hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06347874, orgStudyIdInfo id: ANES-2024-32820, briefTitle: Cryo Rib Fracture Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter., conditionsModule conditions: Rib Fractures, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The individual doing the outcome assessments will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Cryoablation, interventions name: ESP Catheter, outcomesModule primaryOutcomes measure: Maximum pain score on POD (Post Operative Day) 7, primaryOutcomes measure: Opioid Use, primaryOutcomes measure: Functional Pain Scores, primaryOutcomes measure: Number of Patients using opioids at POD 30, primaryOutcomes measure: Length of hospital stay, primaryOutcomes measure: Number of patients returned home by POD 30, primaryOutcomes measure: time to first ambulation, primaryOutcomes measure: number of patients admitted to ICU, primaryOutcomes measure: number of patients that required mechanical ventilation, primaryOutcomes measure: Pulmonary Function Testing., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06347861, orgStudyIdInfo id: C4891003, briefTitle: A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-06-16, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, collaborators name: Arvinas Estrogen Receptor, Inc., descriptionModule briefSummary: The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.This study looks at how the medicine is changed and removed from the body after a participant takes it.This study is seeking for participant who:* are healthy males, and healthy females who do not have the possibility to have children.* are 18 years of age or older.* weigh more than 45 Kilograms (99 pounds).The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: single dose of vepdegestrant as tablet formulation (Treatment A), interventions name: single dose of vepdegestrant as tablet formulation (Treatment B), interventions name: single dose of vepdegestrant as tablet formulation (Treatment C), outcomesModule primaryOutcomes measure: Maximum observed concentration (Cmax) for vepdegestrant, primaryOutcomes measure: Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant, secondaryOutcomes measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants With Clinical Laboratory Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, secondaryOutcomes measure: Number of Participants With Electrocardiogram (ECG) Abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prism Research LLC dba Nucleus Network, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55114, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False
protocolSection identificationModule nctId: NCT06347848, orgStudyIdInfo id: IstanbulUCKA, briefTitle: The Effect of Psychoeducation Focused on Reducing Internalized Stigma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma., conditionsModule conditions: Schizophrenia, conditions: Treatment Adherence, conditions: Stigma, Social, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two parallel groups randomized control study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation Focused on Reducing Internalized Stigma, outcomesModule primaryOutcomes measure: Internalized Stigma of Mental Illness Scale, primaryOutcomes measure: Medication Adherence Reporting Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa (IUC), city: Istanbul, state: Şişli, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06347835, orgStudyIdInfo id: Gut-Intervention-SAR-2024, briefTitle: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: symbiotic, interventions name: whey protein, interventions name: symbiotic placebo, interventions name: whey protein placebo, outcomesModule primaryOutcomes measure: Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks, primaryOutcomes measure: Change from Baseline of grip strength at 12 weeks, secondaryOutcomes measure: Change from Baseline of Short Physical Performance Battery score at 12 weeks, secondaryOutcomes measure: Change from Baseline of gait speed at 12 weeks, secondaryOutcomes measure: Change from Baseline of gut microbiota composition at 12 weeks, secondaryOutcomes measure: Change from Baseline of inflammation status at 12 weeks, secondaryOutcomes measure: Change from Baseline of microbiota-derived metabolites at 12 weeks, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Kang Yu, MD, role: CONTACT, phone: +86 010-69155550, email: yuk1997@sina.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06347822, orgStudyIdInfo id: 23-011276, briefTitle: Increasing Access to Evidence-Based Care in Integrated Behavioral Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future., conditionsModule conditions: Psychotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Therapy Session, outcomesModule primaryOutcomes measure: Satisfaction with IBH therapy, primaryOutcomes measure: Satisfaction with Action Plan, primaryOutcomes measure: Change in readiness for change scores, primaryOutcomes measure: Change in PHQ-9 scores, primaryOutcomes measure: Change in GAD-7 scores, secondaryOutcomes measure: Change in Valuing Questionnaire (Values Progress subscale), secondaryOutcomes measure: Change in Valuing Questionnaire (Values Obstruction subscale), secondaryOutcomes measure: Change in CompACT scores (Valued Action), secondaryOutcomes measure: Change in CompACT scores (Openness to Experience), secondaryOutcomes measure: Change in CompACT scores (Behavioral Awareness), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06347809, orgStudyIdInfo id: 18-006343, secondaryIdInfos id: NCI-2024-01225, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 18-006343, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2018-11-07, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests., conditionsModule conditions: Prostate Adenocarcinoma, conditions: Prostate Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP), secondaryOutcomes measure: Accuracy of CAP detection, secondaryOutcomes measure: Comparison of sample volumes, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06347796, orgStudyIdInfo id: 23-0160, secondaryIdInfos id: 1UG3NS128397-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3NS128397-01A1, briefTitle: Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study, acronym: CHESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2029-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The University of Texas Medical Branch, Galveston, class: OTHER, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), descriptionModule briefSummary: The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?* What is the safety of MMAE and conventional open surgery in these patients?Participants will be asked to:* Share their medical history and undergo physical examinations* Have blood drawn* Have CT scans of the head* Answer questionnaires* Undergo MMAE or conventional open surgery* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety., conditionsModule conditions: Chronic Subdural Hematoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Surgery, interventions name: Middle Meningeal Artery Embolization (MMAE), outcomesModule primaryOutcomes measure: Need for Rescue Surgery or Death, secondaryOutcomes measure: Safety of MMAE and Conventional Open Surgery, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas Medical Branch, city: Galveston, state: Texas, zip: 77555, country: United States, contacts name: Study Manager, role: CONTACT, phone: 262-470-4293, email: jlspahn@utmb.edu, contacts name: Peter Kan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.30135, lon: -94.7977, hasResults: False
protocolSection identificationModule nctId: NCT06347783, orgStudyIdInfo id: STUDY00026893, briefTitle: Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?Participants will be asked to:* Complete questionnaires regarding demographic data and diabetes history.* Complete surveys regarding sleep quality before and after starting an insulin pump.* Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.After 1-2 months after initiation of an insulin pump, participants will be asked again to:* Complete surveys regarding sleep quality* Wear a FitBit during sleep for 2 weeks* Fill out daily sleep diaries over the same 2 week period., conditionsModule conditions: Type1diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Insulin pump, outcomesModule primaryOutcomes measure: Sleep duration, primaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Sleep Disturbance Scale for Children, secondaryOutcomes measure: Promis Short Form 8a, otherOutcomes measure: Time in range, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Oregon Health and Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Rachel L Palting, DO, role: CONTACT, phone: 503-494-1966, email: palting@ohsu.edu, contacts name: Ines Guttman-Bauman, MD, role: CONTACT, phone: 503-494-8509, email: Guttman@ohsu.edu, contacts name: Rachel L Palting, DO, role: PRINCIPAL_INVESTIGATOR, contacts name: Ines Guttman-Bauman, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
protocolSection identificationModule nctId: NCT06347770, orgStudyIdInfo id: ThirdSunYat-senECII202329903, briefTitle: Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Third Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them., conditionsModule conditions: Microbiota, conditions: Postoperative Recovery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic Blend Oral Tablet, outcomesModule primaryOutcomes measure: analysis of postoperative recovery, primaryOutcomes measure: 16S rRNA amplicon sequencing of the V4 region, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhe Li, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Yiwen Zhang, MD, role: CONTACT, phone: +86-18145701061, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06347757, orgStudyIdInfo id: NorthernJiangsuhospital1, briefTitle: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial., conditionsModule conditions: Anti-Reflux Alimentary Reconstruction, conditions: Laparoscopic Proximal Gastrectomy, conditions: Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy, outcomesModule primaryOutcomes measure: Incidence of reflux esophagitis, secondaryOutcomes measure: Incidence of anastomotic leakage, secondaryOutcomes measure: Incidence of anastomotic stenosis, secondaryOutcomes measure: Operative time, secondaryOutcomes measure: Intra-operative blood loss, secondaryOutcomes measure: Overall survival, and disease-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiajie Zhou, city: Yangzhou, country: China, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False