Venezia

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness and safety of CYP-001 combined with corticosteroids compared to corticosteroids alone in adults who have undergone allogeneic hematopoietic stem cell transplant and developed high-risk acute graft versus host disease (aGvHD). This phase 2, randomized, double-blind, placebo-controlled study assesses the severity of aGvHD using the Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines throughout the trial. Participants will be randomly assigned to receive either CYP-001, an intravenous infusion of induced pluripotent stem cell-derived mesenchymal stem cells, on Days 0 and 4 along with corticosteroids, or a placebo infusion on the same days plus corticosteroids. All subjects will receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day or methylprednisolone 1.6 mg/kg/day intravenously as appropriate. The treatment phase includes study visits up to Day 100, followed by a long-term follow-up period with visits extending to 24 months. During the study, participants will undergo regular assessments to monitor the response to treatment and the severity of aGvHD. Researchers will evaluate the overall response rate at 28 days as the primary outcome. Safety and long-term effects will also be monitored throughout the follow-up period, ensuring comprehensive evaluation of both immediate and extended treatment impacts.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Researchers are investigating whether eye movements during free viewing can serve as biomarkers for visuospatial deficits in patients who have suffered a unilateral stroke. The study also explores the feasibility of a new visual exploration training that uses an auditory biofeedback system linked to eye-tracking to improve these visuospatial deficits. This research includes correlating eye movement patterns with standard neuropsychological evaluations and neuroimaging data to understand the cognitive, motor, and functional status of stroke patients. Participants will be divided into groups, including a subsample at the IRCCS San Camillo hospital who will receive a novel visual exploration training alongside standard neuropsychological rehabilitation. This training involves exploring natural scenes guided by real-time auditory feedback that directs eye fixations toward important areas of the images, based on normative data. The study compares changes in eye movement behavior, neuropsychological test scores, and neuroimaging results between the training group, an active control group, and a healthy sample. Throughout the study, participants undergo various assessments at the start (day 0) and after 30 days of rehabilitation. These include tests of eye movement patterns during free viewing, behavioral attention tests, memory and visuospatial tests, and evaluations of anosognosia and functional abilities. Researchers will monitor changes in these measures to assess the impact of the training. Functional and structural brain imaging will also be performed to identify neural correlates of eye movement characteristics. The study carefully tracks participant vigilance and cognitive status during evaluations to ensure accurate results.

Researchers are evaluating the effects of atezolizumab compared to a placebo in patients with malignant pleural mesothelioma who have undergone surgical removal of the tumor and show no visible remaining disease. This phase III, double-blind, placebo-controlled trial aims to assess disease-free survival over 12 weeks. Patients will be grouped based on tumor type and stage, with the goal of understanding how atezolizumab performs as an additional treatment after surgery and chemotherapy. Participants will be randomly assigned in a 2:1 ratio to receive either atezolizumab or placebo. The medication is given for up to 12 months or until the disease returns, unacceptable side effects occur, or a decision is made to stop treatment. Before starting therapy, patients will have a CT scan to confirm no remaining disease after surgery, and follow-up imaging will occur every 12 weeks for two years or until disease progression. Tumor samples collected during the study will be analyzed to explore biological and genetic features. During the study, patients will complete quality of life questionnaires at the start and every 12 weeks. Researchers will monitor blood tests to ensure organ function, and they will track side effects and disease status regularly. The primary outcome is to evaluate how well atezolizumab works in prolonging the time patients remain disease-free. The total study duration involves regular assessments over 24 months, including safety follow-up and biomarker research.

Researchers are evaluating whether biofeedback treatment is more effective than standard verbal feedback in helping patients recover from dysphagia after a stroke. This multicenter randomized, single-blind controlled trial will include 100 patients who have had a stroke and suffer from swallowing difficulties. The study aims to compare the recovery outcomes between a group receiving visual biofeedback and a control group receiving verbal feedback only, based on prior studies suggesting visual feedback may improve swallowing strength, timing, coordination, and effectiveness. Participants will undergo 20 treatment sessions over 4 weeks, attending 5 sessions per week. The experimental group will receive biofeedback treatment using two surface electrodes applied to the mylohyoid muscle, with real-time visual feedback of muscle activity displayed on a screen during swallowing maneuvers such as effortful swallow, timing and coordination tasks, and the Masako maneuver. The control group will perform the same training maneuvers for the same duration but will receive only verbal feedback from a speech and language therapist. Before treatment, after 20 sessions, and at a 2-month follow-up, participants will have clinical and instrumental evaluations of swallowing function using fibroendoscopy. Assessments will include multiple scales and tests to measure swallowing abilities, penetration/aspiration, pharyngeal residue, and quality of life related to swallowing. Researchers will analyze changes over time in swallowing efficacy and safety, monitoring participants throughout the study period to assess treatment effects and recovery progress.

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.