hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06330493, orgStudyIdInfo id: AcoArt BTK Global Trial, briefTitle: AcoArt Litos PCB Below-the-knee Global Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Acotec Scientific Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5), conditionsModule conditions: Chronic Limb-Threatening Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: PCB, interventions name: PTA, outcomesModule primaryOutcomes measure: Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency, primaryOutcomes measure: Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death), secondaryOutcomes measure: Composite of Limb Salvage and Primary Patency, secondaryOutcomes measure: Patency rate, secondaryOutcomes measure: Freedom from CD-TLR, secondaryOutcomes measure: Re-occlusion rate of target lesion, secondaryOutcomes measure: Rate of Major adverse events(MAE), secondaryOutcomes measure: Rate of target limb major amputation, secondaryOutcomes measure: Rate of all-cause death, secondaryOutcomes measure: Amputation free survival rate, secondaryOutcomes measure: Change in ankle-brachial index(ABI), secondaryOutcomes measure: Change in toe-brachial index(TBI), secondaryOutcomes measure: Change in Rutherford category, secondaryOutcomes measure: Change in EQ-5D, secondaryOutcomes measure: Change in VascuQol, secondaryOutcomes measure: Primary sustained clinical improvement, secondaryOutcomes measure: Secondary sustained clinical improvement, secondaryOutcomes measure: Wound healing, secondaryOutcomes measure: Rate of Device Success, secondaryOutcomes measure: Rate of Technical Success, secondaryOutcomes measure: Rate of Procedure Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06330441, orgStudyIdInfo id: MOU-2021-01, briefTitle: Pancreatic Cancer Screening in a Population at High Risk, acronym: ScrePan, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-07, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2028-01-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Masaryk Memorial Cancer Institute, class: OTHER, collaborators name: Masaryk University, descriptionModule briefSummary: Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons"., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, conditions: Hereditary Diseases, conditions: Pancreatitis, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: endoscopic ultrasonography, interventions name: magnetic resonance, interventions name: laboratory examination, outcomesModule primaryOutcomes measure: Number of participants with newly diagnosed pancreatic ductal adenocarcinoma, secondaryOutcomes measure: Methods yield comparison, secondaryOutcomes measure: Screening methods cost-effectiveness, secondaryOutcomes measure: KRAS mutation status evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Masaryk Memorial Cancer Institute, status: RECRUITING, city: Brno, zip: 65653, country: Czechia, contacts name: Martina Lojova, Ph.D., role: CONTACT, phone: +420543136232, email: martina.lojova@mou.cz, contacts name: Dita Kozakova, Ing., role: CONTACT, phone: +420543136236, email: dita.kozakova@mou.cz, contacts name: Petr Karasek, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jana Halamkova, MD, role: SUB_INVESTIGATOR, contacts name: Helena Coupkova, MD, role: SUB_INVESTIGATOR, contacts name: Anna Ondrackova, MD, role: SUB_INVESTIGATOR, contacts name: Marketa Palacova, MD, role: SUB_INVESTIGATOR, contacts name: Radim Nemecek, MD, role: SUB_INVESTIGATOR, contacts name: Lumir Kunovsky, MD, role: SUB_INVESTIGATOR, contacts name: Jan Trna, MD, role: SUB_INVESTIGATOR, contacts name: Lenka Foretova, MD, role: SUB_INVESTIGATOR, contacts name: Zdenka Cermakova, MD, role: SUB_INVESTIGATOR, contacts name: Jan Kristek, MD, role: SUB_INVESTIGATOR, contacts name: Roman Hrstka, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 49.19522, lon: 16.60796, hasResults: False
protocolSection identificationModule nctId: NCT06330428, orgStudyIdInfo id: MU-Ebe-ZDKY-02, briefTitle: Investigation of the Effect of Sexuality-Based Family Planning Education Given to Women Via Podcast on Contraceptive Method Selection and Sexual Life Quality, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-08-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: In this study, it was aimed to examine the effect of Sexuality-Based Family Planning Education given to women of childbearing age via Podcast on contraceptive method selection and sexual life quality.Accordingly, the hypotheses of the study are as follows:Hypotheses of the Project H1: Sexuality-based family planning education via podcast has an effect on women's conscious and appropriate contraceptive method selection.H2: Sexuality-based family planning education via podcast has a positive effect on women's sexual life quality.H3: Sexuality-based family planning education via podcast has a positive effect on the quality of sexual life of women by increasing their level of contraceptive knowledge.H4: Sexuality-based family planning education via podcast has a positive effect on women's attitudes towards family planning., conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One control group, one experimental group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The experimental group will receive sexuality-based family planning education via podcast and outcome assessment will be performed by an investigator who was blinded to group assignment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: Sexuality-Based Family Planning Education via Podcast, outcomesModule primaryOutcomes measure: Contraceptive Knowledge Assessment Scale-Turkish Form, secondaryOutcomes measure: Sexual Quality of Life Scale-Female, otherOutcomes measure: Family Planning Attitudes Scale, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Marmara University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Meltem Demirgöz Bal, role: CONTACT, phone: +905056482983, email: meltemdemirgoz@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06330415, orgStudyIdInfo id: 25603, briefTitle: Effect and Process Evaluation of the SME Tool, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support., conditionsModule conditions: Sick-listed Employees, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 404, type: ESTIMATED, armsInterventionsModule interventions name: The SME tool, outcomesModule primaryOutcomes measure: Satisfaction with the RTW support of employer assessed by the employee, secondaryOutcomes measure: Social support, secondaryOutcomes measure: Total number of sick-leave days, secondaryOutcomes measure: Work performance, secondaryOutcomes measure: Quality of working Life, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Satisfaction with the resumption of work of the respective employee, otherOutcomes measure: Recruitment, otherOutcomes measure: Use of the SME tool, otherOutcomes measure: Perceived usefulness of the SME tool, otherOutcomes measure: Components of the logic model of change, otherOutcomes measure: Experiences, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06330402, orgStudyIdInfo id: N-20220063, briefTitle: Exploration of Gait Biomechanics and Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kristian Kjær Petersen, class: OTHER, descriptionModule briefSummary: This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:* How do gait patterns change during painful walking?* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition)., conditionsModule conditions: Pain, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Hypertonic saline injection, interventions name: Isotonic saline injection, outcomesModule primaryOutcomes measure: Infrared marker XYZ coordinates, primaryOutcomes measure: Pain sensitivity., secondaryOutcomes measure: The Pittsburgh Sleep Quality Index score, secondaryOutcomes measure: The Pain catastrophizing Scale score, secondaryOutcomes measure: The Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Knee symptoms, secondaryOutcomes measure: Ground reaction forces, secondaryOutcomes measure: Ground reaction moments, secondaryOutcomes measure: Ground contact XZ location, secondaryOutcomes measure: Muscle activation, otherOutcomes measure: Pain intensity (NRS 0-10), otherOutcomes measure: Pain distribution, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aalborg University, status: RECRUITING, city: Aalborg, state: Nordjylland, zip: 9000, country: Denmark, contacts name: Kristian K Petersen, Dr. Med, role: CONTACT, phone: (+45) 31697510, email: kkp@hst.aau.dk, contacts name: Emma Hertel, M. Sc., role: CONTACT, phone: (+45) 60887473, email: eh@hst.aau.dk, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
protocolSection identificationModule nctId: NCT06330389, orgStudyIdInfo id: MRC-01-20-1074, briefTitle: Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2021-03-01, completionDateStruct date: 2021-06-25, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, descriptionModule briefSummary: Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic., conditionsModule conditions: SARS-CoV-2 Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Burn Injuries Graft Surgery, outcomesModule primaryOutcomes measure: Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic., secondaryOutcomes measure: Clinical diffreneces between burn injuries with positive vs negative COVID-19 status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HAMAD Medical Corporation- Al Wakra Hospital, city: Doha, zip: 82228, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-05-30, uploadDate: 2021-09-07T14:07, filename: Prot_SAP_000.pdf, size: 273860, hasResults: False
protocolSection identificationModule nctId: NCT06330350, orgStudyIdInfo id: METC 2023-0193, briefTitle: Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals., conditionsModule conditions: Quality of Life, conditions: Ichthyosis, conditions: Palmoplantar Keratoses, conditions: Epidermolysis Bullosa, conditions: Ectodermal Dysplasia, conditions: Basal Cell Nevus Syndrome, conditions: Birt-Hogg-Dube Syndrome, conditions: Tuberous Sclerosis, conditions: Cutis Laxa, conditions: Albinism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Qualitative interview, outcomesModule primaryOutcomes measure: Assessment of perspectives of affected patients + partners and of healthcare professionals concerning reproductive decision-making, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Limburg, zip: 6202 AZ, country: Netherlands, contacts name: Fauve C van Veen, role: CONTACT, phone: +31433877293, email: genodermatose@mumc.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
protocolSection identificationModule nctId: NCT06330324, orgStudyIdInfo id: METC 2023-0182, briefTitle: Reproductive Options in Inherited Skin Diseases, acronym: REPRO-ISD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children.To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe., conditionsModule conditions: Ichthyosis, conditions: Palmoplantar Keratoses, conditions: Epidermolysis Bullosa, conditions: Ectodermal Dysplasia, conditions: Basal Cell Nevus Syndrome, conditions: Birt-Hogg-Dube Syndrome, conditions: Tuberous Sclerosis, conditions: Xeroderma Pigmentosum, conditions: Cutis Laxa, conditions: Albinism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 650, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of clinical outcomes of reproductive options, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, city: Maastricht, state: Limburg, zip: 6202AZ, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
protocolSection identificationModule nctId: NCT06330285, orgStudyIdInfo id: e learning pgme/cpet, briefTitle: Comparison of E-Learning and Face-to-Face Learning in Cardiopulmonary Exercise Test Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, collaborators name: TC Erciyes University, descriptionModule briefSummary: The main purpose of this study is to compare the effect of teaching Cardiopulmonary Exercise Test (CPET) via e-learning and face-to-face to doctors receiving postgraduate medical education (PGME)., conditionsModule conditions: Exercise Test, conditions: Learning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: e-learning, interventions name: face to face learning, outcomesModule primaryOutcomes measure: Open-Ended Achievement Test, primaryOutcomes measure: Adult Motivation Scale, primaryOutcomes measure: Distance Education Attitude Scale in Lifelong Learning, primaryOutcomes measure: Cognitive Flexibility Scale, primaryOutcomes measure: State and Trait Anxiety Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06330272, orgStudyIdInfo id: UCeuma, briefTitle: Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study, acronym: ASHLTDMCS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Meire Coelho Ferreira, class: OTHER, collaborators name: Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão, descriptionModule briefSummary: MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse., conditionsModule conditions: Molar Incisor Hypomineralization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Application of dental mousse based on CPP-ACPF, outcomesModule primaryOutcomes measure: To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Josue Montello, Universidade Ceuma, city: São Luis, state: Maranhão, zip: 65075-120, country: Brazil, geoPoint lat: -2.52972, lon: -44.30278, hasResults: False