hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06279910, orgStudyIdInfo id: 2021 36 (EOm), briefTitle: Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19)., acronym: COVIDIOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-03-21, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Complejo Hospitalario Universitario de Albacete, class: OTHER, descriptionModule briefSummary: Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy., conditionsModule conditions: SARS-CoV 2 Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 275, type: ESTIMATED, armsInterventionsModule interventions name: Calcifediol, outcomesModule primaryOutcomes measure: Measure mortality by differentiating groups: calcifediol yes/no., primaryOutcomes measure: Measure the need for ICU admission by differentiating the groups calcifediol yes/no., secondaryOutcomes measure: Measure mortality in relation to baseline 25(OH)D levels, secondaryOutcomes measure: To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency, secondaryOutcomes measure: Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete, status: RECRUITING, city: Albacete, zip: 02008, country: Spain, contacts name: Jose A Blazquez, MD, role: CONTACT, phone: +34967597100, phoneExt: 37214, email: jblazquez@sescam.jccm.es, contacts name: Laura Navarro, MD, role: CONTACT, phone: +34967597460, email: lnavarro@sescam.jccm.es, contacts name: Javier Torres, PhD., role: SUB_INVESTIGATOR, geoPoint lat: 38.99424, lon: -1.85643, locations facility: Maimónides Biomedical Research Institute of Córdoba (IMIBIC)., status: WITHDRAWN, city: Cordoba, zip: 14004, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, hasResults: False
protocolSection identificationModule nctId: NCT06279897, orgStudyIdInfo id: 2023-068, briefTitle: LBNP Tolerance With Skin Warming After Exercise Cold Stress, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-24, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Colorado Springs, class: OTHER, descriptionModule briefSummary: Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold., conditionsModule conditions: Blood Pressure, conditions: Blood Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will complete trial 1 at the beginning of the study. Participants will then complete trials 2 through 5 in a random, counterbalanced order., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants are blinded to the skin temperature control., enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Skin Surface Rewarming, interventions name: Skin Surface Warming, interventions name: Skin Surface Heating, interventions name: Skin Surface Cooling, outcomesModule primaryOutcomes measure: Arterial blood pressure, primaryOutcomes measure: Tolerance to simulated blood loss, secondaryOutcomes measure: Core temperature, secondaryOutcomes measure: Cutaneous Vascular Conductance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Colorado Springs, status: RECRUITING, city: Colorado Springs, state: Colorado, zip: 80918, country: United States, contacts name: James Pearson, PhD, role: CONTACT, phone: 719-255-3806, email: jpearso5@uccs.edu, geoPoint lat: 38.83388, lon: -104.82136, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-01-03, uploadDate: 2024-02-22T15:33, filename: Prot_ICF_000.pdf, size: 315418, hasResults: False
protocolSection identificationModule nctId: NCT06279884, orgStudyIdInfo id: 2023YFC2308802-03, briefTitle: A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.* Establish a monitoring and early warning system for secondary infections., conditionsModule conditions: Liver Transplantation, conditions: Transplant Recipients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Secondary Infections in liver transplant recipients at 4 weeks, primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection, secondaryOutcomes measure: Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection, secondaryOutcomes measure: qSOFA score at 8 weeks, secondaryOutcomes measure: qSOFA score at 12 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06279871, orgStudyIdInfo id: ARCT-2303-01, briefTitle: Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Arcturus Therapeutics, Inc., class: INDUSTRY, collaborators name: Seqirus, collaborators name: Novotech (Australia) Pty Limited, descriptionModule briefSummary: This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: ARCT-2303, interventions name: Influenza vaccine, interventions name: Influenza vaccine, adjuvanted, interventions name: Placebo, outcomesModule primaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, primaryOutcomes measure: SARS-CoV-2 neutralizing antibody seroconversion rates, primaryOutcomes measure: Hemagglutination Inhibition (HI) titers, primaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody seroconversion rates, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a), secondaryOutcomes measure: Hemagglutination Inhibition (HI) titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody responses, secondaryOutcomes measure: Hemagglutination Inhibition (HI) assay titers, secondaryOutcomes measure: Local and systemic adverse events (AEs), secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06279845, orgStudyIdInfo id: 2023YFC2308802-02, briefTitle: A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression., conditionsModule conditions: Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Secondary infection in patients at 4 weeks, primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06279832, orgStudyIdInfo id: 3994, briefTitle: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer., acronym: Romantic, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: trascriptomic profiling, outcomesModule primaryOutcomes measure: Predictive value of the model, secondaryOutcomes measure: Validity of the model, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli IRCSS, status: RECRUITING, city: Rome, state: Lazio, zip: 00118, country: Italy, contacts name: francesco fanfani, role: CONTACT, phone: 0630151, email: francesco.fanfani@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06279819, orgStudyIdInfo id: 2024-008, briefTitle: Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months., conditionsModule conditions: Hiv, conditions: Cardiovascular Diseases, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: gut microbiota-targeted dietary intervention, outcomesModule primaryOutcomes measure: ASCVD risk estimated by the PCE, primaryOutcomes measure: The composition of gut microbiota, secondaryOutcomes measure: fasting blood lipids, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: BMI, secondaryOutcomes measure: ASCVD symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Junwen Yu, role: CONTACT, phone: 13320178333, email: 13320178333@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06279754, orgStudyIdInfo id: ZLXGBXKYXM-031-01, briefTitle: Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2025-12-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xinxiang Medical College, class: OTHER, descriptionModule briefSummary: This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III., conditionsModule conditions: Locally Advanced Squamous Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant Human Endostatin Injection, outcomesModule primaryOutcomes measure: objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06279728, orgStudyIdInfo id: DS1062-0003-EAP-MA, briefTitle: Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Daiichi Sankyo, class: INDUSTRY, collaborators name: AstraZeneca, descriptionModule briefSummary: The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial., conditionsModule conditions: Advanced Non-Small Cell Lung Cancer, conditions: Metastatic Non Small Cell Lung Cancer, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: Datopotamab deruxtecan, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen's Medical Center, status: AVAILABLE, city: Honolulu, state: Hawaii, zip: 96813, country: United States, contacts name: Principal Investigator, role: CONTACT, geoPoint lat: 21.30694, lon: -157.85833, hasResults: False
protocolSection identificationModule nctId: NCT06279715, orgStudyIdInfo id: 3437, briefTitle: DFI and Aneuploidies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Clinique Ovo, class: INDUSTRY, descriptionModule briefSummary: IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes., conditionsModule conditions: Embryo Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Preimplantation Genetic Testing for Aneuploidy, outcomesModule primaryOutcomes measure: DFI association and aneuploidy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinique ovo, city: Montreal, state: Quebec, zip: H4P 2S4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False