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NCT ID: NCT03318380 Completed - Liver Cirrhosis Clinical Trials

Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis

Start date: January 19, 2018
Phase: N/A
Study type: Interventional

This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

NCT ID: NCT03317847 Completed - Inflammation Eye Clinical Trials

Bromfenac Versus Dexamethasone After Cataract Surgery

BVD
Start date: October 16, 2017
Phase: Phase 4
Study type: Interventional

The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).

NCT ID: NCT03317171 Completed - Clinical trials for Muscular Dystrophies

Safety and Efficacy of a Flavonoids- and omega3s-based Compound for the Treatment of Muscular Dystrophies

PRO1
Start date: February 28, 2016
Phase: N/A
Study type: Interventional

The study aimed to assess the safety and, partially, the efficacy of dietary supplementation of a flavonoids-, DHA- and EPA-based natural supplement in non-ambulant DMD boys and in a cohort of LGMD and FSHD patients to compare its effect in MDs of different aetiology and to eventually highlight any differences in inflammatory involved pathways. To assess safety, patient's laboratory parameters were monitored and adverse events recorded, while efficacy was evaluated through performance scale questionnaire and strength measurement (6 minute walking test and Biodex System 4 Dynamometer parameter evaluation). This study was conceived as proof of principle for the safe use of flavonoids/omega3s-based compound as an adjuvant in the management of neuromuscular disorders; besides, its efficacy in alleviating symptoms linked to secondary effects of genetic mutation as inflammation, muscular pain and weakness was assessed.

NCT ID: NCT03316885 Completed - Cataract Clinical Trials

Post-Market Clinical Investigation of the Clareon® IOL

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

NCT ID: NCT03314883 Completed - Clinical trials for Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)

Diaphragmatic Ultrasound in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)

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

Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) 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 ARF 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 ARF 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 Completed - Cataract Clinical Trials

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

Start date: October 20, 2017
Phase:
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: NCT03313180 Completed - Clinical trials for Lung Diseases, Interstitial

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

NCT ID: NCT03313154 Completed - Clinical trials for Cognitive Impairment

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

Start date: November 2015
Phase:
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: NCT03312751 Completed - Clinical trials for Primary Hemophagocytic Lymphohistiocytosis

Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis

Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term outcomes and quality of life assessments. Emapalumab can be administered as the first-line therapy to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the available standard of care. Emapalumab is to be administered until the start of conditioning for hematopoietic stem cell transplantation (HSCT), with an anticipated duration ranging from a minimum of 4 weeks to approximately 12 weeks and not exceeding 6 months. After treatment completion, patients will continue in the study for long-term follow-up until 1 year after either HSCT or last emapalumab infusion (if HSCT is not performed).

NCT ID: NCT03312634 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.

MOVE
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.