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.
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS).
The COVID-19 emergency has led to the complete closure of all rehabilitation services, both public and/or private, across Italy, including the region of Tuscany. Among the various consequences of the COVID-19 pandemic, a significant negative indirect impact on children with neurodevelopmental disabilities and their families was observed. Specifically within Tuscany, a substantial decline occurred in rehabilitative interventions, including physiotherapy, language therapy, and neuropsychological therapy. Despite these challenges, some healthcare facilities responded by initiating tele-rehabilitation treatments, even if on a limited scale, following the recommendations of scientific societies within the field. In this framework, TABLET-TOSCANA project has been developed, with the overall aim of developing innovative organizational models to ensure the continuity of care for treatment and tele-rehabilitation of neuro-psychomotor and language functions in children with congenital and acquired developmental disabilities. The present proposal aims to evaluate the feasibility of this approach and the economic sustainability of employing the implemented technologies to promote tele-rehabilitation as possible territorial care taking. Additionally, the study aims to conduct a preliminary efficacy evaluation by analyzing pre-post treatment changes identified in outcome measures, providing valuable insights into the potential benefits of this tele-rehabilitation proposal.
The global burden of stroke is staggering, with over 15M new cases reported annually. Of these cases, around 40% require motor and cognitive rehabilitation, resulting in approximately 6M new patients requiring treatment each year, in addition to the more than 33M chronic patients worldwide. This massive incidence puts great pressure on healthcare systems and mounting costs. Consequently, there is an urgent need for patient-specific solutions that maximize rehabilitation efficiency and improve the patient´s performance, activities of daily living (ADLs), and quality of life. While several technological solutions have been proposed for stroke recovery during hospitalization, there is a notable lack of attention to home rehabilitation, which is crucial for long-term recovery, cost reduction and minimizing the demand for rehabilitation personnel. Investigators propose NEST, the Neurorehabilitation Ecosystem for Sustained Treatment based on the Rehabilitation Gaming System (RGS), an advanced digital rehabilitation program that uses serious gaming and Augmented Reality (AR)- and Virtual Reality VR-based training and is grounded on neuroscientific principles, that has been shown to promote motor recovery after stroke at the clinic and at home (Ballester et al., 2017; Ballester et al., 2019). NEST uses a patient's user model solution interfaced via a novel digital and portable technology to provide a home rehabilitation program accepted by the patients and clinicians. The NEST system integrates the following components: - RGS-wear advances a multimodal unobtrusive wearable interface starting from the state-of-the-art wearable technologies including off-the-shelf wearables for the detection of arm activity. This data is sent through Bluetooth to a paired smartphone, which allows for the filtering of body movements. - The RGS-Mobile App (smartphones) communicates with the RGS-wear and integrates sensor data for the delivery of patient-tailored Augmented Reality AR-based exercises for motor and cognitive training, customized feedback via the AWA coach, and activity reports through the MIMS. - The AWA Coach (Agent for Wellbeing Assistance) which provides specific feedback based on the performance and the status of well-being of the user. The user can access information through the AWA Coach dashboard (AWAtar App), which is an interface that reports their performance. and progress. It also provides the user with direct and motivational feedback and training activities in order to assist them in acting when needed. - MIMS (Medical Information Management System) is a cloud service in which relevant information on the patient's state is uploaded, allowing the monitoring of progress and the customization of the RGS-based training and evaluation protocols. Guaranteeing the correct use of this NEST ecosystem by post-stroke patients performing upper limb telerehabilitation implies conducting an usability study to measure its usability, adherence, acceptance and the user's experience. Investigators will also explore effectiveness of the NEST ecosystem in improving motor function of the paretic arm after stroke. Furthermore, uncovering end-user's experiences with NEST in an international multi-centre study should give valuable information into improving its features for a future clinical trial focusing on the effectiveness of the NEST system. This multicenter study will follow a mixed methods approach (quantitative and qualitative measurements).
Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders. However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions. Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.
Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease. Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS. Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.
The proposed study suggests using automatic voice analysis and machine learning algorithms to develop a dysphagia screening tool for neurological patients. The research involves patients with Parkinson's disease, stroke, and amyotrophic lateral sclerosis, both with and without dysphagia, along with healthy individuals. Participants perform various vocal tasks during a single recording session. Voice signals are analysed and used as input for machine learning classification algorithms. The significance of this study is that oropharyngeal dysphagia, a condition involving swallowing difficulties in the transit of food or liquids from the mouth to the esophagus, generates malnutrition, dehydration, and pneumonia, significantly contributing to management costs and hospitalization durations. Currently, there is a lack of rapid and effective dysphagia screening methods for healthcare personnel, with only expensive invasive tests and clinical scales in use.
PURPOSE OF THE STUDY The study aims to evaluate the effectiveness of the Dual Wavelength Laser System (DWLS) diode laser on the treatment of endometrioma (OMA), with ablation and vaporization of the cystic capsule without performing the stripping technique, in terms of ovarian reserve and recurrence rate.
The goal of this observational study is to learn about the role of biomarkers in spontaneous subarachnoid hemorrhage (sSAH) as predictors of severity of clinical outcome. The test of biomarkers is based on regular blood and urinary samples. Blood levels of highly specific cardiac troponin (cTNI), natriuretic peptides (NT-ProBNP), S100 beta protein, neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), ubiquitin carboxy-terminal hydrolase (UCH-L1), soluble Tumor Necrosis Factor Receptor-2 (sST2), and soluble urokinase plasminogen activator receptor (suPAR), as well as urinary levels of epinephrine and norepinephrine are the biomarkers explored. All adult participants with spontaneous subarachnoid hemorrhage are involved in the study. The main questions aim to answer are: - which of these molecules can be prognostic for patients' outcome - which are the prognostic levels of these biomarkers to predict patients' outcome. Participants will undergo blood and urinary samples during hospitalization at 24 hours, 72 hours and after 7 days.
The primary aim of the study is to compare the perception of pain and discomfort with two different protocols of attachments' placement during clear aligner therapy: the conventional protocol (CP), when attachments' placement is performed are placed at the delivery of the first aligner; the delayed protocol (DP), when the attachments' placement is performed at the delivery of the third aligner. The rationale of this study is to evaluate whether dividing the two phases most associated with the onset of pain and discomfort, namely the initiation of aligner therapy and the placement of attachments, can improve patients' quality of life during clear aligner treatment. Patients' discomfort will be evaluated with a questionnaire adapted by OHIP-14 (Oral Health Impact Profile 14).
The trial is designed as a single-arm, open-label, phase I study investigating an off-the-shelf, multi-peptide-base HCC vaccine plus Montanide, combined with Durvalumab in patients with very early, early and intermediate stage of HCC. The investigational agents will be applied without concomitant anti-tumour therapy with the intention to reduce risk of recurrence/progression in patients who have received all indicated standard treatments.