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NCT ID: NCT00158600 Completed - Clinical trials for Pompe Disease (Late-onset)

A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease

Start date: September 2005
Phase: 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 is to evaluate the safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe disease as compared to placebo.

NCT ID: NCT00157768 Completed - Clinical trials for Acute Myocardial Infarction

IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction

Start date: June 9, 1999
Phase: Phase 4
Study type: Interventional

Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.

NCT ID: NCT00157599 Completed - Clinical trials for Deep Vein Thrombosis

MDA D-Dimer / Recurrent DVT Study

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

To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.

NCT ID: NCT00157300 Completed - Clinical trials for Patients Receiving a Kidney From a Non-Heart-Beating Donor

PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

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

Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation. The investigators postulate that erythropoietin reduces the risk of delayed graft function.

NCT ID: NCT00156988 Completed - Burns Clinical Trials

The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns

Start date: March 2004
Phase: Phase 4
Study type: Interventional

The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

NCT ID: NCT00156897 Completed - Obesity Clinical Trials

Efficacy and Safety of ATL-962 in Obese Diabetics

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

NCT ID: NCT00156728 Completed - Clinical trials for Congestive Heart Failure, Atrial Fibrillation

Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

Start date: October 2003
Phase: Phase 4
Study type: Interventional

The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.

NCT ID: NCT00156221 Completed - Autism Clinical Trials

MR Scanning of Very Young Children With Severe Developmental Disorders

Start date: September 2000
Phase: N/A
Study type: Observational

The specific is to study the MR morphologic and spectroscopic brain correlates and predictors of development in children with severe developmental disorders (autistic spectrum disorders and/or mental retardation and/or language disorders). Given the frequently observed association of autism with known medical conditions, particularly in cases with comorbid mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995), children with suspected autism or related developmental disorders will be asked to participate in an extensive state of the art laboratory work-up which includes T1 and T2 weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal abnormalities and degree of myelination, and quantitatively, measuring volumes of total brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data set provides the opportunity to chart brain-behavior relationships in young children with suspected autism and related PDD cross-sectionally.

NCT ID: NCT00154401 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Start date: January 2005
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

NCT ID: NCT00154102 Completed - Clinical trials for Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer

Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

CRYSTAL
Start date: May 2004
Phase: Phase 3
Study type: Interventional

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor. Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data. After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator. The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.