Search

A randomized, double‐blind, placebo‐controlled study (SAVEMORE trial) provided data to support an Emergency Use Authorization (EUA) of anakinra in hospitalized adults with positive results of direct severe acute respiratory syndrome‐coronavirus 2 viral testing with pneumonia requiring supplemental oxygen (low‐ or high‐flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Currently, the suPAR assay is not commercially available in the United States. An alternative method was needed to identify patients that best reflect the population in the clinical trial selected based on suPAR level ≥ 6 ng/mL at baseline. A machine learning approach based on data from the SAVEMORE trial was used to develop a scoring rule to identify patients who are likely to have a suPAR level ≥ 6 ng/mL at baseline. External validation of the scoring rule was conducted with data from a different trial (SAVE). This clinical scoring rule with high positive predictive value, high specificity, reasonable sensitivity, and biological relevance is expected to identify patients who are likely to have an elevated suPAR level ≥ 6 ng/mL at baseline. As such, it is included in the EUA to identify patients that fall within the authorized population for whom the known and potential benefits outweigh the known and potential risks of anakinra. [ABSTRACT FROM AUTHOR]

Due to the significant increase in the incidence and prevalence of the fetal alcohol syndrome (FAS) in developing and developed nations, it is important that dental professionals recognize this condition. Patients with FAS have orofacial characteristics and various psychological and physical symptoms that may affect a dental treatment plan. This article reviews the prevalence, incidence, alcohol dose response and metabolism, and clinical characteristics of FAS. A case demonstrating moderate signs of the condition is included to illustrate some of the characteristics.