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.
Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX). To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX). To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).
The purpose of this study is to verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong the progression free survival of patients affected by neuroendocrine tumors (NET) with inoperable liver metastases
To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.
The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care. The study is divided into two steps. This is step 2. At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care. The study is divided into two steps. This is step 1. Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).