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 primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.
Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine and arginine being the main reactive amino acids on proteins. Following this first step, a molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of Maillard products.
The consumption of wholemeal cereals has been associated with the reduction of several chronic diseases. The mechanisms behind these protective effects may be linked, besides dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly, hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the highest concentration of ferulic acid, principally contained as monomeric form and diferulic acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary excretion of phenolic metabolites in humans fed with two different kind of a commercial bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the pharmacokinetics of the main phenolic compounds was also evaluated by measuring the circulating metabolites in plasma samples.
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible. After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle. In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy. Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy. Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants. Allergies to silicone, infections due to silicone and implants breakage used to be common with previous generations of silicone implants. Publications relative to those implants showed that the survival rates after 5 years of follow-up were unsatisfactory. Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™. The use of this new material in its manufacturing process together with its innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant. The main objective of this study is to evaluate the clinical outcomes of the implantation of Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in terms of functional metrics from documented clinical data. Other objectives are to evaluate the outcomes in terms of radiological evaluation and of safety during all the follow-up.
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation. Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation. Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.
The experience of the chronic illness negatively engraves on the quality of life of patients. Endometriosis is a disease that affects millions of women of childbearing age; it has repercussions on psychological health, as shown by numerous recent studies. The aim of the present study is to validate the italian version of EPH 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.
To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive factors that can be responsible for poor outcome.