hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06345911, orgStudyIdInfo id: NEU-49/899, briefTitle: Do Vacutainers With Animal Characters Reduce Fear and Anxiety?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2022-02-25, completionDateStruct date: 2022-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters., conditionsModule conditions: Procedural Pain, conditions: Acute Pain, conditions: Fear, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Experimental group, outcomesModule primaryOutcomes measure: Children's Fear Scale, primaryOutcomes measure: Wong-Baker FACES Pain Rating Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Karaman Education and Research Hospital, city: Karaman, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False
protocolSection identificationModule nctId: NCT06345898, orgStudyIdInfo id: 2023-1479, briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2029-12-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002., conditionsModule conditions: X Linked Retinoschisis, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: JWK002, outcomesModule primaryOutcomes measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events), secondaryOutcomes measure: Best corrected visual acuity (BCVA), secondaryOutcomes measure: Full-field electroretinogram(ff-ERG), secondaryOutcomes measure: Macular structure as assessed by swept source optical coherence tomography, secondaryOutcomes measure: Visual field, eligibilityModule sex: MALE, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610023, country: China, contacts name: Licong Liang, role: CONTACT, email: 932968425@qq.com, contacts name: Fang Lu, role: CONTACT, email: lufang@wchscu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06345885, orgStudyIdInfo id: PROPMHP002, briefTitle: Immunogenicity and Safety of One Dose of HPV Vaccine, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-23, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-01-17, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Xiamen Innovax Biotech Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil, conditionsModule conditions: Human Papillomavirus Vaccines, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: HPV vaccine, outcomesModule primaryOutcomes measure: Anti-HPV seropositivity, secondaryOutcomes measure: Anti-HPV Seropositivity, secondaryOutcomes measure: HPV Antibody Titers, secondaryOutcomes measure: Local and Systemic Reactions/Event, eligibilityModule sex: FEMALE, minimumAge: 9 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Fujian Provincial Center for Disease Control and Prevention, city: Fuzhou, state: Fujian, zip: 350012, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
protocolSection identificationModule nctId: NCT06345859, orgStudyIdInfo id: UP-23-00467, secondaryIdInfos id: R01MH133842, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MH133842, briefTitle: Regulation of Affect and Physiology in Depression, acronym: RAPID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: Heart rate variability biofeedback, outcomesModule primaryOutcomes measure: Physiological regulation success, primaryOutcomes measure: Average level of heart rate variability, secondaryOutcomes measure: Perceived regulation success, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 27 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Southern California, status: RECRUITING, city: Los Angeles, state: California, zip: 90089, country: United States, contacts name: Umiemah Farrukh, role: CONTACT, phone: 213-740-4503, email: carlab@usc.edu, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06345846, orgStudyIdInfo id: Secondary IOL, briefTitle: Stability of Secondary Intraocular Lenses With no Capsular Support, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-12-30, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: IFIOL, interventions name: SFIOL, outcomesModule primaryOutcomes measure: Centration of the IOL, secondaryOutcomes measure: Tilt of the IOL, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, city: Vienna, zip: 1140, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06345833, orgStudyIdInfo id: ENT-2024-32847, briefTitle: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date., conditionsModule conditions: Hemophilia, conditions: Hemorrhage, conditions: Facelift Surgery, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 1%Tranexamic acid with standard local, interventions name: 3% TXA, interventions name: 1% TXA with local plus 3% TXA-soaked pledgets, outcomesModule primaryOutcomes measure: Blood loss, secondaryOutcomes measure: adverse effects of TXA rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06345820, orgStudyIdInfo id: Evolux, briefTitle: Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-28, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Comparison of the clinical performance of two enhanced monofocal IOLs with similar design., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Evolux, interventions name: Tecnis Eyhance, outcomesModule primaryOutcomes measure: Monocular intermediate visual acuity, secondaryOutcomes measure: Monocular distance visual acuity, secondaryOutcomes measure: Monocular near visual acuity, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, status: RECRUITING, city: Vienna, zip: 1140, country: Austria, contacts name: Andreas Rotter, MD, role: CONTACT, phone: 01 91021, phoneExt: 57564, email: office@viros.at, contacts name: Manuel Ruiss, MSc, role: CONTACT, phone: 01 91021, phoneExt: 57564, email: office@viros.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06345807, orgStudyIdInfo id: 2023-A02617-38, briefTitle: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation, acronym: APIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Elsan, class: OTHER, descriptionModule briefSummary: The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient., conditionsModule conditions: Individualised Physical Activity Program, conditions: Coronary Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: interventional study, randomized in 3 parallel groups, single center,, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Individuals activity programs, interventions name: activity program, interventions name: no Physical Activity program, outcomesModule primaryOutcomes measure: 6 minutes walk test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06345794, orgStudyIdInfo id: 27111, secondaryIdInfos id: J5C-MC-FOAG, type: OTHER, domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, briefTitle: A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-06-17, completionDateStruct date: 2024-06-17, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, class: INDUSTRY, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: LY4100511 (DC-853), interventions name: Itraconazole, interventions name: Fluconazole, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853), primaryOutcomes measure: PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853), primaryOutcomes measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON San Antonio Clinical Research Unit, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts role: CONTACT, phone: 210-283-4500, contacts name: Chinonye Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06345781, orgStudyIdInfo id: 2174433-1, briefTitle: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Craig Hospital, class: OTHER, collaborators name: Neuroscience Research Australia, descriptionModule briefSummary: The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device., conditionsModule conditions: Spinal Cord Injuries, conditions: Neurogenic Bowel, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal Functional Electrical Stimulation, outcomesModule primaryOutcomes measure: Bowel Management Time (BMT), secondaryOutcomes measure: Bowel Management Strategy, secondaryOutcomes measure: Stimulation Dose, secondaryOutcomes measure: EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire, secondaryOutcomes measure: International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Neurogenic Bladder Symptom Score (NBSS), secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Intervention Safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Craig Hospital, city: Englewood, state: Colorado, zip: 80113, country: United States, geoPoint lat: 39.64777, lon: -104.98776, hasResults: False
protocolSection identificationModule nctId: NCT06345768, orgStudyIdInfo id: 147258369, briefTitle: The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort., conditionsModule conditions: Cholecystitis, conditions: Stress, conditions: Fear, conditions: Comfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Stress Ball, outcomesModule primaryOutcomes measure: Fear of surgery, primaryOutcomes measure: Fear of surgery, primaryOutcomes measure: Comfort, primaryOutcomes measure: Comfort, primaryOutcomes measure: Stress, primaryOutcomes measure: Stress, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False