hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06345157, orgStudyIdInfo id: COMB157GIT02, briefTitle: ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ofatumumab, outcomesModule primaryOutcomes measure: Annualized relapse rate (ARR), secondaryOutcomes measure: Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test), secondaryOutcomes measure: Fatigue Severity Scale [FSS], secondaryOutcomes measure: Quality of life parameters assessed by EQ-5D-3L, secondaryOutcomes measure: Treatment satisfaction assessed by TSQM-9, secondaryOutcomes measure: Expanded Disability Status Scale (EDSS), secondaryOutcomes measure: Variation of NfL in plasma, secondaryOutcomes measure: Adverse Events (AEs), secondaryOutcomes measure: Discontinuation rates due to AE and/or other reasons, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06345144, orgStudyIdInfo id: 202307211RINC, briefTitle: Learning Experience of Undergraduate Nursing Students in Pediatric Oncology Ward, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-22, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards., conditionsModule conditions: Pediatric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Explore the experiences of undergraduate nursing students practicing in pediatric oncology wards., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wei-En Li, status: RECRUITING, city: New Taipei City, country: Taiwan, contacts name: Wei-En Li, role: CONTACT, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False
protocolSection identificationModule nctId: NCT06345131, orgStudyIdInfo id: KY20230829-06, briefTitle: Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy., conditionsModule conditions: Surgical Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Non invasive blood pressure monitoring, outcomesModule primaryOutcomes measure: Measure the transverse diameter of the radial artery at each anatomical point, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: Liu Han, MD, role: CONTACT, phone: 18951670163, email: han_cold.student@sina.com, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-07-22, uploadDate: 2024-02-14T20:25, filename: Prot_ICF_000.pdf, size: 166411, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-22, uploadDate: 2024-03-05T21:35, filename: SAP_001.pdf, size: 300501, hasResults: False
protocolSection identificationModule nctId: NCT06345118, orgStudyIdInfo id: FallpreventT2DMelderly, briefTitle: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus, acronym: FallT2DMOLD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Geriatric Hospital, class: OTHER_GOV, descriptionModule briefSummary: .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients* Evaluate the results of fall prevention and related factors in the study population.Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Fall, conditions: Elderly Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Otago exercise program, outcomesModule primaryOutcomes measure: Physical performance 1 - Timed Up and Go (TUG), primaryOutcomes measure: Physical performance 2 -Berg Balance Scale (BBS), secondaryOutcomes measure: Activities of Daily Living (ADLs), secondaryOutcomes measure: Health-related Quality of Life, secondaryOutcomes measure: Functional Reach Test (FRT), secondaryOutcomes measure: Instrumental Activities of Daily Living (IADLs), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Geriatric Hospital, status: RECRUITING, city: Hanoi, zip: 100000, country: Vietnam, contacts name: Huyen TT Vu, PhD, role: CONTACT, phone: +84913531579, email: vuthanhhuyen11@yahoo.com, geoPoint lat: 21.0245, lon: 105.84117, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-11, uploadDate: 2024-03-13T14:07, filename: ICF_000.pdf, size: 320767, hasResults: False
protocolSection identificationModule nctId: NCT06345105, orgStudyIdInfo id: AIeffectiveV4, briefTitle: Real Time Effective Withdrawal Time and Adenoma Detection Rate, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI, conditionsModule conditions: Colon Polyp, conditions: Colon Adenoma, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Endoscreener QC, outcomesModule primaryOutcomes measure: Adenoma detection rates of the endoscopists, secondaryOutcomes measure: Adenoma detection rate, secondaryOutcomes measure: Polyp detection rate, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Mary Hospital, the University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Thomas Ka Luen Lui, role: CONTACT, phone: +852 97360997, email: tkllui@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06345092, orgStudyIdInfo id: Omfs.3-3-3, briefTitle: Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement, conditionsModule conditions: TMJ Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Vitamin C, interventions name: Injectable platelet rich fibrin, outcomesModule primaryOutcomes measure: Pain management, secondaryOutcomes measure: disc position using MRI, otherOutcomes measure: maximum mouth opening, otherOutcomes measure: lateral excursion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry cairo university, city: Cairo, zip: +2, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06345066, orgStudyIdInfo id: 18834, secondaryIdInfos id: J3R-MC-YDAC, type: OTHER, domain: Eli Lilly And Company, briefTitle: A Study of LY3841136 in Overweight and Obese Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks., conditionsModule conditions: Obesity, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tirzepatide, interventions name: LY3841136, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136, secondaryOutcomes measure: Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117, country: United States, contacts name: Hugh Coleman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.21081, lon: -81.02283, locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Dallas, state: Texas, zip: 75247, country: United States, contacts name: Archie Bowie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Fortrea CRU, Inc., status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, contacts name: Nicholas Siebers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06345014, orgStudyIdInfo id: 23CP40803, briefTitle: The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AJU Pharm Co., Ltd., class: INDUSTRY, collaborators name: OM Pharma SA, descriptionModule briefSummary: This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), conditionsModule conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, conditions: Chronic Prostatitis, conditions: Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 332, type: ESTIMATED, armsInterventionsModule interventions name: OM-89 [Uro-Vaxom® Capsule], interventions name: OM-89 Placebo [Uro-Vaxom® Capsule Placebo], outcomesModule primaryOutcomes measure: NIH-CPSI total score, secondaryOutcomes measure: NIH-CPSI domain score, secondaryOutcomes measure: Subject and Investigator's Global Assessment, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: AJU Pharm Co., Ltd., status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: JUNGMIN LEE, role: CONTACT, phone: +82-02-2630-0700, email: ajuf13001@ajupharm.co.kr, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06344975, orgStudyIdInfo id: Starna Therapeutics, briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults, acronym: STR-V003, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Starna Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: STR-V003/Placebo, outcomesModule primaryOutcomes measure: Immediate unsolicited AEs for 30 minutes post-vaccination, primaryOutcomes measure: Solicited injection site (local) and systemic reactions for 7 days postvaccination., primaryOutcomes measure: Unsolicited AEs for 28 days postvaccination, primaryOutcomes measure: Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06344962, orgStudyIdInfo id: QYFYKYLL930611921, briefTitle: Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem., conditionsModule conditions: Suture, Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Absorbable Suture, interventions name: Non-absorbable Suture, outcomesModule primaryOutcomes measure: Incidence rate of anastomotic complications, secondaryOutcomes measure: Time of bronchial anastomosis, secondaryOutcomes measure: Number of stitches, secondaryOutcomes measure: 5-year survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Affiliated Hospital of Qingdao University, status: RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Zhe Wu, PhD, role: CONTACT, phone: +86 17863934867, email: 17863934867@163.com, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False