hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06287177, orgStudyIdInfo id: Protocol 28/2023, briefTitle: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy, acronym: CHOLINET, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population, conditionsModule conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Inclisiran, outcomesModule primaryOutcomes measure: Description of adherence to treatment with Inclisiran in a real-life Italian population, primaryOutcomes measure: Description of persistence to treatment with Inclisiran in a real-life Italian population, primaryOutcomes measure: Description of efficacy of treatment with Inclisiran in a real-life Italian population, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Pasquale Perrone Filardi, MD, role: CONTACT, phone: 0817462224, email: fpperron@unina.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
protocolSection identificationModule nctId: NCT06287164, orgStudyIdInfo id: 101, briefTitle: Management of Heart Failure in Italian Outpatients Clinics: Observational Study, acronym: OPTIMA-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: HF treatment adherence according to the most recent European Guidelines, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Pasquale Perrone Filardi, MD, role: CONTACT, phone: 0817462224, email: fpperron@unina.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
protocolSection identificationModule nctId: NCT06287125, orgStudyIdInfo id: Renal assess in SSc and SLE, briefTitle: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.* Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.* Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.* Correlation between detected markers and other assessment tools., conditionsModule conditions: Systemic Sclerosis and Systemic Lupus Erythematous, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147, outcomesModule primaryOutcomes measure: Evaluate serum levels of CD147 in SSc and SLE patients, primaryOutcomes measure: Evaluate renal resistive index in SSC and SLE patients, primaryOutcomes measure: Evaluate Multiparametric MRI in SSC and SLE, secondaryOutcomes measure: Utility of CD 147 in ssc and SLE patients, secondaryOutcomes measure: Utility of renal resistive index in SSC and SLE patients, secondaryOutcomes measure: Utility of Multiparametric MRI in SSC and SLE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06287112, orgStudyIdInfo id: PAC-ETGBD, briefTitle: Prevention of Acute Cholecystitis With ETGBD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2025-02-20, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility., conditionsModule conditions: Biliary Obstruction, conditions: Acute Cholecystitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic transpapillary gallbladder drainage (ETGBD), outcomesModule primaryOutcomes measure: Incidence rate of acute cholecystitis, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06287099, orgStudyIdInfo id: 2023-BRL-101-SCD, briefTitle: Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-10-20, completionDateStruct date: 2026-05-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: Nanfang Hospital, Southern Medical University, descriptionModule briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: BRL-101, outcomesModule primaryOutcomes measure: Proportion of stem cell engrafted subjects, primaryOutcomes measure: Time to neutrophil engraftment, primaryOutcomes measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06287086, orgStudyIdInfo id: 2024-BRL-101-SCD, briefTitle: Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-14, primaryCompletionDateStruct date: 2025-08-20, completionDateStruct date: 2026-06-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: Chinese Academy of Medical Sciences, descriptionModule briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101), conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule interventions name: BRL-101 autologous hematopoietic stem and progenitor cells injection, outcomesModule primaryOutcomes measure: Proportion of stem cell engrafted subjects, primaryOutcomes measure: Time to neutrophil engraftment, primaryOutcomes measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion.., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06287073, orgStudyIdInfo id: 1245-0323, secondaryIdInfos id: EUPAS107293, type: REGISTRY, domain: EU PAS Register, briefTitle: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-08-18, completionDateStruct date: 2025-11-22, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment., conditionsModule conditions: Kidney Disease, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: JARDIANCE®, outcomesModule primaryOutcomes measure: Number of subjects with adverse events, primaryOutcomes measure: Number of subjects with serious adverse event, primaryOutcomes measure: Number of subjects with non-serious adverse events, primaryOutcomes measure: Number of subjects with adverse drug reaction, primaryOutcomes measure: Number of subjects with serious adverse drug reactions, primaryOutcomes measure: Number of subjects with unexpected adverse events, primaryOutcomes measure: Number of subjects with adverse events of special interest, primaryOutcomes measure: Number of subjects with specific adverse events, primaryOutcomes measure: Number of subjects with adverse events leading to temporary or permanent discontinuation, primaryOutcomes measure: Number of subjects with adverse events by intensity, primaryOutcomes measure: Number of subjects with adverse events by outcome of the events, primaryOutcomes measure: Number of subjects with adverse events by causality, primaryOutcomes measure: Number of subjects with adverse events leading to death, secondaryOutcomes measure: Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 03181, country: Korea, Republic of, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 0808802084, email: namhan@bitrialsupport.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06287060, orgStudyIdInfo id: Strawberry extract, briefTitle: Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining, it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity., conditionsModule conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: strawberry extract., outcomesModule primaryOutcomes measure: Bleaching effect of strawberry extract versus Hydrogen peroxide., secondaryOutcomes measure: post operative sensitivity., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06287047, orgStudyIdInfo id: spinal needle sizes and DPE, briefTitle: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-01-31, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications., conditionsModule conditions: Dural Puncture Epidural Technique, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 81, type: ACTUAL, armsInterventionsModule interventions name: Epidural analgesia, outcomesModule primaryOutcomes measure: Onset of analgesia, secondaryOutcomes measure: Degree of analgesia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medidcne, Cairo Univerisity, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06287034, orgStudyIdInfo id: RS1833/23, briefTitle: The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-21, primaryCompletionDateStruct date: 2025-03-21, completionDateStruct date: 2025-09-21, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, descriptionModule briefSummary: Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT), conditionsModule conditions: Larynx Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Primary suture, outcomesModule primaryOutcomes measure: questionnaires for evaluation of the quality of life, secondaryOutcomes measure: Identification of risk factors, secondaryOutcomes measure: Evaluation of swallowing function, secondaryOutcomes measure: Evaluation of vocal rehabilitation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Pellini Raul, Doctor, role: CONTACT, phone: 06-52664484, email: raul.pellini@ifo.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06287021, orgStudyIdInfo id: TRASERBMD2022, briefTitle: Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Permedica spa, class: INDUSTRY, descriptionModule briefSummary: The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up., conditionsModule conditions: Total Hip Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Controlled, randomized, unblinded, multicenter, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Jump System Traser® cup, interventions name: Jump System HAX-Pore® cup, outcomesModule primaryOutcomes measure: BMD - ROI 1, secondaryOutcomes measure: BMD - ROI 2,3,4, secondaryOutcomes measure: Harris hip score, secondaryOutcomes measure: Moore's osseointegration signs, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico San Siro, city: Milan, zip: 20148, country: Italy, contacts name: Matteo Del Re, MD, role: CONTACT, email: matteodelre91@gmail.com, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio, city: Milan, zip: 20161, country: Italy, contacts name: Ricardo Ciliberto, MD, role: CONTACT, email: rciliberto@gmail.com, contacts name: Laura, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06287008, orgStudyIdInfo id: 2023-0085, briefTitle: ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure., conditionsModule conditions: Kidney Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 239, type: ACTUAL, armsInterventionsModule interventions name: robot-assisted kidney transplantation, outcomesModule primaryOutcomes measure: Graft survival, primaryOutcomes measure: renal function, secondaryOutcomes measure: . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False