Rho

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the efficacy of the drug RO7837195 compared to a placebo in adults with moderately to severely active ulcerative colitis UC who have not responded well to conventional or advanced treatments. This Phase IIb study aims to assess the safety, pharmacokinetics, and clinical effects of RO7837195 in this patient group. The study is sponsored by Genentech, Inc. and focuses on treatment outcomes including clinical remission at Week 12. Participants undergo a screening period lasting up to 5 weeks, followed by a 12-week induction phase where some receive RO7837195 and others receive a placebo. After this, all participants enter a 40-week active treatment extension phase receiving RO7837195 regardless of their initial response. This design allows comparison during induction and continued treatment for all in the extension phase. Safety follow-up occurs after the last dose of study treatment. Throughout the trial, participants will be monitored for clinical remission, response, and endoscopic improvements at Week 12, as well as adverse events and drug concentration levels up to Week 65. The study includes regular evaluations such as clinical assessments and laboratory tests to track treatment effects and safety. Total participation can last up to approximately 57 weeks, covering screening, treatment, and follow-up periods.

This research investigates the real-world use of 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 capabilities. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. The HeartInsight algorithm, validated in previous studies, monitors trends in seven physiological parameters to provide early warnings about worsening heart failure, aiming to improve patient management by alerting healthcare providers well in advance. Patients enrolled in this prospective, multicenter observational registry will be followed for 12 months across approximately 14 centers in Italy. The study does not require additional diagnostic tests beyond standard care. When HeartInsight issues an alert, a standardized workflow guides clinical responses such as device adjustments, therapy changes, or extra visits. Patients may also choose to use the HeartInsight Patient App to assist in monitoring. The study collects data on how often alerts occur, the clinical actions taken, patient interviews, and hospitalizations. Participants will have their device data remotely monitored and attend regular clinical visits as part of routine care. Researchers will track the proportion of alerts that lead to clinical actions and measure secondary outcomes like alert frequency, duration of alert periods, patient interviews, hospitalizations, and app usage. Data are collected securely via electronic forms and monitored for quality. The study aims to provide insights into integrating predictive monitoring tools into everyday practice to potentially enhance heart failure care over a 12-month period.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis UC. The study focuses on participants with a diagnosis of UC for at least 3 months, confirmed by specific clinical and endoscopic criteria. This Phase 2 trial aims to better understand how LY4268989 may impact clinical remission and response in this patient group over a long-term period. Participants will receive either one of two doses of LY4268989 or a placebo, all administered orally. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to approximately 108 weeks, excluding the screening phase, allowing for assessment of the drug over an extended time. During the study, participants will undergo regular evaluations including clinical assessments using the Modified Mayo Score to measure remission and response at multiple time points, including weeks 10 and 52. Researchers will also monitor symptomatic response and measure plasma concentrations of LY4268989. Safety and effectiveness will be tracked through these clinical and laboratory tests to understand the drugs impact on UC over the study duration.

Researchers are evaluating whether treatment with both mirikizumab and tirzepatide compared to mirikizumab and placebo can reduce or eliminate symptoms of moderately to severely active ulcerative colitis UC in adults who are also overweight or have obesity. This Phase 3b randomized controlled study aims to determine if this combination treatment leads to clinical remission and at least a 10% reduction in body weight. Participants receive mirikizumab initially by intravenous IV infusion followed by subcutaneous SC injections. They are randomly assigned to receive either tirzepatide SC or a placebo SC alongside mirikizumab. The treatment period lasts for 52 weeks, with the whole study participation lasting up to 61 weeks. Both study drugs and placebo are administered under medical supervision. During the study, participants are monitored regularly for symptom improvement and weight loss. Researchers assess clinical remission, endoscopic response, histologic-endoscopic mucosal improvement, bowel movement urgency, and histologic remission at weeks 24 and 52. Safety and treatment effects are carefully followed throughout the trial. Participants undergo evaluations to measure changes in UC symptoms and body weight over the study period.

Researchers are evaluating the effectiveness and safety of mirikizumab combined with either tirzepatide or a placebo in adults with moderately to severely active Crohns disease who also have obesity or are overweight. This Phase 3b study aims to compare these treatments in participants who have a confirmed diagnosis and meet specific disease activity and weight criteria. The study is conducted by Eli Lilly and Company and lasts up to 61 weeks. Participants receive mirikizumab initially via intravenous infusion, followed by subcutaneous injections. They are randomly assigned to receive either tirzepatide with mirikizumab or placebo with mirikizumab, both administered subcutaneously. The study involves two experimental groups where treatments are given according to this schedule. During the study, participants will undergo regular assessments to monitor clinical remission using the Crohns Disease Activity Index and endoscopic remission, as well as track weight reduction. Evaluations include inflammatory bowel disease questionnaires and monitoring of corticosteroid use. The main measure is the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight loss by week 52. Safety and maintenance of remission are also assessed throughout the trial.

Researchers are evaluating a cardiogenic shock protocol designed to improve communication and collaboration among hospitals to timely refer cardiogenic shock patients from spoke to hub centres in the Turin and Milan metropolitan areas. This observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort starting in 2024. The purpose is to assess whether implementing this dedicated protocol reduces in-hospital or 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock AMICS. Cardiogenic shock is a critical condition requiring rapid intervention and specialized care, and the study focuses on improving outcomes by optimizing patient transfer and treatment coordination. The study compares two groups one retrospective group of patients admitted before the protocol was implemented, and one prospective group admitted after the protocol adoption. Patients in the prospective cohort are managed under a standardized communication and referral protocol between spoke and hub centres, which include advanced cardiac interventions such as percutaneous mechanical circulatory support and prompt transfer to specialized teams. Hub centres have multidisciplinary shock teams, cardiac surgery backup, and 247 availability of cardiac care services. Spoke centres provide initial care and stabilization. The study involves 16 centres, with four hubs each receiving patients from three spoke centres. Participants will be monitored during their hospital stay and followed up to 30 days from admission. Data collected include clinical characteristics, treatments, timing of mechanical support device insertion, adverse events, and outcomes like mortality, stroke, bleeding, renal replacement therapy, vascular complications, and myocardial infarction. The study uses electronic health records and prospectively collected data, with no changes to standard care. The primary measure is 30-day mortality, and secondary outcomes include various clinical events and timing metrics related to treatment support. The study aims to provide insight into whether the hub-and-spoke protocol improves survival and quality of care for cardiogenic shock patients.

Researchers are collecting data to create an Italian database focused on gastro-entero-pancreatic neuroendocrine tumors GEP-NET. This observational study aims to gather information on how these tumors are diagnosed, treated, and monitored over time. The study continues previous efforts from an international database, ensuring important clinical details are not lost for patients in Italy. Participants data will be entered into a secured online database managed by the Italian Association Neuroendocrine Tumors ITANET. The data collection includes new diagnoses and follow-up visits, with retrospective data allowed for patients diagnosed within one year before consenting. Follow-up visits and treatments are based on individual patient needs, and data accuracy is carefully checked and validated by ITANET. During the study, patients will undergo regular clinical visits as part of their usual care. The data collected will include tumor classification, diagnostic tools used, treatment methods such as surgery or medication, and disease progression. The study tracks important outcomes like tumor incidence, location, diagnosis timing, and treatment types over a three-year period, with ongoing data updates planned annually.

Cerebrovascular diseases CVDs are a major cause of illness and death worldwide, with over 30% of strokes having unknown causes. Rare cerebrovascular diseases rCVDs, including inherited conditions like CADASIL, COL4A1 syndrome, and Fabry disease, as well as acquired ones like Sneddon syndrome and Moyamoya arteriopathy, contribute to some of these strokes. These rare diseases are often misdiagnosed due to difficulty in recognition, yet identifying them is crucial for proper management, genetic counseling, and potential therapy. Currently, diagnosis and care are limited to a few specialized centers, mainly in northern Italy, causing patients to travel long distances for care. This observational study aims to create a clinical and research network across Italy to improve diagnosis and understanding of rCVDs, especially in southern regions. The study will describe the clinical features and natural course of these diseases during the first 12 months. Later, between 12 and 30 months, it will explore molecular mechanisms, identify biomarkers, and work towards better clinical and therapeutic management. Participants diagnosed with rCVDs such as CADASIL, Fabry disease, COL4A1, Sneddon syndrome, or Moyamoya arteriopathy who have had at least one brain MRI will be included. Researchers will collect clinical, genetic, and neuroradiological data to characterize these patients and monitor their disease progression. The study does not involve treatments but focuses on gathering information to improve diagnosis and care. Participation may last up to 30 months with ongoing assessments and data analysis.