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NCT ID: NCT01470625 Completed - End-of-Life Clinical Trials

Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This is a before-after phase II study, according to the Medical Research Council framework, investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient (LCP) in 5 Ligurian hospices.

NCT ID: NCT01470612 Completed - Ulcerative Colitis Clinical Trials

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

OCTAVE
Start date: October 1, 2012
Phase: Phase 3
Study type: Interventional

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

NCT ID: NCT01470547 Completed - Liver Cirrhosis Clinical Trials

Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry

PRO-LIVER
Start date: April 2012
Phase: N/A
Study type: Observational

The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is responsible for about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient. Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can occur in approximately 10% of cirrhotic patients. Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was present in 15.7% of patients, a higher percentage was found in patients with liver cancer (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less frequently complicated by PVT. The PVT development is due to stagnation in the portal circulation, but alterations in the sense of inherited or acquired pro-coagulant may favor its appearance. The causal association of PVT with bleeding and bowel infarction suggests that the PVT may reduce survival in cirrhosis, but data are lacking on this issue. It is also not known whether asymptomatic patients with PVT have a different survival compared to cirrhotic patients without PVT. Further studies should be conducted to clarify this issue. Likewise, prospective studies are needed to better identify risk factors predisposing to PVT in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The impact of PVT on the natural history of cirrhosis is an issue today still debated. The PVT not only favour life-threatening complications (gastrointestinal bleeding and mesenteric thrombosis) but could also contribute to a deterioration of liver function by reducing portal flow. Obtaining such information would be of crucial importance considering that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the need for randomized controlled trials to clarify the potential effectiveness of anticoagulant therapy to improve the survival. To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In the second phase of the project is planned a 2-years follow-up program in order to assess whether the PVT be an additional risk factor for mortality or deterioration of the natural history in patients with cirrhosis.

NCT ID: NCT01470261 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects

ADDUCE
Start date: February 2012
Phase: N/A
Study type: Observational

The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade name ritalin) on growth, neurological system, psychiatric states and cardiovascular system over a two year period in children and adults.

NCT ID: NCT01469728 Completed - Pleural Effusion Clinical Trials

Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Start date: November 2007
Phase: Phase 2
Study type: Interventional

Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence. General anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity. The investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care. In this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.

NCT ID: NCT01468987 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus

IMAGINE 4
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. - To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. - To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

NCT ID: NCT01467427 Completed - Clinical trials for Congenital Bleeding Disorder

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

paradigmâ„¢5
Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

NCT ID: NCT01467349 Completed - HIV Infections Clinical Trials

Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

Real-Life
Start date: December 2011
Phase: N/A
Study type: Observational

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting. Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first. The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.

NCT ID: NCT01467297 Completed - COPD Exacerbation Clinical Trials

Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)

Start date: January 2012
Phase: Phase 4
Study type: Interventional

40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Primary objective of the study is to evaluate the effects of the treatment on serum inflammatory biomarkers and the secondary objective is to evaluate the clinical and microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment). The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4); Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy assessment, Day 28-30). The primary parameter to test the efficacy of the study medications will be the assessment of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10% will be taken into account. The comparison between treatments will be performed at visit 2 and 3.

NCT ID: NCT01467271 Completed - Renal Insufficiency Clinical Trials

Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

NSsaFe
Start date: May 2011
Phase:
Study type: Observational

The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®