[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":255},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,66,83,108,130,157,185,208,234],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100625296","design-and-validation-of-a-generative-ai-and-propensity-score-matching-model-for-the-ven-dec-phase-ii-study-in-elderly-aml-eligible-for-allo-sct-evaluation-of-an-exploratory-approach-respect-to-a-randomized-phase-iii-trial-100625296",false,"NCT07420790","Design and Validation of a Generative AI and Propensity Score Matching Model for the VEN-DEC Phase II Study in Elderly AML Eligible for Allo-SCT; Evaluation of an Exploratory Approach Respect to a Randomized Phase III Trial","Designing a Generative AI Model and Propensity Score Matching Methodology for Validation of \"The Phase II Study on Venetoclax (VEN) Plus Decitabine (DEC) (VEN-DEC) in Elderly (e60 \u003C75years) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Eligible for Allogeneic Stem Cell Transplantation (Allo-SCT)\". Evaluation of an Exploratory Approach Respect to a Randomized Phase III Trial","VenDec-AI","Inclusion Criteria:\n\n* Patients with AML treated with cht (historical cohort) or VenDec (experimental cohort)\n\nExclusion Criteria:\n\n\\-","ALL","18 Years","75 Years",{"count":21,"type":22},1941,"ESTIMATED","OBSERVATIONAL","To better delineate the contribution of VEN-DEC to the treatment of AML patients aged between ≥ 60 and \\\u003C 75 years and deemed fit for Allo-HSCT, real-world data on a patient-level basis will be collected and utilized to generate a matched control cohort of same AML patients treated with intensive chemotherapy.\n\nIn addittion, to further validate the efficacy of the VEN-DEC treatment approach in elderly AML patients, an advanced generative AI model will be constructed and trained using the historical cohort data. The AI model aims to simulate outcomes based on the standard",[26],"Acute Myeloid Leukemia",[28,29,30,31],"Acute Myeloid Leukaemia","Artificial Intelligence","Chemotherapy","Chemo-free regimen","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-04-30","ACTUAL",{"date":38,"type":36},"2026-02-20",{"date":40,"type":22},"2026-12",{"name":42,"class":43},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100467423","bio-car-t-bs-study-100467423","NCT05366569","Bio-CAR-T BS Study","Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy","Inclusion Criteria:\n\n* Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed\u002Frefractory after two lines of treatments;\n* Adequate performance status (0 or 1);\n* Adequate organ function;\n* No active or uncontrolled infections;\n* No thrombo-embolisms within the last 6 months;\n* Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients with B-cell-ALL \\> 25 years\n* Patients with DLBCL \\\u003C18 or \\>70 years\n* Patients with PMBCL \\\u003C18 or \\>70 years\n* Performance status \\> 1;\n* Active or uncontrolled infections;\n* Thrombo-embolisms within the last 6 months;\n* Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy \\\u003C 3 months.","70 Years",{"count":54,"type":22},45,"The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.",[57,58,59],"Diffuse Large B Cell Lymphoma (DLBCL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Acute Lymphoblastic Leukemia (ALL)",{"date":35,"type":36},{"date":62,"type":36},"2022-04-26",{"date":64,"type":22},"2026-12-31",{"name":42,"class":43},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":44},"100290271","next-generation-sequencing-ngs-in-familial-acute-myeloid-leukemia-and-myelodisplastic-syndromes-100290271","NCT03058588","Next Generation Sequencing (NGS) in Familial Acute Myeloid Leukemia and Myelodisplastic Syndromes","Next Generation Sequencing (NGS) Approach to Study Known and New Germline Mutations in Familial Acute Myeloid Leukemia and Myelodisplastic Syndromes","Inclusion criteria:\n\nAny patient with acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS) with:\n\n1. a first- or second-degree relative with Acute leukemia or MDS or other myeloid malignancies\n2. a first- or second-degree relative with Lymphoproliferative neoplasms\n3. or with clinical features that resemble one of the familial MDS\u002FAML predisposition syndromes:\n\n   * History of thrombocytopenia and\u002For a clinical bleeding propensity (as in RUNX1, ANKRD26 or ETV6 germline mutations)\n   * Abnormal nails or skin pigmentation, oral leukoplakia, idiopathic pulmonary fibrosis, unexplained liver disease (as in TERT and TERC germline mutations)\n   * Lymphedema, atypical infections, immune deficiencies (as in GATA2 germline mutations)\n\nExclusion Criteria:\n\n1. any diagnosis other than acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS);\n2. acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS) without a first- or second-degree relative with Acute leukemia or MDS or other myeloid malignancies or without a first- or second-degree relative with Lymphoproliferative neoplasms or with clinical features that resemble one of the familial MDS\u002FAML predisposition syndromes;\n3. unability to sign the informed consent",{"count":74,"type":22},20,"The aim of this study is to look for predisposing mutations in patients and relatives affected by AML and MDS with familial history of myeloid or, less frequently, lymphoid malignancies. Taking advantage of a next generation sequencing (NGS) platform, screening for known and unknown mutations potentially associated with the disease will be done. The screening will be performed on affected and unaffected family members, in order to outline new pedigrees that either validate previous findings or constitute novel discoveries.",[77],"Leukemia",{"date":35,"type":36},{"date":80,"type":36},"2017-02-09",{"date":64,"type":22},{"name":42,"class":43},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":44},"100554024","effectiveness-of-emdr-in-borderline-personality-disorder-100554024","NCT06493708","Effectiveness of EMDR in Borderline Personality Disorder","Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) Applied to Borderline Personality Disorder: an Interventional Prospective Case Control Study in a Real-world Care Setting","EMBODIER","Inclusion Criteria:\n\n* Patients must be over 18 years old\n* A current diagnosis of PBD according to the DSM-5 was confirmed using the SCID-5-CV and SCID-5-PD diagnostic scale\n\nExclusion Criteria:\n\n* Suicidal ideation in the last 3 months (suicidal thoughts active intentionally but without specific planning or suicidal thoughts active with planning and intentionality)\n* Intellectual disability\n* Any active disturbance from use of substances or alcohol\n* Any other diagnosis of Axis I, except for Depressive Disorders, Anxious Spectrum Disorders, Obsessive-Compulsive Disorder.","65 Years",{"count":93,"type":22},56,"INTERVENTIONAL",[96],"NA","Borderline personality disorder (BPD) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. Considering a multifactorial etiological model, it has been suggested that the interaction between behavioral, environmental and genetic factors may promote the development of BPD. Early life stress events (ELS) in childhood and adolescence are highly prevalent in this population and constitute an environmental risk factor for the development of BPD. This correlates with the fact that Post-traumatic Stress Disorder (PTSD) is frequently comorbid in BPD leading to more severe symptoms and worse psychosocial functioning. At the therapeutic level, the treatment of BPD is an open challenge as psychotherapeutic interventions are of limited effectiveness and characterized by high drop-out rates. Eye Movement Desensitization and Reprocessing (EMDR) is the gold standard for treating PTSD. However, scientific evidence on the application of EMDR in patients with BPD is limited. This study aims to assess the feasibility and effectiveness of an EMDR protocol on the nuclear symptomatology of BPD (emotional and behavioral dysregulation) in a group of DBP patients with\u002Fwithout PTSD comorbidity, through a systematic assessment of the peculiar dimensions of the disorder. The basic hypothesis is that EMDR, through a short-term intervention, can act both on the traumatic PTSD-like experiences reported by patients and on the clinical manifestations peculiar to DBP, in particular by improving the emotional regulation capacity of patients with BPD.",[99],"Borderline Personality Disorder","2026-02-23",{"date":102,"type":36},"2026-02-25",{"date":104,"type":36},"2024-10-01",{"date":106,"type":22},"2026-10-01",{"name":42,"class":43},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":94,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":44},"100599521","phase-2-cemiplimab-as-maintenance-treatment-for-advanced-adrenocortical-cancer-100599521","NCT07085572","Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer","INTERVAL","Inclusion Criteria:\n\n1. Male and females \\>18 years of age;\n2. Patients with histologically confirmed ACC;\n3. Previous induction therapy with EDP-M followed by cytoreductive surgery if indicated;\n4. No disease progression after first line 4-6 EDP-M cycles;\n5. An ECOG PS of 0, 1;\n6. Adequate organ and bone marrow function documented by:\n\n   1. Hemoglobin \\>9.0 g\u002FdL\n   2. ANC \\>1.5 x 109\u002FL\n   3. Platelet count \\>75 x 109\u002FL\n   4. Serum creatinine \\\u003C1.5 ULN or estimated CrCl \\>30 mL\u002Fmin\n   5. Adequate hepatic function:\n\n      * Total bilirubin \\\u003C1.5 x ULN;\n      * AST and ALT both \\\u003C3 x ULN;\n      * ALP \\\u003C2.5 x ULN; Note: For patients with Gilbert's syndrome, total bilirubin ≤3x ULN. Gilbert's syndrome must be documented appropriately as past medical history.\n7. Women of child-bearing potential (physiologically capable of becoming pregnant) that must agree to follow instructions for methods of contraception (including at least one highly effective contraception method, see study protocol) for the duration of treatment with study drug, and after discontinuation of treatment as long as mitotane plasma levels are detectable and, in any case, at least for 6 months post treatment completion; must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug;\n8. Women must not be breastfeeding;\n9. Males that must agree to follow instructions for methods of contraception (see study protocol) for the duration of treatment with study drug, and then for a total of 6 months post treatment completion. In addition, male patients must not donate sperm for the time period specified above;\n10. Willing and able to comply with clinic visits and study-related procedures;\n11. Willing and able to provide informed consent signed by study patient or legally acceptable representative;\n12. Able to understand and complete study-related questionnaires.\n\nExclusion Criteria:\n\n1. History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 5 years;\n2. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor;\n3. Administration of a live vaccine within 30 days of the first dose of study treatment;\n4. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs);\n5. Diagnosis of immunodeficiency or systemic steroid therapy (i.e., dosing exceeding 10 mg of prednisone or equivalent). In case of mitotane treatment, a maximum steroid supplementation of 75 mg of cortone acetate (or equivalent hydrocortisone dose) will be accepted;\n6. Uncontrolled HIV, Hepatitis B or Hepatitis C (see protocol for details);\n7. History of (non-infectious) pneumonitis that required steroids or current pneumonitis;\n8. Active infection requiring systemic therapy;\n9. Significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty \u002F stenting \u002F bypass grafting within the last 6 months OR CHF NYHA Class II-IV or history of CHF NYHA Class III or IV;\n10. Pregnancy or breastfeeding;\n11. Continued sexual activity in women of childbearing potential (physiologically capable of becoming pregnant) or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose;\n12. History of active tuberculosis (TB, Bacillus Tuberculosis);\n13. Untreated brain metastasis that may be considered active.\n14. Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.\n15. Patients with a history of solid organ transplant (exception: corneal transplant)\n16. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n17. ECOG PS ≥ 2",{"count":116,"type":22},31,[118],"PHASE2","This clinical trial is a single-arm, non-randomized, prospective phase II study.\n\nThe study aims to evaluate if the maintenance immunotherapy with cemiplimab in patients with AdrenoCortical Carcinoma (ACC), who obtained disease response or stabilization after first-line chemotherapy, may delay\u002Fprevent disease progression.\n\nThe study will be conducted at ASST Spedali Civili Hospital, Brescia - Italy.",[121],"Adrenal Cortical Carcinoma","2025-10-01",{"date":124,"type":36},"2025-10-06",{"date":126,"type":36},"2025-09-18",{"date":128,"type":22},"2028-07",{"name":42,"class":43},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100504367","the-viability-control-of-human-endothelial-cells-before-keratoplasty-v-check-study-100504367","NCT05847387","The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study","Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study","V-CHECK","Inclusion Criteria:\n\n* Age older than 18 years old\n* Planned corneal transplantation: perforating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)\n* Indication for corneal transplantation (low-moderate risk of rejection): keratoconus, Fuchs endothelial dystrophy\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior corneal transplantation\n* Planned preloaded DSAEK or preloaded DMEK\n* Planned keratoplasty not involving corneal endothelium transplantation (i.e., superficial\u002Fdeep anterior lamellar keratoplasty)\n* Evidence of concurrent microbial keratitis\n* Evidence of non-infectious or autoimmune keratitis\n* Impending or frank corneal perforation\n* Uncontrolled, elevated intraocular pressure (IOP)- Previous glaucoma surgery\n* Acute or chronic inflammatory\u002Finfectious anterior segment uveitis\n* Presence of an anterior chamber intraocular lens (IOL) for phakic or aphakic purposes",{"count":139,"type":22},135,"The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.",[142,143],"Corneal Transplant Failure","Corneal Endothelial Cell Loss",[145,146,147],"Keratoplasty","Corneal endothelium","Eye Banking","2025-09-29",{"date":150,"type":36},"2025-10-02",{"date":152,"type":36},"2023-12-01",{"date":154,"type":22},"2026-09-30",{"name":42,"class":43},12,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":94,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100593717","nutritional-support-with-tgf-2-food-for-special-medical-purposes-tgf-2-fsmp-in-adult-allogeneic-hematopoietic-stem-cell-transplantation-allo-hsct-for-the-prevention-of-malnutrition-a-prospective-randomized-multicenter-study-100593717","NCT07010068","Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study","Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study - (TGF-NUTRIALLO Study)","TGF-Nutri","Inclusion Criteria:\n\n* Intact intestinal tract\n* Life expectancy more than 12 weeks\n* Allogeneic stem cell transplantation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active hematological disease at the beginning of conditioning\n* Personal history of inflammatory bowel diseases\n* Personal history of bowel resection\n* Personal history of gastric bypass procedures\n* Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome)\n* Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD",{"count":166,"type":22},214,[96],"prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.",[170,171],"Malnutrition (Calorie)","Stem Cell Transplant Complications",[173,174,175],"Stem Cell Transplant","malnutrution","gvhd","NOT_YET_RECRUITING","2025-06-04",{"date":179,"type":36},"2025-06-08",{"date":181,"type":22},"2025-06-01",{"date":183,"type":22},"2028-06",{"name":42,"class":43},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":44},"100546257","observational-study-on-invasive-fungal-infection-incidence-in-ph-neg-acute-lymphoblastic-leukemia-patients-100546257","NCT06392581","Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients","Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia","ALL-IFI","Inclusion Criteria:\n\n* Patients with B Ph-neg or T ALL at onset\n* Age \\> 18 yr at the time of the study\n* Signature informed consent\n\nExclusion Criteria:\n\n* Patients with Ph-pos ALL\n* Patients with relapsing ALL\n* Patients with B\u002FT lymphoblastic lymphoma",{"count":194,"type":22},150,"Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives\n\n* To document the occurrence of IFI in relation to antifungal prophylaxis adopted\n* To document the occurrence of IFI in relation to the age of the patients\n* Document the occurrence of IFI in relation to the duration of neutropenia\n* Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)\n* Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI\n* Document the outcome of patients with ALL with IFI\n\nStudy design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.\n\nThe incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:\n\n* Age\n* Sex\n* Type of AF prophylaxis performed\n* LLA risk classification according to ESMO 2016 criteria\n* Dose of dexamethasone administered\n* Duration of neutropenia\n* Hematologic and molecular response",[197],"Acute Lymphoblastic Leukemia",[199],"invasive fungal infections; acute lymphoblastic leukemia; outcome","2024-08-04",{"date":202,"type":36},"2024-08-06",{"date":204,"type":36},"2022-04-14",{"date":206,"type":22},"2025-12-30",{"name":42,"class":43},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":94,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":44},"100461750","mitral-regurgitation-treatment-in-advanced-heart-failure-100461750","NCT05292716","Mitral Regurgitation Treatment in Advanced Heart Failure","MITRADVANCE","Inclusion Criteria:\n\n* Age between 18 and 90 years\n* Significant secondary mitral regurgitation (effective regurgitant orifice area ≥ 5 30mm2) confirmed at the end of the screening period\n* Optimal medical therapy (OMT) according to recent guidelines.\n* Advanced heart failure defined as the presence of all the following criteria, despite OMT:\n\n  * Severe and persistent symptoms of HF (NYHA class III or IV)\n  * Severe cardiac dysfunction defined by a reduced left ventricular ejection fraction (LVEF) ≤35% and\u002For high BNP or NTproBNP levels (BNP\\>125 pg\u002Fml or NTproBNP\\>400 pg\u002Fml if sinus rhythm; BNP\\>375 pg\u002Fml or NTproBNP\\>1200 pg\u002Fml if atrial fibrillation)\n  * Impairment of quality of life (KCCQ \\\u003C 75 points) AND severe impairment of exercise capacity with inability to exercise or low 6MWT distance (\\\u003C450 meters) or pVO2 (\\\u003C14 mL\u002Fkg\u002Fmin or \\\u003C50% of predicted) OR at least 1 unplanned visit or hospitalization in the last 12 months, due to HF, and requiring intravenous diuretics and\u002For inotropes.\n\nExclusion Criteria:\n\n* Unfavorable mitral valve anatomy, which implanting investigator judges as not successfully treatable by the MitraClip (i.e. mitral valve area \\\u003C3 mm2, leaflet length \\\u003C7 mm)\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)\n* Active infections requiring current antibiotic therapy\n* Transesophageal echocardiography (TEE) contraindicated or at high risk\n* Untreated significant coronary artery disease requiring revascularization\n* Iron deficiency defined as serum ferritin \\\u003C100 μg\u002FL, or ferritin between 100-299 μg\u002FL and transferrin saturation \\\u003C20% and\u002For intravenous ferric carboxymaltose administration during the 30 days before randomization\n* Coronary artery bypass graft, percutaneous coronary intervention, transcatheter aortic valve replacement or cardiac resynchronization therapy within the prior 30 days\n* Pulmonary vein ablation or cardioversion leading to restore of sinus rhythm or AV node ablation in the last 30 days\n* Myocardial infarction or cerebrovascular accident within prior 30 days\n* Hemodynamic instability defined as systolic blood pressure \\\u003C 90mmHg and cardiogenic shock or need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.\n* Chronic obstructive pulmonary disease, malignancy, or other comorbidities as the main cause of severe symptoms and impaired quality of life.\n* Life expectancy \\\u003C12 months due to non-cardiac conditions","90 Years",{"count":217,"type":22},172,[96],"MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most recent guidelines. Enrolled patients will be randomly assigned, in a 1:1 ratio, to a device arm consisting of MitraClip therapy added to optimal medical therapy (OMT) or a control arm of OMT alone. Approximately 20 Italian high-volume centres will be involved. Enrolment duration will be of 24 months. Follow-up visit will be performed at 3, 6, and 12 months. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up.",[221,222],"Heart Failure","Mitral Regurgitation",[221,222,224,225],"MitraClip","Optimal medical therapy","2024-08-01",{"date":228,"type":36},"2024-08-05",{"date":230,"type":36},"2021-04-21",{"date":232,"type":22},"2026-04-21",{"name":42,"class":43},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":94,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":44},"100509438","phase-2-evaluation-of-the-efficacy-of-addition-of-progesterone-to-standard-chemotherapy-in-adrenocortical-carcinoma-acc-100509438","NCT05913427","Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)","Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC)","PESETA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ACC\n* Locally advanced or metastatic disease not amenable to radical surgery resection\n* ECOG performance status 0-2\n* Effective contraception\n* Life expectancy \\> 3 months\n* Age \\> 18 years\n* Adequate bone marrow reserve (neutrophils \\>1,000\u002Fmm3 and\u002For platelets \\>80,000\u002Fmm3) and organ function (including renal, liver and cardiac function)\n* Be able to comply with the protocol procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years\n* Renal insufficiency (estimated glomerular filtration rate \\[GFR\\]\\\u003C50 mL\u002Fmin\u002F1.73 m2) or significant liver insufficiency (serum bilirubin\\>2 times the upper normal range and\u002For serum alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\]\\>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD)\n* Pregnancy or breast feeding\n* Congestive heart failure (ejection fraction\\\u003C45%)\n* Preexisting grade 2 peripheral neuropathy\n* Previous or current treatment with mitotane or other antineoplastic drugs for ACC\n* Previous radiotherapy for ACC\n* Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":243,"type":22},80,[118],"This is a prospective randomized, double blind, placebo controlled phase II study planned in patients with advanced ACC. The study will be conducted at ASST Spedali Civili Hospital and University of Brescia in Brescia.",[247],"Adrenocortical Carcinoma","2024-07-31",{"date":226,"type":36},{"date":251,"type":36},"2022-06-08",{"date":253,"type":22},"2027-06-08",{"name":42,"class":43},""]