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NCT ID: NCT00686075 Completed - Healthy Clinical Trials

A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

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

Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.

NCT ID: NCT00682136 Completed - Pain Clinical Trials

Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery

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

The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations. TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial. This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.

NCT ID: NCT00681941 Completed - Clinical trials for Chronic Kidney Disease

An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Start date: January 2006
Phase: Phase 3
Study type: Interventional

Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

NCT ID: NCT00681226 Completed - Clinical trials for Peripheral Arterial Disease

Angiotensin Converting Enzyme (ACE) Inhibition and Peripheral Arterial Disease

Start date: January 2008
Phase: Phase 4
Study type: Interventional

Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our preliminary findings indicate that the drug ramipril is much more effective in improving walking ability than current therapies. To be accepted as a new treatment for PAD these findings require validation in a much larger clinical trial.We propose to examine the effects of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If positive, this study will identify ramipril as a potential new therapy for PAD.

NCT ID: NCT00681122 Completed - Breast Cancer Clinical Trials

CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)

CARIATIDE
Start date: May 2008
Phase: N/A
Study type: Observational

This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

NCT ID: NCT00680992 Completed - Cancer Clinical Trials

Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Start date: September 9, 2008
Phase: Phase 2
Study type: Interventional

To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

NCT ID: NCT00680446 Completed - Clinical trials for Primary Immune Deficiency

Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

Start date: April 2008
Phase: Phase 3
Study type: Interventional

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

NCT ID: NCT00680433 Completed - Clinical trials for Major Depressive Episode

Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

Start date: April 2008
Phase: Phase 4
Study type: Interventional

Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties. In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.

NCT ID: NCT00680186 Completed - Thromboembolism Clinical Trials

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

RE-COVER II
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

NCT ID: NCT00679588 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

SAVE-ABDO
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.