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.
This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.
The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME)
Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain
This is a phase 2, randomised, double-blind, placebo controlled study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of givinostat in patients with Becker Muscular Dystrophy. Approximately 48 eligible patients will be randomized in a 2:1 ratio to be treated with givinostat or placebo for a period of 12 months.
AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients. The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery. The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement of ROSC for an AMSA ≥ 15.5 mV-Hz All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation are randomized into two groups: AMSA-guided CPR or standard CPR. In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015 European Resuscitation Council (ERC) CPR guidelines.
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.
Principal aim The main purpose of the study is to describe the distribution of the sagittal profile in elderly subjects in order to bridge the gap present in this type of screening, evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al. in 2005). This classification assigns an integer value from 1 to 4 in relation to the evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population description is therefore divided into four categories. The extension of this classification to elderly can provide useful support for the clinical evaluation and the specific treatment of the elderly patients. Secondary aims The study aims in addition to evaluate the relation between the spine sagittal profile and the objective indexes obtained from the assessment of fall-risk and gait cycle analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This subgroup will consider the subjects older than or equal to 74 years, where the risk of falling is most likely to be expected.
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.