Pistoia

Researchers are conducting a non-interventional, retrospective observational study to better understand the diagnosis and treatment of patients with early-stage and locally advanced non-small cell lung cancer NSCLC, specifically stages I to III. The study addresses the variability in treatment approaches, as there is no clear consensus on the best timing, sequence, or combination of surgery, chemotherapy, and radiotherapy for these patients. This research aims to collect real-world data to improve knowledge on how these patients are managed across different healthcare settings. This study involves reviewing past medical records of patients diagnosed with stage I-III NSCLC who underwent curative surgery or radiotherapy between January 2018 and June 2019. The data collection covers treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs from January 2018 to January 2021. There are no interventions or treatments being given directly as part of this study since it is observational and retrospective. Participants involvement consists of allowing access to their medical charts and treatment records for data capture. Researchers will evaluate treatment timelines and approaches as they occurred in routine clinical practice. The study also tracks the extent of healthcare resources used and costs involved. Data privacy is maintained by obtaining informed consent from patients or their representatives. The study is expected to conclude in June 2025.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.

This research aims to evaluate the impact of Nirsevimab, a monoclonal antibody used to prevent respiratory syncytial virus RSV infection, in reducing hospitalizations related to RSV in infants under one year of age. Conducted at eight pediatric departments in Tuscany, Italy, the study includes a matched case-control portion investigating how well Nirsevimab prevents RSV-related lower respiratory tract infection hospitalizations during the 2024-2025 RSV epidemic season. Additionally, a descriptive study examines how the immunization campaign with Nirsevimab influences RSV patterns, including patient age, other health conditions, infection severity, and clinical results. Findings will help improve RSV prevention strategies and support public health decisions. The study involves evaluating drug exposure to Nirsevimab among two groups infants under 12 months hospitalized with confirmed bronchiolitis or pneumonia cases and infants under 12 months hospitalized for conditions other than respiratory infections controls. The evaluation period spans November 2024 to March 2025, focusing on the proportion of children immunized with Nirsevimab who are hospitalized for RSV-related lower respiratory tract infections compared to controls. This observational study collects data without administering treatments. Participants are infants younger than 12 months admitted to hospital with either RSV-related lower respiratory tract infections or other conditions. Researchers will review medical records and test results, including RSV PCR on nasopharyngeal swabs, to assess immunization status and clinical outcomes. The study monitors the real-world use and effectiveness of Nirsevimab during the RSV season while analyzing patterns of infection and severity. The total study period covers the RSV epidemic season from November 2024 through March 2025.

Researchers are studying acute intoxications in children to better understand how often these poisonings occur and what social and care factors contribute to them. This research focuses on children from 1 month to 16 years old who experience acute intoxication, aiming to improve future national diagnostic and treatment approaches. The study is a prospective, multicenter observational cohort conducted by AMIETOX at Poison Control Centres and paediatric emergency rooms. The study observes children who come to emergency rooms or contact Poison Control Centres due to acute intoxication, defined as exposure to harmful substances either by toxic nature or improper use. It does not involve specific treatments or interventions but records data over approximately one year to assess incidence and prevalence. This observational approach allows researchers to collect real-world information about poisoning cases in paediatric settings. Participants will be monitored through their visits or calls to study centers, with data collected on the nature and circumstances of the intoxications. Researchers will measure how often these poisonings occur and how widespread they are among children in the study. The study involves no active treatment or placebo, focusing instead on gathering information to inform better care strategies. Participation lasts about one year, during which safety and outcomes are tracked through standard care processes.

Researchers are evaluating the healing of chronic diabetic foot ulcers in patients with diabetes using a new treatment system called VULNOFASTplus combined with VULNOLIGHTred light, compared to the usual care alone. This open-label, randomized, multicenter clinical trial aims to determine if adding this system to usual care improves infection control and ulcer healing. The study is sponsored by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

Researchers are evaluating the use of HIV pre-exposure prophylaxis PrEP in Italy to prevent new HIV infections. The study aims to understand how effective and tolerable PrEP is, how well people stick with it, and what barriers exist to its long-term use. It is an observational study coordinated by Fondazione ICONA, including about 5,000 HIV-negative adults who are either starting or continuing PrEP. Participants are followed in 49 hospital and university infectious disease clinics and 4 community-based checkpoints across Italy. They attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires via a mobile app. The study collects data on demographics, clinical status, behavior, and quality of life to monitor HIV seroconversion rates and other outcomes. During the study, participants will be monitored for new HIV infections, side effects related to PrEP, adherence to treatment, and behavioral factors affecting persistence in care. Data are securely collected and managed in an electronic case report form. The study will run for at least 10 years, with regular follow-up visits to ensure ongoing assessment of PrEPs real-world use and impact.

Researchers are investigating the use of extracorporeal blood purification therapies EBPT in critically ill patients, especially those with acute kidney injury and multiorgan failure. EBPT is commonly used in critical care to remove inflammatory substances from the blood, aiming to improve organ function. However, previous clinical trials have not consistently shown benefits on long-term outcomes like 28-day or hospital mortality. This study aims to identify specific groups of patients who might benefit most from different EBPT membranes by collecting detailed clinical data. This observational study involves critically ill patients receiving various EBPT treatments for kidney support or immune system modulation, using commercial membranes as prescribed by their healthcare providers. Treatments include continuous renal replacement therapy, intermittent hemodialysis, hybrid therapies, and immunomodulation through special membranes that adsorb endotoxins or cytokines. Each center records detailed treatment settings and patient information via a web-based registry accessible on smartphones and tablets, which also provides helpful clinical tools for managing patient care. Participants will be observed throughout their EBPT treatment, with researchers gathering data on clinical and biochemical changes over time, including scoring systems and other patient characteristics. The main outcome is to identify which patient subpopulations benefit most from EBPT, measured 10 days after treatment starts. The registry allows centers to monitor their own results in real time and supports personalized treatment approaches. The study is ongoing and aims to improve understanding of how to tailor EBPT to individual patient needs while enhancing clinical practice through shared data.