Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study.

Background: Risankizumab, an anti-interleukin 23 antibody, was superior to placebo in achieving clinical and endoscopic remission at week 12 in a randomised, phase 2 induction study in patients with moderately to severely active Crohn's disease. Here we aimed to assess the efficacy and safety of extended intravenous induction and subcutaneous maintenance therapy with risankizumab.

Methods: All patients who completed the 12-week induction phase of the double-blind phase 2 induction study were included in this open-label extension study.

Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study.

Background: The interleukin-23 pathway is implicated genetically and biologically in the pathogenesis of Crohn's disease. We aimed to assess the efficacy and safety of risankizumab (BI 655066, Boehringer Ingelheim, Ingelheim, Germany), a humanised monoclonal antibody targeting the p19 subunit of interleukin-23, in patients with moderately-to-severely active Crohn's disease.

Methods: In this randomised, double-blind, placebo-controlled phase 2 study, we enrolled patients at 36 referral sites in North America, Europe, and southeast Asia.

A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome.

Objective: This study evaluated the dose-related efficacy and safety of pregabalin in patients with idiopathic restless legs syndrome (RLS).

Methods: This six-arm, double-blind, placebo-controlled, dose-response study randomized patients (N=137) with moderate-to-severe idiopathic RLS in an equal ratio to placebo or pregabalin 50, 100, 150, 300, or 450 mg/day. The dose-response was characterized using an exponential decay model, which estimates the maximal effect (E(max)) for the primary endpoint, the change in the International Restless Legs Study Group Rating Scale (IRLS) total score from baseline to week 6 of treatment.

Sensitivity of amplitude-integrated electroencephalography for neonatal seizure detection.

Background: Conventional electroencephalography remains the gold standard for the diagnosis and quantification of neonatal seizures. However, amplitude-integrated electroencephalography (aEEG) is being introduced to neonatal intensive care as an adjunct for neonatal seizure detection.

Objectives: This study's purpose was to determine the sensitivity of neonatal seizure detection in a single electroencephalogram channel (C3-->C4), used to simulate the raw signal from which aEEG is derived.