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.
Parkinson's disease (PD) leads to multifactorial disabilities with consequent social restrictions, especially in the COVID-19 era. Continuity of care, especially rehabilitation measures, is critical to improve or maintain an adequate QoL for patients. The Parkinson Disease Telerehabilitation Program (PDTR) is an individualized home rehabilitation program using open-source platforms (OSp). The main purpose of this pilot study is to investigate the feasibility of TR in patients with PD by using free OS platforms (PDTR PROGRAM). The target of this study was to have at least 90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions.
Loss of voice is one of the greater consequences of total laryngectomy. The voice prosthesis allows the patients to speak again in a very short time but forces them to use one hand when speaking. In order to reduce this discomfort and to allow "hands-free" speaking, an Automatic Speaking Valve (ASV) has been designed which is positioned on a peristomal adhesive. Peristomal adhesives, however, tend to detach under the influence of mucus, cough, or phonatory pressure. Consequently, the current regular use of the automatic speaking valve in laryngectomees is very low. As a possible solution, Atos Medical AB has developed a moldable peristomal adhesive made of a thermoplastic elastomer, which becomes transparent and moldable when heated and facilitates precise contouring in situ. As the material cools, it loses its malleability but retains the integrity of the molded shape. The expectation was that the moldable adhesive would provide a better individual fit and therefore longer fixation (especially when using the ASV). To study the feasibility of this device, 10 total laryngectomized patients were asked to use the new moldable peristomal adhesive for two weeks in conjunction with their normal daily routine for adhesive application and removal, and speech rehabilitation.
Pilot testing the feasibility of the Transformative Audio Storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.
Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included. Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry. Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).
The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease
The lack of serum markers that can be used to identify the levels of steatosis in obese subjects, or that can indicate a rapid progression of the metabolic disease, in which it is very often difficult to perform analyzes with imaging techniques, limits the current evolution from a generalized medicine to a personalized medicine. With the project proposal the aim is to identify serum markers for the characterization of steatosis in subjects affected by genetic obesity, which will most likely also be used in metabolic obesity.
After recruiting a population of subjects with different metabolic severity (subjects of normal weight and obese patients with and without metabolic syndrome), the objectives of the present research will be: 1. determine leukocyte mRNA levels of Cidea (gene associated with BAT functional status), Hoxc9 (gene associated with browning of WAT) and Cpt1a (gene associated with β-oxidation of fatty acids in both tissues, i.e. BAT and WAT) (secondary endpoint); 2. to determine energy expenditure with indirect calorimetric technique, body temperature and circulating catecholamine levels, which will be correlated to leukocyte levels of Cidea, Hoxc9 and Cpt1a mRNA (secondary endpoint); 3. determine the plasma levels of an extensive panel of sphingolipids, including in particular ceramides and sphingosine-1-phosphate which, by exerting a lipotoxic, lipoinflammatory and anti-adipogenic effect, will be correlated to the leukocyte levels of Cidea, Hoxc9 mRNA and Cpt1a (primary endpoint); 4. determine the erythrocyte, leukocyte and platelet levels of sphingolipids which, acting as peripheral biomarkers of cardiometabolic dysfunction (e.g., atherogenesis, thromboembolism, arterial hypertension, insulin resistance, low-grade chronic inflammation, etc.), could phenotypically identify patients with increased cardiovascular risk (e.g., obese patients with or without metabolic syndrome) (secondary endpoint). Hypothesis: the existence of a relationship between sphingohypotoxicity and transdifferentiation of adipose tissue and a combination of sphingolipids (plasma/erythrocyte/platelet/leukocyte) and gene regulators (WAT/BAT-related) which, with sensitivity and specificity, is associated with diagnosis of metabolic syndrome.
Background. Individuals with obesity can present several functional limitations that can significantly impact on their quality of life. Furthermore, even during the execution of specific motor tasks, subjects with obesity can experience excessive biomechanical overload. It is therefore necessary to develop appropriate assessment protocols that are able to provide support for risk assessment, in consideration of different types of motor tasks, including movements that can reflect the main daily and / or work activities. In this perspective, it is essential to define a protocol that includes an integrated evaluation process based on objective and quantitative metrics, i.e., functional scales, clinical scores, etc. In this context, the quantitative analysis of movement is widely used in clinical practice and in research to investigate in an objective and comprehensive way on movement disorders in various pathological conditions, including obesity. Conventionally, kinematic and kinetic parameters of movement are measured in motion analysis laboratories, using optoelectronic systems based on passive markers, force platforms and electromyographic systems, which represent the gold standard. Although motion analysis is considered accurate, the availability of specific laboratories, high costs and dependence on trained users sometimes limit its use in clinical practice. A variety of wearable sensors available today has enabled researchers and clinicians to pursue applications where individuals are monitored in home and outpatient settings. Hypothesis and significance. The hypothesis is that wearables could reveal a good agreement, accuracy, and correlation between the parameters measured by means of optoelectronic system and those measured by wearables in individuals with obesity. Specific Aims. The main objective is the implementation of an integrated protocol for the clinical evaluation of subjects with obesity through the analysis of the execution of different motor tasks typical of daily life and work. Appropriately identified clinical scores and scales will also be supported by quantitative evaluations carried out with human movement analysis systems (optoelectronic systems based on markers and inertial measurement units).
The project is aimed at investigating the effectiveness of respiratory training protocols in relieving exercise dyspnea, improving respiratory efficiency and the ability to perform physical activity, even daily, in obese patients. Therefore, some respiratory exercises with different characteristics and mechanisms of action will be introduced into the standard program of integrated metabolic rehabilitation implemented at the Istituto Auxologico Italiano, Piancavallo, Italy (Division of Auxology and Division of Metabolic Diseases) in order to identify a suitable training protocol for this population, the development of which can be carried out over time by patients even autonomously (Sheel and Dominelli 2019). The definition of the protocols will be based on what has been observed by recent studies conducted on healthy people (Wuthrich et al., 2015; Schaer et al., 2018) and on patient populations in which respiratory dysfunction is a primary or secondary component of the pathology (Calcaterra et al., 2014; Pomidori et al., 2009). All planned interventions are safe and will be adapted to the obese patient.
QT interval prolongation occurs in athletes and causes concerns, as it may indicate the life-threatening long QT syndrome (LQTS). Clinical and genetic testing identify those clearly affected by LQTS but in many no disease-causing mutations are found and diagnosis remains uncertain while they are barred from competitive sports. The investigators hypothesize that several cases represent an acquired form of LQTS, akin to drug-induced LQTS, caused by exercise training acting as a trigger or "second hit" on a genetic predisposition. The investigators will use next generation sequencing to screen major and minor LQTS genes plus common and rare variants modulating the QT interval in athletes with a QTc>450ms (cases) and in those with a QTc<430ms (controls). Thus, the investigators will quantify the presence of LQTS in athletes and will also focus on those who normalize their QTc after detraining, as this points to activation of stretch-receptors. The investigators will clarify QT prolongation in athletes and contribute to correct diagnosis.