European neurology
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All trials require a principal investigator to take the lead role and act as main contact amongst the various groups of participants. His role ranges from assistance in protocol design; through selection of investigators, monitoring of study conduct and responding to Safety Committee recommendations; to involvement in study reporting and in maintaining access to the data set after the conclusion of the trial. This article describes the role of the principal investigator and Steering Committee in more detail and discusses the issues that arise out of the organisational requirements of modern clinical trials and the potential tensions between the various participating groups.
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The responsibility for reports about drug trials in medical journals should lie with the clinicians in the steering committee, not with the industrial sponsor. Examples of undue influence of sponsors on the conduct and analysis are the choice of surrogate outcome events, changes in the protocol during the trial, discontinuation of the study, post hoc analyses and suppression of publication. Since this essay was written, the International Committee of Medical Journal Editors ("Vancouver Group") has issued the condition that authors of submitted manuscripts should guarantee their independence in data analysis and reporting. ⋯ Institutional Review Boards should routinely take the matter of independence into account. Also, European guidelines should be rewritten to reflect these fundamental issues rather than a multitude of details. In fact not sponsors or physicians but patients and the general public are the true owners of trial data.
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To determine the functional benefit of botulinum toxin A (BtxA) in spasticity of arm flexors, we conducted an open-label study with 10 stroke patients. 480 mouse units BtxA (Dysport((R))) were injected into flexor muscles. Outcome measures were done by the Modified Ashworth Scale, Rivermead Motor Assessment (arm section), active and passive ranges of motion (ROM), grip strength and a 3-dimensional motion analysis. The functional capacity of the entire arm, even of the shoulder, and the ROM of fingers and wrist increased. ⋯ An improvement of forearm extension was only observed in cases of preserved voluntary extensor motricity. Injection of BtxA into spastic distal flexor muscles may lead to a functional improvement of the entire arm. Grip strength is not necessarily reduced.
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Review Case Reports
Hypoglossal nerve palsy as complication of oral intubation, bronchoscopy and use of the laryngeal mask airway.
Hypoglossal nerve injury is a recognized but rare complication of oropharyngeal manipulation during intubation, bronchoscopy and use of a laryngeal mask airway. We present 2 new cases of temporary hypoglossal nerve palsy after orotracheal intubation for general anesthesia. The relevant literature is reviewed and different hypotheses concerning the pathophysiological mechanisms of nerve damage are discussed.
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Ventriculitis may sometimes occur after an external ventricular drain has been removed, and diagnosis has to be made by lumbar puncture. But are the lumbar findings comparable to previously obtained ventricular results? In a prospective study, sample pairs of ventricular and lumbar cerebrospinal fluid (CSF) were obtained at an interval of <30 min in 25 patients with increased intracranial pressure suffering from cerebral hemorrhage (n = 15), meningitis/encephalitis (n = 6), cerebral infarction (n = 3), and meningeosis carcinomatosa (n = 1). CSF was analyzed for protein, albumin, IgG, IgA, IgM, glucose, lactate, and leukocytes including cytological differentiation. ⋯ Cell count failed to show a clear ventriculo-lumbar ratio. Cytological distribution was comparable in lumbar and ventricular CSF, except for macrophages showing a significant rostrocaudal decrease. In conclusion, in cases of clinically suspected bacterial central nervous system infection after removal of an external ventricular drain, lumbar CSF lactate, glucose, and cytology are comparable to previously determined ventricular values, and thus may help physicians to choose the best treatment.