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NCT ID: NCT00516373 Completed - Ovarian Neoplasms Clinical Trials

A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Start date: July 11, 2005
Phase: Phase 1
Study type: Interventional

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

NCT ID: NCT00516321 Completed - Clinical trials for Hepatitis C, Chronic

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease

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

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

NCT ID: NCT00516074 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

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

This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.

NCT ID: NCT00514735 Completed - Atrial Fibrillation Clinical Trials

Tailored Treatment of Permanent Atrial Fibrillation

TTOP-AF
Start date: May 2007
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

NCT ID: NCT00514683 Completed - Pulmonary Fibrosis Clinical Trials

Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

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

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

NCT ID: NCT00513877 Completed - Clinical trials for Malignant Mesothelioma

Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

Start date: May 2006
Phase: Phase 2
Study type: Interventional

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.

NCT ID: NCT00513110 Completed - Endotoxemia Clinical Trials

A Possible Therapeutic Role for Adenosine During Inflammation

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The adenosine receptor is known for its anti-inflammatory actions and could therefore be a potential target in the treatment of sepsis and septic shock. Stimulation of the adenosine receptor could potentially lead to a decrease in inflammation and tissue damage. Under normal conditions adenosine is formed either by an intracellular 5`nucleotidase, which dephosphorylates AMP, or by the hydrolysis of S-adenosylhomcysteine by hydrolase. An alternative pathway of AMP degradations is provided by the cytosolic enzyme AMP deaminase (AMPD), which catalyses the irreversible deamination of AMP to inosine monophosphate and ammonia. In humans four AMPD isoforms have been described, named after the source from which they were initially purified; M (muscle), L (liver), E1 and E2 (erythrocyte), encoded by AMPD1, AMPD2 and AMPD3. Approximately 15-20% of Caucasian and African American individuals are heterozygous or homozygous for the 34C>T variant of AMPD1. We hypothesize that healthy volunteers who have the polymorphism for AMPD1 have a less severe inflammatory response to LPS and show less (severe) organ failure. This hypothesis is based on the expected higher levels of adenosine in patients with the AMPD1 polymorphism. This hypothesis is strengthened by the fact that patients with coronary artery disease and the AMPD1 polymorphism show improved cardiovascular survival (Anderson JL et al. J Am Coll Cardiol 2000; 36: 1248-52) possibly based on higher adenosine levels by reduced AMPD activity. Furthermore the polymorphism predicts improved clinical outcome in patients with heart failure (Loh E et al. Circulation 1999) also based on a hypothetical elevation of adenosine. We hypothesize that: The C34T-polymorphism of the enzyme AMP-deaminase leads to a decreased inflammatory respons and thereby a decrease of LPS-induced tissue damage. A second hypothesis is based on the antagonism of the adenosine receptor, by caffeine; Antagonism of the adenosine receptor by caffeine leads to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissue damage?

NCT ID: NCT00513045 Completed - Nightmares Clinical Trials

A Self-Help Method for Nightmares

Nightmares
Start date: April 2007
Phase: N/A
Study type: Interventional

The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.

NCT ID: NCT00512967 Completed - COPD Clinical Trials

The Occurence of Inflammation and Oxidative Stress in Lung Diseases

Start date: September 2005
Phase: N/A
Study type: Observational

Reactive oxygen species (ROS) are suggested to play a pivotal role in ILD. Little is known, however, about the endogenous antioxidant levels in ILD that can offer protection against ROS. It is expected that the high amount of ROS present in ILD will reduce the antioxidant levels. Therefore, antioxidant therapy to strengthen this reduced antioxidant defense might be efficacious in ILD treatment. Since ROS are capable of initiating and mediating inflammation, antioxidant therapy might also mitigate elevated inflammation. A candidate for antioxidant therapy is the flavonoid quercetin that is known for its anti-oxidative and anti-inflammatory capacities. The aim of the present study is to determine the antioxidant and inflammatory status in ILD, i.e. sarcoidosis and idiopathic pulmonary fibrosis (IPF). Furthermore, to evaluate the possible anti-inflammatory effects of antioxidants, the effect of quercetin will be examined on the ex vivo LPS-induced cytokine production in ILD

NCT ID: NCT00512928 Completed - Healthy Clinical Trials

Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Start date: September 2007
Phase: N/A
Study type: Interventional

Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and matrix-gla protein. It is important to quantify the dose-response relationship of the interaction between vitamin K and oral anticoagulants and to investigate at what dosage vitamin K will interfere with oral anticoagulants in a clinically relevant way.