hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06365840, orgStudyIdInfo id: IMC-001-202, briefTitle: A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor, acronym: TMB-H, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ImmuneOncia Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients., conditionsModule conditions: TMB-H, conditions: Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: IMC-001, outcomesModule primaryOutcomes measure: ORR, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06365827, orgStudyIdInfo id: AZ293/20, briefTitle: Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI), acronym: aMIKI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, descriptionModule briefSummary: Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis., conditionsModule conditions: Cardiac Surgery With Cardiopulmonary Bypass, conditions: Acute Mesenteric Ischemia, conditions: Acute Kidney Injury, conditions: Non-Occlusive Mesenteric Ischaemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: Concentration of I-FABP values with/and without acute mesenteric ischemia, secondaryOutcomes measure: Time interval to mesenteric ischemia, secondaryOutcomes measure: Overall mortality rate, secondaryOutcomes measure: Correlation of I-FABP with biomarkers of acute kidney injury, secondaryOutcomes measure: Association of mesenteric ischemia with hypercoagulable states, otherOutcomes measure: Incidence of stroke, otherOutcomes measure: Association of I-FABP level and multi-organ failure or cardiovascular mortality, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Giessen, Cardiovascular surgery, city: Giessen, state: Hessen, zip: 35392, country: Germany, geoPoint lat: 50.58727, lon: 8.67554, hasResults: False
protocolSection identificationModule nctId: NCT06365814, orgStudyIdInfo id: ERASforNACT, briefTitle: ERAS for Gastric Cancer Patients After NACT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 252, type: ACTUAL, armsInterventionsModule interventions name: enhanced recovery after surgery, interventions name: conventional perioperative management, outcomesModule primaryOutcomes measure: postoperative infectious complications, secondaryOutcomes measure: postoperative recovery parameter, secondaryOutcomes measure: blood test result, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: 3-years recurrence-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, city: Qingdao, state: Shandong, zip: 266000, country: China, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
protocolSection identificationModule nctId: NCT06365801, orgStudyIdInfo id: 2022YFC3500401-IBS, briefTitle: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pain sensitivity, primaryOutcomes measure: Thermal radiation characteristics, primaryOutcomes measure: Microcirculation characteristics, primaryOutcomes measure: Electrical characteristics, primaryOutcomes measure: Biological ultra-weak luminescence, secondaryOutcomes measure: Intestinal flora, secondaryOutcomes measure: Tryptophan metabolites, secondaryOutcomes measure: Bristol Fecal Traits Grading Scale, secondaryOutcomes measure: Severity of IBS (IBS-SSS), secondaryOutcomes measure: IBS Quality of Life (IBS-QOL ), secondaryOutcomes measure: TCM Constitution Survey, secondaryOutcomes measure: Gastrointestinal Symptoms Rating Scale (GSRS), secondaryOutcomes measure: Self-Rating Anxiety Scale (SAS), secondaryOutcomes measure: Self-Rating Depression Scale (SDS), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06365775, orgStudyIdInfo id: TJ-IRB20221229, briefTitle: Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-11-23, completionDateStruct date: 2026-11-23, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Dan Bing, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* to find out which factor from multi-omics data relates to outcomes of SSNHL* to develop the best prognostics model based on the multi-omics data.Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model., conditionsModule conditions: Sudden Sensorineural Hearing Loss, conditions: Hearing Loss, Sensorineural, conditions: Hearing Loss, Sudden, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pure tone audiometry (PTA), secondaryOutcomes measure: Speech reception thresholds, secondaryOutcomes measure: Speech discrimination scores, otherOutcomes measure: Variant detection efficiency, otherOutcomes measure: Exome coverage, otherOutcomes measure: Genome-wide variant distribution, otherOutcomes measure: Head MRI, otherOutcomes measure: Inner Ear MRI, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06365762, orgStudyIdInfo id: CK-0103, briefTitle: The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-01-01, primaryCompletionDateStruct date: 2006-12-31, completionDateStruct date: 2007-04-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Livionex Inc., class: INDUSTRY, descriptionModule briefSummary: The study objectives were:* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s)., conditionsModule conditions: Age Related Cataracts, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: EDTA Ophthalmic Solution 2.6%, interventions name: EDTA Ophthalmic Solution 1.3%, interventions name: Saline Solution (Placebo), outcomesModule primaryOutcomes measure: Contrast Sensitivity (Mesopic) Responder Analysis, secondaryOutcomes measure: Cumulative Improvement in Contrast Sensitivity (Mesopic), otherOutcomes measure: Mean Change in Contrast Sensitivity (Mesopic), otherOutcomes measure: Mean Change in Best-Corrected Visual Acuity (BCVA), otherOutcomes measure: Pentacam Imaging, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Mary's Eye Specialists, Inc., city: San Francisco, state: California, zip: 94117, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Hunkeler Eye Institute, city: Overland Park, state: Kansas, zip: 66210, country: United States, geoPoint lat: 38.98223, lon: -94.67079, locations facility: The Johns Hopkins Hospital & Health System, Wilmer Eye Institute, city: Lutherville, state: Maryland, zip: 21093, country: United States, geoPoint lat: 39.42122, lon: -76.62608, locations facility: Harvard Medical School, Massachusetts Eye and Ear Infirmary, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Charlotte Eye, Ear, Nose, and Throat Associates, city: Charlotte, state: North Carolina, zip: 28210, country: United States, geoPoint lat: 35.22709, lon: -80.84313, locations facility: University of Utah, John Moran Eye Center, city: Salt Lake City, state: Utah, zip: 84132, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
protocolSection identificationModule nctId: NCT06365749, orgStudyIdInfo id: TJ-IRB20221228, briefTitle: Genetic Feature of Congenital Hearing Loss in Chinese Population, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-11-23, completionDateStruct date: 2026-11-23, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Dan Bing, class: OTHER, descriptionModule briefSummary: Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:* to present the genetic characteristics of the infant with hearing loss in the Chinese population* to build up a prognostic model base on diverse data.Participants will be asked to receive audiological tests and collection of the peripheral blood sample., conditionsModule conditions: Congenital Hearing Loss, conditions: Congenital Deafness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Whole exome sequencing data, secondaryOutcomes measure: TEOAE-based otoacoustic emissions test outcome measure, secondaryOutcomes measure: Auditory brainstem response testing, secondaryOutcomes measure: Acoustic impedance, secondaryOutcomes measure: Audiogram, eligibilityModule sex: ALL, maximumAge: 6 Months, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06365710, orgStudyIdInfo id: HUS/206/2022, briefTitle: Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-24, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Töölö Hospital, class: OTHER, descriptionModule briefSummary: Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE)., conditionsModule conditions: Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation, interventions name: Traditional physiotherapy, outcomesModule primaryOutcomes measure: Patient-Rated Wrist Evaluation (PRWE), secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Quick Disabilities of the arm, shoulder, and hand, secondaryOutcomes measure: Pain (Visual Analogue Scale), secondaryOutcomes measure: Wrist range of motion (ROM), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Global improvement, secondaryOutcomes measure: Patient-rated Quality of Life (EQ-5D), secondaryOutcomes measure: Cost-utility analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital, status: RECRUITING, city: Helsinki, state: Uusimaa, zip: 00029, country: Finland, contacts name: Samuli Aspinen, M.D., Ph.D., role: CONTACT, phone: +358406360546, email: samuli.aspinen@hus.fi, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False
protocolSection identificationModule nctId: NCT06365671, orgStudyIdInfo id: ASCT-CART, briefTitle: CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors, conditionsModule conditions: B-NHL, Extranodal, TP53 Alterations, Bulky Mass, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel), outcomesModule primaryOutcomes measure: Best Complete Response (CR) Rate in 3 months, secondaryOutcomes measure: Objective remission rate (ORR) in 3months, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Adverse Events rate as assessed by CTCAE version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06365632, orgStudyIdInfo id: OLTOSPAN-02, briefTitle: Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis, acronym: OLTOSPAN-02, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Research Institute for Physical Chemical Problems of the Belarusian State University, class: OTHER, collaborators name: Unitary Enterprise UNITEHPROM BSU, collaborators name: City Clinical Hospital of Emergency Medical Care of Minsk, descriptionModule briefSummary: The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions., conditionsModule conditions: Abdominal Adhesions, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus, interventions name: antegrade appendectomy, outcomesModule primaryOutcomes measure: Number of patients with acute phlegmonous appendicitis cured, secondaryOutcomes measure: absence of signs of adhesions, otherOutcomes measure: increase in the sliding distance of the cecum, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk, city: Minsk, zip: 220024, country: Belarus, contacts name: Olga Svetlitskaya, role: CONTACT, phone: +375297752697, email: info@bsmp.by, contacts name: Yulia Shabalina, role: CONTACT, phone: +375 (17) 287 00 15, email: info@bsmp.by, geoPoint lat: 53.9, lon: 27.56667, locations facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk, city: Minsk, zip: 220024, country: Belarus, contacts name: Olga Svetlitskaya, role: CONTACT, phone: +375297752697, email: info@bsmp.by, contacts name: Yulia Shabalina, role: CONTACT, phone: +375 (17) 287 00 15, email: info@bsmp.by, contacts name: Stanislav Tretiak, Doctor of Medicine, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexander Zhura, Doctor of Medicine, role: SUB_INVESTIGATOR, geoPoint lat: 53.9, lon: 27.56667, hasResults: False