objective: this clinical trial examines the effect of augmentation of methylphenidate (mph) with folic acid to improve quality of life, and to treat aggression and adhd symptoms . method: participants of this eight week randomized double blind placebo controlled clinical trial were 49 children with adhd. they were randomly assigned into one of the two groups: the first group receiving methylphe...

conclusions the present study showed that g-csf is not superior to placebo in production of protective antibody titers after hbv vaccination but could result in a more rapid antibody response, compared to the placebo. results there was no statistically significant difference between anti-hbv antibody titers in patients receiving double dose hbv vaccination plus g-csf and patients receiving doub...

Advances in preclinical SMA research have identified several candidate treatments. Early clinical trials evaluating these medications are underway or in the planning stage. At the NINDS Workshop on SMA in September 2004 in Washington DC, discussions started within the international SMA community to identify features that should be common to SMA clinical trials [1]. Having a set of design featur...

At the request of the Food and Drug Administration (FDA) and with its funding, the Panel on the Handling of Missing Data in Clinical Trials was created by the National Research Council's Committee on National Statistics. This panel recently published a report(1) with recommendations that will be of use not only to the FDA but also to the entire clinical trial community so that the latter can ta...

– Adaptive clinical trial designs are defined as designs that use data cumulated during trial to possibly modify certain aspects without compromising the validity and integrity of the said trial. Compared to more traditional trials, in theory, adaptive designs allow the same information to be generated but in a more efficient manner. The advantages and limits of this type of design together wit...

INTRODUCTION Psychological support programmes are not currently funded for people with a history of melanoma. A major barrier to the implementation of effective psychological interventions in routine clinical care is a lack of cost-effectiveness data. This paper describes the planned economic evaluation alongside a randomised controlled trial of a psychoeducational intervention for people with ...

Background An increasing number of Clinical Trial Web Portals now include systems to manage endpoint adjudication. These cover the entire process from the initial identification of potential endpoints, the creation of electronic endpoint packages, and assignment of endpoints to members of the relevant Clinical Endpoint Committee (CEC) to the final adjudication verdict being entered into the sys...

Most statistical methods for censored survival data assume there is no dependence between the lifetime and censoring mechanisms, an assumption which is often doubtful in practice. In this paper we study a parametric model which allows for dependence in terms of a parameter delta and a bias function B(t, theta). We propose a sensitivity analysis on the estimate of the parameter of interest for s...