hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06328777 id: CAB-201-003 briefTitle: RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-07 date: 2029-07 date: 2024-03-25 date: 2024-04-26 name: Cabaletta Bio class: INDUSTRY briefSummary: RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis conditions: Systemic Sclerosis conditions: Scleroderma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CABA-201 measure: To evaluate incidence of adverse events measure: To evaluate adverse events and laboratory abnormalities measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacokinetics (PK) measure: To evaluate efficacy sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: James St. Clair role: CONTACT phone: 734-936-5615 email: ssc-coordinator@umich.edu name: Neda Kortam role: CONTACT phone: 734-763-4866 email: ssc-coordinator@umich.edu name: Monalisa Ghosh, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
nctId: NCT06328764 id: CS-101-11 briefTitle: A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2026-01-30 date: 2024-03-25 date: 2024-03-25 name: CorrectSequence Therapeutics Co., Ltd class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CS-101 measure: Frequency and severity of adverse events(AEs）as assessed by CTCAE v5.0 measure: Time to neutrophil and platelet engraftment measure: Proportion of subjects with engraftment measure: Incidence of transplant-related mortality measure: All-cause mortality measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months measure: Time to last red blood cell(RBC) transfusion measure: Change in total hemoglobin(Hb) concentration over time measure: Change in fetal hemoglobin(HbF) concentration over time measure: Chimerism level in Peripheral blood and bone marrow sex: ALL minimumAge: 6 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 hasResults: False
nctId: NCT06328738 id: ELVN-002-003 briefTitle: ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2027-01 date: 2028-07 date: 2024-03-25 date: 2024-03-26 name: Enliven Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer. conditions: HER2-positive Breast Cancer conditions: HER2-positive Gastric Cancer conditions: HER2 Positive Solid Tumors conditions: HER2 Amplification conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a will be a dose escalation of ELVN-002 in combination with fixed doses of trastuzumab or trastuzumab + chemotherapy according to the Bayesian Optimal Interval Design model. Phase 1b will be a dose expansion at one or more doses of ELVN-002. primaryPurpose: TREATMENT masking: NONE count: 255 type: ESTIMATED name: ELVN-002 name: Trastuzumab name: 5-Fluorouracil name: Oxaliplatin name: Capecitabine name: Eribulin name: paclitaxel name: Leucovorin measure: Incidence of dose limiting toxicities (DLTs; Phase 1a only) measure: Incidence of adverse events (AEs) measure: Incidence of laboratory abnormalities measure: Incidence of electrocardiogram abnormalities measure: PK parameter of area under the curve of ELVN-002 (Phase 1a only) measure: PK parameter of maximum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of minimum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of terminal half life of ELVN-002 (Phase 1a only) measure: Confirmed objective response rate (ORR) measure: Duration of response (DOR; Phase 1b only) measure: Brain metastases response (Phase 1b only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD role: CONTACT phone: 703-636-1473 lat: 38.84622 lon: -77.30637 hasResults: False
nctId: NCT06328725 id: EN001_POWER briefTitle: Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Duchenne Muscular Dystrophy conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: \<Phase 1 Clinical Trial\> A total of 6-12 participants (3-6 participants per cohort).
\<Phase 2 Clinical Trial\> Experimental Group: Recommended Phase 2 Dose (RP2D) for EN001 / Control Group: Placebo for EN001 whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: EN001 measure: <Phase 1> Adverse drug reactions related to dose limiting toxicity (DLT) measure: <Phase 1> Adverse drug reactions related to discontinuation of clinical trial drug administration measure: <Phase 2> Change in time to stand test (TTSTAND) measure: <Phase 1> Time to stand test (TTSTAND) change amount measure: <Phase 1> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 1> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 1> TTRW velocity (1/TTRW) change amount measure: <Phase 1> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 1> Time to climb 4 steps test (TTCLIMB) change amount measure: <Phase 1> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 1> 6-minute walk test (6MWT) change amount measure: <Phase 1> Changes amount in muscle strength by region measure: <Phase 1> Changes amount in parameters related to pulmonary function measure: <Phase 1> Changes amount in parameters related to cardiac function measure: <Phase 1> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Time to stand test (TTSTAND) change amount measure: <Phase 2> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 2> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 2> TTRW velocity (1/TTRW) change amount measure: <Phase 2> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 2> Time to climb 4 steps test (TTCLIMB) change measure: <Phase 2> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 2> 6-minute walk test (6MWT) change amount measure: <Phase 2> Changes amount in muscle strength by region measure: <Phase 2> Changes amount and rate of change in whole thigh muscle volume and index assessed by MRI measure: <Phase 2> Changes amount in parameters related to pulmonary function measure: <Phase 2> Changes amount in parameters related to cardiac function measure: <Phase 2> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Pediatric Outcomes Data Collection Instrument (PODCI) item score and total score change measure: <Phase 2> Pediatric Quality of Life inventory™ (PedsQL™) item scores and total score change measure: <Phase 1> Adverse Event measure: <Phase 1> Laboratory examination measure: <Phase 1> Vital sign measure: <Phase 2> Adverse Event measure: <Phase 2> Laboratory examination measure: <Phase 2> Vital sign sex: MALE minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: Samsung Medical Center city: Seoul country: Korea, Republic of name: Jeehun Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of name: Jong-Hee Chae role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
nctId: NCT06328712 id: EN001_MIRACLE1 briefTitle: Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A overallStatus: RECRUITING date: 2024-03 date: 2024-10 date: 2024-10 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: An Open, Dose-escalation, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A (CMT1A) conditions: Charcot-Marie-Tooth Disease Type 1A studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: EN001 measure: Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration measure: CMTNSv2 score change measure: CMT examination score change measure: Rasch-modified CMTNSv2 score change measure: Rasch-modified CMTES score change measure: FDS score change measure: ONLS score change measure: 10MWT score change measure: Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale) measure: Change in Motor Nerve Conduction Velocity (Unit: m/s) measure: Change in Compound Muscle Action Potential (Unit: ㎷) measure: Change in Sensory Nerve Action Potential (Unit: ㎶) measure: Change in Sensory Nerve Conduction Velocity (Unit: m/s) measure: SF-36v2 score change measure: Adverse Event measure: Vital sign measure: Laboratory examination measure: electrocardiography measure: X-ray measure: Physical Examinations sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Byung-Ok Choi role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
nctId: NCT06328699 id: STUDY00006456 id: EU6011-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: K01AT010488 type: NIH link: https://reporter.nih.gov/quickSearch/K01AT010488 id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation overallStatus: RECRUITING date: 2023-10-30 date: 2024-05-01 date: 2024-11-15 date: 2024-03-25 date: 2024-04-01 name: Emory University class: OTHER name: National Cancer Institute (NCI) name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation. conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Spiritual Therapy name: Best Practice measure: Feasibility - patient enrollment and treatment-specific retention rates measure: Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT] measure: Acceptability - Chaplain Satisfaction Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Erin Brauer, MPH role: CONTACT email: erin.graf.brauer@emory.edu lat: 33.749 lon: -84.38798 hasResults: False
nctId: NCT06328686 id: STUDY00005787 id: NCI-2023-10895 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00005787 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: WINSHIP5883-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-19 name: Emory University class: OTHER name: National Cancer Institute (NCI) briefSummary: This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy. conditions: Metastatic Malignant Neoplasm in the Brain conditions: Metastatic Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Arginine name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: Spectroscopy name: Whole-Brain Radiotherapy measure: Peak plasma L-arginine (arginine) and arginine metabolite concentration measure: Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy measure: Side effect profile of oral and IV arginine measure: Frontal cortex blood volume/flow changes with L-arginine administration measure: Describe The Immunological Effects of Oral versus IV Arginine measure: Describe The Metabolic Effects of Oral versus IV Arginine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute city: Atlanta state: Georgia zip: 30322 country: United States name: Lisa Sudmeier, MD, PhD role: CONTACT phone: 404-712-9625 email: lsudmei@emory.edu name: Agnes Harutyunyan role: CONTACT email: aharuty@emory.edu name: Lisa Sudmeier, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False
nctId: NCT06328673 id: DM919-001 briefTitle: A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-28 name: D2M Biotherapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumors
Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: DM919 name: Pembrolizumab measure: Number of treatment-emergent events (TEAEs) in Dose Escalation measure: RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab measure: All cohorts measure: All cohorts measure: All cohorts measure: All cohorts measure: Dose Expansion measure: Dose Expansion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78216 country: United States name: Shiraj Sen role: CONTACT phone: 972-893-8800 lat: 29.42412 lon: -98.49363 hasResults: False
nctId: NCT06328660 id: EX-MKTG-155 briefTitle: Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-06-18 date: 2024-06-18 date: 2024-03-25 date: 2024-03-25 name: Coopervision, Inc. class: INDUSTRY briefSummary: The purpose of this study is to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market. conditions: Presbyopia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ACTUAL name: Lens 1 name: Lens 2 measure: Overall Lens Handling measure: Overall logMAR Visual Acuity sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ocular Technology Group city: London zip: SW1E6AU country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
nctId: NCT06328647 id: 24-010 briefTitle: Quantra Point-of-Care Hemostasis Monitoring acronym: QUANTRA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-23 name: The Cleveland Clinic class: OTHER briefSummary: The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion). conditions: Bleeding conditions: Hemostatic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 666 type: ESTIMATED name: POC Quantra QPlus System name: Routine care measure: Blood and blood component transfusions measure: Bleeding measure: PT/aPTT measure: INR measure: Platelet measure: Fibrinogen measure: hematocrit/hemoglobin measure: ICU length of stay measure: Hospital length of stay. measure: In-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06328634 id: LOCAL/2014/FV-01 briefTitle: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital overallStatus: COMPLETED date: 2008-01-01 date: 2012-12-31 date: 2012-12-31 date: 2024-03-25 date: 2024-03-25 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: OBJECTIVES:
We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients. conditions: Bacillus Cereus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 76 type: ACTUAL measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06328621 id: 19594 id: NCI-2021-05881 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19594 type: OTHER domain: City of Hope Medical Center id: P30CA033572 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA033572 briefTitle: Lung Cancer Risk Assessment and Etiology overallStatus: RECRUITING date: 2021-07-02 date: 2029-06-15 date: 2029-06-15 date: 2024-03-25 date: 2024-03-25 name: City of Hope Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer. conditions: Lung Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Electronic Health Record Review name: Survey Administration measure: Frequency of germline alterations measure: Frequency of abnormal radiographic findings measure: Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes measure: Liquid biopsy (LB) test sensitivity measure: LB test specificity measure: LB test positive predictive value measure: LB test negative predictive value measure: LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Stacy W. Gray role: CONTACT phone: 626-218-6639 email: stagray@coh.org name: Stacy W. Gray role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False