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NCT ID: NCT03314883 Recruiting - Clinical trials for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Diaphragmatic Ultrasound in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

DiaDea
Start date: October 9, 2017
Phase: N/A
Study type: Interventional

Mortality of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) patients underwent invasive mechanical ventilation is demonstrated to be higher than in patients who underwent only non invasive mechanical ventilation (NIV). There is an increased need to detect more predictive factors for NIV failure, in order to better identify patients most at risk of facing negative outcomes. The aim of this experimental pilot study is to evaluate the feasibility of the ultrasound of diaphragm in AECOPD patients underwent non invasive mechanical ventilation ( primary endpoint ). Furthermore the secondary aim is to observe any relationship between diaphragmatic function (excursion), diaphragmatic thickening and the timing of arterial blood gases (ABGs) compensation in patients with AECOPD undergoing NIV treatment; additional outcomes are: correlation with dyspnea level, time of mechanical ventilation, NIV failure, rate of tracheostomy, length of stay in ICU and in-hospital and 90-day mortality.

NCT ID: NCT03314766 Not yet recruiting - Cataract Clinical Trials

Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

Start date: October 20, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

NCT ID: NCT03314740 Recruiting - Ovarian Neoplasms Clinical Trials

BAROCCO Study - Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib (BAROCCO)

BAROCCO
Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer. Patients will be randomised in a 1:1:1 ratio to three treatment arms: - Arm A: Paclitaxel 80 mg/mq every week - Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day - Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks

NCT ID: NCT03313752 Recruiting - Clinical trials for Type2 Diabetes Mellitus

Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity

DapaHeart
Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase. Subjects: Type 2 diabetic patients with coronary artery disease (CAD) not requiring revascularization, with sub-optimal glycemic control (HbA1c 7.5-8.5%) on their current anti-hyperglycemic regimen Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo. Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1. Primary Objective The primary objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity Secondary Objective The secondary objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control. The study aims to enroll patients with type 2 diabetes with poor glycemic control, and with coronary artery disease not requiring revascularization, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).

NCT ID: NCT03313713 Enrolling by invitation - Atherosclerosis Clinical Trials

Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)

BELT
Start date: April 26, 2017
Phase: N/A
Study type: Interventional

This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function

NCT ID: NCT03313154 Recruiting - Chronic Hepatitis c Clinical Trials

Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related

Start date: November 2015
Phase: N/A
Study type: Observational

Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy. Patients with chronic hepatitis C present a prevalence of depressive disorders higher than that of the general population; moreover, it has been repeatedly demonstrated the presence of cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new therapeutic protocols have been introduced, and while some antiviral drugs, including the first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second and third generation antiviral drugs protocols are interferon-free. However, because of the high cost, the access to interferon-free protocols is only for patients with advanced fibrous stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients. Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety, irritability, insomnia) are common during antiviral therapy with IFN. However, in patients with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic disorder, and brief recurrent depression have been observed, irrespective of IFN treatment and the use of alcohol and narcotics; such associations between mood and anxiety disorders and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The presence of severe psychopathological symptoms requires the reduction of posology and causes high rates of discontinuation of antiviral therapy. This project represents an innovative psychiatric and neuropsychological screening program for patients with chronic hepatitis C, eligible for antiviral therapy. 1. Primary objectives: 1. to verify the medium-term impact of new antiviral therapies on quality of life, psychological well-being and cognitive function in subjects with chronic hepatitis C; 2. to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies. 2. Main secondary objectives: 1. to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C; 2. to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

NCT ID: NCT03312179 Completed - Clinical trials for Coronary Artery Disease

STEMI and Incretins Treatment

Start date: January 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.

NCT ID: NCT03312036 Recruiting - Clinical trials for Liver Failure, Acute

HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification

HERCOLE
Start date: June 6, 2013
Phase: N/A
Study type: Interventional

CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.

NCT ID: NCT03311854 Recruiting - Clinical trials for Macrophage Activation Syndrome

A Study to Investigate the Safety and Efficacy of an Anti-IFN-gamma mAb in Children With Systemic Juvenile Idiopathic Arthritis (sJIA) Developing Macrophage Activation Syndrome/ Secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)

Start date: October 2017
Phase: Phase 2
Study type: Interventional

Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA). NI-0501 (Emapalumab) is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of NI-0501 in sJIA patients developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.

NCT ID: NCT03309709 Recruiting - Endometrial Polyp Clinical Trials

Endometrial Polyps Regression With Progesterone Therapy

Start date: October 8, 2017
Phase: Phase 3
Study type: Interventional

This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle