Carpi

Researchers are evaluating if combining atezolizumab with standard chemotherapy can improve treatment for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer (ES-SCLC) after progression following first-line treatment. This phase II multicenter study aims to determine whether this combination increases overall survival and to identify any medical problems participants may experience. Sensitive relapse is defined as cancer returning or progressing at least 60 days after completing initial chemo-immunotherapy including PD-L1 inhibitors like atezolizumab or durvalumab. Participants will receive rechallenge chemotherapy consisting of carboplatin plus etoposide at doses chosen by the investigator along with atezolizumab 1200 mg intravenously on day 1 every 3 weeks. This induction phase lasts up to 4 cycles. After that, participants continue with maintenance atezolizumab every 3 weeks for up to 18 cycles or 1 year, unless disease progression, unacceptable toxicity, or other stopping criteria occur. The study treatment period can last up to 15 months. Radiological assessments with CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to monitor response. Participants attend clinic visits every 3 weeks for treatment and assessments. Researchers continuously monitor for side effects and safety throughout the study. The total study duration is up to 45 months, including about 24 months for enrollment, treatment up to 15 months, and 6 months of survival follow-up. The main outcome measured is overall survival through study completion, averaging 1 year.

Researchers are studying metastatic breast cancer by recruiting 1300 patients from many hospitals across Europe. This study focuses on patients aged 18 or older, both female and male, who have been diagnosed with metastatic breast cancer or a relapse and have not received more than one systemic treatment since the discovery of metastases. The main goal is to better understand the genetic changes in metastatic breast cancer and how patients respond or resist therapies, aiming to find the right treatment for each patient. Patients with genetic changes that match new drug trials may have the option to participate in those trials if available. Participants undergo a biopsy of the metastatic lesion to collect tissue samples, performed by a surgeon or radiologist. Biopsy samples, along with blood, serum, and plasma, are collected both at the start and during follow-up. Some samples are analyzed immediately, while others are stored in a bio-repository for future research. Biopsies can be from bone or brain tissue under specific conditions, and must be collected before starting or changing systemic treatment lines, following precise timing rules. Throughout the study, participants provide regular blood samples and allow collection of tissue samples from both primary and metastatic tumors. Researchers monitor participants' health status and treatment responses. The primary outcome is to improve understanding of metastatic breast cancer over the year following the end of patient recruitment. This research aims to enhance treatment outcomes for all patients diagnosed with metastatic breast cancer by using detailed molecular analyses and offering access to clinical trials when possible.

Researchers are evaluating the effectiveness and safety of a bowel cleansing agent called Mannitol compared to a standard preparation named Plenvu® in adults undergoing elective colonoscopy. The study is designed as a Phase III, international, multicenter, randomized, parallel-group trial with endoscopist blinding. It aims to determine if 100 g Mannitol is not inferior to Plenvu® when both are taken on the same day before the procedure. Participants are divided into two groups: half will receive 100 g of Mannitol dissolved in 1 liter of water, which they should drink within 45 minutes. The other half will use Plenvu®, which involves two doses taken the same day; the first dose is dissolved in 500 ml of water plus an additional 500 ml, taken within an hour, followed by a one-hour wait, then a second dose dissolved in 500 ml of water plus another 500 ml, also taken within an hour. Both preparations are self-administered according to these schedules. During the study, researchers will assess bowel cleanliness using the Boston Bowel Preparation Scale during colonoscopy up to 28 days after consent. Participants will be monitored for the preparation's effectiveness, safety, and acceptance. The study includes regular follow-up visits and adherence to instructions to ensure reliable results and participant safety throughout the trial period.

Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are studying the role of Human Endogenous Retroviruses (HERVs), ancient DNA sequences, and the gut microbiota, the community of microorganisms in the digestive tract, in children with various diseases. These include Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, and febrile virosis. The study aims to understand if there is a link between HERV expression, gut bacteria types, and clinical symptoms in these pediatric conditions, potentially offering new insights for care and treatment. The study involves collecting blood and fecal samples from pediatric patients diagnosed with the diseases mentioned. Blood samples will be analyzed to study HERVs, while fecal samples will be used to characterize the gut microbiota. This approach will help examine how HERV activity and gut bacteria profiles may relate to disease onset, severity, and immune response in affected children. Participants will be monitored throughout the study, with assessments focusing on HERVs and gut microbiota over about one year. The main outcomes measured include the analysis of HERVs and the characterization of microbiota throughout the study period. The results may help identify markers for disease severity and guide personalized treatments and follow-up care in pediatric patients with these inflammatory and infectious conditions.

Researchers are conducting an Italian multicenter, observational, prospective study to gather information on patients with bone metastases. The study aims to establish a National Bone Metastasis Database by collecting detailed data from all patients with bone metastases referred to participating centers. This effort helps track and understand the condition better over a long period. Patients with bone metastases from solid tumors will be registered in a specially designed online database created for this study. Each enrolled patient will be entered into this database and followed over time until death or until follow-up is stopped for any other reason. This approach allows researchers to monitor the disease progression and treatment outcomes using a centralized digital system. Participants will provide informed consent to be part of the study. Their medical data, including diagnosis information, will be collected and stored in the database. This process includes ongoing monitoring and follow-up assessments as available during the study, which may last up to 15 years. The main outcome is the creation and maintenance of the comprehensive National Bone Metastasis Database to support research and patient care.

Infant weaning is the process where a baby's diet changes from only milk to including a variety of foods that provide all necessary nutrients for healthy development. Different weaning methods exist, influenced by culture, tradition, and scientific views. These include traditional weaning, baby-led weaning (BLW), and baby-led introduction to solids (BLISS), each with unique approaches to how and when foods are introduced. This research aims to understand how common each weaning method is and how parents and pediatricians perceive their benefits and risks, especially concerning feeding mistakes and choking hazards. The study involves surveying parents of children aged 4 to 18 months and Italian pediatricians to collect information on weaning practices through dedicated questionnaires. Traditional weaning uses specific infant foods given in set amounts and times, while BLW allows the infant to self-feed at their own pace during family meals. BLISS is a safer variation of BLW, starting at 6 months with advice to reduce choking risks. Pediatricians play an important role by advising on the best weaning methods and food preparation. Participants will be asked to complete surveys that explore the types of weaning used and any perceived advantages or problems. The study will monitor how weaning is implemented over about one year. Researchers are particularly interested in the safety of different weaning styles and how parents and pediatricians manage the transition to complementary feeding. This information may help improve guidance on feeding infants safely and effectively.