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 phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP). The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.
This is a prospective, single-arm, multi-center, international, open-label, clinical study.
Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance. Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.
Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure. The aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block. A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.
This Study Evaluate the efficacy of the subministration of fermented rice flour (7 g/day) on the clinical course of patients with moderate or severe Atopic Dermatitis, in terms of a reduction in the SCORAD score, during the study period and four weeks after the suspension of the treatment.
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: - To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein [Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol [TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides [TG]) in participants with HoFH - To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH - To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH - To assess the potential development of anti-drug (alirocumab) antibodies
Anti-viral, hepatitis C virus (HCV)-specific immune T cell responses are functionally defective in patients with chronic hepatitis C and this functional impairment is believed to contribute to virus persistence. Persistent exposure to high virus loads is likely involved in the pathogenesis of T cell dysfunction. The underlying hypothesis of the project is that the level of anti-viral immune dysfunction in chronic HCV infection is a causal factor which can influence non-response to therapy. Although the rate of response to direct anti-viral agent (DAA) therapy, in untreated, non-cirrhotic, patients is between 95% and 100%, however, the response rate is lower in specific subgroups of patients, including genotype 3 cirrhotics and patients with decompensated cirrhosis, irrespective of the infecting genotype. Aim of the present study will be thus to understand whether non-response to therapy is associated with a wider and deeper anti-viral immune dysfunction, by comparing individual HCV-specific T cell responses in two groups of responder and non-responder patients. Characterization of protective immunity in non-responder patients could allow to identify baseline predictors of non-response to therapy to be used in the daily clinical practice. Objective of the study will be to compare the features (intensity and quality) of the overall HCV-specific immune T cell response in patients non-responder and responder to DAA therapy. To achieve this goal, T lymphocytes (either CD4 or CD8) isolated from the peripheral blood of the patients, before starting DAA therapy, will be stimulated with HCV proteins to evaluate the capacity of those cells to expand, produce cytokines and express cytotoxic capacity.