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Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are investigating whether tumor and lymph node downstaging after neoadjuvant chemo-immunotherapy is linked to improved surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) who undergo robotic-assisted thoracic surgery. The study focuses on patients with resectable or potentially resectable NSCLC receiving standard neoadjuvant chemo-immunotherapy as part of their routine care. The main goal is to determine if downstaging correlates with better results after surgery. Participants will receive robotic-assisted pulmonary surgery following neoadjuvant chemo-immunotherapy, which typically includes PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy. Some may also receive neoadjuvant radiation therapy. Surgery is planned 2 to 10 weeks after the last dose of neoadjuvant treatment, with systematic lymph node removal performed. This is an observational study collecting clinical, operative, pathological, and postoperative data from international centers. During the study, researchers will monitor outcomes such as complete tumor removal (R0 resection), the extent of lung tissue removed, any need to convert to open surgery, postoperative complications, hospital stay length, readmissions, and mortality. Baseline and restaging chest CT or PET-CT scans are performed before and after neoadjuvant therapy. Participants will be followed for 90 days after surgery to assess recovery and outcomes.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Myelodysplastic syndromes (MDS) are a group of blood disorders mainly affecting older adults, causing ineffective blood cell production leading to anemia and other blood-related issues. This trial focuses on patients with MDS who have a specific chromosome 5q deletion (del5q) and are dependent on red blood cell (RBC) transfusions. These patients have low to intermediate risk disease and have not responded well or cannot tolerate prior treatment with lenalidomide. The study aims to evaluate the effect of luspatercept, a drug that helps mature red blood cells, on reducing the need for RBC transfusions in this group. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mg/kg with the possibility to increase the dose up to 1.75 mg/kg. The study includes a screening period, followed by a two-year treatment phase where participants get these injections. After completing treatment, participants will undergo follow-up visits every 24 weeks for up to two years to assess ongoing clinical benefits. During the study, participants will be monitored closely with regular visits to check their blood counts and overall health. Researchers will measure how long participants can avoid RBC transfusions over 24 weeks and evaluate safety and other health outcomes. The total participation time includes screening, treatment for two years, and follow-up for an additional three years, ensuring comprehensive monitoring of treatment effects and safety.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Researchers are evaluating treatments for children and young adults with high-risk neuroblastoma, a type of cancer affecting nerve tissue. This study focuses on patients with advanced stages of the disease, including those with tumors that have an amplified MYCN gene, which is linked to a higher risk of relapse. The trial is part of the European SIOP Neuroblastoma Group (SIOPEN) and aims to improve outcomes using various chemotherapy and immunotherapy strategies. Participants receive a rapid, intensive induction chemotherapy regimen called Rapid COJEC, followed by peripheral blood stem cell collection and surgery to remove the primary tumor. Depending on their response, some patients may receive additional chemotherapy cycles. Consolidation treatment involves high-dose chemotherapy with busulfan and melphalan (BuMel MAT), stem cell rescue, and radiotherapy. The study also tests immunotherapy using the ch14.18/CHO antibody (Dinutuximab beta, Qarziba®) given as a continuous infusion, with or without subcutaneous aldesleukin (IL-2), alongside isotretinoin (13-cis-RA). Patients diagnosed after June 2017 receive immunotherapy without IL-2 as standard care outside trials. During the study, participants undergo various assessments including tumor response evaluations and laboratory tests to monitor their health and treatment effects. The main outcomes measured are event-free survival up to three years and complete metastatic response within about 95 days after induction therapy. Safety and long-term effects are followed regularly over at least five years. The study collects biological tumor samples to assess prognostic factors and requires informed consent and ethical approval before participation.

This research aims to evaluate whether using virtual reality (VR) during pacemaker or defibrillator implantation can reduce pain and improve patient experience. The study focuses on patients undergoing these cardiac device implantations, comparing the effects of standard sedation alone versus sedation combined with VR. The goal is to see if VR can help lower pain, stabilize vital signs, and possibly support same-day discharge after minimally invasive procedures. Participants will be randomly assigned to two groups: one receiving standard sedation and the other receiving standard sedation plus VR. The VR intervention involves wearing a headset that immerses patients in calming natural scenes with relaxing music, starting at least five minutes before the procedure and continuing throughout, unless discomfort occurs. This device-based approach is intended to distract patients and reduce their pain perception during the procedure. During the implantation, researchers will monitor pain and discomfort levels along with vital signs such as blood pressure, heart rate, respiratory rate, and oxygen saturation. Patients' satisfaction and any side effects will be recorded. The study involves continuous observation during the electrophysiology procedures to assess the impact of VR on patient comfort and safety.

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.

Researchers are conducting the RICMAF Study, an observational, multicenter research project in Italy, to better understand Anderson-Fabry Disease (AFD), a rare genetic disorder that affects multiple organs, particularly the heart. This disease is often underdiagnosed due to its nonspecific symptoms, which can lead to delays in treatment. The study aims to analyze the clinical profile, genetic factors, and progression of AFD, focusing especially on cardiac involvement, which is a major cause of mortality in affected patients. The study gathers data from a nationwide patient registry including approximately 800 patients diagnosed with AFD according to international guidelines. It includes both retrospective data collection from January 1981 to 2031 and prospective enrollment of new patients. Data comes from medical records and standard clinical evaluations such as specialist visits, laboratory tests, genetic analyses, and cardiac imaging. These evaluations are part of routine care and include assessments like ECG, echocardiography, and cardiac MRI. Participants will be followed over time to collect detailed information on symptoms, family history, genetic mutations, organ involvement, and treatment outcomes. Researchers will use this data to identify early markers of cardiac damage and predictors of cardiovascular complications. The study's primary measure is the natural history of Fabry disease from enrollment through an average follow-up of five years. The study ensures data privacy and follows ethical guidelines, with no additional costs for participants beyond usual care.