San Raffaele

Researchers are evaluating intravenous brincidofovir IV BCV compared to intravenous cidofovir IV CDV for treating adenovirus infection in children and adults who have received allogeneic hematopoietic cell transplants allo-HCT. This Phase 3, multi-center, randomized, open-label study focuses on patients with adenovirus viremia, aiming to assess the effectiveness of these treatments in clearing the virus. The study uses a virologic response-driven approach to determine treatment duration, following ECIL guidelines for high-risk patients. Participants will be randomly assigned to receive either IV BCV or IV CDV. Treatment will continue until adenovirus DNA in plasma is undetectable for two consecutive tests spaced 7 days apart or until a maximum of 12 weeks of therapy is reached, whichever occurs first. Subjects who clear the virus may stop treatment but can be retreated with their assigned drug if adenovirus viremia recurs at defined levels. The study prohibits switching between the two drugs. Safety will be monitored by an independent board during enrollment. Throughout the study, participants will be assessed weekly until the end of treatment, with additional evaluations at 4 weeks after the last dose and at 12 and 24 weeks post-randomization. Researchers will collect plasma samples to measure drug concentrations and monitor viral response and safety. All participants will be followed for a total of 24 weeks regardless of treatment duration, ensuring comprehensive monitoring of efficacy and safety during and after therapy.

This registry collects real-world safety and performance data on AtriCure devices used to treat Inappropriate Sinus Tachycardia IST and Postural Tachycardia Syndrome POTS. It is both retrospective and prospective, involving multiple centers in the US and internationally. The goal is to understand how these devices are used and their outcomes in typical clinical settings. Participants have undergone or are scheduled to undergo a hybrid epicardial and endocardial ablation procedure using commercially available AtriCure devices. The registry observes these treatments as delivered in routine care without altering clinical decisions. Data collection includes outcomes over a 12-month period following device use for IST or POTS treatment. During participation, researchers collect information on treatment details, safety, and effectiveness from medical records and follow-up visits. The main measurement is device performance and patient outcomes over one year. Participants provide informed consent, and data is gathered both retrospectively and prospectively. The study runs until January 2027, capturing ongoing real-world clinical experiences.

Researchers are evaluating the effectiveness, safety, and lasting effects of faricimab in Caucasian patients with symptomatic macular polypoidal choroidal vasculopathy PCV. PCV is a type of choroidal vasculopathy that causes hemorrhagic and exudative macular degeneration. This study aims to see how intravitreal injections of faricimab 6 mg affect best corrected visual acuity BCVA outcomes in these patients, addressing the current unmet needs due to disease heterogeneity and treatment challenges. The study involves administering faricimab injections directly into the eye following a treat and extend regimen tailored to each patient. It is an open-label, single-arm study lasting approximately 100 weeks, including a screening period of up to 28 days, a 12-week treatment initiation period, and a subsequent treat and extend phase extending to week 100. Participants receive faricimab at intervals up to 24 weeks based on their response and the study protocol. Participants will undergo regular eye examinations, safety assessments, and visual acuity testing using the ETDRS protocol. The study will monitor changes in BCVA from baseline through weeks 40, 44, 48, and up to 104 weeks, along with imaging to assess polypoidal lesion regression and retinal thickness. Adverse events will be tracked throughout the study. Overall participation spans more than two years, allowing detailed evaluation of faricimabs effects on vision and eye health in this population.