hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06293105, orgStudyIdInfo id: MR/T040688/1, briefTitle: Social Responses to Stigma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: Groundswell, collaborators name: Lambeth Service Users Council, collaborators name: Museum of Homelessness, collaborators name: Inclusive Insight, descriptionModule briefSummary: The Social Responses to Stigma study will explore experiences of stigma and discrimination amongst people who are homeless in south London, and then seek to understand how this stigma is created, mediated or mitigated within health, social, housing and legal care and support systems and social contexts.The methodology is an ethnographic case study of the south London care and support system and its social context. The study will use a range of methods for data collection: interviews with people who are homeless, delivery stakeholders, and policy makers; a survey of peoples' experiences; observation within selected care sites; and gathering of documentary sources.The study will be implemented through two parallel studies. The first, with KCL-REMAS approval, will operate in non-NHS sites. The second, with NHS-IRAS approval, will operate in NHS sites. The protocols are aligned with adaptations for each type of site.A linked method to develop theory is cross-case comparison between South London and Vancouver, Canada, through secondary data analysis to linked studies ongoing there. The study will be ongoing from 2022 until January 2025. The project is funded in two phases, with potential to extend the study by a further three years, to January 2028.The results of the study will inform the design of a novel intervention strategy to address the social dimensions of stigma. Subject to additional funding applications, the intervention strategy will be piloted and evaluated from 2025 onwards. The study results will be disseminated through scientific publications, public reports and a range of public and policy engagement activities., conditionsModule conditions: Stigma, Social, conditions: Drug Use, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Qualitative interview, participant observation, outcomesModule primaryOutcomes measure: Experiences of stigma and discrimination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: to Be Determined, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06293092, orgStudyIdInfo id: P.T.REC/012/004008, briefTitle: Effect of Intradialytic Exercises in Chronic Kidney Disease Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-30, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease., conditionsModule conditions: Chronic Kidney Disease stage3, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise, second study group receive medical treatment and intradialytic resistive exercise, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: leg pedaling cycling device, interventions name: sand bags, interventions name: hemodialysis sessions, outcomesModule primaryOutcomes measure: Concentration of immunoglobulin g, primaryOutcomes measure: Total leukocyte count, primaryOutcomes measure: lymphocyte count, primaryOutcomes measure: neutrophil count, primaryOutcomes measure: Concentration of HbA1c, secondaryOutcomes measure: hemoglobin concentration, secondaryOutcomes measure: thrombocytes count, secondaryOutcomes measure: diastolic blood pressure, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: six minute walk test, secondaryOutcomes measure: (KDQOL-SFTM) questionnaire, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fayoum hospital, city: Fayoum, country: Egypt, geoPoint lat: 29.30995, lon: 30.8418, hasResults: False
protocolSection identificationModule nctId: NCT06293066, orgStudyIdInfo id: KCH23-257, briefTitle: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, descriptionModule briefSummary: Primary Objective:To assess whether there is a higher incidence of uninformative ultrasound in black vs white women, conditionsModule conditions: Postmenopausal Bleeding, conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 330, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women, eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suite 8, King's College Hospital, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06293053, orgStudyIdInfo id: PKM17836, secondaryIdInfos id: U1111-1287-7255, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2027-10-28, completionDateStruct date: 2027-11-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.The study consists of 3 periods:* Screening period: 2 to 4 weeks.* Treatment period: 24 weeks.* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).The total number of planned study visits for each participant will be 6., conditionsModule conditions: Prurigo Nodularis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Dupilumab, outcomesModule primaryOutcomes measure: Concentration of dupilumab in serum, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to dupilumab over time, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06293027, orgStudyIdInfo id: IMAGINER FXS, briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Fragile X Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, descriptionModule briefSummary: The objective of this project is to explore the potential of functional near- infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Fragile X Syndrome (FXS) that is still without cure. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With clinical trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. The investigators seek to address this gap by assessing the prognostic reliability of both resting and task- evoked fNIRS. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with FXS; 2. to collect pilot data on individuals with FXS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls., conditionsModule conditions: Fragile X Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Resting-state functional connectivity, primaryOutcomes measure: Amplitude of sensory-evoked hemodynamic responses, secondaryOutcomes measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale., eligibilityModule sex: MALE, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, status: RECRUITING, city: Marina di Pisa-Tirrenia-Calambrone, state: Toscana, zip: 56128, country: Italy, contacts name: Roberta Battini, MD, role: CONTACT, phone: +39 050886282, email: roberta.battini@fsm.unipi.it, contacts name: Laura Baroncelli, PhD, role: CONTACT, phone: +39 050886233, email: laura.baroncelli@fsm.unipi.it, contacts name: Elena Scaffei, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.62719, lon: 10.29204, hasResults: False
protocolSection identificationModule nctId: NCT06293014, orgStudyIdInfo id: QLMA-CRC-IIT-001, briefTitle: TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2026-11-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: TAS-102+bevacizumab, interventions name: Standard chemotherapy+bevacizumab, outcomesModule primaryOutcomes measure: Time to treatment failure (TTF), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university, status: RECRUITING, city: ZhengZhou, state: Henan, zip: 450008, country: China, contacts name: Ying Liu, MD, role: CONTACT, phone: +86-13783604602, email: Yaya7207@126.com, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
protocolSection identificationModule nctId: NCT06292975, orgStudyIdInfo id: RS210 - 326709, briefTitle: Exercise for Improving Radiotherapy Efficacy in Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Hull, class: OTHER, collaborators name: Hull University Teaching Hospitals NHS Trust, descriptionModule briefSummary: This is a single arm feasibility study of exercise for improving short- course neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured aerobic exercises and resistance training in the periods before, during and after their radiotherapy treatment. The patients will be followed up for 6 months post short course neoadjuvant radiotherapy, with a total of 3 assessment periods., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Feasibility study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Supervised Vigorous intensity aerobic interval exercise, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: withdrawal rate, secondaryOutcomes measure: Serum Carcinoembryonic antigen levels, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Physical activity levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06292962, orgStudyIdInfo id: SH-34988389, briefTitle: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain, acronym: VNSDPN, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Saima Abass Tahammal, class: OTHER, collaborators name: Al Ain University, descriptionModule briefSummary: The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes., conditionsModule conditions: Diabetes Mellitus, conditions: Diabetic Neuropathies, conditions: Type2diabetes, conditions: Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: a randomized, double-blinded, sham-controlled, parallel group clinical trial, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 165, type: ACTUAL, armsInterventionsModule interventions name: non-invasive transcutaneous vagal nerve stimulation (tVNS), interventions name: Sham device, outcomesModule primaryOutcomes measure: Neuropathic pain scores, secondaryOutcomes measure: Quality of life score, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shifa Hospital, city: Lahore, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06292910, orgStudyIdInfo id: REC 64-299-1-1, briefTitle: Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery, acronym: VACO2, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-08, primaryCompletionDateStruct date: 2023-12-21, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research, conditionsModule conditions: Congenital Heart Disease, conditions: Perioperative/Postoperative Complications, conditions: Lactate Blood Increase, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 136, type: ACTUAL, armsInterventionsModule interventions name: arterial and central venous blood gas analysis, lactate, outcomesModule primaryOutcomes measure: number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation, secondaryOutcomes measure: ventilator days, secondaryOutcomes measure: inotrope days, secondaryOutcomes measure: length of stay in ICU, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Prince of Songkla University, city: Hat Yai, state: Songkhla, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-05, uploadDate: 2024-02-09T09:23, filename: Prot_SAP_000.pdf, size: 745529, hasResults: False
protocolSection identificationModule nctId: NCT06292897, orgStudyIdInfo id: 3312, briefTitle: Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression, acronym: OBESITA'&PCa, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2026-09-15, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: National Research Council, descriptionModule briefSummary: Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways., conditionsModule conditions: Prostate Cancer, conditions: Prostate Adenocarcinoma, conditions: Prostate Neoplasm, conditions: Prostatic Neoplasm, conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, status: RECRUITING, city: Milan, country: Italy, contacts name: giancarlo albo, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False