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.
Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last for the whole antibiotic course (usually of two weeks) and the patient has to be punctured again for the insertion of a new IV line. With the passing of time the veins are more difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a central venous catheter. This intervention may have contraindications or, specially in adolescents, cause unacceptable alterations of the body image. The aim of this study is to find a way to prolong the duration of the SPVC used by CF patients during antibiotic courses avoiding the irritation of the vein or a phlebitis. Design of the study: randomized controlled trial. The study will see a collaboration of nurses, physicians and technicians of the Tuscan CF Centre. The patients that will participate at the study will be randomly assigned to one of the two groups: one group will receive the antibiotics prescribed according to the maximal dilution suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e. a higher volume of Normal Saline), but the time of administration will be the same. The assessment will regard: the level of inflammation of the vein (with a special visual scale) and the duration of the SPVC. The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of a phlebitis. In case that the hypothesis will be confirmed by this study an easy, secure, low cost and immediately available system will be available to reduce the number of venipunctures necessary to complete a course of IV antibiotics.
The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.
Primary : To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities. Main Secondary : To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.
Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities. Main Secondary objectives: To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective portal pressure reduction (essential in the treatment of those pathologies in which TIPS is indicated) still do not exist. Aim of the study The purpose of our study is to compare the clinical efficacy and the incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with hepatic cirrhosis.
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A. The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period. The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.
The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy
This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.
The aim of the present study was to evaluate whether an in vivo treatment with an antioxidant vitamin (vitamin C) might substantially affect serum levels of resistin, a recently described adipokine, whose clinical significance is still controversial in humans.