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Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of RO7837195 in adults with moderately to severely active ulcerative colitis who have not responded well or tolerated conventional or advanced treatments. This Phase IIb study aims to compare RO7837195 to a placebo during the initial treatment phase and then monitor all participants receiving the active drug to assess clinical remission at 12 weeks. The study includes a screening period lasting up to 5 weeks, followed by a 12-week induction phase where participants receive either RO7837195 or a matching placebo according to a specified schedule. After this induction phase, all participants enter a 40-week active treatment extension where they receive RO7837195 regardless of their earlier response. A safety follow-up period occurs after the last dose to continue monitoring participant health. Participants will undergo assessments throughout the study to measure clinical remission at week 12 and to monitor safety and pharmacokinetics. Researchers will collect data on symptoms, treatment effects, and any side effects experienced. The total participation involves multiple phases designed to carefully evaluate the long-term impact and safety of RO7837195 in ulcerative colitis management.

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.

Researchers are evaluating the HeartInsight algorithm, designed to predict acute heart failure events in patients with implanted Biotronik ICD or CRT-D devices that have atrial sensing and Home Monitoring. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. HeartInsight analyzes trends in seven physiological variables to provide early warnings of worsening heart failure, with a median lead time of 42 days. This study aims to assess how HeartInsight alerts are managed in routine clinical practice across multiple centers in Italy. About 100 patients will be enrolled across 14 centers and followed for 12 months. Participants have implanted devices with Home Monitoring and will be monitored remotely. When HeartInsight generates an alert, a standardized workflow guides clinical responses such as device adjustments, therapy optimization, unscheduled visits, or hospital admissions. The study collects data on alert frequency, clinical actions triggered, and patient use of the HeartInsight Patient App. Participants will provide informed consent and undergo standard remote monitoring and clinical visits. Data will be gathered through electronic case report forms, focusing on the proportion of alerts that lead to clinical actions, alert patterns, hospitalizations, and app usage. Safety and data quality will be monitored throughout. The study results aim to improve integration of predictive monitoring into patient care, potentially enhancing management and outcomes for heart failure patients.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on participants who have had UC for at least 3 months and have specific disease activity scores. The study aims to understand how well LY4268989 works in treating this condition over a long period. Participants will receive either LY4268989 or a placebo, both administered orally. The study includes a treatment period lasting up to approximately 108 weeks, not including the screening phase. Participants are monitored to assess their response to the medication, including whether they achieve clinical remission based on the Modified Mayo Score (mMS). During the study, researchers will conduct various assessments to monitor disease activity and participant safety. They will track the percentage of participants achieving clinical remission at Week 10 and among those who responded at Week 10, the remission status at Week 52. The study involves regular evaluations, including endoscopic confirmation of disease activity and safety monitoring over the entire duration.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.

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 collecting detailed information on patients with gastro-entero pancreatic neuroendocrine tumors (GEP-NET) in Italy to create a national database. This effort continues from a previous international registry halted by ENETS, aiming to preserve and update important clinical data. The study focuses on gathering information about diagnosis, therapies, and follow-up of these tumors, involving patients with confirmed GEP-NET diagnoses. Participating sites in Italy will enter patient data into a secure online database managed by ITANET, accessible only to authorized personnel. Data is collected prospectively for new and follow-up visits, while previously diagnosed patients can provide retrospective data up to one year before consent. Follow-up schedules are personalized based on each patient's clinical situation, including tumor location and treatments received. Patients' information is anonymized using unique codes. Data quality is monitored by ITANET through checks for completeness and consistency, with queries sent to sites for clarification when needed. The study tracks various outcomes over three years, such as tumor types, diagnostic methods, treatment approaches, disease progression, and time from symptom onset to diagnosis, providing valuable insights for better management of GEP-NET in Italy.