hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06263621, orgStudyIdInfo id: 855090, briefTitle: Changing Portion Size Descriptions in a Cafeteria, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2024-05-29, completionDateStruct date: 2024-05-29, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: Restaurant Associates, descriptionModule briefSummary: The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences., conditionsModule conditions: Food Selection, conditions: Obesity, conditions: Weight Gain, conditions: Food Preferences, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Intervention "Standard", outcomesModule primaryOutcomes measure: Average kcal per entree sold, secondaryOutcomes measure: Number of entrée units purchased, secondaryOutcomes measure: Total kcal per transaction, secondaryOutcomes measure: Weekly gross sales, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Courtyard Cafe, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Elements Cafe, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06263595, orgStudyIdInfo id: REB23-1754, briefTitle: Semaglutide and Preoperative Residual Gastric Volumes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Alberta Health services, descriptionModule briefSummary: Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide., conditionsModule conditions: Pulmonary Aspiration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: gastric antral sonography, outcomesModule primaryOutcomes measure: Number of participants presenting with a full stomach, secondaryOutcomes measure: Number of occurrences requiring change in anesthetic management plan, secondaryOutcomes measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume, secondaryOutcomes measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Health Campus, city: Calgary, state: Alberta, zip: T3M 1M4, country: Canada, contacts name: Joanna J Moser, MD, PhD, role: CONTACT, phone: 403-956-3883, email: joanna.moser@ahs.ca, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
protocolSection identificationModule nctId: NCT06263582, orgStudyIdInfo id: IGHID12333, briefTitle: Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants., conditionsModule conditions: Cervix Cancer, conditions: Cervix Intraepithelial Neoplasia Grade 3, conditions: Cervix; Intraepithelial Neoplasia, Grade I, conditions: Cervix; Intraepithelial Neoplasia, Grade II, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Artesunate pessary, interventions name: blood draws for pharmacokinetics of the study drug, outcomesModule primaryOutcomes measure: To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin, secondaryOutcomes measure: To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS), secondaryOutcomes measure: To determine the maximum concentration of Artesunate (AS), secondaryOutcomes measure: To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax), secondaryOutcomes measure: To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days, secondaryOutcomes measure: To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA, secondaryOutcomes measure: To determine the half-life (t1/2) of Artesunate (AS), secondaryOutcomes measure: To determine the half-life (t1/2) of dihydroartemisinin (DHA), secondaryOutcomes measure: To determine the apparent clearance (CL/F) of Artesunate (AS), secondaryOutcomes measure: To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA), secondaryOutcomes measure: To determine the volume of distribution (V/F) of Artesunate (AS), secondaryOutcomes measure: To determine the volume of distribution (V/F) of dihydroartemisinin (DHA), secondaryOutcomes measure: Type, frequency, severity, and duration of adverse events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lumumba Sub-County Hospital, city: Kisumu, country: Kenya, geoPoint lat: -0.10221, lon: 34.76171, hasResults: False
protocolSection identificationModule nctId: NCT06263569, orgStudyIdInfo id: SDB 2023-002, briefTitle: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study, acronym: EAGLE, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-24, primaryCompletionDateStruct date: 2023-05-24, completionDateStruct date: 2023-05-24, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: JointResearch, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial., conditionsModule conditions: Hip Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 156, type: ACTUAL, armsInterventionsModule interventions name: Total hip arthroplasty, outcomesModule primaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline, secondaryOutcomes measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLVG, city: Amsterdam, state: Noord Holland, zip: 1090 HM, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-17, uploadDate: 2024-02-08T10:36, filename: Prot_SAP_000.pdf, size: 949604, hasResults: False
protocolSection identificationModule nctId: NCT06263556, orgStudyIdInfo id: 2023/389, briefTitle: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-11-05, completionDateStruct date: 2024-12-05, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS., conditionsModule conditions: Multiple Sclerosis, conditions: Lower Urinary Tract Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized and assigned to either group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor exercises, interventions name: Transcutaneous posterior tibial nerve stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Incontinence Quality of Life (I-QOL), secondaryOutcomes measure: Post-void residue (PVR), secondaryOutcomes measure: Bladder diary, secondaryOutcomes measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Sibel CAGLAR, role: CONTACT, phone: +905333365651, email: dr.sibelcaglar@gmail.com, contacts name: Arda Can KASAP, role: CONTACT, phone: +905384590119, email: drardakasap@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06263491, orgStudyIdInfo id: 2023-0413, secondaryIdInfos id: NCI-2024-01325, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL., conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Rituximab, interventions name: Pirtobrutinib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Preetesh Jain, MBBS, MD, DM, PhD, role: CONTACT, phone: (713) 563-8786, email: pjain@mdanderson.org, contacts name: Preetesh Jain, MBBS, MD, DM, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06263478, orgStudyIdInfo id: INCA34176-358, briefTitle: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Incyte Biosciences Japan GK, class: INDUSTRY, descriptionModule briefSummary: This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD)., conditionsModule conditions: Chronic Graft-versus-host-disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: INCA034176, outcomesModule primaryOutcomes measure: Overall Response Rate in the First 6 Cycles, secondaryOutcomes measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score, secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Organ-specific Response Rate, secondaryOutcomes measure: Percent reduction in average daily dose (or equivalent) of corticosteroids, secondaryOutcomes measure: Proportion of participants who discontinue corticosteroid use, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Change from baseline in Karnofsky/Lansky performance status, secondaryOutcomes measure: Axatilimab pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Number of Participants with Anti-Drug Antibody (ADA), eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06263465, orgStudyIdInfo id: CALM, briefTitle: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, collaborators name: ZhuHai Hospital, descriptionModule briefSummary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis., conditionsModule conditions: Bacterial Vaginosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Lactobacillus cispatus, interventions name: placebo, outcomesModule primaryOutcomes measure: BV recurrence rate, secondaryOutcomes measure: vaginal secretions 16s rRNA gene sequencing, secondaryOutcomes measure: BV recurrence rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhuhai People'S Hospital, status: RECRUITING, city: Zhuhai, state: Guangdong, zip: 519050, country: China, contacts name: Jingya WU, Doctor, role: CONTACT, phone: +8615902057821, geoPoint lat: 22.27694, lon: 113.56778, hasResults: False
protocolSection identificationModule nctId: NCT06263452, orgStudyIdInfo id: 23-2768, secondaryIdInfos id: 1R01HL157422-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HL157422-01, briefTitle: Beta-Blocker Influences on Inflammatory and Neural Responses to Stress, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: University of California, Los Angeles, collaborators name: Dartmouth College, descriptionModule briefSummary: The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease., conditionsModule conditions: Cardiovascular Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Propranolol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress, primaryOutcomes measure: Change in levels of inflammatory gene expression in response to social stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Social Neuroscience and Health Laboratory, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Keely A Muscatell, PhD, role: CONTACT, phone: 916-495-7661, email: kmuscatell@unc.edu, contacts name: Jessica R Cohen, PhD, role: SUB_INVESTIGATOR, contacts name: Kristen A Lindquist, PhD, role: SUB_INVESTIGATOR, contacts name: Samantha E Meltzer-Brody, MD, MPH, role: SUB_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06263439, orgStudyIdInfo id: RNI 2023 MIRAND, secondaryIdInfos id: 2023-A00585-40, type: OTHER, domain: ANSM, briefTitle: Surveillance of HFMD in Pediatric Outpatients, acronym: PMB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2028-06-20, completionDateStruct date: 2028-06-20, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV., conditionsModule conditions: Hand, Foot and Mouth Disease, conditions: Herpangina, conditions: Enterovirus Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Throat/buccal swab sample, outcomesModule primaryOutcomes measure: Prevalence of different types of Enteroviruses, secondaryOutcomes measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: Lise Laclautre, role: CONTACT, email: promo_interne_drci@chu-clermontferrand.fr, contacts name: Audrey Mirand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False