Clinical trials

The study aims to use 'omics' sciences, employing the most advanced technologies currently available, in order to identify pathogenic genomic variants, proteins and/or altered molecular pathways in neurodegenerative diseases and to obtain a new and more complete characterisation of subjects affected by the neurodegenerative diseases under study. Thanks to the integration of genomic, gene expression (transcriptomic and epigenomic), protein and metabolic data and clinical data, the study also aims to identify new markers for the diagnosis, prognosis, also in terms of response to therapy, and monitoring of neurodegenerative diseases. The study involves the enrolment of at least 1.200 individuals with neurodegenerative disease.

Cognitive impairment (CI) affects a large amount of patients with Multiple Sclerosis (PwMS) even in the early stages of the disease, increasing the perception of fatigue and compromising the quality of life. Different restorative interventions have been tried in order to alleviate CI, but with limited efficacy . Transcranial direct current stimulation (tDCS), represents a very promising alternative, or add-on, to the traditional rehabilitative approaches in MS. Notably, other novel technologies, such as Virtual Reality (VR) and Exergame, are emerging as a reinforcing tool to the rehabilitative treatment of PwMS. tDCS and VR can be combined in protocols aimed at achieving a better therapeutic benefit across different neurological diseases (Cassani 2020). The aim of our project is to explore the potential benefits of the simultaneous application of AtDCS and VR in the rehabilitation of cognitive impairment of PwMS. The VR approach will be implemented with a non-immersive VR system (exergames). As a secondary outcome, we wish to verify whether our protocol may extend its benefits over 6 months. Eighty PwMs with CI will be consecutively enrolled. Their cognitive status will be assessed by a neuropsychological battery: the Brief International Cognitive Assessment for MS and the Paced Auditory Serial Addition Test. To be considered cognitively impaired one has to abnormally score on at least two tests. Forty patients will be randomized to the experimental group (EG) or to the control group (CG). All the patients will undergo rehabilitative treatment with exergame (10 sessions for two consecutive weeks, 5 days per week). The EG patients will undergo a concurrent A-tDCS over the left dorsolateral prefrontal cortex, while the CG will receive a sham stimulation (S-tDCS). The patients will be evaluated at baseline, at the end of the treatment, one month and six months later. The statistical analyses will be done using repeated-measures ANOVA. Expected results: we hypothesize that the cognitive performances of both EG and CG groups will show an improvement in the cognitive performances. We will expect, however, a significative difference between the two groups, with patients in the EG group demonstrating better results than the CG group. Finally, we hypothesize the beneficial effects in EG patients will last at least one month after the end of the experiment.

This study aims to assess the effect of different hormonal contraceptives on 24-h blood pressure in cycling women aged 18-50 years of age. The main question aims to answer: \- Does oral contraceptives, estrogen formulations' based combined with drospirenone or the only drospirenone present minr effect on blod pressure and/or on the heart rate? Participants will: * Receive a contraceptive for at least 4 months * Visit the clinic between days 3 and 8 of the menstrual cycle for recording of vital signs and 40 hours-blood pressure monitoring every 30 min from 17.00 to 8.00 of the following second day * Have a gynecological examination performed at screening and at cycle 4

The goal of this clinical trial is to learn if the GeaMaster stabilometric platform can support rehabilitation and improve balance and walking ability in adults diagnosed with peripheral neuropathy. It will also evaluate whether the platform can provide objective and reliable data that match the results of standard clinical tests. The study will explore if brain and muscle activity, recorded during movement, can indicate how much motor learning and recovery has occurred. Peripheral neuropathies are disorders of the peripheral nerves and can have many causes, including diabetes, autoimmune diseases, toxins, or inherited conditions such as Charcot-Marie-Tooth disease. Symptoms may include reduced sensation, muscle weakness, poor reflexes, balance problems, and frequent falls. Since there are no approved drugs for many of these conditions, physical therapy is the main treatment option. The main questions this study aims to answer are: * Does using GeaMaster improve balance and walking better than traditional rehabilitation alone? * Are GeaMaster's stabilometric data consistent with standard balance and gait test scores? * Can movement-related evoked potentials be used as biomarkers to track and predict motor recovery? To answer these questions, researchers will compare two groups of patients. One group will receive traditional physiotherapy. The other group will receive the same therapy with the support of the GeaMaster platform. Both groups will follow the treatment for 4 weeks. A group of healthy volunteers will also be included for comparison. Participants will: * Be adults aged 18 to 80. Patients must have a diagnosis of peripheral neuropathy and a stable condition. * Be randomly assigned to a control group (traditional rehab) or experimental group (rehab with GeaMaster). * Visit the clinic for balance and walking tests at three time points: before treatment (T0), after 4 weeks of treatment (T1), and 1 month later (T2). * Complete clinical tests such as the Berg Balance Scale, 6-Minute Walk Test, 10-Meter Walk Test, Tinetti Scale, and Modified Barthel Index. * Be assessed using the GeaMaster platform for postural stability under both static and dynamic conditions. * Undergo neurophysiological tests using EEG and EMG to record brain and muscle activity during tasks like walking, writing, or drawing. Healthy volunteers will visit the clinic twice (5 days apart) to check how stable the GeaMaster measurements are over time. GeaMaster is a robotic platform that uses compressed air to gently move the support surface and challenge a patient's balance. It offers different levels of difficulty and provides real-time visual feedback. Its design avoids mechanical inertia, making movements feel more natural and safe for patients of all ages. The main outcome researchers will look for is a significant link between GeaMaster balance data and results of the Berg Balance Scale and the 10-Meter Walk Test. Other outcomes include performance on additional scales, the presence of balance improvements, risk of falling, and changes in movement-related brain signals.

The goal of this clinical trial is to learn if the food supplement based on GABA works to treat climateric symptoms. It will also learn about the safety of supplement based on GABA. The main question aims to answer: * Does food supplement based on GABA lower the climateric symptoms, such as hot flashes, sleep, disturbances, mood swings? * The supplement that will be administered is commonly available on the market and can be used without particular precautions. No important side effects are reported. Researchers will compare supplement based on GABA to a placebo (a look-alike substance that contains no active ingredients) to see if supplement based on GABA works to treat climateric symptoms. Participants will: * Take supplement based on GABA or a placebo every day for 3 months * Visit the clinic on day 7, 37 and 97 after enrolment for checkups and tests * Keep a diary of number and intensity of hot flashes * To fill scales evaluating sleep quality, anxiety, depression and quality of life

The principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use AI, comparing it with age-matched healthy controls, utilizing cognitive assessments and functional magnetic resonance imaging (fMRI). Additionally, the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms, including vasomotor symptoms, and to evaluate a possible correlation with endothelial damage studied through Angio Optical Coherent Tomography (angio OCT). Patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic. After informed consent, the will be asked for detailed demographic data, medical, oncological and gynecological history. Hypoestrogenism symptoms will be collected through validated questionnaires. The cognitive assessment will be performed on the same day, by trained staff. The fMRI and angioOCT will be booked and performed depending on patient and clinic availability.

Primary ovarian insufficiency (POI), also known as premature ovarian failure, is an ovarian defect characterized by the premature (before the age of 40 years) depletion of ovarian follicles. POI affects about 1% of women, reaching 30% in some familial cases. This heterogeneous disorder is characterized by progressive cessation of the ovarian function with temporary or intermittent amenorrhea associated with elevated serum FSH concentration and low AMH dosage. Low serum AMH dosage is able to detect a diminished ovarian pool occurring before the onset of FSH elevation and the ultimate deficiency leading to amenorrhea. POI causes infertility and a poor ovarian response in IVF stimulations, and it has important health consequences for affected patients, including psychological distress, infertility, osteoporosis, autoimmune disorders, ischaemic heart disease. Although the cause of POI remains unknown in about 80% of the cases, several mechanisms have been proposed to explain ovarian dysfunction. Currently, a wide spectrum of causes has been linked to POI, including genetic, autoimmune, infectious, or iatrogenic ones. Genetic causes are highly heterogeneous and might explain at least some of the sporadic idiopathic cases, which comprise 50-90% of cases. Ten to fifteen percent of cases are X-linked abnormalities, mainly Turner Syndrome (45,X) or X structural abnormalities such as X deletions, X inversions, isochromosomes or X-autosome translocations. Also fragile X mental retardation 1 (FMR1) gene permutation (defined as having 55 to 200 CGG repeats in the 5' untranslated region of the gene) is another frequent genetic etiology. Irrespectively, the majority of cases remains idiopathic, and identifying precise causative genes for POI has been challenging.