Taranto

Researchers are evaluating the use, benefits, and safety of cemiplimab-based treatment regimens for adults with advanced non-small cell lung cancer (NSCLC). This observational study focuses on patients prescribed cemiplimab as part of routine care in Europe. The study aims to gather real-world information on how cemiplimab is used and how it affects patient outcomes. Participants receive cemiplimab, given by intravenous infusion, often combined with platinum-based chemotherapy, also administered intravenously. Data collection occurs during regular clinical visits approximately every three months while patients are on cemiplimab treatment. After treatment ends, follow-up visits occur about every six months for up to two years. The recruitment phase will last 48 months. Participants will be followed from the start of cemiplimab treatment until death, loss to follow-up, withdrawal, or up to 72 months after the study begins. During the study, researchers will collect information from routine visits and questionnaires. The primary outcome measured is overall survival up to 72 months. Safety and effectiveness of the treatment regimen will be monitored throughout the study period.

Researchers are evaluating the effects of atezolizumab compared to a placebo in patients with malignant pleural mesothelioma who have undergone surgical removal of the tumor and show no visible remaining disease. This phase III, double-blind, placebo-controlled trial aims to assess disease-free survival over 12 weeks. Patients will be grouped based on tumor type and stage, with the goal of understanding how atezolizumab performs as an additional treatment after surgery and chemotherapy. Participants will be randomly assigned in a 2:1 ratio to receive either atezolizumab or placebo. The medication is given for up to 12 months or until the disease returns, unacceptable side effects occur, or a decision is made to stop treatment. Before starting therapy, patients will have a CT scan to confirm no remaining disease after surgery, and follow-up imaging will occur every 12 weeks for two years or until disease progression. Tumor samples collected during the study will be analyzed to explore biological and genetic features. During the study, patients will complete quality of life questionnaires at the start and every 12 weeks. Researchers will monitor blood tests to ensure organ function, and they will track side effects and disease status regularly. The primary outcome is to evaluate how well atezolizumab works in prolonging the time patients remain disease-free. The total study duration involves regular assessments over 24 months, including safety follow-up and biomarker research.

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 patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Cancer can be a deeply traumatic experience, especially for children. Researchers are studying how pediatric cancer patients cope with their illness, focusing on the important role of the parent-child relationship. The study aims to understand how factors like attachment, age, gender, disease stage, social support, resilience, and caregiver emotional state influence coping strategies in both children and their parents. The study involves a one-time administration of psychological tests to assess coping styles and emotional resources in parents and their children undergoing treatment in Pediatric Oncohematology departments. It examines two main types of coping strategies: emotion-focused, which reduce unpleasant feelings, and problem-focused, which aim to solve stress causes. This research seeks to better tailor psychological support for families based on these coping patterns. Participants will complete assessments including the Child-Parent Relationship Scale and Coping Orientations to Problem Experienced shortly after enrollment. The study evaluates coping strategies and attachment dynamics to help inform interventions that reduce psychological distress and improve mental well-being. Only families with children aged 8 to 17 years currently in treatment and able to understand Italian are included, ensuring focused support during ongoing therapy.

Researchers are evaluating the effects of adding a therapeutic dose of oxygen during exercise on patients with chronic respiratory failure or exertional hypoxemia caused by chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This multicenter crossover trial aims to assess exercise performance, gas exchange, heart rate, symptom perception, and the ease of performing exercise in patients hospitalized in specialized pulmonary rehabilitation centers. The study also seeks to understand differences in responses among different disease groups and to improve oxygen therapy prescriptions during exertion. Participants will perform two 6-minute walk tests under different oxygen conditions in random order: one using their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, and the other with supplemental oxygen set at double the resting flow rate or 2 liters per minute for those with exertional hypoxemia. The tests will be done at least 3 hours apart and within 24 hours. Oxygen is delivered through nasal cannula, and patients will carry oxygen in a stroller or similar device during the walks. The study includes three groups based on diagnosis and oxygen needs: COPD with exertional hypoxemia, COPD with chronic respiratory failure, and ILD with chronic respiratory failure. During the study, researchers will measure walking distance, oxygen saturation, heart rate, blood pressure, and symptom scales before, during, and after each walk. Participants will also complete a questionnaire about the ease of performance. The main outcome is the change in distance walked with supplemental oxygen compared to usual oxygen. Data analysis will explore clinical factors related to oxygen response, aiming to identify which patients benefit most and to inform better oxygen therapy dosing during exercise. The study plans to enroll 114 patients and follow strict statistical methods for comparison.

Researchers are conducting the RICMAF Study, an observational, multicenter research project in Italy, to better understand Anderson-Fabry Disease (AFD), a rare genetic disorder that affects multiple organs, particularly the heart. This disease is often underdiagnosed due to its nonspecific symptoms, which can lead to delays in treatment. The study aims to analyze the clinical profile, genetic factors, and progression of AFD, focusing especially on cardiac involvement, which is a major cause of mortality in affected patients. The study gathers data from a nationwide patient registry including approximately 800 patients diagnosed with AFD according to international guidelines. It includes both retrospective data collection from January 1981 to 2031 and prospective enrollment of new patients. Data comes from medical records and standard clinical evaluations such as specialist visits, laboratory tests, genetic analyses, and cardiac imaging. These evaluations are part of routine care and include assessments like ECG, echocardiography, and cardiac MRI. Participants will be followed over time to collect detailed information on symptoms, family history, genetic mutations, organ involvement, and treatment outcomes. Researchers will use this data to identify early markers of cardiac damage and predictors of cardiovascular complications. The study's primary measure is the natural history of Fabry disease from enrollment through an average follow-up of five years. The study ensures data privacy and follows ethical guidelines, with no additional costs for participants beyond usual care.

This research investigates two different surgical techniques to treat multiple gingival recessions, a condition where the gum tissue pulls away from the teeth. Patients with at least two adjacent teeth having RT1 or RT2 type recessions, with at least one recession deeper than 2 mm, and needing root coverage treatment are included. The trial is a randomized, multi-center clinical study with blinded outcome assessment, aiming to compare the effectiveness of the two methods over a six-month period. Participants are randomly assigned to either the test group receiving a split-thickness non-advanced tunnel procedure based on Zabalegui et al. (1999) or the control group undergoing a full-thickness coronally-advanced tunnel procedure (Modified Coronally Advanced Tunnel - MCAT) as described by Aroca et al. (2010). Each patient will undergo one of these surgical treatments targeting the affected teeth. The study plans to extend follow-up to 3 to 5 years if funding permits. During the study, researchers will evaluate the mean root coverage at six months after surgery using blinded assessments. Participants will be monitored for clinical outcomes and treatment success. The study includes detailed clinical examinations and digital scanning of the treated areas to track progress. Safety and adherence to follow-up visits will be ensured throughout the six-month observation period.

Researchers are conducting a multicenter registry study to better understand outcomes, predictors, and treatment effects in patients with poor grade aneurysmal subarachnoid hemorrhage. The study focuses on identifying factors that influence recovery during different phases after the hemorrhage: the early brain injury phase in the emergency department, the delayed brain injury phase in the neurocritical care unit, and treatment strategies. Additional areas of interest include delayed cerebral ischemia and long-term follow-up, which may reveal important improvements in some patients after 6 to 12 months. Participants will receive standard management according to international and national guidelines, as this is an observational study. The study does not introduce new treatments but gathers data on current care practices for poor grade aneurysmal subarachnoid hemorrhage patients. During the study, researchers will monitor clinical outcomes at 6 months and 12 months to assess recovery and other important health measures. The study involves a long-term follow-up to capture possible improvements over time. Data collected will help define predictors of outcome and evaluate the impact of delayed cerebral ischemia and treatment approaches on patient recovery.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.