Savona

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

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.

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 the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.

Researchers are studying patients with advanced high-grade ovarian cancer to understand outcomes and safety related to treatments based on the tumor's homologous recombination (HR) status. This observational study includes patients tested with validated HR deficiency tests between January 2021 and January 2026. It compares two groups: those with HR deficient tumors and those with HR proficient tumors, focusing on real-world treatment results. One group includes patients with HR deficient tumors treated with Olaparib plus Bevacizumab as maintenance therapy following a response to first-line platinum-based chemotherapy. The other group includes patients with HR proficient tumors who receive standard treatments chosen by their doctors, which may include platinum-based chemotherapy with or without other targeted therapies. Both groups include patients enrolled retrospectively after completing first-line treatment or prospectively as they begin treatment. Participants are monitored for up to three years to evaluate clinical outcomes and safety related to their targeted anticancer therapies. The study tracks treatment responses and any side effects experienced. Patients must provide informed consent and are followed carefully throughout the study period to collect data on how well the therapies work and their safety in a real-world setting.

This research focuses on rare cerebrovascular diseases (rCVDs) such as CADASIL, Fabry disease, COL4A1 syndrome, Sneddon syndrome, and Moyamoya arteriopathy. These rare conditions contribute to a portion of strokes that often remain undiagnosed due to challenges in recognition by clinicians. The study aims to better understand the clinical features and natural progression of these diseases and to improve diagnosis and care through a large Italian network, addressing the limited knowledge and geographical disparities in expertise across Italy. The study does not specify particular interventions but involves creating a clinical and research network to empower diagnostic pathways for rCVDs. This network will help gather detailed clinical and genetic data from patients diagnosed with these rare conditions, who have undergone at least one brain MRI study. The initiative seeks to enhance diagnostic accuracy, share knowledge, and support appropriate management including genetic counseling. Participants will be monitored for up to 12 months to describe their phenotypic characteristics and observe the natural history of their disease. Evaluations include clinical, genetic, and neuroradiological assessments based on existing diagnoses. The study supports improved patient management through better understanding of disease features and progression, aiming to fill gaps in diagnosis and care, especially for patients in Southern Italy.

This research aims to evaluate the effectiveness, safety, and tolerability of atogepant, a medicine approved for preventing migraine, when used to treat migraine attacks quickly. The study focuses on adults aged 18 to 75 years who have a history of moderate to severe migraine attacks. It includes a double-blind phase where neither participants nor doctors know who receives atogepant or placebo, followed by an open-label phase where everyone receives atogepant. The study is conducted at about 160 sites worldwide with around 1300 participants. Participants will receive both atogepant and placebo in a random sequence to treat qualifying migraine attacks during the double-blind phase. After treating four migraine attacks this way, participants will enter an open-label phase lasting until week 24, during which they will receive atogepant for any additional migraine attacks. Treatments are given as oral tablets. Throughout the study, participants will attend regular hospital or clinic visits and telephone check-ins. They will complete electronic diaries with questionnaires about their migraines and treatment effects. Medical assessments, blood tests, and monitoring for side effects will be conducted. The main outcome measured is the percentage of participants who experience freedom from pain two hours after taking the study medication for their first treated migraine attack, observed over about 16 weeks.