The clomethiazole acute stroke study (CLASS): Safety results in 1,356 patients with acute hemispheric stroke.

The Clomethiazole Acute Stroke Study (CLASS) showed no difference in outcome between patients treated with clomethiazole or placebo for all patients treated, but a beneficial effect in patients classified as a total anterior circulation syndrome (TACS). These are patients with clinical symptoms of a large stroke. Safety and tolerability data are reported here with emphasis on the safety of treating stroke patients with a sedative drug. In total, 1,356 patients were eligible for safety analysis. Mortality at 90 days was equal between the treatment groups (clomethiazole, 19.5%; placebo, 19.7%). Clomethiazole was generally well-tolerated. The most common adverse event was sedation (clomethiazo…

An Online Observational Study of Patients With Olfactory and Gustory Alterations Secondary to SARS-CoV-2 Infection

Introduction: Since the beginning of the Covid-19 epidemic produced by SARS2-Cov virus, olfactory alterations have been observed at a greater frequency than in other coronavirus epidemics. While olfactory alterations may be observed in patients with rhinovirus, influenza virus, or parainfluenza virus infection, they are typically explained by nasal obstruction with mucus or direct epithelial damage; in the case of SARS-CoV-2, olfactory alterations may present without nasal congestion with mucus. We performed a study of patients presenting olfactory/gustatory alterations in the context of SARS-CoV-2 infection in order to contribute to the understanding of this phenomenon. Material and Method…

Development and validation of the EUROLIGHT questionnaire to evaluate the burden of primary headache disorders in Europe

We developed a 103-item self-reporting questionnaire to assess the burden of primary headache disorders on those affected by them, including headache characteristics, associated disability, co-morbidities, disease-management and quality of life. We validated the questionnaire in five languages with 426 participants (131 in UK, 60 in Italy, 107 in Spain, 83 in Germany/Austria, and 45 in France). After a linguistic and a face-content validation, we tested the questionnaire for comprehensibility, internal consistency and test–retest reliability at an interval of one month. In the different countries, response rates were between 73% and 100%. Test–retest reliability varied between –0.27 to 1.0…

Stimulation of the sphenopalatine ganglion (SPG) for cluster headache (CH)-/INS;pathway CH-1 — /INS;Effectiveness and quality of life through 18 months

Tinnitus and tinnitus disorder: Theoretical and operational definitions (an international multidisciplinary proposal)

As for hypertension, chronic pain, epilepsy and other disorders with particular symptoms, a commonly accepted and unambiguous definition provides a common ground for researchers and clinicians to study and treat the problem. The WHO's ICD11 definition only mentions tinnitus as a nonspecific symptom of a hearing disorder, but not as a clinical entity in its own right, and the American Psychiatric Association's DSM-V doesn't mention tinnitus at all. Here we propose that the tinnitus without and with associated suffering should be differentiated by distinct terms: "Tinnitus" for the former and "Tinnitus Disorder" for the latter. The proposed definition then becomes "Tinnitus is the conscious a…

The cost of headache disorders in Europe: the Eurolight project

Background and purpose:  Headache disorders are very common, but their monetary costs in Europe are unknown. We performed the first comprehensive estimation of how economic resources are lost to headache in Europe. Methods:  From November 2008 to August 2009, a cross-sectional survey was conducted in eight countries representing 55% of the adult EU population. Participation rates varied between 11% and 59%. In total, 8412 questionnaires contributed to this analysis. Using bottom-up methodology, we estimated direct (medications, outpatient health care, hospitalization and investigations) and indirect (work absenteeism and reduced productivity at work) annual per-person costs. Prevalence data…

Methodological aspects of clinical trials in tinnitus: a proposal for an international standard

Abstract: Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison betwee…