Tradate

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

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 developing and validating an Italian version of the Waddell Disability Index (WDI-I), a self-administered questionnaire used to assess disability related to chronic low back pain. Low back pain is a leading cause of disability worldwide, and patient-reported outcome measures like the WDI-I are important tools for evaluating pain and functional limitations. This prospective observational study aims to ensure the WDI-I is reliable, valid, and culturally appropriate for Italian-speaking patients with chronic low back pain lasting at least three months. The study involves a standardized translation process including forward and backward translations by bilingual translators and review by expert clinicians, followed by pilot testing. After finalizing the Italian version, 115 adult patients will complete the WDI-I together with other established measures such as the Numeric Pain Rating Scale, the Italian Oswestry Disability Index, and the Italian Pain Catastrophizing Scale. The WDI-I will be administered again after 7 to 10 days to assess test-retest reliability. Participants will complete questionnaires at baseline and after 7-10 days, with data collected on disability, pain intensity, and pain-related thoughts. Outcomes measured include internal consistency, reliability, and construct validity of the WDI-I over approximately one year. Statistical analyses will evaluate how well the WDI-I measures disability and correlates with other pain and disability scales, providing a validated tool to support clinical assessment and rehabilitation planning in Italian patients with chronic low back pain.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Chronic Obstructive Pulmonary Disease (COPD) causes exercise intolerance and significant disability due to symptoms like breathlessness and fatigue, which impair daily activities. Pulmonary rehabilitation (PR), especially exercise-based, is key in managing COPD by improving exercise tolerance, reducing symptoms, and enhancing quality of life. This study aims to compare whether combined arm and leg training is more effective than standard lower limb training alone in improving activity of daily living (ADL) performance as measured by the GLITTRE test. Participants will be randomly assigned to one of two rehabilitation programs lasting 14 daily sessions of 90 minutes each. The lower limbs (LL) group will perform 60 minutes of stationary cycling for legs and 30 minutes of strengthening exercises. The lower plus upper limbs (L+UL) group will do 30 minutes of leg cycling, 30 minutes of arm-ergometer training, and 30 minutes of strengthening exercises for both upper and lower limbs. All sessions will be supervised by a physiotherapist, and training intensity will be progressively adjusted based on individual effort. During the study, researchers will collect clinical and lung function data at baseline and assess quality of life and functional ability before and after the program. The primary measure is the change in time to complete the GLITTRE test up to 16 days after randomization. Secondary outcomes include effort tolerance of upper and lower limbs and energy cost of walking. Safety, symptoms, and disability will also be monitored throughout the rehabilitation period.

Researchers are evaluating an instrumented test to measure how well people with various conditions climb and descend stairs. This study includes both children and adults with conditions like cerebral palsy, amputations, Parkinson's disease, stroke, and joint replacements. The goal is to better understand their stair-climbing abilities and compare these findings with standard clinical assessments. The study also aims to check the reliability of the test in healthy individuals by examining consistency between operators and over time. Participants will perform an instrumented stair climb test using wearable sensors that record movement and muscle activity as they go up and down a flight of 10-12 steps. Some participants will repeat the test twice, with repositioning of the sensors between trials. Additional walking and balance tests, such as the 10-meter walk test, the 30-second sit-to-stand test, and the Timed Up & Go test, will also be conducted to further assess mobility and strength. During the study, participants' performance will be monitored through the wearable devices, and various clinical scales and questionnaires will be used to collect information on effort perception and functional mobility. Researchers will analyze the accuracy and consistency of the test results over about one year. Participants will be supervised to ensure safety and proper use of the equipment throughout the evaluations.

Researchers are evaluating whether adding music to rehabilitation training can improve exercise tolerance in people with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure (CRF). This study compares the effects of music-supported training versus usual rehabilitation without music, focusing on endurance, fatigue, and breathlessness. Music therapy is known to help in various medical settings by improving psychological and physical symptoms, and this trial aims to assess its impact specifically in COPD and CRF patients. Participants will be randomly assigned to one of two groups: a music-supported (MS) group and a control (C) group. The MS group will perform their usual training on a cycle ergometer while listening to music chosen from four styles (rock, modern, jazz, classical) with a steady rhythm matching the pedaling pace. The C group will perform supervised exercise sessions without music, with training intensity adjusted based on perceived effort. Both groups will complete 12 to 14 sessions over several weeks, each session lasting about 30 minutes plus warm-up and recovery. During the study, participants will undergo evaluations including lung function tests, a 6-minute walk test measuring fatigue and breathlessness, muscle strength assessments, blood gas analysis, and exercise capacity tests on a cycle ergometer. Heart rate, oxygen saturation, and perceived exertion will be monitored before and after each session. The main outcome is the change in effort tolerance measured by the 6-minute walk test over the program lasting up to 3 weeks. Researchers will also track reasons for withdrawal and analyze factors that predict improvement.

Asthma is a chronic inflammatory disease affecting millions worldwide, with symptoms including wheezing, shortness of breath, chest tightness, and cough. The severity and airflow limitation can vary over time due to factors like exercise, pollution, climate changes, and viral infections. This research explores the role of an "Asthma School" educational program to improve asthma management by addressing psychological factors affecting treatment adherence and enhancing cooperation between patients and healthcare providers, especially for those with severe asthma who struggle to control symptoms despite maximal therapy.