hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06351644, orgStudyIdInfo id: STUDY-24-00244, briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2028-06-05, completionDateStruct date: 2028-06-05, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Adriana Rossi, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial., conditionsModule conditions: Relapsed and/or Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ON 123300, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone, primaryOutcomes measure: Phase I: Dose-Limiting Toxicity (DLT) rate, primaryOutcomes measure: Phase II: Overall response rates (ORR), secondaryOutcomes measure: Number of Adverse events of Special Interest (AESI), secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Fasting insulin levels, secondaryOutcomes measure: Lipid profiles, secondaryOutcomes measure: Free fatty acids, secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Progression (TTP), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Health System, city: New York, state: New York, zip: 10029, country: United States, contacts name: Adriana Rossi, MD, role: CONTACT, contacts name: Katherine Vandris, role: CONTACT, email: Katherine.Vandris@mssm.edu, contacts name: Adriana Rossi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06351631, orgStudyIdInfo id: 3543-017, secondaryIdInfos id: 2023-506996-89, type: OTHER, domain: EU CT, secondaryIdInfos id: U1111-1294-8621, type: OTHER, domain: UTN, secondaryIdInfos id: MK-3543-017, type: OTHER, domain: Merck ID, briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-21, primaryCompletionDateStruct date: 2034-12-04, completionDateStruct date: 2034-12-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.No hypothesis testing will be conducted in this study., conditionsModule conditions: Thrombocythemia, Essential, conditions: Primary Myelofibrosis, conditions: Myelofibrosis, conditions: Post-polycythemia Vera Myelofibrosis, conditions: Post-essential Thrombocythemia Myelofibrosis, conditions: Polycythemia Vera, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Bomedemstat, outcomesModule primaryOutcomes measure: Percentage of participants with one or more adverse events (AEs), primaryOutcomes measure: Percentage of participants who discontinued study treatment due to an AE, secondaryOutcomes measure: For participants with ET or PV: Duration of clinicohematologic response, secondaryOutcomes measure: For participants with ET or PV: Duration of hematologic remission, secondaryOutcomes measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML, secondaryOutcomes measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML, secondaryOutcomes measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events, secondaryOutcomes measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events, secondaryOutcomes measure: For participants with MF, ET, or PV: Event-Free Survival (EFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351618, orgStudyIdInfo id: 2023-06114-01, briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Lund University, class: OTHER, descriptionModule briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions., conditionsModule conditions: Sport Injury, conditions: Ice-Skates Accident, conditions: Sports Accident, conditions: Female Athlete Triad, conditions: Female, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: No intervention will be conducted., outcomesModule primaryOutcomes measure: Injuries per 1000 training hours, primaryOutcomes measure: Injuries per 1000 game hours, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 110 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Faculty of Medicine at Lund University, status: RECRUITING, city: Malmö, zip: 20213, country: Sweden, contacts name: Amanda Lahti, role: CONTACT, phone: 0704854798, email: amanda.lahti@med.lu.se, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False
protocolSection identificationModule nctId: NCT06351605, orgStudyIdInfo id: CSP006, briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: LumiThera, Inc., class: INDUSTRY, descriptionModule briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively., conditionsModule conditions: Dry Age-related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Valeda Light Delivery System, outcomesModule primaryOutcomes measure: Best-Corrected Visual Acuity (BCVA), secondaryOutcomes measure: OCT Imaging, secondaryOutcomes measure: FAF Imaging, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Øygunn Utheim, MD, role: CONTACT, phone: +47 93692578, email: outheim@gmail.com, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False
protocolSection identificationModule nctId: NCT06351579, orgStudyIdInfo id: 1010159, briefTitle: Data Collection Post Radical Prostatectomy, acronym: ALTO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Levee Medical, Inc., class: INDUSTRY, collaborators name: RQMplus, descriptionModule briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP., conditionsModule conditions: Stress Urinary Incontinence, conditions: Radical Prostatectomy, conditions: BPH, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Control, outcomesModule primaryOutcomes measure: The change in average 24-hour pad weight over time, secondaryOutcomes measure: Change in pad weight during a 1-hour provocative pad weight test, otherOutcomes measure: Expanded Prostate Index Composite (EPIC-26) score., eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351566, orgStudyIdInfo id: VD3, Prebiotics in Diabetes, briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D3, interventions name: Prebiotics, interventions name: Vitamin D3 placebo, interventions name: Prebiotics placebo, outcomesModule primaryOutcomes measure: Glycated hemoglobin (HbA1c), primaryOutcomes measure: Concentration of blood lipids, primaryOutcomes measure: Metagenomic analysis of the gut microbiota, secondaryOutcomes measure: Concentration of fasting glucose, secondaryOutcomes measure: Concentration of fasting insulin, secondaryOutcomes measure: Systolic and diastolic blood pressure, secondaryOutcomes measure: Estimated glomerular filtration rate (eGFR), secondaryOutcomes measure: Concentration of C-reactive protein (CRP), secondaryOutcomes measure: Concentration of procalcitonin, secondaryOutcomes measure: Concentration of interleukin-6 (IL-6), secondaryOutcomes measure: Concentration of serum 25(OH)D, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351540, orgStudyIdInfo id: IRB00332797, secondaryIdInfos id: R21DA056687, type: NIH, link: https://reporter.nih.gov/quickSearch/R21DA056687, briefTitle: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users., conditionsModule conditions: Cannabis Use, conditions: Impaired Driving, conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: double-blind, placebo-controlled, within-subjects crossover design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: placebo controlled, double-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cannabis, outcomesModule primaryOutcomes measure: Commission Errors, primaryOutcomes measure: Omission Errors, primaryOutcomes measure: Reaction Time, primaryOutcomes measure: Reaction Time Standard Error, primaryOutcomes measure: Visuomotor Index, secondaryOutcomes measure: Saccade Speed, secondaryOutcomes measure: Visually Guided Oculomotor Performance, secondaryOutcomes measure: Antisaccade, secondaryOutcomes measure: Memory-Guided, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Johns Hopkins Behavioral Pharmacology Research Unit, city: Baltimore, state: Maryland, zip: 21224, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06351527, orgStudyIdInfo id: ICP-CL-01202, briefTitle: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2027-06-25, completionDateStruct date: 2027-10-25, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: InnoCare Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies, conditionsModule conditions: Mature B-cell Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ICP-248, outcomesModule primaryOutcomes measure: Maximum tolerated dose and/or recommended Phase 2 dose, primaryOutcomes measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351462, orgStudyIdInfo id: APHP200008, briefTitle: Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients, acronym: TRANSPLANTORN2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The long term burden of morbidity and mortality in the natural history of sickle cell disease has not been compared up to date to the risks and mortality of a curative option like bone marrow transplantation in severe sickle-cell disease patients. Given this lack of data, primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented from a factual debate over the benefit/risk ratio for each patient and refining indications of transplant in patients. Therefore, the present study seeks to describe and compare the very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling transplantation (study arm) and "non-transplant care" for severe sickle cell disease SCA patients in order to yield robust comparative data regarding both arms.The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT) regarding quality of life compared to standard care after 10 years, in patients with severe Sickle Cell Disease (SCD)., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Spermogram, interventions name: Hospital Anxiety and Depression Scale (HADS), interventions name: SF36 Quality of life questionnaire, interventions name: Psychologist interview, interventions name: Optional sera banking, interventions name: Optional DNA banking, outcomesModule primaryOutcomes measure: Evaluation of quality of life assessed by SF36, secondaryOutcomes measure: Evaluation of gonadal function, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Proportion of patients with anxiety and depression, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351449, orgStudyIdInfo id: 69HCL22_0489, briefTitle: Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool, acronym: PatchCam, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®., conditionsModule conditions: Allergic Contact Dermatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: The patch under study is photographed using the SkinCam®, outcomesModule primaryOutcomes measure: To highlight characteristics of allergic contact dermatitis (ACD), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False