Clinical Trial - Omega-3 Fatty Acid supplementation to Prevent Preterm Birth in High Risk Pregnancies - A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy.
The North American Clinical Trials Network (NACTN) is one more way that the Reeve Foundation is moving promising therapies from the lab to spinal cord injured patients. NACTN is working hard to insure that any clinical trial will be done in a way that maximizes both patient safety and our ability to gather valid, meaningful data. NACTN is an international network of hospitals with highly trained personnel and uniform protocols and data collection that help to ensure safety for all trial subjects and interpretable trial data
As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.
Hypothesis of study is that among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: Twin pregnancy - Triplet pregnancy
Citicoline Brain Injury Treatment (COBRIT) trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury. Citicoline (also known as CDP-Choline) is a naturally occurring endogenous compound. Citicoline may have neuroprotective effects and may potentiate neuro-recovery which has led to the evaluation of it as treatment for both stroke and TBI in animal models and in human clinical trials.
Medical College of Georgia researchers are conducting a clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.
Multicenter, randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary outcome measure is eclampsia, and the secondary outcome measures include blood pressure control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal parameters including adverse effects and complications.
"For over 60 years the most appropriate oxygen level for preterm babies remains unknown. To answer this, we will combine data from over 5300 babies to be sure the expected benefits of lower oxygen for babies' eyes and lungs does not come at the expense of increasing death or major disability in these children. Planning to do this before the results of any of the trials are known is called a prospective meta-analysis. This is the first time this technique has been used in neonatal medicine.
National Library of Medicine. This site offers clinical alert notices. Clinical alerts are provided to expedite the release of findings from the NIH-funded clinical trials where such release could significantly affect morbidity and mortality.
The investigators have planned to perform a trial to study the effect of antioxidant supplementation on pain relief in patients with chronic pancreatitis.
New England Journal of Medicine abstract of study to evaluate the effects of induction of moderate hypothermia in infants who had perinatal asphyxia. Study concluded that Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571 [controlled-trials.com] .)
Completed study. In this feasibility study, hyperoxemia, as proximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of ulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth. This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.
NHLBI ARDS Clinical Network web site. This site was established to provide information to the public on ARDS and the ARDS Network. In order to hasten the development of effective therapy for Acute Respiratory Distress Syndrome (ARDS), the National Heart, Lung, and Blood Institute, National Institutes of Heath, initiated a clinical network to carry out multi center clinical trials of ARDS treatments. The goal of the Network is to efficiently test promising agents, devices, or management strategies to improve the care of patients with ARDS.
McGowan Institute of Regenrative Medicine. A program of the University of Pittsburgh and UPMC. Researchers at the University of Pittsburgh and the University of Pittsburgh Medical Center are working to quickly identify and treat shock, a problem that affects an estimated 1 million emergency room patients every year. Researchers are working on a unique diagnostic medical device currently in clinical trials.
The first comprehensive comparative effectiveness clinical trial of three widely used anti-seizure drugs for childhood absence epilepsy - the most common form of epilepsy in kids - has established an evidence-based approach for initial drug therapy. Published March 4 in the New England Journal of Medicine*, data from the double-blind, randomized, comparative clinical trial fill a large information gap in the treatment of childhood absence epilepsy, also known as "petit mal" epilepsy. The research, which identifies important differences between drugs in seizure control and side effects, is expected to impact how physicians select and monitor initial therapy for children with the disorder and ultimately lead to improved outcomes.
"The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual
wheelchair users."