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 aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.
This study aims to determine the oncological effectiveness, compared to standard surgical treatment, of proactive management including target organs for peritoneal spread resection (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v. 5-fluorouracil/leucovorin) following a curative resection of high-risk ( >/= 5 mm tumor invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens. Hypothesis: The hypothesis is that compared to the standard treatment proactive management following curative resection of high-risk T3 and T4 colon cancer will reduce the development of endoperitoneal metastases
In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life. Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training. The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.
The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy. Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced EGFR mutant NSCLC taking SoC as compared to SoC alone.
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
Multiple Sclerosis (MS), the most common non-traumatic cause of neurologic disability in young adults, affects mobility and ambulation in the majority of patients. Nearly 50% of persons with MS will require an assistive device to ambulate within 10 years of diagnosis. A subgroup of MS is Primary Progressive MS, which manifests with gait disturbances over 80% of patients in the long term. In addition to altered gait, nearly 70% of patients will experience cognitive deficits during the course of the disease. Therefore, actions that facilitate patient involvement in finding solutions for personalized management of disease and disability are needed. Although immunomodulatory drugs offer some benefit in other types of Multiple Sclerosis, there is currently no effective treatment for Primary Progressive MS. A fundamental goal in the management of persons with MS is to maximize their ability to ambulate and perform safe and effective transfers in everyday life. In the last decade, research has increasingly centered on the effects of robot devices in the rehabilitation of patients with neurological diseases. This has led to the development of new robot-assisted gait devices engendered by virtual-reality systems, and several studies have demonstrated the positive effects that these devices have on gait endurance and quality of life in patients with neurological diseases and disability. The aim of this project is to develop and study the effects of a novel, cognitively intensive virtual-reality -based rehabilitation software application that simulates a real-world environment where a person can walk. The virtual-reality application is an upgrade version synchronized to a robotic device, the GEO System. The second aim is to compare the cognitive and motor effects of robot-assisted gait training with this application against training with robot-assisted gait training without virtual reality. The experimental group will receive robot-assisted gait training with the virtual-reality application and the control group will receive robot-assisted gait training All subjects will undergo training for 6 weeks (2 sessions/week) for a total of 12 sessions. Assessments before training, after training, and at follow-up will be performed using clinical and instrumental tests to compare the effects of training. Successful completion of the study may help patients to alleviate the impact of disability, increase their independence in activities of daily life, and improve their quality of life. Through new rehabilitative strategies that combine cognitive and motor training involving higher brain functions and motivation, patients will be stimulated to walk in a reality-based environment.
The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot of acquired risk factors are involved in the development and progression of the disease. Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of developing complications increases with the duration of hyperglycemia, and usually become apparent in the second decade of hyperglycemia. Vascular complications are further subdivided into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about 2.1-2.7 ml/min. While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA in these patients is at physician discretion. ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2 and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin, serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to its short half-life and artifacts associated with platelet activation ex vivo. COX are present in the kidney in the macula densa, in the medulla and in the interstitium. Experimental animals models have demonstrated that COX are involved in regulation of renal blood flow. In particular, in a murine animal model, after the administration of COX inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the relationship between aspirin and renal function in humans are scarce. In a recent work lead on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up. Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of aspirin and with the decrease of eGFR at follow-up. The aim of the study is to evaluate the decline in renal function in diabetic patients treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.
This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.