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 aim of this double blinded study is to assess the abilities of the SpineNav3DTM technology (Accuro) to identify the lumbar epidural space in parturients using as comparator a standar ultrasound (US) device.
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.
This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)
The use of neurorobotic devices into gait rehabilitative programs, including Ekso, is reported to increase the engagement and motivation of the patients while actively performing a task, and to shape the sensory-motor plasticity (SMP) and its balance between the primary motor areas (M1), and the fronto-parietal network (FPN) connectivity, thus contributing to successful gait rehabilitation. Aim of our study was to assess whether Ekso would foster the recovery of deteriorated FPN connectivity and SMP patterns involved in limb coordination during walking in a sample of patients with hemiparesis due to stroke. Twenty outpatients were consecutively included in this study according to the following inclusion criteria: (i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) >24; (v) a Modified Ashworth Scale (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant neurodegenerative diseases or brain surgery. Patients were randomly assigned to the experimental (Ekso gait training -EGT) of control group (conventional overground gait training -OGT- at a velocity matched to the Ekso gait training).
AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO). The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries. Additionally, utilization and treatment regimens in routine clinical practice will be described. Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.
This is a phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years) with aggressive B-Cell lymphomas
Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.
the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group. The primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group
Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.