Tradate

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

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. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are conducting a prospective observational study to develop and validate an Italian version of the Waddell Disability Index WDI-I, a questionnaire that patients complete themselves to assess disability related to chronic low back pain. Low back pain is a major cause of disability worldwide, and patient-reported outcome measures like the WDI are important tools for clinical assessment and rehabilitation planning. This study addresses the need for a culturally adapted Italian version of this well-known tool. The study involves a careful translation process including forward and backward translations by bilingual experts, review by a panel of clinicians, and pilot testing with patients. After finalizing the Italian version, 115 adults with chronic low back pain lasting at least three months will complete the WDI-I along with other established pain and disability scales. The WDI-I will be completed again after 7 to 10 days to evaluate consistency over time. Participants will provide demographic and clinical data and complete questionnaires including the WDI-I, Numeric Pain Rating Scale, Italian Oswestry Disability Index, and Italian Pain Catastrophizing Scale. Researchers will analyze internal consistency, reliability, and validity of the WDI-I using statistical methods. Patient data will be pseudonymized and securely handled. The study will run until late 2026, aiming to offer a reliable and valid Italian tool for assessing disability in chronic low back pain.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Chronic Obstructive Pulmonary Disease COPD causes exercise intolerance and difficulty performing daily activities due to symptoms like breathlessness and fatigue. This research evaluates whether adding upper limb endurance training to the usual lower limb rehabilitation improves patients ability to perform daily tasks, compared to the standard lower limb training alone. The study is a randomized controlled trial aiming to improve exercise tolerance and quality of life in COPD patients. Participants will be assigned to one of two rehabilitation programs lasting 14 daily sessions of 90 minutes each. One group will perform lower limb training on a stationary bike plus strengthening exercises. The other group will combine lower limb cycling, arm ergometer training, and strengthening exercises for both upper and lower limbs. All sessions will be supervised by physiotherapists, and education about disease management will be provided. Throughout the study, participants will undergo clinical evaluations including lung function tests, blood gas analysis, and quality of life questionnaires. The main measurement is the time taken to complete the GLITTRE test, assessing daily living activities, evaluated from randomization to the end of the program up to 16 days. Secondary outcomes include changes in effort tolerance for upper and lower limbs and energy cost of walking. Safety and progress will be monitored during the rehabilitation period.

Researchers are evaluating an instrumented stair climb test designed to assess the ability to climb and descend stairs in both children and adults with various conditions including cerebral palsy, limb amputation, Parkinsons disease, stroke, and joint arthroplasty. The study aims to characterize and compare the stair climbing performance among these groups and healthy individuals, while exploring correlations between the objective measurements from wearable sensors and standard clinical scales. This research also seeks to test the feasibility and reliability of this instrumented stair climb test on healthy subjects. Participants will perform an instrumented test involving climbing and descending a flight of 10-12 steps, using wearable sensors to capture kinematic and electromyographic data. The study includes healthy children, adults, and elderly groups, as well as groups with specific diagnoses. Additional assessments such as the 10-meter walk test, 30-second chair stand test, Timed Up & Go test, and Borg scale are also used to evaluate walking speed, leg strength, balance, and perceived effort. Some tests involve repeating the stair climb with repositioning of sensors to assess reliability. During the study, participants will be monitored for intra- and inter-operator variability and the absolute error in test timing over approximately one year. Researchers will collect data from the instrumented stair test and correlate these with clinical functional tests to assess validity. The study involves multiple centers responsible for recruiting and gathering data, with analysis and algorithm development supported by a technical institute. Total participation time varies, with data collection and evaluations conducted under supervised conditions.

Researchers are studying the effects of adding music to rehabilitation training for patients with Chronic Obstructive Pulmonary Disease COPD and chronic respiratory failure CRF. This trial compares usual rehabilitation training to training supported by music, aiming to see if music can improve exercise capacity, endurance, and reduce fatigue and breathlessness. Previous studies suggest music may help reduce symptoms like anxiety and dyspnea and improve quality of life for COPD patients during exercise. Participants will be randomly assigned to one of two groups a music-supported training group or a usual training group without music. The music group listens to selected music styles with a constant rhythm designed to synchronize with cycling exercise sessions lasting about 30 minutes. Both groups perform supervised training on a cycle ergometer, with the only difference being the presence or absence of music. Training occurs 5 to 6 times per week over 12 to 14 sessions. Throughout the study, participants will undergo various assessments including lung function tests, 6-minute walk tests, muscle strength measurements, blood gas analysis, and exercise endurance tests. Heart rate, oxygen saturation, and breathlessness levels will be monitored before and after each session. The primary outcome is the change in walking test performance after up to three weeks of training, with additional evaluations of breathlessness, fatigue, and disease impact on daily activities. Safety, adherence, and reasons for withdrawal will also be tracked by the study team.

Asthma is a chronic inflammatory disease affecting millions worldwide, characterized by variable and reversible airflow limitation causing symptoms like wheezing, difficulty breathing, chest tightness, and cough. This research evaluates the role of an Asthma School educational intervention in managing asthma, especially for patients with severe asthma who may not control symptoms despite maximum inhalation therapies. The study is interventional and aims to improve patient adherence and cooperation in asthma management through behavioral education. Participants are randomly assigned to either an experimental group receiving the Asthma School intervention or a control group. The experimental group attends regular control visits every three months plus three weekly multidisciplinary lessons within one month after randomization. These lessons cover asthma physiology, symptom and exacerbation recognition, therapy and device education, and nutritional counseling if needed. Participants also use a paper diary and a peak flow meter twice daily to monitor symptoms. Throughout the two-year study, all participants have control visits every three months. Researchers will monitor the number of exacerbations, emergency room visits, and hospitalizations related to asthma. Secondary assessments include asthma control tests, questionnaires, inflammation markers, and respiratory function. This comprehensive monitoring aims to evaluate how education impacts asthma management, symptom control, and healthcare use over time.