[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fabiana Sherine Ganem dos Santos\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100643130","expression-of-inflammatory-markers-in-the-course-of-acute-respiratory-viral-infections-100643130",false,"NCT07643688","Expression of Inflammatory Markers in the Course of Acute Respiratory Viral Infections","Expression of Inflammatory Markers in the Course of Acute Respiratory Viral Infections in Adults Aged 60 Years and Older: a Prospective Observational Study in Primary Case","AIRE-INT","Inclusion Criteria:\n\nGROUP A (Infected-Positive)\n\n* Age ≥60 years.\n* Symptoms compatible with viral respiratory infection (fever, cough, nasal congestion, dyspnea, etc.) between 24h and 72h from symptom onset.\n* Confirmed diagnosis, positive for influenza, RSV, or SARS-CoV-2 by rapid test.\n* Signed informed consent at visit 1.\n\nGROUP B (Non-Infected-Negative. Controls)\n\n* Age ≥60 years.\n* Negative diagnosis for influenza, RSV, or SARS-CoV-2 by rapid test.\n* Signed informed consent at visit 1.\n\nExclusion Criteria:\n\n* Known severe immunosuppression (e.g., transplant recipient, uncontrolled HIV).\n* Chronic immunosuppressive treatment (except low-dose corticosteroids (≤10 mg\u002F3 months)).\n* Participation in another clinical trial within the last 30 days.\n* Inability to comply with the visit schedule.\n* Immunosuppressive drugs.\n* Drugs indicated for treatment.\n* Oncology patients.\n* Terminal patients.\n* Autoimmune diseases associated with alterations in PD-L1.\n* Systemic lupus erythematosus (SLE).\n* Rheumatoid arthritis (RA).\n* Multiple sclerosis (MS).\n* Type 1 diabetes mellitus (T1DM).\n* Sjögren's syndrome.\n* Myasthenia gravis.\n* Autoimmune thyroiditis (Hashimoto's, Graves' disease).","ALL","60 Years",{"count":20,"type":21},150,"ESTIMATED","60 Days","OBSERVATIONAL","Respiratory viral infections caused by influenza, respiratory syncytial virus (RSV), and SARS-CoV-2 remain major causes of morbidity, hospitalization, and mortality among older adults worldwide. Current antiviral therapies have limited effectiveness and generally require administration within the first 48 hours after symptom onset. Increasing evidence suggests that the programmed death receptor-1\u002Fprogrammed death ligand-1 (PD-1\u002FPD-L1) immune checkpoint pathway plays an important role in the host immune response during acute viral respiratory infections. Upregulation of PD-L1 has been associated with impaired antiviral T-cell activity, immune exhaustion, and disease progression in influenza, RSV, and SARS-CoV-2 infections.\n\nThe AIRE-INT study is a prospective, observational, multicenter, non-interventional study designed to characterize the temporal kinetics of PD-L1 expression and inflammatory biomarkers in adults aged 60 years or older presenting with acute respiratory viral infection.\n\nThe study will be conducted in primary care centers and urgent care facilities within the Barcelonès Nord and Maresme healthcare regions in Catalonia, Spain. A total of 150 participants will be enrolled, including 75 with confirmed viral respiratory infection and 75 controls with negative rapid antigen tests for influenza, RSV, and SARS-CoV-2.\n\nEligible participants must be aged ≥60 years and present within 24 to 72 hours after the onset of respiratory symptoms compatible with acute viral infection, including fever, cough, nasal congestion, or dyspnea. Participants in the infected group must have a positive rapid antigen test for influenza, RSV, or SARS-CoV-2. Control participants must test negative for all three viruses. Written informed consent will be obtained before enrollment.\n\nParticipants with severe immunosuppression, chronic immunosuppressive therapy, active oncologic disease, terminal illness, or autoimmune diseases associated with PD-L1 dysregulation will be excluded.\n\nEach participant will be followed for up to 60 days and will complete two in-person study visits and one follow-up assessment.\n\nVisit 1 will occur between 24 and 72 hours after symptom onset and will include informed consent, collection of demographic and clinical data, assessment of symptoms and medical history, rapid antigen testing, and blood sample collection for PD-L1 and inflammatory biomarker analyses.\n\nVisit 2 will occur between 5 and 9 days after symptom onset and will include repeat clinical assessment and blood sample collection to evaluate temporal changes in PD-L1 expression and inflammatory responses during the acute phase of infection.\n\nVisit 3 will occur between 30 and 60 days after symptom onset and will consist of clinical follow-up through telephone contact and electronic medical record review to assess symptom resolution, complications, hospitalization, intensive care admission, and mortality.\n\nLaboratory analyses will include flow cytometry quantification of PD-L1 expression and evaluation of inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), complete blood count parameters, renal and hepatic function markers, and virus-specific IgG antibodies. Blood samples will be processed according to standardized laboratory procedures at the Hospital Germans Trias i Pujol Microbiology Department.\n\nThe primary objective is to characterize the temporal profile of PD-L1 expression from symptom onset to infection resolution in older adults with influenza, RSV, or SARS-CoV-2 infection.\n\nSecondary objectives include:\n\nDescribing the evolution of inflammatory serum biomarkers and their association with disease severity.\n\nIdentifying biomarkers useful for screening, prognosis, and clinical monitoring.\n\nEstablishing a biological reference framework for future evaluation of PD-L1 inhibitors in respiratory viral infections.\n\nThe primary outcome measure is the level and temporal evolution of PD-L1 expression and inflammatory biomarkers between study visits. Secondary outcomes include hospitalization, intensive care admission, mortality at 60 days, symptom duration, and clinical progression.\n\nStatistical analyses will include descriptive and univariate analyses, longitudinal modeling of biomarker kinetics using locally estimated scatterplot smoothing (LOESS) and nonlinear mixed-effects regression models, and predictive logistic regression models evaluating associations between biomarkers and clinical outcomes.\n\nThe study is expected to provide important information regarding the kinetics of PD-L1 expression and inflammatory responses during acute respiratory viral infections in older adults. The findings may support the development of prognostic biomarkers and future host-directed therapeutic strategies targeting the PD-1\u002FPD-L1 pathway across multiple respiratory viruses.",[26,27,28],"SARS CoV 2 Infection","RSV Infections","Influenza Infection",[30,31,32,33,34,35,36],"SARS-CoV-2","Influenza, Human","Respiratory Syncytial Viruses","Observational Study","Programmed Cell Death 1 Receptor","Primary Health Care","Kinetics","NOT_YET_RECRUITING","2026-06-09",{"date":40,"type":41},"2026-06-11","ACTUAL",{"date":43,"type":21},"2026-07-01",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"Fabiana Sherine Ganem dos Santos","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":61,"studyType":23,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100630813","the-t1dwatch-study-a-screening-for-type-1-diabetes-autoantibodies-in-children-for-early-detection-and-intervention-100630813","NCT07492550","The T1DWATCH Study: a Screening for Type 1 Diabetes Autoantibodies in Children for Early Detection and Intervention.","T1D WATCH Study, a Comprehensive Screening for Type 1 Diabetes Autoantibodies in Children: A Proactive Approach to Early Detection and Intervention","T1DWATCH","Inclusion Criteria:\n\n* Age corresponding to one of the predefined screening groups:\n\n  * Young children: 2-6 years\n  * Older children: 7-10 years\n* Attendance at routine pediatric visits within the Preventive Activities and Health Promotion Programme in Childhood in Catalonia (\"Creixer amb Salut\") at the specified ages (2-10 years)\n* Written informed consent provided by parents or legal guardians\n\nExclusion Criteria:\n\n* Presence of primary immunodeficiency\n* Current treatment with immunosuppressive therapy\n* Ongoing participation in another clinical trial\n* Refusal to participate or inability to comply with study procedures","2 Years","10 Years",{"count":60,"type":21},2200,"3 Years","This study aims to identify early-stage type 1 diabetes (T1D) in children aged 2-6 and 8-10 years through autoantibody (Ab) screening, genetic and immunological analyses, and to evaluate the effectiveness of educational interventions, as well as the feasibility and acceptability of their implementation.\n\nIt is a prospective cohort study involving 2,169 children attending primary healthcare centres in the Barcelonès area. Eligible participants will be those engaged in routine paediatric preventive programe with parental informed consent. The screening process consists of three visits: Visit 1: Capillary blood collection for 3 T1D related Ab (3-screen ELISA). Visit 2: Confirmation of positive results through a new venous blood sample to determine single T1D related Ab and metabolic tests (fasting glucose, HbA1c, C-peptide), HLA, imme cell study. Visit 3: Risk stratification based on Ab presence: Group A (negative), Group B (one positive Ab, at risk of T1D), and Group C (two positive Ab, diagnosed at stage 1 or 2). Immunological and metabolic changes will be monitored, and screening effectiveness will be assessed in terms of sensitivity, specificity, and false positive\u002Fnegative rates. The association between HLA genotype and Ab positivity will be analysed using logistic regression. A cost-effectiveness analysis will be conducted alongside a qualitative evaluation of parents' and stakeholders' perceptions regarding the screening process.This study will provide evidence to optimise early T1D detection and its implementation in primary care.",[64],"Diabete Type 1",[66,67,68,69,35,70],"Diabetes TYPE 1","Children","Autoantibodies","Screening","Autoimmunity","2026-03-25",{"date":73,"type":41},"2026-03-31",{"date":75,"type":21},"2026-05",{"date":77,"type":21},"2027-12-30",{"name":47,"class":48},""]