hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06355232, orgStudyIdInfo id: Vaxine-2301, briefTitle: Covid-19 and Influenza Oral Vaccine Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2024-04-21, completionDateStruct date: 2025-04-21, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vaxine Pty Ltd, class: INDUSTRY, collaborators name: Australian Respiratory and Sleep Medicine Institute Ltd, descriptionModule briefSummary: The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines., conditionsModule conditions: covid19 Infection, conditions: Influenza, Human, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised, controlled cross-over study, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: A comparator vaccine (influenza) with an identical appearance will be used as the control., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Covid-19 vaccine, interventions name: Influenza vaccine, outcomesModule primaryOutcomes measure: SARS-CoV-2 Seroconversion, primaryOutcomes measure: Influenza Seroconversion, primaryOutcomes measure: SARS-CoV-2 Seroprotection, primaryOutcomes measure: Influenza Seroprotection, primaryOutcomes measure: SARS-CoV-2 Geometric mean titer fold change, primaryOutcomes measure: Influenza geometric mean titer fold change, primaryOutcomes measure: Safety assessment 1, primaryOutcomes measure: Safety assessment 2, primaryOutcomes measure: SARS-CoV-2 infection, primaryOutcomes measure: Influenza infection, secondaryOutcomes measure: Antibody durability, secondaryOutcomes measure: Seroconversion in participants with and without evidence of past infection, secondaryOutcomes measure: Antibody GMT in participants with and without evidence of past infection, secondaryOutcomes measure: Antibody correlates of protection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ARASMI, city: Adelaide, state: South Australia, zip: 5042, country: Australia, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
protocolSection identificationModule nctId: NCT06355219, orgStudyIdInfo id: IRB #19-066, briefTitle: Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines, acronym: M6, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ali Aminian, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Obesity, conditions: Microvascular Disease, conditions: Macrovascular Disease, conditions: Major Adverse Cardiovascular Events, conditions: Nephropathy, conditions: Retinopathy, conditions: Heart Failure, conditions: All Cause Mortality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3932, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: All-cause Mortality Rate, secondaryOutcomes measure: Incidence of MACE, secondaryOutcomes measure: Incidence of Nephropathy, secondaryOutcomes measure: Incidence of Retinopathy, otherOutcomes measure: Incidence of Components of MACE Separately, otherOutcomes measure: Change in weight percentage, otherOutcomes measure: Change HBA1c percentage, otherOutcomes measure: Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions, otherOutcomes measure: Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline, otherOutcomes measure: Cost-effectiveness of Metabolic Surgery vs GLP-1RAs, otherOutcomes measure: Incidence of Adverse Events After Metabolic Surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06355206, orgStudyIdInfo id: NACRE20230306, briefTitle: Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis, acronym: NACRE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2034-12, completionDateStruct date: 2034-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?Patients will be closely followed and clinical information will be recorded., conditionsModule conditions: Cohort Study, conditions: Recurrent Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: endoscopic intervention, surgery or conservative treatment, outcomesModule primaryOutcomes measure: Recurrence rate of acute pancreatitis, secondaryOutcomes measure: Proportion of patients with different treatment, secondaryOutcomes measure: Characteristics of acute pancreatitis, secondaryOutcomes measure: Proportion of patients wtih pain in RAP patients, secondaryOutcomes measure: Proportion of patients with chronic pancreatitis, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Evaluation of psychological condition, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355193, orgStudyIdInfo id: MZhou, briefTitle: The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2022-12-30, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Central South University, class: OTHER, descriptionModule briefSummary: This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies., conditionsModule conditions: Treatment of Mild Cases of COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 253, type: ACTUAL, armsInterventionsModule interventions name: Langenlianqiao, interventions name: LianhuaQingWen, interventions name: placebo control group, outcomesModule primaryOutcomes measure: Treatment and symptomatic improvement effects of LGLQ, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changde Hospital, city: Changde, state: Hunan, country: China, geoPoint lat: 29.04638, lon: 111.6783, hasResults: False
protocolSection identificationModule nctId: NCT06355167, orgStudyIdInfo id: Bacoxy_I, briefTitle: Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress, acronym: Bacoxy_I, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2022-05-25, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress., conditionsModule conditions: Oxidative Stress, conditions: Cardiovascular Diseases, conditions: Bacopaside II, conditions: Bacopa Monnieri, conditions: Endothelial Dysfunction, conditions: Aquaporin 1, conditions: AQP1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Bacopa monnieri, outcomesModule primaryOutcomes measure: Ex vivo DCFDA test on red blood cells (RBCs), primaryOutcomes measure: Plasma lipid peroxydes, primaryOutcomes measure: Methemoglobin in red blood cells, primaryOutcomes measure: Nitrosylated hemoglobin (HbNO) in red blood cells, secondaryOutcomes measure: haemoglobin, secondaryOutcomes measure: haematocrit, secondaryOutcomes measure: Red blood cells count, secondaryOutcomes measure: Sodium, secondaryOutcomes measure: Potassium, secondaryOutcomes measure: Bicarbonate, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: High-Density Lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Low-Density Lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: aspartate aminotransferase (ASAT), (U/L), secondaryOutcomes measure: alanine aminotransferase (ALAT) (U/L), secondaryOutcomes measure: gamma-glutamyl-transferase (GGT) level, secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Glomerular filtration rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique universitaires saint luc, city: Brussels, zip: 1200, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
protocolSection identificationModule nctId: NCT06355154, orgStudyIdInfo id: 069823- HMO-CTIL, briefTitle: Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT., conditionsModule conditions: Diabetes in Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open label, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional intervention, outcomesModule primaryOutcomes measure: Time in range, primaryOutcomes measure: Time above range, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355141, orgStudyIdInfo id: E-15189967-050.04-494458, briefTitle: Oral Structural and Functional Problems in Children With Autism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-05-13, completionDateStruct date: 2024-08-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: This study aims to examine oral structural and functional problems in children with autism., conditionsModule conditions: Autism Spectrum Disorder, conditions: Chewing Problem, conditions: Drooling, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: oral assessment, outcomesModule primaryOutcomes measure: Demographic Information Form, primaryOutcomes measure: Time to achieve Oromotor skills, primaryOutcomes measure: Oral structural assessment, secondaryOutcomes measure: Chewing evaluation, secondaryOutcomes measure: Drooling of saliva evaluation, secondaryOutcomes measure: Tongue thrust evaluation, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355128, orgStudyIdInfo id: 20240307, briefTitle: A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-02-18, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, collaborators name: Qichun People's Hospital, descriptionModule briefSummary: To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022, conditionsModule conditions: COVID-19, conditions: Ocular Surface Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 16000, type: ACTUAL, armsInterventionsModule interventions name: NOT, outcomesModule primaryOutcomes measure: Questionnaire data were collected and statistically analyzed., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongnan Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430071, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
protocolSection identificationModule nctId: NCT06355102, orgStudyIdInfo id: 2024-SR-116, briefTitle: The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are:* What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL?* Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients?Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis.Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time., conditionsModule conditions: Sudden Sensorineural Hearing Loss, conditions: Tinnitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Brain function states, primaryOutcomes measure: Serum metabolomics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06355089, orgStudyIdInfo id: VAR-MIKRO, briefTitle: Intestinal Microbiota: Immunity, Recovery and Metabolic Health, acronym: VAR-MIKRO, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-09, primaryCompletionDateStruct date: 2023-09-07, completionDateStruct date: 2023-09-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Turku, class: OTHER, collaborators name: Government Body Funding, descriptionModule briefSummary: The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Placebo Comparator, interventions name: Whey protein hydrolysate milk product, interventions name: Postbiotic and whey protein hydrolysate milk product, outcomesModule primaryOutcomes measure: Concentrations of inflammatory markers from the blood samples, secondaryOutcomes measure: Gut microbiota composition in feces, secondaryOutcomes measure: Weight of the participant, secondaryOutcomes measure: Waist circumference of the participant, secondaryOutcomes measure: Infections during the intervention, secondaryOutcomes measure: Development of physical fitness, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Recovery, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: BMI, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 28 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Turku, city: Turku, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
protocolSection identificationModule nctId: NCT06355076, orgStudyIdInfo id: CSZ03, briefTitle: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.Participants will:The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients in the experimental or control group, as well as their family members, are unaware, whoMasked: PARTICIPANT, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: New urethral reconstruction, outcomesModule primaryOutcomes measure: Recovery of urinary incontinence, secondaryOutcomes measure: complication, secondaryOutcomes measure: PSA, secondaryOutcomes measure: recurrence, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 276600, country: China, contacts name: shouzhen chen, role: CONTACT, phone: 18560089085, email: 201900412102@mail.sdu.edu.cn, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False