hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06328829, orgStudyIdInfo id: IOE Alzheimer, briefTitle: Intermittent Oral Tube in Alzheimer's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Care, interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: Nasogastric tube, outcomesModule primaryOutcomes measure: Concentration of Hemoglobin, primaryOutcomes measure: Concentration of Serum albumin, primaryOutcomes measure: Concentration of Total serum protein, primaryOutcomes measure: Concentration of Serum prealbumin, primaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Pulmonary Infections, secondaryOutcomes measure: Mini Nutritional Assessment, secondaryOutcomes measure: Standardized Swallowing Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06328816, orgStudyIdInfo id: Computer-based Training, briefTitle: Computer-based Training on Cognitive Dysphagia in Stroke Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Computer-assisted Cognitive Function Training, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: The coordination of swallowing, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing reflex, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06328803, orgStudyIdInfo id: Active Breathing Exercises, briefTitle: Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation training, interventions name: Active Breathing Exercises, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Yale Pharyngeal Residue Severity Rating Scale, secondaryOutcomes measure: Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray Secretion Scale, secondaryOutcomes measure: Swallowing Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06328777, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-07, completionDateStruct date: 2029-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cabaletta Bio, class: INDUSTRY, descriptionModule 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, conditionsModule conditions: Systemic Sclerosis, conditions: Scleroderma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: CABA-201, outcomesModule primaryOutcomes measure: To evaluate incidence of adverse events, secondaryOutcomes measure: To evaluate adverse events and laboratory abnormalities, secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To evaluate efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: James St. Clair, role: CONTACT, phone: 734-936-5615, email: ssc-coordinator@umich.edu, contacts name: Neda Kortam, role: CONTACT, phone: 734-763-4866, email: ssc-coordinator@umich.edu, contacts name: Monalisa Ghosh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
protocolSection identificationModule nctId: NCT06328764, orgStudyIdInfo id: CS-101-11, briefTitle: A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: CorrectSequence Therapeutics Co., Ltd, class: INDUSTRY, collaborators name: First Affiliated Hospital of Guangxi Medical University, descriptionModule 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., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: CS-101, outcomesModule primaryOutcomes measure: Frequency and severity of adverse events(AEs）as assessed by CTCAE v5.0, primaryOutcomes measure: Time to neutrophil and platelet engraftment, primaryOutcomes measure: Proportion of subjects with engraftment, primaryOutcomes measure: Incidence of transplant-related mortality, primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months, primaryOutcomes measure: Time to last red blood cell(RBC) transfusion, secondaryOutcomes measure: Change in total hemoglobin(Hb) concentration over time, secondaryOutcomes measure: Change in fetal hemoglobin(HbF) concentration over time, secondaryOutcomes measure: Chimerism level in Peripheral blood and bone marrow, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, country: China, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
protocolSection identificationModule nctId: NCT06328738, orgStudyIdInfo id: ELVN-002-003, briefTitle: ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Enliven Therapeutics, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: HER2-positive Breast Cancer, conditions: HER2-positive Gastric Cancer, conditions: HER2 Positive Solid Tumors, conditions: HER2 Amplification, conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 255, type: ESTIMATED, armsInterventionsModule interventions name: ELVN-002, interventions name: Trastuzumab, interventions name: 5-Fluorouracil, interventions name: Oxaliplatin, interventions name: Capecitabine, interventions name: Eribulin, interventions name: paclitaxel, interventions name: Leucovorin, outcomesModule primaryOutcomes measure: Incidence of dose limiting toxicities (DLTs; Phase 1a only), primaryOutcomes measure: Incidence of adverse events (AEs), primaryOutcomes measure: Incidence of laboratory abnormalities, primaryOutcomes measure: Incidence of electrocardiogram abnormalities, secondaryOutcomes measure: PK parameter of area under the curve of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of maximum concentration of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of minimum concentration of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of terminal half life of ELVN-002 (Phase 1a only), secondaryOutcomes measure: Confirmed objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR; Phase 1b only), secondaryOutcomes measure: Brain metastases response (Phase 1b only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alexander Spira, MD, role: CONTACT, phone: 703-636-1473, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False
protocolSection identificationModule nctId: NCT06328712, orgStudyIdInfo id: EN001_MIRACLE1, briefTitle: Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: ENCell, class: INDUSTRY, descriptionModule 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), conditionsModule conditions: Charcot-Marie-Tooth Disease Type 1A, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: EN001, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration, secondaryOutcomes measure: CMTNSv2 score change, secondaryOutcomes measure: CMT examination score change, secondaryOutcomes measure: Rasch-modified CMTNSv2 score change, secondaryOutcomes measure: Rasch-modified CMTES score change, secondaryOutcomes measure: FDS score change, secondaryOutcomes measure: ONLS score change, secondaryOutcomes measure: 10MWT score change, secondaryOutcomes measure: Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale), secondaryOutcomes measure: Change in Motor Nerve Conduction Velocity (Unit: m/s), secondaryOutcomes measure: Change in Compound Muscle Action Potential (Unit: ㎷), secondaryOutcomes measure: Change in Sensory Nerve Action Potential (Unit: ㎶), secondaryOutcomes measure: Change in Sensory Nerve Conduction Velocity (Unit: m/s), secondaryOutcomes measure: SF-36v2 score change, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Vital sign, secondaryOutcomes measure: Laboratory examination, secondaryOutcomes measure: electrocardiography, secondaryOutcomes measure: X-ray, secondaryOutcomes measure: Physical Examinations, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Byung-Ok Choi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06328673, orgStudyIdInfo id: DM919-001, briefTitle: A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: D2M Biotherapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumorsThe main questions it aims to answer are:What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab??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., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: DM919, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Number of treatment-emergent events (TEAEs) in Dose Escalation, primaryOutcomes measure: RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, otherOutcomes measure: Dose Expansion, otherOutcomes measure: Dose Expansion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78216, country: United States, contacts name: Shiraj Sen, role: CONTACT, phone: 972-893-8800, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06328660, orgStudyIdInfo id: EX-MKTG-155, briefTitle: Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2024-06-18, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Coopervision, Inc., class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Presbyopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Lens 1, interventions name: Lens 2, outcomesModule primaryOutcomes measure: Overall Lens Handling, secondaryOutcomes measure: Overall logMAR Visual Acuity, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ocular Technology Group, city: London, zip: SW1E6AU, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06328647, orgStudyIdInfo id: 24-010, briefTitle: Quantra Point-of-Care Hemostasis Monitoring, acronym: QUANTRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule 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)., conditionsModule conditions: Bleeding, conditions: Hemostatic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Clinical Trial, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 666, type: ESTIMATED, armsInterventionsModule interventions name: POC Quantra QPlus System, interventions name: Routine care, outcomesModule primaryOutcomes measure: Blood and blood component transfusions, secondaryOutcomes measure: Bleeding, otherOutcomes measure: PT/aPTT, otherOutcomes measure: INR, otherOutcomes measure: Platelet, otherOutcomes measure: Fibrinogen, otherOutcomes measure: hematocrit/hemoglobin, otherOutcomes measure: ICU length of stay, otherOutcomes measure: Hospital length of stay., otherOutcomes measure: In-hospital mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06328634, orgStudyIdInfo id: LOCAL/2014/FV-01, briefTitle: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital, statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-01, primaryCompletionDateStruct date: 2012-12-31, completionDateStruct date: 2012-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: OBJECTIVES:We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.METHODS: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., conditionsModule conditions: Bacillus Cereus Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 76, type: ACTUAL, outcomesModule primaryOutcomes measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False