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NCT ID: NCT01254409 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

PRM151F-12GL
Start date: March 29, 2011
Phase: Phase 1
Study type: Interventional

The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.

NCT ID: NCT01254123 Recruiting - Clinical trials for Patients With a First Acute Myocardial Infarction to be Treated With Primary Percutaneous Coronary Intervention (PCI).

Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)

EXAMI
Start date: November 2009
Phase: Phase 3
Study type: Interventional

Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular function, morbidity and mortality. The most effective therapy is early reperfusion of the ischemic myocardium by percutaneous coronary intervention (PCI). Reperfusion limits myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium overload: a process referred to as reperfusion injury leading to necrosis and apotosis. Glucagon Like Peptide-1 (GLP-1) is an incretin hormone that has shown to activate anti-apoptotic enzymes, reducing reperfusion injury. GLP-1 agonists have been demonstrated to be cardioprotective in several animal studies and in a single small non-randomized clinical study. In this pilot study we will assess the safety and efficacy of GLP-1 receptor agonist Exenatide infusion compared to placebo in patients with an acute myocardial infarction undergoing primary PCI. A total of 40 patients will be included in this single centre prospective randomised placebo controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours. Blood samples are obtained for assessment of enzymatic infarct size and Exenatide levels. Side effects of Exenatide are stringently monitored. Cardiac function will be measured using Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months post MI. Infarct size will be assessed by means of the final infarct size at 4 months post MI as a percentage of the area at risk at 1 week post MI. Furthermore we will compare the RNA profile of both groups.

NCT ID: NCT01254019 Completed - Clinical trials for Muscular Dystrophies

A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

DMD114044
Start date: December 2, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.

NCT ID: NCT01253993 Completed - Clinical trials for Substance-Related Disorders

Impaired Decision-making in Adolescents

Start date: April 2006
Phase: Phase 0
Study type: Observational

There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. It is likely that a biopsychological vulnerability in some aggressive children and children with DBD makes them liable to substance use and abuse. The investigators hypothesize that deficient decision making is such a biopsychological factor. In this study the investigators aim to test the latter hypothesis by investigating the decision making ability in a group of adolescents with DBD with and without substance use disorders. Decision-making is assessed with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty, reward and punishment. The GT is specifically designed to assess impaired decision-making in individuals who are unable to learn from their mistakes and make decisions that repeatedly lead to negative consequences. This characteristic may be common to individuals with externalizing disorders such as DBD, psychopathy, and substance use disorders.

NCT ID: NCT01253213 Completed - Prostate Cancer Clinical Trials

BR55 in Prostate Cancer: an Exploratory Clinical Trial

Start date: July 2010
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging. This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

NCT ID: NCT01253187 Completed - Contraception Clinical Trials

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)

Start date: October 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception

NCT ID: NCT01252589 Completed - Clinical trials for Chronic Myeloid Leukemia

Patient Reported Outcomes in Chronic Myeloid Leukemia

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

Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison. The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose. The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

NCT ID: NCT01252355 Terminated - Clinical trials for Multiple Sclerosis Relapse

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

TERACLES
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: - Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: - Disease activity as measured by brain Magnetic Resonance Imaging (MRI) - Disability progression - Burden of disease and disease progression as measured by brain MRI - Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy - Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy - Assess associations between variations in genes and clinical outcomes (safety and efficacy) - Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life - Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

NCT ID: NCT01252160 Completed - Clinical trials for Neuralgia, Postherpetic

Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage

STRIDE
Start date: October 28, 2010
Phase: Phase 4
Study type: Interventional

In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.

NCT ID: NCT01251588 Completed - Clinical trials for Articular Cartilage Defects

Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee

Extension
Start date: December 2010
Phase:
Study type: Observational

To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.