Taranto

This research focuses on adults with advanced non-small cell lung cancer NSCLC who have been prescribed cemiplimab-based treatments as part of their standard care. The study aims to better understand how cemiplimab regimens are used, their benefits, and safety in real-world clinical practice across Europe. Participants receive cemiplimab either alone or combined with platinum-based chemotherapy. Data is collected during routine clinical visits about every three months while on treatment and then about every six months for up to two years after stopping cemiplimab. The study follows patients from starting cemiplimab until death, loss to follow-up, withdrawal, or the study end, spanning up to 72 months. During the study, participants complete questionnaires and undergo regular clinical assessments at their usual care visits. Researchers monitor overall survival, response rates, duration and timing of responses, progression-free survival, and time to next treatment. Safety is assessed by tracking treatment-related adverse events, immune-related effects, and infusion reactions throughout the study period.

This research evaluates atezolizumab as an additional treatment for patients with malignant pleural mesothelioma who have undergone surgical removal of the tumor and show no visible remaining disease. This phase III trial compares atezolizumab to a placebo to assess how well it works in preventing disease recurrence. Patients are grouped based on tumor type and cancer stage to better understand treatment effects. Participants receive either atezolizumab at 1200 mg or a matching placebo every 21 days for up to 12 months, or until the disease returns, side effects become unacceptable, or the patient or doctor decide to stop treatment. The study uses a centralized system to randomly assign patients to one of these groups, ensuring a balanced comparison. Tumor samples are analyzed to study biological markers and gene expression. During the trial, patients undergo CT scans before starting treatment and then every 12 weeks for two years or until the disease progresses. Quality of life questionnaires are completed at the start and every 12 weeks. Researchers monitor safety, disease-free survival, and overall survival for up to a year. The study lasts several years, with follow-up assessments to understand treatment impact and patient well-being.

Researchers are evaluating the use of BIOTRONIK dual-chamber pacemakers that combine left bundle branch area pacing LBBAP with Closed Loop Stimulation CLS in patients who have sinus node dysfunction SND and atrioventricular AV conduction disorders. This observational study aims to understand how this combined pacing method works in everyday clinical practice and whether it can help reduce atrial fibrillation detected by the device over 24 months. The goal is to gather real-world evidence to optimize pacemaker programming and improve patient outcomes. Participants receive permanent dual-chamber pacemakers with a ventricular lead placed in the left bundle branch area, activating the CLS rate-responsive algorithm. The study focuses on patients implanted with these devices who have no prior history of atrial fibrillation. The study follows about 150 patients for 24 months after implantation, collecting data on device-detected atrial fibrillation episodes, heart rate patterns, and pacing behavior. This is a prospective observational submodule of the BIOSTREAM.CSP registry without a control group. During the study, researchers monitor device-recorded atrial fibrillation incidence and burden from CLS activation up to 24 months. They also analyze heart rate histograms at one and two years after implantation. Patients are enrolled in the BIOSTREAM.CSP registry and are followed through routine clinical care with data collected on pacing rates and arrhythmia episodes. The study aims to provide insights into the clinical performance of CLS combined with LBBAP to inform decisions on pacemaker programming and reduce atrial arrhythmias.

This observational study evaluates the long-term outcomes, performance, and safety of BIOTRONIK devices used for conduction system pacing CSP in real-life clinical settings. It focuses on patients who receive these devices for cardiac pacing, including those with pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter defibrillators, addressing conditions like bradycardia, tachycardia, and heart failure. Participants receive the Solia CSP S pacing lead for left bundle branch area pacing LBBAP as part of their routine care with BIOTRONIK devices. The study includes patients intended for new implantation or those recently implanted with investigational generators and leads positioned deep within the intraventricular septum. The study observes patients over an average of four years, monitoring device-related safety and electrical parameters through annual evaluations. Participants are involved in regular follow-up visits and use the BIOTRONIK Home Monitoring system via CardioMessenger to track device performance. Researchers measure rates of successful implantation, capture types, pacing thresholds, sensing amplitudes, and pacing impedance throughout the study. Safety is assessed by monitoring serious adverse device effects during the study period. The total participation time averages about four years, with annual assessments to support long-term device evaluation.

This research investigates the coping strategies and attachment dynamics in children with cancer and their parents. It focuses on how parents ways of managing stress influence their childrens coping during cancer treatment. The study aims to better understand emotional resources and psychological factors such as resilience, social support, and emotional states of caregivers in pediatric oncohematology. Participants include pediatric patients aged 8 to 17 receiving treatment at Pediatric Oncohematology departments and their parents. The study involves a single administration of psychological tests to both parents and patients shortly after enrollment. This cross-sectional observational study assesses coping strategies and attachment relationships without intervention or treatment assignment. During the study, participants complete psychological assessments including the Child-Parent Relationship Scale and Coping Orientations to Problem Experienced, all conducted once soon after joining. Researchers measure emotional and attachment factors influencing coping. The study is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia and participation spans a one-time assessment within the treatment period.

Researchers are investigating how adding a therapeutic dose of oxygen during exercise affects people with chronic respiratory failure or exertional hypoxemia due to chronic obstructive pulmonary disease COPD or interstitial lung disease. This multicenter crossover trial aims to evaluate exercise performance, gas exchange, heart rate, symptom perception, and ease of performing exercise in patients hospitalized in pulmonary rehabilitation centers. The study will compare walking ability during two conditions using the 6-minute walk test to understand the benefits of different oxygen levels during exertion. Participants will perform two 6-minute walk tests in random order within 24 hours. One test uses their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, while the other uses double the prescribed oxygen flow or 2 liters per minute for patients with exertional hypoxemia. Oxygen is delivered through nasal cannulas with a stroller carrying the oxygen supply. Tests are separated by at least 3 hours. The study groups include patients with COPD with exertional hypoxemia, COPD with chronic respiratory failure on long-term oxygen therapy, and interstitial lung disease with chronic respiratory failure on long-term oxygen therapy. Participants will be assessed for walking distance, oxygen saturation, heart rate, blood pressure, and symptoms such as breathlessness and fatigue before, during, and after the tests. A questionnaire will capture how easy participants found the test. Researchers will analyze the difference in walking distance between conditions as the primary outcome. The study will also examine how clinical and anthropometric factors influence responses to oxygen therapy. The total planned enrollment is 114 patients, and the trial will provide insights for better oxygen therapy prescriptions during exercise.

Researchers are conducting the RICMAF Study, an observational, multicenter, non-drug study in Italy focused on Anderson-Fabry Disease AFD, a rare genetic disorder that affects multiple organs, especially the heart. The study aims to better understand AFDs clinical course, its cardiac complications, and the relationship between genetic mutations and disease progression. This research seeks to improve patient care by identifying early markers of heart involvement and predicting cardiovascular problems. The study collects data from patients diagnosed with AFD according to international guidelines, starting from January 1, 1981, through December 31, 2031. It includes both retrospective and prospective phases, gathering comprehensive clinical, genetic, laboratory, and imaging information through a national patient registry. Patients undergo regular assessments as part of their standard care, including cardiology evaluations, ECG, echocardiography, and cardiac MRI when appropriate. Participants contribute data during routine clinical visits without additional study-specific procedures. The research team collects information from medical records and follow-up visits, including family history, symptoms, genetic tests, and heart monitoring results. The primary outcome is to define the natural history of Fabry disease over an average follow-up of five years, while secondary outcomes focus on cardiac risk stratification, genotype correlations, and early diagnostic biomarkers. The study duration extends up to 10 years, with ongoing data analysis and publication of findings.

Researchers are observing adult male patients with metastatic castration resistant prostate cancer mCRPC who are treated with lutetium 177Lu vipivotide tetraxetan. This non-interventional, prospective, multicenter study aims to describe routine clinical practice and gather real-world data on this treatment. The study will follow patients for a maximum of 18 months after their treatment ends. The study includes patients who have been prescribed lutetium 177Lu vipivotide tetraxetan by their treating physician team. There are no additional experimental treatments or interventions, as this is an observational study. The observation period covers from the start of treatment up to 18 months post-treatment, including monitoring during the treatment duration. Participants will be monitored through regular clinical assessments and data collection on outcomes such as progression-free survival, overall survival, prostate-specific antigen response, pain medication use, and quality of life measures. Researchers will also track hospitalizations related to the treatment, dosimetry, number of visits, and workdays lost. The total involvement for each participant can last up to 18 months after treatment completion.

This research investigates two surgical techniques for treating multiple gingival recessions, which are areas where the gum has receded from teeth. The trial compares the split-thickness non-advanced tunnel method with the full-thickness coronally-advanced tunnel MCAT approach to evaluate which provides better root coverage. The study is a randomized, outcome-assessor blinded clinical trial conducted at multiple centers, focusing on patients with specific types of gum recession who need root coverage treatment. Participants will be randomly assigned to one of two groups one receiving the split-thickness non-advanced tunnel procedure, and the other undergoing the full-thickness coronally-advanced tunnel MCAT surgery. Each technique follows established methods from previous studies. The main treatment period lasts six months, with an option to extend follow-up to three or five years if funding permits. During the study, participants will undergo assessments including measurements of root coverage at three and six months after surgery. Various clinical and digital evaluations will monitor gum tissue changes, tooth attachment, pocket depth, dental sensitivity, and aesthetic outcomes. The primary outcome is the average root coverage achieved at six months, measured by a blinded assessor. Participants will attend follow-up visits and have their oral health carefully monitored throughout the study period.

Researchers are studying patients with poor grade aneurysmal subarachnoid hemorrhage to understand outcomes, predictors, and treatment effects. The study focuses on three key areas early brain injury phase in the emergency department, delayed brain injury phase in the neurocritical care unit, and treatment strategies. Additional research addresses delayed cerebral ischemia and long-term follow-up, as some patients may improve significantly after 6 to 12 months. This observational study includes patients with poor grade subarachnoid hemorrhage managed according to the latest international and national guidelines. Both prospective and retrospective patients are included, and treatment follows established protocols. The study does not involve experimental treatments but observes standard care practices. Participants will have their clinical outcomes measured at 6 and 12 months after hemorrhage, with additional long-term follow-up up to 60 months. Researchers will also track delayed cerebral ischemia, rebleeding, treatment complications, and surgical interventions within specified timeframes. Imaging analyses will assess bleeding volumes and ischemic changes. The study aims to provide detailed outcome data and predictors over both short and long terms.