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NCT ID: NCT00818753 Completed - Clinical trials for Heart Catheterization

Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

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

To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).

NCT ID: NCT00818064 Completed - Healthy Clinical Trials

Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

Start date: December 2008
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).

NCT ID: NCT00817843 Completed - Metabolic Syndrome Clinical Trials

The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study

PANACEA
Start date: April 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.

NCT ID: NCT00817765 Completed - HIV Infection Clinical Trials

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

EPOS
Start date: January 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.

NCT ID: NCT00817544 Completed - Clinical trials for Healthy Male Volunteers

Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741

ALMAS
Start date: January 2009
Phase: Phase 1
Study type: Interventional

The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream, distribution to bloodstream, metabolism in the liver and excretion of the parent drug and metabolites to faeces, urine and expired air

NCT ID: NCT00817518 Completed - Neoplasms Clinical Trials

A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors

Start date: January 2009
Phase: Phase 1
Study type: Interventional

This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

NCT ID: NCT00817128 Completed - Clinical trials for Complex Regional Pain Syndrome, Type I

Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1)

PEPTOC
Start date: January 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.

NCT ID: NCT00815282 Completed - Clinical trials for Systemic Lupus Erythematosus

Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

HPV-kind
Start date: February 2009
Phase: Phase 4
Study type: Interventional

In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to the National Vaccination Program for girls to protect against the development of cervical cancer. The vaccine protects against HPV type 16 & 18, which cause about 75% of cervical cancer. Studies have shown that the vaccine is effective in healthy subjects in preventing infection by HPV 16 & 18. However, no evidence exists on the immunogenicity and safety of HPV vaccination in patients with an immune system disorder, such as primary humoral immunodeficiency (i.e. hypogammaglobulinemia) or autoimmune diseases. Concerns exist that vaccination may cause an aggravation of the underlying disease. In addition, the immune response to vaccination may be diminished due to immunosuppressive therapy or the underlying disease. Objective: The primary goal of the current study is to study the immunogenicity of HPV vaccination in patients with an autoimmune disease and a primary humoral immunodeficiency. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune diseases who are under immunosuppressive medication and patients with a immune system disorder have a decreased serological response to HPV vaccination, and that the produced HPV antibodies titers decrease more rapidly than in healthy individuals. The secondary objective is to explore safety of HPV vaccination and immune regulatory mechanisms induced by vaccination in a subset of patients. The investigators hypothesize that HPV vaccination is safe and that HPV-induced regulatory T cells are able to prevent an increase in the activity of an autoimmune disease.

NCT ID: NCT00813306 Completed - Reflux Episodes Clinical Trials

14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations

Start date: December 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.

NCT ID: NCT00812084 Completed - Pneumonia Clinical Trials

Costs, Health Status and Outcomes of CAP (Community-Acquired Pneumonia)

CHO-CAP
Start date: November 2008
Phase: N/A
Study type: Observational

The purpose of this study is to collect additional data on hospitalized Community-Acquired Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the differences in the quality of life and resources of elderly persons with and without CAP.