hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06355388, orgStudyIdInfo id: TRAGUSHF, briefTitle: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure, acronym: TRAGUS-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione Toscana Gabriele Monasterio, class: OTHER, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, descriptionModule briefSummary: To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term)., conditionsModule conditions: Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, conditions: Heart Failure With Midrange Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: In order to maintain the 'double-blind,' at the end of the experimental protocol, the data acquired in each phase (baseline, active tVNS, placebo tVNS) will be saved in three different files, made unrecognizable by one of the investigators not involved in the tabulation and data analysis. A second investigator, unaware of the stimulation phases, will proceed with the tabulation of the data for each individual recording (three per patient). Only at the end of the study (or after recruiting 50% of patients for any interim analyses), will the investigators responsible for data analysis be revealed the corresponding phase for each recording., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Active tVNS, interventions name: Sham tVNS, outcomesModule primaryOutcomes measure: Mean change in baroreflex gain (ms/mmHg), primaryOutcomes measure: Mean change in baroreflex gain (ms/mmHg), otherOutcomes measure: Mean change in MSNA burst incidence (bursts/100 heartbeats), otherOutcomes measure: Mean change in peak O2 consumption (mL/Kg/min), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Michele Emdin, city: Pisa, state: Pi, zip: 56120, country: Italy, contacts name: Michele Emdin, MD, PhD, role: CONTACT, email: emdin@ftgm.it, contacts name: Francesco Gentile, MD, role: SUB_INVESTIGATOR, contacts name: Claudio Passino, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
protocolSection identificationModule nctId: NCT06355375, orgStudyIdInfo id: 02.24, briefTitle: Exercise in Pregnancy and Risk of Postpartum Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day, conditionsModule conditions: Depression, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Exercise during pregnancy, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 398, type: ESTIMATED, armsInterventionsModule interventions name: exercise in pregnancy, outcomesModule primaryOutcomes measure: edinburgh depression scale, secondaryOutcomes measure: Postpartum depression, secondaryOutcomes measure: preterm birth, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gabriele Saccone, status: RECRUITING, city: Naples, zip: 80100, country: Italy, contacts name: Gabriele Saccone, role: CONTACT, phone: 0817461111, email: gabriele.saccone.1990@gmail.com, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
protocolSection identificationModule nctId: NCT06355362, orgStudyIdInfo id: HeCoMo, briefTitle: Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality, acronym: HeCoMo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Kliniken Essen-Mitte, class: OTHER, descriptionModule briefSummary: Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities., conditionsModule conditions: High-risk Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of postoperative complications, primaryOutcomes measure: Incidence of postoperative mortalities, secondaryOutcomes measure: Implementation rate of preoperative factors impacting postoperative outcome, secondaryOutcomes measure: Intraoperative hemodynamic characteristics, secondaryOutcomes measure: Postoperative haemodynamic characteristics, secondaryOutcomes measure: Co-morbidities of patients, secondaryOutcomes measure: Transfusion of blood components and administration of coagulation factors, secondaryOutcomes measure: Score of the physical/pathological activity status of the patients, secondaryOutcomes measure: Clinical frailty scale, secondaryOutcomes measure: Characteristics of perioperative care, time in perioperative units and the hospital, secondaryOutcomes measure: Characteristics of provision of anesthesia and type of pain therapy, secondaryOutcomes measure: Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355349, orgStudyIdInfo id: JW22101, briefTitle: To Evaluate the Safety and PK Characteristics in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-28, primaryCompletionDateStruct date: 2023-07-10, completionDateStruct date: 2023-07-17, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: JW Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: Reference Drug or Test Drug, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Center, Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
protocolSection identificationModule nctId: NCT06355336, orgStudyIdInfo id: CCA/IRN-24-001, briefTitle: Real World Prostate Cancer Registry, acronym: RWPCR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2034-03-18, completionDateStruct date: 2034-03-18, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cincinnati Cancer Advisors, class: NETWORK, descriptionModule briefSummary: Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To determine practice patterns for prostate cancer in the region., secondaryOutcomes measure: To determine progression free survival and overall survival of patients., secondaryOutcomes measure: Prevalence of long term complications of prostate cancer treatment., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cincinnati Cancer Advisors, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45212, country: United States, contacts name: Dr. Jazieh, role: CONTACT, phone: 513-731-2273, email: a.jazieh@cincinnaticanceradvisors.org, contacts name: Amy Barber, role: CONTACT, phone: 5137312273, email: ctcoordinator@iresearchnetwork.com, contacts name: Abdul R Jazieh, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
protocolSection identificationModule nctId: NCT06355310, orgStudyIdInfo id: IRB 2023-6429, briefTitle: Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease, acronym: SHIELD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ann & Robert H Lurie Children's Hospital of Chicago, class: OTHER, descriptionModule briefSummary: This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity., conditionsModule conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 randomization, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double blind placebo control, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 10 MG, interventions name: Placebo Oral Tablet, outcomesModule primaryOutcomes measure: Hepatic Fat, secondaryOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355271, orgStudyIdInfo id: 2024-00019, briefTitle: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery, acronym: MoFe, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery, conditionsModule conditions: Obstetric Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Fentanyl 1, interventions name: Fentanyl2, interventions name: Fentanyl 3, outcomesModule primaryOutcomes measure: Patient Controlled Analgesia morphine consumption, primaryOutcomes measure: obstetric quality of recovery score, secondaryOutcomes measure: Visual Analogue Scale, secondaryOutcomes measure: pruritus, secondaryOutcomes measure: nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity, secondaryOutcomes measure: intraoperative hypotension, secondaryOutcomes measure: intraoperative opioids, secondaryOutcomes measure: satisfaction rate, secondaryOutcomes measure: intraoperative pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355258, orgStudyIdInfo id: 20230817LX001, briefTitle: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Westlake University, class: OTHER, collaborators name: Shaoxing Central Hospital, descriptionModule briefSummary: The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:* Does troxerutin lower the number of thrombotic events in participants?* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.Participants will:* Take troxerutin or a placebo every day for 7 days.* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia, conditionsModule conditions: COVID 19 Associated Coagulopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Troxerutin, interventions name: Placebo, interventions name: placebo + low molecular weight heparin, interventions name: troxerutin + low molecular weight heparin, outcomesModule primaryOutcomes measure: Overall number of thrombotic events through 28 days, primaryOutcomes measure: Tolerability of anticoagulation therapy, secondaryOutcomes measure: Time to clinical improvement in patients through 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shaoxing central hospital, status: RECRUITING, city: Shaoxing, state: Zhejiang, country: China, contacts name: Xu Li, Doctor, role: CONTACT, phone: 13811635032, email: lixu@westlake.edu.cn, geoPoint lat: 30.00237, lon: 120.57864, hasResults: False
protocolSection identificationModule nctId: NCT06355245, orgStudyIdInfo id: 2017/2160-31/1, briefTitle: MEDECA - Markers in Early Detection of Cancer, acronym: MEDECA, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-03-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, descriptionModule briefSummary: Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning., conditionsModule conditions: Cancer, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Cancer diagnosis, secondaryOutcomes measure: Other diagnosis, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Cancer diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danderyd Hospital, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Charlotte Thålin, M.D., Ph.D., role: CONTACT, phone: +46709565120, email: charlotte.thalin@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False