Pistoia

Researchers are studying patients with early to locally advanced stages (I-III) of non-small cell lung cancer (NSCLC) to better understand how diagnosis and treatments are managed in real-world settings. Because patients with these stages of NSCLC can vary widely, there is no single standard treatment plan, and practices differ by country and medical center. This study looks closely at how surgery, chemotherapy, and radiotherapy are timed and combined for these patients without interfering with their treatment. This is a non-interventional, retrospective observational study analyzing medical records of patients with stage I-III NSCLC who received curative surgery or radiotherapy between January 2018 and June 2019. Researchers will examine diagnostic and treatment paths, focusing on the use and timing of therapies. The study does not involve new treatments or interventions but reviews past patient data to gather insights. Participants' medical records from January 2018 to January 2021 will be reviewed to assess treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs related to NSCLC care. The study involves collecting data from available charts and follow-up information to understand treatment patterns and outcomes better. No active treatment or patient visits are required as this study relies on existing data.

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 evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or combined, to improve heart-related outcomes in high-risk patients with type 2 diabetes. This Phase 3 trial focuses on adults aged 55 to 80 years who have type 2 diabetes and no prior coronary artery disease events but have additional risk factors like long diabetes duration, high blood sugar levels, smoking, or other markers of cardiovascular risk. The study aims to reduce serious cardiovascular events such as heart attacks, strokes, or urgent hospitalizations. Participants are randomly assigned to receive either colchicine 0.5 mg once daily, aspirin 40 mg twice daily, both medications together, or matching placebos. The aspirin is given as a non-enteric-coated tablet twice daily. Those who cannot take aspirin or have certain conditions may still receive colchicine or its placebo. The treatment and follow-up period lasts up to 60 months, during which the occurrence of serious cardiovascular events is closely monitored. During the study, participants will undergo regular assessments including monitoring for cardiovascular events like heart attacks and strokes. Safety labs and clinical evaluations will be conducted to track any side effects or adverse events. The main outcome measured is the time until the first major cardiovascular event occurs. Researchers will also ensure participants adhere to the medication schedule and will follow all patients for up to five years to evaluate long-term safety and effectiveness.

Researchers are evaluating the effect of Nirsevimab, a monoclonal antibody for RSV prevention, on reducing hospitalizations due to Respiratory Syncytial Virus (RSV) infections in infants under one year old. The study is conducted across eight pediatric departments in Tuscany, Italy, during the RSV epidemic season of 2024-2025. It includes a matched case-control study to assess the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations, alongside a descriptive study examining how the immunization campaign impacts RSV epidemiology, including patient age, existing health conditions, infection severity, and clinical outcomes. The intervention involves evaluating exposure to Nirsevimab among infants hospitalized for RSV-related LRTI compared to control patients hospitalized for other reasons. The study monitors patients during the RSV epidemic season from November 2024 to March 2025, focusing on the proportion of children immunized with Nirsevimab in both groups. This approach helps understand how the immunization affects hospitalization rates and RSV disease patterns. Participants will be infants younger than 12 months admitted to hospital either for RSV-related LRTI or for other conditions. Researchers will gather clinical data, including RSV testing through PCR on nasopharyngeal swabs, and monitor immunization status. The main measure is the rate of Nirsevimab immunization in hospitalized children with RSV-related LRTI compared to controls. The study aims to inform and optimize RSV prevention strategies and public health policies based on these findings.

Acute intoxications are a significant public health concern, especially in children who are more vulnerable and at higher risk for unintentional and preventable poisonings. This research aims to study the patterns and social and care-related factors of acute intoxications in children to improve diagnosis and treatment approaches nationally. The study is a prospective, non-profit, multicenter observational cohort focusing on acute intoxications in pediatric patients, conducted by AMIETOX at Poison Control Centres and pediatric emergency rooms. The study observes children aged from 1 month up to 16 years who have experienced acute intoxication, defined as exposure to toxic substances or harmful amounts of substances via unintended routes. There are no specific treatments or interventions administered as it is an observational study. Participants are identified through visits or telephone contacts to participating centers. The study spans an average duration of one year to gather incidence and prevalence data. Participants will be monitored throughout the study to collect data on the occurrence and characteristics of acute intoxications. Researchers will assess the incidence and prevalence of intoxication in pediatric patients during the study period. Data collection includes social and care factors related to each case. The study ensures informed consent is acquired before including any child. Safety and follow-up are integral to the observational process to understand and eventually improve management of acute intoxications in children.

Researchers are evaluating a treatment for chronic diabetic foot ulcers to see if adding the system VULNOFAST® plus / VULNOLIGHT® to the usual care improves healing compared to usual care alone. This randomized, open-label, multicenter clinical trial focuses on infected diabetic foot ulcers in patients with type 1 or type 2 diabetes. The goal is to assess whether this combined treatment reduces bacterial load and promotes ulcer healing more effectively. Participants are assigned to one of two groups: one receiving usual care alone and the other receiving usual care plus the VULNOFAST® plus sterile solution with the VULNOLIGHT® red light device. Treatments are given twice weekly for four weeks, with eight sessions of usual care in both groups and eight additional sessions of the device treatment in the combination group. Usual care includes procedures such as sharp debridement, washing, antiseptic treatment with iodopovidone, and appropriate wound covering. Each patient’s study involvement lasts up to 57 days, including screening, treatment, and follow-up periods, with thirteen visits planned. All patients receive background antibiotic therapy with amoxicillin and clavulanic acid starting at Visit 1 until antibiogram results guide further treatment. Off-loading devices are used throughout most of the study to relieve pressure on the ulcer. Researchers assess outcomes including bacterial load after two weeks and ulcer size reduction after four weeks, using biopsy and specialized imaging devices, alongside safety and economic evaluations.

This research aims to evaluate the use of HIV pre-exposure prophylaxis (PrEP) in Italy by establishing a large prospective cohort of HIV-negative adults who are sexually active and eligible for PrEP. The study focuses on assessing PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. It also monitors the incidence of new HIV infections and other sexually transmitted infections (STIs), along with psychological, behavioral, and treatment factors related to PrEP use. Participants include about 5,000 adults aged 18 years or older who are either starting or already using PrEP according to national and international guidelines. The study is conducted across 49 university and hospital infectious disease clinics and 4 community-based checkpoints throughout Italy. Participants attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires through a dedicated mobile app. The study will continue for at least 10 years and is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome. During the study, researchers collect sociodemographic, clinical, laboratory, behavioral, and quality-of-life data in a secure electronic case report form managed by the ICONA Foundation. The main outcome measured is the incidence of HIV seroconversion from enrollment onward. Secondary outcomes include monitoring STIs, evaluating PrEP safety and tolerability, and analyzing adherence, persistence in care, and related behavioral factors. Ethics committees at all participating centers have approved the study, ensuring participant safety and confidentiality throughout the long-term follow-up.

Researchers are evaluating a new diagnostic and treatment approach for patients with myocardial bridge (MB), a condition where a coronary artery is compressed during heartbeats. The study aims to compare a full-physiology approach, which uses detailed invasive tests to uncover the causes of heart ischemia, with a standard angiographic evaluation. This randomized, open-label trial seeks to improve diagnosis and personalize treatment plans for MB patients. Patients diagnosed with MB during coronary angiography will be randomly assigned to one of two groups. The full-physiology approach group will undergo comprehensive functional tests including measurements of artery pressure and flow, responses to medications like adenosine and dobutamine, and a provocative acetylcholine test to detect artery spasms. The standard approach group will receive a typical angiographic evaluation of the affected artery segment. Both procedures involve coronary angiography through radial or femoral access. Participants will be monitored for outcomes including significant angina and major adverse cardiac events over a one-year period. The study includes detailed physiological assessments during the initial procedure, continuous symptom and ECG monitoring, and follow-up to evaluate the effectiveness of the diagnostic strategies. Safety and event rates will be analyzed with statistical methods, including an interim analysis after six months for half of the participants.

Researchers are studying extracorporeal blood purification therapies (EBPT) used in critically ill patients, especially those with acute kidney injury, sepsis, or systemic inflammatory response syndrome. The study aims to identify specific groups of patients who benefit most from different EBPT membranes, as previous trials have shown mixed results on long-term outcomes like mortality. Personalized approaches to EBPT, called precision medicine, are being explored to improve patient care and outcomes. Participants will receive EBPT using commercial membranes prescribed by their healthcare centers according to local practices and expertise. This observational study does not change treatment plans but records detailed treatment settings in a web-based registry. This platform, accessible also by smartphone or tablet, helps clinicians manage patients and provides real-time feedback, including clinical scoring and antibiotic adjustments. During the study, researchers will collect and analyze clinical and biochemical data entered into the registry by multiple centers. They will track patient characteristics, treatment details, and outcomes to find patterns indicating which patients respond best to EBPT. The main outcome measured is identifying the subgroup of critically ill patients who most benefit from EBPT within 10 days of starting treatment. This large database approach supports personalized treatment strategies and ongoing clinical monitoring.