Olbia

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are comparing three different Endoscopic Gastroplasty (EG) techniques to treat obesity in adults with a body mass index (BMI) between 30 and 44.99 kg/m2. This single-center, randomized trial is conducted at Mater Olbia Hospital in Italy and Qatar Foundation Endowment from June 2020 to August 2024. The study aims to evaluate the safety and effectiveness of these procedures over an 18-month period, focusing on weight loss outcomes. The three EG techniques being studied include Endoscopic Sleeve Gastroplasty (ESG) using the Overstitch device, Primary Obesity Surgery Endolumenal-2 (POSE-2), and Endoluminal Vertical Gastroplasty (EVG) using different endoscopic suturing devices. Patients are randomly assigned to one of these procedures, each performed under general anesthesia by skilled endoscopists. After the procedure, patients receive a two-month refeeding protocol tailored to their treatment type. Follow-up visits with dietitians, psychologists, and gastroenterologists occur at 30, 90, 180, 360, and 540 days to monitor progress, provide nutritional and psychological support, and check for adverse events. Participants undergo thorough initial assessments including psychoclinical evaluations, dietary interviews, body measurements, blood tests, liver ultrasound, stomach motility studies, and imaging before the procedure. During follow-ups, researchers collect data on weight loss percentages, body measurements, quality of life, hormonal and microbiota changes, and liver and stomach health. The primary outcome measured is the percentage of total body weight loss at various time points up to 18 months post-procedure. The study also tracks patient adherence to lifestyle changes and evaluates overall safety throughout the trial.

Researchers are studying women who carry mutations in the BRCA1 or BRCA2 genes, which increase the risk of developing breast and ovarian cancers. Despite many studies over the past two decades, the best ways to manage these mutation carriers are still not fully established. In Italy, about 140,000 to 150,000 individuals carry these mutations, and it is estimated that 87% of women with these mutations will develop a genetically linked tumor during their lifetime. Approximately 20% of ovarian cancer cases in Italy each year have a genetic origin and could benefit from preventive approaches. Currently, there is no national prospective data collection specifically for women with BRCA mutations in Italy.

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 investigating how different filling volumes of fluid-filled intragastric balloons affect weight loss and safety in overweight or obese patients with a body mass index (BMI) between 27 and 60 kg/m2. This randomized, single-center study aims to find the best balloon volume for effective treatment, as current practice varies without a clear standard. The study is conducted at Mater Olbia Hospital and Gemelli Foundation, Italy, from August 2022 to June 2025, involving a multidisciplinary team for comprehensive patient evaluation. Participants will be randomly assigned to receive an intragastric balloon filled with either 500 ml, 600 ml, or 700 ml of saline solution mixed with methylene blue. The balloon is placed endoscopically into the stomach and remains in place for six months, after which it is removed via esophagogastroduodenoscopy. Before and after placement, patients undergo psychological, nutritional, and physical assessments to monitor their progress and safety. During the study, patients will have their weight loss measured by percentage of total and excess weight lost from enrollment until balloon removal at six months. Researchers will also monitor adverse events such as pain, nausea, vomiting, and any complications requiring medical intervention. Quality of life will be assessed through specific questionnaires. The study includes regular clinical interviews, psychometric tests, dietary evaluations, and physical activity assessments to support patient adherence and measure treatment impact over the six-month period.

Researchers are gathering information on sexual well-being in women who have undergone mastectomy and immediate breast reconstruction. The study aims to support better preoperative counseling and improve care to prevent adverse effects from cancer treatments. It also seeks to identify groups of women who experience significant sexual difficulties after mastectomy and might benefit from specific lifestyle changes and treatments. Participants will be asked to complete surveys that collect information about their sociodemographic background and sexual well-being. Various types of breast reconstruction are included, and the study covers both unilateral and bilateral mastectomies, including cases with or without contralateral breast surgery. During the study, participants will complete questionnaires to assess their sexual well-being. The data collected will help researchers understand the impact of mastectomy and reconstruction on quality of life. This information may guide future interventions to support affected women. The study focuses on women aged 18 years and older who are undergoing mastectomy for primary breast cancer or preventive surgeries.