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Several Clinical Studies (several + clinical_studies)
Selected AbstractsExacerbation of experimental autoimmune encephalomyelitis after withdrawal of phenytoin and carbamazepineANNALS OF NEUROLOGY, Issue 1 2007Joel A. Black PhD Objective In vitro observations and studies in murine experimental autoimmune encephalomyelitis (EAE) have shown protective effects of sodium channel blockers on central nervous system axons and improved clinical status when treatment is continued throughout the period of observation. Several clinical studies of sodium channel blockers are under way in patients with multiple sclerosis. Here we asked whether a protective effect would persist after withdrawal of a sodium channel blocker. Methods We studied a mouse model of myelin oligodendrocyte glycoprotein,induced EAE treated with phenytoin or carbamazepine. Results Both phenytoin and carbamazepine significantly improved the clinical course of the disease. Withdrawal of phenytoin resulted in acute exacerbation, accompanied by a significantly increased inflammatory infiltrate within the central nervous system and the death of nearly 60% of EAE mice. There were no clinical worsening or deaths in control mice after withdrawal of phenytoin. Withdrawal of carbamazepine led to acute worsening of EAE symptoms, increased inflammatory infiltrate, and was associated with the death of 8% of mice. Interpretation These results, together with results showing effects of sodium channel blockers in immune cells, raise questions about the long-term effects of sodium channel blockers in neuroinflammatory disorders, and suggest that clinical studies of sodium channel blockers in these disorders should be planned carefully. Ann Neurol 2007 [source] Carotid Stenosis as Detected by Ultrasound in a General Population is a Strong Predictor of DeathACTA NEUROLOGICA SCANDINAVICA, Issue 5 2001Oddmund Joakimsen Background and Purpose: In the last two decades, ultrasound examinations have increasingly been used as a noninvasive method to screen for carotid stenosis. Several clinical studies have shown that carotid stenosis is a risk factor for ischemic stroke and coronary heart disease and death. However, there is scarce information about stenosis as detected in a general population and the relation with mortality. The purpose of this population-based study was to assess whether carotid stenosis is a predictor of death. Methods: In 1994 to 1995, 248 subjects with suspected carotid stenosis were identified among 6727 men and women 25 to 84 years of age who were examined with ultrasound as part of the population-based Tromsø Study. These subjects and 496 age- and sex-matched control subjects were followed for 4.2 years, and the number and causes of deaths were identified. Results: The unadjusted relative risk for death was 2.72 (95% CI, 1.57 to 4.75) for subjects with stenosis compared with control subjects. Adjusting for cardiovascular risk factors increased the relative risk to 3.47 (95% CI, 1.47 to 8.19). The adjusted relative risk in persons with stenosis and no cardiovascular disease or diabetes was 5.66 (95% CI, 1.53 to 20.90), which was higher than in subjects with stenosis and self-reported disease (1.79; 95% CI, 0.75 to 4.27). There was a dose-response relationship between degree of stenosis and risk of death (P=0.002 for linear trend). Conclusion: Carotid stenosis as detected in a general population is a strong and independent predictor of death. Carotid stenosis was a stronger predictor of death than self-reported cardiovascular disease or diabetes. [source] Assessment and Statistics of Surgically Induced AstigmatismACTA OPHTHALMOLOGICA, Issue thesis1 2008Kristian Næser Abstract. The aim of the thesis was to develop methods for assessment of surgically induced astigmatism (SIA) in individual eyes, and in groups of eyes. The thesis is based on 12 peer-reviewed publications, published over a period of 16 years. In these publications older and contemporary literature was reviewed1. A new method (the polar system) for analysis of SIA was developed. Multivariate statistical analysis of refractive data was described2,4. Clinical validation studies were performed. The description of a cylinder surface with polar values and differential geometry was compared. The main results were: refractive data in the form of sphere, cylinder and axis may define an individual patient or data set, but are unsuited for mathematical and statistical analyses1. The polar value system converts net astigmatisms to orthonormal components in dioptric space. A polar value is the difference in meridional power between two orthogonal meridians5,6. Any pair of polar values, separated by an arch of 45 degrees, characterizes a net astigmatism completely7. The two polar values represent the net curvital and net torsional power over the chosen meridian8. The spherical component is described by the spherical equivalent power. Several clinical studies demonstrated the efficiency of multivariate statistical analysis of refractive data4,9,11. Polar values and formal differential geometry describe astigmatic surfaces with similar concepts and mathematical functions8. Other contemporary methods, such as Long's power matrix, Holladay's and Alpins' methods, Zernike12 and Fourier analyses8, are correlated to the polar value system. In conclusion, analysis of SIA should be performed with polar values or other contemporary component systems. [source] The Organic Brain Syndrome (OBS) scale: a systematic reviewINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 3 2006Karin Björkman Björkelund Abstract Background/Objective The Organic Brain Syndrome (OBS) Scale was developed to determine elderly patients' disturbances of awareness and orientation as to time, place and own identity, and assessment of various emotional and behavioural symptoms appearing in delirium, dementia and other organic mental diseases. The aim of the study was to examine the OBS Scale, using the eight criteria and guidelines formulated by the Scientific Advisory Committee of the Medical Outcomes Trust (SAC), and to investigate its relevance and suitability for use in various clinical settings. Method Systematic search and analysis of papers (30) on the OBS Scale were carried out using the criteria suggested by the SAC. Results The OBS Scale in many aspects satisfies the requirements suggested by the SAC: conceptual and measurement model, reliability, validity, responsiveness, interpretability, respondent and administrative burden, alternative forms of administration, and cultural and language adaptations, but there is a need for additional evaluation, especially with regard to different forms of reliability, and the translation and adaptation to other languages. Conclusions The OBS Scale is a sensitive scale which is clinically useful for the description and long-term follow-up of patients showing symptoms of acute confusional state and dementia. Although the OBS Scale has been used in several clinical studies there is need for further evaluation. Copyright © 2006 John Wiley & Sons, Ltd. [source] Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasisBRITISH JOURNAL OF DERMATOLOGY, Issue 2 2003J.J. Hoefnagel Summary Background Therapy with fumaric acid esters (FAE) has been shown to be safe and effective in patients with severe psoriasis in several clinical studies with limited follow-up periods. In view of the chronic character of psoriasis, long-term safety aspects are of major importance in determining the suitability of a drug during prolonged periods of treatment. Objectives To investigate adverse events of therapy with systemic FAE with follow-up periods of up to 14 years, in order to determine safety aspects of their long-term use in patients with severe psoriasis. Methods Current and/or past therapeutic use of FAE was reviewed in 66 patients with severe psoriasis. Results Forty-one of 66 patients had received FAE for at least 1 year, and 12 of these 41 patients had received FAE for between 10 and 14 years. Adverse events were reported in 73% of the patients. These were usually mild and mainly consisting of flushing (55%), diarrhoea (42%), nausea (14%), tiredness (14%) and stomach complaints (12%). A relative lymphocytopenia was observed in 76% of patients during therapy with FAE, resulting in a permanent discontinuation of therapy with FAE in four patients. A transient eosinophilia and moderate liver enzyme elevations were observed in 14% and 25% of patients, respectively. Conclusions The present study indicates that FAE can be considered as a safe long-term treatment in patients with severe psoriasis. [source] | ||||||||||