There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strength and performance and increased risk of falls and fractures, physical disability and premature death. With the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with HIV (PLWH) with sarcopenia. The investigators plan to enroll 98 elderly and 98 PLWH in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. The investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.
The primary objective is: To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG) The secondary objectives of the study are: - To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on: - Clinician-assessed signs of myasthenia gravis (MG) and muscle strength - Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only). - Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG - Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength - Health related quality of life - Proportion of patients with minimal MG symptoms - Patient- and clinician-reported signs and symptoms of MG - To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy - To assess the concentration of total pozelimab in serum - To assess the concentrations of cemdisiran and its metabolites in plasma - To assess the immunogenicity of pozelimab - To assess the concentration of total C5 in plasma - To assess the immunogenicity of cemdisiran - To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation
The primary objective of this study is to apply a biomechanical system (the NeuroFlexor) associated with the EMG recording to study the physiological mechanisms that contribute to the regulation of muscle tone in healthy subjects and in patients with increased muscle tone. A second fundamental objective of this study is to monitor over time the changes in muscle tone that can be found physiologically in healthy subjects and pathologically in patients with spasticy and/or rigidity. A further objective of this study is the quantitative evaluation of the symptomatic effects of specific therapies in improving the impaired muscle tone. Clinical evaluation In this research project the investigators will recruit 20 patients with upper limb spasticity (regardless of the underlying disease responsible for the spasticity), 20 patients with Parkinson's disease characterized by stiffness of the upper limbs and 20 healthy control subjects. Patients will be recruited from the IRCCS Neuromed Institute, Pozzilli (IS). Participants will give their written informed consent to the study, which will be approved by the institutional ethics committee of the IRCCS Neuromed Institute, in accordance with the Declaration of Helsinki. All participants will be right-handed according to the Edinburgh handedness inventory (EDI) (Oldfield, 1971). Parkinson's disease will be diagnosed in accordance with the updated diagnostic criteria of the MDS (Postuma, RB et al. Validation of the MDS clinical diagnostic criteria for Parkinson's disease. Mov. Disord. Off. J. Mov. Disord. Soc. 33, 1601 -1608 (2018)., Nd). Clinical signs and symptoms of parkinsonian patients will be evaluated using the Hoehn & Yahr scale (H&Y), UPDRS part III (Patrick et al., 2001). The diagnosis of spasticity will be made through the neurological clinical evaluation of the patients and on the basis of the specific clinical history of the various pathologies underlying the spasticity itself (e.g. multiple sclerosis, stroke, spinal injuries). Spasticity will be assessed with the Modified Ashworth Scale "(MAS) (Harb and Kishner, 2021), the Modified Tardieu scale (MTS) (Patrick and Ada, 2006). Cognitive functions and mood, in both pathological conditions, will be evaluated using the clinical Mini-Mental State Evaluation (MMSE) scale (Folstein et al., 1975) and the Hamilton Depression Rating Scale (HAM_D) ( Hamilton, 1967). No participant must report pain problems and / or functional limitations affecting the upper limbs. Exclusion criteria: - insufficient degree of passive wrist movement (<30 ° in flexion and <40 ° in extension) - tension at rest during NeuroFlexor recordings - hand pathologies (neurological or rheumatological) - upper limb fractures in the previous six months - presence of peacemakers or other stimulators - pregnancy. All patients, and the group of healthy control subjects will have comparable anthropometric and demographic characteristics. Experimental paradigm Participants will be seated comfortably, with the shoulder at 45 ° of abduction, the elbow at 90 ° in flexion, the forearm in pronation and the dominant hand placed on the platform of the Neuroflexor device. Participants will be instructed to relax during the test session, which will consist of the passive extension of the wrist at 7 speeds, one slow (5 ° / s) and 6 rapid (50 ° / s, 100 ° / s, 150 ° / s, 200 ° / s, 236 ° / s, 280 ° / s). The total range of wrist movement will be 50 °, starting from an initial angle of 20 ° in palmar flexion up to 30 ° in extension. Before the start of the experiment, participants will do practical tests in order to become familiar with the device. Two slow and five rapid movements will be made for each speed. The different angular velocities of wrist mobilization will be randomized. Slow movements will be performed before fast movements with an interval of 10 seconds between each test. For each participant, a NC, EC and VC value in Newton will be calculated by a dedicated software. The resistance profiles will also be obtained when the device was running idle (without hand) to allow the biomechanical model to isolate the forces originating from the hand from the intrinsic forces of the device. For each movement, the corresponding surface EMG trace will have been recorded, by placing the electrodes on the skin overlying the belly of the FRC and ERC muscles. An accelerometer, fixed on the back of the hand of the limb to be examined, will be used to synchronize the electromyograph with the NeuroFlexor. The EMG activity recorded by means of surface electrodes with belly-tendon type mounting, will be amplified using the Digitimer, will then be digitized at 5 kHz using the CED, and finally it will be stored on a computer dedicated to offline analysis. EMG recordings will be made at 6 speeds, 50°/ s, 100°/ s, 150°/ s, 200 °/s, 236 °/s, 280 °/s. For each trace the following parameters will be analyzed: latency, peak-to-peak amplitude and area of the EMG response.
To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.
The primary objective of this study is to evaluate motor function following treatment with HD nusinersen in participants with spinal muscular atrophy (SMA) previously treated with risdiplam. The secondary objective of this study is to evaluate the safety and tolerability of HD nusinersen in participants with SMA previously treated with risdiplam.
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy. Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
The primary aim of the study is to detect the presence of gluten immunogenic peptides (GIP) in urine samples from celiac patients on a gluten-free diet clinically responsive and non-responsive to dietary treatment and from suspected celiac patients already on a gluten-free diet.
Patients with severe or difficult-to-treat asthma represent a small amount of total asthmatic patients, but weight on the national health system for the costs of disease management. Chronic rhinosinusitis with nasal polyposis, which the Italian severe/uncontrolled asthma registry reported with a prevalence of 30%, represents a comorbidity that significantly impact lung function and asthma control in severe asthma. Recent evidence indicates that there is a consistent heterogeneity regarding mucosal alterations present in subjects with nasal polyposis involving different pathways: inflammatory cells, remodeling, T cell activation, local IgE production, alteration induced by interactions between microorganisms and epithelial cells.
Dysphagia is a disabling, life-threatening symptom that can cause death in Multiple Sclerosis people (pwMS) through aspiration pneumonia. Speech therapists use behavioural therapies (compensatory and rehabilitative) to alleviate such swallowing problems, with limited benefit. Compensatory strategies such as postural changes and changes in food consistency, have been found to be partially effective, especially in patients with mild dysphagia and may be ineffective in patients with more severe dysphagia. The rehabilitative strategies include "no swallow exercises" which aim to strengthen isolated muscles used in swallowing (such as tongue strengthening) and "swallowing exercises" that aim at strengthening all the muscles used in swallowing while executing a hard, effortful, or prolonged swallow. To date, no randomized clinical trials have shown that rehabilitative strategies are effective. Neuromuscular electrical stimulation (NMES), often referred to as electrical stimulation, was introduced as a novel therapy for dysphagia in the late 2001. The principles of NMES in the limb rehabilitation literature are well established. However published protocols applying NMES to swallowing function have shown mixed results in people with stroke and only one study was published on MS people. This will be a double blinded, randomized clinical trial (patients and research staff blinded) with two arms: standard speech therapy plus Active NMES vs speech therapy with Sham NMES. The aim of this study is to determine whether NMES added benefit to a therapy program comprised of standard swallowing exercises in dysphagic pwMS.