hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06335147, orgStudyIdInfo id: HLX10IIT114, briefTitle: PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations, conditionsModule conditions: Metastatic Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, mFOLFOX6, outcomesModule primaryOutcomes measure: pathologic complete response（pCR）, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: 2-year overall survival rate, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06335134, orgStudyIdInfo id: SCW0502-1016, briefTitle: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2024-01-08, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hangzhou Sciwind Biosciences Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: XW003 injection, interventions name: Metformin, interventions name: Warfarin, interventions name: Rosuvastatin, interventions name: Digoxin, outcomesModule primaryOutcomes measure: Pharmacokinetics of metformin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of rosuvastatin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of digoxin: AUC0-inf, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Second University Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Qin Yu, role: CONTACT, phone: 02885503960, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06335121, orgStudyIdInfo id: 21120602, secondaryIdInfos id: 1R01MH134264, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH134264, briefTitle: Implementation of PrEP Care Among Women in Family Planning Clinics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: University of Illinois at Chicago, collaborators name: Planned Parenthood of Illinois, descriptionModule briefSummary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers., conditionsModule conditions: PrEP Uptake, conditions: HIV, conditions: Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: POWER Up strategies -, outcomesModule primaryOutcomes measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP., secondaryOutcomes measure: Receipt of PrEP refills among Black women accessing FP services at 6 months., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06335108, orgStudyIdInfo id: SenoEx_TLA_Maligne, briefTitle: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-05, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery., conditionsModule conditions: Breast Carcinoma, conditions: Breast Carcinoma in Situ, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: General Anaesthesia, interventions name: Local tumescent anaesthesia, outcomesModule primaryOutcomes measure: Postoperative Pain, secondaryOutcomes measure: HRQoL/ Quality of life, secondaryOutcomes measure: Postoperative pain medication requirements, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Drainage delivery rate, secondaryOutcomes measure: Follow-up surgery for R1 situation, secondaryOutcomes measure: Preoperative fear of surgery and anaesthesia, secondaryOutcomes measure: Costs, secondaryOutcomes measure: Satisfaction of the surgeon with the course of the operation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Women's Hospital, status: RECRUITING, city: Tübingen, zip: 72076, country: Germany, contacts name: Bettina Böer, Dr., role: CONTACT, phone: +49 7071 29 82211, email: Bettina.Boeer@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
protocolSection identificationModule nctId: NCT06335069, orgStudyIdInfo id: 2023-508066-15-00, briefTitle: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients., conditionsModule conditions: Breast Cancer, conditions: Breast Neoplasms, conditions: Breast Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-group, single-center pilot study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI, outcomesModule primaryOutcomes measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer., secondaryOutcomes measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center+, city: Maastricht, zip: 5800, country: Netherlands, contacts name: Thiemo JA van Nijnatten, MD, PhD, role: CONTACT, email: thiemo.nijnatten@mumc.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
protocolSection identificationModule nctId: NCT06335056, orgStudyIdInfo id: IRBAM-21-0702, secondaryIdInfos id: 1R15HD108765-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R15HD108765-01A1, briefTitle: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools, acronym: ProudMe, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Louisiana State University and A&M College, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Pennington Biomedical Research Center, collaborators name: Texas A&M University, collaborators name: University of Nevada, Las Vegas, descriptionModule briefSummary: This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost., conditionsModule conditions: Treatment (ProudMe), conditions: Waitlist Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: ProudMe, interventions name: Waitlist Control, outcomesModule primaryOutcomes measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers, primaryOutcomes measure: Screen time, primaryOutcomes measure: Food environment, secondaryOutcomes measure: Body mass index z score, secondaryOutcomes measure: Waist circumference, otherOutcomes measure: Activity self-efficacy, otherOutcomes measure: Self-monitoring, otherOutcomes measure: Social support, otherOutcomes measure: School Wellness Policy, otherOutcomes measure: Cafeteria Nutrition, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: LSU Pedagogical Kinesiology Lab, city: Baton Rouge, state: Louisiana, zip: 70803, country: United States, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False
protocolSection identificationModule nctId: NCT06335004, orgStudyIdInfo id: 926, briefTitle: Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods., conditionsModule conditions: Glymphatic System, conditions: White Matter Disease, conditions: Pediatric Disorder, conditions: Perivascular Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging, outcomesModule primaryOutcomes measure: Extent of white matter lesions, primaryOutcomes measure: Number of perivascular spaces, primaryOutcomes measure: Volume of parasagittal dural space, eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute IRCCS Eugenio Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
protocolSection identificationModule nctId: NCT06334991, orgStudyIdInfo id: QUILT-106, briefTitle: Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: ImmunityBio, Inc., class: INDUSTRY, descriptionModule briefSummary: Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL)., conditionsModule conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study is open label, for Refractory/ Relapsed Non-Hodgkin Lymphoma. Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: CD19 t-haNK, outcomesModule primaryOutcomes measure: Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab, primaryOutcomes measure: Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs., secondaryOutcomes measure: Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06334965, orgStudyIdInfo id: APHP230279, briefTitle: Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort, acronym: OPERANDI-HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Radioembolization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Simultaneous 18F-Choline PET-MRI, outcomesModule primaryOutcomes measure: Clinical response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon hospital, city: Clichy, country: France, contacts name: Mohamed BOUATTOUR, role: CONTACT, geoPoint lat: 48.90018, lon: 2.30952, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: Yann TOUCHEFEU, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
protocolSection identificationModule nctId: NCT06334939, orgStudyIdInfo id: KSH.2023-32, briefTitle: Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ahmet Yuksek, class: OTHER_GOV, descriptionModule briefSummary: Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&amp;#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship., conditionsModule conditions: Emergence Agitation, conditions: Anesthesia Recovery, conditions: Bispectral Index Monitor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bispectal index Monitoring, outcomesModule primaryOutcomes measure: Relationship between BIS SR value and Emergence Agitation, secondaryOutcomes measure: Relationship between average and lowest BIS values and Emergence agitation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli City Hospital, status: RECRUITING, city: Kocaeli, state: Izmıt, zip: 41100, country: Turkey, contacts name: Mehmet Yilmaz, Associate Proffessor, role: CONTACT, phone: 505-217-4432, email: drmyilmaz33@gmail.com, contacts name: Ahmet Yuksek, Md, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False