Vimercate

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

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.

Metastatic breast cancer (mBC) is a common and serious condition affecting many patients worldwide. Emotional distress (ED) is reported by about half of breast cancer patients and can negatively influence treatment adherence, symptom management, and quality of life. This research investigates how baseline emotional distress impacts the outcomes of patients with mBC receiving their first line of treatment, aiming to better understand its effect on therapy effectiveness. Participants will receive first-line treatments based on their breast cancer subtype, including endocrine therapy, chemotherapy, immunotherapy, and targeted therapy. They will be grouped into cohorts depending on their disease characteristics and treatment plans, such as immunotherapy combined with chemotherapy or targeted therapies like CDK4/6 inhibitors and trastuzumab. During the study, patients will complete questionnaires to assess emotional distress and quality of life. Throughout the study, researchers will monitor participants' progression-free survival over two years, focusing on differences related to emotional distress at baseline. Patients will undergo evaluations through specific questionnaires about their emotional and quality of life status. The study includes careful observation of treatment outcomes and safety, providing valuable information on how emotional health relates to treatment effectiveness in metastatic breast cancer.

Researchers are studying patients who have cardiogenic shock caused by acute myocardial infarction or acute heart failure. The goal is to evaluate how a dedicated protocol, designed to improve communication and collaboration between spoke and hub hospitals in the Turin and Milan metropolitan areas, affects 30-day mortality rates. This multicenter observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort from 2024 to 2026. The study focuses on patients classified as SCAI shock class B to D and aims to compare outcomes before and after the protocol's implementation. The study involves 16 centers, with four hub hospitals receiving patients transferred from spoke centers. The hub hospitals have specialized cardiogenic shock teams available 24/7 and advanced mechanical circulatory support devices. The protocol includes a stepwise communication checklist to facilitate timely diagnosis, referral, and transfer of patients requiring advanced care. Patients in the prospective cohort will be managed according to this protocol, while the retrospective cohort provides historical data for comparison. Participants will be monitored up to 30 days after hospital admission. Researchers will collect clinical data, treatments, complications such as stroke, bleeding, renal replacement therapy, vascular issues, and non-fatal myocardial infarction. They will also measure door-to-support time and symptom-to-support time. Data will be gathered from electronic health records and hospital charts, with outcomes adjudicated by an independent committee. Safety events and adverse effects will be tracked as well, with a focus on improving patient care and survival in cardiogenic shock.

Researchers are investigating how a Modified Mediterranean Diet affects the variety of bacteria in the intestines of patients with metastatic colorectal cancer who are receiving chemotherapy with or without biological agents. The study compares this diet's impact on gut microbiota to that of patients following a standard Western diet. It aims to explore how certain bacterial populations that support the intestinal barrier may be promoted by the Modified Mediterranean Diet and to assess how the microbiome influences disease progression, side effects, and quality of life. The study includes a screening visit and baseline visit where nutritional status is assessed through exams, blood tests, and questionnaires. Patients meeting criteria are randomly assigned to either follow the Modified Mediterranean Diet (Arm A) or continue their usual diet (Arm B). Biological samples including stool are collected at baseline and about 45 days later. Follow-up visits occur every 15 to 21 days depending on treatment, with a radiological assessment about 90 days after baseline. Participants will have their nutritional status, lifestyle, and microbiota evaluated through various measurements including bioimpedance and fecal samples. Researchers will monitor the impact of diet on intestinal bacteria at 45 days and review clinical progress and side effects. The study tracks outcomes related to microbiota changes and overall clinical condition during the treatment period.