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NCT ID: NCT01133860 Completed - Clinical trials for Blood Platelet Disorders

Efficacy of Eltrombopag to Improve Thrombocytopenia of MYH9-related Disease

Start date: January 2009
Phase: Phase 2
Study type: Interventional

The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly, Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from mutation of a unique gene, named MYH9, and they have been recognized as different clinical presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD present since birth with thrombocytopenia, which can result in a variable degree of bleeding diathesis; some of them subsequently develop additional clinical manifestations, such as renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral thrombopoietin receptor agonist that stimulates proliferation and differentiation of megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective in increasing platelet count in healthy volunteers, as well as in patients affected by some acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing platelet count of patients affected by MYH9RD. Further aims of this study are to test if eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate safety and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro function of platelets produced during therapy in patients responding to this drug.

NCT ID: NCT01132742 Completed - Malnutrition Clinical Trials

Malnutrition and Outcome in Hospitalized Children in Europe

Start date: February 2010
Phase: N/A
Study type: Observational

Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed. One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.

NCT ID: NCT01132495 Completed - Clinical trials for Coronary Artery Disease

FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

Start date: May 2010
Phase: N/A
Study type: Interventional

The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

NCT ID: NCT01132274 Completed - Clinical trials for Supraventricular Tachycardias

Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

NO-PARTY
Start date: December 2009
Phase: Phase 4
Study type: Interventional

Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus exposing patients to ionizing radiations with an additional risk of cancer. The feasibility and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter, randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically significant reduction of the exposure to ionizing radiations compared with conventional ablation techniques. NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction of ionizing radiation exposure for both the patient and the operator.

NCT ID: NCT01131754 Completed - Occlusion Clinical Trials

Heparin 100U/L for Prevention of PVC Complications

Start date: June 2007
Phase: Phase 3
Study type: Interventional

Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.

NCT ID: NCT01131676 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

NCT ID: NCT01131078 Completed - Colorectal Cancer Clinical Trials

A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Start date: June 2005
Phase: Phase 2
Study type: Interventional

A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.

NCT ID: NCT01131065 Completed - Hepatitis B Clinical Trials

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six and twelve months post-transplantation.

NCT ID: NCT01130493 Completed - Parkinson's Disease Clinical Trials

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

NCT ID: NCT01128335 Completed - Clinical trials for Liver Transplantation

Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

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

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.