Clinical Research Directory

Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly

The ageing population makes it necessary to find effective strategies for the prevention of sarcopenia (the progressive loss of muscle mass and strength and a decline in physical performance) that can be counteracted with foods containing protein and adequate intake of vitamin D. This study will evaluate the effectiveness of consuming a food based on plant proteins and vitamin D supplementation. Intervention studies in humans conducted to date have mostly focused on the effect of animal proteins (mainly from whey) on disease progression. A study on the effect of pea proteins has not yet been conducted and will provide information on the effectiveness of these proteins in modulating markers linked to the disease. The effect on the gut microbiota will also be considered, as the existence of a gut-muscle axis has been suggested, in which microbial genera producing short-chain fatty acids have been linked to a positive effect on muscle mass through anabolic stimulation. Thus, the analysis of the modulation of the intestinal microbiota, through the dietary intervention proposed in this study, may represent a further step in research related to the prevention of this disease. Sarcopenic volunteers aged between 65 and 80 will be recruited to consume either a shortbread biscuit made with wheat flour enriched with hydrolysed pea protein and a vitamin D supplement in extra virgin olive oil, or a control biscuit and a placebo (extra virgin olive oil) for 12 weeks. The study will be randomised, parallel, single-blind. The effect of consuming the experimental biscuit and vitamin D supplementation compared to that of a traditional control biscuit and a placebo oil solution will be evaluated on certain markers related to sarcopenia. In particular, the following will be considered: muscle strength, measuring grip strength and leg strength (chair stand test); muscle mass through the measurement of appendicular muscle mass, and the calculation of the appendicular muscle mass index; physical performance using the Short Physical Performance Battery; the inflammatory response and other blood biomarkers related to sarcopenia. In addition, the following will be assessed: dietary habits through a food diary and quality of life through the SarQoL questionnaire. Finally, the effect of nutritional intervention on the modulation of the gut microbiota will be evaluated through 16S rRNA sequencing and bioinformatic analysis of the data.

Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

The aim of the current study is to evaluate the effects of resveratrol on the clinical outcome(s) of patients with moderate rheumatoid arthritis. Objectives : 1. To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring: * Serum Sirtuin 1(SIRT1) * Serum Myeloperoxidase (MPO) * Serum C-reactive protein (CRP) 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score). 3. To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI). 4. To assess any adverse effects related to Resveratrol. Patients: Eligible patients (no=118) will be randomly assigned in a 1:1 ratio to one of two groups: 1. Control group: 59 patients will receive the standard treatment for management of RA for 3 months. 2. Resveratrol group: 59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily, (Organix Egypt) (given as one 1000 mg tablets once daily) for 3 months.

Survey of Psychological Well-being of Health Care Workers in the Hospital Setting

The psychological well-being of healthcare workers in hospital settings is a topic of growing interest in the scientific literature, given the crucial importance of their role in ensuring high-quality care. In addition, the Covid-19 pandemic health emergency has further accentuated the relevance of this issue, increasing anxiety and stress levels, testing the resilience and resistance of those working in care settings, revealing and highlighting how the accumulation of work-related stress can result in disabling pathologies for the caregiver, with an inevitable impact on the facility and care in general. Recent studies show that health care workers are particularly vulnerable to work-related stress, which can result from various factors such as high work demands, emotional pressure, irregular shifts, and interactions with critically ill patients. Burnout syndrome, characterized by emotional exhaustion, depersonalization and reduced personal accomplishment, is widely documented among hospital staff. Research indicates that burnout not only compromises the psychological health of healthcare workers, but also negatively affects the quality of care provided by increasing the risk of medical errors. In light of these factors, it is crucial to deepen our understanding of the dynamics that influence psychological well-being and work-related stress in health care workers in order to develop effective interventions that can improve their quality of life and consequently the quality of care provided to patients. Preliminary assessment of the emotional burden and motivational aspects of health care workers (showing what very often eludes a first glance, making visible something that is often invisible), along with effective stress management, would allow for greater ability to remain calm under pressure, reduced frustration, increased ability to make informed decisions, and to communicate effectively with patients and colleagues. These aspects translate into an image of a safer and more caring health care system in promoting better quality of care. The aim of this project is to highlight the importance of psychological wellbeing for those working in health care settings and to promote attention to this area, also with a view to identifying possible interventions aimed at identifying preventive and protective factors in relation to health care workers. The aim, therefore, is to show what is very often invisible at first sight, to make visible what is invisible: to explore, accommodate and contain areas of criticality and fragility in the context of work in health care settings, working on interventions aimed at the psychological well-being of workers.

Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma

Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.

Physical Activity and Disability Prevention in Postmenopausal Women

The aim of this clinical study is to examine the impact of physical activity on the physical and mental health of postmenopausal women, with a particular focus on the development of disability. The main questions this study aims to answer are: 1. Can physical activity programs (Nordic walking, Bungy Pump, strength training, functional general conditioning training) prevent loss of mobility, bone density and urinary incontinence, reduce the risk of falls, lower metabolic syndrome parameters, and improve cardiovascular endurance in postmenopausal women? 2. Do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women? Researchers will compare the test groups (Nordic Walking, Bungy Pump, strength training, functional general conditioning training) with the control group to determine whether physical activity brings benefits in terms of physical and mental health compared to no intervention. Participants will: Take part in a three-month physical activity program that includes Nordic walking, Bungy Pump exercises, functional general conditioning training and strength training, depending on the group. The control group will not participate in any additional physical exercise program and will continue with their usual daily activities.