Research and Trials
01 Jan 2013
Evaluate the Survival Benefits of Zemplar versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death. Official Title A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the…
Children's health
01 Jan 2013
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years. Official Title Conditions Bipolar Disorder Study Type Interventional Study Design Treatment…
Bone
01 Jan 2013
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
This is a multicenter, Phase III randomized, placebo-controlled study in which polyarticular JRA subjects who are either MTX treated or non-MTX treated will initially receive Adalimumab by subcutaneous injection every other week for a four-month open-label lead-in period. Subjects who respond to the open-label therapy will then be rolled over…
Blood
01 Jan 2013
Safety of NXY-059 for the Treatment of Patients who have Suffered from a Stroke
This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. Official Title CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of…
Neurology
01 Jan 2013
Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children
This project is evaluating programs to improve reading and writing skills in children who have or are at risk for having reading disabilities. The project focuses on children who are at-risk for low achievement in school and on children with dyslexia. Official Title Learning Disabilities: Links to Schools and Biology…
Children's health
01 Jan 2013
Early Antipseudomonal Therapy in Cystic Fibrosis
To determine a safe, effective, and systematic approach to antibiotic treatment of Pseudomonas infection in young children with cystic fibrosis. Official Title Conditions – Cystic Fibrosis- Infection- Lung Diseases Study Type Interventional Study Design Prevention, Randomized Further Details BACKGROUND: Cystic fibrosis (CF), an autosomal recessive disorder without a cure,…
Cancer
01 Jan 2013
Anti-angiogenesis Agent AG-013736 in Patients with Metastatic Melanoma
This is a Phase 2 study being conducted at multiple centers in the United States. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic…
Blood
01 Jan 2013
Cardiac Function in Patients with Hereditary Hemochromatosis
This study will examine the effect of iron buildup in the hearts of patients with hereditary hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally, early treatment with phlebotomy (periodic removal…
Heart
01 Jan 2013
A Study of Safety, Tolerability & Efficacy of Certican in de novo Heart Transplant (Tx) Patients
The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients. Official Title…