hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06302062, orgStudyIdInfo id: FIT003-001, briefTitle: Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors, acronym: TAL-T, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Guangzhou FineImmune Biotechnology Co., LTD., class: INDUSTRY, descriptionModule briefSummary: A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others., conditionsModule conditions: Advanced Solid Tumor, conditions: Tumor Associated Lymph Node T Cell, conditions: Immunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Associated Lymph node T cell, interventions name: cyclophosphamide, interventions name: IL-2, interventions name: Serplulimab Injection, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: MDT, primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03, secondaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: life quality score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Gaungdong, zip: 510700, country: China, contacts name: Xuzhi Pan, role: CONTACT, phone: 86-020-87343135, email: panxzh@sysucc.org.cn, contacts name: Xiaoshi Zhang, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06302049, orgStudyIdInfo id: 12345, briefTitle: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sadat City University, class: OTHER, descriptionModule briefSummary: The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters., conditionsModule conditions: Fatty Liver Disease, conditions: Steatohepatitis, Nonalcoholic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Esomeprazole, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS), secondaryOutcomes measure: Liver function improvement, secondaryOutcomes measure: Reduction of oxidative stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06302023, orgStudyIdInfo id: HE661462, briefTitle: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm laborThe main questions it aims to answer are:* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day* Group 2 (control) Participant will not need to take a DHA, conditionsModule conditions: Pregnant Women Diagnosed With Threatened Preterm Labor, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Docosahexaenoic acid (DHA) 1000 mg, outcomesModule primaryOutcomes measure: Number of Participants with preterm birth, secondaryOutcomes measure: Rate of low birth weight neonate, secondaryOutcomes measure: Rate of Neonatal Intensive care unit admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06302010, orgStudyIdInfo id: KafkasU3636, briefTitle: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hümeyra TÜLEK DENİZ, class: OTHER, descriptionModule briefSummary: This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST., conditionsModule conditions: Anxiety, conditions: Fetal Conditions, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Stress Ball Intervention, outcomesModule primaryOutcomes measure: Anxiety, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, secondaryOutcomes measure: Fetal well-being, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06301984, orgStudyIdInfo id: ANDROMEDA_01_2023_V1, briefTitle: Safety and Efficacy Evaluation of Insight GS Growing System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: EVEREST PESQUISA E DESENVOLVIMENTO LTDA, class: OTHER, descriptionModule briefSummary: Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events., conditionsModule conditions: Early Onset Scoliosis (EOS), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Insight GS, outcomesModule primaryOutcomes measure: Cobb Angle, secondaryOutcomes measure: Adverse event, secondaryOutcomes measure: Trunk height, secondaryOutcomes measure: Pain, secondaryOutcomes measure: Satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Ortopédico AACD, city: São Paulo, state: SP, zip: 04027-000, country: Brazil, contacts name: Mariana F Goncalves, role: CONTACT, email: mfgoncalves@aacd.org.br, contacts name: Alexandre F Cristante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
protocolSection identificationModule nctId: NCT06301945, orgStudyIdInfo id: Maastro Clinic, secondaryIdInfos id: 72725524, type: OTHER_GRANT, domain: Hanarth Fonds, briefTitle: Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors, acronym: INTHYM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Maastro Clinic, The Netherlands, collaborators name: Hospices Civils de Lyon, descriptionModule briefSummary: Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy., conditionsModule conditions: Thymic Epithelial Tumor, conditions: Thymic Carcinoma, conditions: Thymoma, conditions: Thymoma and Thymic Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1020, type: ESTIMATED, armsInterventionsModule interventions name: Artificial Intelligence Diagnostics, interventions name: Recurrence Prediction Tool, outcomesModule primaryOutcomes measure: WP1 - Databases/Data Pre-processing, secondaryOutcomes measure: WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction, otherOutcomes measure: WP3: Clinical Evaluation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: South Holland, zip: 3015 GD, country: Netherlands, contacts name: Anna Salut Esteve Domínguez, role: CONTACT, email: a.estevedominguez@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
protocolSection identificationModule nctId: NCT06301932, orgStudyIdInfo id: ANE-2562-06771, briefTitle: The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-01-01, primaryCompletionDateStruct date: 2018-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Chiang Mai University, class: OTHER, descriptionModule briefSummary: This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?, conditionsModule conditions: Epidural Analgesia, conditions: Patient Controlled Analgesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 654, type: ACTUAL, armsInterventionsModule interventions name: Open liver resection, outcomesModule primaryOutcomes measure: Post-operative opioid consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06301919, orgStudyIdInfo id: IRBN042024/CHUSTE, briefTitle: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting., conditionsModule conditions: Haemostasis Embolisation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clinical data, interventions name: Imaging data, interventions name: Biological data, outcomesModule primaryOutcomes measure: Evaluation of technical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, secondaryOutcomes measure: Assessment of clinical success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Saint-Etienne, status: RECRUITING, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Rémi Grange, MD, role: CONTACT, phone: (0)477828963, phoneExt: +33, email: remi.grange@chu-st-etienne.fr, contacts name: Sylvain Grange, MD, role: SUB_INVESTIGATOR, contacts name: Rémi Grange, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, hasResults: False
protocolSection identificationModule nctId: NCT06301906, orgStudyIdInfo id: 202301060A3, briefTitle: Red Yeast Rice for Primary Prevention of Hypercholesterolemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota., conditionsModule conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: LipoCol Forte Capsule 600mg bid, outcomesModule primaryOutcomes measure: Low Density Lipoprotein-Cholesterol (LDL-C), secondaryOutcomes measure: 10-Year ASCVD Risk, eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taoyuan branch of Chang Gung Memorial Hospital, status: RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Yueh Hsiang Huang, PhD, role: CONTACT, phone: 886-975360240, email: igighuang@gmail.com, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
protocolSection identificationModule nctId: NCT06301893, orgStudyIdInfo id: US-3_Uganda (IRB#2013-4576), briefTitle: Uganda Sickle Surveillance Study (US-3), statusModule overallStatus: RECRUITING, startDateStruct date: 2013-09-07, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Medical Center, Cincinnati, class: OTHER, collaborators name: Makerere University, collaborators name: Ministry of Health, Uganda, collaborators name: Mulago Hospital, Uganda, descriptionModule briefSummary: It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda., conditionsModule conditions: Sickle Cell Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of HbSS and HbA, secondaryOutcomes measure: Incidence of HbSS and HbA, eligibilityModule sex: ALL, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Makerere University, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Grace Ndeezi, MBChB, MMed, PhD, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, locations facility: Minister of Health, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Jane R. Aceng, MD, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, locations facility: National Coordinator EID Program, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Charles Kiyaga, MBLSM, role: CONTACT, contacts name: Charles Kiyaga, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 0.31628, lon: 32.58219, locations facility: Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Deogratias Manube, MBChB, MMed, role: CONTACT, geoPoint lat: 0.31628, lon: 32.58219, hasResults: False