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Discover 17,468 clinical trials near Dallas, Texas. Find research studies in your area.
Showing 11561-11580 of 17,468 trials
NCT02108912
This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic benefits for persons post stroke that learn to walk utilizing early treadmill training post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based gait training during the same time period. Participants (n=30) will be adults who have completed acute rehabilitation following a stroke. Random assignment will be to either the ESTT or traditional gait training protocol during the outpatient rehabilitation phase. 1. Group A: Traditional outpatient therapy (n = 15) 2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)
NCT00734539
The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. Fluconazole has been commonly used off-label in the neonatal intensive care unit, but definitive recommendations for its use in the nursery have been hampered by the limited number of well-designed trials. In neonates weighing \<750 g, appropriate dosing is not known, definitive safety and long-term follow up trials have not been completed, and there have not been well-powered trials conducted to establish the efficacy of the product using mortality as part of the primary endpoint. Three recent proof-of-concept studies suggest that fluconazole will be safe and effective, and a recently completed pharmacokinetic study is providing data to give preliminary dosing guidance. The next logical step in drug development is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment. 362 neonates, with a birthweight \<750g, were randomized at 33 US centers, to twice weekly fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint will be Candida-free survival at study day 49. The research will establish definitive dosing, safety, and efficacy of fluconazole; it will also provide critical information on the effects of fluconazole on neurodevelopmental impairment and antifungal resistance. Potential Impact: Approximately 17,000 neonates are born \<750 grams each year in the United States. Over 5000 will die or develop invasive Candida infections. Demonstrating safety and efficacy of fluconazole in preterm neonates will improve the survivability and long term outcomes for these neonates.