Olbia

Researchers are evaluating the clinical and health-related outcomes of amivantamab-containing treatment regimens for patients with common EGFR-mutated advanced non-small cell lung cancer NSCLC, including metastatic cases where the cancer has spread. This study observes these treatments in a real-world setting, focusing on patients with specific EGFR mutations exon 19 deletions or exon 21 L858R substitution. It aims to describe how these regimens perform outside of controlled clinical trials. Participants are grouped into two cohorts one receiving amivantamab combined with carboplatin and pemetrexed after prior therapy failure, and another receiving amivantamab with lazertinib as first-line therapy. Treatments are given according to usual clinical practice, and no study drugs are provided. Data collection captures information from routine care, including treatment administration and related medications. During the study, researchers collect data on treatment duration, progression-free survival, overall survival, adverse events, dose changes, concomitant medication use, and quality of life measures using validated questionnaires. Monitoring continues for up to approximately 60 months. Participants provide informed consent, and all data comes from standard medical records without additional interventions or procedures required by the study.

Researchers are evaluating three different Endoscopic Gastroplasty EG techniques for treating obesity in adults with a body mass index BMI between 30 and 44.99 kgm2. This study aims to compare the safety and effectiveness of these minimally invasive procedures, which reduce stomach capacity and alter gastric motility, over an 18-month period. The trial is conducted at a single center and involves a multidisciplinary team to assess patients before and after treatment. Participants will be randomly assigned to one of three EG procedures Endoscopic Sleeve Gastroplasty ESG using the Overstitch suturing device, Primary Obesity Surgery Endolumenal-2 POSE-2 with an overtube-style platform, or Endoluminal Vertical Gastroplasty EVG using a triangulation platform. These procedures are performed under general anesthesia by experienced endoscopists. After the procedure, patients receive tailored diets and follow-up care including psychological support and dietician visits at several time points up to 540 days post-treatment. Throughout the study, patients will undergo regular assessments including anthropometric measurements, blood tests, liver ultrasounds with elastography, transit studies, and barium x-rays to monitor changes in weight, stomach size, and liver health. Researchers will evaluate weight loss outcomes such as total body weight loss and excess weight loss, safety through monitoring adverse events, and quality of life using validated questionnaires. The study includes a comprehensive follow-up schedule to support patient adherence and evaluate long-term effects.

Researchers are studying women who carry mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 to better understand their risk of developing cancer. This observational study aims to collect national data from women with these mutations, as current management strategies are not fully established. The study focuses on the Italian population, where an estimated 140,000 to 150,000 women carry these mutations, and many face a high lifetime risk of genetically linked tumors. Participants will be registered on a platform where their clinical data related to BRCA1 or BRCA2 mutations will be collected. The study does not involve treatment but gathers detailed information about mutation distribution, access to genetic evaluation, lifestyle risk factors, preventive strategies, and surgical risk reduction approaches such as salpingo-oophorectomy. Women in the study will provide data that researchers will analyze to understand mutation geography, related cancer types, and screening criteria. Data collection occurs over different time frames, including immediate and six-month intervals. The study continues through long-term observation to monitor outcomes and preventive efforts, with no active intervention applied to participants.

Researchers are evaluating the effectiveness and safety of different filling volumes of fluid-filled intragastric balloons in overweight or obese adults with a body mass index BMI between 27 and 60 kgm2. This randomized, single-center study aims to identify which balloon volume500 ml, 600 ml, or 700 mlprovides the best outcomes for weight loss and safety during treatment. The trial is conducted by a multidisciplinary team including gastroenterologists, surgeons, nutritionists, psychologists, radiologists, and endocrinologists. Participants will be randomly assigned to one of three groups, each receiving an intragastric balloon filled with either 500 ml, 600 ml, or 700 ml of a saline and methylene blue solution. The balloon is inserted through the mouth using a gastroscope and left in place for six months. This fluid-filled balloon reduces stomach volume to support weight loss. After six months, the balloon will be removed by endoscopy. The study runs from August 2022 to June 2025. During the study, participants will undergo thorough evaluations including psychometric, nutritional, and clinical assessments before the procedure. Researchers will monitor weight loss defined by total and excess weight loss percentages, record any adverse events such as pain or nausea, note early balloon removals, and assess quality of life improvements through specific questionnaires. Safety and effectiveness will be observed through these measures over the six-month treatment period.

Researchers are collecting data from women who have undergone mastectomy and immediate breast reconstruction to understand their sexual well-being through surveys. This study aims to support better preoperative counseling and improve care for the side effects of cancer treatments. It also seeks to identify women with severe sexual impairment who might benefit from lifestyle changes and specialized interventions to enhance their quality of life. Participants are asked to complete questionnaires at a 1-year follow-up after their mastectomy and reconstruction surgery. These questionnaires gather sociodemographic information and details about their sexual well-being. The study includes women with various types of mastectomies and reconstruction procedures, including both unilateral and bilateral cases. During the study, participants will attend a medical consultation followed by completing the questionnaires about their sexual health. Researchers will measure sexual well-being as the primary outcome at enrollment. This study is observational in nature with no masking or placebo involved, and participation involves providing survey responses to help improve future care for breast cancer patients.