hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06368427, orgStudyIdInfo id: D5980R00100, briefTitle: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD, acronym: COnCORD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: budesonide / glycopyrronium / formoterol, outcomesModule primaryOutcomes measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score, secondaryOutcomes measure: Change from baseline to 6 months in the CAT score, secondaryOutcomes measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment, secondaryOutcomes measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment, secondaryOutcomes measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation, secondaryOutcomes measure: Drivers for initiation or switch to BGF MDI via physician questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06368414, orgStudyIdInfo id: KCMLWP-2021-04, briefTitle: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia, acronym: AsterA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2028-08-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Korean Society of Hematology, class: NETWORK, descriptionModule briefSummary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI, conditionsModule conditions: Chronic Myeloid Leukemia, Chronic Phase, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Asciminib, outcomesModule primaryOutcomes measure: MR3.0 or less by 1 year, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-21, uploadDate: 2024-04-11T22:40, filename: Prot_000.pdf, size: 903002, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-21, uploadDate: 2024-04-11T22:40, filename: Prot_001.pdf, size: 903226, hasResults: False
protocolSection identificationModule nctId: NCT06368401, orgStudyIdInfo id: TP_01428, briefTitle: A First in Human Study for the Versa Device for Tricuspid Regurgitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Versa Vascular, Inc, class: INDUSTRY, descriptionModule briefSummary: This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates., conditionsModule conditions: Tricuspid Regurgitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Versa Implant, outcomesModule primaryOutcomes measure: Acute Procedural Success, primaryOutcomes measure: Incidence of major adverse events (MAE), secondaryOutcomes measure: Tricuspid Regurgitation Severity Change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Auckland City Hospital, city: Auckland, country: New Zealand, contacts name: Mark Webster, MD, role: CONTACT, geoPoint lat: -36.84853, lon: 174.76349, hasResults: False
protocolSection identificationModule nctId: NCT06368375, orgStudyIdInfo id: PRPF31-3102022BO2, briefTitle: Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s), conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 87, type: ACTUAL, outcomesModule primaryOutcomes measure: Best Corrected Visual Acuity (BCVA), primaryOutcomes measure: Visual Field (VF), primaryOutcomes measure: Fundus Photography (FP), primaryOutcomes measure: Optos, primaryOutcomes measure: Autofluorescence (AF), primaryOutcomes measure: Optical Coherence Tomography (OCT), primaryOutcomes measure: Full-Field Electroretinogram (ff-ERG), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, city: Tuebingen, state: Baden-Wuerttemberg, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
protocolSection identificationModule nctId: NCT06368362, orgStudyIdInfo id: CBM-I001, briefTitle: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-17, primaryCompletionDateStruct date: 2021-05-01, completionDateStruct date: 2021-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Southampton, class: OTHER, collaborators name: Economic and Social Research Council, United Kingdom, descriptionModule briefSummary: Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals., conditionsModule conditions: Chronic Pain, conditions: Musculoskeletal Pain Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants are not informed of the conditioned they are randomised to in this psychological intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Benign cognitive bias modification for interpretation, interventions name: Pain-related cognitive bias modification for interpretation, outcomesModule primaryOutcomes measure: Emotional response to exercise induced pain, primaryOutcomes measure: Emotional response to pain-related images, secondaryOutcomes measure: Fear of Pain, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Emotional response to average clinical pain, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Pain interference, secondaryOutcomes measure: Pain-related interpretation bias index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southampton, city: Southampton, state: Hampshire, zip: SO17 1BJ, country: United Kingdom, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False
protocolSection identificationModule nctId: NCT06368349, orgStudyIdInfo id: 202101771B0, briefTitle: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-06-21, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry., conditionsModule conditions: Lymphopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 190, type: ACTUAL, outcomesModule primaryOutcomes measure: Persistent lymphopenia predict poor overall survival, primaryOutcomes measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient, primaryOutcomes measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, city: Kaohsiung, zip: 833, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-10-20, uploadDate: 2024-04-11T03:02, filename: Prot_SAP_000.pdf, size: 422513, hasResults: False
protocolSection identificationModule nctId: NCT06368336, orgStudyIdInfo id: 994894, briefTitle: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study., statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-01, primaryCompletionDateStruct date: 2022-04-01, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Uppsala University Hospital, class: OTHER, collaborators name: Sepsisfonden, descriptionModule briefSummary: The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU)., conditionsModule conditions: Sepsis, conditions: Septic Shock, conditions: Sepsis, Severe, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 210484, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis, secondaryOutcomes measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis, secondaryOutcomes measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06368297, orgStudyIdInfo id: BSERE22-APP007-FED, briefTitle: The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Macau, class: OTHER, descriptionModule briefSummary: This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses., conditionsModule conditions: Overweight and Obesity, conditions: Cognitive Change, conditions: Psychophysiologic Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Monoester Supplementation, interventions name: Ketogenic diet, outcomesModule primaryOutcomes measure: Brain Plasticity, primaryOutcomes measure: Grey Matter Volume, primaryOutcomes measure: Cortical Thickness, primaryOutcomes measure: Blood-Oxygen-Level-Dependent (BOLD) Signal Changes, secondaryOutcomes measure: Blood Glucose, secondaryOutcomes measure: Blood Beta-Hydroxybutyrate, secondaryOutcomes measure: Blood Insulin, secondaryOutcomes measure: Leptin, secondaryOutcomes measure: Ghrelin, secondaryOutcomes measure: Brain-Derived Neurotrophic Factor, secondaryOutcomes measure: Reaction Time of Attention Network Test, secondaryOutcomes measure: Accuracy of Attention Network Test, secondaryOutcomes measure: Reaction Time of Stroop Task, secondaryOutcomes measure: Accuracy of Stroop Task, secondaryOutcomes measure: Reaction Time of N-back Task, secondaryOutcomes measure: Accuracy of N-back Task, secondaryOutcomes measure: Cerebral Hemoglobin Concentration, secondaryOutcomes measure: Height in Kilograms, secondaryOutcomes measure: Weight in Meters, secondaryOutcomes measure: Body Fat Percentage, secondaryOutcomes measure: Fat Mass, secondaryOutcomes measure: Muscle Mass, secondaryOutcomes measure: Body Water, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Skinfold Thickness, secondaryOutcomes measure: Maximal Oxygen Uptake, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06368284, orgStudyIdInfo id: IRB-MTP_2022_09_202201170, briefTitle: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results, acronym: TP-JET, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice., conditionsModule conditions: Perineum; Tear, Traumatic, conditions: Anal Tear, conditions: Anal Incontinence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident, outcomesModule primaryOutcomes measure: Rate of fecal incontinence, secondaryOutcomes measure: Rate of permanent stoma, secondaryOutcomes measure: Rate of acontractile bladder, secondaryOutcomes measure: Rate of sexual dysfunction, secondaryOutcomes measure: Rate of impact on quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Montpellier, status: RECRUITING, city: Montpellier, zip: 34295, country: France, contacts name: Thomas BARDOL, MD, role: CONTACT, phone: 04 67 33 90 69, email: t-bardol@chu-montpellier.fr, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
protocolSection identificationModule nctId: NCT06368271, orgStudyIdInfo id: Lipidomix, briefTitle: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile, acronym: Lipidomix, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover., conditionsModule conditions: Healthy Nutrition, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: Lipidomics, outcomesModule primaryOutcomes measure: Meal test including medium-chain fatty acids, secondaryOutcomes measure: Resting metabolic rate, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Nutrition, Exercise and Sports, city: Copenhagen, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06368258, orgStudyIdInfo id: Curr-RYR2023, briefTitle: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated., conditionsModule conditions: Hypercholesterolemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Red yeast rice, interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-dependent change in LDL-C, secondaryOutcomes measure: Treatment-dependent change in Total Cholesterol, secondaryOutcomes measure: Treatment-dependent change in Non-HDL-C, secondaryOutcomes measure: Treatment-dependent change in liver parameters, secondaryOutcomes measure: Treatment-dependent change in CPK plasma levels, secondaryOutcomes measure: Treatment-dependent change in plasma proteomic pattern, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico S.Orsola-Malpighi, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False