Catechyloamines, cortisol, primaryOutcomes measure: CD14, secondaryOutcomes measure: Food intake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06271408, orgStudyIdInfo id: POL-Xe-005, briefTitle: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Polarean, Inc., class: INDUSTRY, collaborators name: Aerogen, descriptionModule briefSummary: The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.Participants will:Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation)., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, interventions name: Vibrating Mesh Nebulizer, interventions name: Metered Dose Inhaler, interventions name: Jet Nebulizer, outcomesModule primaryOutcomes measure: Ventilation Defect Percent, secondaryOutcomes measure: Distribution of ventilated space, secondaryOutcomes measure: Membrane uptake of Xe 129, secondaryOutcomes measure: Red blood cell Xe 129 transfer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit, status: RECRUITING, city: Charlottesville, state: Virginia, zip: 22947, country: United States, contacts name: Roselove Roselove Nunoo-Asare, role: CONTACT, phone: 434-243-6074, email: rnn3b@virginia.edu, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False
protocolSection identificationModule nctId: NCT06271395, orgStudyIdInfo id: Chaoshengqiunang, briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations., conditionsModule conditions: Cricopharyngeal Achalasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Injectable Type A Botulinum Toxin, outcomesModule primaryOutcomes measure: functional oral intake scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: The Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray secretion scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinzhu Rehabilitation Hospital, status: RECRUITING, city: Xinzhu, country: Taiwan, contacts name: Haim Liu, role: CONTACT, geoPoint lat: 22.46205, lon: 120.47335, hasResults: False
protocolSection identificationModule nctId: NCT06271382, orgStudyIdInfo id: AIBU-SBF-SA-05, briefTitle: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Acupressure Group, interventions name: Sham Acupressure Group, interventions name: Foot Ankle Exercise Group, outcomesModule primaryOutcomes measure: Ankle Brachial Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06271369, orgStudyIdInfo id: CCTL019CUS13, briefTitle: Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-11, primaryCompletionDateStruct date: 2023-02-15, completionDateStruct date: 2023-02-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier., conditionsModule conditions: Diffuse Large B-cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 613, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of patients with IP admission, primaryOutcomes measure: Number of IP admissions, primaryOutcomes measure: IP days, primaryOutcomes measure: Number of ICU stays, primaryOutcomes measure: ICU days, primaryOutcomes measure: Number of patients with OP visit, primaryOutcomes measure: Number of OP visits, primaryOutcomes measure: Number of patients with ER visit, primaryOutcomes measure: Number of ER visits, primaryOutcomes measure: Healthcare reimbursement costs, primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Time to next treatment (TTNT) or death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: East Hanover, state: New Jersey, zip: 07936, country: United States, geoPoint lat: 40.8201, lon: -74.36487, hasResults: False
protocolSection identificationModule nctId: NCT06271356, orgStudyIdInfo id: STU00220278, briefTitle: Breast Cancer - Navigate - Prospective Cohort, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: The Chrysalis Initiative, descriptionModule briefSummary: The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach., conditionsModule conditions: Breast Cancer, conditions: Quality of Life, conditions: Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: BC-Navigate, outcomesModule primaryOutcomes measure: Demand of BC-Navi: Recruitment Rate, primaryOutcomes measure: Demand of BC-Navi: Rentention Rate, primaryOutcomes measure: Acceptability of BC-Navi, primaryOutcomes measure: Preliminary Efficacy: Chemotherapy Initiation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Diana Buitrago, role: CONTACT, phone: 312-503-2866, email: diana.buitrago@northwestern.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06271343, orgStudyIdInfo id: RC23_0394, briefTitle: Kidney Graft Tolerance KTOL, acronym: KTOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens., conditionsModule conditions: Kidney Transplant Tolerance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection., secondaryOutcomes measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones., secondaryOutcomes measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire-Atlantique, zip: 44093, country: France, contacts name: Christophe MASSET, PH, role: CONTACT, phone: 33 2 76 64 39 61, email: christophe.masset@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
protocolSection identificationModule nctId: NCT06271330, orgStudyIdInfo id: AP_JBD_FarWest_004, briefTitle: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD., acronym: FAR-WEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Rennes University Hospital, descriptionModule briefSummary: Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication., conditionsModule conditions: AMD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Faricimab, outcomesModule primaryOutcomes measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment., secondaryOutcomes measure: Difference between time to recurrence before switch and after switch., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ducloyer, city: Nantes, zip: 44000, country: France, contacts name: Jean-Baptiste Ducloyer, MD, role: CONTACT, phone: 02 40 08 46 51, email: jeanbaptiste.ducloyer@chu-nantes.fr, contacts name: Yann Maucourant, MD, role: CONTACT, phone: 85 658, email: Yann.MAUCOURANT@chu-rennes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
protocolSection identificationModule nctId: NCT06271317, orgStudyIdInfo id: AP_CL_001, briefTitle: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique, conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Study postoperative morbidity after nissen sleeve gastrectomy in Nantes, primaryOutcomes measure: postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False