hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06322082, orgStudyIdInfo id: 1422024, briefTitle: Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence, acronym: Incontinence, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Khadra Mohamed Ali, class: OTHER, collaborators name: Cairo University, descriptionModule briefSummary: 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment., conditionsModule conditions: Stress Incontinence, Male, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG), outcomesModule primaryOutcomes measure: Cystometry, primaryOutcomes measure: Severity index scale, secondaryOutcomes measure: body mass index, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: faculty of physical therapy, Cairo university, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06322069, orgStudyIdInfo id: 202206260077, briefTitle: The Effect and Mechanism of Self-compassion on Reducing Materialism, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-14, primaryCompletionDateStruct date: 2021-03-03, completionDateStruct date: 2021-03-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Beijing Normal University, class: OTHER, descriptionModule briefSummary: The current study provided an initial investigation of the effect of self-compassion on reducing materialism and explored the basic psychological needs and self-esteem as potential mechanisms. Two studies would be conducted. Study 1 explored the relationships among variables with cross-sectional data, to explore the relationship between self-compassion and materialism, and test the mediating role of basic psychological needs and self-esteem. Study 2 developed a new online self-help self-compassion intervention and conducted a randomized control trial (i.e., intervention group and waitlist group) to further explore the casual effect of self-compassion on materialism, with the mediating effect of basic psychological needs and self-esteem., conditionsModule conditions: Self-Compassion, conditions: Group B, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In study 2, we conducted a randomized control trial, and there are two groups: self-compassion intervention group and waitlist group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 309, type: ACTUAL, armsInterventionsModule interventions name: Self-compassion intervention group, outcomesModule primaryOutcomes measure: Self-compassion, primaryOutcomes measure: Self-Esteem, primaryOutcomes measure: Basic Psychological Needs, primaryOutcomes measure: Materialism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 63 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xianglong Zeng, city: Beijing, state: Beijing, zip: 100875, country: China, geoPoint lat: 39.9075, lon: 116.39723, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-12, uploadDate: 2024-03-12T23:23, filename: Prot_SAP_000.pdf, size: 110133, hasResults: False
protocolSection identificationModule nctId: NCT06322056, orgStudyIdInfo id: 4-2023-1654, briefTitle: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease, acronym: EXCELSIOR-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2029-05-31, completionDateStruct date: 2029-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design., conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 642, type: ESTIMATED, armsInterventionsModule interventions name: Intensive control of SBP and intensive control of LDL-C, interventions name: Intensive control of SBP and standard control of LDL-C, interventions name: Standard control of SBP and intensive control of LDL-C, interventions name: Standard control of SBP and standard control of LDL-C, outcomesModule primaryOutcomes measure: Renal composite outcome, secondaryOutcomes measure: Individual components of renal composite outcome, secondaryOutcomes measure: eGFR slopes, secondaryOutcomes measure: Cardiovascular composite outcome, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance Hospital, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06322043, orgStudyIdInfo id: VM-APFB-1023, briefTitle: Evaluation of Safety of Filler Injection in Subcutaneous Tissues, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Volumina Medical S.A., class: INDUSTRY, descriptionModule briefSummary: Adipearl is an injectable filler intended to be injected subcutaneously., conditionsModule conditions: Volume Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Adipearl, outcomesModule primaryOutcomes measure: Safety of Investigational Medical Device, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Summit Clinic, city: Crans-Montana, country: Switzerland, contacts name: Summit Clinic, role: CONTACT, geoPoint lat: 46.31316, lon: 7.47914, hasResults: False
protocolSection identificationModule nctId: NCT06322030, orgStudyIdInfo id: N4281-R, secondaryIdInfos id: RX004281, type: OTHER_GRANT, domain: VA ORD RR&D, secondaryIdInfos id: PRO0120848, type: OTHER, domain: IRB Approval, briefTitle: Weight Loss and ExeRcise, acronym: EMPOWER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The coordinator will not see group assignment, only a patient number which is entered into a software package., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: FOCUS-15 Lifestyle Management Program, interventions name: Exercise Training, outcomesModule primaryOutcomes measure: Change in distance walk in 6 minute Walk Test, secondaryOutcomes measure: Change in daily step activity, secondaryOutcomes measure: Change in score of Stroke Impact Scale (SIS), secondaryOutcomes measure: Change in score of Sheehan Disability Scale (SDS), secondaryOutcomes measure: Change in score of Inventory of Psychosocial Functioning (IPF), otherOutcomes measure: Change in blood lipid profile, otherOutcomes measure: Change in body composition in Dual-energy x-ray absorptiometry, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ralph H. Johnson VA Medical Center, Charleston, SC, city: Charleston, state: South Carolina, zip: 29401-5703, country: United States, contacts name: R. Amanda C LaRue, PhD, role: CONTACT, phone: 843-789-6707, email: Rutha.Larue@va.gov, contacts name: Thad Abrams, MD, role: CONTACT, phone: (319) 338-0581, phoneExt: 7618, email: thad.abrams@va.gov, contacts name: Chris M Gregory, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
protocolSection identificationModule nctId: NCT06322004, orgStudyIdInfo id: 1718/2022, briefTitle: Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2025-02-05, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: 50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed., conditionsModule conditions: Communication Barriers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Technical Feasibility, primaryOutcomes measure: Usability of video-interpreting, primaryOutcomes measure: Impact on emergency physician's decisions, secondaryOutcomes measure: Demographic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Christina Hafner, DDr., role: CONTACT, email: christina.hafner@meduniwien.ac.at, contacts name: Maike Fink, Dr.med.univ., role: SUB_INVESTIGATOR, contacts name: Christina Hafner, DDr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06321978, orgStudyIdInfo id: MxBFlexUP ESP, briefTitle: Mepilex Border Flex Utilization Pilot Spain, acronym: MxBFlexUPESP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Molnlycke Health Care AB, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency., conditionsModule conditions: Wound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mepilex Border Flex, outcomesModule primaryOutcomes measure: Dressing use, secondaryOutcomes measure: Wound characteristics, secondaryOutcomes measure: Wound management, secondaryOutcomes measure: HCP opinion, secondaryOutcomes measure: Patient Experience, secondaryOutcomes measure: Costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CS Ciudad Expo - Mairena de Aljarafe, status: RECRUITING, city: Sevilla, state: Andalusia, zip: 41927, country: Spain, contacts name: Andrés Roldán Valenzuela, Nurse, role: CONTACT, phone: +34609431073, email: andres.roldan.sspa@juntadeandalucia.es, contacts name: Andrés Roldán Valenzuela, Nurse, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
protocolSection identificationModule nctId: NCT06321952, orgStudyIdInfo id: GTanareesuchoti, briefTitle: Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-17, primaryCompletionDateStruct date: 2023-10-22, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively., conditionsModule conditions: Knee Arthropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: ROSA robotic assist TKA, interventions name: iassist TKA, outcomesModule primaryOutcomes measure: accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Siriraj Hospital, city: Bangkok, zip: 10700, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
protocolSection identificationModule nctId: NCT06321939, orgStudyIdInfo id: NPCNS 001, briefTitle: Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hunan Cancer Hospital, class: OTHER, descriptionModule briefSummary: The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Herpesvirus 4, Human, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EBV-DNA next generation sequencing, outcomesModule primaryOutcomes measure: Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Distant metastasis failure-free survival, secondaryOutcomes measure: Locoregional failure-free survival, secondaryOutcomes measure: Failure-free survival, secondaryOutcomes measure: Patient reported quality-of-life score, secondaryOutcomes measure: Biomarker analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yaqian Han, role: CONTACT, phone: +8618673176667, email: hanyaqiancs@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06321913, orgStudyIdInfo id: CIBI343Y002, briefTitle: Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, collaborators name: Innovent Biologics (Suzhou) Co. Ltd., descriptionModule briefSummary: The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma.The exploratory purpose is to evaluate the correlation between CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy.Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase., conditionsModule conditions: Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: IBI343 combined with IBI308, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: AE, primaryOutcomes measure: Treatment-Emergent Adverse Event (TEAE), primaryOutcomes measure: Adverse Event of Special Interest (AESI), primaryOutcomes measure: Serious Adverse Event (SAE), primaryOutcomes measure: laboratory examinations, primaryOutcomes measure: physical examinations, primaryOutcomes measure: vital signs, secondaryOutcomes measure: PFS, secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Overall Survival (OS), otherOutcomes measure: CLDN18.2 expression level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False