Savona

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

Researchers are evaluating clinical outcomes and safety in patients diagnosed with advanced high-grade ovarian cancer, focusing on how the tumors homologous recombination HR status affects treatment responses. This observational study involves two patient groups based on HR status, aiming to understand the impact of matched therapies in a real-world setting from January 2021 to January 2026. Patients are divided into two cohorts Cohort A includes those with homologous recombination deficient HRD ovarian cancer treated with Olaparib plus Bevacizumab as maintenance therapies after responding to first-line platinum-based chemotherapy Cohort B includes homologous recombination proficient HRP patients receiving standard clinical care chosen by their doctors. Participants are enrolled either retrospectively if already treated or prospectively if starting first-line therapy, based on tumor HR test results. During the study, researchers will monitor clinical outcomes and safety for up to three years after enrollment. Data collection includes treatment details, responses, and adverse events to evaluate therapy effects in each group. Participants provide informed consent and remain under regular care, with outcomes tracked to understand the real-world effectiveness and safety of targeted therapies for advanced ovarian cancer.

Cerebrovascular diseases CVDs are a major cause of illness and death worldwide, with over 30% of strokes having unknown causes. Rare cerebrovascular diseases rCVDs, including inherited conditions like CADASIL, COL4A1 syndrome, and Fabry disease, as well as acquired ones like Sneddon syndrome and Moyamoya arteriopathy, contribute to some of these strokes. These rare diseases are often misdiagnosed due to difficulty in recognition, yet identifying them is crucial for proper management, genetic counseling, and potential therapy. Currently, diagnosis and care are limited to a few specialized centers, mainly in northern Italy, causing patients to travel long distances for care. This observational study aims to create a clinical and research network across Italy to improve diagnosis and understanding of rCVDs, especially in southern regions. The study will describe the clinical features and natural course of these diseases during the first 12 months. Later, between 12 and 30 months, it will explore molecular mechanisms, identify biomarkers, and work towards better clinical and therapeutic management. Participants diagnosed with rCVDs such as CADASIL, Fabry disease, COL4A1, Sneddon syndrome, or Moyamoya arteriopathy who have had at least one brain MRI will be included. Researchers will collect clinical, genetic, and neuroradiological data to characterize these patients and monitor their disease progression. The study does not involve treatments but focuses on gathering information to improve diagnosis and care. Participation may last up to 30 months with ongoing assessments and data analysis.