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STUDY OBJECTIVE The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically ill patients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the(More)
In recent years, the use of a two-stage seamless design in clinical trials has attracted much attention. A two-stage seamless trial design is referred to as a study design that combines two separate clinical studies that are normally conducted to achieve separate objectives, such as a phase II study for treatment selection and a phase III study for efficacy(More)
INTRODUCTION N-acetylcysteine (NAC) and sodium bicarbonate (SOB) therapies may prevent contrast-induced nephropathy (CIN). However, the efficacy of using combination over individual therapies was not established, and there was no large randomised study comparing abbreviated SOB therapy with conventional sustained saline pre-hydration with oral NAC. (More)
PURPOSE To investigate variables associated with myopic progression despite treatment in the Atropine in the Treatment of Myopia Study. DESIGN Retrospective cohort study. METHODS Two hundred of 400 children were randomized to receive atropine 1% in 1 eye only in this institutional study. Children were followed up with cycloplegic autorefraction every 4(More)
In the pharmaceutical industry, it is desirable to apply an adaptive seamless trial design to combine two separate clinical studies that are normally conducted for achieving separate objectives such as a Phase II study for dose finding and a Phase III confirmatory study for efficacy. As a result, an adaptive seamless Phase II/III trial design consisting of(More)
METHODS A novel, fully bacterially produced recombinant virus-like particle (VLP) based influenza vaccine (gH1-Qbeta) against A/California/07/2009(H1N1) was tested in a double-blind, randomized phase I clinical trial at two clinical sites in Singapore. The trial evaluated the immunogenicity and safety of gH1-Qbeta in the presence or absence of alhydrogel(More)
Studies have suggested that selective microbial targets prevail in the fecal microbiota of infants with eczema. This study evaluated the composition of fecal microbiota of infants who developed eczema in the first 5 years of life and compared these with those of healthy controls. Children who developed eczema in the first 2 years, those with eczema at 5(More)
In clinical development, an adaptive design combining results from two separate studies (e.g., a seamless adaptive design with a dose finding study phase and a confirmatory study phase) is commonly considered. The purpose of an adaptive design is not only to reduce lead time between the two studies, but also to evaluate the treatment effect in a more(More)
The problem of testing treatment difference in the occurrence of a safety parameter in a randomized parallel-group comparative clinical trial under the assumption that the number of occurrence follows a zero-inflated Poisson (ZIP) distribution is considered. Likelihood ratio tests (LRT) for homogeneity of two ZIP populations are derived under the hypotheses(More)
WE THANK DR SOLER AND ASSOCIATES VERY MUCH FOR their interest in our paper. The axial length data for the progressors (ie, children whose myopia progressed by 0.5 diopter (D) or more in eyes treated with atropine 1% at 1 year) and nonprogressors in our study were summarized as follows: The progressors had a slightly longer mean axial length (AL) in the(More)