Children's health
01 Jan 2013
Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and…
Children's health
01 Jan 2013
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Objective:Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children. Official Title Conditions Pertussis Whooping Cough Study Type Interventional Study Design Treatment, Randomized. Further Details Protocol Outline: This is a randomized, multicentre study. Patients are…
Children's health
01 Jan 2013
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Primary aim:To evaluate the efficacy of Pulmonarom in the decrease of interleukin-4/interferon gamma after second period of treatment.Secondary aims:To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment.To evaluate loss of working…
Neurology
01 Jan 2013
Depression and Traumatic Brain Injury
Problem: Depressive symptoms are a common mental health problem following traumatic brain injury (TBI), occurring in up to 87% of patients. Depression following TBI has important consequences including poor functioning, lack of ability to return to work and family activities and prolonged TBI symptoms. The reason depression develops in some patients following TBI is unknown, making treatment difficult.One type of brain protein that shows genetic differences between people is called the serotonin transporter. People can be divided by whether or not they have a short protein (S allele) or a long protein (L allele) which influences the amount of serotonin transporter. Serotonin is a key brain chemical in depression in many mental/psychiatric illnesses. We think that the genetic differences in the serotonin transporter, that may not make a difference before TBI, may become important after TBI due to the nature of these injuries.Methods: A consecutive sample of 200 patients attending a TBI clinic who have sustained a mild-to-moderate TBI (American Congress of Rehabilitation Medicine criteria) within the last 2 months will be assessed for the presence of major depression (standard criteria, standardised interview). In phase I, blood samples from patients with mild-to-moderate TBI with depression and without depression will be checked for the presence of the 5-HTTPR genetic difference. This will allow us to study if the S allele is more likely in TBI patients with depression. In phase II, the patients with depression will be treated with the SSRI citalopram for 6 weeks. At 6 weeks, or upon discontinuation of citalopram, depression will be assessed again. This will allow us to study if depressed patients with the S allele respond more poorly to treatment. Persons assessing depression after treatment will not know the genetic makeup of each patient.Results Expected: If the serotonin transporter genetic difference confers susceptibility to depression following TBI, this will provide important information on what causes depression following TBI and document a risk factor for depression previously unstudied in this population. Also, as SSRI antidepressants are used to treat depression in TBI, this study may identify a subgroup of TBI patients in whom different medications should be given or additional medications are required.
Official TitleThe Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury.
Cancer
01 Jan 2013
Magnetic Resonance Imaging Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases From Lung or Breast Cancer
Rationale: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxytol, may help find and diagnose primary brain cancer or brain metastases.Purpose: This randomised clinical trial is studying how well MRI using ferumoxytol works in finding out the extent of the tumour in patients with primary brain cancer or brain metastases…
Neurology
01 Jan 2013
Discrete Hypothermia in the Management of Traumatic Brain Injury
The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete…
Mental Health
01 Jan 2013
Deep Brain Stimulation for Parkinson’s Disease Trial
The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatric function, and quality of life in patients with Parkinson’s disease. Official Title Deep Brain Stimulation for Parkinson’s Disease Trial.
Men's Health
01 Jan 2013
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes. Official Title A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes. Conditions Herpes Genitalis Study Type Interventional Study Design Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment,…
Bone
01 Jan 2013
A Phase III Trial to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated CG5503 Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and…