Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.

Background: Glucocorticoids (GCs), such as prednisone, are the standard of care for several inflammatory and immunologically mediated diseases, but their chronic systemic administration is severely limited by serious adverse effects that are both dose and time dependent. Short-term treatment (7-14 days) with oral prednisone is used for many acute inflammatory and allergic conditions. This study was conducted to characterize the safety and pharmacodynamic (PD) dose-response of a 7-day course of oral prednisone on biomarkers of GC receptor agonism.

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

Study Objective: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.

Design: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1).

Setting: University hospitals and private surgical centers.

Sensitivity of myoma imaging using laparoscopic ultrasound compared with magnetic resonance imaging and transvaginal ultrasound.

Study Objective: To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas.

Design: Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2).

Setting: Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites).

Using graphical displays of exact overall significance levels as a guideline for choosing a significance level for pairwise comparisons of a dichotomous variable.

Exact overall significance levels for selected sample sizes and response probabilities are graphically displayed when a dichotomous variable is compared between a placebo and two or more active treatments. A Z-statistic with a pooled variance estimator is used as the test statistic and critical values are based on the (1 - alpha/2)th percentile of the standard normal distribution. These figures are used as a simple guideline for choosing significance levels that achieve a desired overall significance level.

Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials.

Background: Doxorubicin is a highly effective and widely used cytotoxic agent with application that is limited by cardiotoxicity related to the cumulative dose of the drug. A large-scale study that retrospectively evaluated the cardiotoxicity of doxorubicin reported that an estimated 7% of patients developed doxorubicin-related congestive heart failure (CHF) after a cumulative dose of 550 mg/m(2). To assess whether this estimate is reflective of the incidence in the broader clinical oncology setting, the authors evaluated data from three prospective studies to determine both the incidence of doxorubicin-related CHF and the accumulated dose of doxorubicin at which CHF occurs.