hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06306365, orgStudyIdInfo id: PI-DOC003-WBOA, briefTitle: Effects of Modern Board Games on Well Being in Older Adults, acronym: JUMEMO3e+, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: European University Miguel de Cervantes, class: OTHER, collaborators name: Centro Doctor Villacián, Valladolid, Spain, descriptionModule briefSummary: The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being., conditionsModule conditions: Executive Functions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: No masking., enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Modern board game-based learning, outcomesModule primaryOutcomes measure: Examination for Mental Disorders of the Elderly, primaryOutcomes measure: Trail Making Test to evaluate Executive Functions, primaryOutcomes measure: Assessment of quality of life in older adults and people with disabilities, primaryOutcomes measure: Psychometric development and practical use, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 120 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European University Miguel of Cervante, status: RECRUITING, city: Valladolid, zip: 47012, country: Spain, contacts name: Azael J. Herrero, PhD, role: CONTACT, phone: +34983001000, email: jaherrero@uemc.es, contacts name: Raquel Martínez-Sinovas, PhD, role: CONTACT, phone: +34983001000, email: rmsinovas@uemc.es, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False
protocolSection identificationModule nctId: NCT06306352, orgStudyIdInfo id: 1070, secondaryIdInfos id: NL82999.091.22, type: OTHER, domain: CCMO, briefTitle: Vibrotactile Feedback in Exoskeletons, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-06, primaryCompletionDateStruct date: 2023-06-21, completionDateStruct date: 2023-06-21, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Sint Maartenskliniek, class: OTHER, collaborators name: ABLE Human Motion S.L., collaborators name: Netherlands Organisation for Scientific Research, descriptionModule briefSummary: This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ACTUAL, armsInterventionsModule interventions name: Vibrotactile feedback, outcomesModule primaryOutcomes measure: Walking distance covered, secondaryOutcomes measure: Reach path ratio, secondaryOutcomes measure: Reach time, secondaryOutcomes measure: User experience questionnaire, secondaryOutcomes measure: Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device, otherOutcomes measure: Dutch System Usability Scale (D-SUS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sint Maartenskliniek, city: Nijmegen, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
protocolSection identificationModule nctId: NCT06306339, orgStudyIdInfo id: hzVSF_v13-0015, briefTitle: A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: ImmuneMed, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA)., conditionsModule conditions: Moderate to Severe Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Burfiralimab, interventions name: SOC (Standard of care), interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12, secondaryOutcomes measure: Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined, secondaryOutcomes measure: Clinical response at Week 12, assessed as remission defined, secondaryOutcomes measure: Improvement of physical function at Week 12, secondaryOutcomes measure: Pain relief at Week 12 assessed by the (mean) change from Baseline, secondaryOutcomes measure: Health-related quality of life at Week 12, assessed as the change from Baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Urtrecht, city: Utrecht, state: GA, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
protocolSection identificationModule nctId: NCT06306326, orgStudyIdInfo id: pkussfatgrafting, briefTitle: 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-12-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis., conditionsModule conditions: Adipocytes, conditions: Autografts, conditions: Imaging, Three-Dimensional / Methods, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: 3dMD technology, outcomesModule primaryOutcomes measure: Fat Retention Rate, secondaryOutcomes measure: Patient Satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306274, orgStudyIdInfo id: TACLE trial, briefTitle: Topical Tacrolimus for Breast Cancer-related Lymphedema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months., conditionsModule conditions: Lymphedema, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus, interventions name: Placebo, outcomesModule primaryOutcomes measure: Lymphedema volume, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Odense University Hospital, city: Odense, zip: 5000, country: Denmark, contacts name: Frederik Gulmark Hansen, role: CONTACT, phone: +4521734450, email: frederik.c.gulmark.hansen@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Zealand University Hospital, city: Roskilde, zip: 4000, country: Denmark, contacts name: Michael Rose, role: CONTACT, geoPoint lat: 55.64152, lon: 12.08035, locations facility: Lillebaelt Hospital, city: Vejle, zip: 4000, country: Denmark, geoPoint lat: 55.70927, lon: 9.5357, hasResults: False
protocolSection identificationModule nctId: NCT06306261, orgStudyIdInfo id: TIMAEUS, briefTitle: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis, acronym: TIMAEUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists., conditionsModule conditions: Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, outcomesModule primaryOutcomes measure: to evaluate mental stress/health as an impacting factor on UC progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Ospedale San Raffaele, city: Milano, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306235, orgStudyIdInfo id: 20.84-reva20.06, briefTitle: Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-12, primaryCompletionDateStruct date: 2021-07-31, completionDateStruct date: 2021-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Jessa Hospital, class: OTHER, descriptionModule briefSummary: Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study).Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation., conditionsModule conditions: Cardiac Rehabilitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Willingness to participate in telerehabilitation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jessa Hospital, city: Hasselt, state: Limburg, zip: 3500, country: Belgium, geoPoint lat: 50.93106, lon: 5.33781, hasResults: False
protocolSection identificationModule nctId: NCT06306222, orgStudyIdInfo id: GR-2021-12375430, briefTitle: Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-11-23, completionDateStruct date: 2026-02-23, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL., conditionsModule conditions: Kidney Stone, conditions: Ureteral Stone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Laser lithotripsy, outcomesModule primaryOutcomes measure: Lithotripsy speed, secondaryOutcomes measure: Stone free rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Alessia D'Arma, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306196, orgStudyIdInfo id: IVI Hecolin S001, briefTitle: Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: International Vaccine Institute, class: OTHER, collaborators name: Xiamen Innovax Biotech Co., Ltd, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals, conditionsModule conditions: Hepatitis E Virus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Single, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 860, type: ESTIMATED, armsInterventionsModule interventions name: Hecolin® Recombinant Hepatitis E Vaccine, interventions name: Isotonic Sodium Chloride injection, outcomesModule primaryOutcomes measure: Seroresponse rate, primaryOutcomes measure: Proportion of immediate adverse events, primaryOutcomes measure: Proportion of solicited local and systemic adverse events, primaryOutcomes measure: Proportion of unsolicited adverse events, primaryOutcomes measure: Proportion of SAEs, MAAEs and AESIs, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR and GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR and GMC of anti-HEV IgG, otherOutcomes measure: SR and GMC of anti-HEV IgG, otherOutcomes measure: Safety in all participants as per gender distribution and serostatus, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306170, orgStudyIdInfo id: GYN-ART, briefTitle: Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART), acronym: GYN-ART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2029-02-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed., conditionsModule conditions: Gynecologic Cancer, conditions: Radiotherapy Side Effect, conditions: Radiotherapy; Complications, conditions: Survivorship, conditions: Progression, Disease, conditions: Progression, Clinical, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Image Guided Radiotherapy, outcomesModule primaryOutcomes measure: Local Relapse Free Survival, primaryOutcomes measure: Regional Relapse Free Survival, primaryOutcomes measure: Distant Metastases Free Survival, primaryOutcomes measure: Disease Free Survival, primaryOutcomes measure: Overall Survival, primaryOutcomes measure: Cancer Specific Survival, secondaryOutcomes measure: Acute toxicity, secondaryOutcomes measure: Late toxicity, otherOutcomes measure: Predictive factors for disease progression and death, otherOutcomes measure: Radiomic predictive factors for disease progression and death, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Raffaele Scientific Institute, status: RECRUITING, city: Milan, state: MI, zip: 20132, country: Italy, contacts name: Andrei Fodor, M.D., role: CONTACT, phone: +390226437634, email: fodor.andrei@hsr.it, contacts name: Nadia G Di Muzio, Prof, role: CONTACT, phone: +390226437643, email: dimuzio.nadia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306118, orgStudyIdInfo id: 35-046 ex 22/23, briefTitle: Autoguide Positioning Device for Multiple Stereotactic Biopsies, acronym: AMB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision., conditionsModule conditions: Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection, outcomesModule primaryOutcomes measure: Biopsy Results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, status: RECRUITING, city: Graz, state: Styria, zip: 8036, country: Austria, contacts name: Stefan Wolfsberger, Prof., role: CONTACT, phone: +43031638583102, email: stefan.wolfsberger@medunigraz.at, geoPoint lat: 47.06667, lon: 15.45, hasResults: False