hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06386484, orgStudyIdInfo id: 2019-05463, briefTitle: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-02, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight., conditionsModule conditions: Repetitive Head Impact, conditions: Selective Head and Neck Cooling, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PolarCap System, outcomesModule primaryOutcomes measure: Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight., secondaryOutcomes measure: Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden, status: RECRUITING, city: Lund, state: Skane, zip: 22100, country: Sweden, contacts name: Ali Al-husseini, MD, Medical doctor, PhD stud, role: CONTACT, phone: +46707267261, email: Ali.al-husseini@med.lu.se, contacts name: Ali Al-husseini, role: SUB_INVESTIGATOR, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False
protocolSection identificationModule nctId: NCT06386471, orgStudyIdInfo id: 24093, briefTitle: Personalized GI Motility Responses to Diet, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-06-12, completionDateStruct date: 2025-06-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, descriptionModule briefSummary: The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses., conditionsModule conditions: Nutritional and Metabolic Diseases, conditions: Gastrointestinal Dysfunction, conditions: Cardiovascular Diseases, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, controlled, crossover, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Appearance, flavor, and texture of whole grain vs refined bread could not be masked, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Whole grain rye bread, interventions name: Refined grain rye bread, outcomesModule primaryOutcomes measure: Gastrointestinal Pressure (mmHg), primaryOutcomes measure: Luminal pH (pH units), primaryOutcomes measure: Temperature (degrees celcius), primaryOutcomes measure: Gastrointestinal Transit Time (hours:minutes), primaryOutcomes measure: Blood Glucose, primaryOutcomes measure: Triglycerides, primaryOutcomes measure: Total Cholesterol, primaryOutcomes measure: HDL cholesterol, primaryOutcomes measure: LDL cholesterol, primaryOutcomes measure: Lipopolysaccharide Binding Protein, secondaryOutcomes measure: Microbiome, secondaryOutcomes measure: Metabolomics, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 63 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Illinois at Urbana-Champaign, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Brett R Loman, PhD, RD, role: CONTACT, contacts name: Brett R Loman, PhD, RD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.11059, lon: -88.20727, hasResults: False
protocolSection identificationModule nctId: NCT06386458, orgStudyIdInfo id: AT-01, briefTitle: Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-08, primaryCompletionDateStruct date: 2023-05-09, completionDateStruct date: 2023-05-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hangzhou NOYA MedTech Co. Ltm., class: INDUSTRY, descriptionModule briefSummary: This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups., conditionsModule conditions: Heart Diseases, conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 177, type: ACTUAL, armsInterventionsModule interventions name: AThrough radiofrequency transseptal puncture system, interventions name: Traditional mechanical transseptal puncture needle, outcomesModule primaryOutcomes measure: Transseptal puncture success rate., secondaryOutcomes measure: Initial transseptal puncture success rate., secondaryOutcomes measure: Time required to successfully complete the transseptal puncture., secondaryOutcomes measure: Number of attempts needed to successfully complete the transseptal puncture., secondaryOutcomes measure: Ratio of atrial septal puncture failures that cross over to the opposite group., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The 7th People's Hospital of Zhengzhou, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital with Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Tianjin Chest Hospital, city: Tianjin, state: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Ningbo University, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False
protocolSection identificationModule nctId: NCT06386445, orgStudyIdInfo id: XJTU1AF-CRF-2023-XK013, briefTitle: Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications., conditionsModule conditions: Stem Cell Transplant Complications, conditions: Acute Graft Versus Host Disease, conditions: Acute Kidney Injury, conditions: Major Adverse Cardiac Events, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Serum metabolomics sequencing, outcomesModule primaryOutcomes measure: acute graft versus host disease, secondaryOutcomes measure: acute kidney injury, secondaryOutcomes measure: major adverse cardiac events, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386419, orgStudyIdInfo id: CKJX839A1IN03, briefTitle: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-08-08, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium., conditionsModule conditions: Primary Hypercholesterolemia, conditions: Mixed Dyslipidemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: open label assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: inclisiran, outcomesModule primaryOutcomes measure: Incidence and type of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Mean change in LDL-C from baseline to Day 300., secondaryOutcomes measure: Proportion of the participants with ≥50% LDL-C reduction on Day 300, secondaryOutcomes measure: Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk, secondaryOutcomes measure: Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386406, orgStudyIdInfo id: ORL-ORT-040, briefTitle: This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain, acronym: TAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life., conditionsModule conditions: Plantar Fascitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: TAP insole, outcomesModule primaryOutcomes measure: Change in pain severity according to visual analog scale, secondaryOutcomes measure: Change in pain severity according to visual analog scale, secondaryOutcomes measure: Subjective functional recovery based on the Foot Function Index (FFI) score [, secondaryOutcomes measure: Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ), secondaryOutcomes measure: Patient satisfaction on a 0-10 numeric rating scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: EOC, status: RECRUITING, city: Lugano, zip: 6900, country: Switzerland, contacts name: Martin Riegger, Dr.med, role: CONTACT, phone: +41 (0) 91 811 70 29, email: RicercaOrtopedia.ORL@eoc.ch, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
protocolSection identificationModule nctId: NCT06386380, orgStudyIdInfo id: IRE-4906, briefTitle: Adversity and Its Association With the Development and Expression of Rheumatic Diseases, acronym: RD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran, class: OTHER, descriptionModule briefSummary: Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.With this background, we wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness., conditionsModule conditions: RhA - Rheumatoid Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Rheumatic diseases Mistreatment Scale (RDMS), interventions name: Routine assessment of patient index data 3 (RAPID-3), interventions name: Health Assessment Questionnaire (HAQ), interventions name: WHOQOL-BREF, interventions name: Depression, Anxiety and Stress Scale (DASS-21), interventions name: Brief Resilient Coping Scale, interventions name: Expression of CDKN2A /p16INK4a, interventions name: Immunophenotype of leukocyte subpopulations, interventions name: Telomere length, interventions name: Cellular senescence, outcomesModule primaryOutcomes measure: Adversity and senescence in patients with rheumatoid arthritis, secondaryOutcomes measure: Eexpression of the p16INK4a gene in CD3+, secondaryOutcomes measure: Telomere length, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06386367, orgStudyIdInfo id: MHNO-001, briefTitle: Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Myanmar Health Network Organization, class: OTHER, collaborators name: Chulalongkorn University, collaborators name: Ministry of Health and Sports, Myanmar, descriptionModule briefSummary: Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable., conditionsModule conditions: Buddhist Monks, conditions: Health Education, conditions: Malaria, conditions: Monastery-based, conditions: Myanmar, conditions: Preventive Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 501, type: ACTUAL, armsInterventionsModule interventions name: Monastery-based health education by Buddhist monks, outcomesModule primaryOutcomes measure: Malaria knowledge and preventive practices, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Myanmar Health Network Organization, city: Yangon, zip: 11091, country: Myanmar, geoPoint lat: 16.80528, lon: 96.15611, hasResults: False
protocolSection identificationModule nctId: NCT06386354, orgStudyIdInfo id: 2023-464-1, briefTitle: Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications, acronym: Porcerito, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Dr. Negrin University Hospital, class: OTHER, descriptionModule briefSummary: The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient., conditionsModule conditions: Postoperative Neuromuscular Block, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Train-of-four, outcomesModule primaryOutcomes measure: Residual Neuromuscular Block, primaryOutcomes measure: Residual Neuromuscular Block, secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ángel Becerra, city: Las Palmas De Gran Canaria, state: Las Palmas, zip: 35019, country: Spain, geoPoint lat: 28.09973, lon: -15.41343, hasResults: False
protocolSection identificationModule nctId: NCT06386341, orgStudyIdInfo id: W23.154, briefTitle: QoL in OSA patiënts Treated With MMA Surgery., acronym: QOMAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-02, primaryCompletionDateStruct date: 2026-08-02, completionDateStruct date: 2026-08-02, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Diakonessenhuis, Utrecht, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.The main question it aims to answer is:Does MMA surgery in OSA patiënts improve their quality of life?Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure., conditionsModule conditions: Sleep Apnea, Obstructive, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Maxillomandibular Advancement Surgery, outcomesModule primaryOutcomes measure: SF-36, secondaryOutcomes measure: OHIP-14, secondaryOutcomes measure: ESS, secondaryOutcomes measure: FOSQ, secondaryOutcomes measure: EQ-5D-3L, secondaryOutcomes measure: OQLQ, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diakonessenhuis, status: RECRUITING, city: Utrecht, zip: 3582KE, country: Netherlands, contacts name: Susanne Leij, role: CONTACT, phone: 088-250 6172, email: sleij@diakhuis.nl, contacts name: Maurits de Ruiter, MD, DDS, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Haya Al-Bayyati, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False