[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione IRCCS Policlinico San Matteo di Pavia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":553},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,100,0,25,[9,42,63,83,107,127,155,176,195,216,241,266,289,308,330,353,371,390,413,439,460,479,497,516,533],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100638367","natural-history-of-eosinophilic-esophagitis-in-adult-and-pediatric-population-100638367",false,"NCT07614633","Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population","Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population: a Multicentric Prospective Study in Italy","Inclusion Criteria:\n\n* patients with an established diagnosis of Eosinophilic esophagitis;\n* aged ≥5 years;\n* who gave written informed consent.\n\nExclusion Criteria:\n\n* under 5 years old;\n* Patients who are illiterate;\n* Patients who are unwilling to participate","ALL","5 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.\n\nSymptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.",[25],"Eosinophilic Esophagitis (EoE)",[27,25,28],"NATURAL HISTORY","Dysphagia Symptom Questionnaire","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-09-01",{"date":37,"type":21},"2027-12",{"name":39,"class":40},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100642242","evaluation-of-biomarkers-for-quick-sepsis-diagnosis---erased-study-100642242","NCT07655154","Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study","Inclusion Criteria:\n\n* All patients ≥18 years old meeting criteria for organ dysfunction identified as an acute change in total SOFA score ≥2 points.\n* At least one collected microbiological sample\n* Informed consent signed by patients or legal tutors.\n\nExclusion Criteria:\n\n* Patients with an history of recent traumatic injury.\n* Patients who refuse to sign the informed consent.","18 Years",{"count":41,"type":21},"Since the \"Sepsis-3\" consensus statement in 2016, sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Recognition of sepsis is mostly based on clinical criteria. To aid diagnosis, a wide range of biomarkers has been identified, however, with few exceptions such as procalcitonin, none is part of the routine assessment of a septic patient. Proadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 have been proposed as biomarkers to aid diagnosis and predict prognosis in sepsis, but data about their kinetics and their correlation to mortality, organ dysfunction and microbiological diagnosis is still lacking. The aim is at prospectically studying their kinetics in clinically septic patients during the first hours of their presentation in our Emergency Department, with the aim of assessing their ability to distinguish sepsis from other causes of life-threatening organ dysfunction and disease severity. Patients will be thus divided in cases (culture-confirmed infection) and controls (patient without demonstrated cause of infection). Secondary objectives will evaluate the correlation between the biomarkers' values, mortality, admission to Intensive Care Unit and organ dysfunction. In patients with confirmed infection, moreover, we will correlate biomarkers with the etiological diagnosis. The expectetion is to be able to enrol at least 120 patients in 12 months. With this number of subjects, it will be possible to detect significant differences in the mean values of the biomarkers with a power of 90% and a type I error of 5%. Analyses will produce summary indicators to synthesize the kinetics of the biomarkers including area under the curve, percentage of time spent over a critical threshold (e.g., the 75th percentile of the values), and variability indicators such as standard deviation and difference between the last and the first value. Time series among groups will be analysed with standard statistical techniques such as repeated ANOVA and advanced temporal clustering techniques. For the secondary objectives will be used the Wilcoxon test with suitable post hoc strategies to correct for multiple comparisons.",[52],"Sepsis","NOT_YET_RECRUITING","2026-06-12",{"date":56,"type":33},"2026-06-17",{"date":58,"type":21},"2026-09",{"date":60,"type":21},"2030-09",{"name":39,"class":40},1,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":69,"targetDuration":71,"studyType":22,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":62},"100640033","smatteo-covid19-registry-smacore-100640033","NCT07597876","SMAtteo COvid19 REgistry (SMACORE)","Inclusion Criteria:\n\n* diagnosis of Covid-19\n\nExclusion Criteria:\n\n\\-",{"count":70,"type":21},1000,"1 Day","Since the start of the COVID-19, Italy, and particularly the Northern region, Lombardia, has initially been the centre of the most numerous reports of confirmed cases of COVID-19 since the spread of the infection to Europe, reaching 5469 cases out of 9172 total cases in Italy (corresponding to 0.054% of the region population) within 2 weeks from the identification of the first Italian case at the end of February 2020. Data updated at 25 March 2020 reported 7503 deaths out of 57521cases in Italy. The overall number of patients requiring admission to hospital reached 23112, with another 3489 needing intensive care unit (ICU) management (4). The \"Fondazione IRCCS Policlinico San Matteo\" Pavia's main teaching and research hospital has become one of the main COVID Centers for the treatment of the disease. Several departments have been reassigned to the sole hospitalization of COVID-19 patients in addition to the Infectious Disease Department and the Intensive Care (ICU). Moreover, a dedicated emergency room (ER) has been set up.\n\nAll these measures have given rise to a large amount of clinical, imaging and laboratory data originating from different sources as well data regarding to type and length of stay in each of the ER, medical departments and ICU, that are of use for diagnostic and prognostic purposes. Also the Fondazione IRCCS Policlinico San Matteo has information obligations towards the Regional (Regione Lombardia) and National (Istituto Superiore di Sanità, ISS) authorities.\n\nFor these reasons we plan to set up a structured registry to collect these information on our Covid-19 patients using the secured REDCap platform resident on a server of the local Informative Services.",[74],"COVID-19","2026-05-14",{"date":77,"type":33},"2026-05-19",{"date":79,"type":33},"2020-05-20",{"date":81,"type":21},"2028-01",{"name":39,"class":40},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":91,"targetDuration":18,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":62},"100640846","a-registry-to-assess-the-efficacy-and-safety-of-transcatheter-treatment-for-aortic-valve-disease-at-the-irccs-policlinico-san-matteo-foundation-in-pavia-italy-100640846","NCT07596394","A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).","A Prospective and Retrospective Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (PAVI_TAVI Registry).","PAVI_TAVI","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses\u002Frings.\n\nExclusion Criteria:\n\n* Failure to sign the informed consent.",{"count":92,"type":21},500,"PAVI-TAVI Registry Overview\n\nThe PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for degenerated mitral valves) in patients over 18 years old.\n\nWho Can Join Eligible patients include adults treated with these procedures on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses\u002Frings. The only exclusion is not providing informed consent.\n\nStudy Goals The main goal is to evaluate TAVI's safety and effectiveness over 5 years, focusing on all-cause mortality from the initial procedure. Secondary goals assess complication rates, valve function, inflammation markers, heart failure hospitalizations, heart attacks, strokes, and major cardiac events.\n\nHow It Works No experimental treatments-it's a registry collecting routine clinical data via a secure electronic system. Follow-up happens at your doctor's discretion, ideally at 3 and 12 months, then yearly (often by phone for stable cases). The study aims to enroll 500+ patients.",[95],"Severe Aortic Stenosis",[97,98,99],"aortic stenosis","TAVI","TAVR","2026-05-12",{"date":77,"type":33},{"date":103,"type":33},"2021-03-16",{"date":105,"type":21},"2030-12",{"name":39,"class":40},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":114,"targetDuration":116,"studyType":22,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":62},"100638537","systemic-vasculitis-prognosis-and-outcome-100638537","NCT07586137","SysteMic vAsculitis pRognosis and ouTcome","SMART","Inclusion Criteria:\n\n* Willing and able to give informed consent\n* clinical suspicion or a confirmed diagnosis of Systemic Vasculitis\n\nExclusion Criteria:\n\n* Inability to give informed consent",{"count":115,"type":21},300,"10 Years","This will be a pragmatic programme of research, consecutively recruiting all-comers who have been referred to secondary care for assessment of suspected Systemic Vasculitis (SV) into a longitudinal inception cohort. For patients with a pre-existing diagnosis, data on the disease onset will be collected retrospectively. All patients followed prospectively from the time of inclusion into the study will be followed at intervals corresponding to the recommended standard of care. We will invite participants to consent to the whole programme of research in order to allow their samples, as well as their data, to be used for in multiple related projects that have the same common aim. In this long-term inception cohort we will collect data on clinical features, prognostic factors and outcomes of patients diagnosed with a SV over the course of 10 years. We will examine the role of clinical features, imaging and biomarkers in the characterisation of the disease with a particular focus on risk stratification. This will be closely integrated with the other objectives of the study: analysing clinical features, imaging characteristics, outcomes, rates and predictors of relapses and remission, in order to obtain a prognostic stratification of the patients and to capture a cohort of patients at high risk of relapse and poor outcome who could inform on the potential use of more intensive treatment strategies to be assessed in future studies.\n\nThe SMART programme will be guided by three main overarching themes:\n\n1. \"Theme 1\": The identification of risk factors associated with poor outcome, relapse and failure to achieve remission\n2. \"Theme 2\": The assessment of different tools to assess risk factors (imaging, biomarkers, clinical features)\n3. \"Theme 3\": The analysis of cohorts of SV patients in observational studies The overarching aims of the study will be overlapping throughout the different investigations outlined in the following paragraphs analyzing: outcomes (including treatment-derived damage), monitoring and relapse, and remission in SV.\n\nWe aim to follow patients up over a total of 10 years, in order to provide the richest and most complete set of data that has ever been collected for this patient group.",[119],"Vasculitis","2026-05-08",{"date":75,"type":33},{"date":123,"type":33},"2022-02-08",{"date":125,"type":21},"2030-06-15",{"name":39,"class":40},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":135,"targetDuration":136,"studyType":22,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":62},"100636923","rheumatoid-arthritis-remission-screening-and-prospective-surveillance-100636923","NCT07571993","Rheumatoid Arthritis Remission Screening and Prospective Surveillance","Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)","HARMONICS","Inclusion criteria:\n\n* Age ≥18 years\n* Diagnosis of RA fulfilling the ACR\u002FEULAR 2010 or ACR 1987 classification criteria within 12 months of first evaluation at the Early Arthritis Clinic\n* Initiation of csDMARD therapy within 12 months of symptom onset\n* Continuous treatment with csDMARDs for ≥24 months\n* No prior or current treatment with biologic or targeted synthetic DMARDs\n* DAS28-ESR \\\u003C2.6 for ≥6 months in the absence of glucocorticoid therapy\n* Management with a treatment tapering or discontinuation strategy with planned monitoring as part of routine clinical care, following shared decision-making with the treating rheumatologist\n* Ability to provide written informed consent for participation in the registry\n\nExclusion criteria:\n\n* Extra-articular manifestations of RA\n* Concomitant chronic inflammatory or autoimmune rheumatic diseases other than RA\n* Personal history of cutaneous and\u002For nail psoriasis\n* Severe cardiovascular disease\n* Severe functional disability impairing clinical protocol adherence or follow-up\n* Severe cognitive impairment",{"count":20,"type":21},"60 Months","HARMONICS is a prospective registry embedded in the routine clinical practice of the Early Arthritis Clinic and the Prospective Remission Clinic at Fondazione IRCCS Policlinico San Matteo, with an associated research biorepository of voluntarily donated biological samples. It is designed to collect and generate long-term longitudinal data from patients with early-treated rheumatoid arthritis (RA) who have achieved stable clinical remission with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and undergo treatment tapering or discontinuation according to local care pathways, following shared decision-making between the patient and the treating rheumatologist.\n\nFollowing enrollment in stable clinical remission, patients are monitored as part of standard of care at regular intervals using clinical, ultrasound, and radiographic assessments to evaluate disease activity and outcomes. Treatment modifications, including tapering, discontinuation, and re-treatment, are recorded longitudinally. Participants are followed in the registry from enrollment for up to 60 months, unless a disease flare occurs earlier. Patients experiencing a disease flare within the initial 60-month follow-up period undergo an additional 12 months of follow-up after flare.\n\nThe registry aims to provide a comprehensive longitudinal framework of multimodal data to advance the clinical and pathophysiological understanding of remission phenotypes and natural disease trajectories, with the ultimate goals of:\n\n* optimizing risk stratification and therapeutic decision-making in patients with RA in remission; and\n* identifying and exploring novel targets for potential transformative therapies.",[139],"Rheumatoid Arthritis",[141,142,143,144,145,146],"Rheumatoid arthritis","Clinical remission","Drug-free","Drug-tapering","csDMARDs","Synovitis","2026-04-30",{"date":149,"type":33},"2026-05-07",{"date":151,"type":33},"2022-06-21",{"date":153,"type":21},"2047-06-21",{"name":39,"class":40},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":62},"100627461","one-gene-two-diseases-the-pathologic-role-of-iglv1-44-in-al-amyloidosis-and-poems-100627461","NCT07448935","One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS","ALPS","Inclusion Criteria:\n\n* Biopsy-proven diagnosis of systemic AL amyloidosis, POEMS syndrome or multiple myeloma\n* Planned peripheral blood sampling +\u002F- bone marrow aspiration\n* Age \\> 18 years\n* Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent.\n\nExclusion Criteria:\n\n* Undefined monoclonal gammopathy or non-AL amyloidosis\n* Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy\n* Age \\\u003C18 years\n* Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.","99 Years",{"count":5,"type":21},"By detailed sequence analysis and subsequent biophysical characterization of prototypic light chains, this project aims to identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome. This understanding might help improve the risk stratification and early diagnosis of patients overexpressing pathologic IGLV1-44 LCs. Moreover, the development of nanobodies efficient in recognizing and stabilizing IGLV1-44 light chains which exert direct toxicity in cardiac AL amyloidosis and POEMS syndrome might form the basis for future development of therapeutic agents capable of counteracting IGLV1-44 light chain proteotoxicity.",[166,167,168],"AL Amyloidosis","POEMS Syndrome","Multiple Myeloma",{"date":170,"type":33},"2026-05-06",{"date":172,"type":33},"2025-11-28",{"date":174,"type":21},"2026-06-30",{"name":39,"class":40},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":62},"100636278","prevalence-pathogenesis-and-prognosis-of-pulmonary-hypertension-in-dialysis-patients-100636278","NCT07563608","Prevalence, Pathogenesis, and Prognosis of Pulmonary Hypertension in Dialysis Patients","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years\n* Patients on stable extracorporeal hemodialysis for at least 6 months\n* Dialysis frequency of two or three times per week\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* WHO functional class IV\n* Presence of valvular or congenital heart disease\n* Acute infections within the month preceding the cardiological evaluation","75 Years",{"count":184,"type":21},70,"This prospective multicenter longitudinal study aims to investigate the prevalence, pathogenesis, and prognosis of pulmonary hypertension in patients with end-stage renal disease undergoing chronic hemodialysis. The research seeks to identify specific clinical factors and biomarkers like angiopoietin-2 that contribute to the development of this condition, while evaluating the prognostic value of right ventricular function measured via TAPSE. Participants undergo a standardized screening echocardiogram the day after their intermediate dialysis session to determine the probability of pulmonary hypertension. Those identified as high-risk receive further diagnostic confirmation through right heart catheterization, respiratory function tests, and lung scans to clarify the underlying etiology. The protocol also evaluates the hemodynamic impact of high-flow arteriovenous fistulas and volume overload on pulmonary pressures. Clinical follow-up is conducted at baseline and subsequently at 6, 12, and 24 months to monitor patient outcomes and standardize therapeutic management according to established European guidelines.",[187],"Pulmonary Hypertension","2026-04-29",{"date":190,"type":33},"2026-05-04",{"date":192,"type":33},"2018-11-10",{"date":58,"type":21},{"name":39,"class":40},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":48,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100582280","treosulfan-therapeutic-drug-monitoring-in-pediatric-hematopoietic-stem-cell-transplant-recipients-100582280","NCT06861257","Treosulfan Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Recipients","Inclusion Criteria:\n\n* Age range 0 - 18 years.\n* Life expectancy \\> 12 weeks.\n* Diagnosis of malignant or non-malignant disorder.\n* Pre-HSCT Lansky \u002F Karnofsky score ≥ 40%.\n* Indication to allogeneic or autologous HSCT with TREO as part of the pre-transplant conditioning regimen.\n* Negativity of pregnancy test for female patients.\n* Written informed consent signed by the parents or guardians.\n\nExclusion Criteria:\n\n* Absence of written informed consent signed by the parents or guardians.\n* Current clinically active infectious disease (including positive HIV serology or viral RNA).\n* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \\\u003C40%).\n* Liver dysfunction (AST\u002FALT ≥ 3 times institutional upper limit normal value -ULN- or bilirubin \\> 3 times ULN).\n* Renal dysfunction: serum creatinine \\> 1.5 times ULN or calculated creatinine clearance \\\u003C 60 ml\u002Fmin\u002F1.73 m2\n* End stage irreversible multi-system organ failure.\n* Pregnant or breast feeding female patient.",{"count":184,"type":21},"One of the major challenges to improve the outcome of hematopoietic stem cell transplantation (HSCT) is the reduction of toxicity and non-relapse mortality caused by the pre-transplant conditioning regimen, while maintaining efficacy. Treosulfan (TREO) (L-treitol-1,4-bis-methanesulfonate) is a busulfan analogue with a distinct site of alkylation that results in a more favourable toxicity profile in comparison with busulfan and total body irradiation. TREO is the prodrug of L-epoxybutane, a water-soluble bifunctional alkylating agent with remarkable myeloablative and immunosuppressive properties. The use of TREO, in combination with other chemotherapy agents, as part of the conditioning regimen for hematopoietic stem cell transplantation (HSCT) in children has progressively increased during the last decade for both malignant and non-malignant disorders. Data on TREO pharmacokinetics in the pediatric population are still scarce. To date, only a few studies, including small numbers of pediatric patients, have investigated the PK profile of TREO. These studies reported high variability of TREO pharmacokinetics, and the relationship between TREO exposure, toxicity and clinical outcome is still unresolved. Therefore, therapeutic drug monitoring with a personalized approach may be an important tool to optimize outcomes in the pediatric population. The aim of the investigators' study is to characterize TREO PK\u002FPD profiles in children undergoing HSCT and to evaluate the relationship between TREO exposure and early toxicity and clinical outcome.",[204,205,206],"Pediatric Hematopoietic Stem Cell Transplantation","Malignant Disorders","Non-malignant Disorders","2026-04-23",{"date":209,"type":33},"2026-04-24",{"date":211,"type":33},"2021-02-24",{"date":213,"type":21},"2027-07-31",{"name":39,"class":40},10,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":17,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100582042","coping-and-attachment-in-pediatric-oncohematology-100582042","NCT06858163","Coping and Attachment in Pediatric Oncohematology","Coping and Attachment in Pediatric Oncohematology: Multicenter Cross-sectional Study to Assess Emotional Resources and Attachment Dynamics Related to Coping Strategies in Parents of Children With Oncohematologic Disease","CopAt","Parents Inclusion Criteria:\n\n* parents of both sexes\n* age of son\u002Fdaughter between 8 and 17 years old (included)\n* son\u002Fdaughter being treated at the Pediatric Oncohematology departments involved in the research (Day Hospital and hospitalization)\n* good understanding of the Italian language\n\nParents Exclusion Criteria:\n\n● son\u002Fdaughter in off-therapy\n\nPatients Inclusion Criteria:\n\n* age between 8 and 17 years old (included), undergoing treatment at the Pediatric Oncohematology departments (Day Hospital and hospitalization)\n* parents enrolled in the study\n* good understanding of the Italian language\n\nPatients Exclusion Criteria:\n\n● patients in off-therapy",true,"8 Years","17 Years",{"count":228,"type":21},60,"Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child.\n\nDespite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. Coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations.\n\nCurrently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. The former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution\u002Falteration (e.g., problem identification and resolution, stress cause research). Some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment.\n\nThe clinical experience with patients in the Pediatric Oncohematology Department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed.\n\nThe research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.",[231,232,233],"Pediatric Cancer","Coping Behavior","Relationship, Parent Child",{"date":209,"type":33},{"date":236,"type":33},"2023-07-12",{"date":238,"type":21},"2026-12-31",{"name":39,"class":40},3,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":62},"100581018","evaluation-of-genetic-molecular-causes-of-out-of-hospital-cardiac-arrest-from-patients-to-families-100581018","NCT06844851","Evaluation of Genetic-molecular Causes of Out-of-Hospital Cardiac Arrest: From Patients to Families","GenetiCA","Inclusion Criteria:\n\n* All the patients suffering from OHCA of medical etiology in Lombardy Region ≤50 years, for whom resuscitation manoeuvres was started by EMS (AREU)\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients with a non-medical cause of the cardiac arrest","50 Years",{"count":250,"type":21},1725,"The aims are to define the exact prevalence of hereditary heart diseases in out-of-hospital cardiac arrest (OHCA) patients taking also into account gender, patient and OHCA characteristics, provincial settings and environmental pollution; to stratify the individualized arrhythmic risk of proband's family members to prevent further sudden cardiac deaths; to refine the classification of the variants of uncertain significance (VUS) on genes which can have the capability to drive to molecular alterations leading to arrhythmogenic hereditary heart diseases. A blood sample will be obtained during resuscitation from all the patients aged ≤50 years suffering an OHCA in Lombardy Region and then analysed for genetic variants possibly causative of cardiac diseases. Genetic data will be merged with patient, OHCA and post-resuscitation data thanks to the connection with LombardiaCARe, whilst pollution data will be retrieved from ARPA Lombardia for free. A genetic counselling and clinical-instrumental evaluation of the proband's first-degree family members will be performed if a pathogenic\u002Flikely pathogenic variant or a VUS will be disclosed during the genetic analysis.",[253],"Cardiac Arrest (CA)",[255,256,257],"Out-of-hospital cardiac arrest","genetic","cardiovascular diseases","2026-04-22",{"date":260,"type":33},"2026-04-27",{"date":262,"type":33},"2021-09-09",{"date":264,"type":21},"2027-12-31",{"name":39,"class":40},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":162,"enrollmentInfo":273,"targetDuration":275,"studyType":22,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100545533","promoting-diagnosis-and-management-of-al-in-italy-prodigality-100545533","NCT06383143","Promoting Diagnosis and Management of AL in Italy (ProDigALIty)","ProDigALIty","PART A\n\nInclusion Criteria:\n\n* diagnosis of MGUS with altered FLCR or SMM;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* Diagnosis of symptomatic monoclonal gammopathies;\n* Previous treatment for monoclonal gammopathies.\n\nPART B\n\nInclusion criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.",{"count":274,"type":21},760,"2 Years","The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:\n\n1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)\n2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical\u002Fclinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;\n3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis",[166,278,279],"Smoldering Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance","2026-04-13",{"date":282,"type":33},"2026-04-16",{"date":284,"type":33},"2023-05-01",{"date":286,"type":21},"2026-05-01",{"name":39,"class":40},4,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":162,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100531911","a-european-registry-and-sample-sharing-network-to-promote-the-diagnosis-and-management-of-light-chain-amyloidosis-eureka-100531911","NCT06205953","A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","EUREKA","Inclusion Criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.",{"count":298,"type":21},400,"A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.",[166],{"date":282,"type":33},{"date":303,"type":33},"2024-01-01",{"date":305,"type":21},"2026-06-01",{"name":39,"class":40},6,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":162,"enrollmentInfo":316,"targetDuration":18,"studyType":22,"phases":4,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":62},"100426899","a-registry-of-al-amyloidosis-real-100426899","NCT04839003","A Registry of AL Amyloidosis (ReAL)","A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)","ReAL","Inclusion Criteria:\n\n1. diagnosis of systemic AL amyloidosis;\n2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);\n3. age ≥18 years;\n4. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);\n5. planned (or ongoing) follow-up at participating center.\n\nExclusion Criteria:\n\n1. non-AL amyloidosis;\n2. previous treatment for AL amyloidosis.",{"count":317,"type":21},5000,"The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.",[166],[321,322,323],"amyloidosis","prognosis","registry",{"date":282,"type":33},{"date":326,"type":33},"2020-02-27",{"date":328,"type":21},"2027-05",{"name":39,"class":40},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":62},"100634001","comprehensive-characterization-of-immune-response-induced-by-adjuvanted-glycoprotein-e-ge-based-recombinant-vaccine-zoster-in-vulnerable-population-receiving-immunomodulant-therapies-100634001","NCT07534007","Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies","Inclusion Criteria:\n\n* • Patients over 18 years of age;\n\n  * All genders are eligible for the study;\n  * Patients with psoriasis receiving immunomodulant therapy (anti-TNF);\n  * Patients with psoriasis who do not require immunomodulant therapy;\n  * Patients with myelofibrosis receiving immunomodulant therapy (anti-JAK, such as Ruxolitinib);\n  * Patients with myelofibrosis not receiving immunomodulant treatment;\n  * Life expectancy (as estimated by the treating physician) ≥ 12 months or more;\n  * Signed informed consent.\n\nExclusion Criteria:\n\n* • At the end of the observation period;\n\n  * In case of death;\n  * If informed consent is revoked.","100 Years",{"count":338,"type":21},150,"Varicella-zoster virus (VZV) is one of the eight herpesviruses that infect humans by manifesting as varicella. After primary infection VZV remains latent for life. In 30% of individuals the virus reactivates causing a secondary infection, herpes zoster (HZ). The most common complication of HZ is post-herpetic neuralgia (PHN) and, in severe cases, disseminated infection and death. The incidence of HZ increases as cell-mediated immunity (CMI) declines due to advanced age or the administration of immunomodulatory or immunosuppressive therapies. With the approval of the recombinant adjuvanted glycoprotein E (gE) vaccine (RZV; Shingrix™, GSK) also in immunocompromised individuals (IC) HZ is now considered a vaccine preventable disease. The development of novel biologic therapies has revolutionized the treatment of inflammatory skin conditions improving clinical responses in psoriasis and psoriatic arthritis patients. Although the overall safety records of biologic therapies are outstanding, there is evidence of an increased risk of contracting viral infections by nature of their inherent immunomodulatory and immunosuppressive effects.\n\nPrimary myelofibrosis (MF) is a myeloproliferative neoplasm. The development and approval of ruxolitinib, the first JAK1\u002F2 inhibitor indicated to treat MF, has improved patient outcomes and overall survival. However, JAK inhibitors also suppressed the immune system impairing Natural Killer cell function and virus-specific T cell response. These may potentially result in increased infections (and in particular of VZV reactivation).\n\nGiven the increased risk of HZ associated with immunomodulant therapy, data on the immunogenicity and safety of RZV in IC populations are urgently needed.",[341],"RZV Vaccine (Shingrix ®)",[343,344,345],"ELISpot","immune response","serology","2026-04-10",{"date":282,"type":33},{"date":349,"type":33},"2026-02-24",{"date":351,"type":21},"2027-12-01",{"name":39,"class":40},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":182,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":62},"100634107","radiological-and-clinical-evaluation-of-renal-embolization-using-evoh-in-dialysis-patients-with-autosomal-dominant-polycystic-kidney-disease-a-prospective-longitudinal-observational-study-100634107","NCT07535385","RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY","Inclusion Criteria:\n\n* aged over 18 and under 75\n* written informed consent\n* Patients with autosomal dominant polycystic kidney disease, with a kidney volume of between 2000 and 5000 mL, on dialysis, undergoing renal embolisation\n\nExclusion Criteria:\n\n• Contraindications to MRI without contrast (ferromagnetic implants, incompatible pacemakers, surgical clips, severe claustrophobia or other conditions that may interfere with MRI)",{"count":360,"type":21},30,"Autosomal dominant polycystic kidney disease (ADPKD) is an inherited cystic disorder characterised by the progressive degeneration of the renal parenchyma into cystic formations, with involvement of other organs to varying degrees and incidence (liver, pancreas and brain).\n\nThis condition is the most common inherited kidney disorder; in fact, it affects 1 in 400-1,000 births and has a prevalence of 5% among dialysis patients and an incidence of 10% among patients with end-stage renal failure in Europe. It is caused by mutations in the PKD1 or PKD2 genes, which are involved in the production of an abnormal protein that leads to tubular dysplasia.\n\nCystic degeneration leads to progressive loss of renal function, with the development of hypertension, haematuria and concomitant enlargement of the renal parenchyma. The progression of the disease is precisely marked by an increase in renal volume. The increase in the organ's overall volume is secondary to the development and enlargement of cysts, whilst the proportion of functioning renal parenchyma progressively decreases. For these reasons, the increase in renal volume over time is a powerful predictor of the risk of end-stage renal disease (ESRD).\n\nIn addition to its prognostic significance, the enlargement of the kidneys is itself a cause of complications. Indeed, the space occupied within the abdomen can become so extensive as to cause abdominal distension, malaise, pain, loss of appetite, constipation, nausea and vomiting, reduced diaphragmatic movement, breathing difficulties and lower back pain. Overall, patients' quality of life can be severely compromised.\n\nIt is not uncommon for the kidneys of patients with ADPKD to occupy the pelvic cavity, the preferred site for kidney transplant placement, which represents the optimal treatment option for the disease once ESRD has been reached. This situation, which is not uncommon, represents a temporary contraindication to kidney transplantation: delaying the procedure also has repercussions on the patient's survival.\n\nThe contraindication to transplantation due to anatomical unavailability has so far necessitated surgical nephrectomy (so-called 'debridement nephrectomy') as the sole preventive or pre-transplant therapeutic option. Nephrectomy carries the risks inherent in surgery, including haemorrhage, herniation of the abdominal wall, vascular complications of varying severity-such as arteriovenous fistulas, thrombosis, and vascular wall injury-and the risk of infection. Surgical nephrectomy also has a negative impact on the subsequent possibility of using the peritoneal membrane for dialysis (peritoneal dialysis) and, should blood transfusions be required to correct intraoperative blood loss, contributes to increasing the likelihood of the patient becoming immunised, with the associated risks of reduced availability of compatible donors (so-called hyperimmune patients), and, in any case, a higher risk of acute and chronic rejection, conditions that negatively impact transplant survival.\n\nGiven the high risks associated with nephrectomy, a non-invasive alternative has been proposed: reduction of renal volume via transcatheter arterial embolisation.\n\nRenal embolisation can be performed in the Interventional Radiology department via the controlled occlusion of renal vessels using a liquid embolisation agent composed of ethylene vinyl alcohol (EVOH). The literature reports the assessment of embolised patients using CT without contrast medium, but recent technological innovations allow for accurate and precise volumetric assessment of organs using MRI without contrast medium, with reduced inter-operator variability and without the need to subject the patient to ionising radiation during follow-up.",[363],"Autosomal Dominant Polycystic Kidney Disease (ADPKD)",{"date":365,"type":33},"2026-04-17",{"date":367,"type":33},"2020-08-17",{"date":369,"type":21},"2026-08-17",{"name":39,"class":40},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":377,"targetDuration":116,"studyType":22,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":62},"100632874","a-comprehensive-register-of-lymphoproliferative-disorders-rely-100632874","NCT07519356","A Comprehensive Register Of Lymphoproliferative Disorders (ReLy)","Inclusion Criteria:\n\n* Patients ≥ 18 years diagnosed with and\u002For treated for lymphoproliferative disorders.\n* Prospective patients (or their or legal guardians) who have the ability to understand and be willing to sign a written informed consent document\n* Retrospective patients who have signed the institutional document allowing the use of their data for research on their disease\n\nExclusion Criteria:\n\n* Patients who are unable to understand informed consent document",{"count":378,"type":21},9000,"The primary objective of this study is to assess the 10-year overall survival (OS) of patients with different lymphoproliferative disorders. Secondary objectives include evaluating the comorbidities and fitness of patients and their impact on treatment choices and outcomes. Additionally, the study will examine the effectiveness of various therapeutic regimens, with a particular focus on new treatments, such as chemo-free protocols, targeted drugs, and cell therapies, in order to determine the best treatment sequence for refractory and relapsed cases.\n\nThe research will also investigate how clinical and biological factors influence disease progression or relapse. Another aim is to explore potential correlations between genotype, clinical phenotype, and outcomes, both at diagnosis and during various disease stages. The study will also assess the incidence of tumor lysis syndrome and other adverse events during treatment, considering how these factors might affect treatment discontinuations or dose reductions.\n\nAnother objective is to evaluate the outcomes of patients who are managed with a \"watch and wait\" approach. Long-term toxicities and the occurrence of secondary malignancies will also be studied, alongside the analysis of healthcare costs and the resources used in patient management.",[381],"Lymphoproliferative Disease","2026-04-02",{"date":384,"type":33},"2026-04-09",{"date":386,"type":33},"2022-06-09",{"date":388,"type":21},"2030-12-30",{"name":39,"class":40},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":182,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":62},"100626324","evaluation-of-oxidative-stress-comparison-between-type-1-diabetes-mellitus-and-latent-autoimmune-diabetes-in-adults-100626324","NCT07434154","Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults","Inclusion Criteria:\n\nPatients with with already known or newly diagnosed type 1 diabetes mellitus or LADA Patients aged ≥ 18 years and ≤ 75 years Patients of both sexes All patients will be selected among outpatients attending the Center of Diabetes and Metabolic Diseases of First Department of Internal Medicine, IRCCS Policlinico San Matteo Foundation.\n\nExclusion Criteria:\n\nPatients refusing to sign informate consent.",{"count":397,"type":21},75,"After obtaining informed consent, the investigators will recruit 75 patients with T1DM and 75 with LADA with an age ≥ 18 years and ≤ 75 years, of both sexes. All patients will be selected among outpatients attending the Center of Diabetes and Metabolic Diseases of First Department of Internal Medicine, IRCCS Policlinico San Matteo Foundation. The study design will include one single visit where patients' medical history and blood samples will be collected. For incident cases, a follow-up visit at 3 months from the start of treatment will be scheduled to assess whether a decrease in HbA1c corresponds to a decrease in the biomarkers. For a comprehensive oxidative balance evaluation, the d-ROMs test will be carried out to evaluate the pro-oxidant status linked to one of the parameters related to the antioxidant potential (BAP test, OXY-Adsorbent test, -SHp test and anti-ROMs test). Parameters will be evaluated using Free Radical Elective Evaluator (FREE) Duo by Diacron International s.r.l. (Grosseto, ITALY), an integrated analytical system that permits any type of chemical-clinical analysis based on the principle of photometry. The investigators will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA). To evaluate if there is an association between a worse stage of the diseases and some oxidative stress markers, the investigators will also evaluate glycated hemoglobin (HbA1c) fasting plasma glucose (FPG), post-prandial glucose (PPG). All plasmatic parameters will be determined after a 12-h overnight fast, with the exception of PPG, determined 2 hours after a standardized meal. Venous blood samples will be taken for all patients between 8 A.M. and 9 A.M. The investigators will use plasma obtained by addition of Na2-ethylenediaminetetraacetic acid (EDTA), 1 mg\u002Fml, and centrifuged at 3000 g for 15 minutes at 4°C. Immediately after centrifugation, the plasma samples will be frozen and stored at -80 °C for no more than 3 months. All measurements will be analyzed by the Laboratory of Molecular Medicine, General Medicine 1, IRCCS Policlinico San Matteo Foundation with proven experience in the dosage of these markers.",[400,401],"Type 1 Diabetes Mellitus","Latent Autoimmune Diabetes in Adult (LADA)",[403,404,405],"Type 1 diabetes mellitus","Latent Autoimmune Diabetes in Adult","Oxidative stress","2026-03-28",{"date":382,"type":33},{"date":409,"type":33},"2025-10-01",{"date":411,"type":21},"2026-08-31",{"name":39,"class":40},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":423,"conditions":424,"keywords":429,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":62},"100620358","neonatal-enterovirus-infections-in-italy-virological-characterization-genomic-and-clinical-epidemiological-insights-on-echovirus-11-100620358","NCT07356583","Neonatal Enterovirus Infections in Italy: Virological Characterization, Genomic and Clinical-epidemiological Insights on Echovirus 11","Entero-Neo","Inclusion Criteria:\n\nSamples from consecutive neonates admitted to neonatal intensive care unit.\n\nExclusion Criteria:\n\nInsufficient residual samples (volume less than 1 mL of nasal swab) will be excluded from the study","28 Days",{"count":422,"type":21},1600,"The Enterovirus genus, belonging to the Picornaviridae family, consists of positively polarized single-stranded RNA viruses classified into the species Enterovirus (EV, comprising Coxsackievirus, Echovirus and Poliovirus) A-J and Rhinovirus (RV) A-C, of which more than 200 different genotypes have been described. Enteroviruses have a global spread and are a common cause of febrile, gastroenteric and exanthematous diseases, usually self-limiting, which are widespread in infants and pediatric populations. However, they can occasionally cause serious diseases, including meningoencephalitis, myelitis, paralysis, myocarditis, sepsis, severe respiratory syndromes, and acute hepatitis. They can be transmitted by respiratory route, with most cases in temperate regions occurring during summer and early autumn. Enteroviruses are characterized by a rapid evolution determined by the high mutation rate (due to the presence of an RNA-dependent RNA-polymerase that lacks proofreading activity) and the high probability of undergoing recombination events. The latter, in particular inter-typical recombination, plays a crucial role in the evolutionary process of Enteroviruses and has been recognized as a major cause of the emergence of strains with higher pathogenicity and\u002For epidemic potential, although the associated genetic determinants are not known to date. Between July 2022 and April 2023, nine cases of neonatal Echovirus 11 (E-11) infection with severe liver failure and neurological and myocardial involvement were reported in France; seven of these cases resulted in fatal outcomes. Following these reports, the World Health Organization (WHO) issued an alert that quickly led to the identification of further cases in Italy, Spain, Croatia and the United Kingdom. As EV infections are not subject to systematic surveillance, there is a lack of data on the actual burden of disease associated with these infections. Thus, EV infections are underestimated and, even more so, data on their typing are scarce - if not absent -, which involve second-level analyses that are generally not carried out routinely in clinical microbiological diagnostic laboratories, are rarely available and are not systematically collected, not even at European level. A condition that therefore makes it impossible to estimate either the impact of EV infections in general, and of E-11 in particular, or the risk factors related to the most serious cases and the most significant transmission routes. Moreover, the characteristics of the immunological and inflammatory response to infection remain to be defined. These elements would allow, if available, the formulation of a specific case definition to ensure rapid laboratory confirmation and recognition of the disease.To strengthen knowledge of the spread and impact of enterovirus infections in newborns, with a focus on E-11, by carrying out the following activities, within the scope of the project's proposed objectives: design and pilot implementation (proof of concept) of epidemiological and genomic surveillance systems with potential national application; molecular characterization and evaluation of viral pathogenic features; search for possible immunological markers and host risk factors associated with severe EV disease, including E-11.\n\nSpecific objectives\n\n1. To implement and validate a protocol for screening activities in neonatal units and neonatal intensive care units aimed at checking for the presence of infections caused by EV and identifying severe forms of infection, with particular attention to E-11.\n2. Characterize EV strains, identified within the activities carried out by specific objectives 1, using next-generation sequencing (NGS) approaches to obtain the whole genome sequence and identify possible recombinant forms. Carry out phylogenetic analysis of the obtained sequences compared with those deposited in the main international databases, to define genomes that can be traced back to variant strains or with specific mutations in the genome.",[425,426,427,428,52],"Enterovirus","Clinical Syndrome","Respiratory Complications","Gastrointestinal",[430],"Enterovirus, E-11, NGS","2026-03-26",{"date":433,"type":33},"2026-03-27",{"date":435,"type":33},"2026-02-01",{"date":437,"type":21},"2027-02-01",{"name":39,"class":40},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":162,"enrollmentInfo":447,"targetDuration":18,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":360},"100473440","the-italian-transthyretin-amyloidosis-web-network-100473440","NCT05444920","The Italian Transthyretin Amyloidosis Web-Network","The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)","ITA-WebNet","Inclusion Criteria:\n\n1. Suspected diagnosis of systemic and localized amyloidosis;\n2. age .18 years;\n3. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);\n4. planned (or ongoing) follow-up at participating center.\n\nExclusion Criteria:\n\n1\\. Diagnosis of light chain (AL) amyloidosis",{"count":70,"type":21},"The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.",[450],"ATTR Amyloidosis",[321,452],"systemic amyloidosis","2026-03-23",{"date":433,"type":33},{"date":456,"type":33},"2022-07-13",{"date":458,"type":21},"2027-11-01",{"name":39,"class":40},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":62},"100630951","italian-retrospectiveprospective-observational-study-on-prosthetic-surgery-in-patients-with-congenital-coagulation-diseases-mec-100630951","NCT07494344","Italian Retrospective\u002FProspective Observational Study on Prosthetic Surgery in Patients With Congenital Coagulation Diseases (MEC).","Inclusion Criteria:\n\n* adult patients with MEC (in particular Haemophilia A and Haemophilia B, with and without inhibitor, Von Willebrand's disease (VWD), other coagulation factor deficits)\n* they are undergoing prosthetic surgery\n* they have signed informed consent.\n\nExclusion Criteria:\n\n* Subjects \\\u003C 18 years old;\n* Subjects with acquired haemorrhagic disorders\n* Lack of signed informed consent.",{"count":467,"type":21},425,"The number of hip, knee, shoulder, ankle and elbow prostheses, as well as the amount of economic resources dedicated to this type of intervention, are constantly growing. Prosthetic interventions are not always effective, in some cases they have shown poor results and a high incidence of infections. For rare diseases such as haemophilia and haemophilic arthropathy, collecting retrospective and prospective data is the first step in estimating prevalence or incidence and the opportunity to stimulate future research and to facilitate recruitment into studies. Such studies may present data on the demographic aspects of patients to describe the population receiving the procedures, the patterns of use over time, the risks of review and the outcomes reported by patients. This retrospective\u002Fprospective study aims to describe and analyze the risk factors associated with the patient, the surgical technique and obtain outcomes.",[470,471],"Prosthetic Surgery","Congenital Coagulation Diseases","2026-03-20",{"date":433,"type":33},{"date":475,"type":33},"2026-02-20",{"date":477,"type":21},"2031-02-20",{"name":39,"class":40},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":485,"maxAge":48,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":62},"100630953","adenoidectomy-correlation-between-individual-factors-surgical-technique-and-residual-adenoids-100630953","NCT07494370","Adenoidectomy: Correlation Between Individual Factors, Surgical Technique, and Residual Adenoids","Inclusion Criteria:\n\n* Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy","0 Years",{"count":487,"type":21},1200,"Adenoidectomy is the most commonly performed otolaryngological surgical procedure in children. The removal of adenoid lymphoid tissue is intended to clear the nasopharynx and restore the patency of the nasal airways. In most cases, adenoidectomy leads to an improvement in symptoms and quality of life. However, in some patients, symptoms recur with the presence of lymphoid tissue obstructing the nasopharynx. In these cases, a surgical revision is often necessary.\n\nThe traditional surgical technique is performed using an adenoid curette or Shambaugh adenotome without direct visualization of the surgical field. Among the known limitations of this surgery is the possibility of leaving intraoperative adenoid residues. In the literature, regarding the detection of adenoid vegetations in patients who have already undergone adenoidectomy, the term \"regrowth\" of lymphoid tissue is often used; however, this term is correctly applied only when there is certainty of complete adenoid excision during the procedure. In the absence of this certainty, it would therefore be more accurate to speak of persistence or recurrence of adenoid hypertrophy after adenoidectomy. However, this phenomenon is poorly understood due to the scarcity of information in the literature regarding the incidence, associated factors, and etiology of this clinical entity. In particular, there is still debate over whether the recurrence of symptoms following the detection of nasopharyngeal lymphoid tissue is due to incomplete surgical resection, or whether individual factors may coexist and contribute to the recurrence of adenoid lymphoid tissue. To date, the scientific literature has focused almost exclusively on intraoperative variables independent of the patient. The aim of this study is to evaluate whether there are patient-specific factors at the time of surgery-such as sex, age, weight, height, and soft palate length-that may influence the surgical efficacy of the traditional technique in terms of complete removal of adenoid lymphoid tissue.",[490],"Tonsillectomy",{"date":433,"type":33},{"date":493,"type":33},"2020-08-20",{"date":495,"type":21},"2026-08-20",{"name":39,"class":40},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":62},"100630862","magnetic-resonance-imaging-of-the-lung-non-oncological-applications-100630862","NCT07493187","Magnetic Resonance Imaging of the Lung: Non-Oncological Applications","Inclusion Criteria:\n\n* Clinical and radiological diagnosis of early-stage IPF\n\nExclusion Criteria:\n\n* Absolute contraindications to bronchoalveolar lavage or magnetic resonance imaging",{"count":504,"type":21},50,"Non-neoplastic pulmonary proliferative diseases are characterized by a complex interaction between proliferating lung cells and a variety of resident and infiltrating host cells, secreted factors, and extracellular matrix proteins, collectively referred to as the microenvironment. Idiopathic pulmonary fibrosis (IPF) refers to a specific condition characterized by chronic interstitial pneumonia and fibrosis of unknown cause, for which there are still no effective treatments. According to the current pathogenetic perspective, the aberrant proliferative events in IPF resemble those occurring during malignant transformation in tumors. Growing evidence supports the neoplasm-like molecular profile of IPF, and this fascinating hypothesis is beginning to be exploited for therapeutic purposes. Tyrosine kinase receptors (RTKs) are known to be major players in the onset and progression of cancer. Among these, the proto-oncogene MET is a key regulator of the invasive growth program. MET encodes the TK receptor for the \"dispersion factor\" or hepatocyte growth factor (HGF), a sensor of adverse microenvironmental conditions (e.g., hypoxia and ionizing radiation) that drives cellular invasion and metastasis through transcriptional activation of the \"invasive growth signature.\" We and others have previously reported that both myofibroblasts and epithelial cells in fibroblastic foci (FFs) in IPF express MET in its activated form (MACTIF study). MRI technology will help identify hypoxic areas and thus those patients who may potentially benefit from anti-MET therapeutic lockade. Magnetic resonance imaging (MRI) has an incredible ability to distinguish between different tissue components. Advanced techniques such as diffusion, mapping, ventilation, and perfusion allow for even more precise tissue characterization.\n\nFor example, perfusion imaging can quantify the spatial distribution and extent of oxygen delivery to tissues in vivo and is therefore the best method for assessing vascular oxygenation. On the other hand, ventilation imaging allows for a quantitative analysis of pulmonary physiology, in vivo pulmonary ventilation, and oxygen sensitivity; in this way, the \"alveolar\" aspect of the oxygenation process will be explored.\n\nSince the introduction of MRI imaging for the evaluation of lung diseases, various limitations, primarily related to the relatively low proton density of the lung parenchyma and respiratory motion artifacts, have hindered the clinical application of this technique. In recent decades, technical advances have addressed many of these limitations.\n\nMRI could enable the assessment of hypoxic areas in IPF and thus lead to the identification of patients at risk of disease progression and validate MET as a new therapeutic target. No attempts have yet been reported in the literature regarding the study of pulmonary microenvironment characteristics using advanced MRI imaging.",[507],"Interstitial Lung Disease","2026-03-19",{"date":510,"type":33},"2026-03-25",{"date":512,"type":33},"2020-12-28",{"date":514,"type":21},"2026-04-28",{"name":39,"class":40},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":62},"100630326","magnetic-resonance-imaging-of-the-lung-oncological-applications-100630326","NCT07486219","Magnetic Resonance Imaging of the Lung: Oncological Applications","Inclusion Criteria:\n\n* Primary NSCLC of the lung (TNM 8th edition T parameter ≥T1c)\n* Biopsy examination of the primary tumor adequate at least for PDL-1 quantification\n* Staging CT scan with uncertain N parameter and definite M parameter.\n\nExclusion Criteria:\n\n* Absolute contraindications to magnetic resonance imaging or the administration of gadolinium-based contrast agents",{"count":504,"type":21},"Lung neoplasms are characterized by a complex interaction between tumor cells and a variety of resident and infiltrating host elements, secreted factors, and extracellular matrix proteins, collectively referred to as the microenvironment. Nowadays, in the setting of lung cancer, and in particular non-small cell lung cancer (NSCLC), the evaluation of microenvironment characteristics can only be performed by a pathologist and only on histological material. By combining different MRI parameters, it may be possible to create a specific imaging \"signature\" for the three different immune phenotypes and thus be able to make a distinction based on MRI examination.",[525],"Lung Cancer (NSCLC)","2026-03-18",{"date":472,"type":33},{"date":529,"type":33},"2020-01-15",{"date":531,"type":21},"2026-04",{"name":39,"class":40},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":539,"minAge":48,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":62},"100629688","immunological-and-virological-prognostic-markers-of-human-cytomegalovirus-hcmv-congenital-infection-in-pregnant-women-with-primary-hcmv-infection-100629688","NCT07477925","Immunological and Virological Prognostic Markers of Human Cytomegalovirus (HCMV) Congenital Infection in Pregnant Women With Primary HCMV Infection.","Inclusion Criteria:\n\n* Pregnant women \\>18 years.\n* HCMV primary infection occurring within 26 weeks of gestation.\n* HCMV primary infection onset within 3 months before enrollment.\n* HCMV pre-conception (non-primary) infection and congenitally infected newborn\n\nExclusion Criteria:\n\n* HBV, HCV, HIV infection.\n* Known immunodeficiency, immunosuppression or autoimmune disease.\n* Inability to comply with the requirements of the protocol.","FEMALE",{"count":541,"type":21},90,"Human cytomegalovirus (HCMV) establishes a lifelong relationship with its host: primary infection is followed by a latency phase with intermittent reactivation episodes, despite a robust, long-lasting immune response. Primary and non-primary infection (the latter indicating both reactivation and re-infection) is usually asymptomatic in immunocompetent individuals.\n\nApart from immunocompromised subjects, HCMV is potentially dangerous during pregnancy: the fetus may become infected and develop symptoms at birth or severe long-term sequelae in about 20% of cases (Stagno et al, JAMA 1986; Dollard et al, Rev Med Virol 2007). HCMV is the most common congenital infection with vertical transmission occurring in about 0.64% pregnancies (Cannon \\& Davis, BMC Public Health 2005).\n\nOur studies on the T and B cell response to HCMV suggest that a delayed development of the immune response to HCMV primary infection in pregnant women is associated with virus transmission to fetus (Revello et al., J Infect Dis 2006; Lilleri et al., J Infect Dis 2007; 2008; PLoS ONE 2013; Fornara et al., J Clin Immunol 2011, J Med Virol 2015).\n\nMore recently, we observed that women transmitting the virus to the fetus had a higher percentage of \"short-term effector\" (STE) HCMV-specific CD4+ T cells, while an earlier development of \"long-term memory\" (LTM) cells was associated with a lower risk of virus transmission to the fetus (Mele et al., PLosOne 2017). LTM are characterized by the expression of the receptor for IL-7 (IL-7R), a cytokine involved in the homeostatic maintenance of memory (and naïve) T cells, whereas STE lack expression of IL-7R and are maintained by antigen stimulation. On the same direction, results of another study showed that the earlier development of memory-like CD4+ T cells specific for the pp65 antigen of HCMV (i.e. T cells able to proliferate in vitro in response to the antigen) as determined by a culture ELISPOT is associated with a lower risk of HCMV transmission (Fornara et al., CID 2017).\n\nThe limitation of our study of LTM vs STE resides on the fine but cumbersome technique applied, which was based on sorting of the two T-cell subsets and subsequent 3-weeks expansion of multiple T-cell culture replicates (T-cell library), before testing their specificity for HCMV (Geiger et al., J Exp Med 2009). However, our preliminary results show that LTM and STE HCMV-specific T cells can be detected also by direct ex vivo stimulation of T cells and simultaneous determination of IFNγ production (HCMV-specificity) and IL-7R expression (T-cell phenotype) by flow cytometry.\n\nThe aims of the present study is to determine the prognostic performance of the combination of different parameters of HCMV-specific T cell response (CD45RA re-expression, LTM phenotype, IL-2 production and lymphoproliferation), in order to be used in the clinical practice to assess the risk of HCMV transmission to the fetus after maternal primary infection. In addition, we will explore whether the presence of memory-like (i.e. expandable) CD4+ T cells able to proliferate in response to other individual HCMV antigens are associated with the risk of virus transmission to the fetus.\n\nHCMV vaccine is actively sought and several candidates are being proposed (Wang \\& Fu, Curr Opin Virol 2014) and the definition of immune parameters associated with protection against non-primary infection and virus transmission is mandatory to analyze the effectiveness of different vaccines being developed.",[544],"Human Cytomegalovirus (HCMV)","2026-03-12",{"date":547,"type":33},"2026-03-17",{"date":549,"type":33},"2018-10-03",{"date":551,"type":21},"2026-10-03",{"name":39,"class":40},""]