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.
Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.
This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF)-related gastrointestinal (GI) Adverse Events (AEs) in subjects with Multiple Sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of dimethyl fumarate treatment in this study population.
Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias for which international guidelines suggest the implantation of an implantable cardiac defibrillator (ICD). The educational nursing program would improve clinical outcomes in patients with HF and ICD like control their sickness, known and acknowledge symptoms, improve their skills to self-care. The main aim of this study is to assess how much the nursing-therapeutics skills and an educational intervention, in patients with HF during the follow-up period after the implantation of ICD reduces clinical costs, re-hospitalizations, and mortality at 180 days. Methods: The investigators start a multicenter randomized clinical trial. The sample is made of 128 subjects (64 patients treatment group and 64 control group). The investigators measured the self-care level administering to HF patients the "Self-Care of Heart Failure Index (SCHFI) v. 6.2", and the self-perception of own life quality using a Numeric Rating Scale from 0 to 100. Secondary outcomes recorded are i) the numbers of accesses to the ED (Emergency Department) and/or hospitalizations during the follow-up period, ii) mortality rate due to HF, and iii) infection rate of the device pocket. Data Analysis: Categorical variables will be presented in terms of frequencies and percentages. The statistical power was fixed at the 80%. Data will be considered significant for a p-value ≤ 0.05. The Cox proportional hazards model will be used to analyze mortality in subjects involved in the educational program.
The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.