Venezia

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are studying how eye movements during natural viewing might serve as markers for visuospatial difficulties in people who have had a stroke. This study aims to evaluate a new visual exploration training that uses an auditory biofeedback system to help improve these visuospatial problems. The study involves assessing eye movements, cognitive, motor, and functional status, along with brain imaging to understand the neurological basis of these eye movement patterns. Participants will be randomly assigned to one of two groups. One group will receive ten sessions of the new visual exploration training combined with standard neuropsychological rehabilitation at the IRCCS San Camillo hospital. This training guides eye movements toward important areas of images using real-time auditory feedback. The other group will receive only the standard neuropsychological rehabilitation. Both treatments are conducted in a clinical setting. During the study, participants will undergo assessments before and after rehabilitation, including eye movement recordings during free viewing, multiple neuropsychological tests, and brain imaging to measure structural and functional brain connectivity. The main outcomes are changes in eye movement patterns and improvements on various cognitive and visuospatial tests over 30 days. The study also monitors changes in brain connectivity to understand training effects.

This research evaluates atezolizumab as an additional treatment for patients with malignant pleural mesothelioma who have undergone surgical removal of the tumor and show no visible remaining disease. This phase III trial compares atezolizumab to a placebo to assess how well it works in preventing disease recurrence. Patients are grouped based on tumor type and cancer stage to better understand treatment effects. Participants receive either atezolizumab at 1200 mg or a matching placebo every 21 days for up to 12 months, or until the disease returns, side effects become unacceptable, or the patient or doctor decide to stop treatment. The study uses a centralized system to randomly assign patients to one of these groups, ensuring a balanced comparison. Tumor samples are analyzed to study biological markers and gene expression. During the trial, patients undergo CT scans before starting treatment and then every 12 weeks for two years or until the disease progresses. Quality of life questionnaires are completed at the start and every 12 weeks. Researchers monitor safety, disease-free survival, and overall survival for up to a year. The study lasts several years, with follow-up assessments to understand treatment impact and patient well-being.

Researchers are evaluating whether biofeedback treatment is more effective than standard verbal feedback training in helping people recover from dysphagia after a stroke. This multicenter randomized controlled study will enroll 100 patients who have had a stroke and experience swallowing difficulties. The goal is to compare the recovery of swallowing function between those receiving biofeedback and those receiving conventional therapy without visual feedback. Participants will undergo 20 sessions over 4 weeks, attending five one-hour sessions each week. In the biofeedback group, sensors will be placed on the mylohyoid muscle to provide real-time visual feedback on muscle activity during swallowing exercises. The control group will perform the same swallowing maneuvers but will receive only verbal feedback from a speech therapist. Both groups will use effortful swallow techniques, timing and coordination tasks, and the Masako maneuver during training. Before starting treatment, and at two follow-up pointsafter 4 weeks of therapy and again two months laterpatients will have clinical and instrumental evaluations including fibroendoscopy and several swallowing function scales. Researchers will measure swallowing efficacy, penetrationaspiration, pharyngeal residues, and quality of life related to swallowing. Data will be analyzed statistically to assess treatment effects and safety throughout the study duration.

Researchers are evaluating the Italian translation and validation of several clinical tools designed to assess swallowing and oral-motor function in patients with neurogenic dysphagia. These tools include the New Zealand Secretion Severity Scale for secretion management, the Reflex Cough Test from the cranial nerves assessment, the VASES scale used during fiberoptic endoscopic evaluation of swallowing, and the Drooling Severity Scale for saliva control. The study aims to provide reliable and standardized assessment instruments in Italian to help clinicians caring for people with neurological swallowing difficulties. The study involves no active treatment but focuses on validating these assessment tools in about 100 adult patients diagnosed with neurogenic dysphagia caused by various neurological conditions. Participants will undergo evaluations using the translated scales to test their internal consistency and inter-rater reliability. This observational study does not involve experimental interventions but uses diagnostic tests to collect data. Participants will be assessed once at baseline, with researchers measuring the consistency and reliability of the secretion and drooling scales as primary and secondary outcomes. The study includes clinical evaluations of swallowing and reflex cough function, with all assessments performed under stable medical conditions. The total duration of participation and follow-up is not specified, but the focus is on one-time validation measurements to support future clinical use of these tools.

This trial evaluates different doses of the drug AP31969 to control the rhythm of atrial fibrillation AF and to determine its safety. The study is a randomized Phase 2 trial comparing AP31969 to a placebo in adults diagnosed with paroxysmal or persistent AF who have a measurable AF burden. The study aims to reduce AF burden and improve quality of life using oral medication. Participants are assigned randomly to receive one of several doses of AP31969 100 mg, 200 mg, 350 mg, or later 500 mg or a placebo. All treatments are given as tablets taken orally twice daily for 12 weeks. The study includes three periods screening up to 4 weeks, treatment 12 weeks, and a follow-up period of 30 days. Participants will have an implantable loop recorder to monitor heart rhythm continuously. During the study, participants will attend scheduled visits where blood and urine tests, electrocardiograms, and other assessments will be performed. Researchers will track AF burden, the number of AF episodes, quality of life changes, and episodes of ventricular tachycardia. The total participation time is about 20 weeks, including all study periods, with safety and treatment effects monitored carefully.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.