Effect of high-dose phenobarbital on oxidative stress in perinatal asphyxia: An open label randomized controlled trial

2010 ◽  
Vol 48 (8) ◽  
pp. 613-617 ◽  
Author(s):  
Geeta Gathwala ◽  
Ashish Marwah ◽  
Veena Gahlaut ◽  
Poonam Marwah
Keyword(s):  
Oxidative Stress ◽  
Randomized Controlled Trial ◽  
Perinatal Asphyxia ◽  
Controlled Trial ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled

scholarly journals An open label randomized controlled trial of tamoxifen combined with amphotericin B and fluconazole for cryptococcal meningitis

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Nguyen Thi Thuy Ngan ◽  
Nhat Thanh Hoang Le ◽  
Nguyen Ngo Vi Vi ◽  
Ninh Thi Thanh Van ◽  
Nguyen Thi Hoang Mai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cryptococcal Meningitis ◽  
Standard Care ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Cancer Agent

Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential.Methods:Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031 .Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation.Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.Funding:The trial was funded through the Wellcome Trust Asia Programme Vietnam Core Grant 106680 and a Wellcome Trust Intermediate Fellowship to JND grant number WT097147MA.

High dose (4mg/kg/day) versus usual dose (2mg/kg/day) oral prednisolone for treatment of infantile spasms: An open-label, randomized controlled trial

2014 ◽  
Vol 108 (8) ◽  
pp. 1378-1384 ◽  
Author(s):  
Prabaharan Chellamuthu ◽  
Suvasini Sharma ◽  
Puneet Jain ◽  
Jaya Shankar Kaushik ◽  
Anju Seth ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Infantile Spasms ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Usual Dose
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