1,214 research outputs found
Rethinking clinical trials of transcranial direct current stimulation: Participant and assessor blinding is inadequate at intensities of 2mA
Get PDFCopyright @ 2012 The Authors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and 85 reproduction in any medium, provided the original author and source are credited. The article was made available through the Brunel University Open Access Publishing Fund.Background: Many double-blind clinical trials of transcranial direct current stimulation (tDCS) use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. Methods:
A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised) at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. Results: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ) 0.28, 95% confidence interval (CI) 0.09 to 0.47 p = 0.005) and the second session (κ = 0.77, 95%CI 0.64 to 0.90), p = <0.001) indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ = 0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ = 0.677, 95%CI 0.534 to 0.82) indicating inadequate assessor blinding. Conclusions: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.GLM is supported by the National Health & Medical Research Council of Australia ID 571090
From sham to reality: Should a wrong be taxed as a right?
No full textHow should a sham be treated for tax purposes? In 1524994 Ontario Ltd. v. M.N.R., the Federal Court of Appeal treated a sham as if it reflected the true agreement between the parties in order to uphold a GST assessment. The result was inconsistent with existing jurisprudence and undesirable. Courts should apply the law to the true facts only, and should not overlook or give effect to a sham in order to achieve the desired juridical consequences. The author reviews the origins and development of the sham doctrine and introduces a three-part typology of sham cases. In situations like 1524994 Ontario Ltd. v. M.N.R., the sham is intended to obtain non-tax benefits from a third-party victim, but in the process triggers unintended tax consequences, which are the subject of litigation. Although the traditional approach in Continental Bank Leasing Corp. v. M.N.R. (under which recharacterization is permissible only if the label attached to a transaction does not reflect its actual legal effect) could result in non-payment of taxes and retention of improperly obtained benefits, the author concludes that this result would be preferable to that of the Federal Court of Appeal judgment. Treating a sham as real, and taxing a wrong as a right (1) will not deter parties from creating shams to obtain non-tax benefits, (2) will violate longstanding principles that tax law be applied with neutrality and equity and without considering its effects, and (3) will increase uncertainty and inconsistency in the case law
Bone Marrow Transplant
Get PDFDriven by access to better drugs, on average, newly diagnosed multiple myeloma patients have over 10 years overall survival. Using modern combination therapies-with or without the addition of high-dose melphalan and autologous stem cell transplantation-up to 80% of patients reach a complete response. As a logical and necessary step forward, clinical studies have explored strategies to detect minimal residual disease (MRD) and its correlation with clinical outcomes. In this context, MRD has been proposed as a regulatory end point for drug approval in newly diagnosed multiple myeloma. To better define the role of MRD negativity in relation to clinical outcomes, we undertook a meta-analysis including published clinical trials of newly diagnosed multiple myeloma patients. We applied a random effects model which weighted studies using the inverse-variance method. Studies were combined on the scale of the logarithm of the hazard ratio (HR) and the corresponding s.d. We found that MRD negativity (versus positivity) was associated with better PFS (HR=0.35; 95% confidence interval (CI) 0.27-0.46; P<0.001) and overall survival (HR=0.48; 95% CI 0.33-0.70; P<0.001). Our results show that MRD negativity is a strong predictor of clinical outcomes, supportive of MRD becoming a regulatory end point for drug approval in newly diagnosed multiple myeloma.20162017-08-25T00:00:00ZP30 CA008748/CA/NCI NIH HHS/United StatesU01 FD005642/FD/FDA HHS/United StatesU01 OH011475/OH/NIOSH CDC HHS/United States27595280PMC55717521050
SHAM WOMEN.
No full textThe object of this study is to investigate specific sham woman image in art works, and to analyse the treatment of woman as object in art and society. To analyse the general conception of props and sham, look through the cultural history on purpose to find how they were used in practical part of art. The author of this study examines the sham principle in fashion, analyses components of the costume and focuses on phenomenon how the part of the costume can change the person into the sham object. The corset is used as such changing part of the costume. It is chosen as the artistic expression of the practical work of women photographers trying to visualize sham principle. The concept of theoretical part deals with the culture for and (postmodern) culture in the context of the feminist analysis of the representatives of the claims. Also the most popular images of woman in art and the main principles of making these images were discussed in this study. A lot of attention was paid to fashion photography and also graphic design, having an assumption that most important part of graphic design for this study is calendar design. The correlation between art photography and graphic design was used as purpose to expose visualization of sham woman in calendar which was designed especially for this study. Also the relevance for pedagogy and practical adaptation of this study in the fields of art education were evaluated
Dealing with the Emerging Popularity of Sham Trusts
No full textThis article considers the doctrines of sham trusts and alter egos currently causing some controversy among trust lawyers. The author analyses recent decisions of the High Court involving allegations of sham trusts and alter egos and relevant authorities from other jurisdictions and assesses the legitimacy of the concepts in the context of established trusts law. While the author accepts the existence of sham trusts, she advocates for a narrower ambit limiting their application only to ab initio shams and rejects both emerging shams and alter egos. Further, the relevant intention with which sham trusts are concerned is only that of the settlor and there should therefore be no requirement of a common sham intention as a prerequisite to finding a sham trust
Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World
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