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NCT ID: NCT00127010 Completed - Measles Clinical Trials

Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

Start date: November 2005
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

NCT ID: NCT00126698 Completed - Clinical trials for Urinary Tract Infection

Prophylactic Antibiotics on Urethral Catheter Withdrawal

Start date: January 2005
Phase: Phase 4
Study type: Interventional

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

NCT ID: NCT00126347 Completed - Healthy Clinical Trials

Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers

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

The purpose of this study is to determine whether reducing the increase in plasma homocysteine concentrations following an oral methionine load affects vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.

NCT ID: NCT00126035 Completed - Clinical trials for Migraine With Typical Aura

Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura

Start date: February 2004
Phase: N/A
Study type: Interventional

The purpose of the study was to assess the efficacy of Migraid in terms of preventing headaches in patients with migraine with typical aura. The secondary objectives were to assess whether Migraid is able to achieve pain relief and/or relief of migraine associated symptoms and to evaluate the safety and tolerability of the study treatment.

NCT ID: NCT00125879 Completed - Clinical trials for Glycogen Storage Disease Type II

Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.

NCT ID: NCT00125541 Completed - Angioedema Clinical Trials

C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema

Start date: November 2006
Phase: Phase 2/Phase 3
Study type: Interventional

A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B + C will provide data on the efficacy of C1-esteraseremmer-N. The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor® nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide more safety regarding viruses. In part C of the study, a number of HAE patients will be treated prophylactically with open-label C1-esteraseremmer-N for a period of 16 weeks. The number of attacks occurring will be compared with historical data. If possible, also some patients treated prophylactically with C1 inhibitor for acquired angioedema will be included.

NCT ID: NCT00125151 Completed - Angioedema Clinical Trials

C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema

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

A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be performed. This study (KB2003.01) consists of three parts: Part A - pharmacokinetics (phase II); Part B - treatment of attacks of angioedema (phase III); and Part C - prophylactic use of C1 inhibitor (phase III). Parts B + C will provide data on the efficacy of C1-esteraseremmer-N. The changes within the manufacturing process of C1-esteraseremmer-N, compared to Cetor® nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide more safety regarding viruses. In Part B of the study, 15 attacks of hereditary angioedema will be treated with open-label C1-esteraseremmer-N. Attack severity and duration will be monitored by the subjective experience of the patient himself (which has been shown to be the most sensitive way of monitoring attack severity) and compared with historical (and literature) data. If possible, some attacks of acquired angioedema will also be included.

NCT ID: NCT00124852 Completed - Depression Clinical Trials

The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People

Start date: October 2005
Phase: N/A
Study type: Interventional

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.

NCT ID: NCT00124774 Completed - Herniated Disc Clinical Trials

Nucleoplasty for Contained Herniated Lumbar Discs

Start date: November 2004
Phase: Phase 3
Study type: Interventional

This is a prospective randomised double blind comparison trial. Fifty patients will be included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment. Both groups will undergo a standardised post-operative care program. The study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

NCT ID: NCT00124332 Completed - Clinical trials for Coronary Atherosclerosis

STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)

Start date: January 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.