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 purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).
The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines. Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.
Optical coherence tomography (OCT) is a well-established and safe technique that offers the possibility of visualizing retinal structure and measuring retinal thickness. Time-domain (TD)OCT is considered the "gold standard" technique for retinal thickness measurements. Spectral-domain (SD) OCT has to face the gold standard technique prior to obtain scientific and clinical consensus. In our study in healthy subjects foveal thickness will be measured with both TD and SD OCT , and the data will be compared to evidence any difference between the two retinal measurements techniques.
Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and wide QRS at surface electrocardiogram. However, there is a growing evidence that QRS duration poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria. A number of echocardiographic criteria have been proposed to assess mechanical LV dyssynchrony, but at present there is no consensus on their use to predict response to CRT. Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to assess feasibility and predictive power of mechanical dyssynchrony assessed by echocardiography in consecutive consenting patients candidate to CRT by clinical and electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early 2009. Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The IMPROVE study has been designed to evaluate reference values of indexes of ultrasound mechanical dyssynchrony that have been proposed in the literature and compare their ability to predict response to CRT in HF patients.
The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients with hematological undergone allogenic bone marrow transplantation and CMV positive. The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the infection complications.
Scientific background. Dysregulated systemic inflammation is a key pathogenetic mechanism for morbidity and mortality in ALI/ARDS, and is associated with tissue insensitivity and/or resistance to inappropriately elevated endogenous glucocorticoids. In one study, prolonged methylprednisolone treatment of ARDS patients resulted in rapid and sustained reduction in circulating and pulmonary levels of pro-inflammatory cytokines, chemokines, and procollagen. Preliminary work. Five randomized trials (N = 518) investigating prolonged glucocorticoid treatment in acute lung injury/ARDS reported a significant physiological improvement and a sizable reduction in duration of mechanical ventilation and ICU length of stay. Insufficient data is available on the effects of low dose prolonged methylprednisolone treatment initiated in early ALI/ARDS on mortality. Hypothesis. We hypothesized that the anti-inflammatory activity associated with prolonged methylprednisolone administration improves pulmonary and extra-pulmonary organ dysfunction in early ALI/ARDS and reduces mortality. Objective. To investigate the effects of prolonged low-dose methylprednisolone infusion on mortality and morbidity in early ALI/ARDS. Study design. Multicenter, prospective randomized, placebo-controlled, double-blind clinical trial. Entry criteria. Patients with ALI/ARDS of less than 72 hours duration. Stratification. Patients are prospectively stratified prior to randomization as (1) intubated versus NPPV treated, and (2) ARDS versus severe ARDS. The purpose of stratification is to distribute equally in both arms intubated versus NPPV treated, and ARDS versus severe ARDS. End-points. The primary end-point of trial is 28 days all cause mortality; the secondary end-points are (a) ventilator-free days at 28 days following study entry, (b) organ failure-free days at 28 days following study entry, and (c) duration of ICU stay.
The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.