hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06313697, orgStudyIdInfo id: GR2102-001, briefTitle: A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-24, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-12-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Genrix (Shanghai) Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。, conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: GR2102 injection, interventions name: placebo, outcomesModule primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Maximum Observed Serum Concentration, secondaryOutcomes measure: Terminal Elimination Half Life, secondaryOutcomes measure: anti-respiratory syncytial virus neutralizing antibodies titer levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Shandong First Medical University, city: Jinan, state: Shandong, zip: 250102, country: China, contacts name: linlin song, MD, role: CONTACT, phone: 18853169334, email: qylcsyllwyh@163.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06313684, orgStudyIdInfo id: Fondecyt 1230787, briefTitle: Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure, acronym: COCREATIONHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Universidad de La Frontera, class: OTHER, collaborators name: University of Chile, descriptionModule briefSummary: CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone., conditionsModule conditions: Heart Failure NYHA Class II, conditions: Heart Failure NYHA Class III, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive Initial Assessment, interventions name: Continuous evaluation, interventions name: Interval Exercise, interventions name: Psychosocial support, interventions name: Diet management, interventions name: Resistance exercise, interventions name: Continuous exercise, interventions name: Initial Assessment, outcomesModule primaryOutcomes measure: Cardiorespiratory fitness, primaryOutcomes measure: Functional capacity, primaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Program adherence and completion, secondaryOutcomes measure: Concentration of Pro-B-type Natriuretic Peptide, secondaryOutcomes measure: Functioning, secondaryOutcomes measure: Mortality and Hospital admission, secondaryOutcomes measure: Upper-body muscle strength, secondaryOutcomes measure: Lower-body muscle strength, secondaryOutcomes measure: Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario San José, city: Santiago, country: Chile, contacts name: Manuel Galvez, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Hospital Clínico Universidad de Chile, city: Santiago, country: Chile, contacts name: Karen Rouliez, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Hospital San Borja Arriarán, city: Santiago, country: Chile, contacts name: Gonzalo Latin, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Universidad de La Frontera, city: Temuco, country: Chile, contacts name: Francisca Contreras, role: CONTACT, geoPoint lat: -38.73965, lon: -72.59842, hasResults: False
protocolSection identificationModule nctId: NCT06313671, orgStudyIdInfo id: Perfusion Index - FR study, briefTitle: Plethysmographic Perfusion Index and Fluid Responsiveness, acronym: PPI-FR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Avicenna Military Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care., conditionsModule conditions: Fluid Responsiveness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Perfusion index, outcomesModule primaryOutcomes measure: Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Avicenna Military Hospital, status: RECRUITING, city: Marrakesh, state: Marrakesh Tensift El Haouz, zip: 40000, country: Morocco, contacts name: Younes Aissaoui, MD, role: CONTACT, phone: +21266140333, email: younes.aissaoui@live.fr, contacts name: Chaimae Abouelkemhe, MD, role: CONTACT, phone: +212694830675, email: chaimaeabouelkemhe@gmail.com, geoPoint lat: 31.63416, lon: -7.99994, hasResults: False
protocolSection identificationModule nctId: NCT06313658, orgStudyIdInfo id: Total BPBI, briefTitle: Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes., conditionsModule conditions: Brachial Plexus Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Total brachial plexus exploration and reconstruction, outcomesModule primaryOutcomes measure: Active Movement Scale (AMS), secondaryOutcomes measure: Al-Qattan pronation/Supination score, secondaryOutcomes measure: Raimondi hand score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University Hospitals, status: RECRUITING, city: Assiut, zip: 71526, country: Egypt, contacts name: Yousif T El-Gammal, MD, role: CONTACT, phone: 5023797500, email: yousif.elgammal@med.aun.edu.eg, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
protocolSection identificationModule nctId: NCT06313632, orgStudyIdInfo id: STUDY-23-01105, briefTitle: Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone., conditionsModule conditions: Pleural Disease, conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple blind study, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine injection, interventions name: Placebo, interventions name: Monitored Anesthesia Care, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS) for Pain, secondaryOutcomes measure: Change in the Numerical Rating Scale, secondaryOutcomes measure: Type of Analgesic use, secondaryOutcomes measure: Number of Analgesic use, secondaryOutcomes measure: Dosage of Analgesic use, secondaryOutcomes measure: Quality of Recovery-15 (QoR-15) Survey Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai West Hospital, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Udit Chaddha, MBBS, role: CONTACT, phone: 212-824-8546, email: udit.chaddha@mssm.edu, contacts name: Udit Chaddha, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06313606, orgStudyIdInfo id: 2047436, briefTitle: Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool., conditionsModule conditions: Dietary Fat Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dietary fat positive control, interventions name: Dietary fat negative control, outcomesModule primaryOutcomes measure: Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Davis School of Medicine, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Sean H. Adams, PhD, role: CONTACT, phone: 916-734-4868, email: shadams@ucdavis.edu, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False
protocolSection identificationModule nctId: NCT06313593, orgStudyIdInfo id: INCB160058-101, briefTitle: A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-14, primaryCompletionDateStruct date: 2027-06-06, completionDateStruct date: 2027-09-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms., conditionsModule conditions: Myeloproliferative Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: INCB160058, outcomesModule primaryOutcomes measure: Number of participants with Dose Limiting Toxicities (DLTs), primaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), primaryOutcomes measure: Number of participants with TEAEs leading to dose modification or discontinuation, secondaryOutcomes measure: INCB160058 pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Response using the revised IWG-MRT and ELN response criteria for MF, secondaryOutcomes measure: Percentage of participants achieving spleen volume reduction as defined in the protocol, secondaryOutcomes measure: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS), secondaryOutcomes measure: Participants with MF with symptomatic anemia: Anemia Response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313580, orgStudyIdInfo id: 22-1055, briefTitle: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Alabama, Tuscaloosa, class: OTHER, collaborators name: McCormick Science Institute, descriptionModule briefSummary: Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites., conditionsModule conditions: Cardiometabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded., whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Yogurt with added Spices, interventions name: Yogurt without added Spices, outcomesModule primaryOutcomes measure: Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate, primaryOutcomes measure: Concentration of serum leptin, primaryOutcomes measure: Concentration of serum ghrelin (pg/mL), primaryOutcomes measure: Concentration of serum peptide tyrosine tyrosine (PYY), eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Alabama, status: RECRUITING, city: Tuscaloosa, state: Alabama, zip: 35487, country: United States, contacts name: Kristi M. Crowe-White, PhD, RD, role: CONTACT, phone: 205-348-6173, email: kcrowe@ches.ua.edu, geoPoint lat: 33.20984, lon: -87.56917, hasResults: False
protocolSection identificationModule nctId: NCT06313567, orgStudyIdInfo id: Meca-GC, briefTitle: Metronomic Capecitabine in Stage III Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2029-03-10, completionDateStruct date: 2029-03-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 722, type: ESTIMATED, armsInterventionsModule interventions name: Metronomic capecitabine, interventions name: Observation, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Dazhi Xu, MD,PHD, role: CONTACT, phone: 021-64175590, email: xudzh@shca.org.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06313554, orgStudyIdInfo id: HMPL-012-SH-ICC101, briefTitle: Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2027-05-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin, outcomesModule primaryOutcomes measure: ORR objective response rate, secondaryOutcomes measure: Progression-Free Survival(PFS), secondaryOutcomes measure: OS overall survival, secondaryOutcomes measure: DCR disease control rate, secondaryOutcomes measure: Adverse events as assessed by NCI CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313541, orgStudyIdInfo id: 2024-Lung-LDRT/SBRT, briefTitle: Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC, conditionsModule conditions: NSCLC Stage IV, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: SBRT or LDRT, interventions name: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy, outcomesModule primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression free survival 2, secondaryOutcomes measure: Treatment-related adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False