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protocolSection identificationModule nctId: NCT06280833, orgStudyIdInfo id: 10001884, secondaryIdInfos id: 001884-HG, briefTitle: Care Choreographies and the Making of the Psychosocial in Genetic Counseling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Human Genome Research Institute (NHGRI), class: NIH, descriptionModule briefSummary: Background:Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care.Objective:To observe how genetic counselors at NIH manage the social and psychological aspects of patient care.Eligibility:Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed.Design:An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked.The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks.Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH.Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months., conditionsModule conditions: Genetic Counselor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Care, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 115 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Human Genome Research Institute (NHGRI), status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Sara Hull, Ph.D., role: CONTACT, phone: 301-435-8712, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, hasResults: False |
protocolSection identificationModule nctId: NCT06280820, orgStudyIdInfo id: 10001889, secondaryIdInfos id: 001889-H, briefTitle: Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2034-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Heart, Lung, and Blood Institute (NHLBI), class: NIH, descriptionModule briefSummary: Background:More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.Objective:To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.Eligibility:People aged 18 years and older with heart failure.Design:Participants will be asked to join the study based on a review of their medical records.They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.Researchers will follow the participants health by monitoring their medical records for up to 5 years., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To study the association between multi-omics signatures with all-cause mortality, secondaryOutcomes measure: Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2), secondaryOutcomes measure: To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Heart, Lung and Blood Institute (NHLBI), city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Veronique Roger, M.D., role: CONTACT, phone: 301-402-1715, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, hasResults: False |
protocolSection identificationModule nctId: NCT06280807, orgStudyIdInfo id: 10001617, secondaryIdInfos id: 001617-E, briefTitle: Observation of Environment and Reproductive-Endocrine Effects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2039-03-28, completionDateStruct date: 2039-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Environmental Health Sciences (NIEHS), class: NIH, descriptionModule briefSummary: Background:Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.Objective:To learn how environmental factors may affect the endocrine and reproductive systems.Eligibility:Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.Design:Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest...., conditionsModule conditions: Hypogonadism, conditions: Hypergonadism, conditions: Precocious Puberty, conditions: Late Puberty, conditions: Amenorrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology., secondaryOutcomes measure: the relationship between nutrition, diet and reproduction, secondaryOutcomes measure: the impact of stress on reproductive dysfunction, secondaryOutcomes measure: the influence of behavioral and psychological factors on reproductive function, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NIEHS Clinical Research Unit (CRU), status: RECRUITING, city: Research Triangle Park, state: North Carolina, zip: 27709, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: [email protected], contacts name: NIEHS Join A Study Recruitment Group, role: CONTACT, phone: (855) 696-4347, email: [email protected], geoPoint lat: 35.90567, lon: -78.90497, hasResults: False |
protocolSection identificationModule nctId: NCT06280794, orgStudyIdInfo id: Laser-Bell-2024, briefTitle: Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: Objective:Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.Methods:This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Betahistine Mesylate tablet, Vitamin B1 tablet and Prednisolone.Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24., conditionsModule conditions: Bell's Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 336, type: ACTUAL, armsInterventionsModule interventions name: Laser acupuncture, interventions name: Steroids, outcomesModule primaryOutcomes measure: House Brackmann Grading System (HB), secondaryOutcomes measure: Sunnybrook Facial Grading Scale (SB Grading), secondaryOutcomes measure: Facial Disability Index (FDI), secondaryOutcomes measure: Facial Clinimetric Evaluation Scale (FaCE Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing TongRen Hospital, Capital Medical University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06280781, orgStudyIdInfo id: 22CX7971, secondaryIdInfos id: NIHR152027, type: OTHER_GRANT, domain: National Institute of Health Research - Health Technology Assessment, briefTitle: Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance), acronym: IP9-ATLAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Imperial College Healthcare NHS Trust, class: OTHER, collaborators name: East London NHS Foundation Trust, collaborators name: King's College, collaborators name: University College, London, collaborators name: University of York, collaborators name: University College London Hospitals, descriptionModule briefSummary: The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Current (NICE defined active surveillance):PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually. MRI will be carried out at 12 months (if not had one at diagnosis). A biopsy will be required if indicated due to changes in rectal exam or PSA.Planned (Regular MRI based active surveillance):Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1263, type: ESTIMATED, armsInterventionsModule interventions name: MRI Scans, outcomesModule primaryOutcomes measure: Biopsy, primaryOutcomes measure: Staging, secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Biopsy Measurement, secondaryOutcomes measure: MRI & biopsy-related adverse events, secondaryOutcomes measure: Treatment, secondaryOutcomes measure: Compliance, secondaryOutcomes measure: EPIC Questionnaires, secondaryOutcomes measure: HADS Questionnaires, secondaryOutcomes measure: EQ-5D-5L Questionnaires, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-07, uploadDate: 2024-01-24T08:54, filename: Prot_SAP_000.pdf, size: 1231033, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-07, uploadDate: 2024-01-24T09:01, filename: ICF_001.pdf, size: 286927, hasResults: False |
protocolSection identificationModule nctId: NCT06280768, orgStudyIdInfo id: SHR-2004-102, briefTitle: Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Beijing Suncadia Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: SHR-2004 injection, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (including bleeding events), secondaryOutcomes measure: Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of Dupilumab: Elimination half life (t1/2), secondaryOutcomes measure: PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity, secondaryOutcomes measure: PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT), secondaryOutcomes measure: Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280755, orgStudyIdInfo id: ICO-S-002, briefTitle: Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study., acronym: RECLAIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: icometrix, class: INDUSTRY, collaborators name: Charite University, Berlin, Germany, collaborators name: Ruhr University of Bochum, collaborators name: Technische Universität Dresden, collaborators name: University Hospital, Lille, collaborators name: Casa di Cura IGEA, collaborators name: General University Hospital, Prague, collaborators name: Hoffmann-La Roche, collaborators name: Bristol-Myers Squibb, collaborators name: Imcyse SA, collaborators name: AB Science, collaborators name: Nocturne UG, collaborators name: Aalto University, descriptionModule briefSummary: The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression., conditionsModule conditions: Multiple Sclerosis, conditions: NMO Spectrum Disorder, conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, conditions: Radiologically Isolated Syndrome, conditions: Clinically Isolated Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 7000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The number of patients from each institution who have contributed data to the database., primaryOutcomes measure: The number of patients from each institution whose data was mapped to the common data model of the harmonised database., primaryOutcomes measure: The number of patients from the control arms of clinical trials who have contributed data to the database., primaryOutcomes measure: The data completeness of each variable in the harmonised database., secondaryOutcomes measure: The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level, secondaryOutcomes measure: The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable., secondaryOutcomes measure: The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured)., secondaryOutcomes measure: The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable., secondaryOutcomes measure: The presence of contextual information on standard data gathering and analysis processes of each institution, secondaryOutcomes measure: The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient., secondaryOutcomes measure: The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient., secondaryOutcomes measure: The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines., secondaryOutcomes measure: The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis., secondaryOutcomes measure: The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day., secondaryOutcomes measure: The percentage of patients with a complete disease history available, from the date of diagnosis to the current day., secondaryOutcomes measure: The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280742, orgStudyIdInfo id: APHP221366, briefTitle: Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET), acronym: INFLANET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The Service Hospitalier Frédéric-Joliot (SHFJ) and Paris Brain Institute (ICM) groups have identified \[18F\]-DPA-714 as a promising second-generation TSPO tracer, a macromolecule overexpressed in neuroinflammatory conditions, for PET imaging. They have also developed a non-invasive quantification methodology, enabling the generation of individual neuroinflammation maps in MS patients. Recent findings from \[18F\]-DPA-714 PET imaging in MS patients revealed that most of the white matter lesions contained a smoldering component, even when considered inactive on MRI, and that their neuroinflammatory profiles were associated with longitudinal disability worsening. The Inflanet project aims to leverage a unique consortium comprising French radiochemists, radiopharmacists, nuclear medicine/neuroimaging experts, and MS neurologists to establish the first national network dedicated to \[18F\]-DPA-714 PET imaging in MS, so far limited to monocentric studies.The objectives of the INFLANET project are (1) to conduct the first multicenter study assessing neuroinflammation in patients with active MS using \[18F\]DPA-714 PET tracer, and (2) to establish a methodology suitable for the quantification of multicenter PET data obtained with \[18F\]DPA-714. The INFLANET initiative aims to disseminate TSPO PET within the French MS research community, thereby opening the unique perspective of future large-scale, multicenter studies. These endeavors are expected to enhance our capacity to predict diseases, stratify patients, and assess new therapeutic interventions., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ESTIMATED, armsInterventionsModule interventions name: PET-MRI with [18F]-DPA-714, outcomesModule primaryOutcomes measure: To quantify the smoldering component of white matter lesions in people with MS, as compared with [18F]-DPA-714 binding in the white matter of HC who underwent a PET a acquisition with the same camera camera than patients in each center., secondaryOutcomes measure: To quantify for each patient the regional neuroinflammatory load, measured as [18F]-DPA-714 DVR, in specific regions of interest: total brain, normal appearing white matter, cortex, thalami, deep grey matter., secondaryOutcomes measure: The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Département de Neurologie,Pierre Wertheimer Neurological Hospital, city: Lyon, zip: 69500, country: France, contacts name: Françoise DURAND-DUBIEF, MD, role: CONTACT, phone: 04 72 35 75 22, phoneExt: +33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: CERMEP, city: Lyon, zip: 69677, country: France, contacts name: Françoise DURAND-DUBIEF, MD, role: CONTACT, phone: 04 72 35 75 22, phoneExt: +33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: CIC Neurosciences, GH Pitié-Salpêtrière, city: Paris, zip: 75013, country: France, contacts name: Bruno Stankoff, MD, role: CONTACT, phone: 0171970659, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Centre Eugène Marquis, city: Rennes, zip: 35000, country: France, contacts name: Xavier Palard, MD, role: CONTACT, phone: 02 99 25 30 83, phoneExt: +33, email: [email protected], geoPoint lat: 48.11198, lon: -1.67429, locations facility: Service de Neurologie, CHU Pontchaillou, city: Rennes, zip: 35000, country: France, contacts name: Anne Kerbrat, MD, role: CONTACT, phone: 02 99 28 42 94, phoneExt: +33, email: [email protected], geoPoint lat: 48.11198, lon: -1.67429, hasResults: False |
protocolSection identificationModule nctId: NCT06280729, orgStudyIdInfo id: AI-TRYDIA, briefTitle: AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study, acronym: AI-TRYDIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: AI-Analyis, outcomesModule primaryOutcomes measure: Primary Endpoint, primaryOutcomes measure: Primary Endpoint, primaryOutcomes measure: Primary Endpoint, secondaryOutcomes measure: Exploratory Objectives, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diabetes Research Institute-IRCCS Ospedale San Raffaele, city: Milan, state: Lombardy, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06280716, orgStudyIdInfo id: 18817, secondaryIdInfos id: J2T-MC-KGBW, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-12-17, completionDateStruct date: 2026-11-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 430, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Lebrikizumab, interventions name: Topical Corticosteroid, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort, primaryOutcomes measure: Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wannan Medical College Yijishan Hospital, city: Wuhu, state: Anhui, zip: 241001, country: China, contacts name: Chao Ci, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.33728, lon: 118.37351, locations facility: China-Japan Friendship Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Yong Cui, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Jianzhong Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Children's hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Zigang Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Linfeng Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100091, country: China, contacts name: Wenhui Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tongren Hospital affiliated to Capital Medical University, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Aihua Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tsinghua Changgung Hospital, city: Beijing, state: Beijing, zip: 102202, country: China, contacts name: Yi Zhao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Children's Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, zip: 400065, country: China, contacts name: Hua Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Zhongshan Hospital Fudan University (Xiamen Branch), city: Xiamen, state: Fujian, zip: 361015, country: China, contacts name: Yi Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Guangdong Province Dermatology Hospital, city: Guangzhou, state: Guangdong, zip: 510018, country: China, contacts name: Yunsheng Liang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510180, country: China, contacts name: Jiande han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Children's Hospital, city: Shenzhen, state: Guangdong, zip: 518026, country: China, contacts name: Ping Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Peking University Shenzhen Hospital, city: Shenzhen, state: Guangdong, zip: 518036, country: China, contacts name: Xia Dou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The University of Hong Kong-Shenzhen Hospital, city: Shenzhen, state: Guangdong, zip: 518053, country: China, contacts name: zhenying zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Hainan General Hospital, city: Haikou, state: Hainan, zip: 570311, country: China, contacts name: Ke Han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.04583, lon: 110.34167, locations facility: The First Hospital of Wuhan, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Liuqing Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Nengxing Lin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Renmin Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430060, country: China, contacts name: Tiechi Lei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Children's Hospital, city: Changsha, state: Hunan, zip: 410007, country: China, contacts name: Zhu Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Su Juan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Second Xiangya Hospital of Central South University, city: Changsha, state: Hunan, zip: 410011, country: China, contacts name: Hai Long, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Wuxi No.2 People's Hospital, city: Wuxi, state: Jiangsu, zip: 214000, country: China, contacts name: Xunyi Dai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Affiliated Hospital of Jiangsu University, city: Zhenjiang, state: Jiangsu, zip: 212000, country: China, contacts name: Yumei Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.21086, lon: 119.45508, locations facility: The Second Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Fuqiu Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Shanshan Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xi'An, state: Shaanxi, zip: 710004, country: China, contacts name: Songmei Geng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Huashan Hospital Affiliated Fudan University, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Chaoying Gu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Tenth People's Hospital, city: Shanghai, state: Shanghai, zip: 200072, country: China, contacts name: Jun Gu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Children's Hospital of Shanxi, city: Taiyuan, state: Shanxi, zip: 030013, country: China, contacts name: Xinglian Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.86944, lon: 112.56028, locations facility: West China Hospital, Sichuan University, city: Cheng Du, state: Sichuan, zip: 610041, country: China, contacts name: Xian Jiang, role: PRINCIPAL_INVESTIGATOR, locations facility: Kunming Children's hospital, city: Kunming, state: Yunnan, zip: 650034, country: China, contacts name: Hong Shu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The First Affiliated Hospital, Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Jianjun Qiao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Hangzhou Third People's Hospital, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Aie Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Sir Run Run Shaw Hospital, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Hao Cheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital, city: Yiwu, state: Zhejiang, zip: 322000, country: China, contacts name: Lunfei Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.31506, lon: 120.07676, locations facility: The First Affiliated Hospital Of Fujian Medical University, city: Fuzhou, zip: 350005, country: China, contacts name: Chao JI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Shanghai Skin Disease Hospital, city: Shanghai, zip: 200071, country: China, contacts name: Yuling Shi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Hospital of Hebei Medical University, city: Shijiazhuang, zip: 050031, country: China, contacts name: Guoqiang Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Catholic University of Korea, Incheon St. Mary's Hospital, city: Bupyeong-gu, state: Incheon-gwangyeoksi [Incheon], zip: 21431, country: Korea, Republic of, contacts name: Sang-Hyun Cho, role: PRINCIPAL_INVESTIGATOR, locations facility: Korea University Ansan Hospital, city: Ansan-si, state: Kyǒnggi-do, zip: 15355, country: Korea, Republic of, contacts name: Sang Wook Son, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.32361, lon: 126.82194, locations facility: National Medical Center, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 01812, country: Korea, Republic of, contacts name: JiYoung Ahn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 05505, country: Korea, Republic of, contacts name: Chong Hyun Won, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06280703, orgStudyIdInfo id: 18792, secondaryIdInfos id: J4P-MC-IYAB, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: U1111-1301-8386, type: OTHER, domain: Universal Trial Number, secondaryIdInfos id: 2023-510365-10-00, type: OTHER, domain: EU Trial Number, briefTitle: A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-02-17, completionDateStruct date: 2025-02-17, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion.The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period., conditionsModule conditions: Healthy, conditions: Type 1 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Parallel (Part A) and Crossover design (Part B and Part C), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Double-Blind (Part A) and Open-Label (Part B and Part C), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: LY3938577, interventions name: Placebo, interventions name: Insulin Degludec, interventions name: Insulin Lispro, outcomesModule primaryOutcomes measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration., primaryOutcomes measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration., primaryOutcomes measure: Part A: Number of Participants With Clinically Significant Changes in Vital Signs, primaryOutcomes measure: Part B: Number of Participants With Clinically Significant Changes in Vital Signs, primaryOutcomes measure: Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, primaryOutcomes measure: Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, primaryOutcomes measure: Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577, primaryOutcomes measure: Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577, primaryOutcomes measure: Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577, primaryOutcomes measure: Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577, primaryOutcomes measure: Part C: PK: Concentration of LY3938577, secondaryOutcomes measure: Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577, secondaryOutcomes measure: Part C: PD: Glucose infusion rate (GIR) of LY3938577, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Profil Institut für Stoffwechselforschung, city: Neuss, state: Nordrhein-Westfalen, zip: 41460, country: Germany, contacts role: CONTACT, phone: +49 (0) 2131 4018 450, contacts name: Oliver Klein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.19807, lon: 6.68504, hasResults: False |
protocolSection identificationModule nctId: NCT06280690, orgStudyIdInfo id: NL83765.058.23, briefTitle: SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia, acronym: SGM-T1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101., conditionsModule conditions: Colorectal Cancer, conditions: Image, conditions: Low Grade Dysplasia of Colon, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC)., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SGM-101, outcomesModule primaryOutcomes measure: The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic)., secondaryOutcomes measure: - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective), secondaryOutcomes measure: - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope., secondaryOutcomes measure: - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo, secondaryOutcomes measure: -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo, secondaryOutcomes measure: - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3), secondaryOutcomes measure: - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University Medical Center, status: RECRUITING, city: Leiden, zip: 2333ZA, country: Netherlands, contacts name: Mats Warmerdam, Msc, role: CONTACT, phone: +31715298420, email: [email protected], geoPoint lat: 52.15833, lon: 4.49306, hasResults: False |
protocolSection identificationModule nctId: NCT06280677, orgStudyIdInfo id: 2023.Aurora-Donor, briefTitle: Aurora Test for ART Donor Patients (AURORA-Donor), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fertiga, Belgium, class: INDUSTRY, collaborators name: Fertilab, collaborators name: Ferring Pharmaceuticals, descriptionModule briefSummary: This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AURORA-Donor, outcomesModule primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: P4, primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: E2, primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose, primaryOutcomes measure: Clinical evaluation: number of Follicles, primaryOutcomes measure: Clinical evaluation: number of cumulus-oocyte complex, primaryOutcomes measure: Clinical evaluation: Meiosis II oocytes, primaryOutcomes measure: Clinical evaluation: Abnormal fertilization, primaryOutcomes measure: Clinical evaluation: Normal Fertilization, primaryOutcomes measure: Clinical evaluation: Day 3 embryo evaluation, primaryOutcomes measure: Clinical evaluation: Day 5/6 embryo evaluation, primaryOutcomes measure: Clinical evaluation: Day5/6 good quality blastocyst rate, primaryOutcomes measure: Clinical evaluation: Embryo utilization, primaryOutcomes measure: Expression profile: blastocyst formation, secondaryOutcomes measure: Biochemical pregnancy, secondaryOutcomes measure: Clinical pregnancy with positive fetal heartbeat, secondaryOutcomes measure: Expression profile: pregnancy prediction, secondaryOutcomes measure: Normalized messenger ribonucleic acid (mRNA) expression, otherOutcomes measure: Ongoing pregnancy rate, otherOutcomes measure: Live birth, otherOutcomes measure: Cumulative pregnancy, otherOutcomes measure: Cumulative live birth, otherOutcomes measure: Miscarriage rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertilab, status: RECRUITING, city: Barcelona, zip: 08017, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06280664, orgStudyIdInfo id: IRB20-1151, briefTitle: Efficacy Of Hiatal Closure For GERD, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-02, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD., conditionsModule conditions: Gastro Esophageal Reflux, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Concentration of pH testing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Carlisa Dixon, role: CONTACT, phone: 773-834-4337, email: [email protected], contacts name: Leila Yazdanbakhsh, role: CONTACT, phone: 773-834-5087, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06280651, orgStudyIdInfo id: RGP 2/348/44, secondaryIdInfos id: RGP 2/348/44, type: OTHER_GRANT, domain: kING kHALID UNIVERSITY, briefTitle: Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis, acronym: OHIDPAP-CS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: King Khalid University, class: OTHER, descriptionModule briefSummary: The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism., conditionsModule conditions: Dental Caries in Children, conditions: Autistic Disorder, conditions: Dietary Habits, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: dietary preferences and their implications for oral health in children with Autism Spectrum Disorder, outcomesModule primaryOutcomes measure: Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280638, orgStudyIdInfo id: 2023-2095, briefTitle: CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS), acronym: CT-COMPASS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90)., conditionsModule conditions: Percutaneous Coronary Intervention, conditions: Coronary Physiology, conditions: Computed Tomography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Virtual stent-guided incremental optimization strategy (VIOS), interventions name: Standard angiographic strategy, outcomesModule primaryOutcomes measure: The proportion of patients with a final post-PCI FFR result ≥0.90, secondaryOutcomes measure: The proportion of patients with final post-PCI FFR ≤0.80, secondaryOutcomes measure: The rate of target vessel failure (TVF) and its component features at 6 months., secondaryOutcomes measure: The rate of target vessel failure (TVF) and its component features at 1 year., secondaryOutcomes measure: Change from baseline in self-reported Health-related quality of life evaluation at 6 months., secondaryOutcomes measure: Change from baseline in self-reported Health-related quality of life evaluation at 1 year., secondaryOutcomes measure: Change from baseline in self-reported Angina status evaluation at 6 months., secondaryOutcomes measure: Change from baseline in self-reported Angina status evaluation at 1 year., secondaryOutcomes measure: Procedure Duration, secondaryOutcomes measure: Fluoroscopy Dose, secondaryOutcomes measure: Contrast Material Dose, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, city: Beijing, state: Beijing, zip: 100037, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06280625, orgStudyIdInfo id: 24388, briefTitle: The Effect of the Inclusion of Soybean Flour on Glycemic Responses, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-03-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, collaborators name: Kenneth Dallmier Consulting, LLC, descriptionModule briefSummary: Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: People will be evaluated with a food product prepared with different % of replacement of wheat flour for soy flour. Each person will be their own control. In other words, in randomized order, they will all be assessed with the food product prepared with the regular wheat flour (either bread, tortillas or arepas) and on two other visits with different percentages of soy flour., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Replacement of wheat flour by soyflour, outcomesModule primaryOutcomes measure: Plasma glucose, primaryOutcomes measure: Plasma insulin, secondaryOutcomes measure: Hunger-Satiety, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Illinois at Urbana Champaign, status: RECRUITING, city: Champaign, state: Illinois, zip: 61820, country: United States, contacts name: Marta Y Pepino, MSc, RD, role: CONTACT, phone: 217-300-2374, email: [email protected], contacts name: Stephanie Okoye, Pharm D, role: CONTACT, phone: 2173004709, email: [email protected], geoPoint lat: 40.11642, lon: -88.24338, hasResults: False |
protocolSection identificationModule nctId: NCT06280612, orgStudyIdInfo id: RCS10042023, briefTitle: The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-07-15, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Karadeniz Technical University, class: OTHER, descriptionModule briefSummary: It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined., conditionsModule conditions: Therapy-Associated Cancer, conditions: Cancer Patient, conditions: Happiness, conditions: Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The sample number of the research was calculated in the G\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Since the possibility of patients being affected by each other was minimal, the study was continued with only one of the live cat groups, the simulation cat group, and the control group. For example, only the live cat group and those who received chemotherapy treatment were studied before Monday afternoon., whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Pet therapy, outcomesModule primaryOutcomes measure: Edmonton Symptom Diagnostic Scale, primaryOutcomes measure: Oxford Happiness Scale Short Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gümüşhane University, city: Gümüşhane, zip: 29600, country: Turkey, geoPoint lat: 40.46001, lon: 39.47176, hasResults: False |
protocolSection identificationModule nctId: NCT06280599, orgStudyIdInfo id: SON KMU, briefTitle: Transitional Care Model for Patients With Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University, class: OTHER, descriptionModule briefSummary: Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Transitional care model, outcomesModule primaryOutcomes measure: Self-efficacy, primaryOutcomes measure: Activities of daily living, secondaryOutcomes measure: Instrumental activities of daily living, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Quality of life in stroke patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RSUD Prof. Dr. W Z Johannes Kupang, status: RECRUITING, city: Kupang, zip: 308, country: Indonesia, contacts name: Sakti Oktaria Batubara, role: CONTACT, email: [email protected], contacts role: CONTACT, phoneExt: Saragih, email: [email protected], contacts name: Ita Daryanti Saragih, Doctoral, role: SUB_INVESTIGATOR, geoPoint lat: -10.17083, lon: 123.60694, hasResults: False |
protocolSection identificationModule nctId: NCT06280586, orgStudyIdInfo id: 44/21, briefTitle: Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly, acronym: ESPAI-F, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-15, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari del Maresme, class: OTHER, descriptionModule briefSummary: Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in., conditionsModule conditions: Muscle Strengh, conditions: Frailty, conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 232, type: ACTUAL, armsInterventionsModule interventions name: Multidisciplinary intervention, outcomesModule primaryOutcomes measure: Muscle Mass, primaryOutcomes measure: Muscle strength and/or Muscle function, primaryOutcomes measure: Sarcopenia, primaryOutcomes measure: Frailty, secondaryOutcomes measure: Functional Capacity 1, secondaryOutcomes measure: Functional Capacity 2, secondaryOutcomes measure: Functional Capacity 3, secondaryOutcomes measure: Functional Capacity 4, secondaryOutcomes measure: Functional Capacity 5, secondaryOutcomes measure: Functional Capacity 6, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consorci Sanitari del Maresme, city: Mataró, state: Barcelona, zip: 08304, country: Spain, geoPoint lat: 41.54211, lon: 2.4445, locations facility: Mateu Serra-Prat, city: Mataró, state: Barcelona, zip: 08304, country: Spain, geoPoint lat: 41.54211, lon: 2.4445, hasResults: False |
protocolSection identificationModule nctId: NCT06280573, orgStudyIdInfo id: MS1, briefTitle: COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS), acronym: COBRAMS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Comenius University, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.Researchers will compare the effect to control groups of MS patients without intervention., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Wim Hoff method, outcomesModule primaryOutcomes measure: concentration of pro-inflammatory cytokines, primaryOutcomes measure: concentration of markers of oxidative stress, primaryOutcomes measure: concentration of NfL, primaryOutcomes measure: concentration of GFAP, primaryOutcomes measure: concentration of ecDNA, secondaryOutcomes measure: Expanded Disability Status Scale, secondaryOutcomes measure: Timed 25-Foot Walk, secondaryOutcomes measure: Nine-Hole Peg Test, secondaryOutcomes measure: Symbol Digit Modalities Test, secondaryOutcomes measure: Fatigue Scale for Motor and Cognitive Functions, secondaryOutcomes measure: General Anxiety Disorder-7, secondaryOutcomes measure: Patient Health Questionnaire-9, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Derer's University Hospital, city: Bratislava, zip: 83305, country: Slovakia, geoPoint lat: 48.14816, lon: 17.10674, hasResults: False |
protocolSection identificationModule nctId: NCT06280560, orgStudyIdInfo id: 2109-FIVI-087-FD, secondaryIdInfos id: PI23/00860, type: OTHER_GRANT, domain: Instituto de Salud Carlos III, co-funded by European Union, briefTitle: Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation, acronym: HormoSenoRec, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fundación IVI, class: OTHER, collaborators name: Instituto Valenciano de Infertilidad, IVI VALENCIA, descriptionModule briefSummary: Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients., conditionsModule conditions: Endometrial Receptivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Controlled Ovarian Stimulation + Luteal Phase Support, interventions name: Hormonal Replacement Therapy programmed artificial cycle, interventions name: Natural Cycle (NC), interventions name: Endometrial receptivity reference group, outcomesModule primaryOutcomes measure: Endometrial receptivity, secondaryOutcomes measure: Senescent Cell Pathological Accumulation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: IVI-RMA Valencia Clinic, status: RECRUITING, city: Valencia, zip: 46015, country: Spain, contacts name: Laura Caracena, PhD, role: CONTACT, phone: 651791000, email: [email protected], geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06280547, orgStudyIdInfo id: CUP 13-2, secondaryIdInfos id: Cairo university, type: OTHER, domain: Cairo University, briefTitle: The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children, acronym: KAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-03-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt., conditionsModule conditions: Dental Caries in Children, conditions: Knowledge, Attitudes, Practice, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 115, type: ESTIMATED, armsInterventionsModule interventions name: Oral health education, outcomesModule primaryOutcomes measure: Oral health related attitude, secondaryOutcomes measure: Change in oral health related Knowledge, attitude and practice, otherOutcomes measure: Caries experience, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 15 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06280534, orgStudyIdInfo id: XT1061-2022-01, briefTitle: Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects, acronym: XT1061, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Xi'an Xintong Pharmaceutical Research Co.,Ltd., class: OTHER, descriptionModule briefSummary: A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects., conditionsModule conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Test drug XT1061 capsules and placebo,Single dose group, interventions name: Test drug XT1061 capsules and placebo，Multiple dosing group, interventions name: Test drug XT1061 capsules and placebo，Food Impact Group, outcomesModule primaryOutcomes measure: Treatment-related adverse events, primaryOutcomes measure: Cmax, primaryOutcomes measure: Tmax, primaryOutcomes measure: t1/2, primaryOutcomes measure: AUC, primaryOutcomes measure: CL/F, primaryOutcomes measure: Vz/F, primaryOutcomes measure: CLr/F, secondaryOutcomes measure: Ae0-72 h, secondaryOutcomes measure: Fe0-72 h, secondaryOutcomes measure: bioavailability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, status: RECRUITING, city: Jilin, state: Changchun, country: China, contacts name: Ding Yanhua, master, role: CONTACT, phone: 18743062721, email: [email protected], geoPoint lat: 43.85083, lon: 126.56028, hasResults: False |
protocolSection identificationModule nctId: NCT06280521, orgStudyIdInfo id: 38RC23.0331, briefTitle: Validation of the Girls Questionnaire for Autism Spectrum Condition in French Langage, acronym: fGQ-ASC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: Autism spectrum disorders (ASD) are currently diagnosed at a rate of approximately 3 males per 1 female, while evidence suggests the rate may be 1.8 males per 1.2 females. It has been shown that affected women receive an autism diagnosis on average 5 years later than men. This delay is associated with deleterious consequences on the educational, psychological and physical health levels in these women. Currently, there are a number of obstacles that delay or prevent women with ASD from accessing diagnosis and specialized support. These include, in particular, gendered assumptions about how ASD manifests depending on the gender of the person concerned, a tendency for clinicians to attribute female autistic traits to causes other than ASD, measures of standardized ASD assessments that may not be sensitive enough to identify ASD females, and finally a demonstrated greater tendency among ASD females to camouflage or mask autistic traits in order to blend in in social situations. It is in this context that the Girl Questionnaire for Autism Spectrum Conditions (GQ-ASC) was developped and validated to address these fundamental gaps in the early identification and measurement of female ASD symptoms.The GQ-ASC is presented as a self-questionnaire with 29 items which assess clinical characteristics specific to the adult female presentation of ASD in the dimensions (five) of imagination and play, camouflage, sensoriality, social situations and interests. To date, several studies have relevantly used the GQ-ASC in populations of adult ASD women, but none in French.The main objective of this online study is therefore to measure the predictive validity of the French version of the Girl Questionnaire for Autism Spectrum Conditions (fGQ-ASC) for the diagnosis of ASD in adult women over 18 years of age and speaking French kindergarten. Subjects included in this online study will complete the protocol using any computer, tablet, or cell phone. We will include 400 participants (100 females-ASD, 100 females-nonASD, 100 males-ASD, 100 males-nonASD). This study will validate for the first time a screening tool for the diagnosis of ASD in women of French mother tongue over 18 years of age (the Girls Questionnaire for Autism Spectrum Condition French version - fGQ-ASC). This tool will have particularly significant benefits since it will help reduce the diagnostic delay among adult women with ASD in France and accelerate their access to specialized support., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: fGQ-ASC, outcomesModule primaryOutcomes measure: VP fGQ-ASC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06280508, orgStudyIdInfo id: SYSKY-2024-082-01, briefTitle: Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer., conditionsModule conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, Apatinib, Gemcitabine, cisplatin, outcomesModule primaryOutcomes measure: 1-year EFS rate, secondaryOutcomes measure: R0 Resection rate, secondaryOutcomes measure: EFS, secondaryOutcomes measure: RFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, status: RECRUITING, city: Guangzhou, state: China/Guangdong, country: China, contacts name: Yajin Chen, role: CONTACT, phone: 13719006202, email: [email protected], contacts name: Changzhen Shang, role: CONTACT, phone: 13711279678, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06280495, orgStudyIdInfo id: INTENSIFY-CRC, briefTitle: Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone., conditionsModule conditions: Colorectal Cancer, conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized, multicenter clinical trial. Stratified randomization based on liver metastasis characteristics, including timing, number, and size, will be conducted in eligible patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Oxaliplatin, interventions name: Fluorouracil, interventions name: Serplulimab, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: 3-year Progression-Free Survival Rate, secondaryOutcomes measure: Median Overall Survival, secondaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Pathologic complete response (pCR), secondaryOutcomes measure: Pathological Partial Response, secondaryOutcomes measure: Disease Free Survival, secondaryOutcomes measure: Treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Yu-hong Li, MD, Ph D, role: CONTACT, email: [email protected], contacts name: Yu-hong Li, MD, Ph D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06280482, orgStudyIdInfo id: HSC-MS-23-0332, briefTitle: Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-07-25, completionDateStruct date: 2025-07-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients., conditionsModule conditions: Smooth Muscle Dysfunction Syndrome (SMDS), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Nicotinamide riboside (NR), outcomesModule primaryOutcomes measure: Change in Fluoro-18-Deoxyglucose (18F-FDG ) uptake in aortic wall as measured by positron emission tomography (PET)/computerized tomography (CT) imaging, secondaryOutcomes measure: Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC), secondaryOutcomes measure: Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC), secondaryOutcomes measure: Change in aortic measurements as assessed by echocardiography, secondaryOutcomes measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork, secondaryOutcomes measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork, secondaryOutcomes measure: Tolerability as assessed by the number of patients who complete study, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: David Murdock, MD, role: CONTACT, phone: 713-500-6735, email: [email protected], contacts name: Dianna Milewicz, MD, PhD, role: CONTACT, phone: (713) 500-6725, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06280469, orgStudyIdInfo id: KY20232298-C-1, briefTitle: Single-operator Versus Double-operator in Single-Balloon Enteroscopy, acronym: SBE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Shuhui Liang, class: OTHER, descriptionModule briefSummary: Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy., conditionsModule conditions: Single-balloon Enteroscopy, conditions: Operation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Single-Balloon Enteroscopy, outcomesModule primaryOutcomes measure: Maximum insertion depth, secondaryOutcomes measure: Total enteroscopy rate, secondaryOutcomes measure: Positive findings, secondaryOutcomes measure: Advent events, secondaryOutcomes measure: procedural time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital of Digestive Diseases, status: RECRUITING, city: Xi'an, country: China, contacts name: Shuhui Liang, role: CONTACT, phone: +862084771536, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06280456, orgStudyIdInfo id: 2023-09-017A, briefTitle: Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-05, primaryCompletionDateStruct date: 2023-01-05, completionDateStruct date: 2023-02-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4., conditionsModule conditions: Anterior Cruciate Ligament Reconstruction, conditions: Tranexamic Acid, conditions: Hemarthrosis, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: Tranexamic Acid Powder, outcomesModule primaryOutcomes measure: The volume of drainage, secondaryOutcomes measure: Visual analog scale (VAS), secondaryOutcomes measure: International Knee Documentation Committee (IKDC) functional score, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06280443, orgStudyIdInfo id: CE22407B, briefTitle: Sarcopenia in Chronic Lung Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-25, primaryCompletionDateStruct date: 2024-10-13, completionDateStruct date: 2032-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources, conditionsModule conditions: Sarcopenia, conditions: COPD, conditions: Asthma, conditions: ILD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: sarcopenia rate, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, status: RECRUITING, city: Taichung, zip: 40705, country: Taiwan, contacts name: Pin-Kuei Fu, MD, PhD, role: CONTACT, phone: 886-4-23592525, phoneExt: 3213, email: [email protected], geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06280430, orgStudyIdInfo id: Vascular affection in behcet, briefTitle: Vascular Affection in Behcet Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity, conditionsModule conditions: Behcet Disease and Vascular Involvement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To measure the level of serum elafin in behcet patients and compare it with control group, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06280417, orgStudyIdInfo id: Unreamed IMN In IIIa tibia, briefTitle: Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome ., conditionsModule conditions: Tibia Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Unreamed intramedullary tibial nail, outcomesModule primaryOutcomes measure: Incidence of non union, secondaryOutcomes measure: Incidince of fracture related infection, secondaryOutcomes measure: The rate of reoperation for delayed union or non-union, infection and fasciotomy, secondaryOutcomes measure: functional evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280404, orgStudyIdInfo id: Body first in lap chole, briefTitle: Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-08-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle., conditionsModule conditions: Cholecystitis, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Lap cholecystectomy, outcomesModule primaryOutcomes measure: Safe laparoscopic cholecystectomy., secondaryOutcomes measure: Evaluation of the body first approach technique, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280391, orgStudyIdInfo id: ACT18018, secondaryIdInfos id: U1111-1295-3237, type: REGISTRY, domain: ICTRP, secondaryIdInfos id: 2023-508663-70, type: REGISTRY, domain: CTIS, briefTitle: A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-03-24, completionDateStruct date: 2026-08-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).Study details include:* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.* The treatment duration will be up to 24-52 weeks.* The follow-up duration will be 20 weeks.* Site/phone visits are at a monthly interval., conditionsModule conditions: Bronchiectasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Itepekimab (SAR440340), interventions name: Placebo, outcomesModule primaryOutcomes measure: Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period, secondaryOutcomes measure: Time to first moderate or severe PE over the treatment period, secondaryOutcomes measure: Percentage of participants who are PE free over the treatment period, secondaryOutcomes measure: Annualized rate of severe PEs over the treatment period, secondaryOutcomes measure: Percentage of participants who are severe PE free over the treatment period, secondaryOutcomes measure: Time to first severe PE over the treatment period, secondaryOutcomes measure: Change From Baseline in FEV1 at Week 8 and Week 24, secondaryOutcomes measure: Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use, secondaryOutcomes measure: Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24, secondaryOutcomes measure: Change from baseline in SGRQ total score at Week 24, secondaryOutcomes measure: Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24, secondaryOutcomes measure: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period, secondaryOutcomes measure: Serum concentrations of itepekimab from baseline to end of study, secondaryOutcomes measure: Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Allianz Research Institute Site Number : 8400013, status: RECRUITING, city: Westminster, state: California, zip: 92683, country: United States, geoPoint lat: 33.75918, lon: -118.00673, locations facility: Southeastern Research Center Site Number : 8400008, status: RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Investigational Site Number : 8260008, status: RECRUITING, city: Norwich, state: Norfolk, zip: NR4 7UY, country: United Kingdom, geoPoint lat: 52.62783, lon: 1.29834, locations facility: Investigational Site Number : 8260003, status: RECRUITING, city: Tyne And Wear, state: North Tyneside, zip: NE29 8NH, country: United Kingdom, locations facility: Investigational Site Number : 8260001, status: RECRUITING, city: Newcastle upon Tyne, zip: NE7 7DN, country: United Kingdom, geoPoint lat: 54.97328, lon: -1.61396, locations facility: Investigational Site Number : 8260005, status: RECRUITING, city: Reading, zip: RG1 5AN, country: United Kingdom, geoPoint lat: 51.45625, lon: -0.97113, hasResults: False |
protocolSection identificationModule nctId: NCT06280378, orgStudyIdInfo id: CP-KL003-003/01, briefTitle: A Phase I/II Clinical Study of the KL003 Cell Injection in β-Thalassemia Major Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kanglin Biotechnology (Hangzhou) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major., conditionsModule conditions: Transfusion-dependent Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ESTIMATED, armsInterventionsModule interventions name: KL003 Cell Injection Drug Product, outcomesModule primaryOutcomes measure: KL003 engraftment, primaryOutcomes measure: Engraftment time of neutrophil and platelet, primaryOutcomes measure: Overall Survival, primaryOutcomes measure: The number, frequency and severity of adverse events (AE) within 1 year after infusion of KL003 drug products, primaryOutcomes measure: Clonal dominance or secondary tumors caused by lentiviral vector insertional-mutation, primaryOutcomes measure: Numbers of Participants With Vector-Derived Replication-Competent Lentivirus (RCL), secondaryOutcomes measure: The proportion of participants achieved Transfusion Independence (TI)for at least 6 months, secondaryOutcomes measure: The proportion of participants achieved TI 12, secondaryOutcomes measure: The start time of Transfusion Independence (TI) after KL003 infusion, secondaryOutcomes measure: Total Hb and the vector-derived HbA^T87Q, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, country: China, contacts name: Wei Tang, PhD, role: CONTACT, phone: +86 13472889588, contacts name: Saijuan Chen, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Institute of Hematology & Blood Diseases Hospital, city: Tianjin, state: Tianjin, country: China, contacts name: Zhen Gao, Master, role: CONTACT, phone: +86 15522360862, email: [email protected], contacts name: Jun Shi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06280365, orgStudyIdInfo id: 012, briefTitle: MWM Technique in Patients With Knee OA, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Okan University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA)., conditionsModule conditions: Mobilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Mulligan Mobilization with Movement Technique, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Short form-36 (SF-36), primaryOutcomes measure: Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC), primaryOutcomes measure: Evaluation of proprioception, primaryOutcomes measure: The range of motion, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emine Atıcı, city: Tuzla, state: İstanbul, country: Turkey, hasResults: False |
protocolSection identificationModule nctId: NCT06280352, orgStudyIdInfo id: AUVA_Knieathlon_2024, briefTitle: Robotic Assisted vs Custom Made Total Knee Arthroplasty, acronym: Knieathlon, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Austrian Workers Compensation Board Styria, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:* Which implant/philosophy yields better clinical outcomes?* Which implant/philosophy yields better satisfaction?* Which system is more OR efficient? Participants will be followed for 2 years postoperatively., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Custom made Total Knee Arthroplasty, interventions name: Functionally aligned robotically assisted total knee arthroplasty, outcomesModule primaryOutcomes measure: Clinical Outcome using the Forgotten Joint Score, secondaryOutcomes measure: Clinical outcomes using the Kujala anterior knee pain Score, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Visual analog pain (VAS) scale, secondaryOutcomes measure: Surgical and total theatre time, secondaryOutcomes measure: Opioid use, secondaryOutcomes measure: Number of physiotherapy sessions, secondaryOutcomes measure: Range of motion measurements (in degrees), secondaryOutcomes measure: Radiographic data including radiolucent lines, secondaryOutcomes measure: Revision rate, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AUVA UKH Steiermark Standort Graz, status: RECRUITING, city: Graz, state: Styria, zip: 8020, country: Austria, contacts name: Antonio Klasan, MD, PHD, EMBA, role: CONTACT, geoPoint lat: 47.06667, lon: 15.45, locations facility: AUVA UKH Steiermark Standort Kalwang, status: RECRUITING, city: Kalwang, state: Styria, zip: 8775, country: Austria, contacts name: Antonio Klasan, MD, PhD, EMBA, role: CONTACT, geoPoint lat: 47.42172, lon: 14.75221, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-27, uploadDate: 2024-02-05T09:59, filename: Prot_SAP_000.pdf, size: 156436, hasResults: False |
protocolSection identificationModule nctId: NCT06280339, orgStudyIdInfo id: IRB23-0190, briefTitle: Food Cravings Strategies During Dietary Weight Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, descriptionModule briefSummary: The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings., conditionsModule conditions: Obesity, conditions: Food Cravings, conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Test two food cravings strategies during dietary weight loss, interventions name: Dietary weight loss program +Food cravings strategies, outcomesModule primaryOutcomes measure: Body weight, primaryOutcomes measure: Food Craving Strategies Compliance, primaryOutcomes measure: Food Cravings, primaryOutcomes measure: Food Cravings, secondaryOutcomes measure: Dietary intake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bevier HAll UIUC, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Nouf Alfouzan, role: CONTACT, phone: 217-898-5480, email: [email protected], geoPoint lat: 40.11059, lon: -88.20727, locations facility: Bevier HAll UIUC, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Nouf Alfouzan, role: CONTACT, phone: 217-898-5480, email: [email protected], contacts name: Manabu Nakamura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.11059, lon: -88.20727, hasResults: False |
protocolSection identificationModule nctId: NCT06280326, orgStudyIdInfo id: Orogastric Tube Removal, briefTitle: Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-08-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage., conditionsModule conditions: Neonatal Skin Conditions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled experimental trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 86, type: ACTUAL, armsInterventionsModule interventions name: Sunflower oil, interventions name: Slicone based spray, outcomesModule primaryOutcomes measure: Neonatal Skin Condition Score, eligibilityModule sex: ALL, minimumAge: 32 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Hatice Uzşen, city: Samsun, state: Atakum, zip: 55100, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False |
protocolSection identificationModule nctId: NCT06280313, orgStudyIdInfo id: uHCC-STI-TJ01, briefTitle: Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2028-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Zhiyong Huang, class: OTHER, collaborators name: Wuhan Union Hospital, China, collaborators name: Wuhan University, collaborators name: Renmin Hospital of Wuhan University, collaborators name: Taihe Hospital, collaborators name: Hubei Cancer Hospital, collaborators name: Xiangyang Central Hospital, collaborators name: Wuhan Central Hospital, collaborators name: Yichang Third Renmin Hospital, descriptionModule briefSummary: Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Splenectomy+Targeted therapy+ Immunotherapy, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Zhiyong Huang, role: CONTACT, phone: 86-13995507729, email: [email protected], contacts name: Erlei Zhang, role: CONTACT, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06280300, orgStudyIdInfo id: UVMMC2203, briefTitle: Multi-disciplinary Care for Brain Metastases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Vermont Medical Center, class: OTHER, descriptionModule briefSummary: This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases., conditionsModule conditions: Brain Metastases, Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: cohort study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: health services intervention, outcomesModule primaryOutcomes measure: Patient reported outcomes, secondaryOutcomes measure: Feasibility, secondaryOutcomes measure: Patient understanding of prognosis, secondaryOutcomes measure: survival, otherOutcomes measure: Exploratory survival outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vermont Medical Center, status: RECRUITING, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, hasResults: False |
protocolSection identificationModule nctId: NCT06280287, orgStudyIdInfo id: FAPI-PLAQUE, briefTitle: PET Imaging of Fibroblast Activation in Atherosclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome., conditionsModule conditions: Atherosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: FAPI PET, outcomesModule primaryOutcomes measure: SUVmax of atherosclerotic plaque in carotid or coronary arteries, primaryOutcomes measure: TBR of atherosclerotic plaque in carotid or coronary arteries, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Li Huo, role: CONTACT, phone: 86-13910801986, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06280274, orgStudyIdInfo id: STUDY00025798, briefTitle: Metformin Use in Patients Undergoing Total Joint Replacement Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial., conditionsModule conditions: Hyperglycemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Rate of participant enrollment, primaryOutcomes measure: Rate of appropriate study drug administration, primaryOutcomes measure: Rate of participant adherence to trial intervention per protocol, primaryOutcomes measure: Rate of participant retention to 90-day follow up, secondaryOutcomes measure: Perioperative glycemic variability, secondaryOutcomes measure: Sliding scale insulin utilization, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: 90-day Rate of surgical site infection, secondaryOutcomes measure: 90-day Rate of periprosthetic joint infection, secondaryOutcomes measure: 90-day Rate of mortality, secondaryOutcomes measure: 90-day rate of readmission, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Ryland Kagan, role: CONTACT, phone: 503-494-5649, email: [email protected], geoPoint lat: 45.52345, lon: -122.67621, hasResults: False |
protocolSection identificationModule nctId: NCT06280261, orgStudyIdInfo id: GO20/296, briefTitle: The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-27, primaryCompletionDateStruct date: 2020-09-01, completionDateStruct date: 2020-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents., conditionsModule conditions: Psychological Well-Being, conditions: Caregiver Burden, conditions: Life Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: PROSPECTIVE, enrollmentInfo count: 156, type: ACTUAL, armsInterventionsModule interventions name: parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire, outcomesModule primaryOutcomes measure: Rosenberg Self-Esteem Scale, primaryOutcomes measure: Stait trait anxiety inventory, primaryOutcomes measure: Strenghts and difficulties questionnaire, primaryOutcomes measure: Zarit burden scale, primaryOutcomes measure: Parenting stress index, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Sihhiye, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-10-20, uploadDate: 2024-02-19T08:48, filename: Prot_SAP_000.pdf, size: 288978, hasResults: False |
protocolSection identificationModule nctId: NCT06280248, orgStudyIdInfo id: EUS in pancreatic fluid, briefTitle: EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice \[Lin et al., 2014\]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:* Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.* Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed., conditionsModule conditions: Pancreas Pseudocyst, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst, outcomesModule primaryOutcomes measure: Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06280235, orgStudyIdInfo id: 1447-0005, secondaryIdInfos id: U1111-1297-3126, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), secondaryIdInfos id: 2023-507942-10-00, type: REGISTRY, domain: CTIS, briefTitle: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-08-12, completionDateStruct date: 2025-10-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.Participants continue their standard therapy throughout the study.Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: BI 1569912, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8, secondaryOutcomes measure: Change from baseline in MADRS total score at Week 6, secondaryOutcomes measure: Response defined as ≥50% MADRS reduction from baseline at Day 8, secondaryOutcomes measure: Response defined as ≥50% MADRS reduction from baseline at Week 6, secondaryOutcomes measure: Remission defined as MADRS total score ≤10 at Week 6, secondaryOutcomes measure: Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8, secondaryOutcomes measure: Change from baseline in SMDDS total score at Week 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hassman Research Institute, status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: [email protected], geoPoint lat: 39.89122, lon: -74.92183, locations facility: Neurobehavioral Research, Inc., status: RECRUITING, city: Cedarhurst, state: New York, zip: 11516, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: [email protected], geoPoint lat: 40.62288, lon: -73.7243, locations facility: Sooner Clinical Research, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: [email protected], geoPoint lat: 35.46756, lon: -97.51643, locations facility: Grayline Research Center, status: RECRUITING, city: Wichita Falls, state: Texas, zip: 76309, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: [email protected], geoPoint lat: 33.91371, lon: -98.49339, hasResults: False |
protocolSection identificationModule nctId: NCT06280222, orgStudyIdInfo id: VR FOR ANXIETY-HMO-CTIL, briefTitle: The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation., acronym: VRFORANXIETY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level ., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: The VR instrument - Oculus Quest 2, outcomesModule primaryOutcomes measure: Vital signs, primaryOutcomes measure: Vital signs, primaryOutcomes measure: VAS (visual-analogue scale), primaryOutcomes measure: State and Trait Anxiety (STAI) Score, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hadassah mound scopus IVF unit, status: RECRUITING, city: Jerusalem, country: Israel, contacts name: Anat Hershko-Klement, M.D, role: CONTACT, phone: +972549170084, email: [email protected], geoPoint lat: 31.76904, lon: 35.21633, hasResults: False |
protocolSection identificationModule nctId: NCT06280209, orgStudyIdInfo id: 351-201, secondaryIdInfos id: 2023-506737-30-00, type: OTHER, domain: EU CT, briefTitle: A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: BioMarin Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: BMN 351, outcomesModule primaryOutcomes measure: To evaluate and safety and tolerability of single and multiple doses of BMN 351 (incidence, severity, and dose-relationship of adverse effects and changes in laboratory parameters)., secondaryOutcomes measure: Pharmacokinetics (PK) concentration of BMN 351 in plasma, urine and muscle approximately every 8 weeks for up to 48 weeks., otherOutcomes measure: To evaluate the immune response to BMN 351., otherOutcomes measure: To evaluate the effect of BMN 351 on physical function., otherOutcomes measure: To evaluate the effect of BMN 351 on physical function., otherOutcomes measure: Change from baseline in dystrophin expression measured by Liquid chromatography-mass spectrometry (LC-MS)., eligibilityModule sex: MALE, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Sant Joan de Deu, status: RECRUITING, city: Barcelona, zip: 08950, country: Spain, contacts name: Soraya Peralta, role: CONTACT, phone: +34 673200068, email: [email protected], contacts name: Andres Nascimento, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Viamed Santa Angela De la Cruz, status: RECRUITING, city: Sevilla, zip: 41013, country: Spain, contacts name: Carmen Silva, role: CONTACT, phone: +34 669393637, email: [email protected], contacts name: Marcos Madruga-Garrido, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Great Ormond Street Hospital NHS Foundation Trust, status: RECRUITING, city: London, zip: WC1N 3JH, country: United Kingdom, contacts name: Marta Zancolli, role: CONTACT, phone: +44 (0)20 7905 2188, email: [email protected], contacts name: Giovanni Baranello, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06280196, orgStudyIdInfo id: BAT-3306-002-CR, briefTitle: A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-15, primaryCompletionDateStruct date: 2027-07-30, completionDateStruct date: 2028-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Bio-Thera Solutions, class: INDUSTRY, descriptionModule briefSummary: To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind, randomized, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 676, type: ESTIMATED, armsInterventionsModule interventions name: BAT3306, interventions name: EU-Keytruda®, interventions name: US-Keytruda®, interventions name: Pemetrexed, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: clinical equivalence, secondaryOutcomes measure: safety of BAT3306-AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280183, orgStudyIdInfo id: 323132, briefTitle: Functional Inspiratory Muscle Training in Obese Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, collaborators name: Istanbul Galata University, descriptionModule briefSummary: In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, single-blind study three arm study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The assessor will be blind to the group allocation, and participants will be blind to group allocation, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Functional Inspiratory Muscle Training, interventions name: Aerobic+Resistive Exercise Traning, outcomesModule primaryOutcomes measure: Respiratory Muscle Strength, primaryOutcomes measure: Incremental load test (Respiratory Muscle Endurance), primaryOutcomes measure: Forced expiratory volume 1st second (Respiratory Function), primaryOutcomes measure: Forced vital capacity (Respiratory Function), secondaryOutcomes measure: Comorbidity Assessment, secondaryOutcomes measure: Physical Activity Assessment, secondaryOutcomes measure: Edmonton Obesity Staging System (EOSS), secondaryOutcomes measure: Functional Capacity, secondaryOutcomes measure: Peripheral Muscle Strength, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body fat-muscle ratios, secondaryOutcomes measure: Glucose profile, secondaryOutcomes measure: Lipid profile, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280170, orgStudyIdInfo id: ST11480, briefTitle: AI to Support Mental Health Case Management Providers, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Eleos Health, class: INDUSTRY, collaborators name: Centerstone Research Institute, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:1. Is the AI platform acceptable and feasible for case managers?2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation., conditionsModule conditions: Depressive Disorder, conditions: Anxiety Disorders, conditions: Substance Use Disorders, conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The masking in this study involves a differential approach between providers and clients. Providers will be aware of whether they are in the Services-As-Usual (SAU) or Artificial Intelligence (AI) phase. However, participating clients will not be informed about the platform their provider is using to document their therapy sessions., enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Artificial Intelligence platform for case managers, outcomesModule primaryOutcomes measure: Case manager satisfaction, primaryOutcomes measure: Case manager productivity, primaryOutcomes measure: Case manager note completion time, secondaryOutcomes measure: Clients' crisis services utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centerstone, city: Alton, state: Illinois, zip: 62002, country: United States, geoPoint lat: 38.8906, lon: -90.18428, hasResults: False |
protocolSection identificationModule nctId: NCT06280157, orgStudyIdInfo id: MVX0007, secondaryIdInfos id: 332126, type: OTHER, domain: IRAS, briefTitle: A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Minervax ApS, class: OTHER, collaborators name: Simbec-Orion Group, descriptionModule briefSummary: The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination., conditionsModule conditions: Group B Streptococcus Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: GBS-NN/NN2, outcomesModule primaryOutcomes measure: Antibody Concentration Specific for GBS-NN and GBS-NN2, primaryOutcomes measure: Antibody Responses Specific to AlpCN, RibN, Alp1N and Alp2-3N, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Simbec-Orion Clinical Pharmacology, city: Merthyr Tydfil, state: Pentrebach Merthyr Tydfil CF48 4DR, country: United Kingdom, geoPoint lat: 51.74794, lon: -3.37779, hasResults: False |
protocolSection identificationModule nctId: NCT06280144, orgStudyIdInfo id: PF20230428, briefTitle: Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-22, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Changchun BCHT Biotechnology Co., class: INDUSTRY, collaborators name: Hu Bei province Center for Disease control and prevention, collaborators name: The Inner Mongolia Autonomous Region Center for Disease Control and Prevention, descriptionModule briefSummary: To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine., conditionsModule conditions: Influenza Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 6080, type: ESTIMATED, armsInterventionsModule interventions name: Influenza Vaccine, Live, Nasal, Freeze-dried, interventions name: Sterile water for inhalation, outcomesModule primaryOutcomes measure: Primary influenza protective effect endpoint, primaryOutcomes measure: Primary influenza protective effect endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Secondary protective efficacy endpoint, secondaryOutcomes measure: Safety, secondaryOutcomes measure: Study on detoxification, otherOutcomes measure: Protective effect of COVID-19 cases., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations status: RECRUITING, city: Chi Feng, state: Inner Mongolia Autonomous Region, zip: 024000, country: China, contacts name: Xiaoling Tian, role: CONTACT, phone: 13848710296, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06280131, orgStudyIdInfo id: multiple sclerosis and pulse, briefTitle: The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate, conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: to evaluate efficacy of a pulse therapy on clinical outcome, secondaryOutcomes measure: clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional, secondaryOutcomes measure: clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280118, orgStudyIdInfo id: EFCPR008, briefTitle: The Effect of Fatigue on CPR, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-20, primaryCompletionDateStruct date: 2023-06-20, completionDateStruct date: 2023-10-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Artvin Coruh University, class: OTHER, descriptionModule briefSummary: Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program., conditionsModule conditions: Resuscitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Fatigue, outcomesModule primaryOutcomes measure: Correct number of ventilations, primaryOutcomes measure: Correct number of compression, secondaryOutcomes measure: CPR duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: Resuscitation simulation laboratory of Artvin Çoruh University Health Services Vocational School, city: Artvin, zip: 08000, country: Turkey, geoPoint lat: 41.18161, lon: 41.82172, hasResults: False |
protocolSection identificationModule nctId: NCT06280105, orgStudyIdInfo id: 2023_148_01, briefTitle: A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Meng Chao Hepatobiliary Hospital of Fujian Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab+regorafenib, outcomesModule primaryOutcomes measure: objective response rate (ORR) per RECIST1.1, secondaryOutcomes measure: Progression-free survival（PFS）, secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Occurence of AE and SAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mengchao Hepatobiliary Hospital, Fujian Medical University, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06280092, orgStudyIdInfo id: 23-009133, briefTitle: Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Sanjeet S. Grewal, class: OTHER, descriptionModule briefSummary: This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy.Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation.Patients will be followed in the outpatient setting for up to a year after therapy application.Surgical, clinical, and radiographic data will be obtained during these visits, conditionsModule conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: This is an unmasked study, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: AMSCs, outcomesModule primaryOutcomes measure: Primary Objective, primaryOutcomes measure: Secondary Objective, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280079, orgStudyIdInfo id: LIPCAL-ALS II 1.1, briefTitle: Ultra-high-caloric, Fatty Diet in ALS, acronym: LIPCAL-ALS II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Ulm, class: OTHER, descriptionModule briefSummary: This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS)., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 392, type: ESTIMATED, armsInterventionsModule interventions name: Ultra-high-caloric fatty diet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Survival, secondaryOutcomes measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised, secondaryOutcomes measure: Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale, secondaryOutcomes measure: Individual Quality of Life, secondaryOutcomes measure: Slow vital capacity, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Time to death, secondaryOutcomes measure: Time to tracheostomy, secondaryOutcomes measure: Time to permanent continous ventilator dependence, secondaryOutcomes measure: Ventilation assistance-free survival, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Council of Nutrition Appetite Questionnaire, secondaryOutcomes measure: Eating Habits, secondaryOutcomes measure: Neurofilament light chain, secondaryOutcomes measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model, secondaryOutcomes measure: Neurofilament Assess Score, otherOutcomes measure: Microtubule-associated protein 2 in serum, otherOutcomes measure: Microtubule-associated protein 2 in cerebrospinal fluid, otherOutcomes measure: Ubiquitin carboxy-terminal hydrolase L1 in serum, otherOutcomes measure: Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid, otherOutcomes measure: Transmembrane glycoprotein NMB in serum, otherOutcomes measure: Transmembrane glycoprotein NMB in cerebrospinal fluid, otherOutcomes measure: Human cartilage glycoprotein 39 in serum, otherOutcomes measure: Human cartilage glycoprotein 39 in cerebrospinal fluid, otherOutcomes measure: SNAP-25 in serum, otherOutcomes measure: SNAP-25 in cerebrospinal fluid, otherOutcomes measure: Beta-synuclein in serum, otherOutcomes measure: Beta-synuclein in cerebrospinal fluid, otherOutcomes measure: Aquaporin-4 in serum, otherOutcomes measure: Aquaporin-4 in cerebrospinal fluid, otherOutcomes measure: Glial fibrillary acidic protein in serum, otherOutcomes measure: Glial fibrillary acidic protein in cerebrospinal fluid, otherOutcomes measure: Soluble triggering receptor expressed on myeloid cell-1 in serum, otherOutcomes measure: Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid, otherOutcomes measure: CC-chemokine ligand 2 in serum, otherOutcomes measure: CC-chemokine ligand 2 in cerebrospinal fluid, otherOutcomes measure: interleukin-1b in serum, otherOutcomes measure: interleukin-1b in cerebrospinal fluid, otherOutcomes measure: interleukin-2 in serum, otherOutcomes measure: interleukin-2 in cerebrospinal fluid, otherOutcomes measure: interleukin-4 in serum, otherOutcomes measure: interleukin-4 in cerebrospinal fluid, otherOutcomes measure: interleukin-6 in serum, otherOutcomes measure: interleukin-6 in cerebrospinal fluid, otherOutcomes measure: interleukin-10 in serum, otherOutcomes measure: interleukin-10 in cerebrospinal fluid, otherOutcomes measure: interleukin-12p70 in serum, otherOutcomes measure: interleukin-12p70 in cerebrospinal fluid, otherOutcomes measure: interleukin-17 in serum, otherOutcomes measure: interleukin-17 in cerebrospinal fluid, otherOutcomes measure: Tumor necrosis factor alpha in serum, otherOutcomes measure: Tumor necrosis factor alpha in cerebrospinal fluid, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RWTH Aachen, city: Aachen, country: Germany, geoPoint lat: 50.77664, lon: 6.08342, locations facility: Charité Universitätsmedizin Berlin, city: Berlin, country: Germany, contacts name: André Maier, Dr., role: CONTACT, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Clinic Bochum, city: Bochum, country: Germany, geoPoint lat: 51.48165, lon: 7.21648, locations facility: University Clinic Bonn, city: Bonn, country: Germany, contacts name: Patrick Weydt, Dr., role: CONTACT, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Technical University Dresden, city: Dresden, country: Germany, contacts name: René Günther, Dr., role: CONTACT, geoPoint lat: 51.05089, lon: 13.73832, locations facility: University Clinic Erlangen, city: Erlangen, country: Germany, contacts name: Jürgen Winkler, Prof. Dr., role: CONTACT, geoPoint lat: 49.59099, lon: 11.00783, locations facility: Alfried Krupp Krankenhaus Essen, city: Essen, country: Germany, contacts name: Torsten Grehl, Dr., role: CONTACT, geoPoint lat: 51.45657, lon: 7.01228, locations facility: University Clinic Göttingen, city: Göttingen, country: Germany, contacts name: Jan C Koch, Dr., role: CONTACT, geoPoint lat: 51.53443, lon: 9.93228, locations facility: University Clinic Halle, city: Halle, country: Germany, contacts name: Elena Schlapakow, Dr., role: CONTACT, geoPoint lat: 51.48159, lon: 11.97948, locations facility: Hannover Medical School, city: Hannover, country: Germany, contacts name: Susanne Petri, Prof. Dr., role: CONTACT, geoPoint lat: 52.37052, lon: 9.73322, locations facility: University Clinic Jena, city: Jena, country: Germany, contacts name: Annekathrin Rödiger, Dr., role: CONTACT, geoPoint lat: 50.92878, lon: 11.5899, locations facility: DRK Clinic Kassel, city: Kassel, country: Germany, contacts name: Clemens Eickhoff, Dr., role: CONTACT, geoPoint lat: 51.31667, lon: 9.5, locations facility: Klinikum Kempten, city: Kempten, country: Germany, contacts name: Elmar Pinkhardt, Dr., role: CONTACT, geoPoint lat: 47.72674, lon: 10.31389, locations facility: University Clinic Leipzig, city: Leipzig, country: Germany, contacts name: Moritz Metelmann, Dr., role: CONTACT, geoPoint lat: 51.33962, lon: 12.37129, locations facility: University Clinic Lübeck, city: Lübeck, country: Germany, contacts name: Julian Großkreutz, Prof. Dr., role: CONTACT, geoPoint lat: 53.86893, lon: 10.68729, locations facility: University Clinic Mannheim, city: Mannheim, country: Germany, contacts name: Joachim Wolf, Dr., role: CONTACT, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Technical University Munich, city: Munich, country: Germany, contacts name: Paul Lingor, Prof. Dr., role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, locations facility: University Clinic Münster, city: Münster, country: Germany, contacts name: Matthias Böntert, Dr., role: CONTACT, geoPoint lat: 51.96236, lon: 7.62571, locations facility: University Clinic Regensburg, city: Regensburg, country: Germany, contacts name: Zacharias Kohl, Dr., role: CONTACT, geoPoint lat: 49.01513, lon: 12.10161, locations facility: University Clinic Rostock, city: Rostock, country: Germany, contacts name: Johannes Prudlo, Prof. Dr., role: CONTACT, contacts name: Andreas Herrmann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.0887, lon: 12.14049, locations facility: University of Ulm, city: Ulm, country: Germany, contacts name: Johannes Dorst, Prof. Dr., role: CONTACT, geoPoint lat: 48.39841, lon: 9.99155, locations facility: DKD HELIOS Clinic Wiesbaden, city: Wiesbaden, country: Germany, contacts name: Bertold Schrank, Dr., role: CONTACT, geoPoint lat: 50.08258, lon: 8.24932, locations facility: University Clinic Würzburg, city: Würzburg, country: Germany, contacts name: Daniel Zeller, Dr., role: CONTACT, geoPoint lat: 49.79391, lon: 9.95121, hasResults: False |
protocolSection identificationModule nctId: NCT06280066, orgStudyIdInfo id: 2023/607, briefTitle: An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, collaborators name: TC Erciyes University, descriptionModule briefSummary: Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers.In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months., conditionsModule conditions: Cystic Fibrosis, conditions: Children, conditions: Resilience,Psychological, conditions: Laughter Yoga, conditions: Laughter Therapy, conditions: Mothers, conditions: Psychological Health, conditions: Lung Functions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, outcomesModule primaryOutcomes measure: The Respiratory Function Test, primaryOutcomes measure: The Revised Cystic Fibrosis Questionnaire Child Form, primaryOutcomes measure: Psychological Resilience Attitude and Skills Scale Child Form, primaryOutcomes measure: Functional Disability Inventory Child, primaryOutcomes measure: The Revised Cystic Fibrosis Questionnaire Parent Form, primaryOutcomes measure: Depression Anxiety and Stress Scale, primaryOutcomes measure: Post-Traumatic Growth Scale, primaryOutcomes measure: Brief Psychological Resilience Scale, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Erciyes University, city: Kayseri, zip: 38000, country: Turkey, contacts name: Selin Söyünmez, role: CONTACT, phone: +905319762180, email: [email protected], contacts name: Yağmur Sezer Efe, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Selin Söyünmez, PhD Student, role: PRINCIPAL_INVESTIGATOR, contacts name: Mehmet Köse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06280053, orgStudyIdInfo id: 103-3024A3, briefTitle: HealiAid in the Treatment of Different Wounds, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-03-02, primaryCompletionDateStruct date: 2018-04-11, completionDateStruct date: 2018-10-26, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Maxigen Biotech Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds.The main questions it aims to answer are:1. The wound healing which was defined as the percentage of area change.2. The duration of wound healing.3. The granulation tissue growth of the wound.4. The wound exudate.5. Safety Indicators of which incidences after treatment.HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks., conditionsModule conditions: Venous Ulcers, conditions: Bedsores, conditions: Diabetic Foot Wound, conditions: Burn Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: HealiAid Collagen Wound Dressing, outcomesModule primaryOutcomes measure: Wound Healing, secondaryOutcomes measure: Wound Healing, secondaryOutcomes measure: Duration of Wound Healing, secondaryOutcomes measure: Granulation Tissue Growth, secondaryOutcomes measure: Wound Exudate, secondaryOutcomes measure: Incidence of Safety Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06280040, orgStudyIdInfo id: UM Longitudinal 1942/2022, briefTitle: Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry., conditionsModule conditions: Uveal Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Clinical examination and multimodal ocular imaging, outcomesModule primaryOutcomes measure: Incidence and Severity of Retinopathy, secondaryOutcomes measure: Incidence and Severity of Opticopathy, secondaryOutcomes measure: Functional Outcome, secondaryOutcomes measure: Incidence and Severity of Retinopathy and Opticopathy in oximeter, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology and Optometry, Medical University Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Judith Kreminger, MD, role: CONTACT, phone: 0043 1 40400 48470, email: [email protected], contacts name: Reinhard Told, MD, PhD, Priv.-Doz., role: CONTACT, phone: 0043 1 40400 48470, email: [email protected], contacts name: Adrian Reumueller, MD, Priv.-Doz, role: SUB_INVESTIGATOR, contacts name: Roman Dunavoelgyi, MD, Assoc.-Prof., role: SUB_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False |
protocolSection identificationModule nctId: NCT06280027, orgStudyIdInfo id: MUDHF_BK1, briefTitle: Effect of Midline Discrepancy and Crown Width Disporportion on Esthetics, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-05, primaryCompletionDateStruct date: 2023-06-12, completionDateStruct date: 2023-12-22, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: In the web-based cross-sectional study 180 participants were included. Half of them (n = 90) were patients (laypeople) of the university clinic and the remaining half were restorative dentists and prosthodontists with similar levels of clinical experience (at least 3 years of academic training).A frontal view full-face portrait image of a 25-year-old female was selected as a model for the study, with a smile exhibiting good dental alignment, a quite good midline position, and tooth size symmetry.The original image was digitally modified by a single restorative instructor using Photoshop CC (Adobe, USA) software program. The modifications were divided into three parts. The first part was the generation of midline discrepancy at different levels. The midline was digitally moved to the right side of the patient 1 - 4 millimeters, gradually. The midline movement was performed together with the whole maxillary arch.The second part was the generation of individual crown width disproportions. Accordingly, the mesiodistal width of the left central, lateral, and canine was digitally decreased one by one, gradually, while the width of the symmetrical teeth on the right side was simultaneously increased.The third part was the generation of distributed crown width disproportions. Accordingly, the total mesiodistal width of the left central, lateral, and canine was equally decreased, gradually, while the total width of the symmetrical teeth on the right side was simultaneously increased.In total, 15 images were displayed in random order to the participants including the original image. An online survey was generated to quantitatively evaluate the level of esthetic perception. Subsequently, the participants were asked to evaluate the level of smile esthetics of the presented random images, without being informed about the digital manipulations of the images. The participants were even not informed about the original image. They were expected to answer the question "How esthetic do you consider this smile?" The evaluation of each image was performed via a Visual analog scale VAS, ranging from point 0 (extremely not esthetic) to point 100 (extremely esthetic)., conditionsModule conditions: Esthetics, Dental, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: survey, outcomesModule primaryOutcomes measure: survey on midline discrepancy at different levels, primaryOutcomes measure: survey on individual crown width disproportions, primaryOutcomes measure: survey on distributed crown width disproportions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University Faculty of Dentistry, city: İstanbul, zip: 34854, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06280014, orgStudyIdInfo id: YYU-09/15.12.2021, briefTitle: Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-20, primaryCompletionDateStruct date: 2022-02-20, completionDateStruct date: 2023-09-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Yuzuncu Yıl University, class: OTHER, descriptionModule briefSummary: This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated., conditionsModule conditions: Tooth, Impacted, conditions: Tooth Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Surgery of impacted mandibular wisdom teeth, interventions name: Surgery of impacted mandibular wisdom teeth, outcomesModule primaryOutcomes measure: Mouth opening measurements, primaryOutcomes measure: Facial edema, primaryOutcomes measure: Visual Analog Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Serap Keskin Tunc, city: Van, zip: 65100, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False |
protocolSection identificationModule nctId: NCT06280001, orgStudyIdInfo id: 2023YFC2308802-04, briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.* Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.* Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection., conditionsModule conditions: Acquired Immunodeficiency Syndrome, conditions: HIV Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Secondary infections in patients with HIV/AIDS at 4 weeks, primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279988, orgStudyIdInfo id: K24, briefTitle: BRING-UP 3 Heart Failure, acronym: BRING-UP3HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-07-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Heart Care Foundation, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF)., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF, secondaryOutcomes measure: Rate of patient achieving appropriate dosages of GDMTs, secondaryOutcomes measure: Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF), secondaryOutcomes measure: Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF, secondaryOutcomes measure: All cause and specific causes of death and hospitalization (Exploratory endpoint), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Santo Spirito - Sc Cardiologia, status: RECRUITING, city: Casale Monferrato, state: AL, zip: 15033, country: Italy, contacts name: FEDERICO NARDI, MD, role: CONTACT, geoPoint lat: 45.13338, lon: 8.4525, locations facility: Ospedale San Giacomo - Sc Cardiologia, status: RECRUITING, city: Novi Ligure, state: AL, zip: 15067, country: Italy, contacts name: MARIA E ROVERE, MD, role: CONTACT, geoPoint lat: 44.76246, lon: 8.787, locations facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic, status: RECRUITING, city: Ancona, state: AN, zip: 60122, country: Italy, contacts name: ILARIA BATTISTONI, MD, role: CONTACT, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia, status: RECRUITING, city: Ancona, state: AN, zip: 60131, country: Italy, contacts name: PAOLA TAMBURRINI, MD, role: CONTACT, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale San Donato - U.O.C Cardiologia, status: RECRUITING, city: Arezzo, state: AR, zip: 52100, country: Italy, contacts name: MATTEO ROCCO RECCIA, MD, role: CONTACT, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona, status: RECRUITING, city: Cortona, state: AR, zip: 52044, country: Italy, contacts name: SIMONA D'ORAZIO, MD, role: CONTACT, geoPoint lat: 43.27467, lon: 11.98533, locations facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti', status: RECRUITING, city: Avellino, state: AV, zip: 83100, country: Italy, contacts name: EMILIO DI LORENZO, MD, role: CONTACT, geoPoint lat: 40.91494, lon: 14.79103, locations facility: Ospedale Miulli - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Acquaviva Delle Fonti, state: BA, zip: 70021, country: Italy, contacts name: NICOLA VITULANO, MD, role: CONTACT, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic, status: RECRUITING, city: Altamura, state: BA, zip: 70022, country: Italy, contacts name: PIETRO SCICCHITANO, MD, role: CONTACT, geoPoint lat: 40.82664, lon: 16.54952, locations facility: Ospedale San Paolo - Cardiologia-Utic, status: RECRUITING, city: Bari, state: BA, zip: 70123, country: Italy, contacts name: PASQUALE CALDAROLA, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ics Maugeri Spa Societa' Benefit Irccs Bari - Cardiologia Riabilitativa, status: RECRUITING, city: Bari, state: BA, zip: 70124, country: Italy, contacts name: ANDREA PASSANTINO, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Mater Dei Hospital - Riabilitazione Cardiologica, status: RECRUITING, city: Bari, state: BA, zip: 70124, country: Italy, contacts name: ROCCO LAGIOIA, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Di Venere - U.O.C. Di Cardiologia, status: RECRUITING, city: Carbonara Di Bari, state: BA, zip: 70012, country: Italy, contacts name: MASSIMO V BONFANTINO, MD, role: CONTACT, geoPoint lat: 41.06667, lon: 16.86667, locations facility: Ospedale San Giacomo - Uoc Cardiologia, status: RECRUITING, city: Monopoli, state: BA, zip: 70043, country: Italy, contacts name: ONOFRIO ROSSI, MD, role: CONTACT, geoPoint lat: 40.94918, lon: 17.29717, locations facility: Ospedale Degli Infermi - Sc Di Cardiologia, status: RECRUITING, city: Ponderano, state: BI, zip: 13875, country: Italy, contacts name: ANDREA ROGNONI, MD, role: CONTACT, geoPoint lat: 45.53846, lon: 8.05592, locations facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic, status: RECRUITING, city: Feltre, state: BL, zip: 32032, country: Italy, contacts name: FRANCESCA DE CIAN, MD, role: CONTACT, geoPoint lat: 46.02085, lon: 11.90031, locations facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura, status: RECRUITING, city: Bentivoglio, state: BO, zip: 40010, country: Italy, contacts name: GIANFRANCO TORTORICI, MD, role: CONTACT, geoPoint lat: 44.6369, lon: 11.41737, locations facility: Ospedale Maggiore - U.O.C. Di Cardiologia, status: RECRUITING, city: Bologna, state: BO, zip: 40133, country: Italy, contacts name: GIULIA BUGANI, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Policlinico S. Orsola-Malpighi - Medicina Interna - Borghi, status: RECRUITING, city: Bologna, state: BO, zip: 40138, country: Italy, contacts name: CLAUDIO BORGHI, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Perrino - U.O.C. Di Cardiologia, status: RECRUITING, city: Brindisi, state: BR, zip: 72100, country: Italy, contacts name: GIAN PAOLO GIORDA, MD, role: CONTACT, geoPoint lat: 40.63215, lon: 17.93607, locations facility: Istituto Ospedaliero Fondazione Poliambulanza - Unita Operativa Di Cardiologia E Utic, status: RECRUITING, city: Brescia, state: BS, zip: 25124, country: Italy, contacts name: LORENZO CAPRINI, MD, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C., status: RECRUITING, city: Desenzano Del Garda, state: BS, zip: 25015, country: Italy, contacts name: GIOSUE' MASCIOLI, MD, role: CONTACT, geoPoint lat: 45.47127, lon: 10.53559, locations facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia, status: RECRUITING, city: Gavardo, state: BS, zip: 25085, country: Italy, contacts name: MARCO TRIGGIANI, MD, role: CONTACT, geoPoint lat: 45.58939, lon: 10.44257, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Lumezzane - U.O. Di Cardiologia Riabilitativa, status: RECRUITING, city: Lumezzane, state: BS, zip: 25065, country: Italy, contacts name: EMANUELA ZANELLI, MD, role: CONTACT, geoPoint lat: 45.64789, lon: 10.26487, locations facility: Ospedale Monsignor Angelo R. Di Miccoli - Uoc Cardiologia/Utic, status: ACTIVE_NOT_RECRUITING, city: Barletta, state: BT, zip: 76121, country: Italy, geoPoint lat: 41.31429, lon: 16.28165, locations facility: Ospedale Caduti in Guerra - U.O.S.V.D Di Riabilitazione Cardiologica, status: RECRUITING, city: Canosa Di Puglia, state: BT, zip: 76012, country: Italy, contacts name: FRANCESCO BARTOLOMUCCI, MD, role: CONTACT, geoPoint lat: 41.21954, lon: 16.06768, locations facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali, status: RECRUITING, city: Bolzano, state: BZ, zip: 39100, country: Italy, contacts name: PRISCILLA MILEWSKI, MD, role: CONTACT, geoPoint lat: 46.49067, lon: 11.33982, locations facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic, status: RECRUITING, city: Caserta, state: CE, zip: 81100, country: Italy, contacts name: PAOLO CALABRO', MD, role: CONTACT, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Villa Delle Magnolie - Riabilitazione Cardiologica, status: RECRUITING, city: Castel Morrone, state: CE, zip: 81020, country: Italy, contacts name: FRANCESO PERONE, MD, role: CONTACT, geoPoint lat: 41.12102, lon: 14.35473, locations facility: Casa Di Cura San Michele - Uo Cardiologia, status: RECRUITING, city: Maddaloni, state: CE, zip: 81024, country: Italy, contacts name: MARCO PEPE, MD, role: CONTACT, geoPoint lat: 41.03578, lon: 14.3823, locations facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic, status: RECRUITING, city: Chieti, state: CH, zip: 66013, country: Italy, contacts name: MARCO ZIMARINO, MD, role: CONTACT, geoPoint lat: 42.34827, lon: 14.16494, locations facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia, status: RECRUITING, city: Cuneo, state: CN, zip: 12100, country: Italy, contacts name: ROBERTA ROSSINI, MD, role: CONTACT, geoPoint lat: 44.39071, lon: 7.54828, locations facility: Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic, status: RECRUITING, city: Mondovì, state: CN, zip: 12084, country: Italy, contacts name: MAURO FEOLA, MD, role: CONTACT, geoPoint lat: 44.39603, lon: 7.81764, locations facility: Ospedale Maggiore Ss. Annunziata - Sc Cardiologia, status: RECRUITING, city: Savigliano, state: CN, zip: 12038, country: Italy, contacts name: MICHELE DE BENEDICTIS, MD, role: CONTACT, geoPoint lat: 44.64808, lon: 7.65677, locations facility: Ospedale Pietro E Michele Ferrero - Cardiologia E Utic, status: RECRUITING, city: Verduno, state: CN, zip: 12060, country: Italy, contacts name: VIRGINIA BOVOLO, MD, role: CONTACT, geoPoint lat: 44.66614, lon: 7.93074, locations facility: Ospedale S. Anna - U.O.C. Di Cardiologia, status: RECRUITING, city: San Fermo Della Battaglia, state: CO, zip: 22020, country: Italy, geoPoint lat: 45.80868, lon: 9.04744, locations facility: Ospedale Oglio Po - U.O. Di Cardiologia-Utic, status: RECRUITING, city: Casalmaggiore, state: CR, zip: 26041, country: Italy, contacts name: CARLO PISCICELLI, MD, role: CONTACT, geoPoint lat: 44.98981, lon: 10.42055, locations facility: Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic, status: RECRUITING, city: Castrovillari, state: CS, zip: 87012, country: Italy, contacts name: ANDREA MADEO, MD, role: CONTACT, geoPoint lat: 39.81632, lon: 16.20183, locations facility: Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia, status: RECRUITING, city: Paola, state: CS, zip: 87027, country: Italy, contacts name: MARIA T MANES, MD, role: CONTACT, geoPoint lat: 39.36313, lon: 16.03691, locations facility: P.O. Garibaldi-Nesima - Arnas Garibaldi - U.O.C. Di Cardiologia Con Utic, status: RECRUITING, city: Catania, state: CT, zip: 95122, country: Italy, contacts name: MICHELE M GULIZIA, MD, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Policlinico Catania Po G. Rodolico - Cardiologia Utic, status: RECRUITING, city: Catania, state: CT, zip: 95125, country: Italy, contacts name: GIUSEPPE LEONARDI, MD, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Azienda Ospedaliera Cannizzaro - Uoc Cardiologia, status: RECRUITING, city: Catania, state: CT, zip: 95126, country: Italy, contacts name: FRANCESCO AMICO, MD, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: P.O. "Materdomini" - A.O.U. "Renato Dulbecco" - Ssd Cardiologia Riabilitativa, status: RECRUITING, city: Catanzaro, state: CZ, zip: 88100, country: Italy, contacts name: DOMENICO ZUCCO, MD, role: CONTACT, geoPoint lat: 38.88247, lon: 16.60086, locations facility: P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica, status: RECRUITING, city: Catanzaro, state: CZ, zip: 88100, country: Italy, contacts name: FRANCESCO CASSADONTE, MD, role: CONTACT, geoPoint lat: 38.88247, lon: 16.60086, locations facility: Presidio Ospedaliero Umberto I - Cardiologia - Utic- Riabilitazione, status: RECRUITING, city: Enna, state: EN, zip: 94100, country: Italy, contacts name: RAFFAELLA IUDICELLO, MD, role: CONTACT, geoPoint lat: 37.5655, lon: 14.27433, locations facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia, status: RECRUITING, city: Forli', state: FC, zip: 47121, country: Italy, contacts name: ELISA GARDINI, MD, role: CONTACT, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Ospedale Ss. Annunziata - U.O. Di Cardiologia Provinciale, status: RECRUITING, city: Cento, state: FE, zip: 44042, country: Italy, contacts name: BIAGIO SASSONE, MD, role: CONTACT, geoPoint lat: 44.73099, lon: 11.28716, locations facility: Arcispedale Sant'Anna - U.O. Cardiologia, status: RECRUITING, city: Ferrara, state: FE, zip: 44124, country: Italy, contacts name: ALESSANDRO FUCILI, MD, role: CONTACT, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Ospedale Del Delta - U.O. Cardiologia, status: RECRUITING, city: Lagosanto, state: FE, zip: 44023, country: Italy, contacts name: BIAGIO SASSONE, MD, role: CONTACT, geoPoint lat: 44.76282, lon: 12.14005, locations facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic, status: RECRUITING, city: Foggia, state: FG, zip: 71100, country: Italy, contacts name: NATALE D BRUNETTI, MD, role: CONTACT, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica, status: ACTIVE_NOT_RECRUITING, city: San Giovanni Rotondo, state: FG, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Ospedale San Giuseppe - Cardiologia, status: RECRUITING, city: Empoli, state: FI, zip: 50053, country: Italy, contacts name: FLAVIO VENTURI, MD, role: CONTACT, geoPoint lat: 43.71795, lon: 10.94758, locations facility: Ospedale Santa Maria Nuova - Cardiologia, status: RECRUITING, city: Firenze, state: FI, zip: 50122, country: Italy, contacts name: MASSIMO MILLI, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale San Giovanni Di Dio - Sos Cardiologia, status: RECRUITING, city: Firenze, state: FI, zip: 50124, country: Italy, contacts name: MASSIMO MILLI, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Aou Careggi - Geriatria - Utig, status: RECRUITING, city: Firenze, state: FI, zip: 50141, country: Italy, contacts name: ANDREA UNGAR, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Padre Antero Micone - Sc Cardiologia - Utic, status: RECRUITING, city: Genova, state: GE, zip: 16100, country: Italy, contacts name: SILVIA COSTA, MD, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Irccs Ospedale Policlinico San Martino - Clinica Malattie Apparato Cardiovascolare, status: RECRUITING, city: Genova, state: GE, zip: 16132, country: Italy, contacts name: MARCO CANEPA, MD, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic, status: RECRUITING, city: Lavagna, state: GE, zip: 16033, country: Italy, contacts name: GUIDO PARODI, MD, role: CONTACT, geoPoint lat: 44.3062, lon: 9.35383, locations facility: Ospedale San Giovanni Di Dio - Sc Cardiologia (Gorizia-Monfalcone), status: RECRUITING, city: Gorizia, state: GO, zip: 34170, country: Italy, contacts name: GERARDINA LARDIERI, MD, role: CONTACT, geoPoint lat: 45.94088, lon: 13.62167, locations facility: Ospedale Civile San Polo - Sc Cardiologia (Gorizia-Monfalcone), status: RECRUITING, city: Monfalcone, state: GO, zip: 34074, country: Italy, contacts name: GERARDINA LARDIERI, MD, role: CONTACT, geoPoint lat: 45.80463, lon: 13.53292, locations facility: Ospedale S. Andrea - Alta Maremma - Uosd Cardiologia, status: RECRUITING, city: Massa Marittima, state: GR, zip: 58024, country: Italy, contacts name: NICOLA D'APRILE, MD, role: CONTACT, geoPoint lat: 43.04779, lon: 10.89293, locations facility: Ospedale Alessandro Manzoni - S.C. Di Cardiologia, status: RECRUITING, city: Lecco, state: LC, zip: 23900, country: Italy, contacts name: ROBERTO SPOLADORE, MD, role: CONTACT, geoPoint lat: 45.85589, lon: 9.39704, locations facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia, status: ACTIVE_NOT_RECRUITING, city: Copertino, state: LE, zip: 73043, country: Italy, geoPoint lat: 40.26821, lon: 18.0543, locations facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica, status: RECRUITING, city: Lecce, state: LE, zip: 73100, country: Italy, contacts name: STEFANIA MARAZIA, MD, role: CONTACT, geoPoint lat: 40.35481, lon: 18.17244, locations facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei", status: RECRUITING, city: Scorrano, state: LE, zip: 73020, country: Italy, contacts name: COSIMO A GRECO, MD, role: CONTACT, geoPoint lat: 40.09018, lon: 18.29993, locations facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic, status: RECRUITING, city: Livorno, state: LI, zip: 57124, country: Italy, contacts name: EMILIO M PASANISI, MD, role: CONTACT, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Ospedale Villamarina - Cardiologia E Utic Piombino Elba, status: RECRUITING, city: Piombino, state: LI, zip: 57025, country: Italy, contacts name: LARA FREDIANI, MD, role: CONTACT, geoPoint lat: 42.92554, lon: 10.52585, locations facility: Nuovo Ospedale Versilia - Sc Cardiologia, status: RECRUITING, city: Camaiore, state: LU, zip: 55041, country: Italy, contacts name: GIANCARLO CASOLO, MD, role: CONTACT, geoPoint lat: 43.94265, lon: 10.29754, locations facility: Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist., status: ACTIVE_NOT_RECRUITING, city: Castelnuovo Di Garfagnana, state: LU, zip: 55032, country: Italy, geoPoint lat: 44.1126, lon: 10.40518, locations facility: Ospedale Pio Xi - U.O.C. Di Cardiologia, status: RECRUITING, city: Desio, state: MB, zip: 20832, country: Italy, contacts name: FELICE ACHILLI, MD, role: CONTACT, geoPoint lat: 45.61831, lon: 9.20249, locations facility: Policlinico Di Monza - Cardiologia Clinica E Utic, status: RECRUITING, city: Monza, state: MB, zip: 20900, country: Italy, contacts name: MATTEO OLDANI, MD, role: CONTACT, geoPoint lat: 45.58005, lon: 9.27246, locations facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic, status: RECRUITING, city: Vimercate, state: MB, zip: 20871, country: Italy, contacts name: ANTONIO CIRO', MD, role: CONTACT, geoPoint lat: 45.61545, lon: 9.36801, locations facility: Ospedale Generale Provinciale - U.O. Cardiologia, status: RECRUITING, city: Macerata, state: MC, zip: 62100, country: Italy, contacts name: DANIELE CONTADINI, MD, role: CONTACT, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Irccs Centro Neurolesi Bonino Pulejo - P.O Piemonte - Cardiologia E Utic, status: RECRUITING, city: Messina, state: ME, zip: 98124, country: Italy, contacts name: MYRIAM D'ANGELO, MD, role: CONTACT, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Azienda Ospedaliera Papardo - U.O. Cardiologia Con Utic - Emodinamica, status: RECRUITING, city: Messina, state: ME, zip: 98158, country: Italy, contacts name: MARIA C TODARO, MD, role: CONTACT, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Asst Papa Giovanni Xxiii - Sc Cardiologia 1, status: RECRUITING, city: Bergamo, state: MI, zip: 24127, country: Italy, contacts name: EMILIA D'ELIA, MD, role: CONTACT, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc, status: RECRUITING, city: Cernusco Sul Naviglio, state: MI, zip: 20063, country: Italy, contacts name: SERGIO SALA, MD, role: CONTACT, geoPoint lat: 45.52526, lon: 9.33297, locations facility: Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg), status: RECRUITING, city: Cinisello Balsamo, state: MI, zip: 20092, country: Italy, contacts name: GRAZIA M CASTELLI, MD, role: CONTACT, geoPoint lat: 45.55823, lon: 9.21495, locations facility: Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica, status: RECRUITING, city: Legnano, state: MI, zip: 20025, country: Italy, contacts name: CORINNA A INSERRA, MD, role: CONTACT, geoPoint lat: 45.59788, lon: 8.91506, locations facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari, status: RECRUITING, city: Milano, state: MI, zip: 20122, country: Italy, contacts name: STEFANO CARUGO, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Fatebenefratelli E Oftalmico - Cardiologia E U.C.C., status: RECRUITING, city: Milano, state: MI, zip: 20122, country: Italy, contacts name: ADA F GIGLIO, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Centro Cardiologico Monzino Irccs - Scompenso,Cardiologia Clinica, status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: PIETRO PALERMO, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Riabilitazione Cardiologica, status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: MAURO MONELLI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Uo Cure Subacute, status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: MAURO PROIETTI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC, status: RECRUITING, city: Milano, state: MI, zip: 20153, country: Italy, contacts name: STEFANO LUCREZIOTTI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco, status: RECRUITING, city: Milano, state: MI, zip: 20157, country: Italy, contacts name: EDOARDO CONTE, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 2 - Insufficienza Cardiaca E Trapianto, status: RECRUITING, city: Milano, state: MI, zip: 20162, country: Italy, contacts name: ANDREA GARASCIA, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Clinica San Carlo - U.O. Cardiologia-Unita'Cure Coronariche, status: RECRUITING, city: Paderno Dugnano, state: MI, zip: 20037, country: Italy, contacts name: ALESSIO CAPPELLERI, MD, role: CONTACT, geoPoint lat: 45.56899, lon: 9.16483, locations facility: Presidio Ospedaliero Di Passirana - Cardiologia Riabilitativa, status: RECRUITING, city: Passirana, state: MI, zip: 20017, country: Italy, contacts name: ANNA FRISINGHELLI, MD, role: CONTACT, geoPoint lat: 45.54792, lon: 9.04412, locations facility: Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc, status: RECRUITING, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: GIUSEPPE PINTO, MD, role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Irccs Policlinico San Donato - U.O. Cardiologia Con Utic, status: RECRUITING, city: San Donato Milanese, state: MI, zip: 20097, country: Italy, contacts name: MASSIMO PIEPOLI, MD, role: CONTACT, geoPoint lat: 45.41047, lon: 9.26838, locations facility: Irccs Policlinico Multimedica - Uo Di Cardiologia, status: RECRUITING, city: Sesto San Giovanni, state: MI, zip: 20099, country: Italy, contacts name: GIUSEPPE GALATI, MD, role: CONTACT, geoPoint lat: 45.53329, lon: 9.22585, locations facility: Ospedale Madonna Delle Grazie - Ssd Utic, status: ACTIVE_NOT_RECRUITING, city: Matera, state: Mount, zip: 75100, country: Italy, geoPoint lat: 40.66599, lon: 16.60463, locations facility: Ospedale Giovanni Paolo Ii - Uosd Utic, status: RECRUITING, city: Policoro, state: Mount, zip: 75025, country: Italy, contacts name: ANDREA ANDRIANI, MD, role: CONTACT, geoPoint lat: 40.2128, lon: 16.67795, locations facility: Ospedale Santa Maria Bianca - U.O. Di Cardiologia, status: RECRUITING, city: Mirandola, state: MO, zip: 41037, country: Italy, contacts name: BENEDETTA VERONESI, MD, role: CONTACT, geoPoint lat: 44.88515, lon: 11.06902, locations facility: Ospedale Di Sassuolo - Cardiologia, status: RECRUITING, city: Sassuolo, state: MO, zip: 41049, country: Italy, contacts name: ANNA MARTELLI, MD, role: CONTACT, geoPoint lat: 44.5432, lon: 10.7848, locations facility: Ospedale Giovanni Paolo Ii - Utic - Cardiologia, status: RECRUITING, city: Olbia, state: OT, zip: 07026, country: Italy, contacts name: MARIA ELENA L PICOI, MD, role: CONTACT, geoPoint lat: 40.92337, lon: 9.49802, locations facility: Fondazione G. Giglio - U.O. Di Cardiologia, status: RECRUITING, city: Cefalu', state: PA, zip: 90015, country: Italy, contacts name: TOMMASO A CIPOLLA, MD, role: CONTACT, geoPoint lat: 38.03856, lon: 14.02285, locations facility: Ospedale Buccheri La Ferla Fatebenefratelli - Ssd Riabilitazione Cardiovascolare, status: RECRUITING, city: Palermo, state: PA, zip: 90123, country: Italy, contacts name: FILIPPO M SARULLO, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Arnas P.O. Civico E Benfratelli - Uoc Utic, status: RECRUITING, city: Palermo, state: PA, zip: 90127, country: Italy, contacts name: IGNAZIO M SMECCA, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Arnas P.O. Civico E Benfratelli - Uosd Cardiologia Clinica Trattam. Scompenso Card., status: RECRUITING, city: Palermo, state: PA, zip: 90127, country: Italy, contacts name: EGLE INCALCATERRA, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Maria Eleonora Hospital - Cardiologia, status: RECRUITING, city: Palermo, state: PA, zip: 90135, country: Italy, contacts name: VINCENZO PERNICE, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello, status: RECRUITING, city: Palermo, state: PA, zip: 90146, country: Italy, contacts name: VINCENZO POLIZZI, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia, status: RECRUITING, city: Palermo, state: PA, zip: 90146, country: Italy, contacts name: AGATA M FLORESTA, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale Unico Della Val Tidone - Cardiologia E Riabilitazione, status: RECRUITING, city: Castel San Giovanni, state: PC, zip: 29015, country: Italy, contacts name: GIANLUCA LANATI, MD, role: CONTACT, geoPoint lat: 45.06014, lon: 9.43784, locations facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic, status: RECRUITING, city: Piacenza, state: PC, zip: 29100, country: Italy, contacts name: DANIELA ASCHIERI, MD, role: CONTACT, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Ospedali Riuniti Padova Sud - U.O.C. Cardiologia, status: RECRUITING, city: Monselice, state: PD, zip: 35043, country: Italy, contacts name: FRANCESCA E BOVOLATO, MD, role: CONTACT, geoPoint lat: 45.239, lon: 11.74984, locations facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic, status: RECRUITING, city: Pescara, state: PE, zip: 65124, country: Italy, contacts name: MASSIMO DI MARCO, MD, role: CONTACT, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic, status: RECRUITING, city: Citta' Di Castello, state: PG, zip: 06012, country: Italy, contacts name: KWAME MBOUMI, MD, role: CONTACT, geoPoint lat: 43.46556, lon: 12.2375, locations facility: Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia, status: RECRUITING, city: Foligno, state: PG, zip: 06034, country: Italy, contacts name: EMILIA BISCOTTINI, MD, role: CONTACT, geoPoint lat: 42.95488, lon: 12.70268, locations facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia, status: RECRUITING, city: Gubbio, state: PG, zip: 06024, country: Italy, contacts name: DEBORAH COSMI, MD, role: CONTACT, geoPoint lat: 43.34996, lon: 12.57309, locations facility: Centro Servizi Grocco - Cardiologia Riabilitativa E Prevenzione, status: RECRUITING, city: Perugia, state: PG, zip: 06123, country: Italy, contacts name: LUCIA FILIPPUCCI, MD, role: CONTACT, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare, status: RECRUITING, city: Pisa, state: PI, zip: 56124, country: Italy, contacts name: MICHELE EMDIN, MD, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale Generale Provinciale Lotti - U.O. Malattie Cardiovascolari Vde E Avc, status: ACTIVE_NOT_RECRUITING, city: Pontedera, state: PI, zip: 56025, country: Italy, geoPoint lat: 43.66141, lon: 10.63067, locations facility: Ospedale Di S. Vito Al Tagliamento - Ssd Cardiologia San Vito - Spilimbergo, status: RECRUITING, city: San Vito Al Tagliamento, state: PN, zip: 33078, country: Italy, contacts name: ARIANNA GARDIN, MD, role: CONTACT, geoPoint lat: 45.9168, lon: 12.85945, locations facility: Ospedale San Jacopo - Soc Cardiologia, status: RECRUITING, city: Pistoia, state: Point, zip: 51100, country: Italy, contacts name: MICHELA TAGLIOLI, MD, role: CONTACT, geoPoint lat: 43.93064, lon: 10.92365, locations facility: Ospedale Civile - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Fidenza, state: PR, zip: 43036, country: Italy, contacts name: GIOVANNI TORTORELLA, MD, role: CONTACT, geoPoint lat: 44.86694, lon: 10.06039, locations facility: Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1, status: RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: ANNALISA TURCO, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Pavia - U.O. Di Riabilitazione Cardiologica, status: RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: GIOVANNI FORNI, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Civile - U.O. Di Cardiologia, status: RECRUITING, city: Voghera, state: PV, zip: 27058, country: Italy, contacts name: MICHELA G COCCIA, MD, role: CONTACT, geoPoint lat: 44.99151, lon: 9.01175, locations facility: Ospedale Civile - Uo Servizio Cardiologia, status: RECRUITING, city: Lugo, state: RA, zip: 48022, country: Italy, contacts name: GIULIA RICCI LUCCHI, MD, role: CONTACT, geoPoint lat: 44.42137, lon: 11.91094, locations facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia, status: RECRUITING, city: Ravenna, state: RA, zip: 48121, country: Italy, contacts name: ANDREA RUBBOLI, MD, role: CONTACT, geoPoint lat: 44.41344, lon: 12.20121, locations facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord, status: RECRUITING, city: Guastalla, state: RE, zip: 42016, country: Italy, contacts name: ALESSANDRO NAVAZIO, MD, role: CONTACT, geoPoint lat: 44.91172, lon: 10.66186, locations facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera, status: RECRUITING, city: Reggio Emilia, state: RE, zip: 42100, country: Italy, contacts name: ALESSANDRO NAVAZIO, MD, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic, status: RECRUITING, city: Vittoria, state: RG, zip: 97019, country: Italy, contacts name: GIUSEPPE DI STABILE, MD, role: CONTACT, geoPoint lat: 36.95151, lon: 14.52788, locations facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia, status: RECRUITING, city: Rieti, state: RI, zip: 02100, country: Italy, contacts name: AMIR KOL, MD, role: CONTACT, geoPoint lat: 42.40476, lon: 12.85735, locations facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic, status: RECRUITING, city: Ariccia, state: RM, zip: 00072, country: Italy, contacts name: ANNA R FELICI, MD, role: CONTACT, geoPoint lat: 41.72063, lon: 12.6723, locations facility: Ospedale Civile San Paolo - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Civitavecchia, state: RM, zip: 00053, country: Italy, contacts name: SERGIO CALCAGNO, MD, role: CONTACT, geoPoint lat: 42.09325, lon: 11.79674, locations facility: Campus Biomedico - Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00128, country: Italy, contacts name: FRANCESCA GRIGIONI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa, status: RECRUITING, city: Roma, state: RM, zip: 00135, country: Italy, contacts name: FURIO COLIVICCHI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Inmi Lazzaro Spallanzani Irccs - Servizio Di Cardiologia Del Dipartimento Clinico, status: RECRUITING, city: Roma, state: RM, zip: 00149, country: Italy, contacts name: MARIA C GATTO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Camillo - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00152, country: Italy, contacts name: GIOVANNI PULIGNANO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00157, country: Italy, contacts name: ANTONINO GRANATELLI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Casilino - U.O.C. Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00169, country: Italy, contacts name: LEONARDO CALO', MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ao San Giovanni Addolorata - Uoc Cardiologia D'Urgenza E Utic, status: RECRUITING, city: Roma, state: RM, zip: 00184, country: Italy, contacts name: VITTORIA RIZZELLO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic, status: RECRUITING, city: Roma, state: RM, zip: 00188, country: Italy, contacts name: MATTEO RUZZOLINI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00189, country: Italy, contacts name: EMANUELE BARBATO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Santo Spirito - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00193, country: Italy, contacts name: ANGELA B SCARDOVI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic, status: RECRUITING, city: Tivoli, state: RM, zip: 00019, country: Italy, contacts name: ALFREDO POSTERARO, MD, role: CONTACT, geoPoint lat: 41.95952, lon: 12.8016, locations facility: Ospedale Infermi - U.O. Cardiologia, status: RECRUITING, city: Rimini, state: RN, zip: 47900, country: Italy, contacts name: SAMUELA CARIGI, MD, role: CONTACT, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic, status: RECRUITING, city: Eboli, state: SA, zip: 84025, country: Italy, contacts name: ELISA DI IACONI, MD, role: CONTACT, geoPoint lat: 40.61747, lon: 15.05693, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva Ospedaliera, status: RECRUITING, city: Salerno, state: SA, zip: 84131, country: Italy, contacts name: MICHELE R DI MURO, MD, role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic, status: RECRUITING, city: Salerno, state: SA, zip: 84131, country: Italy, contacts name: AMELIA RAVERA, MD, role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Ospedale San Luca - U.O. Utic - Cardiologia, status: RECRUITING, city: Vallo Della Lucania, state: SA, zip: 84078, country: Italy, contacts name: ANTONIO ALOIA, MD, role: CONTACT, geoPoint lat: 40.22786, lon: 15.26635, locations facility: Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic, status: RECRUITING, city: Poggibonsi, state: SI, zip: 53036, country: Italy, contacts name: VALERIO ZACA', MD, role: CONTACT, geoPoint lat: 43.47064, lon: 11.14804, locations facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia, status: RECRUITING, city: Siena, state: SI, zip: 53100, country: Italy, contacts name: SERAFINA VALENTE, MD, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Ospedale San Bartolomeo - Sc Riabilitazione Cardiologica, status: RECRUITING, city: Sarzana, state: SP, zip: 19038, country: Italy, contacts name: DANIELE BERTOLI, MD, role: CONTACT, geoPoint lat: 44.11178, lon: 9.9622, locations facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic, status: RECRUITING, city: Augusta, state: SR, zip: 96011, country: Italy, contacts name: GIOVANNI LICCIARDELLO, MD, role: CONTACT, geoPoint lat: 37.24065, lon: 15.22121, locations facility: Ospedale G. Di Maria - Cardiologia Utic, status: RECRUITING, city: Avola, state: SR, zip: 96012, country: Italy, contacts name: PAOLO COSTA, MD, role: CONTACT, geoPoint lat: 36.9084, lon: 15.13937, locations facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica, status: RECRUITING, city: Sassari, state: SS, zip: 07100, country: Italy, contacts name: GAVINO CASU, MD, role: CONTACT, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic, status: RECRUITING, city: San Gavino Monreale, state: SU, zip: 09037, country: Italy, contacts name: MARGHERITA CASULA, MD, role: CONTACT, geoPoint lat: 39.55008, lon: 8.79065, locations facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente, status: RECRUITING, city: Pietra Ligure, state: SV, zip: 17027, country: Italy, contacts name: CHIARA BERNELLI, MD, role: CONTACT, geoPoint lat: 44.1492, lon: 8.28206, locations facility: P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante, status: RECRUITING, city: Savona, state: SV, zip: 17100, country: Italy, contacts name: ALBERTO SOMASCHINI, MD, role: CONTACT, geoPoint lat: 44.30905, lon: 8.47715, locations facility: Casa Di Cura Villa Verde - Cardiologia, status: RECRUITING, city: Taranto, state: TA, zip: 74100, country: Italy, contacts name: ANGELO ALOISIO, MD, role: CONTACT, geoPoint lat: 40.46435, lon: 17.24707, locations facility: Ospedale Santa Chiara - Divisione Di Cardiologia, status: RECRUITING, city: Trento, state: TN, zip: 38122, country: Italy, contacts name: MICHELE MORETTI, MD, role: CONTACT, geoPoint lat: 46.06787, lon: 11.12108, locations facility: Ospedale Civico - Sc Cardiologia, status: RECRUITING, city: Chivasso, state: TO, zip: 10034, country: Italy, contacts name: CLAUDIO MORETTI, MD, role: CONTACT, geoPoint lat: 45.19093, lon: 7.88981, locations facility: Por Cirié- Lanzo Presidio Cirié - S.C. Cardiologia, status: RECRUITING, city: Cirié, state: TO, zip: 10073, country: Italy, contacts name: MICHELE CAPRIOLO, MD, role: CONTACT, geoPoint lat: 45.23486, lon: 7.60125, locations facility: Ospedale Civile - S.C. Cardiologia, status: RECRUITING, city: Ivrea, state: TO, zip: 10015, country: Italy, contacts name: MARCO M CINGOLANI, MD, role: CONTACT, geoPoint lat: 45.46723, lon: 7.87617, locations facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia, status: RECRUITING, city: Orbassano, state: TO, zip: 10043, country: Italy, contacts name: CARLOALBERTO BIOLÉ, MD, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, locations facility: Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U, status: RECRUITING, city: Torino, state: TO, zip: 10126, country: Italy, contacts name: Gaetano M De Ferrari, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Martini - Cardiologia (Mrt-Mv), status: RECRUITING, city: Torino, state: TO, zip: 10142, country: Italy, contacts name: MASSIMO GIAMMARIA, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Maria Vittoria - Cardiologia (Mrt-Mv), status: ACTIVE_NOT_RECRUITING, city: Torino, state: To, zip: 10149, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale San Giovanni Bosco - Sc Cardiologia, status: RECRUITING, city: Torino, state: TO, zip: 10154, country: Italy, contacts name: PIERLUIGI SBARRA, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Santa Maria Del Carmine - Cardiologia, status: RECRUITING, city: Rovereto, state: Trento, zip: 38068, country: Italy, contacts name: ANNA MANICA, MD, role: CONTACT, geoPoint lat: 45.8904, lon: 11.04053, locations facility: Asugi Trieste - Sc Patologie Cardiovascolari, status: RECRUITING, city: Trieste, state: TS, zip: 34125, country: Italy, contacts name: GIULIA RUSSO, MD, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia, status: RECRUITING, city: Udine, state: UD, zip: 33100, country: Italy, contacts name: MARZIA DE BIASIO, MD, role: CONTACT, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Ospedale Multimedica Castellanza - Cardiologia, status: RECRUITING, city: Castellanza, state: VA, zip: 21053, country: Italy, contacts name: LUCIA SAPORITI, MD, role: CONTACT, geoPoint lat: 45.61079, lon: 8.89616, locations facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia, status: RECRUITING, city: Saronno, state: VA, zip: 21047, country: Italy, contacts name: DANIELE NASSIACOS, MD, role: CONTACT, geoPoint lat: 45.62513, lon: 9.03517, locations facility: Ospedale Di Circolo Galmarini - Cardiologia, status: RECRUITING, city: Tradate, state: VA, zip: 21049, country: Italy, contacts name: PAOLA ANTOGNAZZA, MD, role: CONTACT, geoPoint lat: 45.70843, lon: 8.90763, locations facility: Ospedale Sant'Andrea - Sc Cardiologia, status: RECRUITING, city: Vercelli, state: VC, zip: 13100, country: Italy, contacts name: ELISA RONDANO, MD, role: CONTACT, geoPoint lat: 45.32163, lon: 8.41989, locations facility: Ospedale Dell'Angelo - U.O.C. Cardiologia, status: RECRUITING, city: Mestre, state: VE, zip: 30171, country: Italy, contacts name: SAKIS THEMISTOCLAKIS, MD, role: CONTACT, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Ospedale P.F. Calvi - Uos Di Cardiologia Riabilitativa, status: RECRUITING, city: Noale, state: VE, zip: 30033, country: Italy, contacts name: VALENTINA PESCATORE, MD, role: CONTACT, geoPoint lat: 45.54596, lon: 12.06445, locations facility: Ospedale Civile - U.O.C. Di Cardiologia, status: RECRUITING, city: Arzignano, state: VI, zip: 36071, country: Italy, contacts name: CLAUDIO BILATO, MD, role: CONTACT, geoPoint lat: 45.52027, lon: 11.33446, locations facility: Ospedale Alto Vicentino - U.O.C. Cardiologia - Ucic, status: RECRUITING, city: Santorso, state: VI, zip: 36014, country: Italy, contacts name: GIOVANNI MORANI, MD, role: CONTACT, geoPoint lat: 45.73383, lon: 11.38785, locations facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia, status: RECRUITING, city: San Bonifacio, state: VR, zip: 37047, country: Italy, contacts name: MAURIZIO ANSELMI, MD, role: CONTACT, geoPoint lat: 45.39595, lon: 11.27352, locations facility: Ospedale Civita Castellana - Ssd Cardiologia, status: ACTIVE_NOT_RECRUITING, city: Civita Castellana, state: VT, zip: 01033, country: Italy, geoPoint lat: 42.29304, lon: 12.40885, locations facility: Ospedale Belcolle - Uoc Cardiologia Ed Emodinamica, status: RECRUITING, city: Viterbo, state: VT, zip: 01100, country: Italy, contacts name: LUIGI SOMMARIVA, MD, role: CONTACT, geoPoint lat: 42.41937, lon: 12.1056, locations facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia, status: RECRUITING, city: Borgomanero, zip: 28021, country: Italy, contacts name: PIERFRANCO S DELLAVESA, MD, role: CONTACT, geoPoint lat: 45.69873, lon: 8.4623, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Veruno - Uo Cardiologia Riabilitativa, status: RECRUITING, city: Gattico, zip: 28013, country: Italy, contacts name: MASSIMO PISTONO, MD, role: CONTACT, geoPoint lat: 45.70717, lon: 8.52003, locations facility: Ospedale Anna Rizzoli - Cardiologia-Utic, status: ACTIVE_NOT_RECRUITING, city: Lacco Ameno, zip: 80076, country: Italy, geoPoint lat: 40.74901, lon: 13.88718, locations facility: Ospedale Buon Consiglio Fatebenefratelli - U.O.Complessa Di Cardiologia E Utic, status: RECRUITING, city: Napoli, zip: 80123, country: Italy, contacts name: GAETANO M RUOCCO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Cardarelli - U.O. Cardiologia Con Utic, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: CIRO MAURO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Card. Riabilitativa Intensiva E Scompenso, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: GIUSEPPE PACILEO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Malattie Cardiologiche Congenite Adulti-Guch, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: BERARDO SARUBBI, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale S. Giovanni Bosco - Sc Cardiologia - Utic, status: RECRUITING, city: Napoli, zip: 80134, country: Italy, contacts name: PAOLO TAMMARO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: LIDIA ROSSI, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica, status: RECRUITING, city: Pozzuoli, zip: 80078, country: Italy, contacts name: MARIANO AVERSA, MD, role: CONTACT, geoPoint lat: 40.84394, lon: 14.0952, hasResults: False |
protocolSection identificationModule nctId: NCT06279975, orgStudyIdInfo id: Req-2023-01275; am23Sutter2, briefTitle: Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study, acronym: INSPECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination., conditionsModule conditions: Brain Death, conditions: Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: non-invasive device-supported, automated pupillometry, outcomesModule primaryOutcomes measure: Reliability of clinical examination of pupils in patients with suspected brain death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Intensive care unit at the University Hospital Basel, status: RECRUITING, city: Basel, state: Basel-Stadt, zip: 4031, country: Switzerland, contacts name: Raoul Sutter, Prof., role: CONTACT, phone: +41 61 328 7928, email: [email protected], contacts name: Raoul Sutter, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Pascale Grzonka, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, locations facility: University Hospital Basel, status: RECRUITING, city: Basel, country: Switzerland, contacts name: Raoul Sutter, Prof., role: CONTACT, email: [email protected], contacts name: Pascale Grzonka, MD, role: CONTACT, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06279962, orgStudyIdInfo id: 2000034620, briefTitle: Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2023-09-15, completionDateStruct date: 2023-09-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: Empower Through Health, descriptionModule briefSummary: This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness., conditionsModule conditions: Mental Illness, conditions: Stigma, Social, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 379, type: ACTUAL, armsInterventionsModule interventions name: Survey questionnaire, outcomesModule primaryOutcomes measure: Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE, primaryOutcomes measure: Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Empowerment to Heal - Uganda, city: Iganga, country: Uganda, geoPoint lat: 0.60917, lon: 33.46861, hasResults: False |
protocolSection identificationModule nctId: NCT06279949, orgStudyIdInfo id: 2000036999, secondaryIdInfos id: 1K01MH136929-01, type: OTHER, domain: NIMH *ID not yet added, briefTitle: Confidential Care and Adolescent HIV Testing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-04, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care., conditionsModule conditions: Hiv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Provider training, interventions name: Clinic protocols, outcomesModule primaryOutcomes measure: Feasibility, defined as the extent to which structural intervention components to improve confidential care implementation can be successfully carried out in pediatric primary care settings, primaryOutcomes measure: Acceptability, defined as the perception among pediatric primary care clinic leadership and providers that structural intervention components to improve confidential care implementation are agreeable or satisfactory, primaryOutcomes measure: Change in HIV testing uptake, secondaryOutcomes measure: Reach, defined as the number of adolescent patients who receive confidential care, secondaryOutcomes measure: Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients, secondaryOutcomes measure: Implementation, defined as pediatric primary care provider fidelity to confidential care provision, secondaryOutcomes measure: Maintenance, defined as the extent to which confidential care is provided and adolescent patients are screened for, accept, and receive results of HIV testing 6-months post-intervention, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279936, orgStudyIdInfo id: B3002021000171, briefTitle: Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID, acronym: Cov-N-Psy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: UZA Foundation, descriptionModule briefSummary: Objectives:To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.Study design:Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients., conditionsModule conditions: Long COVID, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Neuropsychological battery, interventions name: Surveys and symptom severity questionnaires, interventions name: Blood withdrawal, interventions name: Saliva swabs, outcomesModule primaryOutcomes measure: Concentration of immunological and HPA-axis markers, secondaryOutcomes measure: Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints, secondaryOutcomes measure: Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SINAPS, city: Duffel, state: Antwerp, zip: 2570, country: Belgium, geoPoint lat: 51.09554, lon: 4.50903, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-10-01, uploadDate: 2024-02-08T04:56, filename: Prot_SAP_000.pdf, size: 1140716, hasResults: False |
protocolSection identificationModule nctId: NCT06279923, orgStudyIdInfo id: TXB2023023, briefTitle: CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Shanghai YaKe Biotechnology Ltd., descriptionModule briefSummary: Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases., conditionsModule conditions: Autoimmune Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: CD19-BAFF Targeted CAR T-cells, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Multiple Myeloma (MM), Overall response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of remission,DOR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first affiliated hospital of medical college of zhejiang university, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: He Huang, MD, role: CONTACT, phone: 86-13605714822, email: [email protected], contacts name: Yongxian Hu, MD, role: CONTACT, phone: +8615957162012, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06279910, orgStudyIdInfo id: 2021 36 (EOm), briefTitle: Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19)., acronym: COVIDIOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-03-21, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Complejo Hospitalario Universitario de Albacete, class: OTHER, descriptionModule briefSummary: Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy., conditionsModule conditions: SARS-CoV 2 Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 275, type: ESTIMATED, armsInterventionsModule interventions name: Calcifediol, outcomesModule primaryOutcomes measure: Measure mortality by differentiating groups: calcifediol yes/no., primaryOutcomes measure: Measure the need for ICU admission by differentiating the groups calcifediol yes/no., secondaryOutcomes measure: Measure mortality in relation to baseline 25(OH)D levels, secondaryOutcomes measure: To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency, secondaryOutcomes measure: Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete, status: RECRUITING, city: Albacete, zip: 02008, country: Spain, contacts name: Jose A Blazquez, MD, role: CONTACT, phone: +34967597100, phoneExt: 37214, email: [email protected], contacts name: Laura Navarro, MD, role: CONTACT, phone: +34967597460, email: [email protected], contacts name: Javier Torres, PhD., role: SUB_INVESTIGATOR, geoPoint lat: 38.99424, lon: -1.85643, locations facility: Maimónides Biomedical Research Institute of Córdoba (IMIBIC)., status: WITHDRAWN, city: Cordoba, zip: 14004, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, hasResults: False |
protocolSection identificationModule nctId: NCT06279897, orgStudyIdInfo id: 2023-068, briefTitle: LBNP Tolerance With Skin Warming After Exercise Cold Stress, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-24, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Colorado Springs, class: OTHER, descriptionModule briefSummary: Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold., conditionsModule conditions: Blood Pressure, conditions: Blood Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will complete trial 1 at the beginning of the study. Participants will then complete trials 2 through 5 in a random, counterbalanced order., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants are blinded to the skin temperature control., enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Skin Surface Rewarming, interventions name: Skin Surface Warming, interventions name: Skin Surface Heating, interventions name: Skin Surface Cooling, outcomesModule primaryOutcomes measure: Arterial blood pressure, primaryOutcomes measure: Tolerance to simulated blood loss, secondaryOutcomes measure: Core temperature, secondaryOutcomes measure: Cutaneous Vascular Conductance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Colorado Springs, status: RECRUITING, city: Colorado Springs, state: Colorado, zip: 80918, country: United States, contacts name: James Pearson, PhD, role: CONTACT, phone: 719-255-3806, email: [email protected], geoPoint lat: 38.83388, lon: -104.82136, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-01-03, uploadDate: 2024-02-22T15:33, filename: Prot_ICF_000.pdf, size: 315418, hasResults: False |
protocolSection identificationModule nctId: NCT06279884, orgStudyIdInfo id: 2023YFC2308802-03, briefTitle: A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.* Establish a monitoring and early warning system for secondary infections., conditionsModule conditions: Liver Transplantation, conditions: Transplant Recipients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Secondary Infections in liver transplant recipients at 4 weeks, primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection, secondaryOutcomes measure: Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection, secondaryOutcomes measure: qSOFA score at 8 weeks, secondaryOutcomes measure: qSOFA score at 12 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279871, orgStudyIdInfo id: ARCT-2303-01, briefTitle: Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Arcturus Therapeutics, Inc., class: INDUSTRY, collaborators name: Seqirus, collaborators name: Novotech (Australia) Pty Limited, descriptionModule briefSummary: This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: ARCT-2303, interventions name: Influenza vaccine, interventions name: Influenza vaccine, adjuvanted, interventions name: Placebo, outcomesModule primaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, primaryOutcomes measure: SARS-CoV-2 neutralizing antibody seroconversion rates, primaryOutcomes measure: Hemagglutination Inhibition (HI) titers, primaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody seroconversion rates, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a), secondaryOutcomes measure: Hemagglutination Inhibition (HI) titers, secondaryOutcomes measure: SARS-CoV-2 neutralizing antibody responses, secondaryOutcomes measure: Hemagglutination Inhibition (HI) assay titers, secondaryOutcomes measure: Local and systemic adverse events (AEs), secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279858, orgStudyIdInfo id: 1-2024, briefTitle: Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Specila hospital for cerebral palsy and developmental neurology, class: OTHER, collaborators name: FRAXA Research Foundation, descriptionModule briefSummary: The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years. Specifically, links between microbiome modifications by probiotic mixture and behavioral manifestations and brain processing (eye tracker, EEG analysis) will be assessed. Exploratory objects of this trial are analyses of microbiome composition and assessment of its alterations and modifications (by probiotic mixture) that may lead to clinical improvement and prediction which patients with FXS may be likely to benefit from probiotics treatment.This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. The study plans to enroll 15 participants with FXS, aged 3-18 years, both sexes, during 1-year period and complete all study-related activities by January 2025. During the 3-month study period, subjects will attend three visits (screening/baseline, 6-week, and 3-month visits) to the Fragile X Clinic at the Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, Serbia. The primary outcome measureswill be Vineland Adaptive Behavior Scales-Third Edition (VABS-III) and eye tracking measures (social gaze and pupillometry). Exploratory endpoint will be microbiome analyses. Secondary outcome measures will be: CGI-S and CGI-I scores, ABC-CFX score, quality of life, sleep habits and EEG analyses., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. In this approach, participants act as their own controls by measuring the microbiome and other parameters before and after taking the probiotics. This design was chosen because individual's microbiome is highly personalized. Even within a family, individuals can have distinct microbiomes. The unique composition of an individual's microbiome can have implications for the effectiveness of probiotics. Thus, changes in analyses and scores between baseline and 3-month study period will be assessed for everyone. Specifically, microbiome modifications that may be associated with changes in behavior and brain processing will be examined., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Probiotics, outcomesModule primaryOutcomes measure: 1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III), primaryOutcomes measure: Eye tracking, secondaryOutcomes measure: Clinical Global Impression Scales of Severity (CGI-S) and Improvement (CGI-I) -, secondaryOutcomes measure: The Aberrant Behavior Checklist - Community Edition (ABC-C), scored using the FXS-specific factoring system (ABC-CFX), secondaryOutcomes measure: Pediatric Quality of Life Questionnaire (PedsQL) Parent Proxy, secondaryOutcomes measure: Child Sleep Habits Questionnaire (CSHQ), secondaryOutcomes measure: EEG analyses, otherOutcomes measure: Microbiome analyses, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Special Hospital for Cerebral Palsy and Developmental Neurology, status: RECRUITING, city: Belgrade, zip: 11000, country: Serbia, contacts name: Dragana Protic, Prof., role: CONTACT, phone: +381640667466, email: [email protected], contacts name: Sanja Dimitrijevic, PhD, role: CONTACT, phone: +381640667466, email: [email protected], geoPoint lat: 44.80401, lon: 20.46513, hasResults: False |
protocolSection identificationModule nctId: NCT06279845, orgStudyIdInfo id: 2023YFC2308802-02, briefTitle: A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression., conditionsModule conditions: Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Secondary infection in patients at 4 weeks, primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279832, orgStudyIdInfo id: 3994, briefTitle: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer., acronym: Romantic, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: trascriptomic profiling, outcomesModule primaryOutcomes measure: Predictive value of the model, secondaryOutcomes measure: Validity of the model, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli IRCSS, status: RECRUITING, city: Rome, state: Lazio, zip: 00118, country: Italy, contacts name: francesco fanfani, role: CONTACT, phone: 0630151, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06279819, orgStudyIdInfo id: 2024-008, briefTitle: Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months., conditionsModule conditions: Hiv, conditions: Cardiovascular Diseases, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: gut microbiota-targeted dietary intervention, outcomesModule primaryOutcomes measure: ASCVD risk estimated by the PCE, primaryOutcomes measure: The composition of gut microbiota, secondaryOutcomes measure: fasting blood lipids, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: BMI, secondaryOutcomes measure: ASCVD symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Junwen Yu, role: CONTACT, phone: 13320178333, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06279806, orgStudyIdInfo id: SerapAlkas, briefTitle: The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses., conditionsModule conditions: Posttraumatic Growth, conditions: Grief, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will also be analyzed by an independent statistician., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Mobile health application use, interventions name: Information of the breast cancer survivor period booklet, outcomesModule primaryOutcomes measure: Women's progression through the stages of grief, secondaryOutcomes measure: Women's increased level of posttraumatic development, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279793, orgStudyIdInfo id: MODIFYCSX, briefTitle: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients., acronym: MODIFYCSX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: GCP-Service International West GmbH, class: INDUSTRY, collaborators name: Charite University, Berlin, Germany, collaborators name: Wuerzburg University Hospital, descriptionModule briefSummary: The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care., conditionsModule conditions: Cardiac Surgery, conditions: High Risk Patients, conditions: Intensive Care Unit, conditions: Cardiopulmonary Bypass, conditions: Valve Surgeries, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous FO- based lipid emulsion (Omegaven®), or placebo., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Researchers and clinical staff will be blinded to study intervention allocation. Unblinded delegate at each site will be able to prepare and dispense the investigational drug or placebo., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Long-chain n-3 fatty acids, interventions name: Intravenous 0.9% Sodium Chloride, outcomesModule primaryOutcomes measure: Atrial fibrillation, secondaryOutcomes measure: Weaning from cardiopulmonary bypass (CPB), secondaryOutcomes measure: Time to discharge alive, secondaryOutcomes measure: Persistent Organ Dysfunction + Death, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: Simplified Acute Physiology Score, secondaryOutcomes measure: Therapeutic Intervention Scoring System, secondaryOutcomes measure: ICU and Hospital Readmission rates, secondaryOutcomes measure: Delta Sequential Organ Failure Assessment Score (SOFA) Score, secondaryOutcomes measure: Mechanical ventilation, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Acute Kidney Injury, secondaryOutcomes measure: Infections rate, secondaryOutcomes measure: Clinical frailty scale, secondaryOutcomes measure: Development of delirium, secondaryOutcomes measure: Survival status, secondaryOutcomes measure: Physical activity assessment, secondaryOutcomes measure: Quality of Life (SF-36), secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Postoperative bleeding, otherOutcomes measure: Optional-Ultrasound measurement, otherOutcomes measure: Optional-Functional Status Score for Intensive Care Unit, otherOutcomes measure: Optional-Short Physical Performance Battery test, otherOutcomes measure: Optional-Hand grip dynamometer, otherOutcomes measure: Optional-Hand held dynamometer, otherOutcomes measure: Optional-Manual Muscle Testing, otherOutcomes measure: Optional-Left ventricular ejection function, otherOutcomes measure: Optional-Markers of inflammation, otherOutcomes measure: Optional-Hemodynamics, otherOutcomes measure: Sub-study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RWTH Aachen University, status: NOT_YET_RECRUITING, city: Aachen, country: Germany, contacts name: Moritz Immohr, M.D, role: CONTACT, email: [email protected], contacts name: Aileen Hill, M.D, role: CONTACT, email: [email protected], geoPoint lat: 50.77664, lon: 6.08342, locations facility: Charité Universitätsmedizin Berlin, status: NOT_YET_RECRUITING, city: Berlin, country: Germany, contacts name: Sascha Ott, M.D, role: CONTACT, email: [email protected], contacts name: Maren Kleine-Brüggeney, M.D, role: CONTACT, email: [email protected], geoPoint lat: 52.52437, lon: 13.41053, locations facility: University of Bonn, status: NOT_YET_RECRUITING, city: Bonn, country: Germany, contacts name: Markus Velten, M.D, role: CONTACT, email: [email protected], contacts name: Maria Wittmann, M.D, role: CONTACT, email: [email protected], geoPoint lat: 50.73438, lon: 7.09549, locations facility: Universität Göttingen, status: NOT_YET_RECRUITING, city: Göttingen, country: Germany, contacts name: Reiner Wäschle, M.D, role: CONTACT, email: [email protected], contacts name: Anselm Bräuer, M.D., role: CONTACT, email: [email protected], geoPoint lat: 51.53443, lon: 9.93228, locations facility: University Medical Center Schleswig-Holstein, status: NOT_YET_RECRUITING, city: Kiel, country: Germany, contacts name: Elke Gunnar, M.D, role: CONTACT, email: [email protected], contacts name: Matthias Lindner, M.D, role: CONTACT, email: [email protected], geoPoint lat: 54.32133, lon: 10.13489, locations facility: University of Muenster, status: RECRUITING, city: Münster, country: Germany, contacts name: Alexander Zarbock, M.D, role: CONTACT, email: [email protected], contacts name: Carola Wempe, M.D, role: CONTACT, email: [email protected], geoPoint lat: 51.96236, lon: 7.62571, hasResults: False |
protocolSection identificationModule nctId: NCT06279780, orgStudyIdInfo id: PI18/00932, briefTitle: Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Celia Bañuls, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers., conditionsModule conditions: Obesity Adult Onset, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 109, type: ACTUAL, armsInterventionsModule interventions name: very low-calorie diet, outcomesModule primaryOutcomes measure: Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention., primaryOutcomes measure: Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO)., secondaryOutcomes measure: Evaluate significant changes in body fat mass percentage after the dietetic intervention., secondaryOutcomes measure: Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention., secondaryOutcomes measure: Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention., secondaryOutcomes measure: Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention., secondaryOutcomes measure: Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention., secondaryOutcomes measure: Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention., secondaryOutcomes measure: Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention., secondaryOutcomes measure: Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention., secondaryOutcomes measure: Analyze the significant differences between metabolomic profile before and after the dietetic intervention., secondaryOutcomes measure: Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels., secondaryOutcomes measure: Assess if there is a significant reduction after the dietetic intervention in glutathione levels., secondaryOutcomes measure: Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels., secondaryOutcomes measure: Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production., secondaryOutcomes measure: Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential., secondaryOutcomes measure: Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: FISABIO, city: Valencia, zip: 46020, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06279767, orgStudyIdInfo id: 2022-SR-557, briefTitle: Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Glioblastoma, the most prevalent malignant tumor in the central nervous system, is characterized by high invasiveness and a propensity to recur, contributing to a relatively elevated mortality rate. Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months. Presently, the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy, with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis. Temozolomide (TMZ), a cutting-edge oral alkylating agent known for its advantageous properties, including easy traversal of the blood-brain barrier, induces DNA alkylation in tumor cells, fostering apoptosis. Currently, it serves as a frontline medication for postoperative chemotherapy in glioblastoma. However, clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages. We have recently discovered and validated that 5-aminoimidazole-4-carboxamide (AICA), derived from TMZ, can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate (AICAR) in GBM cells. Hypoxanthine phosphoribosyltransferase 1 (HPRT1) has been identified as the catalyst for the AICA reaction, generating AICAR. AICAR acts as an endogenous activator of AMP-activated protein kinase (AMPK), fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway. 6-mercaptopurine (6-MP) competes effectively to inhibit HPRT1 activity, thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ. In this project, we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma., conditionsModule conditions: Glioblastoma, conditions: Cancer, conditions: Temozolomide, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: 6-mercaptopurine, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: Safety evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Yongping You, PhD, role: CONTACT, phone: 13770694258, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06279754, orgStudyIdInfo id: ZLXGBXKYXM-031-01, briefTitle: Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2025-12-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xinxiang Medical College, class: OTHER, descriptionModule briefSummary: This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III., conditionsModule conditions: Locally Advanced Squamous Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant Human Endostatin Injection, outcomesModule primaryOutcomes measure: objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06279741, orgStudyIdInfo id: EVENEW, secondaryIdInfos id: 2022-500293-34, type: EUDRACT_NUMBER, secondaryIdInfos id: U1111-1291-0283, type: OTHER, domain: Universal Trial Number, briefTitle: Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants, acronym: EVENEW, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-28, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: EXO Biologics S.A., class: INDUSTRY, descriptionModule briefSummary: The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution).Infants will be followed up to 2 years of corrected age (end of study)., conditionsModule conditions: Bronchopulmonary Dysplasia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase 1 is an open-labelled, dose-escalated, and single-arm of EXOB-001. Phase 2 is a randomised, double-blind, placebo-controlled, and dose-finding of EXOB-001., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Phase 1 is an open-label, dose-escalation and single-arm study. In phase 2, Investigators will remain blinded to each subject's assigned treatment throughout the study. The Sponsor will put in place procedures to maintain this blind. Indeed, to ensure the blinding of the groups, the preparation and administration of the test product will be organized by different teams. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study treatment records at the site(s) to verify that randomisation/dispensing has been done accurately. Blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further subject care. In addition, subjects will be unblinded for safety reports, as per regulatory requirements. Study blind will be broken after the database lock., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 265, type: ESTIMATED, armsInterventionsModule interventions name: Endotracheopulmonary Instillation, Suspension, outcomesModule primaryOutcomes measure: Number of subjects with treatment-emergent adverse events (phase 1), primaryOutcomes measure: Number of subjects with BPD grade II-III incidence rate per groups (phase 2)., secondaryOutcomes measure: Assessment of medium-term safety of EXOB-001 (phase 1/2), secondaryOutcomes measure: Number of subjects with dose-limiting toxicity (DLT) (phase 1), secondaryOutcomes measure: Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2), secondaryOutcomes measure: Assessment of immune markers (phase 2), secondaryOutcomes measure: Assessment of BPD incidence and severity (phase 1/2), secondaryOutcomes measure: Safety evaluation (phase 1/2), secondaryOutcomes measure: Assessment of lung ultrasound score (phase 1/2), secondaryOutcomes measure: Number of subjects with complications of prematurity (phase 1/2), secondaryOutcomes measure: Assessment of the respiratory morbidity (phase 1/2), secondaryOutcomes measure: Assessment of neurodevelopment (phase 1/2), eligibilityModule sex: ALL, maximumAge: 10 Days, stdAges: CHILD, contactsLocationsModule locations facility: Cliniques Universitaires Saint-Luc (UCLouvain), status: NOT_YET_RECRUITING, city: Brussels, zip: 1200, country: Belgium, contacts name: Olivier Danhaive, M.D., role: CONTACT, phone: +32 2 764 79 00, email: [email protected], contacts name: Olivier Danhaive, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: ISPPC CHU Charleroi, status: NOT_YET_RECRUITING, city: Charleroi, zip: 6000, country: Belgium, contacts name: Serge Vanden Eijnden, M.D., role: CONTACT, phone: +32 7 192 12 43, email: [email protected], contacts name: Serge Vanden Eijnden, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.41136, lon: 4.44448, locations facility: Clinique CHC Montlégia, status: NOT_YET_RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Pierre Maton, M.D., role: CONTACT, phone: +32 4 355 56 17, email: [email protected], contacts name: Pierre Maton, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: AOU Careggi, status: NOT_YET_RECRUITING, city: Florence, country: Italy, contacts name: Carlo Dani, M.D., role: CONTACT, phone: +39 055 7948421, email: [email protected], contacts name: Carlo Dani, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Instituto Giannina Gaslini, status: NOT_YET_RECRUITING, city: Genova, country: Italy, contacts name: Giorgia Brigati, M.D., role: CONTACT, phone: +39 010 56362218, email: [email protected], contacts name: Giorgia Brigati, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: NOT_YET_RECRUITING, city: Milan, country: Italy, contacts name: Anna Lavizzari, M.D., role: CONTACT, email: [email protected], contacts role: CONTACT, phone: +39 025 5032907, contacts name: Anna Lavizzari, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: AOU Policlinico di Modena, status: NOT_YET_RECRUITING, city: Modena, country: Italy, contacts name: Alberto Berardi, M.D., role: CONTACT, phone: +39 333 1053301, email: [email protected], contacts name: Alberto Berardi, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova, status: RECRUITING, city: Padua, zip: 35128, country: Italy, contacts name: Eugenio Baraldi, Prof, role: CONTACT, phone: +39 049 8213578, email: [email protected], contacts name: Eugenio Baraldi, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, hasResults: False |
protocolSection identificationModule nctId: NCT06279728, orgStudyIdInfo id: DS1062-0003-EAP-MA, briefTitle: Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Daiichi Sankyo, class: INDUSTRY, collaborators name: AstraZeneca, descriptionModule briefSummary: The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial., conditionsModule conditions: Advanced Non-Small Cell Lung Cancer, conditions: Metastatic Non Small Cell Lung Cancer, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: Datopotamab deruxtecan, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen's Medical Center, status: AVAILABLE, city: Honolulu, state: Hawaii, zip: 96813, country: United States, contacts name: Principal Investigator, role: CONTACT, geoPoint lat: 21.30694, lon: -157.85833, hasResults: False |
protocolSection identificationModule nctId: NCT06279715, orgStudyIdInfo id: 3437, briefTitle: DFI and Aneuploidies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Clinique Ovo, class: INDUSTRY, descriptionModule briefSummary: IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes., conditionsModule conditions: Embryo Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Preimplantation Genetic Testing for Aneuploidy, outcomesModule primaryOutcomes measure: DFI association and aneuploidy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinique ovo, city: Montreal, state: Quebec, zip: H4P 2S4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06279702, orgStudyIdInfo id: OCalisir, briefTitle: Serious Game Simulation and Comics in School Students, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-19, primaryCompletionDateStruct date: 2025-07-19, completionDateStruct date: 2025-07-19, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the effect of first aid training for injuries given to secondary school students through serious game simulation and comic books on knowledge, skills and motivation.Hypotheses:H1: First aid training given through simulation applications affects the level of knowledge.H2: First aid training given through simulation applications affects the skill level.H3: First aid training given with simulation application affects motivation.H4: First aid training given with comics affects the level of knowledge.H5: First aid training given with comic books affects the skill level.H6: First aid training given with comics affects motivation.METHOD: The research will be conducted as a randomized controlled experimental study with a pre-test-post-test design with children studying in the 5th and 6th grades of schools in the central district of Aksaray. One group will be given first aid training for injuries prepared with serious games, the other group will be given first aid training for injuries prepared with comic books. No intervention will be made to the control group. Serious game scenario software prepared based on the literature will be integrated into the computer. Appropriate statistics will be made after the research by applying the prepared data collection tools. With this research, the gap in the literature will be filled, children's first aid knowledge and skills in injuries will be increased, and school health nurses will be provided with up-to-date teaching material., conditionsModule conditions: First Aid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: serious game and comics, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: SERIOUS GAME, interventions name: COMICS, outcomesModule primaryOutcomes measure: Motivation Scale for Teaching Materials, primaryOutcomes measure: Student Knowledge Level Evaluation Form for First Aid Application in Injuries, primaryOutcomes measure: Student Skill Level Evaluation Form for First Aid Application in Injuries, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Özlem Çalışır, city: Aksaray, state: Center, zip: 68200, country: Turkey, geoPoint lat: 38.37255, lon: 34.02537, hasResults: False |
protocolSection identificationModule nctId: NCT06279689, orgStudyIdInfo id: CJTCDZ2301, briefTitle: Echography Study_Anthropometric Measurements, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Crossject, class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound scans, outcomesModule primaryOutcomes measure: STBD : Skin To Bone Distance, primaryOutcomes measure: STMD: Skin To Muscle Distance, primaryOutcomes measure: Thickness of skin layers (dermis, hypodermis), primaryOutcomes measure: Thickness of muscle layers, secondaryOutcomes measure: Circumferences measurements (thigh, upper arm, waist, hip), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06279676, orgStudyIdInfo id: SaFeGreff, briefTitle: Improvement of Women's Health After Allogeneic Stem Cell Transplantation, acronym: SaFeGreff, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, collaborators name: Centre hospitalier de l'Université de Montréal (CHUM), descriptionModule briefSummary: The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women., conditionsModule conditions: GVHD, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice., secondaryOutcomes measure: Evaluate genital cGVHD treatment response, secondaryOutcomes measure: Evaluate the frequency of premature ovarian failure, secondaryOutcomes measure: Measure the incidence and prevalence of HPV infection, secondaryOutcomes measure: Evaluate the quality of life (QoL) of allografted women, secondaryOutcomes measure: Evaluate intimacy within relationships of allografted women, secondaryOutcomes measure: Evaluate sexual function of allografted women, secondaryOutcomes measure: Evaluate sexual distress of allografted women, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279663, orgStudyIdInfo id: NSTE-ACS Multivessel Trial, briefTitle: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease, acronym: NSTE-ACSMT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me, class: OTHER_GOV, collaborators name: Kemerovo Cardiology Center, Tarasov Roman Sergeevich, collaborators name: Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich, descriptionModule briefSummary: The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG., conditionsModule conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Revascularization, outcomesModule primaryOutcomes measure: Death from any cause, primaryOutcomes measure: Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization), primaryOutcomes measure: target LDL level, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Repeated unplanned myocardial revascularization, secondaryOutcomes measure: Duration of the hospital period, secondaryOutcomes measure: Intra/perioperative complications, secondaryOutcomes measure: Significant hemorrhagic complications (grade 3 or more on the BARC scale), secondaryOutcomes measure: Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anton, status: RECRUITING, city: Novosibirsk, state: Novosibirsk Obl, zip: 630055, country: Russian Federation, contacts name: Anton Obedinskiy, 1, role: CONTACT, phone: +73833476099, phoneExt: 1, email: [email protected], geoPoint lat: 55.0415, lon: 82.9346, locations facility: Anton, status: RECRUITING, city: Novosibirsk, state: Rechkunovskaya Str., zip: 630055, country: Russian Federation, contacts name: Anton Obedinskiy, role: CONTACT, phone: 89139322885, email: [email protected], geoPoint lat: 55.0415, lon: 82.9346, hasResults: False |
protocolSection identificationModule nctId: NCT06279650, orgStudyIdInfo id: 2022-2741, briefTitle: Self-hypnosis Training for Chronic Pain Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, descriptionModule briefSummary: Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.Adverse events: none expected., conditionsModule conditions: Hypnosis, Chronic Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Self-hypnosis, interventions name: Psycho-education and cognitive Bahavioral therapy (CBT), outcomesModule primaryOutcomes measure: Time 1 : Numerical Rating Scale (NRS) from 0 to 10, primaryOutcomes measure: Time 1 : Questionnaire Brief Pain Inventory (BPI), primaryOutcomes measure: Time 1 : Hospital anxiety and depression scale (HADS), primaryOutcomes measure: Time 1 : SF-36 (36-Item Short Form Survey), primaryOutcomes measure: Time 1 : Questionnaire socio-demographic and clinical, secondaryOutcomes measure: Time 2 : Numerical Rating Scale (NRS) from 0 to 10, secondaryOutcomes measure: Time 2 : Questionnaire Brief Pain Inventory (BPI), secondaryOutcomes measure: Time 2 : Hospital anxiety and depression scale (HADS), secondaryOutcomes measure: Time 2 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 3 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 3 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 3 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 3 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 4 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 4 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 4 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 4 : SF-36 (36-Item Short Form Survey), otherOutcomes measure: Time 5 : Numerical Rating Scale (NRS) from 0 to 10, otherOutcomes measure: Time 5 : Questionnaire Brief Pain Inventory (BPI), otherOutcomes measure: Time 5 : Hospital anxiety and depression scale (HADS), otherOutcomes measure: Time 5 : SF-36 (36-Item Short Form Survey), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 5415 Bd de l'Assomption, status: RECRUITING, city: Montréal, state: Quebec, zip: H1T 2M4, country: Canada, contacts name: David Ogez, role: CONTACT, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06279637, orgStudyIdInfo id: PRO00046457, briefTitle: Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, descriptionModule briefSummary: This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.The aims of the study are:Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Joint Home-DM-BAT Intervention, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Glycemic Control (Hemoglobin A1C [HbA1C]), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279624, orgStudyIdInfo id: NRCT9-4, briefTitle: Effectiveness of the PCV13 in Older Thai Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: National Research Council of Thailand, descriptionModule briefSummary: This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge.The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions.The main questions it aims to answer is:• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults?The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.-The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward).Participants will be* collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.* explored their vaccine status by either vaccine book checking or hospital database.Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 840, type: ESTIMATED, outcomesModule primaryOutcomes measure: Vaccine effectiveness of PCV13 on all types of pneumococcal CAP, secondaryOutcomes measure: Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06279611, orgStudyIdInfo id: LY007C1101, briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL, acronym: r/r B-NHL, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-25, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Longyao Biotechnology Inc., Ltd., class: OTHER, collaborators name: The First Affiliated Hospital with Nanjing Medical University, collaborators name: Ruijin Hospital, descriptionModule briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research, conditionsModule conditions: B-NHL, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: LY007, outcomesModule primaryOutcomes measure: Maximum tolerated dose or clinically recommended dose, primaryOutcomes measure: Dose limiting toxicity, primaryOutcomes measure: Adverse Events, Serious Adverse Events, Adverse Events of Particular Concern, secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PD aspect, secondaryOutcomes measure: therapeutic effect, secondaryOutcomes measure: Anti LY007 antibody, secondaryOutcomes measure: The titer of human anti mouse antibody, otherOutcomes measure: Exploratory study endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: zhao weili, MD, role: CONTACT, phone: 13512112076, phoneExt: 610707, email: [email protected], contacts name: yan zixun, MD, role: CONTACT, phone: +8613482056727, phoneExt: 610707, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06279598, orgStudyIdInfo id: UniversityGroningen, briefTitle: PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD, acronym: PT-STRESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2031-05-20, completionDateStruct date: 2032-08-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Groningen, class: OTHER, collaborators name: Dimence, descriptionModule briefSummary: The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.Key questions:1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?Secondary goals:* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;* Investigating how much the quality of the therapeutic alliance influences outcomes.Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom., conditionsModule conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 442, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged Exposure therapy, interventions name: Eye Movement Desensitization Reprocessing (EMDR), interventions name: Interpersonal Psychotherapy (IPT), outcomesModule primaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), secondaryOutcomes measure: International Trauma Questionnaire (ITQ), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Mental Health Continuum Short Form (MHC-SF), secondaryOutcomes measure: Positive and Negative Experiences of Psychotherapy questionnaire (PNEP), otherOutcomes measure: Age, otherOutcomes measure: Gender, otherOutcomes measure: Education, otherOutcomes measure: Employment, otherOutcomes measure: Marital status, otherOutcomes measure: Ethnicity/race, otherOutcomes measure: Medication use, otherOutcomes measure: Treatment history, otherOutcomes measure: Mini-Schedules for Clinical Assessment in Neuropsychiatry (mini-SCAN), otherOutcomes measure: Life Events Checklist for DSM-5 (LEC-5), otherOutcomes measure: The Childhood Trauma Questionnaire-Short Form (CTQ-SF), otherOutcomes measure: Symptom Checklist-90 (SCL-90), Hostility subscale, otherOutcomes measure: Experiences in Close Relationships-Relationship Structures (ECR-RS), otherOutcomes measure: The Brief Experiental Avoidance Questionnaire (BEAQ), otherOutcomes measure: Improving Access to Psychological Therapies (IAPT), otherOutcomes measure: Posttraumatic Cognitions Inventory (PTCI), otherOutcomes measure: Trauma Related Guilt Inventory (TRGI), otherOutcomes measure: Trauma Related Shame Iventory (TRSI), otherOutcomes measure: Working Alliance Questionnaire shortened version (WAV-12), otherOutcomes measure: Expectancy rating (patients and therapists), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dimence, status: RECRUITING, city: Deventer, country: Netherlands, contacts name: Maarten K van Dijk, PhD, role: CONTACT, phone: +31 0570-604000, email: [email protected], contacts name: Dominique Jonkers, Master, role: CONTACT, phone: +31 038-4692300, email: [email protected], geoPoint lat: 52.255, lon: 6.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06279585, orgStudyIdInfo id: ECA GVHD, briefTitle: Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD., conditionsModule conditions: Graft-versus-host-disease, conditions: Graft Versus Host Disease, Chronic, conditions: Stem Cell Transplant Complications, conditions: Hematological Malignancy, conditions: Hematologic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Physical therapy, outcomesModule primaryOutcomes measure: Health-related quality of life, primaryOutcomes measure: Chronic Graft-Versus-Host Disease (cGVHD) symptom burden, secondaryOutcomes measure: Muscular strength, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Functional status, secondaryOutcomes measure: Distress, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Biological markers, secondaryOutcomes measure: Responses to medical treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Seville; Manuel Siurot Avenue, no number, city: Seville, zip: 41013, country: Spain, contacts name: Raquel P Aguilar, Ph.D.cand., role: CONTACT, phone: 955 013 260, phoneExt: 34, email: [email protected], contacts name: José Antonio P Simón, PhD, role: CONTACT, phone: 955 013 260, phoneExt: 34, email: [email protected], geoPoint lat: 37.38283, lon: -5.97317, hasResults: False |
protocolSection identificationModule nctId: NCT06279572, orgStudyIdInfo id: 20-011624, secondaryIdInfos id: NCI-2022-09618, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 20-011624, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-22, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspirate, interventions name: Electronic Health Record Review, outcomesModule primaryOutcomes measure: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: NOT_YET_RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Cecilia Y. Arana Yi, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Talha Badar, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Mayo Clinic in Rochester, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Mithun V. Shah, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06279559, orgStudyIdInfo id: MTinHRP_v1_10/01/2023, briefTitle: Music Therapy and High-risk Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Istituto Giannina Gaslini, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?3. How does the risk of preterm birth modulate the future attachment bond between mother and child?Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question., conditionsModule conditions: High Risk Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Music-therapy, outcomesModule primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: State anxiety and trait anxiety, primaryOutcomes measure: Perceived stress, primaryOutcomes measure: Perceived positive and negative feelings, primaryOutcomes measure: Mother-fetus attachment bond, primaryOutcomes measure: Mother-child attachment bond, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Giannina Gaslini, status: RECRUITING, city: Genova, zip: 16147, country: Italy, contacts name: Cristina Venturino, role: CONTACT, phone: 010 5636.2346, email: [email protected], geoPoint lat: 44.40478, lon: 8.94438, hasResults: False |
protocolSection identificationModule nctId: NCT06279546, orgStudyIdInfo id: IECED-12345, briefTitle: Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2024-01-26, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Instituto Ecuatoriano de Enfermedades Digestivas, class: OTHER, collaborators name: The Methodist Hospital Research Institute, collaborators name: Baylor Saint Luke's Medical Center, collaborators name: Beth Israel Deaconess Medical Center, collaborators name: Barra Life Medical Center, Brazil, collaborators name: Hospital Clinico Universitario de Santiago, collaborators name: Universitair Ziekenhuis Brussel, collaborators name: Hospital Civil de Morelia, Michoacan, collaborators name: ELIAS Emergency University Hospital, collaborators name: Larkin Community Hospital, collaborators name: Carol Davila University of Medicine and Pharmacy, collaborators name: mdconsgroup, Guayaquil, Ecuador, descriptionModule briefSummary: Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures., conditionsModule conditions: Gastrointestinal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Detection of structures, outcomesModule primaryOutcomes measure: Diagnostic accuracy, secondaryOutcomes measure: Interobserver agreement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IECED, city: Guayaquil, state: Guayas, zip: 090505, country: Ecuador, geoPoint lat: -2.20584, lon: -79.90795, hasResults: False |
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