Human placenta-derived cells (PDA-001) for the treatment of adults with multiple sclerosis: a randomized, placebo-controlled, multiple-dose study.

Background: Infusion of PDA-001, a preparation of mesenchymal-like cells derived from full-term human placenta, is a new approach in the treatment of patients with multiple sclerosis.

Objective: This safety study aimed to rule out the possibility of paradoxical exacerbation of disease activity by PDA-001 in patients with multiple sclerosis.

Methods: This was a phase 1b, multicenter, randomized, double-blind, placebo-controlled, 2-dose ranging study including patients with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis.

Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.

Background: In patients with relapsing-remitting multiple sclerosis (RRMS), subcutaneous (sc) interferon (IFN)β-1a and IFNβ-1b have been shown to reduce relapse rates. A formulation of IFNβ-1a has been produced without fetal bovine serum and without human serum albumin as an excipient (not currently approved for use in the US). The objectives of this study were to evaluate tolerability, injection-site redness, subject-reported satisfaction with therapy, and clinical safety and efficacy of the serum-free formulation of IFNβ-1a versus IFNβ-1b in IFNβ-treatment-naïve patients with RRMS.

Effect of vicriviroc on the QT/corrected QT interval and central nervous system in healthy subjects.

Vicriviroc is a CCR5 antagonist in clinical development for the treatment of HIV-1. Two phase I studies were conducted to assess the safety of vicriviroc. One study characterized the drug's potential to prolong the QT/corrected QT (QTc) interval and to induce arrhythmia.

The relationship between manual handling performance and recent flying experience in air transport pilots.

Modern jet transport aircraft are typically flown using the on-board automation by the pilot programming commands into the auto-flight systems. Anecdotal evidence exists suggesting that pilots of highly automated aircraft experience manual flying skills decay as a result of a lack of opportunity to practise hand-flying during line operations. The ability of a pilot to revert to basic manual control is essential, for example, in cases where the aircraft's automatic capability is diminished or when reconfiguring the automatics is an ineffective use of crew capacity.

Combining control input with flight path data to evaluate pilot performance in transport aircraft.

Introduction: When deriving an objective assessment of piloting performance from flight data records, it is common to employ metrics which purely evaluate errors in flight path parameters. The adequacy of pilot performance is evaluated from the flight path of the aircraft. However, in large jet transport aircraft these measures may be insensitive and require supplementing with frequency-based measures of control input parameters.