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Interventional Trials (interventional + trials)
Selected AbstractsReview article: permissive underfeeding in short-term nutritional supportALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010A. E. Owais Aliment Pharmacol Ther 2010; 32: 628,636 Summary Background, The importance of adequate nutritional support in selected patient groups is well established. Traditionally, the amounts of macronutrients provided have been based on a perceived need to achieve, if not exceed, energy and protein balance. In recent years, there has been increasing interest in the concept of ,permissive underfeeding'. Aim, To determine whether or not there is evidence of benefit for permissive underfeeding in selected groups. Methods, Studies were identified from MEDLINE, Embase and PubMed databases and the Cochrane collaboration. The search was limited from January 1950 to January 2010. Further searches were made from the references of original articles. The literature search revealed 591 abstracts of relevant studies. All abstracts were initially reviewed by the primary author (AO) and those that did not fulfil the inclusion criteria were discarded. The remaining articles were requested and were reviewed independently by two authors (AO, JM). Results, Twelve studies were included in the final analysis. Eight of these were randomized interventional trials. Three were prospective cohort studies and one was a retrospective analysis. Conclusion, This review suggests that permissive underfeeding may be associated with improved outcomes and reduced morbidity in patients requiring short-term nutritional support. [source] Thrombophilia and pregnancy outcomesJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2005I. PABINGER Summary., Pregnancy complications are still a challenge for physicians, because knowledge of pathomechanisms and prophylactic measures is still limited. In recent years thrombophilia as a risk factor for pregnancy complications has gained much attention in the scientific community. However, data on this topic in the literature are conflicting. Besides an established association between antiphospholipid antibodies and pregnancy loss, available data suggest additional associations for antithrombin deficiency, hyperhomocysteinemia and also for factor (F)V Leiden, prothrombin G20210A variation, and protein S-deficiency. The contribution of thrombophilia to the risk of pre-eclampsia is less well established and recent studies did not confirm earlier data suggesting an association between thrombophilia and pre-eclampsia. A limited number of prospective studies have failed to reveal an increased risk of pregnancy complications in unselected women with thrombosis risk factors. Low-molecular weight heparin (LMWH) seems to have a positive effect on pregnancy outcome after single or recurrent abortions, however, data from only one controlled trial are available. Experience in the prevention of pre-eclampsia by prophylactic heparin is very limited, and in addition, data on pregnancy complications in women with known heritable thrombophilia or a history of thrombosis are inconsistent. These women will usually have a favorable pregnancy outcome referring to the European Prospective Cohort on Thrombophilia Study. In conclusion, thrombophilia screening might be justified in women with pregnancy loss and treatment with LMWH might be considered in those with pregnancy loss and thrombophilia. Further prospective studies and controlled interventional trials are urgently needed. [source] Self-rated health status in spinocerebellar ataxia,Results from a European multicenter study,MOVEMENT DISORDERS, Issue 5 2010Tanja Schmitz-Hübsch MD Abstract Patient-based measures of subjective health status are increasingly used as outcome measures in interventional trials. We aimed to determine the variability and predictors of subjective health ratings in a possible target group for future interventions: the spinocerebellar ataxias (SCAs). A consecutive sample of 526 patients with otherwise unexplained progressive ataxia and genetic diagnoses of SCA1 (117), SCA2 (163), SCA3 (139), and SCA6 (107) were enrolled at 18 European referral centers. Subjective health status was assessed with a generic measure of health related quality of life, the EQ-5D (Euroqol) questionnaire. In addition, we performed a neurological examination and a screening questionnaire for affective disorders (patient health questionnaire). Patient-reported health status was compromised in patients of all genotypes (EQ-5D visual analogue scale (EQ-VAS) mean 61.45 ± 20.8). Specifically, problems were reported in the dimensions of mobility (86.9% of patients), usual activities (68%), pain/discomfort (49.4%), depression/anxiety (46.4%), and self care (38.2%). Multivariate analysis revealed three independent predictors of subjective health status: ataxia severity, extent of noncerebellar involvement, and the presence of depressive syndrome. This model explained 30.5% of EQ-VAS variance in the whole sample and might be extrapolated to other SCA genotypes. © 2010 Movement Disorder Society [source] Quality and reporting of trial design in scientific papers in Anaesthesia over 25 yearsANAESTHESIA, Issue 1 2009R. A. Langford Summary We determined how the quality of trial design and its reporting in scientific papers published in Anaesthesia has changed in the last 25 years. All articles between the years 1983,87 and 2003,07 were reviewed and classified according to methodology. Reporting and trial design of all prospective, comparative clinical interventional trials were compared between the two time periods using 12 criteria. Fewer articles now originate from the United Kingdom and Ireland than 25 years ago. Although fewer human interventional trials are now published in Anaesthesia, the quality of these trials has improved in terms of study design, bias control and proper disclosure. Significant improvements were observed in all criteria of trial design except for the declaration of non-primary adverse outcomes and the minimisation of the risk of type I errors. Further improvements could still be made with respect to sample size calculation, description of the method of randomisation, and blinding. [source] New perspectives in retinal imaging: fundus autofluorescence and age-related macular degenerationACTA OPHTHALMOLOGICA, Issue 2007F HOLZ Fundus Autofluorescence (FAF) imaging using confocal scanning laser ophthalmoscopy is a non-invasive method to to accurately record the topographic distribution of RPE lipofuscin in the human eye in vivo. Excessive lipofuscin accumkulation in the RPE is a common downstream pathogenetic pathway in various complex and monogenetic retinal diseases. Toxic compounds and molecular mechanisms of interference with normal cellular functions have been identified including the dominant fluorophore A2-E. Alterations in fundus autofluorescence (FAF) appearance in eyes with early and late age-related macular degeneration (AMD) can be striking. FAF patterns and distribution do not necessarily correlate with the features of interest in color or angiographic images of eyes with early or late AMD. In the prospective, multicenter FAM study distinct patterns of abnormal FAF were identified and classified in the junctional zone of geographic atrophy (GA). Areas of increased FAF outside GA were associated with variable degrees of loss of retinal sensitivity when tested with microperimetry which suggests a functional correlate of lipofuscin accumulation. Increased FAF preceded the development and enlargement of outer retinal atrophy associated with spread of absolute scotoma in eyes with AMD. Longitudinal examinations showed that the abnormal phenotypic FAF patterns serve as novel prognostic determinants which allows to distinguish fast vs. slow progressors. These findings are relevant and now used to design and carry out interventional trials with agents aimed at slowing down spread of atrophy, e.g. using visual cycle modulators to influence lipofuscinogenesis. Hereby FAF imaging also serves as a mean to accurately delineate and measure areas of GA over time in an automated fashion. A phenotype-genotype correlation was identified for a distinct FAF phenotype subset which was found to represent late-onset Stargardt macular dystrophy mimicking late-stage atrophic AMD. New imaging technologies were recently applied including simultaneous recordings of FAF images and high-resolution, spectral-domain optical coherence tomography (OCT) which allows to identify morphological correlates of abnormal FAF signals in optical biopsies. [source] Assessment of coronary blood flow and the reactivity of the microcirculation non-invasively with transthoracic echocardiographyCLINICAL PHYSIOLOGY AND FUNCTIONAL IMAGING, Issue 3 2008Tuomas Kiviniemi Summary Background:, The development in ultrasound technology has allowed the use of non-invasive transthoracic echocardiography (TTE) for the study of coronary artery physiology and pathophysiology. TTE can be used to detect atherosclerotic changes in epicardial coronary arteries and to study the effects of specific interventions on coronary microcirculation. Aim:, The purpose of this review was to summarize the development of TTE, and outweigh the strenghts and weaknesses of the method for the evaluation of coronary artery blood flow. Moreover, findings from clinical trials studying microcirculatory reactivity using TTE are presented. Conclusions:, TTE is a feasible and reproducible method for the evaluation of coronary artery blood flow. It can also be used in assessing the vasodilation of the epicardial coronary artery simultaneously with flow velocity measurement during the cold pressor test and coronary flow velocity reserve assessment. It is specifically suitable for repeated measurements in interventional trials. [source] | ||||||||||