[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mario Negri Institute for Pharmacological Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":628},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,43,64,85,108,128,143,161,181,213,237,265,289,322,349,370,400,434,457,478,505,527,549,577,604],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644365","thyroid-hormones-in-ckd-100644365",false,"NCT07663773","Thyroid Hormones in CKD","Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease","THYROID-CKD","Inclusion criteria\n\n* Non-ADPKD CKD\n\n  * CKD stage G4, included in the ADAPT study\n  * Availability of stored serum and urine samples in the biobank suitable for thyroid hormone analysis\n  * Availability of relevant clinical and laboratory data within a predefined time window from sample collection\n  * Signed informed consent for storage and future research use of biological samples and clinical data\n* ADPKD CKD\n\n  * CKD stage G4, included in the REORIENTED study\n  * Availability of complete thyroid hormone profile and relevant clinical data\n\nExclusion criteria (applied to both groups as far as possible)\n\n* Known history of thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis, or thyroid cancer)\n* Treatment with thyroid hormone replacement or antithyroid drugs\n* Use of medications known to interfere with thyroid function (e.g., amiodarone, lithium, interferon)\n* Systemic corticosteroid or immunosuppressive therapy at the time of sampling (if data available)\n* Dialysis treatment or history of kidney transplantation at the time of sampling\n* Acute illness, infection, or hospitalization close to the time of sample collection (if identifiable)","ALL","18 Years",{"count":21,"type":22},51,"ESTIMATED","OBSERVATIONAL","This is a retrospective, observational, study evaluating circulating thyroid hormone profiles in patients with severe chronic kidney disease (CKD stages G4-G5, non-dialysis). The study includes one cohort of patients with non-ADPKD CKD and a second including a matched subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) at the same CKD stage,.\n\nFor the non-ADPKD CKD group, serum and urine samples will be retrieved from the certified biobank of the Centro Daccò (Mario Negri IRCCS). For the ADPKD group, analyses will be performed exclusively using existing clinical and laboratory data available within the REORIENTED study database.\n\nLaboratory measurements will be performed on stored biological samples from the non-ADPKD CKD group to assess thyroid hormones (rT3, fT3, tT3, fT4, tT4, and TSH). Clinical and laboratory data for both cohorts will be obtained from the respective study databases and linked within a predefined temporal window relative to sample collection (where applicable).",[26],"Chronic Kidney Disease (Stages 4 and 5)",[28,29],"Thyroid Hormones","CKD","NOT_YET_RECRUITING","2026-06-18",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":22},"2026-09",{"date":38,"type":22},"2027-09",{"name":40,"class":41},"Mario Negri Institute for Pharmacological Research","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100637409","emergency-and-urgent-care-indicators-in-piedmont-100637409","NCT07606209","Emergency and Urgent Care Indicators in Piedmont","Project on Indicators for Emergency and Urgent Care Services in the Piedmont Region","PRIME","Inclusion Criteria:\n\n* Adult patients (age \\>18 years) who presented to the participating Emergency Departments between 1\u002F1\u002F2023 and 31\u002F12\u002F2025.\n\nExclusion Criteria:\n\n* All patients under 18 years.",{"count":52,"type":22},650000,"The Emergency Department represents the main entry point to the hospital and a key setting for the management of urgent healthcare needs in the population. To date, the assessment of care quality has mainly focused on organizational aspects, with limited structured tools to systematically measure clinical and care processes.\n\nOvercrowding and limited resources make dedicated data collection unsustainable; therefore, it is necessary to rely on data already available from routine healthcare information systems. In this context, the study aims to assess the feasibility of using these data to construct quality indicators, as well as to evaluate their availability and reliability across participating centers.\n\nThe study will also analyze variability in indicators among participating Emergency Departments, with the goal of identifying differences in care processes and potential areas for improvement.",[55],"Emergency Departments","2026-05-25",{"date":58,"type":34},"2026-05-28",{"date":60,"type":22},"2026-07-01",{"date":62,"type":22},"2027-07-01",{"name":40,"class":41},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100594566","mild-tbi-in-the-emergency-department-100594566","NCT07021118","Mild TBI in the Emergency Department","The Use of Brain Computed Tomography in the Management of the Patient With Mild TBI in the Emergency Department","Inclusion Criteria:\n\nAdult patients arriving in the emergency department. Adult patients with mild TBI Adult patients with Glasgow Coma Scale 13-15.\n\nExclusion Criteria:\n\nAll patients under 18 years. Patients with trauma-associated loss of consciousness lasting more than 30 minutes.\n\nPatients with post-traumatic amnesia lasting more than 24 hours.",{"count":72,"type":22},2500,"Mild TBI is one of the main causes of admission to the Emergency Department (ED). Brain computed tomography (CT) is one of the most widely used diagnostic tools to assess the presence of intracranial lesions. However, in Western countries, 85-95% of CT scans performed in the ED for mild TBI are negative. It is therefore conceivable that a significant number of CTs could be avoided by a more careful use of this exam. On the other hand, excessive use of CT exposes patients to unnecessary radiation, increases healthcare costs and slows down the management of patients in the ED.\n\nThis study aims to analyze the variability in the use of CT in mild TBI in Italian EDs, validate the scores designed to help the physician decide when to use it and develop a model that predicts the medium-term outcome of patients with mild head trauma.",[55],"RECRUITING","2026-05-18",{"date":78,"type":34},"2026-05-20",{"date":80,"type":34},"2026-01-21",{"date":82,"type":22},"2027-08-31",{"name":40,"class":41},24,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100581174","evaluation-of-the-quality-of-care-in-the-emergency-department-by-studying-the-appropriateness-of-hospitalizations-100581174","NCT06846879","Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations","Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations: Validation of an Algorithm Based on Computerized Hospital Databases","Inclusion Criteria:\n\nAll patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.\n\nExclusion Criteria:\n\nAll patients under 18 years of age arriving at participating centers between January 1, 2023 and December 31, 2024 and all patients arriving at participating centers outside the time frame January 1, 2023 - December 31, 2024.",{"count":93,"type":22},240000,"The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.",[96,97,98,99],"Quality of Care","Evaluation","Emergency Department","Appropriateness",{"date":101,"type":34},"2026-05-19",{"date":103,"type":34},"2026-01-05",{"date":105,"type":22},"2027-06",{"name":40,"class":41},7,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100544706","development-of-a-multipurpose-dashboard-to-monitor-the-situation-of-emergency-departments-100544706","NCT06372379","Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments","Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments. An Observational Prospective Study","eCREAM-UC2","Inclusion Criteria:\n\n* Adult\n* Arrived at emergency department between 1 January 2025 and 31 December 2025\n\nExclusion Criteria:\n\n\\- None",{"count":117,"type":22},162000,"An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner.",[120],"Emergency Medicine",{"date":78,"type":34},{"date":123,"type":34},"2025-09-22",{"date":125,"type":22},"2027-02",{"name":40,"class":41},2,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":141,"leadSponsor":142,"locationsCount":127},"100543353","propensity-to-hospitalize-patients-from-the-ed-in-european-centers-100543353","NCT06354764","Propensity to Hospitalize Patients From the ED in European Centers.","Propensity to Hospitalize Patients From the ED in European Centers.An Observational Retrospective Quality-of-care Study","eCREAM-UC1","Inclusion Criteria:\n\n* Adult\n* Arrived at emergency department between 1 January 2021 and 31 December 2023\n\nExclusion Criteria:\n\n* None",{"count":117,"type":22},"The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated.",[120],{"date":78,"type":34},{"date":123,"type":34},{"date":125,"type":22},{"name":40,"class":41},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":135,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":159,"locationsCount":160},"100534572","development-of-a-natural-language-processing-tool-to-enable-clinical-research-in-emergency-medicine-100534572","NCT06240572","Development of a Natural Language Processing Tool to Enable Clinical Research in Emergency Medicine","Development and Validation of a Natural Language Processing Tool to Enable Clinical Research in Emergency and Acute Care Medicine: Retrospective Cohort Study","NLP-DeVal",true,{"count":152,"type":22},300000,"The goal of this retrospective cohort study is to develop and validate a language model that can interpret the contents of emergency department electronic medical records and extract relevant information for research purposes in all adult patients who arrived at the participating emergency departments in a three-year period.\n\nThe main question it aims to answer is: is the language model able to interpret the contents of emergency department electronic medical records and extract the requested information from them so that it can be used to make accurate analyses and predictions?\n\nThe study is retrospective and data will be extracted automatically from the medical health records.",[120],{"date":78,"type":34},{"date":157,"type":34},"2024-10-01",{"date":38,"type":22},{"name":40,"class":41},8,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100414417","health-care-quality-in-semi-intensive-care-units-100414417","NCT04676347","Health-care Quality in Semi-intensive Care Units","Evaluation and Improvement of the Health-care Quality in Semi-intensive Care Units","Inclusion Criteria:\n\n* all patients hospitalised in a semi-intensive care unit\n\nExclusion Criteria:\n\n* None",{"count":169,"type":22},39000,"The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.",[172,97,173],"Semi-intensive Care Unit","Quality",{"date":78,"type":34},{"date":176,"type":34},"2021-07-01",{"date":178,"type":22},"2029-12",{"name":40,"class":41},18,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":127},"100637926","mitigating-mitochondrial-rna-release-during-aging-to-control-inflammation-and-senescence-100637926","NCT07596615","Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence","Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence, Preserving Organ Function and Enhancing Healthspan","MIRACLE","Inclusion Criteria:\n\n* Male and female\n* Age between 18 and 90 years (stratified in three groups: young, middle-aged, elderly)\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to understand the potential risk and benefits of the study\n* Legal incapacity\n* Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days\n* Diagnosis of diabetes mellitus\n* Use of anticoagulant medications\n* Any subject with a contraindication to the mini-invasive biopsy procedure","90 Years",{"count":191,"type":22},90,"INTERVENTIONAL",[194],"NA","The MIRACLE study aims to investigate age-related mitochondrial dysfunction, mitochondrial RNA (mtRNA) release, inflammation, and cellular senescence in adult participants across three age groups. Skin-derived fibroblasts and peripheral blood mononuclear cells (PBMCs) will be isolated from skin biopsy and blood samples to characterize age-related cellular and molecular changes and to test experimental therapeutic strategies identified in preclinical studies. Serum, plasma, and whole-blood RNA will be used for protocol-defined analyses of circulating inflammatory mediators and systemic transcriptional signatures related to inflammation, type I interferon activation, mitochondrial stress response, immune aging, and senescence-associated pathways.",[197,198,199],"Aging","Inflammation","Healthy Ageing",[201,202,203,204,205,206],"mitochondrial dysfunction","skin-derived fibroblasts","mtRNA","PBMCs","senescence","inflammaging","2026-05-12",{"date":101,"type":34},{"date":36,"type":22},{"date":211,"type":22},"2031-09",{"name":40,"class":41},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":127},"100534707","an-outcome-analysis-of-primary-membranous-nephropathy-100534707","NCT06242327","An Outcome Analysis of Primary Membranous Nephropathy","An Observational, Longitudinal Study to Describe the Outcome, and Outcome Predictors, of Patients With Primary Membranous Nephropathy, and the Nephrotic Syndrome Treated With Rituximab, or Other Monoclonal Antibodies","PROMENADE","Inclusion Criteria:\n\n* Adults (≥18 years old) on the day of signing informed consent.\n* Diagnosis of primary membranous nephropathy\n* Nephrotic syndrome (proteinuria \\>3.5 g\u002F24 hours)\n* Written informed consent to the use of recorded data for research purposes.\n\nExclusion Criteria:\n\n* Legal incapacity or limited legal capacity.\n* Any contraindication to treatment with rituximab or other monoclonal antibody",{"count":222,"type":22},500,"This is an observational study intended to track the course of the primary membranous nephropathy disease in real-world clinical practice.\n\nThe study will primarily assess the long-term outcomes of patients with primary membranous nephropathy in the context of advances in treatment options.",[225],"Membranous Nephropathy",[227,228],"Primary Membranous Nephropathy","Nephrotic Syndrome","2026-03-19",{"date":231,"type":34},"2026-03-23",{"date":233,"type":34},"2024-11-29",{"date":235,"type":22},"2054-06",{"name":40,"class":41},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":150,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":192,"phases":246,"briefSummary":247,"conditions":248,"keywords":253,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":42},"100515839","developing-a-pipeline-to-employ-rna-seq-as-a-complementary-diagnostic-tool-in-rare-diseases-100515839","NCT05996731","Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases","ANTHEM","Healthy subjects.\n\nInclusion Criteria:\n\n* Male and female adults\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to understand the potential risk and benefits of the study\n* Legal incapacity\n\nValidation cohort.\n\nInclusion criteria:\n\n* Male and female adults\n* Genetic diseases affecting RNA levels (frameshifts, stop, large deletions, alteration of canonical splicing sites)\n* Written informed consent\n\nExclusion criteria:\n\n* Underage patients\n* Inability to understand the potential risk and benefits of the study\n* Legal incapacity\n\nDiscovery cohort.\n\nInclusion criteria:\n\n* Male and female patients (children and adults with onset in infancy or early adulthood) with rare genetic undiagnosed diseases\n* Patients with no strong candidates based on previous genetic analysis such as WES, but with clinically suspicion of a genetic rare disease\n* Written informed consent\n\nExclusion criteria:\n\n* Inability to understand the potential risk and benefits of the study\n* Legal incapacity",{"count":245,"type":22},105,[194],"This project aims to identify, through RNA-Seq technology, the genetic alterations underlying undiagnosed rare diseases in pediatric and adult patients with early onset and with negative WES.\n\n* Objective 1: Set up and validate techniques. Set-up and validation of the transcriptome analysis protocol in healthy subjects and in patients with known splicing alterations and\u002For altered RNA expression.\n* Objective 2: Diagnostic phase. Study of splicing alterations and RNA levels in cultured fibroblasts obtained from skin biopsies of patients with rare genetic diseases and negative exome.\n\nExploratory goals\n\n* Compare the RNA expression profile obtained from skin biopsy-derived fibroblasts with the RNA expression profile from blood. The most relevant results will be validated in qRT-PCR.\n* To analyze the transcriptional and protein profile heterogeneity in skin-derived fibroblasts in enrolled subjects.\n\nTo explore the effects of genetic (from WES) and transcriptional (from RNA-seq) alterations in participants' plasma and serum.\n\nHealthy controls Five healthy subjects will be recruited from the staff of the Mario Negri Institute for Pharmacological Research. The coded samples will be used to set up the method of isolation and culture of skin fibroblasts and RNA-Seq.\n\nValidation group For the set-up and validation of the skin fibroblast isolation and RNA-Seq procedure, ten adult patients with known diagnosis and with alterations in RNA levels and\u002For splicing will be recruited as positive controls.\n\nPatients who meet the requirements described above will be contacted by the doctors of the Daccò Center for an interview explaining the project. Those who agree to participate in the study will be asked to sign the informed consent before proceeding with the experimental part.\n\n\"Discovery\u002FExploration\" group The exploration cohort will be composed of 30 symptomatic undiagnosed patients with suspected genetic disease (children and adults with infantile onset) belonging to the Clinical Center of the Mario Negri Institute for Pharmacological Research and for whom WES investigations did not reveal causative genetic alterations.",[249,250,251,252],"Atypical Hemolytic Uremic Syndrome","Membranoproliferative Glomerulonephritis","Autosomal Dominant Polycystic Kidney","Healthy",[254,255,256,257,258],"Undiagnosed genetic rare diseases","Whole-exome sequencing","RNA-Sequencing","Molecular diagnosis","Skin-derived fibroblasts",{"date":231,"type":34},{"date":261,"type":34},"2024-02-21",{"date":263,"type":22},"2026-06",{"name":40,"class":41},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":42},"100369808","autoreactive-b-cells-in-membranous-nephropathy-100369808","NCT04095156","Autoreactive B Cells in Membranous Nephropathy","PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy: Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis","PEPTIDE","Inclusion Criteria:\n\nPatients inclusion criteria\n\n* Males and females.\n* Adults (\\> 18 years old).\n* Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice.\n* Mental state is such that they are able to understand and give valid consent to the study;\n* Written informed consent according to the guidelines of the Declaration of Helsinki.\n\nHealthy volunteers inclusion criteria\n\n* Male and female (\\>18 years) not known to suffer of any significant illness;\n* Not assuming any medication or drug on a regular basis;\n* Negative urine analysis (urine dipstick, multistick);\n* Written informed consent according to the guidelines of the Declaration of Helsinki\n\nExclusion Criteria:\n\nPatients exclusion criteria\n\n* Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine).\n* Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.\n\nHealthy volunteers exclusion criteria\n\n\\- Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.",{"count":274,"type":22},86,"Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 receptor (PLA2R). Infusion of anti-CD20 monoclonal antibodies results in a profound depletion of B-cells, which are thought to be responsible for anti-PLA2R production. B-cell depletion is followed by NS remission in 70% of cases. Limited evidence highlighted that differences in the B- and T-cell compartments may exist between responders and non-responders. Owing to the non-homogenous efficacy of anti-CD20 treatment, investigators hypothesize that in MN patients who experience NS remission after B-cell depleting therapy, autoreactive B-cells may be mostly circulating, whereas in patients who do not respond to the same treatment, autoreactive B-cells may chiefly reside into secondary lymphoid organs - and thus be more resistant to the drug action. Researchers will therefore extensively analyze the circulating immune repertoire of MN patients before and after the infusion of B-cell lineage depleting agents, assessing the presence of circulating PLA2R autoreactive B cells from appropriately stratified responder and non-responder patients. Patients and healthy controls will be enrolled in this study. Patients will be stratified according to gender, anti-PLA2R status, type of B-cell lineage depleting agent received and response to treatment.",[225],[278,279,280,281],"Membranous nephropathy","B cells","Anti-PLA2R","Anti-CD20 antibodies",{"date":283,"type":34},"2026-03-20",{"date":285,"type":34},"2019-09-25",{"date":287,"type":22},"2026-11",{"name":40,"class":41},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":297,"minAge":19,"maxAge":189,"enrollmentInfo":298,"targetDuration":4,"studyType":192,"phases":300,"briefSummary":302,"conditions":303,"keywords":308,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":42},"100625852","phase-2-pragmatic-study-to-optimize-neoadjuvant-treatment-and-surgical-de-escalation-in-hrher2--early-breast-cancer-using-oncotype-dx-and-abemaciclib-100625852","NCT07428018","Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","VIOLET","Inclusion Criteria:\n\n* female aged 18 years or older\n* primary, histologically confirmed diagnosis of invasive breast carcinoma,\n* estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO\u002FCAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)\n* documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO\u002FCAP guidelines, assessed locally,\n* stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),\n* candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,\n* not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND\u002FOR not candidate to sentinel lymph node dissection because of clinical node positive disease\n* Eastern Cooperative Oncology Group Performance Status 0-1,\n* The patient is able to swallow oral medications\n* normal hematologic parameters:\n\n  a.) absolute neutrophil count ≥ ≥1500\u002Fmm3 (1.5 × 10 9\u002FL), b) platelets ≥ 100 × 10 9\u002FL, c)hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula,\n* normal liver function:\n\n  a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,\n* women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,\n* willingness to undergo breast surgery after optimal neoadjuvant treatment, and to provide blood and tumor samples for the study purposes, including the submission for central assessment of Oncotype Dx test.\n\nExclusion Criteria:\n\n* presence of distant metastases (stage IV) or stage IIIC disease,\n* inflammatory or locally-advanced, inoperable breast cancer\n* previous invasive ipsilateral breast cancer at any time,\n* previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:\n\n  1. basal or squamous cell carcinoma of the skin,\n  2. melanoma in situ,\n  3. in situ non-breast carcinoma without invasion,\n  4. contra- or ipsilateral in situ breast carcinoma,\n  5. non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,\n  6. stage I papillary thyroid cancer,\n  7. stage Ia carcinoma of the cervix,\n  8. stage Ia or b endometrioid endometrial cancer,\n  9. borderline or stage I ovarian cancer\n* known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* females who are pregnant or lactating (lactation has to stop before study entry)\n* the patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea),\n* The patient has had major surgery within 14 days prior to study entry.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to study entry, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\])\n* contraindications or known hypersensitivity to the trial medication or excipients,\n* use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment","FEMALE",{"count":299,"type":22},150,[301],"PHASE2","This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)\u002FHER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and\u002For sentinel node biopsy",[304,305,306,307],"Breast Cancer","HER2 + Breast Cancer","HR Positive","Neoadjuvant Therapy",[309,310,311,312,313],"breast","oncotype dx","abemaciclib","neoadjuvant treatment","surgical deescalation","2026-03-03",{"date":316,"type":34},"2026-03-05",{"date":318,"type":22},"2026-04-30",{"date":320,"type":22},"2029-04-30",{"name":40,"class":41},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":42},"100625000","omics-of-rituximab-resistance-100625000","NCT07416942","Omics of Rituximab-resistance","Identification of a Pharmacogenomic Signature for Anti-B Cell Precision Therapy in Membranous Nephropathy","CONFUCIUS","Patients\n\nInclusion Criteria:\n\n* Adult patients\n* Biopsy-proven primary membranous nephropathy (MN)\n* Written informed consent for storage of biological samples in the local biobank\n\nExclusion Criteria:\n\n* Absence of signed written informed consent for the storage of samples in the biobank\n\nHealthy subjects\n\nInclusion Criteria:\n\n* Adult male and female\n* Written informed consent\n\nExclusion Criteria:\n\n* History of renal diseases, autoimmune disorders, diabetes mellitus, current allergies\n* Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days",{"count":331,"type":22},120,"The CONFUCIUS project aims to establish a personalised medicine framework for MN patients by integrating pharmacogenomics with other -omics technologies in order to identify biomarkers that predict response to RTX, ultimately enabling optimized treatment selection. Using a multiomics approach, we will analyse genetic variants, serum and kidney proteomics, and serum metabolomics profiles from a well-characterised retrospective cohort of MN patients to uncover predictive biomarkers of RTX response.\n\nThis is a non-pharmacological interventional study, conducted on biological samples from patients stored in the local biobank and on samples from healthy volunteers, which will be collected and subsequently stored in the biobank.",[225],[335,336,279,337,338,339,340],"membranous nephropathy","rituximab","pharmacogenetics","proteomics","metabolomics","scRNAseq","2026-02-10",{"date":343,"type":34},"2026-02-18",{"date":345,"type":22},"2026-04",{"date":347,"type":22},"2029-03",{"name":40,"class":41},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":192,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":369,"locationsCount":42},"100610880","phase-2-obinutuzumab-in-adult-rituximab-dependent-nephrotic-syndrome-100610880","NCT07233330","Obinutuzumab in Adult Rituximab-Dependent Nephrotic Syndrome","Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a Fully Academic, Single-arm, Open, Prospective, Intervention Trial","OASIS","Inclusion Criteria:\n\n* Adult age (≥18 years old)\n* Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as:\n\n  * Availability of a recent (over the last 5 years) diagnostic kidney biopsy to confirm the diagnosis of MCD, FSGS or IgM glomerulonephritis and quantify the severity of chronic changes\n  * Previous history of multi-relapsing, steroid-dependent nephrotic syndrome\n  * Previous history (previous to start of the prophylactic protocol) of relapse of the nephrotic syndrome after initial complete or partial remission and further remission achieved by steroid\n  * Relapse of the nephrotic syndrome within 12 months after withdrawal of rituximab prophylactic treatment defined as protein increase to \\>3.5g\u002F24H P\u002FC\\>3500 mg\u002Fg along with serum albumin \\\u003C3.5 g\u002Fdl (A clinical, rituximab-based B-cell driven treatment protocol that, per Center practice, is aimed to prevent recurrence of the nephrotic syndrome upon re-emergence of CD20+ B cells into the circulation. Rituximab is administered as soon as B-cell counts exceed 5 cells\u002Fmm3 in at least two consecutive evaluations)\n* Estimated GFR by the CKD-Epi creatinine equation (2021) ≥30 ml\u002Fmin\u002F1.73 m2\n* Ability to understand and provide a valid written consent to the study according to the guidelines of the Declaration of Helsinki and Good Clinical Practice\n* Compliance with an effective contraception without interruption, from 28 days before treatment start up to 18 months after treatment discontinuation, agreeing not to donate semen during treatment and for 18 months after discontinuation (if the participant is male). Furthermore, women should be advised to discontinue nursing during obinutuzumab therapy and for 18 months after the last dose of Obinutuzumab. (Please see the attached 2020 CTFG \"Recommendations related to contraception and pregnancy testing in clinical trials\"). Each female participant will undergo pregnancy test during the course of the study at fixed timepoints.\n\nExclusion Criteria:\n\n* Concomitance of clinical conditions that could jeopardize completion of the treatment\u002Fobservation period and\u002For confound data interpretation including:\n\n  * Active or recent (\\\u003C 5 years before enrolment) history of malignancy.\n  * Other active systemic immune diseases requiring concomitant treatment with steroids or any other immunosuppressive agent\n  * Severe\u002Funstable heart failure requiring hospitalization or changes in pharmacological therapy\n  * Refractory severe hypertension (BP \\>180\u002F100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)\n  * Recent (within the last 4 weeks) severe infections requiring hospitalization or intravenous antibiotics\n  * Patients with untreated or not fully cured HCV infection\n  * Planning a vaccination with live virus vaccines\n  * Active bacterial, viral and\u002For fungal infections\n  * Drug or alcohol abuse\n* Pregnancy, lactation, or intention to become pregnant before or during the study period, or up to 18 months of the last dose of study treatment\n* Intention to donate ova or sperm over the same time period.\n* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1\\_updated.pdf)\n* Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n* Inability to fully understand the potential risks and benefits related to study participation\n* Participation in another interventional clinical study with an investigational product since the last month before enrolment\n* Any other serious medical condition, uncontrolled intercurrent illness or laboratory abnormality that, according to the investigator's judgement, would constitute an unacceptable risk of premature discontinuation from the study.",{"count":358,"type":22},10,[301],"This is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the safety, efficacy, and immunological effects of obinutuzumab in adult patients with multi-relapsing, rituximab-dependent steroid-sensitive NS.\n\nObinutuzumab is a glycoengineered, humanized type II anti-CD20 monoclonal antibody that was initially developed to overcome rituximab resistance in B-cell malignancies. Obinutuzumab induced a longer and deeper B cell depletion than rituximab being able to deplete B cells in lymphoid tissue other than peripheral blood, as shown in both animal models and patients with chronic lymphocytic leukemia or kidney transplantation. Notably, obinutuzumab was found to be more efficient than rituximab in inducing B-cell cytotoxicity in-vitro, especially on naïve (IgD+CD27-) and switched (IgD-CD27+) memory B cells. This is a clinically relevant finding, because memory B cells are known to be associated with the risk of relapse after rituximab treatment in children with nephrotic syndrome. A recent retrospective study in 41 children \\[median (IQR) age: 10.6 (8.5-14.29) years\\] with steroid-dependent or frequently relapsing nephrotic syndrome, showed that treatment with obinutuzumab achieved B-cell depletion and sustained remission in 38 (93%) and 28 (68%) children at 12 and 24 months after treatment, respectively. Treatment was safe and well tolerated. Moreover, preliminary data indicate that obinutuzumab treatment can achieve complete or partial remission of the nephrotic syndrome in the large majority of adult participants with membranous nephropathy refractory to different immunosuppressive medications including rituximab, and even the human type 1 anti-CD20 antibody ofatumumab or the anti-CD38 antibody felzartamab (NCT05050214). Notably, obinutuzumab treatment achieved B-cell depletion and proteinuria reduction in all treated participants and persistent circulating anti-PLA2R antibody depletion in all participants with PLA2R-related disease even during the recovery of circulating B cells (NCT05050214). Conceivably, obinutuzumab could achieve remission of idiopathic nephrotic syndrome by inducing profound and sustained B-cell depletion, thereby inhibiting the production of anti-podocyte autoantibodies or the production of still unknown B-cell derived nephritogenic mediators and autoantibodies.\n\nThus, whether obinutuzumab treatment may achieve persistent remission also in adult participants with multi-relapsing, rituximab-dependent nephrotic syndrome, as previously reported in children, and as already observed in adult participants with refractory membranous nephropathy (NCT05050214), and whether this effect is associated with delayed recovery of switched memory B cells and emergence of B cells with a naïve phenotype as well as sustained reduction or depletion of circulating anti-podocyte antibodies is worth investigating.\n\nIn parallel to the evaluation of the phenotype of repopulating B cells, we will evaluate serum levels of the B-cell activating factor (BAFF). BAFF is a cytokine that orchestrates peripheral tolerance of B cells and promotes the survival of autoreactive B cells escaping central tolerance mechanisms. In participants with autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis, the relapse of disease activity after rituximab treatment has been associated with compensatory elevation of the B cell-activating factor BAFF levels. Elevated BAFF levels at baseline or during the follow-up may explain the resistance or dependency to anti-CD20 depleting antibodies in participants with idiopathic nephrotic syndrome.",[362],"Nephrotic Syndrome，Idiopathic","2026-01-23",{"date":365,"type":34},"2026-01-26",{"date":367,"type":22},"2026-02",{"date":347,"type":22},{"name":40,"class":41},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":192,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":42},"100617392","avf-monitor-poc-proof-of-concept-study-100617392","NCT07318025","AVF-MONITOR POC Proof-of-concept Study","AVF-MONITOR: a New Wearable Device for Vascular Access Monitoring in Hemodialysis Patients - Proof-of-concept Study","AVFMONITOR POC","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Female and\u002For male aged ≥ 18.\n* Patients undergoing HD with a mature and functioning native AVF.\n\nExclusion Criteria:\n\n* Patients with a history of complications related to the AVF in use.\n* Patients who use a graft or catheter to perform HD.\n* Patients with reduced life expectancy (less than 1 year).",{"count":379,"type":22},6,[194],"This is a proof-of-concept single-centre prospective longitudinal interventional study performed in AVF patients under HD treatment at the Nephrology and Dialysis Department of the ASST-Papa Giovanni XXIII (Bergamo, Italy), involving the recording of AVF sounds by the AVF-MONITOR wearable prototype device.\n\nParticipants will undergo a screening and enrollment visit, then follow-up visits for AVF sounds registration will be conducted once a week for all participants, prior to dialysis session, over a period of 8 weeks.",[383],"Hemodyalysis",[385,386,387,388,389,390,391,392],"arteriovenous fistula","hemodialysis","vascular access","monitoring","sound recording","proof-of-concept study","prototype device","vascular stenosis","2026-01-12",{"date":395,"type":34},"2026-01-14",{"date":397,"type":22},"2026-03",{"date":36,"type":22},{"name":40,"class":41},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":192,"phases":411,"briefSummary":412,"conditions":413,"keywords":417,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},"100618398","resolving-inflammation-through-diet-for-health-resolvin-100618398","NCT07331103","RESOLving INflammation Through Diet for Health (RESOLVIN)","RESOLving INflammation Through Diet for Health Multicenter, Prospective Randomized, Controlled and Open- Label to Examine the Impact of a Diet Enriched in Omega 3 Fatty Acids of Animal and Vegetal Origin on Circulating Lipid-driven Pro-\u002FAntiinflammatory Balance in Subjects at Moderate to High Cardiovascular Risk.","RESOLving","Inclusion Criteria:\n\n* Participants are subjects \\>55 y old from both sexes (\\>=40% women) with moderate to high cardiovascular risk (ANNEX 1: SCORE2, SCORE2-OP and SCORE2-Diabetes assessment).\n\nExclusion Criteria:\n\n* cardiovascular disease,\n* established atherosclerotic vascular disease involving the coronary, peripheral, carotid, or aortic territories (identified by computerized tomography (CT) of coronary arteries, MRI, carotid or peripheral ultrasound imaging),\n* chronic treatment with n-3 PUFA containing products (i.e., Vazkepa),\n* a condition that interferes with the possibility to follow the dietary intervention, such as fish allergy or being a vegan,\n* significant liver dysfunction,\n* participation in another intervention clinical study.","55 Years",{"count":410,"type":22},324,[194],"Hyperlipidemia is the main driver of atherosclerotic cardiovascular disease (ASCVD), both through direct effects and as trigger of the chronic inflammation behind a cardiovascular health-to-disease transition. While lipid-lowering is an effective way to reduce the ASCVD risk, the residual risk remains high. In addition, a substantial proportion of ASCVD events occur in the absence of overt hyperlipidemia. Several lines of evidence ranging from experimental models to population studies and interventional clinical trials support chronic inflammation as the causal residual risk of CVD. The CVD risk-associated lipid classes contain fatty acids that can be liberated and metabolized into both inflammation-promoting as well as inflammation-resolving drivers, providing the rationale for focusing on this balance in the present project. Above all, the omega-3 fatty acid class can resolve inflammation but the potential impact is currently largely underestimated in CVD preventive recommendations. As cardiovascular preventive measures ease the burden placed on the individual, population, and on the health care system, it is critical to raise public awareness for chronic inflammation as a causative and modifiable cardiovascular risk factor and to provide tools for how to control and monitor it. As an alternative to marine sources, principally eicosapentaenoic acid (EPA) and less docosahexaenoic acid (DHA) can be endogenously produced from alpha-linolenic acid (ALA) found in plant oils. Secondarily the possibility to increase the consumption of vegetable oil may possibly decrease the environmental impacts of an intensive fishing and consecutive marine system imbalance. The overarching objective of CARE-IN-HEALTH is to assess if PUFAs may contribute to the resolution of the chronic lipid-driven\u002F-regulated vascular inflammation in order to develop and test, in a real-life setting, tools for use in health care and by citizens to stay healthy by an adequate resolution of the chronic inflammation. The primary objective of the present study is to compare the effect on a lipid\u002Finflammation-derived risk score of diets supplemented with polyunsaturated fatty acids (PUFA) of animal or vegetal origin with a nonenriched diet. The secondary objectives are a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipid, inflammatory glycemic profile based on serial measurements of circulating biomarkers by means of PUFA supplementation. The study aims to identify a blueprint for how to control lipid-driven chronic inflammation by simple dietary interventions. Study population Participants to be considered for eligibility in the trial are adults aged \\>55 y, of both sexes (\\>=40% women), at moderate to high cardiovascular risk. The inclusion criteria are: Eligible participants will be at moderate to high SCORE2, SCORE2-OP and SCORE2-Diabetes risk level.\n\nNon-eligible subjects will be those with:\n\n* cardiovascular disease,\n* established atherosclerotic vascular disease involving the coronary, peripheral, carotid, or aortic territories (identified by computerized tomography (CT) of coronary arteries, MRI, carotid or peripheral ultrasound imaging),\n* chronic treatment with n-3 PUFA containing products (i.e., Vazkepa) or fibrates,\n* a condition that interferes with the possibility to follow the dietary intervention, such as fish allergy or being a vegan,\n* significant liver dysfunction,\n* participation in another intervention clinical study. Participants will be centrally randomized by a web-based system to one of the 3 diets: 1) supplementation with 4 grams n-3 PUFAs (containing 2262.5 mg DHA plus 1739.1 mg EPA), 2) diet enriched with n-3 PUFAs of vegetable origin (Camelina Sativa Oil) + vitamin E 24 mg, and 3) regular uncontrolled diet + vitamin E 24 mg. The daily intake of 10 grams of ALA for participants randomized to Camelina Sativa Oil is equivalent to approximately 1500 mg of n-3 PUFAs. Fish oil and Camelina Sativa oil will be administered as liquid oils for the duration of 12 weeks. The addition of vitamin E is aimed at supplementing the same amount of this vitamin to participants. Eligible participants will undergo a clinical visit when also a blood sample will be taken at baseline and at 12 weeks follow-up. The main analysis will be performed according to a per protocol approach, therefore only participants compliant with study treatments will be included in the analysis. Primary objective: to compare the effect on a lipid\u002Finflammation-derived risk score, based on circulating molecules, of diets enriched with PUFA of animal or vegetal origin with a non-enriched diet. Secondary objectives: a) to assess the acceptance of supplementation of diet with animal-derived or plant-derived PUFAs; b) to improve circulating lipidic\u002Fglycemic inflammatory profile. All 324 participants enrolled in the trial will have blood samples taken twice (at baseline and 12 weeks),",[414,415,198,416],"Cardiovascualr Disease","Lipids","n-3 Polyunsatured Fatty Acids (n-3 PUFA)",[418,419,420,421,422,423,424],"ASCVD","n-3 polyunsatured fatty acids","lipid driven\u002Fregulated vascular inflammation","n-3 PUFA","DHA","EPA","ALA","2025-12-29",{"date":427,"type":34},"2026-01-09",{"date":429,"type":34},"2025-11-26",{"date":431,"type":22},"2026-06-30",{"name":40,"class":41},5,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":192,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"100568348","phase-2-phase-ii-study-of-radiotherapy-followed-by-durvalumab-and-ceralasertib-in-stage-iii-nsclc-patients-with-thoracic-relapses---oligometastases-after-pacific-regimen-100568348","NCT06680050","Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +\u002F- Oligometastases After PACIFIC Regimen","AUSTRAL Trial: An Open-Label, Multicenter, Phase II Study Of Radiotherapy Followed By Durvalumab (MEDI4736) And Ceralasertib (AZD6738) In Stage III NSCLC Patients With Thoracic Relapses +\u002F- Oligometastases After PACIFIC Regimen","AUSTRAL","Inclusion Criteria:\n\n1. Provision of signed, written and dated informed consent and any locally required authorization\n2. Male or female aged 18 years or older\n3. ECOG Performance Status of 0-2\n4. Life expectancy ≥ 6 months at the start of treatment\n5. Body weight \\>30kg\n6. Maintenance treatment with durvalumab for a minimum of 3 months\n7. Histologically or cytologically documented locally advanced NSCLC at relapse\n8. Measurable disease as defined by RECIST v1.1\n9. Documented tumor cell PD-L1 status at first diagnosis and\u002For at relapse\n10. Thoracic progression as defined by PACIFIC protocol, with or without a maximum of 3 metastatic lesions amenable to local radiotherapy (at discretion of treating center)\n11. Interval of \\> 12 months between the end of the first thoracic radiotherapy (PACIFIC)\n12. Pre-treatment whole body CT scan with i.v. contrast medium\n13. Pre-treatment CT-PET scan\n14. Pre-treatment brain MRI\n15. Evidence of post-menopausal status, or negative urinary\u002Fserum pregnancy test for female pre-menopausal patients\n16. Patient willing and able to comply with the protocol procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Patients who discontinued durvalumab due to local or systemic progression during the maintenance phase \\\u003C 12 months after the end of CRT\n2. Patients who experienced, during the maintenance phase with durvalumab after CRT, grade 3 or more documented immune-related toxicity (with the exception of fully recovered endocrine toxicities) or grade 3 or more radiation-induced pneumonitis.\n3. Any unresolved toxicity NCI CTCAE from previous anticancer therapy not completely resolved or not resolved to baseline prior to screening for this study with the exception of alopecia, vitiligo, and the laboratory values defined below\n\n   1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n   2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n   3. Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n4. Any toxicity that led to permanent discontinuation of prior immunotherapy\n5. Patients with more than 3 distant metastases (non-oligometastatic disease)\n6. Patients with metastatic disease progression not amenable for radical radiotherapy such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, metastasis invading the GI tract, abdominal masses\u002Fabdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques.\n7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n8. Diagnosis of ataxia telangiectasia\n9. Patients harboring targetable genomic alterations, such as EGFR, HER-2 or MET exon14 skipping mutations, ALK, ROS1, RET or NTRK rearrangements. Molecular profiling can be assessed on archival tumor samples or on new tissue or liquid biopsy.\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n11. Concurrent participation (including the follow-up period) in another clinical study with an investigational product or during the last 4 weeks unless it is an observational (non-interventional) clinical study.\n12. Any concurrent chemotherapy, immunotherapy, biological or hormonal therapy only for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n13. Inadequate bone marrow reserve or organ function as defined below:\n\n    1. Absolute neutrophil count \\\u003C1.5 x 109\u002FL (1500\u002Fmm3)\n    2. Platelets \\\u003C100 x 109\u002FL (100000\u002Fmm3)\n    3. Haemoglobin \\\u003C9.0 g\u002FdL (5.59 mmol\u002FL)\n    4. Serum bilirubin \\\u003C1.5 x upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinaemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.\n    5. AST and ALT \\\u003C2.5 x ULN.\n    6. Inadequate renal function: measured creatinine clearance (CL) \\\u003C40 ml\u002Fmin or calculated CL (according to Cockroft-Gault): \\\u003C40ml\u002Fmin or by 24-hour urine collection for determination of CL\n14. History of active primary immunodeficiency\n15. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n1\\. Patients with vitiligo or alopecia 2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 3. Any chronic skin condition that does not require systemic therapy 4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 5. Patients with celiac disease controlled by diet alone 16. Female patients who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an effective method of birth control from screening to 90 days after the last dose of durvalumab.\n\n17\\. History of allogenic organ transplantation 18. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results.",{"count":443,"type":22},21,[301],"Aim of this phase 2 study is to explore the safety and efficacy of thoracic re-irradiation +\u002F- SBRT to oligometastases (\\\u003C3) followed after an interval of 2 weeks by durvalumab and ceralasertib for patients with thoracic relapses +\u002F- oligometastases after PACIFIC or PACIFIC-like (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab) regimens.",[447],"Non Small Cell Lung Cancer NSCLC","2025-12-10",{"date":450,"type":34},"2025-12-18",{"date":452,"type":34},"2025-08-07",{"date":454,"type":22},"2029-01",{"name":40,"class":41},9,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":192,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":42},"100613715","mechanisms-underlying-sglt2i-kidney-effect-in-dkd-progression-100613715","NCT07270198","Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression","Longitudinal Multicentre Clinical Study to Explore the Mechanisms Underlying Kidney Effect of SGLT2i in Diabetic Kidney Disease Patients at Risk of Disease Progression by Multiparametric Renal MRI and Biochemical Markers","PERSONALISEDKD","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* male and female subjects aged ≥ 18 years;\n* written informed consent prior to any study specific procedures\n* type 2 Diabetes Mellitus with DKD\n* CKD stage 1 to 3 (eGFR\\>30 ml\u002Fmin) with moderate or severe risk of renal disease progression (according to KDIGO 2024 CKD guidelines, G1 and G2 with albuminuria \\>300 mg\u002Fg, G3a with albuminuria \\>30 mg\u002Fg, and G3b independently of albuminuria levels)\n* ongoing SGLT2i treatment (e.g. canagliflozin, empagliflozin or dapagliflozin) for at least 1 year and stable RAS inhibitor therapy with ACE inhibitors and\u002For ARBs (or without RAS inhibitors in patients with specific contraindications for this medication)\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Uncontrolled diabetes (glycated hemoglobin (A1C) \\> 8%; 64 mmol\u002Fmol)\n* Contraindications to MRI including claustrophobia, pregnancy or lactating, cardiac pacemakers, or other MRI-incompatible prostheses, or impossibility to perform MRI\n* Any chronic clinical condition (e.g. history of malignancy) other than CKD and related complications that could affect completion of the trial or confound data interpretation\n* Non-diabetic CKD: CKD highly suspected to be related with a different renal condition other than Diabetes Mellitus as the cause of CKD (i.e. glomerular disease, tubulo-interstitial nephritis, microangiopathic thrombotic disease, renovascular\u002Fischemic kidney disease, etc)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Chronic heart failure with New York Heart Association class III-IV at the screening visit\n* Intention to become pregnant in the following 2 years (female patients)\n* Drug or alcohol abuse",{"count":466,"type":22},100,[194],"This is a multicentre and multi-national non-pharmacological, uncontrolled interventional study conducted in a clinical practice setting in DKD patients with CKD stages 1 to 3 with moderate or severe risk of renal function decline in chronic treatment with SGLT2i.\n\nThe main aim of the study is to assess the independent role of baseline individual mpMRI markers (hemodynamic, oxygenation, microstructure, perfusion, and fat fraction) and biochemical markers of MMP-related pathways (MMP-10 and TIMP-1) in the prediction of chronic eGFR decline in the above mentioned patients who are on chronic SGLT2i therapy.",[470],"Diabetic Kidney Disease (DKD)","2025-11-25",{"date":473,"type":34},"2025-12-08",{"date":367,"type":22},{"date":476,"type":22},"2027-08",{"name":40,"class":41},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":150,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":192,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":42},"100501126","functional-implications-of-rare-gene-mutations-in-ahus-open-the-door-to-personalized-therapy-100501126","NCT05805202","Functional Implications of Rare Gene Mutations in aHUS Open the Door to Personalized Therapy","aHUS-iPSC-EC","Inclusion Criteria:\n\n* Adults and children with aHUS defined by history of microangiopathic hemolytic anemia and thrombocytopenia (hematocrit (Ht) \\\u003C30%, hemoglobin (Hb) \\\u003C10 g\u002FdL, LDH \\>500 IU\u002FL, undetectable haptoglobin, fragmented erythrocytes in the peripheral blood smear with negative Coomb's test, and platelet count \\\u003C150,000\u002FmicroL), associated with acute renal failure.\n* Written informed consent\n\nExclusion Criteria:\n\n* TTP (ADAMTS13 activity \\\u003C10%)\n* STEC-HUS (presence of stx and eae genes or Shiga-toxin in the stools and\u002For serum antibodies against Shiga-toxin and\u002For STEC LPS).\n* Disseminated intravascular coagulation (prolonged thromboplastin time and lower than normal fibrinogen levels).",{"count":486,"type":22},112,[194],"Hemolytic Uremic Syndrome (HUS) is a rare disease characterized by rupture of red blood cells (hemolytic anemia), low platelet count (thrombocytopenia), and thrombotic occlusion of small vessels (thrombotic microangiopathy), with prevalent involvement of the kidneys.\n\nSEU, in its typical form is caused by gastrointestinal infection with Escherichia coli.\n\nThe atypical form of SEU (aSEU), which is not caused by an Escherichia coli infection, is a very rare disease that may have a genetic origin; it affects both children and adults and may occur in a sporadic or familial form. Many studies have shown that about 60% of cases of atypical HUS are associated with genetic abnormalities of the complement system (particularly the so-called \"alternative pathway\"), which is a key part of the immune system for responding to infection. Complement consists of a series of proteins that, when activated, create a so-called \"cascade,\" which leads to the elimination of the infectious agent, either directly or through other cells. Complement is finely regulated in such a way as to prevent damage to healthy cells in one's own body. Genetic defects in some of these complement regulatory proteins cause reduced protection of the endothelial surface (thus the vessel wall) against complement activation.\n\nRecently, new mutations have been described in a gene unrelated to the complement pathway, the DKGE gene, which codes for the intracellular isoform of diacylglycerol kinase . In these patients, small renal vessel occlusion appears to occur as a result of altered endothelial cell proliferation and angiogenesis through mechanisms apparently unrelated to complement activation. However, to date these mechanisms are poorly studied. Throughout the entire project statistical methods will be applied to optimize the characterization of the abnormalities in phenotype and function of iPSC-EC derived from aHUS patients with either DGKE or MCP genetic abnormalities as compared with control iPSC-EC, including identifying potential drugs that could correct the abnormalities",[249],[491,492,493,494,495,496],"Atypical hemolytic uremic syndrome","Induced pluripotent stem cells","Endothelial cells","Alternative complement pathway","Eculizumab","Drug screening (in vitro)","2025-09-23",{"date":499,"type":34},"2025-09-29",{"date":501,"type":34},"2023-05-03",{"date":503,"type":22},"2026-12-31",{"name":40,"class":41},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":192,"phases":515,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":526},"100525790","phase-2-trial-on-the-biological-and-clinical-effects-of-acetyl-l-carnitine-in-als-100525790","NCT06126315","Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS","A Randomized, Phase II\u002FIII Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS","ALCALS","Inclusion Criteria:\n\n1. Age 18+;\n2. ALS diagnosis according to the Gold Coast Criteria;\n3. Disease duration \\\u003C 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization\u002Fbaseline visit\\*;\n4. Self-sufficiency \\[Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)\\];\n5. Satisfactory respiratory function (FVC ≥80% of predicted);\n6. Documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\\>= 0.33. DFS =(48- ALSFRS-R at screening)\u002Fmonths from onset to screening.\n7. Ability to understand and comply with the study requirements;\n8. Ability to give written informed consent personally or, as an alternative, via a legally authorized representative;\n9. Treatment with riluzole 50 mg twice\u002Fday for at least 4 weeks prior to randomization visit;\n10. Intact cognitive function, again determined by the Principal Investigator.\n\n    * The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles. Cramps, fasciculations, or fatigue should not be taken in isolation as a first symptom of ALS.\n\nExclusion Criteria:\n\n1. Antecedent polio infection or other active infection;\n2. Motor neuron disease (MND) other than ALS;\n3. Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study;\n4. Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months;\n5. Previous use of ALCAR for any reason;\n6. Poor compliance with previous treatments;\n7. Other experimental treatments in the three months prior to the screening visit (if a subject is receiving another experimental drug, a 3-month wash-out period before participating in the present clinical trial will be required);\n8. Women who are lactating or able to become pregnant (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and three months after its completion;\n9. Inability to understand and comply with the study requirements;\n10. Unwillingness or inability to take riluzole.",{"count":514,"type":22},246,[301,516],"PHASE3","Phase II\u002FIII multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g\u002Fday and 3g\u002Fday) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin\u002Fosteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events.\n\nStudy population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites.\n\nInclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Criteria; disease duration \\\u003C24 months; satisfactory bulbar and spinal function (self-sufficiency evaluated by a score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking); satisfactory respiratory function (FVC ≥80% of predicted); documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\\>= 0.33. DFS =(48- ALSFRS-R at screening)\u002Fmonths from onset to screening, treatment with Riluzole in the last four weeks. Exclusion criteria: antecedent polio infection; other motor neuron disease; involvement of other systems possibly determining a functional impairment; other severe clinical conditions; unwillingness or inability to take riluzole; previous use of ALCAR for any reason; inability to understand and comply with the study requirements, and to give written informed consent personally or via their legally authorized representative.\n\nAll eligible participants will be randomized to receive ALCAR (1,5 or 3 g\u002Fday) or placebo in addition to riluzole 50 mg b.i.d. Permuted block (with a block size of 6), 1:1:1 centralized randomization scheme will be used. The overall treatment duration will be 48 weeks. After enrolment, each participant will be followed up until death. Eligible subjects will be seen after 4, 12, 24, 36 and 48 weeks. At each visit, a general assessment will be made, including vital signs, body mass index (BMI), neurological examination (including quantitative and qualitative evaluation of the motor system), comorbidity, concomitant treatments and adverse events. Blood samples will be collected at baseline -Day 1 (randomization)-, 4, 12, 24, 36 and 48 weeks to test biomarkers. Functional disability will be assessed at each visit using the ALS-FRS-R scale. The respiratory function will be assessed using a spirometer to measure FVC before starting treatment (baseline visit) and at 4, 12, 24, 36 and 48 weeks. Cognitive function will be evaluated at baseline, weeks 24 and 48, using ECAS scale. Health-related quality of life, measured by the ALSAQ-40, will be tested at baseline, 24 and 48 weeks. Compliance will be tested by the local investigators, counting unused packages at each follow-up visit. Pre-planned statistical analyses will be done on Intention-to-treat and Per-protocol (PP) populations. The statistical plan will include descriptive statistics and a comparison of the proportions of self-sufficient participants at week 48 using the chi-square or Fisher's exact test for the primary endpoint. Secondary endpoints measured by numerical scores obtained from clinical scales will be analyzed using repeated measures mixed models, while biomarkers using repeated measures ANOVA. Time-to-event endpoints, such as survival and the probability of remaining self-sufficient over 48 weeks, will be analyzed with Kaplan-Meier curves. The number of adverse events and serious adverse events after 48 weeks will be compared between treatment arms.",[519],"Amyotrophic Lateral Sclerosis",{"date":521,"type":34},"2025-09-25",{"date":523,"type":34},"2025-03-26",{"date":38,"type":22},{"name":40,"class":41},19,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":192,"phases":535,"briefSummary":536,"conditions":537,"keywords":540,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":456},"100476362","phase-2-cardiopulmonary-resuscitation-with-argon-cpar-trial-100476362","NCT05482945","CardioPulmonary Resuscitation With Argon (CPAr) Trial","CPAr","Inclusion Criteria:\n\n* ICU admission after resuscitation from witnessed non-traumatic out-of-hospital cardiac arrest (OHCA) of presumably cardiac etiology with a presenting shockable rhythm;\n* age ≥ 18 years;\n* unconsciousness after return of spontaneous circulation (ROSC);\n* duration of CPR ≤ 40 mins;\n* initiation of study intervention ≤ 4 hrs from ROSC;\n* stable SaO2 ≥ 94% with a FiO2 of 30%.\n\nExclusion Criteria:\n\n* Non-witnessed CA;\n* CA of traumatic origin or from a non-presumably cardiac cause;\n* CA with a non-shockable presenting rhythm (pulseless electrical activity and asystole);\n* female of childbearing potential defined as younger of 50 years;\n* pregnancy;\n* known terminal illness;\n* pre-CA cerebral performance category (CPC) ≥ 3;\n* initiation of the study intervention \\> 4 hrs from ROSC;\n* participation to another clinical trial",{"count":331,"type":22},[301],"Preclinical studies suggest that argon (Ar) might diminish the neurological and myocardial damage after any hypoxic-ischemic insult. Indeed, Ar has been tested in different models of ischemic insult, at concentrations ranging from 20% up to 80%. Overall, Ar emerged as a protective agent on cells, tissues and organs, showing less cell death, reduced infarct size and faster functional recovery. More specifically, encouraging data has been reported in animal studies on cardiac arrest (CA) in which a better and faster neurological recovery was achieved when Ar was used in the post-resuscitation ventilation. More importantly, these benefits have been replicated in different studies, enrolling both small and large animals. Finally, ventilation with Ar in O2 has been demonstrated to be safe both in animals and humans. Based on this evidence, a clinical translation is advocated. Thus, the CardioPulmonary resuscitation with Argon - CPAr trial has been conceived. The trial initially started as phase I-II trial to specifically address the question about the safety of the post resuscitation Ar-treatment. The available data on the first 30 randomized patients, evaluated by the Data Safety Monitoring Board (DSMB), were considered absolutely reassuring with regard to the safety of the experimental treatment. In this perspective, the DSMB supported the continuation of the study as a phase II trial, maintaining the study protocol in all its aspects. Thus, the aim of the CPAr trial is now to evaluate efficacy in reducing post-CA neurological injury of Ar\u002FO2 ventilation in patients resuscitated from CA.",[538,539],"Cardiac Arrest, Out-Of-Hospital","Cardiac Arrest With Successful Resuscitation",[541],"Cardiac arrest; Cardiopulmonary resuscitation; Argon.","2025-09-11",{"date":544,"type":34},"2025-09-17",{"date":546,"type":34},"2022-05-30",{"date":431,"type":22},{"name":40,"class":41},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":556,"enrollmentInfo":557,"targetDuration":4,"studyType":192,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":576},"100584059","reproducibility-of-multiparametric-renal-magnetic-resonance-imaging-on-15t-mri-scanners-100584059","NCT06884410","Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners","Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)","Inclusion Criteria:\n\n* Provision of written informed consent prior to any study specific procedures\n* Male and female subjects aged \\[18-70\\] years\n* Office SBP values \\\u003C 140 mmHg and DBP values ≤ 90 mmHg, under no antihypertensive therapy\n* Normal renal function defined as: estimated glomerular filtration rate \\[eGFR\\] ≥ 60mL\u002Fmin\u002F1.73m2 (using CKD-EPI Creatinine Equation)\n* Negative result upon urine testing for haematuria or proteinuria.\n\nExclusion Criteria:\n\n* Previous enrollment in the present substudy\n* Contraindications to MRI including caustrophobia, pregnancy, cardiac pacemakers or other MRI-incompatible prostheses\n* Ongoing therapy (e.g. for diabetes, dyslipidemia, or any acute disease)\n* Past or current oncological pathology","70 Years",{"count":558,"type":22},48,[194],"This is an interventional, multicenter, prospective study involving healthy volunteers, to primarily assess the reproducibility of multiparametric renal MRI on 1.5T scanners. The study is also aimed at assessing possible differences in renal MRI reproducibility on 1.5T MRI scanners by sex and age, and assessing possible differences in renal MRI reproducibility across field strengths (1.5T vs 3T) in the subgroup of subjects enrolled in both RESPECT clinical study and in the current subproject.",[562],"Multiparametric MRI",[564,565,566,567,568],"multiparametric MRI","standardization","reproducibility","kidney","MRI scanners","2025-08-29",{"date":571,"type":34},"2025-09-02",{"date":573,"type":34},"2025-04-12",{"date":345,"type":22},{"name":40,"class":41},4,{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":42},"100580790","new-advanced-vascular-imaging-ultrasound-protocols-100580790","NCT06841887","New Advanced Vascular Imaging Ultrasound Protocols","Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols","RESONA-SETTING","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Female and\u002For male aged between 18 and 75 years\n* No previous history of kidney or cerebral disease and no pathologies that might have affected the vascular system\n\nExclusion Criteria:\n\n* Previous history of kidney or cerebral disease or pathologies that might have affected the vascular system\n* Legal incapacity, limited legal capacity, intellectual disability, uncooperative attitude or any other evidence that the subject will not be able to understand the study aims and procedures","75 Years",{"count":587,"type":22},60,"This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. The subjects enrolled in the study will be examined the first time and will then provide consent to be examined again in the future if needed.\n\nThe primary aim of this study is to set-up and test new advanced US protocol for the arm and cerebral blood vessels\n\nThe secondary objectives will be:\n\n* Define ranges of normality\u002Freference values of US-based parameters to be compared with pathological values.\n* Evaluate the repeatability and reproducibility of the acquired US measurements.\n* Evaluate the correlation between age and the acquired US measurements.\n* Evaluate the correlation between gender and the acquired US measurements.",[590,591],"Renal Diseases","Cerebral Disorder",[593,594,595],"ultrasound","imaging","vascular protocol","2025-08-28",{"date":598,"type":34},"2025-09-05",{"date":600,"type":34},"2025-05-09",{"date":602,"type":22},"2027-03",{"name":40,"class":41},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":192,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":42},"100582051","phase-3-patiromer-and-diethrqol-in-chronic-dialysis-100582051","NCT06858280","Patiromer and Diet\u002FhrQoL in Chronic Dialysis","Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial","PRINCE","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* More than 18-year-old\n* Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD\n* Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq\u002FL confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia\n* Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics\n* On standardized and stable (moderately or strictly restricted) low-potassium diet\n* Compliance with recommended diet\n* Written informed consent\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Hyperkalemia (pre-dialysis potassium \\>5.5 mEq\u002FL during the long interdialytic period)\n* Hypomagnesemia (serum magnesium \\\u003C1.7 mg\u002FdL)\n* Hypercalcemia (serum calcium \\>10.5mg\u002Fdl)\n* Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)\n* Ongoing treatment with potassium-sparing diuretics\n* Pre-dialysis potassium \\\u003C4.0 mEq\u002FL during the long interdialytic period\n* One or two weekly dialysis session\n* Poor compliance to prescribed potassium-restricted diet\n* History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders\n* Previous history of cardiac arrhythmias potentially related to hypokalemia\n* Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n* Inability to fully understand the potential risks and benefits related to study participation\n* Concomitance of clinical conditions that could jeopardize the completion of the treatment period and\u002For confound data interpretation including:\n* Cancer (except non-metastatic cutaneous cancers)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Severe\u002Funstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months\n* Refractory severe hypertension (BP \\>180\u002F100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)\n* Known to be positive for human immunodeficiency virus\n* Drug or alcohol abuse\n* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment\n* Intention to donate ova or sperm over the same period\n* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1\\_updated.pdf)\n* Involvement in the study planning and\u002For conduct\n* Participation in another clinical study with an investigational product during the last month",{"count":613,"type":22},40,[516],"This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.",[617,618,619],"Hyperkalaemia","Chronic Kidney Disease Stage 3 and 4","Dietary Intervention","2025-08-27",{"date":622,"type":34},"2025-09-04",{"date":624,"type":34},"2025-07-08",{"date":626,"type":22},"2026-07",{"name":40,"class":41},""]