hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06274788, orgStudyIdInfo id: OMEG-054-CP4, briefTitle: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fresenius Kabi, class: INDUSTRY, descriptionModule briefSummary: This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population, conditionsModule conditions: Parenteral Nutrition Associated Liver Disease (PNALD), conditions: Essential Fatty Acid Deficiency, conditions: Malnutrition, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Omegaven® (fish oil triglycerides) Injectable Emulsion, outcomesModule primaryOutcomes measure: Incidence of essential fatty acid deficiency (EFAD), secondaryOutcomes measure: Incidence of clinical EFAD, secondaryOutcomes measure: Time from treatment start to EFAD diagnosis, secondaryOutcomes measure: Incidence of adverse events (AEs)/serious adverse events (SAEs), secondaryOutcomes measure: Routine laboratory tests: Direct or conjugated bilirubin, secondaryOutcomes measure: Routine laboratory tests: triglycerides, secondaryOutcomes measure: Fatty acid profiles: α-linolenic acid, secondaryOutcomes measure: Fatty acid profiles: linoleic acid, secondaryOutcomes measure: Fatty acid profiles: arachidonic acid, secondaryOutcomes measure: Fatty acid profiles: mead acid, secondaryOutcomes measure: Fatty acid profiles: oleic acid, secondaryOutcomes measure: Fatty acid profiles: docosahexaenoic acid (DHA), secondaryOutcomes measure: Fatty acid profiles: eicosapentaenoic acid (EPA), secondaryOutcomes measure: Anthropometric measures: body weight, secondaryOutcomes measure: Anthropometric measures: body height/length, secondaryOutcomes measure: Anthropometric measures: head circumference, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06274775, orgStudyIdInfo id: 23-12026811, briefTitle: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, descriptionModule briefSummary: The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures., conditionsModule conditions: Anxiety, conditions: Literacy, conditions: Satisfaction, Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Educational Video, outcomesModule primaryOutcomes measure: Anxiety, as measured by the State Trait Anxiety Inventory, primaryOutcomes measure: Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale, primaryOutcomes measure: Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale, primaryOutcomes measure: Health literacy, as measured by 4 domains of The Health Literacy Questionnaire, primaryOutcomes measure: Patient satisfaction, as measured by a patient satisfaction survey, secondaryOutcomes measure: Quality of video intervention for intervention participants, as measured by a qualitative feedback survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Medicine, city: New York, state: New York, zip: 10065, country: United States, contacts name: Shari R. Lipner, MD, PhD, role: CONTACT, email: shl9032@med.cornell.edu, contacts name: Rachel C Hill, BS, role: CONTACT, phone: 5024170984, email: shl9032@med.cornell.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06274762, orgStudyIdInfo id: MARU-SBF-ROKÇ-01, briefTitle: Visually Impaired Women Model-based Cancer Education and Breast Self-examination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination., conditionsModule conditions: Breast Cancer Awareness and BSE in Visually Impaired Women, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Training and BSE application on a model, outcomesModule primaryOutcomes measure: Champion health belief model scale, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University, city: Istanbul, country: Turkey, contacts name: Marmara University, role: CONTACT, email: sevalsaray.demir@gmail.com, contacts name: Seval Saraydemir Kıromeroglu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06274736, orgStudyIdInfo id: CLINP-001012, briefTitle: Safety and Performance of Motiva® Sizers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2027-04-10, completionDateStruct date: 2027-07-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Establishment Labs, class: INDUSTRY, descriptionModule briefSummary: The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook., conditionsModule conditions: Breast Implant; Complications, conditions: Breast Implantation; Methods, Safety and Performance, conditions: Mammaplasty, conditions: Breast Reconstruction, conditions: Breast Augmentation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Motiva Sizer, outcomesModule primaryOutcomes measure: Motiva Sizers Safety (complications), primaryOutcomes measure: Motiva Sizers Performance (satisfaction), secondaryOutcomes measure: Motiva Sizers Safety (reoperations), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Establishment Labs, status: RECRUITING, city: Coyol, state: Alajuela, zip: 20102, country: Costa Rica, geoPoint lat: 10.00126, lon: -84.26124, hasResults: False
protocolSection identificationModule nctId: NCT06274723, orgStudyIdInfo id: STUDY00001220, secondaryIdInfos id: 1K99CA281094-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1, briefTitle: Responses to E-cigarette Message Source and Presentation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape., conditionsModule conditions: Vaping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Expert, interventions name: Peer, interventions name: 1 Sided, interventions name: 2 Sided, outcomesModule primaryOutcomes measure: Message acceptance, primaryOutcomes measure: Harm perceptions, secondaryOutcomes measure: Psychological reactance, secondaryOutcomes measure: Message liking, secondaryOutcomes measure: Source trust, secondaryOutcomes measure: Attitudes, secondaryOutcomes measure: Behavioral intentions to vape or try vaping, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-17, uploadDate: 2024-01-31T10:44, filename: SAP_000.pdf, size: 176839, hasResults: False
protocolSection identificationModule nctId: NCT06274684, orgStudyIdInfo id: 2023-01100, briefTitle: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Geneva, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.The main question it aims to answer:- Is there a significant decrease on anxiety level thanks to VR-assistance?Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.Researchers will compare standardised anxiety scores with a control group., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Use of Virtual Reality Assistance during prostate biopsies, outcomesModule primaryOutcomes measure: Anxiety level, secondaryOutcomes measure: Anxiety level of the surgeon, secondaryOutcomes measure: Biopsies complications, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06274658, orgStudyIdInfo id: STUDY00006517, briefTitle: The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, descriptionModule briefSummary: The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls., conditionsModule conditions: Autonomic Nervous System Disease, conditions: Spinal Cord Injuries, conditions: Cognition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity interval exercise, outcomesModule primaryOutcomes measure: Low frequency of systolic blood pressure variability, primaryOutcomes measure: High frequency of heart rate variability, primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Heart rate, secondaryOutcomes measure: Cerebral blood flow velocity, secondaryOutcomes measure: Symbol Digit Matched Test score, secondaryOutcomes measure: California Verbal Learning Test score, secondaryOutcomes measure: Color-Word Stroop Test score, secondaryOutcomes measure: Controlled Word Association Task score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University at Buffalo, South Campus, status: RECRUITING, city: Buffalo, state: New York, zip: 14214, country: United States, contacts name: Wenjie Ji, role: CONTACT, phone: 716-907-2508, phoneExt: 1, email: wji4@buffalo.edu, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
protocolSection identificationModule nctId: NCT06274645, orgStudyIdInfo id: IVUS CHIP China Registry, briefTitle: IVUS CHIP China Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI., conditionsModule conditions: Complex Higher Risk Indicated Patients Undergoing PCI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2020, type: ESTIMATED, armsInterventionsModule interventions name: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific, outcomesModule primaryOutcomes measure: Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints., secondaryOutcomes measure: Time-to-first-event analysis will be primarily used for clinical endpoints., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan Zhongshan Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Chenguang Li, Doctor, role: CONTACT, email: li.chenguang@zs-hospital.sh.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06274632, orgStudyIdInfo id: 2023P001913, briefTitle: ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Baylor College of Medicine, collaborators name: University of Miami, descriptionModule briefSummary: The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization., conditionsModule conditions: HIV/AIDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ADELANTE, outcomesModule primaryOutcomes measure: 12-month viral suppression, secondaryOutcomes measure: Number of Emergency department visits, secondaryOutcomes measure: Number of Hospitalizations, secondaryOutcomes measure: 6-month viral suppression, secondaryOutcomes measure: Retention in care, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33146, country: United States, contacts name: Allan Rodriguez, MD, role: CONTACT, phone: 305-243-3711, email: arodriguez2@miami.edu, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Baylor College of Medicine, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Thomas P Giordano, MD, role: CONTACT, phone: 713-798-8918, email: tpg@bcm.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06274593, orgStudyIdInfo id: AP_JBD_MJ_003, briefTitle: Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma, acronym: OGA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl)., conditionsModule conditions: Glaucoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: OCT, outcomesModule primaryOutcomes measure: Compare the progression of vascular density (VD) in advanced glaucoma patients., primaryOutcomes measure: Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients., primaryOutcomes measure: Compare the progression of visual field in advanced glaucoma patients., secondaryOutcomes measure: CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jean-Baptiste Ducloyer, city: Nantes, zip: 44093, country: France, contacts name: Jean-Baptiste Ducloyer, MD, role: CONTACT, email: jeanbaptiste.ducloyer@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False