hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06358781, orgStudyIdInfo id: xuyajun197673-002, briefTitle: A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains., conditionsModule conditions: Chronic Disease Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Whole grain wheat flour, outcomesModule primaryOutcomes measure: whole grain plasma and urine biomarkers discovery and identification, secondaryOutcomes measure: Validate the performance of the potential WG biomarkers., otherOutcomes measure: Dose-response of WG wheat biomarkers., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06358768, orgStudyIdInfo id: ObGynEASC005, briefTitle: Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations, acronym: PPH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: G. d'Annunzio University, class: OTHER, collaborators name: A.O. Ospedale Papa Giovanni XXIII, descriptionModule briefSummary: Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management, conditionsModule conditions: PPH - Postpartum Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: teamwork job improvement overall, interventions name: teamwork job improvement in actor scenario vs mannequin scenario, outcomesModule primaryOutcomes measure: teamwork, primaryOutcomes measure: skills, secondaryOutcomes measure: scenario quality, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Claudio Celentano, city: Pescara, state: PE, zip: 65100, country: Italy, contacts name: Claudio Celentano, MD, role: CONTACT, phone: +393285577305, email: celentanoclaudio70@gmail.com, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Ospedale Giovanni XXIII, city: Bergamo, country: Italy, contacts name: Luisa Patanè, MD, role: CONTACT, phone: 349 3503920‬, phoneExt: +39, email: luisapatane@me.com, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
protocolSection identificationModule nctId: NCT06358755, orgStudyIdInfo id: 10211476, secondaryIdInfos id: P0041308, type: OTHER, domain: The Hong Kong Polytechnic University, briefTitle: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: The University of Hong Kong, descriptionModule briefSummary: The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Defocus Incorporated Multiple Segments lenses, interventions name: single vision spectacle lenses, interventions name: Low dose atropine, outcomesModule primaryOutcomes measure: Changes in cycloplegic refraction, primaryOutcomes measure: Changes in axial length, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong, city: Hong Kong, zip: No postcode, country: Hong Kong, contacts name: Rachel Ka Man Chun, PhD, role: CONTACT, phone: +852-27664224, email: rachel.chun@polyu.edu.hk, contacts name: Dennis Yan-yin Tse, PhD, role: CONTACT, phone: +852-27666096, email: dennis.tse@polyu.edu.hk, contacts name: Christopher Kai-shun Leung, MD and Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06358742, orgStudyIdInfo id: ORL-GUM-2787, briefTitle: Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-10, primaryCompletionDateStruct date: 2017-05-19, completionDateStruct date: 2017-05-19, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Unilever R&D, class: INDUSTRY, collaborators name: Intertek, descriptionModule briefSummary: This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion criteria. After recruitment, subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study. Following the run-in period, baseline supragingival plaque samples will be collected 12 hours after last brushing, from the upper and lower jaws separately. Subjects will then then randomly allocated to one of two products (zinc citrate trihydrate \[ZCT\] toothpaste or control toothpaste) according to the randomization. Subjects will be instructed to use the toothpaste at home, brushing twice a day for 12-weeks. Supragingival plaque samples will be collected again from the upper and lower jaws after 2, 6 and 12 weeks. Plaque samples will then undergo metataxonomic and metatranscriptomic analyses., conditionsModule conditions: Dental Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Toothpaste packaged in white tubes with a study label which only differentiates products with a alphanumeric code., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: ZCT toothpaste, interventions name: Control toothpaste, outcomesModule primaryOutcomes measure: Plaque microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358729, orgStudyIdInfo id: HUM00239775, briefTitle: Pre-Pregnancy Weight Loss and Baby Behavior Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple., conditionsModule conditions: Obesity; Familial, conditions: Pregnancy Related, conditions: Infant Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Typical Nipple, interventions name: Challenging Nipple, outcomesModule primaryOutcomes measure: Suck effect, secondaryOutcomes measure: Sucking pressure, secondaryOutcomes measure: Sucking frequency, secondaryOutcomes measure: Milk/Formula intake, secondaryOutcomes measure: Milk/Formula consumption rate, secondaryOutcomes measure: Number of Feedings Over 24 Hours, secondaryOutcomes measure: Total Hours of Sleep per 24 Hours within 24 hours of intervention, secondaryOutcomes measure: Total Night Wake-ups within 24 hours of intervention, eligibilityModule sex: ALL, minimumAge: 3 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Amanda Crandall, PhD, role: CONTACT, contacts name: Amanda Crandall, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
protocolSection identificationModule nctId: NCT06358716, orgStudyIdInfo id: CEIC-3037, briefTitle: Glycaemic Index Determination in Oral Nutrition Supplements, acronym: BEGINS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Universitat de Lleida, class: OTHER, collaborators name: Lactalis, descriptionModule briefSummary: The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response., conditionsModule conditions: Glucose Metabolism Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Complete Oral Nutrition Supplement 1, interventions name: Complete Oral Nutrition Supplement 2, interventions name: Complete Oral Nutrition Supplement 3, interventions name: Complete Oral Nutrition Supplement 4, interventions name: Complete Oral Nutrition Supplement 5, interventions name: Complete Oral Nutrition Supplement 6, interventions name: Complete Oral Nutrition Supplement 7, interventions name: Complete Oral Nutrition Supplement 8, interventions name: Complete Oral Nutrition Supplement 9, interventions name: Glucose, outcomesModule primaryOutcomes measure: Glycemic Index, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Lleida, status: RECRUITING, city: Lleida, zip: 25198, country: Spain, contacts name: Jose Serrano, PhD, role: CONTACT, phone: 973702408, email: josecarlos.serrano@udl.cat, contacts name: Manuel Portero, PhD, role: CONTACT, phone: 973702408, email: manuel.portero@udl.cat, geoPoint lat: 41.61674, lon: 0.62218, hasResults: False
protocolSection identificationModule nctId: NCT06358703, orgStudyIdInfo id: P400, briefTitle: Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors, acronym: NeST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: US Thrombotic Microangiopathy Alliance, class: OTHER, descriptionModule briefSummary: 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI, conditionsModule conditions: Immune Thrombotic Thrombocytopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: Caplacizumab, outcomesModule primaryOutcomes measure: Silent cerebral infarction, primaryOutcomes measure: Cognitive impairment, secondaryOutcomes measure: Depression scores on BDI-II, secondaryOutcomes measure: SF-36 scores for quality of life, secondaryOutcomes measure: Patient reported cognitive performance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USTMA, city: Groveport, state: Ohio, zip: 43125, country: United States, contacts name: Clare Martin, role: CONTACT, phone: 614-999-4900, email: Clare@ustma.org, geoPoint lat: 39.8784, lon: -82.88379, hasResults: False
protocolSection identificationModule nctId: NCT06358690, orgStudyIdInfo id: HSC-MS-24-0050, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06358677, orgStudyIdInfo id: HCI171997, briefTitle: Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer, acronym: FACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2029-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment.Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact., conditionsModule conditions: Metastatic Colon Cancer, conditions: Metastatic Rectum Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in metastatic colorectal cancer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Topical Tretinoin, interventions name: Placebo, outcomesModule primaryOutcomes measure: The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment., secondaryOutcomes measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntsman Cancer Institute at University of Utah, city: Salt Lake City, state: Utah, zip: 84112, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
protocolSection identificationModule nctId: NCT06358664, orgStudyIdInfo id: Caffeine Vitrectomy, briefTitle: Caffeine and Cataract After Pars Plana Vitrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Pars plana vitrectomy, outcomesModule primaryOutcomes measure: Significant cataract formation at year 1, secondaryOutcomes measure: Significant cataract formation at month 6, secondaryOutcomes measure: Distance corrected visual acuity (DCVA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, status: RECRUITING, city: Vienna, zip: 1140, country: Austria, contacts name: Andreas Schlatter, MD, role: CONTACT, phone: +4391021, phoneExt: 57564, email: office@viros.at, contacts name: Christoph Leisser, MMD, role: CONTACT, phone: +4391021, phoneExt: 57564, email: office@viros.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False