Telese

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

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 studying how the autonomic nervous system is involved in patients with relapsing-remitting and primary progressive multiple sclerosis. The goal is to understand characteristics of autonomic dysfunction, such as issues with blood pressure regulation and temperature control, and how these affect patients' lives and rehabilitation. The study also explores the relationship between nerve fiber damage and disease severity, as well as differences in autonomic involvement across multiple sclerosis types. Participants will undergo diagnostic tests including cardiovascular reflex testing through various maneuvers like deep breathing and head-up tilt, and a punch skin biopsy to measure small nerve fibers in the thigh, leg, and fingertip. They will also complete clinical questionnaires assessing autonomic symptoms, pain, and neuropathy. The study compares findings between the two multiple sclerosis types and with healthy control data. Patients will be hospitalized for rehabilitation during the study and will have sensory and autonomic function tests along with skin biopsies. Researchers will measure outcomes such as cardiovascular reflexes and sudomotor function at recruitment. The study monitors symptoms and nerve fiber status to better understand autonomic nerve involvement and its impact on disease progression and treatment response.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating whether a high-tech rehabilitation approach is more effective than traditional rehabilitation in improving balance and motor function for adults with acute neuromuscular diseases such as Guillain-Barré Syndrome, Critical Illness Myopathy, and Critical Illness Polyneuromyopathy. This study focuses on patients within 15 to 30 days of disease onset and aims to improve outcomes like balance control, fatigue, muscle strength, cognitive engagement, and quality of life. The study is designed as a randomized, controlled trial comparing advanced technology-based rehabilitation to standard care. The high-tech rehabilitation includes the use of a Robotic Verticalization System to help regain upright posture and mobility, Virtual Reality for engaging cognitive and motor exercises, Stabilometric Platforms for balance training, and a Treadmill System for aerobic exercise with gait analysis and feedback. The control group receives traditional rehabilitation treatment. The treatment period lasts 60 days. Participants will be assessed for changes in balance using the Berg Balance Scale at the end of treatment. Throughout the study, researchers will monitor motor function, fatigue levels, muscle strength, and overall quality of life. Safety and adherence will be tracked, and participants will undergo regular evaluations to measure the effectiveness of the rehabilitation methods over the 60-day treatment period.

Researchers are investigating whether advanced rehabilitation methods using robotic and technological devices are as effective as traditional rehabilitation in reducing fatigue among adults with chronic neuromuscular diseases such as Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Polyneuropathy, and Charcot-Marie-Tooth Disease. This study aims to evaluate if high-tech interventions can improve balance, motor function, fatigue, muscle loss, cognitive engagement, and quality of life better or as well as conventional treatments. The study compares two groups: one receiving high-tech rehabilitation including virtual reality for cognitive and motor exercises, stabilometric platforms for balance and posture training, and treadmill systems for aerobic exercise with gait analysis; and a control group receiving traditional rehabilitation treatments. This randomized, pragmatic trial tests the non-inferiority of the high-tech approach compared to standard methods. Participants will be assessed multiple times over 60 days to monitor changes in fatigue using the Fatigue Severity Scale, as well as improvements in balance and other motor functions. Researchers will perform evaluations at baseline and at several points during the study to gather data on treatment effects. Safety and adherence to the protocol will be monitored throughout the trial period.

Researchers are studying how autonomic and sensory nerve involvement progresses in patients with amyotrophic lateral sclerosis (ALS) who have been diagnosed within 18 months of motor symptom onset. The study aims to understand if autonomic nervous system problems at diagnosis are related to how fast the disease progresses and to survival. They also want to find skin biomarkers that could help track disease progression and be used in future clinical trials to group patients and measure treatment effects. Participants will undergo a detailed clinical and instrumental examination at the start, including genetic testing for common ALS-related genes, questionnaires on clinical symptoms, quality of life, and pain, as well as neuropsychological testing. Tests of autonomic function will include cardiovascular reflex tests and a dynamic sweat test. A 3mm punch skin biopsy will be done to examine nerve fibers in the skin. At follow-up, about six months later, clinical scales and another skin biopsy will be performed. Results from ALS patients will be compared to healthy individuals matched by age and sex. Throughout the study, participants will be evaluated for sensory and autonomic nerve function at recruitment and at follow-up using skin biopsies and autonomic assessments. Questionnaires and clinical scales will track symptoms and quality of life. The study will monitor changes in peripheral nerve innervation and autonomic function over time to better understand ALS progression and potential biomarkers for future research.

Researchers are investigating the impact of different types of pain and autonomic symptoms in patients diagnosed with Parkinson's disease (PD) and multiple system atrophy (MSA). The study focuses on evaluating how prevalent pain and autonomic symptoms are in these conditions, and how they affect patients' quality of life. It also aims to assess the effect of rehabilitation on these symptoms by comparing patients with PD and MSA. This observational study is conducted at the Istituti Clinici Scientifici Maugeri Centers and includes both inpatients and outpatients. All participants will receive a neurological examination and undergo a personalized rehabilitation program designed to improve strength, coordination, balance, endurance, and daily living activities. Alongside rehabilitation, clinical scales will be used to assess disease stage, severity, motor and non-motor symptoms, cognitive function, depression, quality of life, autonomic dysfunction, and pain. The rehabilitation program allows evaluation over time to observe any significant changes in clinical parameters. Participants will be closely monitored before and after the rehabilitation program, with outcome measures including the prevalence and characterization of pain at recruitment and after about 30 days of rehabilitation. Researchers will collect data through clinical scales and neurological examinations to understand the impact of pain and autonomic symptoms on disability and quality of life. This comprehensive evaluation aims to guide clinicians in managing patient disability and refining rehabilitation strategies to improve patient outcomes.

Researchers are evaluating the effects of prismatic adaptation combined with Serious Games on cognitive and behavioral deficits in patients who have experienced traumatic brain injury (TBI). The study compares this novel rehabilitation protocol to a training program using Serious Games without prismatic adaptation. The aim is to assess how these treatments impact cognitive functions like attention, memory, and executive abilities, as well as functional cognitive outcomes. The study involves patients admitted within 90 days of TBI onset, focusing on those with moderate cognitive functioning levels. Participants will be randomly assigned to two groups. The experimental group will receive prismatic adaptation treatment (PAT) involving pointing exercises with prismatic lenses using an 11-inch tablet, alternating rightward and leftward prism deviation over 10 sessions in 2 weeks. Each session includes 10 minutes of prismatic adaptation followed by 30 minutes of cognitive training using Serious Games designed to improve attention, memory, inhibition, and planning. The control group will engage in the same Serious Games without the prismatic adaptation. Both groups also receive standard cognitive rehabilitation using paper and pen materials. Sessions last about one hour, five days a week, for two weeks. Participants will be assessed before treatment and after completing 10 rehabilitation sessions. Assessments include neuropsychological tests and resting-state EEG to observe changes in brain activity. The main outcome measured is cognitive improvement from enrollment to treatment completion at two weeks. Safety monitoring is minimal due to low risk, and all data are securely stored. After the study treatment, both groups continue standard cognitive and motor rehabilitation. The total participation duration corresponds to the hospital stay during rehabilitation.

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.