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NCT ID: NCT00299325 Completed - Metabolic Syndrome Clinical Trials

VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

VICTORIA
Start date: March 2006
Phase: Phase 3
Study type: Interventional

Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: - To assess the effect of rimonabant over a period of 12 months on: - Liver fat content using CT scan (Computed Tomography scan) - Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA)) - Lipid, lipoprotein profile - Glycemia, insulinemia and HbA1c - Adipokines, inflammatory and hemostatic markers - To evaluate the percentage of patients with metabolic syndrome at 12 months - To evaluate the safety and tolerability of rimonabant in these patients In four selected US sites the effect of rimonabant at 12 months will be also assessed on: - Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp). - Resting metabolic rate and substrate oxidation at rest using indirect calorimetry. - Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).

NCT ID: NCT00299013 Completed - Ulcerative Colitis Clinical Trials

Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

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

The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

NCT ID: NCT00298324 Terminated - Clinical trials for Graft vs Host Disease

Myfortic - Treatment for Extensive cGvHD

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

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

NCT ID: NCT00297895 Completed - Melanoma Clinical Trials

Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

Start date: September 30, 2004
Phase: N/A
Study type: Interventional

Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If the subject is sentinel node positive and meets study requirements, the subject is randomized to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound. Subjects are then followed for 10 years.

NCT ID: NCT00297791 Active, not recruiting - Rectal Cancer Clinical Trials

COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

COLORII
Start date: June 2004
Phase: Phase 3
Study type: Interventional

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

NCT ID: NCT00297778 Completed - Depression Clinical Trials

Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms

Start date: March 2006
Phase: Phase 4
Study type: Interventional

Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance. However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression. The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients. Also data on the safety of the product in the disease will be collected.

NCT ID: NCT00297414 Completed - Clinical trials for Mild Cognitive Impairment

An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

Start date: June 2004
Phase: Phase 3
Study type: Observational

The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

NCT ID: NCT00297232 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Natalizumab (Tysabri) Re-Initiation of Dosing

STRATA
Start date: March 2006
Phase: Phase 3
Study type: Interventional

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

NCT ID: NCT00296361 Completed - Clinical trials for Kidney Transplantation

To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

RESTORE
Start date: October 2004
Phase: Phase 3
Study type: Interventional

Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

NCT ID: NCT00296348 Completed - Clinical trials for Kidney Transplantation

Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation

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

The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.