82 research outputs found

    Previous Leisure-Time Physical Activity Dose Dependently Decreases Ischemic Stroke Severity

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    In the present subanalysis of a cross-sectional study showing the favorable effect of prior transient ischemia, leisure-time physical activity, and lipid-lowering drug therapy on stroke severity, we aimed to evaluate whether previous physical activity was dose dependently associated to minor stroke (NIHSS 0–3) and to identify possible underlying factors. Among 362 consecutive patients, less severe stroke was related to weekly exercise duration prior to stroke (no exercise: 36.1%; <2 hours: 49.3%; 2–5 hours: 58.8%; >5 hours: 64.0%; P = 0.003). Only weak and moderate exercise practices were protective (weak: 50.0%; moderate: 79.3%; heavy: 22.2%; P < 0.0001). Such a beneficial effect was observed independently of age and was associated with a trend to a lower frequency of arterial hypertension, alcohol abuse, and a better metabolic profile. Besides other therapeutic approaches, physical activity may be a simple way to decrease cerebral ischemia severity

    ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters

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    <p>Abstract</p> <p>Background</p> <p>Suicide attempts (SA) constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients.</p> <p>Methods/Design</p> <p>Multicentre randomized controlled trial.</p> <p>We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters) and «Crisis card» (effective only in first-attempters). Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards».</p> <p>Discussion</p> <p>ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy.</p> <p>Trial Registration</p> <p>The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174.</p

    Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

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    <p>Abstract</p> <p>Background</p> <p>In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.</p> <p>Methods</p> <p>We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries.</p> <p>Results</p> <p>Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised.</p> <p>Conclusion</p> <p>The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.</p

    Evaluation of iron status in European adolescents through biochemical iron indicators: the HELENA Study

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    BACKGROUND/OBJECTIVES: To assess the iron status among European adolescents through selected biochemical parameters in a cross-sectional study performed in 10 European cities. SUBJECTS/METHODS: Iron status was defined utilising biochemical indicators. Iron depletion was defined as low serum ferritin (SF8.5 mg/l) plus iron depletion. Iron deficiency anaemia (IDA) was defined as ID with haemoglobin (Hb) below the WHO cutoff for age and sex: 12.0 g/dl for girls and for boys aged 12.5-14.99 years and 13.0 g/dl for boys aged ≄15 years. Enzyme linked immunosorbent assay was used as analytical method for SF, sTfR and C-reactive protein (CRP). Subjects with indication of inflammation (CRP >5 mg/l) were excluded from the analyses. A total of 940 adolescents aged 12.5-17.49 years (438 boys and 502 girls) were involved. RESULTS: The percentage of iron depletion was 17.6%, significantly higher in girls (21.0%) compared with boys (13.8%). The overall percentage of ID and IDA was 4.7 and 1.3%, respectively, with no significant differences between boys and girls. A correlation was observed between log (SF) and Hb (r = 0.36, P < 0.01), and between log (sTfR) and mean corpuscular haemoglobin (r = -0.30, P < 0.01). Iron body stores were estimated on the basis of log (sTfR/SF). A higher percentage of negative values of body iron was recorded in girls (16.5%) with respect to boys (8.3%), and body iron values tended to increase with age in boys, whereas the values remained stable in girls. CONCLUSIONS: To ensure adequate iron stores, specific attention should be given to girls at European level to ensure that their dietary intake of iron is adequate.status: publishe

    Suivi Thérapeutique Pharmacologique

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    Suivi Thérapeutique Pharmacologique

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    Editorial

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    Les agents hypolipémiants (fibrates, statines) (approche expérimentale et clinique des effets protecteurs dans les pathologies ischémiques et dégénératives)

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    Une meilleure compréhension des différentes voies métaboliques impliquées dans la maladie d'Alzheimer et l'accident vasculaire cérébral constitue autant de cibles pharmacologiques à développer pour induire une neuroprotection. Certains agents pharmacologiques comme les hypolipémiants ont démontré expérimentalement leur capacité à induire une telle neuroprotection grùce à leurs propriétés pléiotropes anti-inflammatoires ou anti-oxydantes mais aussi cliniquement en terme de réduction du risque. Dans un premiÚre partie de nos travaux, nous avons montré que, dans une population de 342 patients alzheimer, la maldie progresse significativement moins vite chez les patients avec une hypercholestérolémie traitée par hypolipémiant (perte de 1,5 point au MMS/an), que chez les patients avec une hypercholestérolémie non traitée (2,4) et que chez les patients sans dyslipémie (2,6) (p=0,0102). Par la régression logistique prenant pour variable dépendante le déclin au MMS, le seul facteur lié à un déclin plus lent est le traitement hypolipémiant (OR=0,45, p=0,002). Dans une seconde partie, nous avons montré que chez 362 patients admis pour un accident vasculaire cérébral ischémique, de moins de 48heures, les facteurs indépendamment liés à une moindre sévérité à l'admission sur l'échelle du NIHSS sont la pratique d'une activité physique réguliÚre (OR=1,67), un antécédent ischémique transitoire (OR=2,28), et un traitement par hypolipémiant (OR=1,76). Dans une troisiÚme partie, à 7 jours d'une ischémie-reperfusion cérébrale chez le rat, aprÚs avoir constaté un déficit de mémoire spatiale, parallÚlement à l'apparition d'une immunoréactivité pour le peptide amyloïde , nous avons observé une tendance à un effet neuroprotecteur par fénofibrate, sur la taille de la lésion, sur l'altération cognitive, et sur l'expression du peptide amyloïde .Best knowledge of metabolic pathway involved in Alzheimer and stroke pathogenesis leads to new therapeutic approach to induce neuroprotection. The pleiotropic effects, such as anti-inflammatory or anti-oxidants effects, were described for lipid lowering agents (LLAs). First we investigate in an observational study whether LLAs are associated with a slower cognitive decline in Alzheimer's disease. Patients treated with lipid lowering agents had a slower decline on the MMSE (1.5/year, p=0.0102) than patients with untreated dyslipemia (2.4), or normolipemic patients (2.6). Patients with a slower decline were more likely to be treated with LLAs. Logistic regression analysis, with low annual cognitive decline as dependant variable, showed that the independent variable LLAs was positively associated with the probability of lower cognitive decline (OR=0.45, p=0.002). Second, we aim to determine clinical and pharmacological factors taht could influence the initial severity and short term outcom of cerebral ischemia. 362 consecutive patients were included in a cross-sectional hospital-based study of patients with acute ischemic stroke. Independent factors associated with a lower severity measured on the NIH scale at admission were previous leisure-time physical activity (OR=1.67), TIA (OR=2.28) and treatment with lipid lowering agents (OR=1.76). third, 1 week after reperfusion, we observed in rats submitted to cerebral ischemia, appearance of amyloid peptide immunoreactivity associated with decreased performance on place recognition task of Y-maze. Fenofibrate allows to prevent partially these alterations : a trend for decreased cognitive impairment and amyloid peptide immunoreactivity and a significant reduction of infarct size.LILLE2-BU Santé-Recherche (593502101) / SudocPARIS-BIUP (751062107) / SudocSudocFranceF
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