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NCT ID: NCT00526227 Completed - Tachyarrhythmias Clinical Trials

SecuraTM ICD Clinical Evaluation Study

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

The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)

NCT ID: NCT00526136 Completed - Atrial Fibrillation Clinical Trials

Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

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

To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).

NCT ID: NCT00525551 Completed - Otosclerosis Clinical Trials

Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Start date: September 2007
Phase: Phase 4
Study type: Interventional

In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage. Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.

NCT ID: NCT00525213 Completed - Clinical trials for Rheumatoid Arthritis

Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

ROBUST
Start date: October 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

NCT ID: NCT00521625 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury

PALIVE1
Start date: June 2007
Phase: N/A
Study type: Observational

PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.

NCT ID: NCT00519597 Completed - Clinical trials for Coronary Artery Disease

Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea

RICCADSA
Start date: December 2005
Phase: Phase 4
Study type: Interventional

Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA. The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.

NCT ID: NCT00519285 Completed - Prostatic Neoplasms Clinical Trials

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

VENICE
Start date: August 2007
Phase: Phase 3
Study type: Interventional

Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: - To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); - To assess the overall safety in both treatment arms; - To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; - to determine immunogenicity of IV aflibercept.

NCT ID: NCT00519103 Completed - Exercise Clinical Trials

Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients

Start date: December 2002
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of physical exercise on gene expression in muscle biopsies from patients with chronic polymyositis or dermatomyositis

NCT ID: NCT00518882 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

LEAD-6
Start date: August 2007
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

NCT ID: NCT00518427 Completed - Diabetes Type 2 Clinical Trials

Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine

QoL
Start date: October 2005
Phase: Phase 4
Study type: Interventional

Primary objective: To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine. Secondary objective: To determine: change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.