hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06334133, orgStudyIdInfo id: TTP399-302, briefTitle: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes, acronym: CATT1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: vTv Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Cadisegliatin 800 mg QD, interventions name: Cadisegliatin 800 mg BID, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in incidence of Level 2 or Level 3 hypoglycemia, secondaryOutcomes measure: To assess the change in HbA1c, secondaryOutcomes measure: To assess the effects of treatment on CGM-based metrics for glycemic control, secondaryOutcomes measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis, secondaryOutcomes measure: To assess the effects of treatment on insulin dosing, secondaryOutcomes measure: To assess the effects of treatment on body weight, secondaryOutcomes measure: To assess the incidence of adverse events, otherOutcomes measure: Change in incidence of Level 2 or Level 3 hypoglycemia, otherOutcomes measure: To assess the change in HbA1c, otherOutcomes measure: To assess the effects of treatment on CGM-based metrics for glycemic control, otherOutcomes measure: To assess the incidence of adverse events, otherOutcomes measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis, otherOutcomes measure: To assess the effects of treatment on insulin dosing, otherOutcomes measure: To assess the effects of treatment on body weight, otherOutcomes measure: High sensitivity C-reactive protein, otherOutcomes measure: N-terminal pro brain [or B-type] natriuretic peptide, otherOutcomes measure: Urinary albumin excretion ratio, otherOutcomes measure: Estimated glomerular filtration rate, otherOutcomes measure: Gold hypoglycemia awareness score, otherOutcomes measure: Item 7 of Clarke hypoglycemia awareness scale, otherOutcomes measure: Snyder's 1-item quality of sleep questionnaire, otherOutcomes measure: World Health Organization-5 Well-Being Index, otherOutcomes measure: 8-item Diabetes Distress Scale (participant and partner or family member), otherOutcomes measure: Hypoglycemia Confidence Scale for participant and partner or family member, otherOutcomes measure: 11-item/Short Form Hypoglycemia Fear Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06334094, orgStudyIdInfo id: IRB-23-486, secondaryIdInfos id: IM047-1054, type: OTHER_GRANT, domain: Bristol Myers Squibb, briefTitle: Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: The University of Texas at Dallas, class: OTHER, collaborators name: Texas Institute for Neurological Disorders, descriptionModule briefSummary: The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ozanimod, outcomesModule primaryOutcomes measure: Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance, secondaryOutcomes measure: Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging, secondaryOutcomes measure: Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Brain Health, city: Dallas, state: Texas, zip: 75228, country: United States, contacts name: Jessica Ma, BS, role: CONTACT, phone: 972-883-3414, email: jxm180043@utdallas.edu, contacts name: Ashley M Campos, MA, role: CONTACT, email: amc230006@utdallas.edu, contacts name: Bart Rypma, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
protocolSection identificationModule nctId: NCT06334081, orgStudyIdInfo id: A02040230S, briefTitle: Different Surgical Drilling Protocols in Posterior Maxilla, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants, conditionsModule conditions: Missing Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: undersized drilling technique, interventions name: single drilling technique, outcomesModule primaryOutcomes measure: bone density measurement, primaryOutcomes measure: marginal bone loss, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Heba Elsheikh, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
protocolSection identificationModule nctId: NCT06334055, orgStudyIdInfo id: CIP-1091, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06334042, orgStudyIdInfo id: GO 23/488, briefTitle: Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Oguzhan Kahveci, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit., conditionsModule conditions: Chromium Deficiency, conditions: Diabetes Mellitus, conditions: Hyperlipidemias, conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Serum Chromium Level, outcomesModule primaryOutcomes measure: Serum Chromium Level, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Blood Glucose, secondaryOutcomes measure: Lipid Profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, zip: 06230, country: Turkey, contacts name: Oguzhan Kahveci, MD, role: CONTACT, phone: +903123051207, email: oguzhan.kahveci@hacettepe.edu.tr, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06334003, orgStudyIdInfo id: H-23071266, briefTitle: Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology, acronym: COMPART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Herlev Hospital, descriptionModule briefSummary: The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC., conditionsModule conditions: ART, conditions: IVF, conditions: Children, Only, conditions: Cardiovascular Disease Other, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Offspring body composition, primaryOutcomes measure: Maternal cardiometabolic profile, secondaryOutcomes measure: Epigenetic in placenta and cord blood, secondaryOutcomes measure: Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS), secondaryOutcomes measure: Telomere length in children born after FET, fresh-ET and NC children, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Dept. of Paediatric and Adolescent Medicine, Herlev Hospital, city: Copenhagen, country: Denmark, contacts name: Rikke B. Jensen, MD, Ass. Prof, role: CONTACT, contacts name: Maria L. Vestager, MD, PhD-student, role: CONTACT, email: maria.linander.vestager.01@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06333990, orgStudyIdInfo id: 20220796HU, briefTitle: Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Foundation for Advancing Veterans' Health Research, class: OTHER, collaborators name: The University of Texas Health Science Center at San Antonio, collaborators name: Biomedical Research Institute of New Mexico, descriptionModule briefSummary: A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD)., conditionsModule conditions: Mild Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Quetiapine Fumarate, interventions name: TAU, outcomesModule primaryOutcomes measure: Neurobehavioral Symptom Inventory, primaryOutcomes measure: World Health Organization Disability Assessment Scale, primaryOutcomes measure: World Health Organization Quality of Life BREF, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06333977, orgStudyIdInfo id: LG-GQCL001, briefTitle: A Study of LC542019 in Healthy Subjects and Subjects With T2DM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-25, primaryCompletionDateStruct date: 2023-12-14, completionDateStruct date: 2023-12-14, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: LG Chem, class: INDUSTRY, descriptionModule briefSummary: to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM)., conditionsModule conditions: Healthy, conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: LC542019, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity of adverse events, secondaryOutcomes measure: Maximum Concentration (Cmax) in Plasma, secondaryOutcomes measure: Renal Clearance (CLR) in urine, otherOutcomes measure: Cardiodynamic evaluation, otherOutcomes measure: Fasting Plasma Glucose, otherOutcomes measure: HbA1c, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas), city: Las Vegas, state: Nevada, zip: 89113, country: United States, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False
protocolSection identificationModule nctId: NCT06333938, orgStudyIdInfo id: 01968, briefTitle: Veterans Enhanced Recovery Using Integrative Treatments Around Surgery, acronym: VERITAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Durham VA Medical Center, class: FED, descriptionModule briefSummary: The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA)., conditionsModule conditions: Anesthesia, conditions: Surgery, conditions: Knee Arthropathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bridge, interventions name: BFA, outcomesModule primaryOutcomes measure: Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0, primaryOutcomes measure: Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate., primaryOutcomes measure: Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures., primaryOutcomes measure: Fidelity of Treatment among Patients as assessed by a Fidelity Checklist, primaryOutcomes measure: Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures., primaryOutcomes measure: Fidelity of Treatment among Providers as assessed by a Fidelity Checklist, secondaryOutcomes measure: Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents., secondaryOutcomes measure: Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06333912, orgStudyIdInfo id: ridgesplittingguided, briefTitle: Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-02, primaryCompletionDateStruct date: 2024-01-29, completionDateStruct date: 2024-02-27, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency., conditionsModule conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: dental implant placement with ridge splitting., outcomesModule primaryOutcomes measure: Assessing the accuracy of guided surgery, secondaryOutcomes measure: the bone-width increase between control and study group., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alexandria University, Faculty of dentistry, city: Alexandria, zip: 21619, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
protocolSection identificationModule nctId: NCT06333873, orgStudyIdInfo id: P22-09, briefTitle: Impact of Age-related Macular Degeneration on Daily Living Activitie, acronym: AMDAY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, class: OTHER, descriptionModule briefSummary: The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA), conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: patient-reported outcome, outcomesModule primaryOutcomes measure: Validity of criteria, primaryOutcomes measure: Validity of content, primaryOutcomes measure: Reproducibility of results, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False