WorldWideScience

Sample records for subjects post hoc

  1. Tavaborole in Difficult-to-Treat Onychomycosis Cases: A Post-hoc Assessment of Phase III Subjects.

    Science.gov (United States)

    Aly, Raza; Gupta, Aditya K; Winter, Tate; Zane, Lee T; Vlahovic, Tracey

    2017-10-01

    Toenail onychomycosis is a chronic fungal infection that often requires prolonged treatment in order to effectively manage pathogenic organisms and obtain a clear nail. Traditionally, certain clinical features of onychomycosis, including the presence of substantial lateral disease, focal fungal masses, yellow/brown streaks, and extensive nail involvement (ie, >50%), indicate a poor treatment prognosis and have proven difficult-to-treat with oral or traditional topical therapies. Owing to the novel features of topical tavaborole, we sought to understand the potential utility of tavaborole in difficult-to-treat onychomycosis. A blinded, post-hoc assessment of Phase III trials was conducted, focusing on initial presentation, midpoint assessment (24 weeks), and final outcomes (52 weeks) in subjects identified as having difficult-to-treat onychomycosis and treated for 48 weeks with once-daily application of either tavaborole 5% solution or vehicle. Our post-hoc analysis identified 84 difficult-to-treat cases (tavaborole 5%; n=60; vehicle, n=24) in subjects with toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. No subjects identified as difficult-to-treat and treated with vehicle achieved a complete cure, while 6 subjects treated with tavaborole 5% attained a completely clear nail and negative mycology. Similarly, 7 subjects treated with tavaborole 5% solution achieved an almost complete cure (≤10% involvement and negative mycology) while 1 subject on vehicle achieved an almost complete cure. We present a case series of 4 patients, of varying age and difficult-to-treat clinical features, which responded positively to tavaborole 5% solution. Three of the subjects achieved complete cure after being treated with tavaborole 5%, with one additional subject (an 88-year-old female) achieving an almost complete clear nail by treatment end. The outcomes presented here may not be reflective of patients that may present with these clinical

  2. Post hoc Bayesian model selection.

    Science.gov (United States)

    Friston, Karl; Penny, Will

    2011-06-15

    This note describes a Bayesian model selection or optimization procedure for post hoc inferences about reduced versions of a full model. The scheme provides the evidence (marginal likelihood) for any reduced model as a function of the posterior density over the parameters of the full model. It rests upon specifying models through priors on their parameters, under the assumption that the likelihood remains the same for all models considered. This provides a quick and efficient scheme for scoring arbitrarily large numbers of models, after inverting a single (full) model. In turn, this enables the selection among discrete models that are distinguished by the presence or absence of free parameters, where free parameters are effectively removed from the model using very precise shrinkage priors. An alternative application of this post hoc model selection considers continuous model spaces, defined in terms of hyperparameters (sufficient statistics) of the prior density over model parameters. In this instance, the prior (model) can be optimized with respect to its evidence. The expressions for model evidence become remarkably simple under the Laplace (Gaussian) approximation to the posterior density. Special cases of this scheme include Savage-Dickey density ratio tests for reduced models and automatic relevance determination in model optimization. We illustrate the approach using general linear models and a more complicated nonlinear state-space model. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. POST-HOC SEGMENTATION USING MARKETING RESEARCH

    National Research Council Canada - National Science Library

    CRISTINEL CONSTANTIN

    2012-01-01

    .... These methods are K-means cluster and TwoStep cluster, which are available in SPSS system. Such methods could be used in post-hoc market segmentations, which allow companies to find segments with specific behaviours or attitudes...

  4. Post hoc analyses: after the facts.

    Science.gov (United States)

    Srinivas, Titte R; Ho, Bing; Kang, Joseph; Kaplan, Bruce

    2015-01-01

    Prospective clinical trials are constructed with high levels of internal validity. Sample size and power considerations usually address primary endpoints. Primary endpoints have traditionally included events that are becoming increasingly less common and thus have led to growing use of composite endpoints and noninferiority trial designs in transplantation. This approach may mask real clinical benefit in one or the other domain with regard to either clinically relevant secondary endpoints or other unexpected findings. In addition, endpoints solely chosen based on power considerations are prone to misjudgment of actual treatment effect size as well as consistency of that effect. In the instances where treatment effects may have been underestimated, valuable information may be lost if buried within a composite endpoint. In all these cases, analyses and post hoc analyses of data become relevant in informing practitioners about clinical benefits or safety signals that may not be captured by the primary endpoint. On the other hand, there are many pitfalls in using post hoc determined endpoints. This short review is meant to allow readers to appreciate post hoc analysis not as an entity with a single approach, but rather as an analysis with unique limitations and strengths that often raise new questions to be addressed in further inquiries.

  5. On the Post Hoc Power in Testing Mean Differences

    Science.gov (United States)

    Yuan, Ke-Hai; Maxwell, Scott

    2005-01-01

    Retrospective or post hoc power analysis is recommended by reviewers and editors of many journals. Little literature has been found that gave a serious study of the post hoc power. When the sample size is large, the observed effect size is a good estimator of the true power. This article studies whether such a power estimator provides valuable…

  6. Post Hoc Analyses of ApoE Genotype-Defined Subgroups in Clinical Trials.

    Science.gov (United States)

    Kennedy, Richard E; Cutter, Gary R; Wang, Guoqiao; Schneider, Lon S

    2016-01-01

    Many post hoc analyses of clinical trials in Alzheimer's disease (AD) and mild cognitive impairment (MCI) are in small Phase 2 trials. Subject heterogeneity may lead to statistically significant post hoc results that cannot be replicated in larger follow-up studies. We investigated the extent of this problem using simulation studies mimicking current trial methods with post hoc analyses based on ApoE4 carrier status. We used a meta-database of 24 studies, including 3,574 subjects with mild AD and 1,171 subjects with MCI/prodromal AD, to simulate clinical trial scenarios. Post hoc analyses examined if rates of progression on the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) differed between ApoE4 carriers and non-carriers. Across studies, ApoE4 carriers were younger and had lower baseline scores, greater rates of progression, and greater variability on the ADAS-cog. Up to 18% of post hoc analyses for 18-month trials in AD showed greater rates of progression for ApoE4 non-carriers that were statistically significant but unlikely to be confirmed in follow-up studies. The frequency of erroneous conclusions dropped below 3% with trials of 100 subjects per arm. In MCI, rates of statistically significant differences with greater progression in ApoE4 non-carriers remained below 3% unless sample sizes were below 25 subjects per arm. Statistically significant differences for ApoE4 in post hoc analyses often reflect heterogeneity among small samples rather than true differential effect among ApoE4 subtypes. Such analyses must be viewed cautiously. ApoE genotype should be incorporated into the design stage to minimize erroneous conclusions.

  7. Comparison of steady-state plasma concentrations of armodafinil and modafinil late in the day following morning administration: post hoc analysis of two randomized, double-blind, placebo-controlled, multiple-dose studies in healthy male subjects.

    Science.gov (United States)

    Darwish, Mona; Kirby, Mary; Hellriegel, Edward T

    2009-01-01

    Armodafinil, the R- and longer-lasting isomer of modafinil, may maintain higher plasma drug concentrations compared with racemic modafinil because of stereospecific differences in elimination of its isomers. This analysis set out to compare the steady-state pharmacokinetic profiles of armodafinil and modafinil on a milligram-to-milligram basis following once-daily administration. A post hoc analysis of two multiple-dose pharmacokinetic studies in healthy male subjects aged 18-50 years was conducted to compare dose-normalized (200 mg/day) plasma drug concentration and pharmacokinetic data for subjects in each study who completed 7 days of once-daily (morning) administration of armodafinil (n = 34) or modafinil (n = 18). Dose-normalized plasma concentrations of armodafinil on day 7 were higher than those of modafinil, with the greatest differences being observed later in the day. Across the 24-hour dose interval, plasma drug concentration fluctuation and swing were 28% and 42% less, respectively, with armodafinil than with modafinil. In addition, average late-day (3 pm to 7 pm after an 8 am dosing) plasma drug concentrations and partial values for the area under the plasma concentration versus time curve for 7-11 hours after dosing were both 44% higher with armodafinil. At steady state, armodafinil produces consistently higher plasma drug concentrations late in the day than modafinil when compared on a milligram-to-milligram basis. The distinct pharmacokinetic profile of armodafinil compared with that of the racemate may result in fundamentally different durations of action. These differences between the two medications cannot be made equivalent by increasing the dose of the racemate without introducing potential safety concerns.

  8. Post-hoc selection of dynamic causal models

    Science.gov (United States)

    Rosa, M.J.; Friston, K.; Penny, W.

    2012-01-01

    Dynamic causal modelling (DCM) was originally proposed as a hypothesis driven procedure in which a small number of neurobiologically motivated models are compared. Model comparison in this context usually proceeds by individually fitting each model to data and then approximating the corresponding model evidence with a free energy bound. However, a recent trend has emerged for comparing very large numbers of models in a more exploratory manner. This led Friston and Penny (2011) to propose a post-hoc approximation to the model evidence, which is computed by optimising only the largest (full) model of a set of models. The evidence for any (reduced) submodel is then obtained using a generalisation of the Savage-Dickey density ratio (Dickey, 1971). The benefit of this post-hoc approach is a huge reduction in the computational time required for model fitting. This is because only a single model is fitted to data, allowing a potentially huge model space to be searched relatively quickly. In this paper, we explore the relationship between the free energy bound and post-hoc approximations to the model evidence in the context of deterministic (bilinear) dynamic causal models (DCMs) for functional magnetic resonance imaging data. PMID:22561579

  9. Post Hoc Tourist Segmentation with Conjoint and Cluster Analysis

    Directory of Open Access Journals (Sweden)

    Sérgio Dominique Ferreira Lopes

    2009-01-01

    Full Text Available En el presente trabajo los autores pretenden ilustrar las ventajas del uso combinado del Análisis Conjunto y del Análisis de Conglomerados, en la segmentación del mercado turístico. Los beneficios son fácilmente entendidos, una vez que el Análisis Conjunto permite a los investigadores conocer la estructura de las preferencias de los consumidores y el Análisis de Conglomerados los agrupa en segmentos, a partir de las preferencias de éstos. Habida cuenta de la enorme complejidad y diversificación que está adquiriendo el mercado turístico en nuestros días, carece de sentido adoptar estrategias de segmentación a priori, basadas únicamente en variables clásicas de corte sociodemográfico, cuya capacidad explicativa ha demostrado ser muy limitada. En su lugar, optar por procedimientos de segmentación post hoc, donde se incluya información más elaborada, como pueden ser las preferencias de los consumidores turistas (estimadas a partir de procedimientos estadísticos avanzados como el Análisis Conjunto, se convierte en una ventaja competitiva. La segmentación basada en las preferencias permite a investigadores y gestores disponer de un conocimiento más preciso del mercado y desarrollar estrategias de Marketing adecuadas a cada uno de los segmentos de interés.

  10. Studying synaptic efficiency by post-hoc immunolabelling

    Science.gov (United States)

    2013-01-01

    Background In terms of vesicular recycling, synaptic efficiency is a key determinant of the fidelity of synaptic transmission. The ability of a presynaptic terminal to reuse its vesicular content is thought to be a signature of synaptic maturity and this process depends on the activity of several proteins that govern exo/endocytosis. Upon stimulation, individual terminals in networks of cultured cerebellar granule neurons exhibit heterogeneous exocytic responses, which reflect the distinct states of maturity and plasticity intrinsic to individual synaptic terminals. This dynamic scenario serves as the substrate for processes such as scaling, plasticity and synaptic weight redistribution. Presynaptic strength has been associated with the activity of several types of proteins, including the scaffolding proteins that form the active zone cytomatrix and the proteins involved in presynaptic exocytosis. Methods We have combined fluorescence imaging techniques using the styryl dye FM1-43 in primary cultures of cerebellar granule cells with subsequent post-hoc immunocytochemistry in order to study synaptic efficiency in terms of vesicular release. We describe a protocol to easily quantify these results with minimal user intervention. Results In this study we describe a technique that specifically correlates presynaptic activity with the levels of presynaptic markers. This method involves the use of the styryl dye FM1-43 to estimate the release capacity of a synaptic terminal, and the subsequent post-hoc immunolabelling of thousands of individual nerve terminals. We observed a strong correlation between the release capacity of the nerve terminal and the levels of the RIM1α but not the Munc13-1 protein in the active zone. Conclusions Our findings support those of previous studies and point out to RIM1α as a crucial factor in determining synaptic efficiency. These results also demonstrate that this technique is a useful tool to analyse the molecular differences

  11. POST-HOC AND MULTIPLE COMPARISON TEST – AN OVERVIEW WITH SAS AND R STATISTICAL PACKAGE

    OpenAIRE

    Editor,IJSMI

    2016-01-01

    Analysis of Variance (ANOVA) is a basic but most important tool in Statistics. The simplest form is one way ANOVA wherein equivalence of treatment means are tested. If the means are not equal then the next step is to check which means are different from each other. Post-Hoc and multiple comparison tests are used to identify which pairs of treatment means differ. This paper starts with the overview of Post-Hoc and Multiple Comparison test and discusses the various Post-hoc multiple comparison ...

  12. Danni cerebrali neonatali: la fallacia del post hoc ergo propter hoc

    OpenAIRE

    Magini, Marina; Ingravallo, Francesca; Cicognani, Alberto

    2007-01-01

    Perinatal cerebral injury is an important subject in medical malpractice litigation. In most cases of claims for neonatal injuries the Italian Courts sentence the medical or hospital liability. The authors present a case of obstetrical negligence claim, in which parents alleged the severe mental retardation of their term born infant to negligence during labour. Although the most part of severe mental retardation is not the result of intrapartum injuries, the official expert call upon to judge...

  13. Post hoc interpretation of urodynamic evaluation is qualitatively different than interpretation at the time of urodynamic study.

    Science.gov (United States)

    Smith, Phillip P; Hurtado, Eric A; Appell, Rodney A

    2009-01-01

    Intraobserver reliability of post hoc urodynamic interpretation is greater than interobserver reliability, attributable to interpreter bias. If post hoc interpretation is qualitatively similar to interpretation at the time of study by a urodynamicist in attendance ("live" interpretation), a similar intraobserver bias should be observed. We therefore evaluated the intra- and interobserver reliability of post hoc versus "live" interpretation. Fifty-five consecutive urodynamic studies administered by each of two urodynamicists and interpreted at the time of study were de-identified and later re-interpreted by the same two physicians. History and exam findings, cystometric tracing, uroflow summary and radiographs were available for interpretation. Intraobserver (post hoc vs. live), interobserver (post hoc vs. live) and interobserver (post hoc vs. post hoc) reliability was assessed by correlation coefficients for quantitative data, and Cohen's kappa statistic for categorical data. Post hoc versus live interpretations demonstrated no superiority of intraobserver reliability. For categorical observations, intraobserver reliability was best for urodynamic observations, but worse for clinical diagnosis (kappa = 0.37) and primary treatment recommendation (kappa = 0.26). Interobserver reliabilities were similar to intraobserver. Post hoc/post hoc interobserver correlations for quantitative data were good to very good, r(2) = 0.611-0.914. In contrast to previously reported post hoc/post hoc comparisons, post hoc/live comparison demonstrated no superiority of intraobserver reliability. Urodynamic observations and impressions are more reliable than are clinical diagnosis and therapeutic recommendation based upon urodynamic evaluation. Unrecorded and heuristic observations at the time of study as well as interpreter judgment may thus be determinants of diagnostic interpretation of urodynamic evaluation. (c) 2009 Wiley-Liss, Inc.

  14. Valid randomization-based p-values for partially post hoc subgroup analyses.

    Science.gov (United States)

    Lee, Joseph J; Rubin, Donald B

    2015-10-30

    By 'partially post-hoc' subgroup analyses, we mean analyses that compare existing data from a randomized experiment-from which a subgroup specification is derived-to new, subgroup-only experimental data. We describe a motivating example in which partially post hoc subgroup analyses instigated statistical debate about a medical device's efficacy. We clarify the source of such analyses' invalidity and then propose a randomization-based approach for generating valid posterior predictive p-values for such partially post hoc subgroups. Lastly, we investigate the approach's operating characteristics in a simple illustrative setting through a series of simulations, showing that it can have desirable properties under both null and alternative hypotheses. Copyright © 2015 John Wiley & Sons, Ltd.

  15. A-priori and post-hoc segmentation in the design of healthy eating campaigns

    DEFF Research Database (Denmark)

    Kazbare, Laura; van Trijp, Hans C. M.; Eskildsen, Jacob Kjær

    2010-01-01

    . Although such practice may be justifiable from the practical point of view, it is unclear how effective these implicit segmentations are. In this study the authors argue that  it is important to transcend demographic boundaries and to further segment demographic groups. A study with 13-15-year...... and a post-hoc segmentation. The results of the study show that it is useful and also ethical to differentiate people using segmentation methods, since it facilitates reaching more vulnerable segments of society that in general resist change. It also demonstrates that post-hoc segmentation is more helpful...

  16. An Analysis of Application of Multiple Comparison Tests (post-hoc) in ANOVA in Recently Published Medical Research Literature

    OpenAIRE

    Swati Patel, Vipin Naik, Prakash Patel

    2015-01-01

    "Background: The usage of statistical methods specially ANOVA and post hoc test are increase in medical research, however inaccurate application of ANOVA and post hoc test were observed commonly. So we reviewed application of ANOVA and post-hoc test in recent published biomedical research literature. Method: Original articles published in bio-medical journals subscribed by the central library of our institute (SMIMER, Surat) were reviewed for statistical applications mainly ANOVA and ...

  17. Using DDF in a Post Hoc Analysis to Understand Sources of DIF

    Science.gov (United States)

    Banks, Kathleen

    2009-01-01

    The purpose of this article is to describe and demonstrate a three-step process of using differential distractor functioning (DDF) in a post hoc analysis to understand sources of differential item functioning (DIF) in multiple-choice testing. The process is demonstrated on two multiple-choice tests that used complex alternatives (e.g., "No…

  18. Post-Hoc IRT Equating of Previously Administered English Tests for Comparison of Test Scores

    Science.gov (United States)

    Saida, Chisato; Hattori, Tamaki

    2008-01-01

    Despite growing concerns about declining scholastic abilities of Japanese students throughout Japan prior to the implementation of the revised Courses of Study in 2002, little empirical evidence was available at that time to support this perceived decline in academic performance. This research describes post-hoc IRT equating of previously…

  19. Moving beyond Univariate Post-Hoc Testing in Exercise Science: A Primer on Descriptive Discriminate Analysis

    Science.gov (United States)

    Barton, Mitch; Yeatts, Paul E.; Henson, Robin K.; Martin, Scott B.

    2016-01-01

    There has been a recent call to improve data reporting in kinesiology journals, including the appropriate use of univariate and multivariate analysis techniques. For example, a multivariate analysis of variance (MANOVA) with univariate post hocs and a Bonferroni correction is frequently used to investigate group differences on multiple dependent…

  20. Benefits of Using Planned Comparisons Rather Than Post Hoc Tests: A Brief Review with Examples.

    Science.gov (United States)

    DuRapau, Theresa M.

    The rationale behind analysis of variance (including analysis of covariance and multiple analyses of variance and covariance) methods is reviewed, and unplanned and planned methods of evaluating differences between means are briefly described. Two advantages of using planned or a priori tests over unplanned or post hoc tests are presented. In…

  1. Post Hoc

    Science.gov (United States)

    Ikeme, Jesse C; Pergola, Pablo E; Scherzer, Rebecca; Shlipak, Michael G; Benavente, Oscar R; Peralta, Carmen A

    2017-07-07

    Despite the high burden of CKD, few specific therapies are available that can halt disease progression. In animal models, clopidogrel has emerged as a potential therapy to preserve kidney function. The effect of clopidogrel on kidney function in humans has not been established. The Secondary Prevention of Small Subcortical Strokes Study randomized participants with prior lacunar stroke to treatment with aspirin or aspirin plus clopidogrel. We compared annual eGFR decline and incidence of rapid eGFR decline (≥30% from baseline) using generalized estimating equations and interval-censored proportional hazards regression, respectively. We also stratified our analyses by baseline eGFR, systolic BP target, and time after randomization. At randomization, median age was 62 (interquartile range, 55-71) years old; 36% had a history of diabetes, 90% had hypertension, and the median eGFR was 81 (interquartile range, 65-94) ml/min per 1 m 2 . Persons receiving aspirin plus clopidogrel had an average annual change in kidney function of -1.39 (95% confidence interval, -1.15 to -1.62) ml/min per 1.73 m 2 per year compared with -1.52 (95% confidence interval, -1.30 to -1.74) ml/min per 1.73 m 2 per year among persons receiving aspirin only ( P =0.42). Rapid kidney function decline occurred in 21% of participants receiving clopidogrel plus aspirin compared with 22% of participants receiving aspirin plus placebo (hazard ratio, 0.94; 95% confidence interval, 0.79 to 1.10; P =0.42). Findings did not vary by baseline eGFR, time after randomization, or systolic BP target (all P values for interaction were >0.3). We found no effect of clopidogrel added to aspirin compared with aspirin alone on kidney function decline among persons with prior lacunar stroke. Copyright © 2017 by the American Society of Nephrology.

  2. Regressive research: The pitfalls of post hoc data selection in the study of unconscious mental processes.

    Science.gov (United States)

    Shanks, David R

    2017-06-01

    Many studies of unconscious processing involve comparing a performance measure (e.g., some assessment of perception or memory) with an awareness measure (such as a verbal report or a forced-choice response) taken either concurrently or separately. Unconscious processing is inferred when above-chance performance is combined with null awareness. Often, however, aggregate awareness is better than chance, and data analysis therefore employs a form of extreme group analysis focusing post hoc on participants, trials, or items where awareness is absent or at chance. The pitfalls of this analytic approach are described with particular reference to recent research on implicit learning and subliminal perception. Because of regression to the mean, the approach can mislead researchers into erroneous conclusions concerning unconscious influences on behavior. Recommendations are made about future use of post hoc selection in research on unconscious cognition.

  3. Level of literacy and dementia: A secondary post-hoc analysis from North-West India.

    Science.gov (United States)

    Raina, Sunil Kumar; Chander, Vishav; Kumar, Dinesh; Raina, Sujeet; Bhardwaj, Ashok

    2014-10-01

    A relation between literacy and dementia has been studied in past and an association has been documented. This is in spite of some studies pointing to the contrary. The current study was aimed at investigating the influence of level of literacy on dementia in a sample stratified by geography (Migrant, Urban, Rural and Tribal areas of sub-Himalayan state of Himachal Pradesh, India). The study was based on post-hoc analysis of data obtained from a study conducted on elderly population (60 years and above) from selected geographical areas (Migrant, Urban, Rural and Tribal) of Himachal Pradesh state in North-west India. Analysis of variance revealed an effect of education on cognitive scores [F = 2.823, P =0.01], however, post-hoc Tukey's HSD test did not reveal any significant pairwise comparisons. The possibility that education effects dementia needs further evaluation, more so in Indian context.

  4. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes: methodological challenges.

    Science.gov (United States)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John; Knol, Miriam J; Leufkens, Hubert G M; Woodward, Mark; Patel, Anushka; Grobbee, Diederick E; De Bruin, Marie L

    2013-11-01

    Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges, which need to be addressed when re-analysing trial data for cancer related outcomes. Substantial amount of information on cancer outcomes is available from RCTs. Hence, making use of such data could save time and spare patients from inclusion in further trials. However, methodological challenges must be addressed to enhance the likelihood of reliable conclusions. Advantages of post-hoc analyses of RCTs include quality of data collected and sometimes randomisation to exposure of interest. Limitations include confounding and sample size, which is fixed to suit the purposes of the trial, insufficient duration of exposure and identification of underlying biological mechanisms relating treatment to cancer to formulate the most appropriate post-hoc study design.

  5. An alternative to post hoc model modification in confirmatory factor analysis: The Bayesian lasso.

    Science.gov (United States)

    Pan, Junhao; Ip, Edward Haksing; Dubé, Laurette

    2017-12-01

    As a commonly used tool for operationalizing measurement models, confirmatory factor analysis (CFA) requires strong assumptions that can lead to a poor fit of the model to real data. The post hoc modification model approach attempts to improve CFA fit through the use of modification indexes for identifying significant correlated residual error terms. We analyzed a 28-item emotion measure collected for n = 175 participants. The post hoc modification approach indicated that 90 item-pair errors were significantly correlated, which demonstrated the challenge in using a modification index, as the error terms must be individually modified as a sequence. Additionally, the post hoc modification approach cannot guarantee a positive definite covariance matrix for the error terms. We propose a method that enables the entire inverse residual covariance matrix to be modeled as a sparse positive definite matrix that contains only a few off-diagonal elements bounded away from zero. This method circumvents the problem of having to handle correlated residual terms sequentially. By assigning a Lasso prior to the inverse covariance matrix, this Bayesian method achieves model parsimony as well as an identifiable model. Both simulated and real data sets were analyzed to evaluate the validity, robustness, and practical usefulness of the proposed procedure. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  6. Selective disinhibition: A unified neural mechanism for predictive and post hoc attentional selection.

    Science.gov (United States)

    Sridharan, Devarajan; Knudsen, Eric I

    2015-11-01

    The natural world presents us with a rich and ever-changing sensory landscape containing diverse stimuli that constantly compete for representation in the brain. When the brain selects a stimulus as the highest priority for attention, it differentially enhances the representation of the selected, "target" stimulus and suppresses the processing of other, distracting stimuli. A stimulus may be selected for attention while it is still present in the visual scene (predictive selection) or after it has vanished (post hoc selection). We present a biologically inspired computational model that accounts for the prioritized processing of information about targets that are selected for attention either predictively or post hoc. Central to the model is the neurobiological mechanism of "selective disinhibition" - the selective suppression of inhibition of the representation of the target stimulus. We demonstrate that this mechanism explains major neurophysiological hallmarks of selective attention, including multiplicative neural gain, increased inter-trial reliability (decreased variability), and reduced noise correlations. The same mechanism also reproduces key behavioral hallmarks associated with target-distracter interactions. Selective disinhibition exhibits several distinguishing and advantageous features over alternative mechanisms for implementing target selection, and is capable of explaining the effects of selective attention over a broad range of real-world conditions, involving both predictive and post hoc biasing of sensory competition and decisions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Smoking cessation and inattention or hyperactivity/impulsivity: a post hoc analysis

    Science.gov (United States)

    Covey, Lirio S.; Manubay, Jeanne; Jiang, Huiping; Nortick, Mariel; Palumbo, Domenica

    2012-01-01

    Tobacco use is more prevalent and smoking cessation less likely among persons with attention deficit hyperactivity disorder (ADHD) than the general population. Evidence that tobacco use and nicotine hold divergent relationships with inattention (IN) and hyperactivity/impulsivity (HI), the core symptoms of ADHD, prompted this post hoc investigation of abstinence patterns by type of ADHD symptoms. Subjects were 583 adult smokers treated openly with bupropion and nicotine patch during the initial eight-week phase of a maintenance treatment study. Using the ADHD Current Symptom Scale, clinically significant ADHD symptom subtypes, i.e., predominantly inattention (ADHD-IN) and predominantly hyperactivity/impulsivity with or without inattention (ADHD-HI+/-IN), were identified. The study outcome was abstinence status, verified by expired carbon monoxide <8 parts per million, at five clinic visits from Week 1 through the end of treatment at Week 8. The distribution by ADHD symptom status was: No ADHD=540; ADHD-IN=20; ADHD-HI+/-IN=23. The study groups did not differ on demographic or smoking variables. The frequency of past major depression was highest with ADHD-IN and the frequency of past alcohol dependence was highest with ADHD-HI+/-IN. Compared to smokers with no ADHD, smokers of both ADHD subtypes combined showed lower abstinence rates throughout the study (OR=0.54, 95% CI: 0.32-0.99). Disaggregation by symptom subtype and separate comparisons against smokers with no ADHD showed that lower odds of quitting occurred mainly with ADHD-HI+/-IN (OR=0.40, 95% CI:=0.19-0.82), not with ADHD-IN (OR=0.74, 95% CI=p=0.36-1.51). Combined bupropion and nicotine patch treatment appears to be helpful for smokers with IN but not smokers with HI symptoms. The reasons for this divergent treatment response warrant further investigation. PMID:19023824

  8. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

    National Research Council Canada - National Science Library

    Brown, Justin C; Schmitz, Kathryn H

    2015-01-01

    .... We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer...

  9. Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis.

    Science.gov (United States)

    Sakaida, Isao; Terai, Shuji; Nakajima, Koji; Shibasaki, Yoshiyuki; Tachikawa, Sayaka; Tsubouchi, Hidetsugu

    2017-02-01

    Tolvaptan has been approved in Japan for the treatment of hepatic edema. An important consideration in providing a clinical benefit to patients with liver cirrhosis is the improvement of ascites-related clinical symptoms. In the present post hoc analysis, we aimed to identify factors that were predictive of the potency of tolvaptan, and to examine the relationship between changes in initial urine volume and improvement in ascites-related clinical symptoms. This post hoc analysis was based on three previous phase 2 and 3 clinical trials of tolvaptan in patients with liver cirrhosis. Predictive factors associated with a change in initial urine volume were identified. A change of ≥500 mL from baseline confirmed the pharmacological action of tolvaptan treatment. The relationship between the change in initial urine volume and improvement in ascites-related clinical symptoms was also examined. A total of 152 patients were enrolled in this study. Body weight and BUN were identified as predictive parameters. Among patients with a change in initial urine volume of ≥500 mL, 75 % demonstrated improvement in ascites-related clinical symptoms, while no improvement was seen in those with a change of <500 mL. None of the patients with initial urine volume of <500 mL showed resolution of symptoms. Change in urine volume was affected by both baseline body weight and BUN in tolvaptan-treated subjects. Higher urine output was associated with improvements in ascites-related clinical symptoms.

  10. The choice of product indicators in latent variable interaction models: post hoc analyses.

    Science.gov (United States)

    Foldnes, Njål; Hagtvet, Knut Arne

    2014-09-01

    The unconstrained product indicator (PI) approach is a simple and popular approach for modeling nonlinear effects among latent variables. This approach leaves the practitioner to choose the PIs to be included in the model, introducing arbitrariness into the modeling. In contrast to previous Monte Carlo studies, we evaluated the PI approach by 3 post hoc analyses applied to a real-world case adopted from a research effort in social psychology. The measurement design applied 3 and 4 indicators for the 2 latent 1st-order variables, leaving the researcher with a choice among more than 4,000 possible PI configurations. Sixty so-called matched-pair configurations that have been recommended in previous literature are of special interest. In the 1st post hoc analysis we estimated the interaction effect for all PI configurations, keeping the real-world sample fixed. The estimated interaction effect was substantially affected by the choice of PIs, also across matched-pair configurations. Subsequently, a post hoc Monte Carlo study was conducted, with varying sample sizes and data distributions. Convergence, bias, Type I error and power of the interaction test were investigated for each matched-pair configuration and the all-pairs configuration. Variation in estimates across matched-pair configurations for a typical sample was substantial. The choice of specific configuration significantly affected convergence and the interaction test's outcome. The all-pairs configuration performed overall better than the matched-pair configurations. A further advantage of the all-pairs over the matched-pairs approach is its unambiguity. The final study evaluates the all-pairs configuration for small sample sizes and compares it to the non-PI approach of latent moderated structural equations. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  11. Recognition of activities of daily living in healthy subjects using two ad-hoc classifiers.

    Science.gov (United States)

    Urwyler, Prabitha; Rampa, Luca; Stucki, Reto; Büchler, Marcel; Müri, René; Mosimann, Urs P; Nef, Tobias

    2015-06-06

    Activities of daily living (ADL) are important for quality of life. They are indicators of cognitive health status and their assessment is a measure of independence in everyday living. ADL are difficult to reliably assess using questionnaires due to self-reporting biases. Various sensor-based (wearable, in-home, intrusive) systems have been proposed to successfully recognize and quantify ADL without relying on self-reporting. New classifiers required to classify sensor data are on the rise. We propose two ad-hoc classifiers that are based only on non-intrusive sensor data. A wireless sensor system with ten sensor boxes was installed in the home of ten healthy subjects to collect ambient data over a duration of 20 consecutive days. A handheld protocol device and a paper logbook were also provided to the subjects. Eight ADL were selected for recognition. We developed two ad-hoc ADL classifiers, namely the rule based forward chaining inference engine (RBI) classifier and the circadian activity rhythm (CAR) classifier. The RBI classifier finds facts in data and matches them against the rules. The CAR classifier works within a framework to automatically rate routine activities to detect regular repeating patterns of behavior. For comparison, two state-of-the-art [Naïves Bayes (NB), Random Forest (RF)] classifiers have also been used. All classifiers were validated with the collected data sets for classification and recognition of the eight specific ADL. Out of a total of 1,373 ADL, the RBI classifier correctly determined 1,264, while missing 109 and the CAR determined 1,305 while missing 68 ADL. The RBI and CAR classifier recognized activities with an average sensitivity of 91.27 and 94.36%, respectively, outperforming both RF and NB. The performance of the classifiers varied significantly and shows that the classifier plays an important role in ADL recognition. Both RBI and CAR classifier performed better than existing state-of-the-art (NB, RF) on all ADL. Of the two

  12. P-method post hoc test for adaptive trimmed mean, HQ

    Science.gov (United States)

    Low, Joon Khim; Yahaya, Sharipah Soaad Syed; Abdullah, Suhaida; Yusof, Zahayu Md; Othman, Abdul Rahman

    2014-12-01

    Adaptive trimmed mean, HQ, which is one of the latest additions in robust estimators, had been proven to be good in controlling Type I error in omnibus test. However, post hoc (pairwise multiple comparison) procedure for HQ was yet to be developed then. Thus, we have taken the initiative to develop post hoc procedure for HQ. Percentile bootstrap method or P-Method was proposed as it was proven to be effective in controlling Type I error rate even when the sample size was small. This paper deliberates on the effectiveness of P-Method on HQ, denoted as P-HQ. The strength and weakness of the proposed method were put to test on various conditions created by manipulating several variables such as shape of distributions, number of groups, sample sizes, degree of variance heterogeneity and pairing of sample sizes and group variances. For such, a simulation study on 2000 datasets was conducted using SAS/IML Version 9.2. The performance of the method on various conditions was based on its ability in controlling Type I error which was benchmarked using Bradley's criterion of robustness. The finding revealed that P-HQ could effectively control Type I error for almost all the conditions investigated.

  13. Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis.

    Science.gov (United States)

    Swann, Alan C; Fava, Maurizio; Tsai, Joyce; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony

    2017-04-01

    The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability. The data in this analysis were derived from a study of patients meeting DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/d (n=109) or placebo (n=100). We defined "irritability" as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability. Some 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (-22.6 vs. -9.5, ppost-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.

  14. F-18 fluorodeoxyglucose PET/CT and post hoc PET/MRI in a case of primary meningeal melanomatosis.

    Science.gov (United States)

    Lee, Hong Je; Ahn, Byeong-Cheol; Hwang, Seong Wook; Cho, Suk Kyong; Kim, Hae Won; Lee, Sang-Woo; Hwang, Jeong-Hyun; Lee, Jaetae

    2013-01-01

    Primary meningeal melanomatosis is a rare, aggressive variant of primary malignant melanoma of the central nervous system, which arises from melanocytes within the leptomeninges and carries a poor prognosis. We report a case of primary meningeal melanomatosis in a 17-year-old man, which was diagnosed with (18)F-fluorodeoxyglucose (F-18 FDG) PET/CT, and post hoc F-18 FDG PET/MRI fusion images. Whole-body F-18 FDG PET/CT was helpful in ruling out the extracranial origin of melanoma lesions, and in assessing the therapeutic response. Post hoc PET/MRI fusion images facilitated the correlation between PET and MRI images and demonstrated the hypermetabolic lesions more accurately than the unenhanced PET/CT images. Whole body F-18 FDG PET/CT and post hoc PET/MRI images might help clinicians determine the best therapeutic strategy for patients with primary meningeal melanomatosis.

  15. Erythropoietin to Reduce Mortality in Traumatic Brain Injury: A Post-hoc Dose-effect Analysis.

    Science.gov (United States)

    Gantner, Dashiell C; Bailey, Michael; Presneill, Jeffrey; French, Craig J; Nichol, Alistair; Little, Lorraine; Bellomo, Rinaldo

    2017-02-01

    We aimed to assess whether the dosing regimen of erythropoietin shows a relationship to mortality in critically ill patients with traumatic brain injury (TBI). Erythropoietin may decrease mortality in patients with TBI; however, the optimal dosing regimen remains uncertain. We conducted a post-hoc analysis of a multicenter, randomized trial of weekly erythropoietin versus placebo in patients with moderate and severe TBI admitted to intensive care. We assessed whether the cumulative dosage of erythropoietin was differentially associated with all-cause patient mortality evaluated at 6 months after injury. There was a nonlinear relationship between dose and mortality (P = 0.008) that remained after adjustment for site and severity of illness (P = 0.01). Six-month mortality was lower in randomized patients who received 1 [adjusted hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.33-1.01; P = 0.06] or 2 doses of erythropoietin (HR 0.31, 95% CI 0.12-0.80; P = 0.02) compared with those who received no doses. No benefit was seen with 3 doses (HR 1.55, 95% CI 0.66-3.62; P = 0.33). There was no differential effect of dose on functional neurological outcomes. Results across subgroups and secondary intention to treat analyses were consistent with primary findings. This post-hoc, hypothesis-generating analysis found potential reductions in mortality following 1 or 2 weekly doses of 40,000 IU of erythropoietin in intensive care unit patients with moderate or severe TBI, but not with 3 doses. These findings will inform the design of future trials of erythropoietin in critically ill patients with TBI and trauma.

  16. Fisher's exact approach for post hoc analysis of a chi-squared test.

    Science.gov (United States)

    Shan, Guogen; Gerstenberger, Shawn

    2017-01-01

    This research is motivated by one of our survey studies to assess the potential influence of introducing zebra mussels to the Lake Mead National Recreation Area, Nevada. One research question in this study is to investigate the association between the boating activity type and the awareness of zebra mussels. A chi-squared test is often used for testing independence between two factors with nominal levels. When the null hypothesis of independence between two factors is rejected, we are often left wondering where does the significance come from. Cell residuals, including standardized residuals and adjusted residuals, are traditionally used in testing for cell significance, which is often known as a post hoc test after a statistically significant chi-squared test. In practice, the limiting distributions of these residuals are utilized for statistical inference. However, they may lead to different conclusions based on the calculated p-values, and their p-values could be over- o6r under-estimated due to the unsatisfactory performance of asymptotic approaches with regards to type I error control. In this article, we propose new exact p-values by using Fisher's approach based on three commonly used test statistics to order the sample space. We theoretically prove that the proposed new exact p-values based on these test statistics are the same. Based on our extensive simulation studies, we show that the existing asymptotic approach based on adjusted residual is often more likely to reject the null hypothesis as compared to the exact approach due to the inflated family-wise error rates as observed. We would recommend the proposed exact p-value for use in practice as a valuable post hoc analysis technique for chi-squared analysis.

  17. Fisher’s exact approach for post hoc analysis of a chi-squared test

    Science.gov (United States)

    Gerstenberger, Shawn

    2017-01-01

    This research is motivated by one of our survey studies to assess the potential influence of introducing zebra mussels to the Lake Mead National Recreation Area, Nevada. One research question in this study is to investigate the association between the boating activity type and the awareness of zebra mussels. A chi-squared test is often used for testing independence between two factors with nominal levels. When the null hypothesis of independence between two factors is rejected, we are often left wondering where does the significance come from. Cell residuals, including standardized residuals and adjusted residuals, are traditionally used in testing for cell significance, which is often known as a post hoc test after a statistically significant chi-squared test. In practice, the limiting distributions of these residuals are utilized for statistical inference. However, they may lead to different conclusions based on the calculated p-values, and their p-values could be over- o6r under-estimated due to the unsatisfactory performance of asymptotic approaches with regards to type I error control. In this article, we propose new exact p-values by using Fisher’s approach based on three commonly used test statistics to order the sample space. We theoretically prove that the proposed new exact p-values based on these test statistics are the same. Based on our extensive simulation studies, we show that the existing asymptotic approach based on adjusted residual is often more likely to reject the null hypothesis as compared to the exact approach due to the inflated family-wise error rates as observed. We would recommend the proposed exact p-value for use in practice as a valuable post hoc analysis technique for chi-squared analysis. PMID:29261690

  18. Post-Hoc Pattern-Oriented Testing and Tuning of an Existing Large Model: Lessons from the Field Vole

    DEFF Research Database (Denmark)

    Topping, Christopher John; Dalkvist, Trine; Grimm, Volker

    2012-01-01

    environment closely. We therefore conclude that post-hoc POM is a useful and viable way to test a highly complex simulation model, but also warn against the dangers of over-fitting to real world patterns that lack details in their explanatory driving factors. To overcome some of these obstacles we suggest...

  19. Preventive Ceftriaxone in Patients with Stroke Treated with Intravenous Thrombolysis: Post Hoc Analysis of the Preventive Antibiotics in Stroke Study

    NARCIS (Netherlands)

    Vermeij, Jan-Dirk; Westendorp, Willeke F.; Roos, Yvo B.; Brouwer, Matthijs C.; van de Beek, Diederik; Nederkoorn, Paul J.

    2016-01-01

    The Preventive Antibiotics in Stroke Study (PASS), a randomized open-label masked endpoint trial, showed that preventive ceftriaxone did not improve functional outcome at 3 months in patients with acute stroke (adjusted common OR 0.95; 95% CI 0.82-1.09). Post-hoc analyses showed that among patients

  20. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...

  1. Evolution of Blood Lactate and 90-Day Mortality in Septic Shock. A Post Hoc Analysis of the FINNAKI Study

    DEFF Research Database (Denmark)

    Varis, Elina; Pettilä, Ville; Poukkanen, Meri

    2017-01-01

    Hyperlactatemia predicts mortality in patients with sepsis and septic shock, and its normalization is a potential treatment goal. We investigated the association of blood lactate and its changes over time with 90-day mortality in septic shock. We performed a post hoc analysis of 513 septic shock...... surrogate endpoints for mortality in septic shock patients....

  2. Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: the case of acute stroke trials.

    Science.gov (United States)

    Jafari, Nahid; Hearne, John; Churilov, Leonid

    2013-11-10

    A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. Copyright © 2013 John Wiley & Sons, Ltd.

  3. Lung function in patients with lung injury due to household chemical inhalation: Post hoc analysis of a prospective nationwide cohort.

    Science.gov (United States)

    Kim, Won-Young; Park, Soonyoung; Kim, Hwa Jung; Chae, Eun Jin; Do, Kyung-Hyun; Huh, Jin Won; Lim, Chae-Man; Koh, Younsuck; Hong, Sang-Bum

    2017-02-01

    Inhalation exposure to household chemicals can result in serious health problems, although the long-term outcomes are unclear. We evaluated the changes in lung function after home humidifier disinfectant (HD) exposure. This post hoc analysis of a prospective nationwide cohort involved patients with inhalation lung injury due to HD. Patients underwent spirometric measurements at onset and annually thereafter. Forty subjects met the eligibility criteria. Overall, mean forced vital capacity (FVC) increased significantly during the first 3 years from 2.10 ± 0.74 to 3.06 ± 1.08 L. Mean forced expiratory volume in 1 s (FEV 1 ) also rose from 1.84 ± 0.63 to 2.62 ± 0.88 L. Both variables then stabilized. However, in 19 (48%) patients, the FVCs did not normalize. Compared to subjects with an FVC at onset of lung function within several years of onset. However, lung function was impaired in the remaining patients. This impairment associated with lung function at onset and exposure intensity. © 2016 Asian Pacific Society of Respirology.

  4. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone

    Science.gov (United States)

    Khan, Arif; Durgam, Suresh; Tang, Xiongwen; Ruth, Adam; Mathews, Maju; Gommoll, Carl P.

    2016-01-01

    Objective To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). Method Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). Results The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (−1.83, P psychic anxiety (−1.21, P psychic and somatic HARS items. Trial Registration ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115. PMID:27486544

  5. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Astrid V Fahlenkamp

    Full Text Available Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV. We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.220 subjects with elevated PONV risk (Apfel score ≥2 undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044. Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138. After xenon, nausea occurred significantly earlier (p = 0.014, was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  6. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    Science.gov (United States)

    Fahlenkamp, Astrid V; Stoppe, Christian; Cremer, Jan; Biener, Ingeborg A; Peters, Dirk; Leuchter, Ricarda; Eisert, Albrecht; Apfel, Christian C; Rossaint, Rolf; Coburn, Mark

    2016-01-01

    Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV). We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis. 220 subjects with elevated PONV risk (Apfel score ≥2) undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up. Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044). Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138). After xenon, nausea occurred significantly earlier (p = 0.014), was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups. In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea. EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  7. Hypertension and diabetes as risk factors for dementia: A secondary post-hoc analysis from north-west India.

    Science.gov (United States)

    Raina, Sunil Kumar; Chander, Vishav; Raina, Sujeet; Kumar, Dinesh; Grover, Ashoo; Bhardwaj, Ashok

    2015-01-01

    A relation between midlife risk factors (hypertension and diabetes) and dementia has been studied in past and an association has been documented, in spite of some studies pointing to the contrary. The study was based on post-hoc analysis of data obtained from a study conducted on an elderly population (60 years and above) from selected geographical areas (migrant, urban, rural and tribal) of the Himachal Pradesh state in North-West India. Analysis of variance revealed an effect of risk factors on cognitive scores; however, post hoc Tukey's honest significant difference (HSD) test revealed that only hypertensives' demonstrated higher chances of scoring lower on cognitive measures. The possibility that hypertension and diabetes affect dementia needs further evaluation, more so in Indian context.

  8. M.mode.ify: A Free Online Tool to Generate Post Hoc M-Mode Images From Any Ultrasound Clip.

    Science.gov (United States)

    Smith, Benjamin C; Avila, Jacob

    2016-02-01

    We present a software tool designed to generate an M-mode image post hoc from any B-mode ultrasound clip, along any possible axis. M.mode.ify works by breaking down an ultrasound clip into individual frames. It then rotates and crops these frames by using a user-selected M-mode line. The post hoc M-mode image is created by splicing these frames together. Users can measure time and distance after proper calibration through the M.mode.ify interface. This tool opens up new possibilities for clinical application, quality assurance, and research. It is available free for public use at http://www.ultrasoundoftheweek.com/M.mode.ify/. © 2016 by the American Institute of Ultrasound in Medicine.

  9. An efficient post-hoc integration method improving peak alignment of metabolomics data from GCxGC/TOF-MS

    Science.gov (United States)

    2013-01-01

    Background Since peak alignment in metabolomics has a huge effect on the subsequent statistical analysis, it is considered a key preprocessing step and many peak alignment methods have been developed. However, existing peak alignment methods do not produce satisfactory results. Indeed, the lack of accuracy results from the fact that peak alignment is done separately from another preprocessing step such as identification. Therefore, a post-hoc approach, which integrates both identification and alignment results, is in urgent need for the purpose of increasing the accuracy of peak alignment. Results The proposed post-hoc method was validated with three datasets such as a mixture of compound standards, metabolite extract from mouse liver, and metabolite extract from wheat. Compared to the existing methods, the proposed approach improved peak alignment in terms of various performance measures. Also, post-hoc approach was verified to improve peak alignment by manual inspection. Conclusions The proposed approach, which combines the information of metabolite identification and alignment, clearly improves the accuracy of peak alignment in terms of several performance measures. R package and examples using a dataset are available at http://mrr.sourceforge.net/download.html. PMID:23575005

  10. Tolvaptan use in cancer patients with hyponatremia due to the syndrome of inappropriate antidiuretic hormone: a post hoc analysis of the SALT-1 and SALT-2 trials.

    Science.gov (United States)

    Gralla, Richard J; Ahmad, Fatima; Blais, Jaime D; Chiodo, Joseph; Zhou, Wen; Glaser, Linda A; Czerwiec, Frank S

    2017-04-01

    Hyponatremia is a common electrolyte disorder in cancer patients and has been associated with poor prognosis. A frequent cause of cancer-related hyponatremia is the syndrome of inappropriate antidiuretic hormone (SIADH). This study was a post hoc subgroup analysis of the SALT-1 (Study of Ascending Levels of Tolvaptan in Hyponatremia) and SALT-2 clinical trials. Hyponatremic subjects with SIADH and cancer received the oral selective vasopressin V2-receptor antagonist tolvaptan (n = 12) or matching placebo (n = 16) once-daily for 30 days. The initial tolvaptan dose (15 mg) was titrated over 4 days to 30 or 60 mg per day, as needed, according to serum sodium level and tolerability. Baseline serum sodium levels in the SIADH/cancer cohort of the SALT trials was 130 and 128 mEq/L for tolvaptan and placebo, respectively. Mean change from baseline in average daily serum sodium AUC for tolvaptan relative to placebo was 5.0 versus -0.3 mEq/L (P post hoc study of the SALT trial population, oral tolvaptan was an effective and safe therapy for the treatment of hyponatremia in subjects with SIADH and cancer. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  11. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study.

    Science.gov (United States)

    Kassubek, Jan; Chaudhuri, Kallol Ray; Zesiewicz, Theresa; Surmann, Erwin; Boroojerdi, Babak; Moran, Kimberly; Ghys, Liesbet; Trenkwalder, Claudia

    2014-03-06

    Pain is a troublesome non-motor symptom of Parkinson's disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting 'any' pain (pain score ≥1) at baseline, and subgroups reporting 'mild' (score 1-3), and 'moderate-to-severe' pain (score ≥4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a ≥30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported 'any' pain; of these 87 (33%) reported 'mild', and 100 (37%) 'moderate-to-severe' pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with 'any' pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with 'moderate-to-severe' pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders. The results

  12. Illustrating, Quantifying, and Correcting for Bias in Post-hoc Analysis of Gene-Based Rare Variant Tests of Association.

    Science.gov (United States)

    Grinde, Kelsey E; Arbet, Jaron; Green, Alden; O'Connell, Michael; Valcarcel, Alessandra; Westra, Jason; Tintle, Nathan

    2017-01-01

    To date, gene-based rare variant testing approaches have focused on aggregating information across sets of variants to maximize statistical power in identifying genes showing significant association with diseases. Beyond identifying genes that are associated with diseases, the identification of causal variant(s) in those genes and estimation of their effect is crucial for planning replication studies and characterizing the genetic architecture of the locus. However, we illustrate that straightforward single-marker association statistics can suffer from substantial bias introduced by conditioning on gene-based test significance, due to the phenomenon often referred to as "winner's curse." We illustrate the ramifications of this bias on variant effect size estimation and variant prioritization/ranking approaches, outline parameters of genetic architecture that affect this bias, and propose a bootstrap resampling method to correct for this bias. We find that our correction method significantly reduces the bias due to winner's curse (average two-fold decrease in bias, p post-hoc estimation and ranking of variants after a gene-based test. Further work is necessary to continue seeking ways to reduce bias and improve inference in post-hoc analysis of gene-based tests under a wide variety of genetic architectures.

  13. Lurasidone in post-menopausal females with major depressive disorder with mixed features: Post-hoc analysis of a placebo-controlled trial.

    Science.gov (United States)

    Sramek, John; Loebel, Antony; Murphy, Michael; Mao, Yongcai; Pikalov, Andrei; Cutler, Neal R

    2017-08-01

    Several studies have found that depressed, post-menopausal females may respond differently to antidepressants compared to pre-menopausal females. The atypical antipsychotic lurasidone, whose mechanism of action differs from SSRIs and other standard antidepressants, was shown in a 6-week randomized, flexible-dose, placebo-controlled study (n=209), to be effective in treating major depressive disorder (MDD) with mixed features (subthreshold hypomanic symptoms). This post-hoc analysis assessed the efficacy of lurasidone in this study by menopausal status. The main outcome measure for this post-hoc analysis was change in MADRS score from baseline to week 6 endpoint for two lurasidone-treated subgroups: presumptive pre-menopausal (women (ages 45-51years) to allow for clearer definition of pre- and post-menopausal status. A total of 56 lurasidone-treated and 47 placebo-treated pre-menopausal females, and 17 lurasidone-treated and 25 placebo-treated post-menopausal females were available from the larger study for comparison on key outcome measures. The pre- and post-menopausal subgroups had similar demographic and clinical characteristics at study baseline (other than age), including number of past major depressive episodes as well as depressive and manic symptom severity. Mean daily lurasidone dose was similar for each subgroup during the study. Both the primary and exploratory analyses showed that both lurasidone-treated post-menopausal and pre-menopausal females responded significantly compared to placebo (p=0.016 or less) on the MADRS, and that post-menopausal patients had a numerically larger response (effect size=0.96) than pre-menopausal patients (effect size=0.64). All other secondary outcome measures for lurasidone compared with placebo treatment were significant (p=0.045 or less) for both subgroups. In this post-hoc analysis, lurasidone was found to be effective in treating post-menopausal MDD patients with mixed features (subthreshold hypomanic symptoms

  14. Effect of Intravenous Recombinant Tissue-Type Plasminogen Activator in Patients With Mild Stroke in the Third International Stroke Trial-3: Post Hoc Analysis.

    Science.gov (United States)

    Khatri, Pooja; Tayama, Darren; Cohen, Geoff; Lindley, Richard I; Wardlaw, Joanna M; Yeatts, Sharon D; Broderick, Joseph P; Sandercock, Peter

    2015-08-01

    Randomized trial evidence on the risk/benefit ratio of thrombolysis for mild stroke is limited. We sought to determine the efficacy of intravenous recombinant tissue-type plasminogen activator (IV r-tPA) in a subset of patients with mild deficit in the third International Stroke Trial (IST-3). IST-3 compared IV r-tPA with control within 6 hours of onset in patients for whom IV r-tPA was considered promising but unproven. Analysis was restricted to subjects randomized within 3 hours of onset with a baseline National Institutes of Health Stroke Scale ≤5, pretreatment blood pressure post hoc analysis in a highly selected sample of IST-3 supports the rationale of A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS) trial-a randomized, phase IIIb study to evaluate IV r-tPA in mild ischemic stroke. © 2015 American Heart Association, Inc.

  15. Preventive Ceftriaxone in Patients with Stroke Treated with Intravenous Thrombolysis: Post Hoc Analysis of the Preventive Antibiotics in Stroke Study.

    Science.gov (United States)

    Vermeij, Jan-Dirk; Westendorp, Willeke F; Roos, Yvo B; Brouwer, Matthijs C; van de Beek, Diederik; Nederkoorn, Paul J

    2016-01-01

    The Preventive Antibiotics in Stroke Study (PASS), a randomized open-label masked endpoint trial, showed that preventive ceftriaxone did not improve functional outcome at 3 months in patients with acute stroke (adjusted common OR 0.95; 95% CI 0.82-1.09). Post-hoc analyses showed that among patients who received intravenous thrombolysis (IVT), patients who received ceftriaxone had a significantly better outcome as compared with the control group. This study aimed to gain more insight into the characteristics of these patients. In PASS, 2,550 patients were randomly assigned to preventive antibiotic treatment with ceftriaxone or standard care. In current post-hoc analysis, 836 patients who received IVT were included. Primary outcome included functional status on the modified Rankin Scale, analyzed with adjusted ordinal regression. Secondary outcomes included infection rate and symptomatic intracerebral hemorrhage (sICH) rate. For all patients in PASS, the p value for the interaction between IVT and preventive ceftriaxone regarding functional outcome was 0.03. Of the 836 IVT-treated patients, 437 were administered ceftriaxone and 399 were allocated to the control group. Baseline characteristics were similar. In the IVT subgroup, preventive ceftriaxone was associated with a significant reduction in unfavorable outcome (adjusted common OR 0.77; 95% CI 0.61-0.99; p = 0.04). Mortality at 3 months was similar (OR 0.75; 95% CI 0.48-1.18). Preventive ceftriaxone was associated with a reduction in infections (OR 0.43; 95% CI 0.28-0.66), and a trend towards an increased risk for sICH (OR 3.09; 95% CI 0.85-11.31). Timing of ceftriaxone administration did not influence the outcome (aOR 1.00; 95% CI 0.98-1.03; p = 0.85). According to the post-hoc analysis of PASS, preventive ceftriaxone may improve the functional outcome in IVT-treated patients with acute stroke, despite a trend towards an increased rate of post-IVT-sICH. © 2016 S. Karger AG, Basel.

  16. 手術時血清25OHD 濃度と大腸直腸がんの患者生存のpost-hoc analysis

    OpenAIRE

    目澤, 秀俊

    2013-01-01

    Serum vitamin D levels and survival of patients with colorectal cancer: Post-hoc analysis of a prospective cohort study(手術時血清250HD濃度と大腸直腸がんの患者生存のpost-hocanalysis) BMC Cancer 2010 10:347

  17. Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis.

    Science.gov (United States)

    Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

    2016-04-02

    Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD). To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. 130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p  65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD.

  18. Switching to olanzapine long-acting injection from either oral olanzapine or any other antipsychotic: comparative post hoc analyses

    Science.gov (United States)

    Ciudad, Antonio; Anand, Ernie; Berggren, Lovisa; Casillas, Marta; Schacht, Alexander; Perrin, Elena

    2013-01-01

    Background A considerable proportion of patients suffering from schizophrenia show suboptimal responses to oral antipsychotics due to inadequate adherence. Hence, they are likely to benefit from switching to a long-acting injectable formulation. These post hoc analyses assessed the clinical effects of switching to olanzapine long-acting injection (OLAI) from either oral olanzapine (OLZ) or other antipsychotics (non-OLZ). Methods Post hoc analyses were done based on two randomized studies (one short-term, one long-term) conducted in patients suffering from schizophrenia and treated with OLAI. The short-term study was an 8-week placebo-controlled, double-blind trial in acute patients, and the long-term study was a 2-year, oral olanzapine-controlled, open-label, follow-up of stabilized outpatients. Results These analyses used data from 62 OLAI-treated patients (12 switched from OLZ, 50 from non-OLZ) from the short-term study and 190 OLAI-treated patients (56 switched from OLZ, 134 from non-OLZ) from the long-term study. Kaplan–Meier survival analyses of time to all-cause discontinuation of OLAI treatment did not differ significantly between OLZ and non-OLZ patients in the short-term study (P=0.209) or long-term study (P=0.448). Similarly, the proportions of OLZ and non-OLZ patients that discontinued OLAI were not statistically different in the short-term (16.7% versus 36.0%, respectively; P=0.198) or long-term (57.1% versus 47.8% respectively; P=0.238) studies. In the short-term study, no significant differences were detected between the patient groups in mean change in Positive and Negative Syndrome Scale (PANSS) total score (−13.4 OLZ versus −20.8 non-OLZ; P=0.166). In the long-term study, mean change in PANSS total score (3.9 OLZ versus −3.6 non-OLZ; P=0.008) was significantly different between the non-OLZ and OLZ groups. Rates of treatment-emergent adverse events were similar in OLZ and non-OLZ groups per study. Conclusion These post hoc analyses suggest

  19. Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson’s Disease: A Post Hoc Analysis

    Science.gov (United States)

    Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

    2016-01-01

    Background: Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson’s disease (PD). Objective: To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. Methods: In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as “Selegiline+Rotigotine” and “Selegiline+Placebo”. Outcome measures included change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. Results: 130 patients were evaluable for efficacy analyses (“Selegiline+Rotigotine”: 84, “Selegiline+Placebo”: 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: –4.89 [–7.87 to –1.91], p = 0.0015; for UPDRS II+III: –5.76 [–9.71 to –1.82], p = 0.0045). Higher proportion of patients in the “Selegiline+Rotigotine” group were classified as ≥20%, ≥25% or ≥30% responders (all p  65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. Conclusions: In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements

  20. Glutamine and antioxidants in the critically ill patient: a post hoc analysis of a large-scale randomized trial.

    Science.gov (United States)

    Heyland, Daren K; Elke, Gunnar; Cook, Deborah; Berger, Mette M; Wischmeyer, Paul E; Albert, Martin; Muscedere, John; Jones, Gwynne; Day, Andrew G

    2015-05-01

    The recent large randomized controlled trial of glutamine and antioxidant supplementation suggested that high-dose glutamine is associated with increased mortality in critically ill patients with multiorgan failure. The objectives of the present analyses were to reevaluate the effect of supplementation after controlling for baseline covariates and to identify potentially important subgroup effects. This study was a post hoc analysis of a prospective factorial 2 × 2 randomized trial conducted in 40 intensive care units in North America and Europe. In total, 1223 mechanically ventilated adult patients with multiorgan failure were randomized to receive glutamine, antioxidants, both glutamine and antioxidants, or placebo administered separate from artificial nutrition. We compared each of the 3 active treatment arms (glutamine alone, antioxidants alone, and glutamine + antioxidants) with placebo on 28-day mortality. Post hoc, treatment effects were examined within subgroups defined by baseline patient characteristics. Logistic regression was used to estimate treatment effects within subgroups after adjustment for baseline covariates and to identify treatment-by-subgroup interactions (effect modification). The 28-day mortality rates in the placebo, glutamine, antioxidant, and combination arms were 25%, 32%, 29%, and 33%, respectively. After adjusting for prespecified baseline covariates, the adjusted odds ratio of 28-day mortality vs placebo was 1.5 (95% confidence interval, 1.0-2.1, P = .05), 1.2 (0.8-1.8, P = .40), and 1.4 (0.9-2.0, P = .09) for glutamine, antioxidant, and glutamine plus antioxidant arms, respectively. In the post hoc subgroup analysis, both glutamine and antioxidants appeared most harmful in patients with baseline renal dysfunction. No subgroups suggested reduced mortality with supplements. After adjustment for baseline covariates, early provision of high-dose glutamine administered separately from artificial nutrition was not beneficial and may be

  1. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials.

    Science.gov (United States)

    Citrome, Leslie; Durgam, Suresh; Lu, Kaifeng; Ferguson, Paul; Laszlovszky, István

    2016-01-01

    Although most patients with schizophrenia are not aggressive, individuals with the disorder have increased risk of hostile behavior. Cariprazine, a dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, was evaluated for antihostility effects in patients with schizophrenia. Post hoc analyses were conducted using pooled data from 3 positive randomized, placebo-controlled, phase 2/3 studies in inpatients (18-60 years) with acute exacerbation of schizophrenia according to DSM-IV-TR criteria; data were collected between 2008 and 2011. The principal post hoc outcome was mean change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) hostility item (P7); separate analyses adjusted for certain PANSS positive symptoms and sedation covariates. Analyses were based on the pooled intent-to-treat population (N = 1,466) using a mixed-effects model for repeated measures approach; separate analyses were conducted in subgroups categorized by baseline hostility item scores (P7: ≥ 2, ≥ 3, ≥ 4). The least squares mean difference (LSMD) in change from baseline to week 6 was statistically significant on all PANSS hostility item analyses in favor of cariprazine versus placebo: unadjusted (-0.28; P < .0001), adjusted for PANSS positive symptoms (-0.12; P < .05), adjusted for positive symptoms plus sedation (-0.12; P < .05). The magnitude of change for cariprazine increased with greater baseline hostility (LSMD vs placebo for ≥ 2, ≥ 3, ≥ 4 subgroups: -0.32, -0.37, -0.51, respectively; P < .01 all). Significant improvement on the hostility item was seen in cariprazine- versus placebo-treated patients with schizophrenia; the effect of cariprazine increased with greater levels of baseline hostility. ClinicalTrials.gov identifiers: NCT00694707, NCT01104766, and NCT01104779. © Copyright 2016 Physicians Postgraduate Press, Inc.

  2. Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

    Science.gov (United States)

    Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

    2012-03-01

    IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. Illustrating, Quantifying, and Correcting for Bias in Post-hoc Analysis of Gene-Based Rare Variant Tests of Association

    Directory of Open Access Journals (Sweden)

    Kelsey E. Grinde

    2017-09-01

    Full Text Available To date, gene-based rare variant testing approaches have focused on aggregating information across sets of variants to maximize statistical power in identifying genes showing significant association with diseases. Beyond identifying genes that are associated with diseases, the identification of causal variant(s in those genes and estimation of their effect is crucial for planning replication studies and characterizing the genetic architecture of the locus. However, we illustrate that straightforward single-marker association statistics can suffer from substantial bias introduced by conditioning on gene-based test significance, due to the phenomenon often referred to as “winner's curse.” We illustrate the ramifications of this bias on variant effect size estimation and variant prioritization/ranking approaches, outline parameters of genetic architecture that affect this bias, and propose a bootstrap resampling method to correct for this bias. We find that our correction method significantly reduces the bias due to winner's curse (average two-fold decrease in bias, p < 2.2 × 10−6 and, consequently, substantially improves mean squared error and variant prioritization/ranking. The method is particularly helpful in adjustment for winner's curse effects when the initial gene-based test has low power and for relatively more common, non-causal variants. Adjustment for winner's curse is recommended for all post-hoc estimation and ranking of variants after a gene-based test. Further work is necessary to continue seeking ways to reduce bias and improve inference in post-hoc analysis of gene-based tests under a wide variety of genetic architectures.

  4. A post hoc analysis of long-term prognosis after exenatide treatment in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Kyhl, Kasper; Lønborg, Jacob; Vejlstrup, Niels

    2016-01-01

    AIMS: We aimed to assess the effect of exenatide treatment as an adjunct to primary percutaneous coronary intervention (PCI) on long-term clinical outcome. METHODS AND RESULTS: We performed a post hoc analysis in 334 patients with a first STEMI included in a previous study randomised to exenatide......% in the exenatide group versus 9% in the placebo group (HR 1.45, p=0.20). CONCLUSIONS: In this post hoc analysis of patients with a STEMI, treatment with exenatide at the time of primary PCI did not reduce the primary composite endpoint or the secondary endpoint of all-cause -mortality. However, exenatide treatment...

  5. Importance of Contrast Aortography With Lotus Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the RESPOND Post-Market Study.

    Science.gov (United States)

    van Gils, Lennart; Wöhrle, Jochen; Hildick-Smith, David; Bleiziffer, Sabine; Blackman, Daniel J; Abdel-Wahab, Mohamed; Gerckens, Ulrich; Brecker, Stephen; Bapat, Vinayak; Modine, Thomas; Soliman, Osama I; Nersesov, Andrey; Allocco, Dominic; Falk, Volkmar; Van Mieghem, Nicolas M

    2018-01-22

    The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI. Copyright © 2018. Published by Elsevier Inc.

  6. Prevalence of Chronic Kidney Disease in Turkish Adults With Obesity and Metabolic Syndrome: A Post Hoc Analysis from Chronic Renal Disease in Turkey Study.

    Science.gov (United States)

    Arinsoy, Turgay; Deger, Serpil Muge; Ates, Kenan; Altun, Bulent; Ecder, Tevfik; Camsari, Taner; Serdengecti, Kamil; Suleymanlar, Gultekin

    2016-11-01

    Obesity confers an increased risk of chronic kidney disease (CKD), which is increased further by accompanying metabolic abnormalities. To investigate the relationship of the risk of CKD with obesity and metabolic syndrome (MS) in adults by means of post hoc analysis of data from the Chronic Renal Disease in Turkey (CREDIT) study. The anthropometric measurements of a total of 9,100 adult participants in the CREDIT study were included in the analyses. Subjects were classified according to the presence or absence of obesity (body mass index [BMI] > 30) and MS. Logistic regression analyses were used to estimate odds ratio for CKD. Effect modification analyses were also performed. The prevalence of obesity was 20.6% and that of MS was 31.3%. The prevalence of CKD was higher among obese subjects compared to those with a normal BMI (20.5% vs. 14%; P < .001). The odds ratio (OR) for CKD was 1.296 (95% confidence interval [CI], 1.121-1.498) for subjects who were overweight, 1.718 (95% CI, 1.444-2.044) for those with class I obesity, 1.983 (95% CI, 1.489-2.641) for those with class II obesity and 2.799 (95% CI, 1.719-4.557) for subjects with extreme obesity (P < .001 for each subgroup) compared to subjects with a normal BMI. CKD was significantly more prevalent in subjects with MS (21.9% vs. 12.3%, P < .001). The OR for CKD was higher in obese subjects with MS (adjusted OR, 1.321; 95% CI, 1.109-1.573; P = .002). The stratification of obese individuals based on their metabolic phenotype is important for prevention and treatment of CKD. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  7. Automated post-hoc noise cancellation tool for audio recordings acquired in an MRI scanner

    NARCIS (Netherlands)

    Cusack, R.; Cumming, N.; Bor, D.; Norris, D.; Lijzenga, J.

    2005-01-01

    There are several types of experiment in which it is useful to have subjects speak overtly in a magnetic resonance imaging (MRI) scanner, including those studying the articulatory apparatus and the neural basis of speech production, and fMRI experiments in which speech is used as a response

  8. Global improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis.

    Science.gov (United States)

    Durgam, Suresh; Earley, Willie; Lu, Kaifeng; Németh, György; Laszlovszky, István; Volk, Stephen; Litman, Robert E

    2017-12-01

    Global rating scale measures are useful for assessing the clinical relevance of patient change. Cariprazine, a dopamine D3 and D2 receptor partial agonist, is FDA-approved for the adult treatment of acute manic/mixed episodes of bipolar I disorder and schizophrenia. Post hoc evaluations of Clinical Global Impressions-Severity (CGI-S) scores from the cariprazine pivotal trials in both indications were conducted. Data from 3 bipolar mania and 3 schizophrenia trials were pooled by indication (bipolar disorder = 1033; schizophrenia = 1466). Cariprazine- and placebo-treated patients were categorised by baseline CGI-S scores; the proportion of patients who improved from more severe categories at baseline to less severe categories at end-point was evaluated using a logistic regression model. Correlations between Young Mania Rating Scale and Positive and Negative Syndrome Scale total score changes and category shifts were also evaluated. In both disease states, more cariprazine- than placebo-treated patients had improved CGI-S scores at end-point; more placebo-treated patients had worse end-point scores. More cariprazine- vs placebo-treated patients shifted from the extremely/severely ill to mildly ill/better category (bipolar disorder = 55% vs 36%, odds ratio [OR] = 2.1; P = .09; schizophrenia = 42% vs 18%, OR = 3.4, PPost hoc analyses showed that more cariprazine- than placebo-treated patients with bipolar mania or schizophrenia had statistically significant and clinically meaningful CGI-S improvement. © 2017 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

  9. Lenient vs. strict rate control in patients with atrial fibrillation and heart failure : a post-hoc analysis of the RACE II study

    NARCIS (Netherlands)

    Mulder, Bart A.; Van Veldhuisen, Dirk J.; Crijns, Harry J. G. M.; Tijssen, Jan G. P.; Hillege, Hans L.; Alings, Marco; Rienstra, Michel; Groenveld, Hessel F.; Van den Berg, Maarten P.; Van Gelder, Isabelle C.

    2013-01-01

    AIMS: It is unknown whether lenient rate control is an acceptable strategy in patients with AF and heart failure. We evaluated differences in outcome in patients with AF and heart failure treated with lenient or strict rate control. METHODS AND RESULTS: This post-hoc analysis of the RACE II trial

  10. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data

    National Research Council Canada - National Science Library

    Michael J Davies; Katherine Merton; Ujjwala Vijapurkar; Jacqueline Yee; Rong Qiu

    2017-01-01

    ...) with a favourable tolerability profile in a broad range of patients with T2DM. This post hoc analysis assessed the efficacy and safety of canagliflozin in patients with T2DM based on CV disease history or CV risk factors...

  11. The effect of fluid resuscitation on the effective circulating volume in patients undergoing liver surgery : a post-hoc analysis of a randomized controlled trial

    NARCIS (Netherlands)

    Vos, Jaap Jan; Kalmar, A. F.; Hendriks, H. G. D.; Bakker, J.; Scheeren, T. W. L.

    To assess the significance of an analogue of the mean systemic filling pressure (Pmsa) and its derived variables, in providing a physiology based discrimination between responders and non-responders to fluid resuscitation during liver surgery. A post-hoc analysis of data from 30 patients undergoing

  12. The effect of fluid resuscitation on the effective circulating volume in patients undergoing liver surgery: a post-hoc analysis of a randomized controlled trial

    NARCIS (Netherlands)

    Vos, J.J. (Jaap Jan); Kalmar, A.F.; H.G.D. Hendriks (Herman); J. Bakker (Jan); Scheeren, T.W.L.

    2017-01-01

    textabstractTo assess the significance of an analogue of the mean systemic filling pressure (Pmsa) and its derived variables, in providing a physiology based discrimination between responders and non-responders to fluid resuscitation during liver surgery. A post-hoc analysis of data from 30 patients

  13. Influencing Anesthesia Provider Behavior Using Anesthesia Information Management System Data for Near Real-Time Alerts and Post Hoc Reports.

    Science.gov (United States)

    Epstein, Richard H; Dexter, Franklin; Patel, Neil

    2015-09-01

    In this review article, we address issues related to using data from anesthesia information management systems (AIMS) to deliver near real-time alerts via AIMS workstation popups and/or alphanumeric pagers and post hoc reports via e-mail. We focus on reports and alerts for influencing the behavior of anesthesia providers (i.e., anesthesiologists, anesthesia residents, and nurse anesthetists). Multiple studies have shown that anesthesia clinical decision support (CDS) improves adherence to protocols and increases financial performance through facilitation of billing, regulatory, and compliance documentation; however, improved clinical outcomes have not been demonstrated. We inform developers and users of feedback systems about the multitude of concerns to consider during development and implementation of CDS to increase its effectiveness and to mitigate its potentially disruptive aspects. We discuss the timing and modalities used to deliver messages, implications of outlier-only versus individualized feedback, the need to consider possible unintended consequences of such feedback, regulations, sustainability, and portability among systems. We discuss statistical issues related to the appropriate evaluation of CDS efficacy. We provide a systematic review of the published literature (indexed in PubMed) of anesthesia CDS and offer 2 case studies of CDS interventions using AIMS data from our own institution illustrating the salient points. Because of the considerable expense and complexity of maintaining near real-time CDS systems, as compared with providing individual reports via e-mail after the fact, we suggest that if the same goal can be accomplished via delayed reporting versus immediate feedback, the former approach is preferable. Nevertheless, some processes require near real-time alerts to produce the desired improvement. Post hoc e-mail reporting from enterprise-wide electronic health record systems is straightforward and can be accomplished using system

  14. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis.

    Science.gov (United States)

    Nasrallah, Henry A; Earley, Willie; Cutler, Andrew J; Wang, Yao; Lu, Kaifeng; Laszlovszky, István; Németh, György; Durgam, Suresh

    2017-08-24

    Schizophrenia is a chronic and debilitating neuropsychiatric disorder that often requires long-term pharmacotherapy to manage symptoms and prevent relapse. Cariprazine is a potent dopamine D3 and D2 receptor partial agonist that is FDA-approved in the US for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults; the recommended dose range is 1.5-6 mg/d. To further characterize the long-term safety of cariprazine, data from two 48-week open-label, flexible-dose extension studies were pooled for post hoc analyses. Outcomes were evaluated in the pooled safety population (patients who received ≥1 dose of cariprazine during an open-label extension period); findings were summarized using descriptive statistics for the overall cariprazine group and in modal daily dose groups (1.5-3, 4.5-6, and 9 mg/d). Of the 679 patients in the overall cariprazine safety population, 40.1% completed the study. The only adverse events (AEs) leading to discontinuation of ≥2% of patients in any dose group were akathisia, worsening of schizophrenia, and psychotic disorder. Treatment-emergent AEs (TEAEs) of akathisia, insomnia, weight increased, and headache were reported in ≥10% of the overall population. Mean prolactin levels decreased in all dose groups (overall, -15.4 ng/mL). Clinically insignificant changes in aminotransferase levels and alkaline phosphatase were observed; no dose-response relationship was observed across groups. Mean total (-5.3 mg/dL), low-density lipoprotein (-3.5 mg/dL), and high-density lipoprotein (-0.8 mg/dL) cholesterol levels decreased; no dose-response relationship was observed for metabolic parameters. Mean change in body weight was 1.58 kg; body weight increase and decrease ≥7% occurred in 27% and 11% of patients, respectively. Mean changes in cardiovascular parameters, including blood pressure and pulse, were generally not considered clinically significant. EPS-related TEAEs that occurred in

  15. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study.

    Science.gov (United States)

    Asadi-Pooya, Ali A; Sperling, Michael R; Chung, Steve; Klein, Pavel; Diaz, Anyzeila; Elmoufti, Sami; Schiemann, Jimmy; Whitesides, John

    2017-03-01

    Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED) for adjunctive treatment of focal (partial-onset) seizures in adults with epilepsy. This post-hoc analysis was conducted to explore the efficacy of adjunctive BRV in patients with prior levetiracetam (LEV) exposure and whether changes in efficacy were related to the similar mechanism of action of these two drugs. Data were pooled from three Phase III studies (NCT00490035; NCT00464269; NCT01261325) of adults with focal seizures taking 1-2 AEDs who received placebo or BRV 50-200mg/day without titration over a 12-week treatment period. Patients taking concomitant LEV at enrollment were excluded from this analysis. Patients were categorized by their status of prior exposure to LEV, carbamazepine (CBZ), topiramate (TPM), or lamotrigine (LTG), to investigate any consistent trend towards reduced response in AED-exposed subgroups compared to AED-naïve subgroups, regardless of the mechanism of action. Study completion rates, percent reduction from baseline in focal seizure frequency over placebo, ≥50% responder rates, and tolerability were evaluated for each subgroup. A total of 1160 patients were investigated. Study completion rates were similar in the AED-exposed subgroups and AED-naïve subgroups. In subgroups with (531 patients) or without (629 patients) prior LEV exposure, ≥50% responder rates for each dose of BRV compared with placebo were generally higher among the LEV-naïve subgroups than the previously LEV-exposed subgroups. LEV-exposed subgroups receiving BRV doses ≥50mg/day showed greater ≥50% responder rates than those receiving placebo. Similar results were observed for CBZ, TPM, and LTG. Previous treatment failure with commonly prescribed AEDs (LEV, CBZ, TPM, or LTG) is associated with a reduced response to BRV irrespective of the mechanism of action. Hence, this post-hoc analysis indicates that previous treatment failure with LEV

  16. Prophylactic Azithromycin Therapy After Lung Transplantation: Post hoc Analysis of a Randomized Controlled Trial.

    Science.gov (United States)

    Ruttens, D; Verleden, S E; Vandermeulen, E; Bellon, H; Vanaudenaerde, B M; Somers, J; Schoonis, A; Schaevers, V; Van Raemdonck, D E; Neyrinck, A; Dupont, L J; Yserbyt, J; Verleden, G M; Vos, R

    2016-01-01

    Prophylactic azithromycin treatment has been demonstrated to improve freedom from bronchiolitis obliterans syndrome (BOS) 2 years after lung transplantation (LTx). In the current study, we re-evaluated the long-term effects of this prophylactic approach in view of the updated classification system for chronic lung allograft dysfunction (CLAD). A retrospective, intention-to-treat analysis of a randomized controlled trial comparing prophylactic treatment with placebo (n = 43) versus azithromycin (n = 40) after LTx was performed. Graft dysfunction (CLAD), graft loss (retransplantation, mortality), evolution of pulmonary function and functional exercise capacity were analyzed 7 years after inclusion of the last study subject. Following LTx, 22/43 (51%) patients of the placebo group and 11/40 (28%) patients of the azithromycin group ever developed CLAD (p = 0.043). CLAD-free survival was significantly longer in the azithromycin group (p = 0.024). No difference was present in proportion of obstructive versus restrictive CLAD between both groups. Graft loss was similar in both groups: 23/43 (53%) versus 16/40 (40%) patients (p = 0.27). Long-term pulmonary function and functional exercise capacity were significantly better in the azithromycin group (p azithromycin therapy reduces long-term CLAD prevalence and improves CLAD-free survival, pulmonary function, and functional exercise capacity after LTx. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

  17. SSRI versus bupropion effects on symptom clusters in suicidal depression: post-hoc analysis of a randomized clinical trial

    Science.gov (United States)

    Grunebaum, Michael F.; Keilp, John G.; Ellis, Steven P.; Sudol, Katherin; Bauer, Neal; Burke, Ainsley K.; Oquendo, Maria A.; Mann, J. John

    2015-01-01

    Objective Identifying the depression symptoms most closely associated with suicidal thoughts and which medications provide the fastest relief may help suicide prevention. Method Post hoc analysis of data from a randomized, double-blind, eight-week clinical trial of the serotonin reuptake inhibitor paroxetine (N=36) versus the norepinephrine-dopamine reuptake inhibitor bupropion (N=38) in patients with DSM-IV major depressive disorder and past suicide attempt or current suicidal thoughts. Treatment effects on Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory symptom clusters were compared. We hypothesized a superior effect of paroxetine on non-suicide, affective/cognitive depression symptom clusters that our prior work found to be associated with suicidal thoughts and attempts. Data were collected from February 2005 to January 2010. Results There was a treatment main effect on HDRS Psychic Depression (depressed mood, guilt, retardation, helpless, hopeless, worthless) (estimate = −2.2, 95% CI = −3.2 to −1.1, t = −4.01, df = 67.16, p Psychic Depression scores after one week of paroxetine, compared to bupropion, and was statistically significant until Week 4. Results for other depression scale factors were non-significant (p > 0.05). Conclusion The results require replication, but suggest a pathway by which SSRI treatment may exert a stronger effect compared with NDRI treatment on reduction of suicidal thoughts during initial weeks of pharmacotherapy in these higher risk patients. PMID:24107760

  18. Nerve endoneurial microstructure facilitates uniform distribution of regenerative fibers: a post hoc comparison of midgraft nerve fiber densities.

    Science.gov (United States)

    Johnson, Philip J; Newton, Piyaraj; Hunter, Daniel A; Mackinnon, Susan E

    2011-02-01

    Despite their inferiority to nerve autograft, clinical alternatives are commonly used for reconstruction of peripheral nerve injuries because of their convenient off-the-shelf availability. Previously, our group compared isografts with NeuraGen(®) (Integra, Plainsboro, NJ) nerve guides, which are a commercially available type I collagen conduit and processed rat allografts comparable to Avance(®) (AxoGen, Alachua, FL) human decellularized allograft product. From this study, qualitative observations were made of distinct differences in the pattern of regenerating fibers within conduits, acellular allografts, and isografts. In the current post hoc analysis, these observations were quantified. Using nerve density, we statistically compared the differential pattern of regenerating axon fibers within grafts and conduit. The conduits exhibited a consistent decrease in midgraft density when compared with the isograft and acellularized allografts at two gap lengths (14 mm and 28 mm) and time points (12 and 22 weeks). The decrease in density was accompanied by clustered distribution of nerve fibers in conduits, which contrasted the evenly distributed regeneration seen in processed allografts and isografts. We hypothesize that the lack of endoneurial microstructure of conduits results in the clustering regenerating fibers, and that the presence of microstructure in the acellularized allograft and isografts facilitates even distribution of regenerating fibers. © Thieme Medical Publishers.

  19. TRIBUNALES PENALES INTERNACIONALES AD HOC DEL POST-GUERRA FRÍA: CAMBIANDO PARADIGMAS EN EL TRATAMIENTO DE CUESTIONES DE GÉNERO

    Directory of Open Access Journals (Sweden)

    Camila Soares Lippi

    2011-12-01

    Full Text Available Analizaremos como la jurisprudencia de los Tribunales Penales Internacionales ad hoc del post-Guerra Fría representa un cambio de paradigmas en cuestiones de género en el Derecho Penal Internacional y en el Derecho Internacional Humanitario. Para eso, partimos del concepto de género, o sea, las construcciones sociales cuanto a los roles masculino y femenino, como categoría central de análisis. Analizamos, primeramente, el post-Segunda Guerra Mundial. Ese momento histórico, ejemplificado por los Tribunales de Núremberg y de Tokio y por los Convenios de Ginebra de 1949. Después analizase los Tribunales Penales Internacionales ad hoc del post-Guerra Fría. Finalmente, analizamos la definición de género en el Estatuto de Roma, que instituye el Tribunal Penal Internacional.

  20. Factors influencing patients' recovery and the efficacy of a psychosocial post-discharge intervention: post hoc analysis of a randomized controlled trial.

    Science.gov (United States)

    Hengartner, Michael P; Passalacqua, Silvia; Heim, Gisela; Andreae, Andreas; Rössler, Wulf; von Wyl, Agnes

    2016-12-01

    The aim of this post hoc analysis was to examine self-reported recovery following a post-discharge intervention and to focus on the moderators of this intervention programme. RCT using parallel group block randomisation, including 151 patients with ≤3 hospitalisations within the last 3 years, a GAF score ≤60, and aged 18-64 years, assessed at two psychiatric hospitals from Zurich, Switzerland, between September 2011 and February 2014. In the present study, the main outcome was the OQ-45 as assessed prior to discharge from the index hospitalisation and at 12-month follow-up. Participants received either the post-discharge intervention provided by a social worker or treatment as usual (TAU). Patients in the intervention group showed substantially less recovery over the 12-month observation period than controls (d = 0.44). In the TAU group, 15.6 % remained clinically impaired at 12-month follow-up as opposed to 48.1 % in the intervention group (p = 0.001). Among participants in the intervention group, an interdisciplinary meeting of significant network members was associated with less recovery (d = 0.46). Involuntary index admission (d = 0.42) and high educational degree (d = 0.52) were significant moderators of the intervention. Both factors related to less recovery over time in the intervention group relative to TAU. According to the OQ-45, this psychosocial post-discharge intervention revealed an unintended negative effect on self-reported recovery over time. Specifically, the meeting of significant network members related to a moderate deteriorating effect, suggesting that the involvement of some carers, relatives, or friends may cause harm to the patient. Considering with reservation pending replication, these findings could have important implications for brief interventions targeted at patients' social networks. This study was supported by a private foundation. ISRCTN58280620.

  1. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial.

    Science.gov (United States)

    Jaspers Focks, Jeroen; Brouwer, Marc A; Wojdyla, Daniel M; Thomas, Laine; Lopes, Renato D; Washam, Jeffrey B; Lanas, Fernando; Xavier, Denis; Husted, Steen; Wallentin, Lars; Alexander, John H; Granger, Christopher B; Verheugt, Freek W A

    2016-06-15

     To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation.  Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)-a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011.  18 201 ARISTOTLE trial participants.  In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, ≥9 drugs) with a median follow-up of 1.8 years.  Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country).  Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (≥5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, ≥9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (Pinteraction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers of concomitant drugs (Pinteraction=0.017). Patients with interacting

  2. Rasagiline adjunct therapy in patients with Parkinson's disease: post hoc analyses of the PRESTO and LARGO trials.

    Science.gov (United States)

    Elmer, Lawrence W

    2013-11-01

    Rasagiline was safe and effective when used as adjunct therapy with levodopa in patients with moderate-to-advanced Parkinson's disease (PD) in the phase III PRESTO and LARGO studies. To assess clinical effects of rasagiline 1 mg/day on cardinal PD symptoms and motor fluctuations in defined patient subgroups using pooled data from PRESTO and LARGO. Both double-blind, randomized, and placebo-controlled studies included PD patients with motor fluctuations despite optimized therapy with levodopa, with or without concomitant dopamine agonists (DA) or catechol-O-methyltransferase inhibitor (COMT-I) treatment. These post hoc analyses measured effects of rasagiline 1 mg vs placebo on individual cardinal PD symptoms during ON time and mean change from baseline in daily OFF time in subgroups of patients who at baseline were receiving only levodopa, were considered "mild fluctuators" (daily OFF time ≤ 4 h), and who were or were not receiving concomitant DA or COMT-I therapy. Compared with placebo, rasagiline significantly improved all cardinal PD symptoms and significantly reduced adjusted mean daily OFF time when used as first adjunct therapy in levodopa-treated patients and in patients with mild motor fluctuations. Significant improvement in motor fluctuations was reported with rasagiline regardless of concomitant DA or COMT-I use. Overall incidence of dopaminergic adverse events did not increase with concomitant DA or COMT-I use. Rasagiline was an effective first adjunct therapy in levodopa-treated patients; benefited patients with signs of early "wearing off"; improved all cardinal PD symptoms; and further improved symptoms in patients already receiving other adjunctive dopaminergic treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Post-hoc pattern-oriented testing and tuning of an existing large model: lessons from the field vole.

    Directory of Open Access Journals (Sweden)

    Christopher J Topping

    Full Text Available Pattern-oriented modeling (POM is a general strategy for modeling complex systems. In POM, multiple patterns observed at different scales and hierarchical levels are used to optimize model structure, to test and select sub-models of key processes, and for calibration. So far, POM has been used for developing new models and for models of low to moderate complexity. It remains unclear, though, whether the basic idea of POM to utilize multiple patterns, could also be used to test and possibly develop existing and established models of high complexity. Here, we use POM to test, calibrate, and further develop an existing agent-based model of the field vole (Microtus agrestis, which was developed and tested within the ALMaSS framework. This framework is complex because it includes a high-resolution representation of the landscape and its dynamics, of the individual's behavior, and of the interaction between landscape and individual behavior. Results of fitting to the range of patterns chosen were generally very good, but the procedure required to achieve this was long and complicated. To obtain good correspondence between model and the real world it was often necessary to model the real world environment closely. We therefore conclude that post-hoc POM is a useful and viable way to test a highly complex simulation model, but also warn against the dangers of over-fitting to real world patterns that lack details in their explanatory driving factors. To overcome some of these obstacles we suggest the adoption of open-science and open-source approaches to ecological simulation modeling.

  4. Is a reduction in albuminuria associated with renal and cardiovascular protection? A post hoc analysis of the ALTITUDE trial.

    Science.gov (United States)

    Heerspink, H J L; Ninomiya, T; Persson, F; Brenner, B M; Brunel, P; Chaturvedi, N; Desai, A S; Haffner, S M; Mcmurray, J J V; Solomon, S D; Pfeffer, M A; Parving, H-H; de Zeeuw, D

    2016-02-01

    To investigate whether the degree of albuminuria reduction observed in the ALTITUDE trial is associated with renal and cardiovascular protection, and secondly, whether the reduction in albuminuria was too small to afford clinical benefit. In a post hoc analysis of the ALTITUDE trial in 8561 patients with type 2 diabetes and chronic kidney disease or cardiovascular disease we examined the effect of albuminuria changes at 6 months on renal and cardiovascular outcomes using Cox proportional hazard regression. The median change in albuminuria in the first 6 months in the aliskiren arm of the trial was -12% (25th to 75th percentile: -48.7_to_ +41.9%) and 0.0% (25th to 75th percentile: -40.2_to_55%) in the placebo arm. Changes in albuminuria in the first 6 months were linearly associated with renal and cardiovascular endpoints: a >30% reduction in albuminuria in the first 6 months was associated with a 62% reduction in renal risk and a 25% reduction in cardiovascular risk compared with an increase in albuminuria. The association between changes at 6 months in albuminuria and renal or cardiovascular endpoints was similar in the two treatment groups (p for interaction >0.1 for both endpoints). The addition of aliskiren to angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy resulted in albuminuria changes that were associated with renal and cardiovascular risk changes. This did not translate into renal or cardiovascular protection because the overall reduction in albuminuria in the aliskiren arm was too small and nearly similar to that in the placebo arm. © 2015 John Wiley & Sons Ltd.

  5. Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Takei, Koji; Tsuda, Kikumi; Takahashi, Fumihiro; Palumbo, Joseph

    2017-10-01

    Study MCI186-19 investigated the safety and efficacy of edaravone in the treatment of ALS. The 24-week, double-blind period was followed by a 24-week, open-label, active extension period. Patients originally receiving edaravone continued edaravone (E-E group, n = 65), and patients originally receiving placebo switched to edaravone (P-E group, n = 58). Because no statistical tests had been prospectively planned in the open-label period, we performed post-hoc analyses to assist in the interpretation of efficacy data. A mixed model for repeated measures (MMRM) and the Combined Assessment of Function and Survival (CAFS) were assessed. Additionally, slopes of time-dependent change between baseline in cycle 1 and the end of cycle 6 (24 weeks double-blind) and between the end of cycle 6 and end of cycle 12 (24 weeks open-label) were calculated using a random coefficient model including all available data during each period. At week 48, the MMRM analysis showed significantly less decline in ALS Functional Rating Scale-Revised (ALSFRS-R) total score in the E-E group than in the P-E group (least-squares mean change from baseline ± standard error, 4.17 ± 1.40, p = 0.0037), meaning that the differences in the ALSFRS-R total score during the 24-week double-blind period were maintained in patients receiving edaravone for an additional 24 weeks. The CAFS endpoint (p = 0.0089) supported this finding. The slope analysis during the double-blind period showed a significant difference between the treatment groups, while there was no significant difference between the groups during the active extension period. These analyses suggest a potential benefit of early and continued edaravone treatment over delayed edaravone treatment.

  6. What Factors Determine Treatment Outcome in Aneurysmal Subarachnoid Hemorrhage in the Modern Era? A Post Hoc STASH Analysis.

    Science.gov (United States)

    Teo, Mario; Guilfoyle, Mathew R; Turner, Carole; Kirkpatrick, Peter J

    2017-09-01

    The management of aneurysmal subarachnoid hemorrhage (aSAH) has changed dramatically in the last few decades with the publication of a few major studies, including ISAT (International Subarachnoid Aneurysm Trial, the International Cooperative Study on the Timing of Aneurysm Surgery Study). The aim of this study is to analyze the outcome of patients with aSAH based on a contemporary series, identify the risk factors for poor outcome, and focus on patients with good-grade aSAH (to match the ISAT cohort). Baseline demographic and outcome data (modified Rankin Scale) were available for the 803 patients recruited from the STASH (Simvastatin in Aneurysmal Subarachnoid Haemorrhage) trial for post hoc analysis, using a χ2 test or 2-sample t test. Logistic regression analysis was performed to assess the risk factors for poor outcome at 6 months. Propensity matched analysis comparing coiling and clipping, and subgroup analysis of good-grade patients (World Federation of Neurosurgical Societies grade I-II) were also performed. Logistic regression analysis showed that the treatment modality (i.e., coiling or clipping) was not associated with poor outcome at 6 months (P = 0.839). The risk factors associated with poor outcome at 6 months were poor admission World Federation of Neurosurgical Societies grade (P < 0.0001), Fisher grade on initial computed tomography scan (P = 0.013), and the development of delayed cerebral ischemia (P < 0.0001). Subgroup analysis for good-grade patients only showed that 82% of patients after coiling and 78% of patients after clipping were classed as good outcome at 6 months (P = 0.181). In the current era of aSAH management, apart from patients' admission status, SAH blood load and the development of delayed cerebral ischemia, treatment modality with either coiling or clipping was not associated with poor outcome difference at 6 months. Copyright © 2017. Published by Elsevier Inc.

  7. Prevalence of Medication-Related Risks for Falls and Osteoporosis at a Hospital Network: A Post-hoc Analysis

    Directory of Open Access Journals (Sweden)

    Iouri Banakh

    2016-04-01

    Full Text Available AIM: PRO-OSTEO Extend 1was an osteoporosis management study at a Victorian Healthcare service. This post-hoc analysis examined comorbidities and drug-related risks for falls and osteoporosis, and analysed the accuracy of the medication subcomponent of the falls risk assessment tool used at the service. The secondary aim of this analysis was to evaluate the impact of proton pump inhibitors on the success of anti-osteoporosis therapies. MATERIAL AND METHODS: This analysis was part of a two year retrospective cohort study. The falls risk assessment tool medication subsection results, completed by nursing staff, were compared to scores given by the data collection pharmacist based on medical history notes using Mann-Whitney U test. The impact of proton pump inhibitors use on active osteoporosis therapy in patients admitted after a fall was analysed using the Fisher Exact test. Prevalence of medical and medication-related risk factors for osteoporosis and falls was compared between patients with fractures without osteoporosis treatment at admission and patient who were excluded from the primary study due to active osteoporosis therapy, or admission after a fall without a fracture. RESULTS: The falls risk assessment tool completion rate was approximately 80%, with accuracy below 50% P < 0.001. Medications which increase osteoporosis and falls risk were prevalent, with high use of benzodiazepines, opioids, serotonin reuptake inhibitors antidepressants and proton pump inhibitors. The impact of proton pump inhibitors carried a 14% increased relative risk of a fracture in this cohort (P = 0.218. There was also high prevalence of pre-existing fractures, pulmonary disease, heart failure and strokes in the study population. CONCLUSION: Falls risk assessment in relation to medication use is frequently inaccurate and is not done at all for a significant proportion of patients. The use proton pump inhibitors and medication-related risks for falls and

  8. Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial.

    Science.gov (United States)

    Arcoraci, Vincenzo; Atteritano, Marco; Squadrito, Francesco; D'Anna, Rosario; Marini, Herbert; Santoro, Domenico; Minutoli, Letteria; Messina, Sonia; Altavilla, Domenica; Bitto, Alessandra

    2017-02-22

    Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in postmenopausal women with low bone mineral density. The parent study was a randomized, double-blind, placebo-controlled trial involving postmenopausal women with a femoral neck (FN) density post-hoc analysis is a proof-of concept study suggesting that genistein may be useful not only in postmenopausal osteopenia but also in osteoporosis. However, this proof-of concept study needs to be confirmed by a large, well designed, and appropriately focused randomized clinical trial in a population at high risk of fractures.

  9. Efficacy of Tiotropium?+?Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis

    OpenAIRE

    Ferguson, Gary T.; Fle?ar, Matja?; Korn, Stephanie; Korducki, Lawrence; Gr?nke, Lars; Abrahams, Roger; Buhl, Roland

    2015-01-01

    Introduction The once-daily long-acting muscarinic antagonist (LAMA) tiotropium and once-daily long-acting ?2-agonist (LABA) olodaterol have been studied as a once-daily fixed-dose combination (FDC) in patients with chronic obstructive pulmonary disease (COPD). Two large, 52-week, double-blind, parallel-group studies in patients with moderate?very severe COPD demonstrated that tiotropium?+?olodaterol significantly improved lung function and symptoms versus the monocomponents. This post hoc an...

  10. Dose-Dependent Effect of Sitagliptin on Carotid Atherosclerosis in Patients with Type 2 Diabetes Mellitus Receiving Insulin Treatment: A Post Hoc Analysis.

    Science.gov (United States)

    Mita, Tomoya; Katakami, Naoto; Shiraiwa, Toshihiko; Yoshii, Hidenori; Gosho, Masahiko; Shimomura, Iichiro; Watada, Hirotaka

    2017-10-01

    Dipeptidyl peptidase-4 (DPP-4) inhibitors reduce blood glucose in a dose-dependent manner, but the dose-dependent effect relationship between DPP-4 inhibitors and atherosclerosis has not been investigated. Patients with type 2 diabetes mellitus (T2DM) treated with insulin were randomized to the sitagliptin (n = 137) or conventional treatment group (n = 137). In the sitagliptin group, each investigator was allowed to adjust the sitagliptin dose to avoid hypoglycemia. In this post hoc analysis, subjects in the sitagliptin group were divided into two groups based on the average dose of sitagliptin during the study period: greater than or equal to median (higher sitagliptin dose group) or less than median (lower sitagliptin dose group). In this study, subjects were divided into three groups: the conventional treatment group (n = 137), lower sitagliptin dose group (n = 42), and higher sitagliptin dose group (n = 95). The higher sitagliptin dose group had a significantly larger reduction in HbA1c (-0.62 ± 1.05%) than the conventional treatment group (-0.20 ± 0.91%, P = 0.007). Over 104 weeks, the higher sitagliptin dose significantly reduced the mean intima media thickness-common carotid artery (IMT-CCA) and left max-IMT-CCA relative to baseline. In addition, the higher sitagliptin dose significantly inhibited the progression in mean-IMT-CCA compared with conventional treatment. Multiple linear regression analysis showed that changes in mean-IMT-CCA and left max-IMT-CCA decreased with higher sitagliptin dose. Addition of sitagliptin to insulin therapy might attenuate the progression of atherosclerosis in patients with T2DM in a dose-dependent manner. Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., and Novo Nordisk. UMIN000007396.

  11. Post-thrombotic syndrome in patients treated with rivaroxaban or enoxaparin/vitamin K antagonists for acute deep-vein thrombosis. A post-hoc analysis.

    Science.gov (United States)

    Cheung, Y Whitney; Middeldorp, Saskia; Prins, Martin H; Pap, Akos F; Lensing, Anthonie W A; Ten Cate-Hoek, Arina J; Villalta, Sabina; Milan, Marta; Beyer-Westendorf, Jan; Verhamme, Peter; Bauersachs, Rupert M; Prandoni, Paolo

    2016-09-27

    Post-thrombotic syndrome (PTS) is a common complication of deep-vein thrombosis (DVT). Poor quality treatment with vitamin K antagonists (VKA) is a risk factor for PTS. We hypothesised that treatment with the direct oral anticoagulant (DOAC) rivaroxaban may lower PTS incidence as compared to enoxaparin/VKA, as DOACs have a more stable pharmacologic profile than VKA. We performed a post-hoc subgroup analysis of the Einstein DVT trial (n=3449). Kaplan-Meier survival analysis was performed to compare the cumulative incidence of PTS between the rivaroxaban and enoxaparin/VKA groups. Hazard ratios (HR) and 95 % confidence intervals (CI) were calculated using Cox proportional hazards models. We included 336 patients with a mean age of 58 ± 16 years and a median follow-up after index DVT of 57 months (interquartile range 48-64). Of these, 162 (48 %) had been treated with rivaroxaban and 174 (52 %) with enoxaparin/VKA. The cumulative PTS incidence at 60 months follow-up was 29 % in the rivaroxaban group and 40 % in the enoxaparin/VKA group. After adjusting for age, gender, body mass index, previous VTE, ipsilateral recurrent DVT, extent of DVT, idiopathic DVT, duration of anticoagulant treatment, compliance to assigned study medication, elastic compression stocking use and active malignancy, the HR of PTS development for rivaroxaban was 0.76 (95 % CI: 0.51-1.13). In conclusion, treatment of acute DVT with rivaroxaban was associated with a numerically lower but statistically non-significant risk of PTS compared to enoxaparin/VKA treatment. The potential effect on reducing PTS deserves evaluation in a large randomised trial.

  12. Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study

    Directory of Open Access Journals (Sweden)

    Tsuji T

    2017-09-01

    Full Text Available Toshinaga Tsuji,1 Naohiro Itoh,1 Mitsuhiro Ishida,2 Toshimitsu Ochiai,3 Shinichi Konno4 1Medical Affairs Department, 2Clinical Research Development, 3Biostatistics Department, Shionogi & Co. Ltd, Osaka, 4Department of Orthopedic Surgery, Fukushima Medical University, Fukushima, Japan Purpose: Duloxetine is efficacious for chronic low back pain (CLBP. This post hoc analysis of a Japanese randomized, placebo-controlled trial (ClinicalTrials.gov, NCT01855919 assessed whether patients with CLBP with early pain reduction or treatment-related adverse events of special interest (TR-AESIs; nausea, somnolence, constipation have enhanced responses to duloxetine. Patients and methods: Patients (N = 456 with CLBP for ≥6 months and Brief Pain Inventory (BPI average pain severity score of ≥4 were randomized (1:1 to duloxetine 60 mg/day or placebo for 14 weeks. Primary outcome was change from baseline in BPI average pain severity score (pain reduction. Subgroup analyses included early pain reduction (≥30%, 10%–30%, or <10% at Week 4 and early TR-AESIs (with or without TR-AESIs by Week 2. Measures included changes from baseline in BPI average pain severity score and BPI Interference scores (quality of life; QOL, and response rate (≥30% or ≥50% pain reduction at Week 14. Results: Patients with ≥30% early pain reduction (n = 108 or early TR-AESIs (n = 50 had significantly greater improvements in pain and QOL than placebo-treated patients (n = 226, whereas patients with 10%–30% (n = 63 or <10% (n = 48 pain reduction did not; patients without early TR-AESIs (n = 180 had significant improvements in pain at Week 14. Response rates (≥30%/≥50% pain reduction were 94.4%/82.4%, 66.7%/49.2%, and 25.0%/18.8% for patients with ≥30%, 10%–30%, and <10% early pain reduction, respectively, 74.0%/64.0% for patients with early TR-AESIs, 67.2%/54.4% for patients without early TR-AESIs, and 52.2%/39.4% for placebo.Conclusion: Early pain reduction or TR

  13. Relationship between exercise endurance and static hyperinflation in a post hoc analysis of two clinical trials in patients with COPD

    Science.gov (United States)

    Singh, Sally; Maltais, François; Tombs, Lee; Fahy, William A; Vahdati-Bolouri, Mitra; Locantore, Nicholas; Riley, John H

    2018-01-01

    Background Lung hyperinflation and exercise intolerance are hallmarks of chronic obstructive pulmonary disease (COPD). However, their relationship remains uncertain. A combined analysis of two placebo-controlled, randomized studies examined the effects of the long-acting muscarinic antagonist umeclidinium (UMEC) and long-acting β2-agonist vilanterol (VI) separately and in combination on static hyperinflation, exercise endurance time (EET), and their relationship in patients with COPD. Methods Patients with moderate-to-severe stable COPD and resting functional residual capacity >120% predicted were randomized to UMEC/VI 62.5/25 μg, UMEC 62.5 μg, VI 25 μg, or placebo for 12 weeks. Inspiratory capacity (IC), residual volume (RV), total lung capacity (TLC), and EET in an endurance shuttle-walk test were measured. In this post hoc analysis, IC/TLC, RV/TLC, and IC were used as hyperinflation markers. Results After 12 weeks, UMEC/VI and UMEC and VI showed significant improvements in hyperinflation versus placebo when measured by absolute change from baseline in IC/TLC (trough and 3 hours postdose [P≤0.011]). UMEC/VI showed significant improvements versus UMEC and VI in absolute changes in IC/TLC (trough and 3 hours postdose [P≤0.001]). Statistical significance for comparisons with placebo and between treatments for absolute changes in IC and percentage changes in RV/TLC followed similar patterns to those for absolute changes in IC/TLC. UMEC/VI showed significant improvements in EET versus placebo at day 2 and week 12, measured as change from baseline in seconds (P≤0.002) and as a percentage from baseline (P≤0.005). There was a lack of evidence to suggest a correlation between improvements in static hyperinflation and EET at any time point. Conclusion Although the dual bronchodilator UMEC/VI demonstrated greater improvements in static hyperinflation markers than UMEC or VI and significant improvements in exercise endurance, no direct relationship was observed

  14. Substantial Effects of Luseogliflozin Revealed by Analyzing Responses to Postprandial Hyperglycemia: Post Hoc Subanalyses of a Randomized Controlled Study.

    Science.gov (United States)

    Samukawa, Yoshishige; Omiya, Hirohisa; Watase, Hirotaka; Nozaki, Kazunari; Sakai, Soichi; Nishimura, Rimei

    2016-07-01

    In our previous study investigating effects of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, on 24-h glycemic variability by continuous glucose monitoring (CGM), luseogliflozin elicited parallel downward shifts in fasting and postprandial glucose levels. However, further review of individual patients' data revealed that postprandial hyperglycemia was not reduced in some patients, while preprandial glucose was ameliorated in most patients. Therefore, we divided patients into two groups according to their postprandial glucose responses and conducted a post hoc subanalyses to elucidate which factors contributed to the differential effects of luseogliflozin. Thirty-four Japanese type 2 diabetic patients in our previous randomized, double-blind, placebo-controlled, crossover study with 7-day luseogliflozin administration were divided into postprandial glucose responders (PGR, n = 23, ameliorated peak glucose) and postprandial glucose non-responders (PGNR; n = 11, non-ameliorated peak glucose). Baseline characteristics, variations in CGM-measured 24-h glucose levels, and other pharmacodynamic variabilities were compared. Baseline characteristics did not differ significantly between groups. Placebo-subtracted peak glucose was significantly lowered in PGR and significantly increased in PGNR (-43.8 and 17.9 mg/dL; both p < 0.05). Luseogliflozin significantly lowered "lowest glucose" (defined as the lowest level measured throughout a 24-h period) similarly in PGR and PGNR (-19.2 and -24.0 mg/dL; both p < 0.05), significantly reduced the mean amplitude of glucose excursions in PGR (-15.50 mg/dL; p < 0.05), and increased the area under the curve for plasma glucagon over 24 h in PGNR (median difference vs. placebo: 240 pg/mL h; p < 0.05). Luseogliflozin increased urinary glucose excretion (UGE) and decreased serum insulin by similar magnitudes in both groups. Luseogliflozin diminished glucose fluctuations in most patients by lowering peak glucose

  15. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis

    Science.gov (United States)

    LeWitt, Peter A.; Poewe, Werner; Elmer, Lawrence W.; Asgharnejad, Mahnaz; Boroojerdi, Babak; Grieger, Frank; Bauer, Lars

    2016-01-01

    Objectives Transdermal delivery of rotigotine maintains stable plasma concentrations for 24 hours. Three phase 3 studies of rotigotine as add-on to levodopa in advanced Parkinson's disease showed a significant reduction in “off” time from baseline to end of maintenance (EoM). However, detailed analyses over the range of a day have not yet been performed. The objective was to examine the time course of the efficacy profile of rotigotine throughout the day. Methods Post hoc analysis of diary data from 3 double-blind, placebo-controlled studies of rotigotine in patients with advanced Parkinson's disease inadequately controlled with levodopa, with average “off” time of ≥2.5 h/d (CLEOPATRA-PD [NCT00244387], 16-week maintenance; PREFER, 24-week maintenance; SP921 [NCT00522379], 12-week maintenance). Patients marked 30-minute intervals as “off,” “on without troublesome dyskinesia,” “on with troublesome dyskinesia,” or “sleep.” Diaries completed on the 3 days before EoM were analyzed. A 2-sample t test was performed for comparison of rotigotine + levodopa versus placebo + levodopa for mean percentage of time per status during four 6-hour periods: 12:00am (midnight) to 6:00am, 6:00am to 12:00pm (noon), noon to 6:00pm, and 6:00pm to midnight. Results Data were available for 967 patients (placebo + levodopa, 260; rotigotine + levodopa, 707). During the 24-hour period at EoM, an advantage in mean percentage time spent “off” and “on without troublesome dyskinesia” was observed with rotigotine + levodopa versus placebo + levodopa during the three 6-hour periods from 6:00am to midnight (P < 0.05; exploratory analysis). Conclusions These exploratory analyses of patients with motor fluctuations suggest that the efficacy of rotigotine transdermal patch, as captured by diary data, in reducing “off” time and increasing “on time without troublesome dyskinesia” may cover the full waking day. PMID:26882318

  16. Relationship between exercise endurance and static hyperinflation in a post hoc analysis of two clinical trials in patients with COPD

    Directory of Open Access Journals (Sweden)

    Singh S

    2018-01-01

    Full Text Available Sally Singh,1 François Maltais,2 Lee Tombs,3 William A Fahy,4 Mitra Vahdati-Bolouri,4 Nicholas Locantore,5 John H Riley4 1Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK; 2Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, QC, Canada; 3Precise Approach Ltd, London, UK; 4GSK, Stockley Park West, Uxbridge, UK; 5GSK, King of Prussia, PA, USA Background: Lung hyperinflation and exercise intolerance are hallmarks of chronic obstructive pulmonary disease (COPD. However, their relationship remains uncertain. A combined analysis of two placebo-controlled, randomized studies examined the effects of the long-acting muscarinic antagonist umeclidinium (Umec and long-acting β2-agonist vilanterol (Vi separately and in combination on static hyperinflation, exercise endurance time (EET, and their relationship in patients with COPD. Methods: Patients with moderate-to-severe stable COPD and resting functional residual capacity >120% predicted were randomized to Umec/Vi 62.5/25 µg, Umec 62.5 µg, Vi 25 µg, or placebo for 12 weeks. Inspiratory capacity (IC, residual volume (RV, total lung capacity (TLC, and EET in an endurance shuttle-walk test were measured. In this post hoc analysis, IC/TLC, RV/TLC, and IC were used as hyperinflation markers. Results: After 12 weeks, Umec/Vi and Umec and Vi showed significant improvements in hyperinflation versus placebo when measured by absolute change from baseline in IC/TLC (trough and 3 hours postdose [P≤0.011]. Umec/Vi showed significant improvements versus Umec and Vi in absolute changes in IC/TLC (trough and 3 hours postdose [P≤0.001]. Statistical significance for comparisons with placebo and between treatments for absolute changes in IC and percentage changes in RV/TLC followed similar patterns to those for absolute changes in IC/TLC. Umec/Vi showed significant improvements

  17. Improvement in 24-hour bronchodilation and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post hoc analysis of a Phase IIIb study.

    Science.gov (United States)

    Beier, Jutta; Mroz, Robert; Kirsten, Anne-Marie; Chuecos, Ferran; Gil, Esther Garcia

    2017-01-01

    A previous Phase IIIb study (NCT01462929) in patients with moderate to severe COPD demonstrated that 6 weeks of treatment with aclidinium led to improvements in 24-hour bronchodilation comparable to those with tiotropium, and improvement of symptoms versus placebo. This post hoc analysis was performed to assess the effect of treatment in the symptomatic patient group participating in the study. Symptomatic patients (defined as those with Evaluating Respiratory Symptoms [E-RS™] in COPD baseline score ≥10 units) received aclidinium bromide 400 μg twice daily (BID), tiotropium 18 μg once daily (QD), or placebo, for 6 weeks. Lung function, COPD respiratory symptoms, and incidence of adverse events (AEs) were assessed. In all, 277 symptomatic patients were included in this post hoc analysis. Aclidinium and tiotropium treatment improved forced expiratory volume in 1 second (FEV1) from baseline to week 6 at all time points over 24 hours versus placebo. In addition, improvements in FEV1 from baseline during the nighttime period were observed for aclidinium versus tiotropium on day 1 (aclidinium 157 mL, tiotropium 67 mL; Ppost hoc analysis of symptomatic patients with moderate to severe COPD, aclidinium 400 μg BID provided additional improvements compared with tiotropium 18 μg QD in: 1) bronchodilation, particularly during the nighttime, 2) daily COPD symptoms (E-RS), 3) early-morning and nighttime symptoms, and 4) early-morning limitation of activity.

  18. Political Subjects: Decision and Subjectivity from a Post-Fundational Perspective

    Directory of Open Access Journals (Sweden)

    Martín Retamozo

    2011-12-01

    Full Text Available The problem of decision and of political subjects was addressed in the field of 20th century political philosophy by authors such as Carl Schmitt, Hannah Arendt, and Jacques Derrida, who related it closely to the concepts of sovereignty, freedom, and contingency. The works of Ernesto Laclau and Slavoj Žižek have currently turnedto the issue of decision in order to address the constitutive spects of the political. In a context dominated by deconstruction, post-Marxism, and post-structuralism,the article inquires into the elation between decision and political subjects in a contemporary setting, examining in depth the difference between subjectivity,subjectivization, and subject.

  19. Reverse-flow anterolateral thigh perforator: an ad hoc flap for severe post-burn knee contracture.

    Science.gov (United States)

    Ismail, H A; El-Bassiony, L E

    2016-03-31

    We evaluate function outcomes of the reverse-flow ALT perforator flap to reconstruct severe post-burn knee contracture. Between October 2012 and December 2014, 10 patients with severe post-burn knee contracture were subjected to reconstruction with 10 ipsilateral reversed-flow ALT perforator flaps. All the patients were male. Ages ranged from 15 to 47 years (mean = 32 years). Time from burn injury to patient presentation ranged from 2-8 months. All patients demonstrated post-burn flexion contracture of the knee joint, ranging from 35 to 75 degrees. Flap sizes ranged from 8×16 to 12×26 cm. The flaps and skin grafts were carried out without major complications. Only minor complications occurred, such as transient, mild congestion immediately after inset in two flaps. Two flaps developed superficial necrosis at the distal edge. One case sustained partial skin graft loss due to haematoma. One case complained of skin hyperpigmentation and hypertrophic scars around the graft. Secondary debulking procedures were required in two cases. The entire donor sites were closed by partial thickness skin graft with acceptable appearance, except one case that was closed primarily. Eight out of ten patients (80%) demonstrated gradual improvement in range of knee motion after a specialized rehabilitation program. Two patients (20%) did not get back full range of motion. RALT perforator flap is the cornerstone for the reconstruction of soft-tissue defects around the knee with acceptable aesthetic and functional results provided that the following items are fulfilled: inclusion of muscle cuff around the pedicle, the pivot point, prevention of pedicle compression after transfer and early surgical intervention on the post-burn knee contracture.

  20. Effects of statins on the progression of cerebral white matter lesion: Post hoc analysis of the ROCAS (Regression of Cerebral Artery Stenosis) study.

    Science.gov (United States)

    Mok, Vincent C T; Lam, Wynnie W M; Fan, Yu Hua; Wong, Adrian; Ng, Ping Wing; Tsoi, Tak Hon; Yeung, Vincent; Wong, Ka Sing

    2009-05-01

    Arteriosclerotic related cerebral white matter lesion (WML) is associated with increased risk of death, stroke, dementia, depression, gait disturbance, and urinary incontinence. We investigated the effects of statins on WML progression by performing a post hoc analysis on the ROCAS (Regression of Cerebral Artery Stenosis) study, which is a randomized, double-blind, placebo-controlled study evaluating the effects of statins upon asymptomatic middle cerebral artery stenosis progression among stroke-free individuals. Two hundreds and eight randomized subjects were assigned to either placebo (n = 102) or simvastatin 20 mg daily (n = 106) for 2 years. Baseline severity of WML was graded visually into none, mild, and severe. Volume (cm3) of WML was determined quantitatively at baseline and at end of study using a semi-automated method based on MRI. Primary outcome was the change in WML volume over 2 years. After 2 years of follow-up, there was no significant change in WML volume between the active and the placebo group as a whole. However, stratified analysis showed that for those with severe WML at baseline, the median volume increase in the active group (1.9 cm3) was less compared with that in the placebo group (3.0 cm3; P = 0.047). Linear multivariate regression analysis identified that baseline WML volume (beta = 0.63, P < 0.001) and simvastatin treatment (beta = -0.214, P = 0.043) independently predicted change in WML volume. Our findings suggest that statins may delay the progression of cerebral WML only among those who already have severe WML at baseline.

  1. Correlations between cytogenetic and molecular monitoring among patients with newly diagnosed chronic myeloid leukemia in chronic phase: post hoc analyses of the Rationale and Insight for Gleevec High-Dose Therapy study

    National Research Council Canada - National Science Library

    Akard, Luke P; Cortes, Jorge E; Albitar, Maher; Goldberg, Stuart L; Warsi, Ghulam; Wetzler, Meir; Ericson, Solveig G; Radich, Jerald P

    2014-01-01

    ...) monitoring methods may be more convenient. To conduct post hoc analyses of the Rationale and Insight for Gleevec High-Dose Therapy study to evaluate correlations between results of cytogenetic testing and molecular monitoring from BM and PB...

  2. Influence of Hip Abductor Strength on Functional Outcomes Before and After Total Knee Arthroplasty: Post Hoc Analysis of a Randomized Controlled Trial.

    Science.gov (United States)

    Loyd, Brian J; Jennings, Jason M; Judd, Dana L; Kim, Raymond H; Wolfe, Pamela; Dennis, Douglas A; Stevens-Lapsley, Jennifer E

    2017-09-01

    Total knee arthroplasty (TKA) is associated with declines in hip abductor (HA) muscle strength; however, a longitudinal analysis demonstrating the influence of TKA on trajectories of HA strength change has not been conducted. The purpose of this study was to quantify changes in HA strength from pre-TKA through 3 months post-TKA and to characterize the relationship between HA strength changes and physical performance. This study is a post hoc analysis of a randomized controlled trial. Data from 162 participants (89 women, mean age = 63 y) were used for analysis. Data were collected by masked assessors preoperatively and at 1 and 3 months following surgery. Outcomes included: Timed "Up and Go" test (TUG), Stair Climbing Test (SCT), Six-Minute Walk Test (6MWT), and walking speed. Paired t tests were used for between- and within-limb comparisons of HA strength. Multivariable regression was used to determine contributions of independent variables, HA and knee extensor strength, to the dependent variables of TUG, SCT, 6MWT, and walking speed at each time point. Hip abductor strength was significantly lower in the surgical limb pre-TKA (mean = 0.015; 95% CI = 0.010-0.020), 1 month post-TKA (0.028; 0.023-0.034), and 3 months post-TKA (0.02; 0.014-0.025) compared with the nonsurgical limb. Hip abductor strength declined from pre-TKA to 1 month post-TKA (18%), but not at the 3-month time point (0%). Hip abductor strength independently contributed to performance-based outcomes pre-TKA; however, this contribution was not observed post-TKA. The post hoc analysis prevents examining all outcomes likely to be influenced by HA strength. Surgical limb HA strength is impaired prior to TKA, and worsens following surgery. Furthermore, HA strength contributes to performance-based outcomes, supporting the hypothesis that HA strength influences functional recovery.

  3. Rotigotine transdermal system and evaluation of pain in patients with Parkinson’s disease: a post hoc analysis of the RECOVER study

    Science.gov (United States)

    2014-01-01

    Background Pain is a troublesome non-motor symptom of Parkinson’s disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. Methods PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting ‘any’ pain (pain score ≥1) at baseline, and subgroups reporting ‘mild’ (score 1–3), and ‘moderate-to-severe’ pain (score ≥4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a ≥30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Results Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported ‘any’ pain; of these 87 (33%) reported ‘mild’, and 100 (37%) ‘moderate-to-severe’ pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with ‘any’ pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with ‘moderate-to-severe’ pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders

  4. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    Science.gov (United States)

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P post hoc analyses should be viewed with caution given the potential for bias, in eyes with a VA of 20/50 or worse, aflibercept has the greatest improvement in VA over 2 years. Focal/grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years. clinicaltrials.gov Identifier NCT01627249.

  5. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Fu Dong-Jing

    2011-05-01

    Full Text Available Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal. These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial, 652 subjects with schizophrenia were randomized to paliperidone palmitate 39, 156, or 234 mg (corresponding to 25, 100, or 150 mg equivalents of paliperidone, respectively or placebo (NCT#00590577. Subjects randomized to paliperidone palmitate received 234 mg on Day 1, followed by their randomized fixed dose on Day 8, and monthly thereafter, with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS score compared to placebo (Analysis of Covariance [ANCOVA] models and Last Observation Carried Forward [LOCF] methodology without adjusting for multiplicity using data from the Days 4, 8, 22, and 36 assessments. Adverse event (AE rates and relative risks (RR with 95% confidence intervals (CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares (LS mean PANSS total score at Day 8 (p = 0.037. After the Day 8 injection of 156 mg, there was continued PANSS improvement at Day 22 (p ≤ 0.007 vs. placebo and Day 36 (p Conclusions Significantly greater symptom improvement was observed by Day 8 with paliperidone palmitate (234 mg on Day 1 compared to placebo; this effect was maintained after the 156 mg Day 8 injection, with a trend towards a dose

  6. Post-deformation examination of specimens subjected to SCC testing

    Energy Technology Data Exchange (ETDEWEB)

    Gussev, Maxim N. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Field, Kevin G. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Busby, Jeremy T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Leonard, Keith J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-09-01

    This report details the results of post-radiation and post-deformation characterizations performed during FY 2015–FY 2016 on a subset of specimens that had previously been irradiated at high displacement per atom (dpa) damage doses. The specimens, made of commercial austenitic stainless steels and alloys, were subjected to stress-corrosion cracking tests (constant extension rate testing and crack growth testing) at the University of Michigan under conditions typical of nuclear power plants. After testing, the specimens were returned to Oak Ridge National Laboratory (ORNL) for further analysis and evaluation.

  7. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.

    Science.gov (United States)

    le Roux, Carel; Aroda, Vanita; Hemmingsson, Joanna; Cancino, Ana Paula; Christensen, Rune; Pi-Sunyer, Xavier

    2017-11-17

    To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup. Significantly greater weight loss (0-56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups. This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m². © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  8. Inclusion of Vancomycin as Part of Broad-Spectrum Coverage Does Not Improve Outcomes in Patients with Intra-Abdominal Infections: A Post Hoc Analysis.

    Science.gov (United States)

    Sanders, James M; Tessier, Jeffrey M; Sawyer, Robert G; Lipsett, Pam A; Miller, Preston R; Namias, Nicholas; O'Neill, Patrick J; Dellinger, E P; Coimbra, Raul; Guidry, Chris A; Cuschieri, Joseph; Banton, Kaysie L; Cook, Charles H; Moore, Billy J; Duane, Therese M

    2016-12-01

    Management of complicated intra-abdominal infections (cIAIs) includes broad-spectrum antimicrobial coverage and commonly includes vancomycin for the empiric coverage of methicillin-resistant Staphylococcus aureus (MRSA). Ideally, culture-guided de-escalation follows to promote robust antimicrobial stewardship. This study assessed the impact and necessity of vancomycin in cIAI treatment regimens. A post hoc analysis of the Study to Optimize Peritoneal Infection Therapy (STOP-IT) trial was performed. Patients receiving piperacillin-tazobactam (P/T) and/or a carbapenem were included with categorization based on use of vancomycin. Univariate and multivariable analyses evaluated effects of including vancomycin on individual and the composite of undesirable outcomes (recurrent IAI, surgical site infection [SSI], or death). The study cohort included 344 patients with 110 (32%) patients receiving vancomycin. Isolation of MRSA occurred in only eight (2.3%) patients. Vancomycin use was associated with a similar composite outcome, 29.1%, vs. no vancomycin, 22.2% (p = 0.17). Patients receiving vancomycin had (mean [standard deviation]) higher Acute Physiology and Chronic Health Evaluation II scores (13.1 [6.6] vs. 9.4 [5.7], p post hoc analysis reveals that addition of vancomycin occurred in nearly one third of patients and more often in sicker patients. Despite this selection bias, no appreciable differences in undesired outcomes were demonstrated, suggesting limited utility for adding vancomycin to cIAI treatment regimens.

  9. A post hoc analysis of long-term prognosis after exenatide treatment in patients with ST-segment elevation myocardial infarction.

    Science.gov (United States)

    Kyhl, Kasper; Lønborg, Jacob; Vejlstrup, Niels; Kelbæk, Henning; Helqvist, Steffen; Holmvang, Lene; Jørgensen, Erik; Saunamäki, Kari; Bøtker, Hans Erik; Clemmensen, Peter; Køber, Lars; Treiman, Marek; Engstrøm, Thomas

    2016-07-20

    We aimed to assess the effect of exenatide treatment as an adjunct to primary percutaneous coronary intervention (PCI) on long-term clinical outcome. We performed a post hoc analysis in 334 patients with a first STEMI included in a previous study randomised to exenatide (n=175) or placebo (n=159) as an adjunct to primary PCI. The primary endpoint was a composite of all-cause mortality and admission for heart failure during a median follow-up of 5.2 years (interquartile range: 5.0-5.5). Secondary endpoints were all-cause mortality and admission for heart failure, individually. The primary composite endpoint occurred in 24% in the exenatide group versus 27% in the placebo group, p=0.44 (HR 0.80, p=0.35). Admission for heart failure was lower in the exenatide (11%) compared to the placebo group (20%) (HR 0.53, p=0.042). All-cause mortality occurred in 14% in the exenatide group versus 9% in the placebo group (HR 1.45, p=0.20). In this post hoc analysis of patients with a STEMI, treatment with exenatide at the time of primary PCI did not reduce the primary composite endpoint or the secondary endpoint of all-cause -mortality. However, exenatide treatment reduced the incidence of admission for heart failure.

  10. Vitamin D supplementation improves well-being in patients with frequent respiratory tract infections: a post hoc analysis of a randomized, placebo-controlled trial.

    Science.gov (United States)

    Bergman, Peter; Norlin, Anna-Carin; Hansen, Susanne; Björkhem-Bergman, Linda

    2015-09-29

    The aim of this study was to test the hypothesis that vitamin D supplementation improves well-being in patients with frequent respiratory tract infections (RTIs). We performed a post hoc analysis of a randomized, placebo-controlled and double-blind study in which patients with frequent RTIs were randomized to placebo or vitamin D (4000 IE/day for 1 year, n = 124). At the last visit of the study, patients were asked to perform a general assessment of their well-being during the study. The majority of patients, both placebo- and vitamin D treated, stated that they had felt 'better' during the study; 52% in the placebo group and 70% in the vitamin D group, relative risk 1.3 (95% CI 1.0-1.8; p = 0.06, Fisher's exact test). Statement of better well-being was associated with an increase in 25-hydroxyvitamin D (25-OHD) levels (p Vitamin D supplementation to patients with frequent RTIs might be beneficial, not only for infections, but also for their general well-being. However, given the post hoc design of this study, these findings need to be confirmed in additional clinical trials before firm conclusions can be drawn. http://www.clinicaltrials.gov (NCT01131858), registered March 22, 2010.

  11. Indomethacin reduces glomerular and tubular damage markers but not renal inflammation in chronic kidney disease patients: a post-hoc analysis.

    Directory of Open Access Journals (Sweden)

    Martin H de Borst

    Full Text Available Under specific conditions non-steroidal anti-inflammatory drugs (NSAIDs may be used to lower therapy-resistant proteinuria. The potentially beneficial anti-proteinuric, tubulo-protective, and anti-inflammatory effects of NSAIDs may be offset by an increased risk of (renal side effects. We investigated the effect of indomethacin on urinary markers of glomerular and tubular damage and renal inflammation. We performed a post-hoc analysis of a prospective open-label crossover study in chronic kidney disease patients (n = 12 with mild renal function impairment and stable residual proteinuria of 4.7±4.1 g/d. After a wash-out period of six wks without any RAAS blocking agents or other therapy to lower proteinuria (untreated proteinuria (UP, patients subsequently received indomethacin 75 mg BID for 4 wks (NSAID. Healthy subjects (n = 10 screened for kidney donation served as controls. Urine and plasma levels of total IgG, IgG4, KIM-1, beta-2-microglobulin, H-FABP, MCP-1 and NGAL were determined using ELISA. Following NSAID treatment, 24 h -urinary excretion of glomerular and proximal tubular damage markers was reduced in comparison with the period without anti-proteinuric treatment (total IgG: UP 131[38-513] vs NSAID 38[17-218] mg/24 h, p<0.01; IgG4: 50[16-68] vs 10[1-38] mg/24 h, p<0.001; beta-2-microglobulin: 200[55-404] vs 50[28-110] ug/24 h, p = 0.03; KIM-1: 9[5]-[14] vs 5[2]-[9] ug/24 h, p = 0.01. Fractional excretions of these damage markers were also reduced by NSAID. The distal tubular marker H-FABP showed a trend to reduction following NSAID treatment. Surprisingly, NSAID treatment did not reduce urinary excretion of the inflammation markers MCP-1 and NGAL, but did reduce plasma MCP-1 levels, resulting in an increased fractional MCP-1 excretion. In conclusion, the anti-proteinuric effect of indomethacin is associated with reduced urinary excretion of glomerular and tubular damage markers, but not with reduced excretion of renal

  12. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies.

    Science.gov (United States)

    Sajatovic, Martha; Forester, Brent P; Tsai, Joyce; Kroger, Hans; Pikalov, Andrei; Cucchiaro, Josephine; Loebel, Antony

    2016-10-01

    The aim of this post hoc analysis was to evaluate the efficacy of lurasidone in patients aged 55 years and older with bipolar depression. A post hoc analysis was performed on the older adult subgroup (n = 142) of outpatients meeting DSM-IV-TR criteria for bipolar I depression in 2 placebo-controlled, 6-week, randomized, double-blind studies conducted from 2009-2012: a monotherapy study comparing fixed flexible-dose ranges of lurasidone 20-60 mg/d or 80-120 mg/d with placebo and an adjunctive therapy study comparing flexible doses of lurasidone 20-120 mg/d with placebo adjunctive to either lithium or valproate. The primary endpoint was mean change at week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. In the randomized sample, the proportion of older adults was 88/505 (17.4%) in the monotherapy study and 54/348 (15.5%) in the adjunctive therapy study. In the older adult subgroup in the monotherapy study, mean change at week 6 in the MADRS was significantly greater for lurasidone versus placebo (-14.8 vs -7.1; P = .003; effect size, 0.83; pooled doses), and in the adjunctive therapy study, mean change for lurasidone was not significantly different from placebo (-13.9 vs -11.1; P = .398; effect size, 0.26). Discontinuation rates due to adverse events for lurasidone versus placebo were similar for the monotherapy (6.8% vs 6.9%) and adjunctive therapy (3.8% vs 7.1%) studies. Lurasidone had minimal effects on metabolic laboratory values. The results of these post hoc analyses, which assessed the efficacy of lurasidone in older adults with bipolar disorder, found that monotherapy was significantly effective while adjunctive therapy was not associated with significant improvement. Both monotherapy and adjunctive therapy with lurasidone were safe and well-tolerated in this older adult population. ClinicalTrials.gov identifiers: NCT00868699, NCT00868452.

  13. Inherent Risk Factors for Nosocomial Infection in the Long Stay Critically Ill Child Without Known Baseline Immunocompromise: A Post Hoc Analysis of the CRISIS Trial.

    Science.gov (United States)

    Carcillo, Joseph A; Dean, J Michael; Holubkov, Richard; Berger, John; Meert, Kathleen L; Anand, Kanwaljeet J S; Zimmerman, Jerry; Newth, Christopher J; Harrison, Rick; Burr, Jeri; Willson, Douglas F; Nicholson, Carol; Bell, Michael J; Berg, Robert A; Shanley, Thomas P; Heidemann, Sabrina M; Dalton, Heidi; Jenkins, Tammara L; Doctor, Allan; Webster, Angie

    2016-11-01

    Nosocomial infection remains an important health problem in long stay (>3 days) pediatric intensive care unit (PICU) patients. Admission risk factors related to the development of nosocomial infection in long stay immune competent patients in particular are not known. Post-hoc analysis of the previously published Critical Illness Stress induced Immune Suppression (CRISIS) prevention trial database, to identify baseline risk factors for nosocomial infection. Because there was no difference between treatment arms of that study in nosocomial infection in the population without known baseline immunocompromise, both arms were combined and the cohort that developed nosocomial infection was compared with the cohort that did not. There were 254 long stay PICU patients without known baseline immunocompromise. Ninety (35%) developed nosocomial infection, and 164 (65%) did not. Admission characteristics associated with increased nosocomial infection risk were increased age, higher Pediatric Risk of Mortality version III score, the diagnoses of trauma or cardiac arrest and lymphopenia (P hoc stratification randomization strategies for prospective studies designed to prevent nosocomial infection in this population.

  14. Lurasidone for major depressive disorder with mixed features and anxiety: a post-hoc analysis of a randomized, placebo-controlled study.

    Science.gov (United States)

    Tsai, Joyce; Thase, Michael E; Mao, Yongcai; Ng-Mak, Daisy; Pikalov, Andrei; Loebel, Antony

    2017-04-01

    The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety. The data in this analysis were derived from a study of patients meeting the DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM-A≤14) and moderate-to-severe anxiety (HAM-A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures. Treatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (-18.4 vs. -12.8, ppost-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.

  15. Inherent Risk Factors for Nosocomial Infection in the Long Stay Critically Ill Child Without Known Baseline Immunocompromise: A PostHoc Analysis of the CRISIS Trial

    Science.gov (United States)

    Carcillo, Joseph A; Dean, J Michael; Holubkov, Richard; Berger, John; Meert, Kathleen L; Anand, KJS; Zimmerman, Jerry; Newth, Christopher J; Harrison, Rick; Burr, Jeri; Willson, Douglas F.; Nicholson, Carol; Bell, Michael J.; Berg, Robert A.; Shanley, Thomas P.; Heidemann, Sabrina M; Dalton, Heidi; Jenkins, Tammara L.; Doctor, Allan; Webster, Angie

    2016-01-01

    Background Nosocomial infection remains an important health problem in long stay (> 3 days) pediatric intensive care unit (PICU) patients. Admission risk factors related to the development of nosocomial infection in long stay immune competent patients in particular are not known. Methods Post-hoc analysis of the previously published Critical Illness Stress induced Immune Suppression (CRISIS) prevention trial database, to identify baseline risk factors for nosocomial infection. Because there was no difference between treatment arms of that study in nosocomial infection in the population without known baseline immunocompromise, both arms were combined and the cohort that developed nosocomial infection was compared with the cohort that did not. Results There were 254 long stay PICU patients without known baseline immunocompromise. Ninety (35%) developed nosocomial infection, and 164 (65%) did not. Admission characteristics associated with increased nosocomial infection risk were increased age, higher PRISM III score, the diagnoses of trauma or cardiac arrest, and lymphopenia (p infection at admission was associated with reduced risk of developing nosocomial infection (p nosocomial infection development (p = 0.07). Conclusions These data suggest that increasing age, cardiac arrest, and lymphopenia predispose long stay PICU patients without known baseline immunocompromise to nosocomial infection. These findings may inform pre-hoc stratification randomization strategies for prospective studies designed to prevent nosocomial infection in this population. PMID:27753764

  16. Improvement in Renal Function and Reduction in Serum Uric Acid with Intensive Statin Therapy in Older Patients: A Post Hoc Analysis of the SAGE Trial.

    Science.gov (United States)

    Deedwania, Prakash C; Stone, Peter H; Fayyad, Rana S; Laskey, Rachel E; Wilson, Daniel J

    2015-12-01

    Improvement in renal function and decreases in serum uric acid (SUA) have been reported following prolonged high-intensity statin (HMG-CoA reductase inhibitor) therapy. This post hoc analysis of the SAGE trial examined the effect of intensive versus less intensive statin therapy on renal function, safety, and laboratory parameters, including SUA, in elderly coronary artery disease (CAD) patients (65-85 years) with or without chronic kidney disease (CKD). Patients were randomized to atorvastatin 80 mg/day or pravastatin 40 mg/day and treated for 12 months. Patients were stratified using Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rates (eGFRs) in CKD (eGFR 3 times the upper limit of normal occurred in 4.4% of atorvastatin- and 0.2% of pravastatin-treated patients. Intensive management of dyslipidemia in older patients with stable coronary heart disease may have beneficial effects on renal function and SUA.

  17. Post-hoc comparisons among iron electrode formulations based on bismuth, bismuth sulphide, iron sulphide, and potassium sulphide under strong alkaline conditions

    Science.gov (United States)

    Gil Posada, Jorge Omar; Hall, Peter J.

    2014-12-01

    Iron electrodes were prepared by hot-pressing iron-polyethylene based formulations on nickel foam stripes. NiFe cells were tested by using commercial nickel electrodes and our iron electrodes. Post-hoc comparisons were used to identify meaningful differences between iron electrode formulations (based upon bismuth, bismuth sulphate, potassium sulphide and iron sulphide as additives). Our results confirm that both bismuth sulphide and iron sulphide favour the process of charge/discharge of a NiFe cell. In addition, we have found that the use of metallic bismuth only marginally influences coulombic efficiency; likewise, the presence of the soluble bisulfide anion is not sufficient to increase coulombic efficiency. Finally, NiFe cells prepared with bismuth sulphide outperformed their iron sulphide counterparts.

  18. Post-hoc principal component analysis on a largely illiterate elderly population from North-west India to identify important elements of mini-mental state examination.

    Science.gov (United States)

    Raina, Sunil Kumar; Chander, Vishav; Raina, Sujeet; Grover, Ashoo

    2016-01-01

    Mini-mental state examination (MMSE) scale measures cognition using specific elements that can be isolated, defined, and subsequently measured. This study was conducted with the aim to analyze the factorial structure of MMSE in a largely, illiterate, elderly population in India and to reduce the number of variables to a few meaningful and interpretable combinations. Principal component analysis (PCA) was performed post-hoc on the data generated by a research project conducted to estimate the prevalence of dementia in four geographically defined habitations in Himachal Pradesh state of India. Questions on orientation and registration account for high percentage of cumulative variance in comparison to other questions. The PCA conducted on the data derived from a largely, illiterate population reveals that the most important components to consider for the estimation of cognitive impairment in illiterate Indian population are temporal orientation, spatial orientation, and immediate memory.

  19. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Gilbert, Richard E; Mende, Christian; Vijapurkar, Ujjwala; Sha, Sue; Davies, Michael J; Desai, Mehul

    2017-04-01

    The objective of this study was to evaluate the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on serum magnesium in hypomagnesemic patients with type 2 diabetes. This post hoc analysis was based on pooled data from four placebo-controlled studies of canagliflozin (N = 2313). The proportion of patients with baseline serum magnesium magnesium ≥0.74 mmol/L at week 26 was evaluated. At week 26, canagliflozin 100 and 300 mg increased serum magnesium versus placebo in patients with baseline serum magnesium magnesium magnesium ≥0.74 mmol/L at week 26 with canagliflozin 100 and 300 mg versus placebo (74.1% and 80.6% vs 28.8%). Canagliflozin was associated with normalization of serum magnesium in hypomagnesemic patients with type 2 diabetes, potentially leading to improved cardiometabolic outcomes. ClinicalTrials.gov Identifiers, NCT01081834, NCT01106677, NCT01106625, NCT01106690.

  20. Short-term blood pressure variability in acute stroke: post hoc analysis of the controlling hypertension and hypotension immediately post stroke and continue or stop post-stroke antihypertensives collaborative study trials.

    Science.gov (United States)

    Manning, Lisa S; Mistri, Amit K; Potter, John; Rothwell, Peter M; Robinson, Thompson G

    2015-06-01

    Short-term blood pressure variability (BPV) may predict outcome in acute stroke. We undertook a post hoc analysis of data from 2 randomized controlled trials to determine the effect of short-term BPV on 2-week outcome. Controlling Hypertension and Hypotension Immediately Post Stroke (CHHIPS) was a trial of BP-lowering, enrolling 179 acute stroke patients (onset3) at 2 weeks. Seven hundred six (92.5%) and 171 (95.5%) participants were included in the analysis for the COSSACS and CHHIPS data sets, respectively. Adjusted logistic regression analyses revealed no statistically significant associations between any of the included BPV parameters with 2-week death or disability in either study data set: COSSACS, odds ratio SD systolic BP 0.98 (0.78-1.23); CHHIPS, odds ratio SD systolic BP 0.97 (0.90-1.11). When derived from casual cuff BP measures, short-term BPV is not a useful predictor of early (2 weeks) outcome after acute stroke. Differing methodology may account for the discordance with previous studies indicating long-term (casual BPV) and short-term (beat-to-beat BPV) prognostic value. COSSACS was registered on the International Standard Randomised Controlled Trial Register; URL: http://www.isrctn.com. Unique identifier: ISRCTN89712435. CHHIPS was registered on the National Research Register; URL: http://public.ukcrn.org.uk. Unique identifier: N0484128008. © 2015 American Heart Association, Inc.

  1. Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure: Post-Hoc Analysis of the PASSION Trial.

    Science.gov (United States)

    Vink, Maarten A; Vos, Nicola S; Dirksen, Maurits T; Suttorp, Maarten J; Slagboom, Ton; Patterson, Mark S; Kiemeneij, Ferdinand; Laarman, GertJan

    2015-12-01

    Our aim was to investigate the risk of events related to non-culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD). In patients undergoing primary PCI for ST-elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non-culprit lesions when compared with culprit-lesion PCI only. We performed a post-hoc analysis of 279 patients with MVD included in the Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis. After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1-vessel disease (HR 1.06, 95%CI 0.52-2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment. In this post-hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non-culprit coronary artery. © 2015, Wiley Periodicals, Inc.

  2. Erythropoietin in patients with traumatic brain injury and extracranial injury-A post hoc analysis of the erythropoietin traumatic brain injury trial.

    Science.gov (United States)

    Skrifvars, Markus B; Bailey, Michael; French, Craig; Presneill, Jeffrey; Nichol, Alistair; Little, Lorraine; Duranteau, Jacques; Huet, Olivier; Haddad, Samir; Arabi, Yaseen; McArthur, Colin; Cooper, D James; Bellomo, Rinaldo

    2017-09-01

    Erythropoietin (EPO) may reduce mortality after traumatic brain injury (TBI). Secondary brain injury is exacerbated by multiple trauma, and possibly modifiable by EPO. We hypothesized that EPO decreases mortality more in TBI patients with multiple trauma, than in patients with TBI alone. A post hoc analysis of the EPO-TBI randomized controlled trial conducted in 2009 to 2014. To evaluate the impact of injuries outside the brain, we calculated an extracranial Injury Severity Score (ISS) that included the same components of the ISS, excluding head and face components. We defined multiple trauma as two injured body regions with an Abbreviated Injury Scale (AIS) score of 3 or higher. Cox regression analyses, allowing for potential differential responses per the presence or absence of extracranial injury defined by these injury scores, were used to assess the effect of EPO on time to mortality. Of 603 included patients, the median extracranial ISS was 6 (interquartile range, 1-13) and 258 (43%) had an AIS score of 3 or higher in at least two body regions. On Cox regression, EPO was associated with decreased mortality in patients with greater extracranial ISS (interaction p = 0.048) and weakly associated with differential mortality with multiple trauma (AIS score > 3 or in two regions, interaction p = 0.17). At 6 months in patients with extracranial ISS higher than 6, 10 (6.8%) of 147 EPO-treated patients compared with 26 (17%) of 154 placebo-treated patients died (risk reduction, 10%; 95% confidence interval, 2.9-17%; p = 0.007). In this post hoc analysis, EPO administration was associated with a potential differential improvement in 6-month mortality in TBI patients with more severe extracranial injury. These findings need confirmation in future clinical and experimental studies. Therapeutic study, level III.

  3. Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study.

    Science.gov (United States)

    Nishikawa, Atsushi; Yoshiki, Fumito; Taketsuna, Masanori; Kajimoto, Kenta; Enomoto, Hiroyuki

    2016-01-01

    Teriparatide (recombinant 1-34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed.

  4. A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    Science.gov (United States)

    2017-10-01

    Our first phase III study failed to demonstrate efficacy of edaravone for amyotrophic lateral sclerosis (ALS) compared to placebo. Here, we performed post-hoc subgroup analysis to identify a subgroup in which edaravone might be expected to show efficacy. We focussed on two newly defined subgroups, EESP and dpEESP2y. The EESP was defined as the efficacy-expected subpopulation with % forced vital capacity of ≥80%, and ≥2 points for all item scores in the revised ALS functional rating scale (ALSFRS-R) score before treatment. The dpEESP2y was defined as the greater-efficacy-expected subpopulation within EESP having a diagnosis of 'definite' or 'probable' ALS according to the El Escorial revised Airlie House diagnostic criteria and onset of disease within two years. The primary endpoint of the post-hoc analysis was the change in the ALSFRS-R score during the 24-week treatment period. The intergroup differences of the least-squares mean change in the ALSFRS-R score ± standard error during treatment were 0.65 ± 0.78 (p = 0.4108) in the full analysis set, 2.20 ± 1.03 (p = 0.0360) in the EESP, and 3.01 ± 1.33 (p = 0.0270) in the dpEESP2y. Edaravone exhibited efficacy in the dpEESP2y subgroup. A further clinical study in patients meeting dpEESP2y criteria is warranted.

  5. Assessment of direct analgesic effect of duloxetine for chronic low back pain: post hoc path analysis of double-blind, placebo-controlled studies.

    Science.gov (United States)

    Enomoto, Hiroyuki; Fujikoshi, Shinji; Funai, Jumpei; Sasaki, Nao; Ossipov, Michael H; Tsuji, Toshinaga; Alev, Levent; Ushida, Takahiro

    2017-01-01

    Comorbid depression and depressive symptoms are common in patients with chronic low back pain (CLBP). Duloxetine is clinically effective in major depressive disorder and several chronic pain states, including CLBP. The objective of this post hoc meta-analysis was to assess direct and indirect analgesic efficacy of duloxetine for patients with CLBP in previous clinical trials. Post hoc path analyses were conducted of 3 randomized, double-blind, clinical studies of patients receiving duloxetine or placebo for CLBP. The primary outcome measure for pain was the Brief Pain Inventory, average pain score. A secondary outcome measure, the Beck Depression Inventory-II, was used for depressive symptoms. The changes in score from baseline to endpoint were determined for each index. Path analyses were employed to calculate the proportion of analgesia that may be attributed to a direct effect of duloxetine on pain. A total of 851 patients (400 duloxetine and 451 placebo) were included in this analysis. Duloxetine significantly improved pain scores compared with placebo (p<0.001). It also significantly improved depressive scores compared with placebo (p=0.015). Path analyses showed that 91.1% of the analgesic effect of duloxetine could be attributed to a direct analgesic effect, and 8.9% to its antidepressant effect. Similar results were obtained when data were evaluated at weeks 4 and 7, and when patients were randomized to subgroups based on baseline pain scores, baseline depressive symptoms scores, and gender. Duloxetine significantly improved pain in patients with CLBP. Path analyses results suggest that duloxetine produced analgesia mainly through mechanisms directly impacting pain modulation rather than lifting depressive symptoms. This effect was consistent across all subgroups tested.

  6. Tolerability of cariprazine in the treatment of acute bipolar I mania: A pooled post hoc analysis of 3 phase II/III studies.

    Science.gov (United States)

    Earley, Willie; Durgam, Suresh; Lu, Kaifeng; Debelle, Marc; Laszlovszky, István; Vieta, Eduard; Yatham, Lakshmi N

    2017-06-01

    Atypical antipsychotics have broad-spectrum efficacy against core symptoms of acute mania/mixed states in bipolar disorder; however, they are associated with clinically significant adverse effects (AEs). This post hoc analysis evaluated the safety and tolerability of the atypical antipsychotic cariprazine in the treatment of adult patients with acute manic/mixed episodes of bipolar I disorder. Data were taken from three 3-week randomized, double-blind, placebo-controlled, flexible-dose trials of cariprazine 3-12mg/d. Patient subgroups categorized by modal daily dose (3-6mg/d; 9-12mg/d) were used to assess dose response. The pooled safety population comprised 1065 patients (placebo=442; cariprazine 3-6mg/d=263; cariprazine 9-12mg/d=360). More cariprazine- than placebo-treated patients reported double-blind treatment-emergent AEs; the overall AE incidence was similar among cariprazine-dose groups. AEs reported in ≥5% of cariprazine patients overall with at least twice the incidence of placebo were akathisia, extrapyramidal symptoms, restlessness, and vomiting. The incidence of SAEs was low and similar between the placebo- and cariprazine-treatment groups. Metabolic parameter changes were small and generally similar between cariprazine and placebo groups; mean increases in fasting glucose levels were greater with cariprazine (3-6mg/d=6.6mg/dL; 9-12mg/d=7.2mg/dL) than placebo (1.7mg/dL). Mean weight change was 0.54kg and 0.17kg for cariprazine and placebo, respectively; weight increase ≥7% was Post hoc analysis, flexible-dose design, short trial duration. Cariprazine was generally safe and well-tolerated in patients with manic/mixed episodes associated with bipolar I disorder. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  7. Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms; post-hoc analyses of three randomized controlled trials.

    Science.gov (United States)

    Kerwin, Edward; Barnes, Neil; Gibbs, Michael; Leather, David; Forth, Richard; Jacques, Loretta; Yates, Louisa J

    2017-08-07

    Symptoms, including night-time awakenings, affect the quality of life of people with asthma. Fluticasone furoate/vilanterol (FF/VI) reduces exacerbations, improves lung function, and rescue-free and symptom-free 24-hour periods in patients with asthma. These post-hoc analyses compared daytime and night-time symptoms in patients with asthma who received FF/VI, versus FF, fluticasone propionate (FP) or placebo. Daytime and night-time symptoms were collected via electronic daily diary cards in three Phase III randomized studies of once-daily FF/VI in patients with uncontrolled asthma on inhaled corticosteroids (ICS) ±long-acting beta2-agonists (LABA) (n = 609/1039/586). Endpoints included: change from baseline in symptom-free days and nights (analyzed by Analysis of Covariance, covariates: baseline, region, sex, age, treatment), time for patients to achieve 7 consecutive symptom-free nights (analyzed by Cox proportional hazards model, covariates as above), and proportion of patients experiencing 100% symptom-free nights per week (analyzed by logistic regression, covariates: percentage of symptom-free nights, sex, age, treatment). Improvements in symptom-free days and nights were generally observed for all treatments. More patients who received FF/VI experienced 100% symptom-free nights in the last week of the treatment period than patients who received ICS alone or placebo. FF/VI also reduced time to 7 consecutive symptom-free nights. Patients with at least one night of symptoms at baseline experienced an additional 2.7 and 2.0 symptom-free nights per week with FF/VI 100/25 µg, versus 1.9 and 1.7 with FF alone; similar findings were seen with FF/VI 200/25 µg. Benefits in terms of symptom-free days and nights were observed for patients receiving FF/VI versus comparators in these post-hoc analyses.

  8. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial

    Science.gov (United States)

    Gommoll, Carl P.; Tang, Xiongwen; Nunez, Rene; Mathews, Maju

    2015-01-01

    The aim of this study was to evaluate the efficacy of vilazodone using different definitions of remission. Post-hoc analyses were carried out using data from an 8-week, multicenter, randomized, double-blind, placebo-controlled trial of vilazodone 40 mg/day in adults with major depressive disorder (NCT01473394). The primary efficacy endpoint was a mean change in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score; additional measures included the Clinical Global Impressions-Severity (CGI-S) and Hamilton Rating Scale for Anxiety (HAMA) scores. In addition to treatment response (MADRS≥50% improvement), post-hoc analyses were carried out for remission of depressive symptoms [MADRS score≤10; MADRS≤5 (complete remission)], anxiety symptoms (HAMA≤7), and combined depression and anxiety symptoms (MADRS/HAMA≤10/≤7), as well as for overall symptom severity (CGI-S=1). Odds ratios (ORs) and numbers needed to treat (NNTs) were also calculated. Significant outcomes were obtained with vilazodone versus placebo for MADRS response (50.6 vs. 33.3%, OR=2.04, P<0.001, NNT=6), remission (34.0 vs. 21.8%, OR=1.82, P=0.003, NNT=9), and complete remission (18.2 vs. 8.3%, OR=2.42, P=0.002, NNT=11). More patients receiving vilazodone rather than placebo also met remission criteria for HAMA (48.8 vs. 35.2%, OR=1.82, P=0.002, NNT=8), MADRS/HAMA (32.1 vs. 20.4%, OR=1.83, P=0.004, NNT=9), and CGI-S (24.1 vs. 11.5%, OR=2.41, P<0.001, NNT=8). Treatment with vilazodone 40 mg/day may help adult patients with major depressive disorder achieve remission of depression and/or anxiety symptoms. PMID:25396353

  9. Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage.

    Science.gov (United States)

    Giladi, Nir; Nicholas, Anthony P; Asgharnejad, Mahnaz; Dohin, Elisabeth; Woltering, Franz; Bauer, Lars; Poewe, Werner

    2016-10-19

    The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in 'off' state) Parkinson's disease (PD). To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory. Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1-4).

  10. Efficacy of Rotigotine at Different Stages of Parkinson’s Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage

    Science.gov (United States)

    Giladi, Nir; Nicholas, Anthony P.; Asgharnejad, Mahnaz; Dohin, Elisabeth; Woltering, Franz; Bauer, Lars; Poewe, Werner

    2016-01-01

    Background: The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in ‘off’ state) Parkinson’s disease (PD). Objective: To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. Methods: Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory. Results: Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1–4). PMID:27567886

  11. Effect of vitamin D3 on bone turnover markers in critical illness: post hoc analysis from the VITdAL-ICU study.

    Science.gov (United States)

    Schwetz, V; Schnedl, C; Urbanic-Purkart, T; Trummer, C; Dimai, H P; Fahrleitner-Pammer, A; Putz-Bankuti, C; Christopher, K B; Obermayer-Pietsch, B; Pieber, T R; Dobnig, H; Amrein, K

    2017-12-01

    In this post hoc analysis of the VITdAL-ICU study, an RCT in critically ill adults with 25-hydroxyvitamin D levels ≤20 ng/ml, vitamin D3 did not have a significant effect on β-Crosslaps and osteocalcin. Observational studies have shown accelerated bone loss in ICU survivors. A reversible contributor is vitamin D deficiency. In a post hoc analysis of the VITdAL-ICU study, we evaluated the effect of high-dose vitamin D3 on the bone turnover markers (BTM) β-Crosslaps (CTX) and osteocalcin (OC). The VITdAL-ICU study was a randomized, double-blind, placebo-controlled trial in critically ill adults with 25-hydroxyvitamin D levels ≤20 ng/ml who received placebo or high-dose vitamin D3 (a loading dose of 540,000 IU and starting 1 month after the loading dose five monthly maintenance doses of 90,000 IU). In this analysis on 289 survivors (209 telephone, 80 personal follow-up visits), BTM were analyzed on days 0, 3, 7, 28, and 180; self-reported falls and fractures were assessed. Bone mineral density (BMD) was measured after 6 months. At baseline, CTX was elevated; OC was low in both groups-after 6 months, both had returned to normal. There were no differences between groups concerning BTM, BMD, falls, or fractures. In linear mixed effects models, CTX and OC showed a significant change over time (p < 0.001, respectively), but there was no difference between the vitamin D and placebo group (p = 0.688 and p = 0.972, respectively). Vitamin D supplementation did not have a significant effect on BTM. Further studies should assess the effectiveness of vitamin D on musculoskeletal outcomes in ICU survivors.

  12. The Value of Abdominal Drainage After Laparoscopic Cholecystectomy for Mild or Moderate Acute Calculous Cholecystitis: A Post Hoc Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Prevot, Flavien; Fuks, David; Cosse, Cyril; Pautrat, Karine; Msika, Simon; Mathonnet, Muriel; Khalil, Haitham; Mauvais, François; Regimbeau, Jean-Marc

    2016-11-01

    Although the preoperative management of mild and moderate (Grade I-II) acute calculous cholecystitis (ACC) has been standardized, there is no consensus on the value of abdominal drainage after early cholecystectomy. In a post hoc analysis of a randomized controlled trial (NCT01015417) focused on the value of postoperative antibiotic therapy in patients with ACC, we determined the value of abdominal drainage in patients having undergone laparoscopic cholecystectomy for Grades I-II ACC. All postoperative complications were analyzed after using a propensity score. A post hoc test was used to assess the statistical robustness of our results. Of the 414 enrolled patients, 178 did not have abdominal drainage (forming the no-drainage group) and 236 had drainage (the drainage group). After matching on PS, the deep incisional site infection was 1.1 versus 0.8 %, p = 0.78. This result is similar for the superficial incisional site infections; the distant infections; the overall morbidity, and the readmission rate. Only the hospital length of stay was significantly longer in the drainage group (3.3 vs. 5.1 days, p = 0.003). Neither abdominal drainage nor the absence of postoperative antibiotic therapy was found to be a risk factor for deep incisional site infections. The use of abdominal drainage depends on the surgeon's personal preferences but is often used in high-risk populations. However, abdominal drainage does not appear to be of any benefit (in terms of postoperative outcomes) and may even compromise recovery in patients having undergone early laparoscopic cholecystectomy for mild or moderate ACC.

  13. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Takei, Koji; Takahashi, Fumihiro; Liu, Shawn; Tsuda, Kikumi; Palumbo, Joseph

    2017-10-01

    Post-hoc analyses of the ALS Functional Rating Scale-Revised (ALSFRS-R) score data, the primary endpoint in the 24-week double-blind placebo-controlled study of edaravone (MCI186-19, NCT01492686), were performed to confirm statistical robustness of the result. The previously reported original analysis had used a last observation carried forward (LOCF) method and also excluded patients with fewer than three completed treatment cycles. The post-hoc sensitivity analyses used different statistical methods as follows: 1) including all patients regardless of treatment cycles received (ALL LOCF); 2) a mixed model for repeated measurements (MMRM) analysis; and 3) the Combined Assessment of Function and Survival (CAFS) endpoint. Findings were consistent with the original primary analysis in showing superiority of edaravone over placebo. We also investigated the distribution of change in ALSFRS-R total score across all patients in the study as well as which ALSFRS-R items and domains may have contributed to the overall efficacy findings. The distribution of changes in ALSFRS-R total score from baseline to the end of cycle 6 (ALL LOCF) shifted in favour of edaravone compared to placebo. Edaravone was descriptively favoured for each ALSFRS-R item and each of the four ALSFRS-R domains at the end of cycle 6 (ALL LOCF), suggesting a generalised effect of edaravone in slowing functional decline across all anatomical regions. The effect of edaravone appeared to be similar in patients with bulbar onset and limb onset. Together, these observations would be consistent with its putative neuroprotective effects against the development of oxidative damage unspecific to anatomical regions.

  14. Effects of dronedarone on clinical outcomes in patients with lone atrial fibrillation: pooled post hoc analysis from the ATHENA/EURIDIS/ADONIS studies.

    Science.gov (United States)

    Duray, Gabor Z; Torp-Pedersen, Christian; Connolly, Stuart J; Hohnloser, Stefan H

    2011-07-01

    Dronedarone has been shown to reduce cardiovascular hospitalizations or death in patients with atrial fibrillation (AF) and additional risk factors. This post hoc exploratory analysis examines its effects in the subgroup of lone AF patients. Individual data from patients with lone AF enrolled in the EURIDIS, ADONIS, and ATHENA trials were entered in a central database. The effects of dronedarone compared to placebo on the composite endpoint of cardiovascular hospitalizations or death, and their individual components, were evaluated. A total of 432 (192 placebo and 240 dronedarone) patients (7% of the total population) were classified as having lone AF (69.4% male patients, mean age 64 ± 13 years). The patients were followed for 13.8 ± 7.2 months. The risk for first cardiovascular hospitalizations or death from any cause in the placebo group after 1 year was 25% in the lone AF group compared to 29% the rest of the population. For patients with lone AF, dronedarone led to a 44% reduction of cardiovascular hospitalizations or death (hazard ratio (HR) 0.56; 95%CI 0.36-0.88, P = 0.004) and to a 46% reduction in cardiovascular hospitalizations alone (HR 0.54; 95%CI 0.34-0.87, P = 0.004) compared to placebo. HR for all-cause mortality was 1.02 (95%CI 0.31-3.34, P = 0.885). All findings were homogeneous across the 3 studies and similar to those observed in the overall population. According to this post hoc analysis, patients with lone AF have a high risk for cardiovascular hospitalization within 1 year. Dronedarone when added to standard of care reduces the risk of cardiovascular hospitalizations in this population. © 2011 Wiley Periodicals, Inc.

  15. Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study.

    Science.gov (United States)

    Ohta, Hiroaki; Hamaya, Etsuro; Taketsuna, Masanori; Sowa, Hideaki

    2015-01-01

    To assess the effect of active vitamin D3 on quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis. This is a post hoc analysis of a previous prospective postmarketing observational study conducted without a comparator group. This study was conducted in 60 Japanese hospitals from September 2007 to February 2009. We compared changes from baseline in QOL and pain in patients receiving raloxifene plus active vitamin D3 with those in patients receiving raloxifene monotherapy at 8 and 24 weeks after treatment. Japan Pharmaceutical Information Center (JapicCTI-070465). QOL and pain were assessed using Short Form-8 (SF-8), European Quality of Life Instrument 5 Dimensions (EQ-5D), Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), visual analogue pain scales (VAS pain), and pain frequency scores. A total of 506 patients were included in the post hoc analysis. Both raloxifene monotherapy (RLX, n = 354) and active vitamin D3 cotreatment (COMBI, n = 152) significantly improved QOL and reduced pain from the baseline at Week 8 and Week 24. The COMBI group had significantly greater improvements in JOQOL total score and activity of daily living (total) domain at Week 24 and last observation carried forward (LOCF) than the RLX group. The COMBI group also had significantly greater improvements in SF-8 domains of general health (at Week 8, Week 24, and LOCF), role physical (at Week 24 and LOCF), and mental health (at LOCF) than the RLX group. The COMBI group also had significantly greater reduction in VAS pain at LOCF than the RLX group (mean [SD]: RLX = -0.99 [2.72], COMBI = -1.54 [2.21], P = 0.042). Active vitamin D3 supplementation to raloxifene treatment for 24 weeks may have additional benefits in improving QOL and relieving pain in Japanese women with postmenopausal osteoporosis.

  16. Chronic exposure to ivabradine reduces readmissions in the vulnerable phase after hospitalization for worsening systolic heart failure: a post-hoc analysis of SHIFT.

    Science.gov (United States)

    Komajda, Michel; Tavazzi, Luigi; Swedberg, Karl; Böhm, Michael; Borer, Jeffrey S; Moyne, Aurélie; Ford, Ian

    2016-09-01

    During the post-discharge phase following a heart failure hospitalization (HFH), patients are at high risk of early readmission despite standard of care therapy. We examined the impact of chronic exposure to ivabradine on early readmissions in patients hospitalized for heart failure during the course of the SHIFT study (Systolic Heart Failure treatment with the If inhibitor ivabradine Trial). A total of 1186 of the 6505 randomized patients experienced at least one HFH during the study, and had a more severe profile than those without HFH. Of these 1186 patients, 334 patients (28%) were rehospitalized within 3 months for any reason, mostly for cardiovascular causes (86%), including HFH (61%). Ivabradine was associated with fewer all-cause hospitalizations at 1 month [incidence rate ratio (IRR) 0.70, 95% confidence interval (CI) 0.50-1.00, P post-hoc analysis that chronic exposure to ivabradine reduces the incidence of all-cause hospitalizations during the vulnerable phase after a HFH. Further studies are needed to investigate if in-hospital or early post-discharge initiation of ivabradine could be useful to improve early outcomes in patients hospitalized for HF. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

  17. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302.

    Science.gov (United States)

    de Bono, Johann S; Smith, Matthew R; Saad, Fred; Rathkopf, Dana E; Mulders, Peter F A; Small, Eric J; Shore, Neal D; Fizazi, Karim; De Porre, Peter; Kheoh, Thian; Li, Jinhui; Todd, Mary B; Ryan, Charles J; Flaig, Thomas W

    2017-04-01

    Treatment patterns for metastatic castration-resistant prostate cancer (mCRPC) have changed substantially in the last few years. In trial COU-AA-302 (chemotherapy-naïve men with mCRPC), abiraterone acetate plus prednisone (AA) significantly improved radiographic progression-free survival and overall survival (OS) when compared to placebo plus prednisone (P). This post hoc analysis investigated clinical responses to docetaxel as first subsequent therapy (FST) among patients who progressed following protocol-specified treatment with AA, and characterized subsequent treatment patterns among older (≥75 yr) and younger (AA arm received subsequent treatment with one or more agents approved for mCRPC. Efficacy analysis was performed for patients for whom baseline and at least one post-baseline prostate-specific antigen (PSA) values were available. Baseline and at least one post-baseline PSA values were available for 100 AA patients who received docetaxel as FST. While acknowledging the limitations of post hoc analyses, 40% (40/100) of these patients had an unconfirmed ≥50% PSA decline with first subsequent docetaxel therapy, and 27% (27/100) had a confirmed ≥50% PSA decline. The median docetaxel treatment duration among these 100 patients was 4.2 mo. Docetaxel was the most common FST among older and younger patients from each treatment arm. However, 43% (79/185) of older patients who progressed on AA received no subsequent therapy for mCRPC, compared with 17% (60/361) of younger patients. Patients with mCRPC who progress with AA treatment may still derive benefit from subsequent docetaxel therapy. These data support further assessment of treatment patterns following AA treatment for mCRPC, particularly among older patients. ClinicalTrials.gov NCT00887198. Treatment patterns for advanced prostate cancer have changed substantially in the last few years. This additional analysis provides evidence of clinical benefit for subsequent chemotherapy in men with advanced

  18. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis.

    Science.gov (United States)

    Ruiz-Palacios, Guillermo M; Leroux-Roels, Geert; Beran, Jiri; Devaster, Jeanne-Marie; Esen, Meral; Launay, Odile; McElhaney, Janet E; van Essen, Gerrit A; Benoit, Anne; Claeys, Carine; Dewé, Walthère; Durand, Christelle; Duval, Xavier; Falsey, Ann R; Feldman, Gregory; Galtier, Florence; Gervais, Pierre; Hwang, Shinn-Jang; McNeil, Shelly; Richardus, Jan Hendrik; Trofa, Andrew; Oostvogels, Lidia

    2016-12-01

    In this study we describe the immunogenicity results from a subset of older people (N = 5187) who participated in a Phase 3 randomized, observer-blinded trial of AS03-TIV versus TIV (Fluarix™) (ClinicalTrials.gov, NCT00753272). Participants received one dose of AS03-TIV or TIV in each study year and antibody titers against the vaccine strains were assessed using hemagglutination-inhibition (HI) assay at 21 d and 180 d post-vaccination in each vaccine group in the 2008/09 (Year 1) and 2009/10 (Year 2) influenza seasons. Manufacturing consistency of 3 lots of AS03-TIV for HI antibody responses in Year 1 was a co-primary objective. In a post-hoc analysis, a statistical regression model included 4830 subjects in whom immunogenicity and laboratory-confirmed attack rate data were available; the analysis was performed to assess HI antibody titers against A/H3N2 as a correlate of protection for laboratory-confirmed A/H3N2 influenza. AS03-TIV and TIV elicited strong HI antibody responses against each vaccine strain 21 d post-vaccination in both years. The manufacturing consistency of 3 lots of AS03-TIV was demonstrated. In both years and each vaccine group, HI antibody responses were lower for A/H1N1 than the other vaccine strains. Day 180 seroconversion rates (proportion with ≥4-fold increase in titer compared with pre-vaccination titer) in Year 1 in the AS03-TIV and TIV groups, respectively, were 87.7% and 74.1% for A/H3N2, 69.7% and 59.6% for influenza B, and 58.3% and 47.4% for A/H1N1. The post-hoc statistical model based on A/H3N2 attack rates and HI antibody titers estimated that a 4-fold increase in post-vaccination titers against A/H3N2 was associated with a 2-fold decrease in the odds of A/H3N2 infection.

  19. Effect of immediate and prolonged GLP-1 receptor agonist administration on uric acid and its kidney clearance: post-hoc analyses of four clinical trials.

    Science.gov (United States)

    Tonneijck, Lennart; Muskiet, Marcel H A; Smits, Mark M; Bjornstad, Petter; Kramer, Mark H H; Diamant, Michaela; Hoorn, Ewout J; Joles, Jaap A; van Raalte, Daniël H

    2018-01-17

    To determine effects of glucagon-like peptide (GLP)-1 receptor agonists (RA) on uric acid (UA)-levels and kidney UA-clearance. Post-hoc analyses of four controlled clinical trials, which assessed actions of GLP-1RA-administration on kidney physiology. Immediate effects of GLP-1RA exenatide-infusion versus placebo was determined in 9 healthy overweight males (Study-A) and in 52 overweight T2DM-patients (Study-B). Effects were also examined of 12-week long-acting GLP-1RA liraglutide versus placebo in 36 overweight T2DM-patients (Study-C) and of 8-week short-acting GLP-1RA lixisenatide versus once-daily titrated insulin-glulisine in 35 overweight T2DM-patients (Study-D). Plasma-UA, fractional (inulin-corrected) and absolute urinary-excretion of UA (UEUA ) and sodium (UENa ), and urine-pH was determined. Median baseline plasma-UA levels was 5.39 to 6.33 mg/dL across all studies (17-22% of subjects were hyperuricemic). In study-A, exenatide-infusion slightly increased plasma-UA (+0.07±0.02mg/dL, P=0.04), and raised absolute-UEUA (+1.58±0.65mg/min/1.73m2 , P=0.02), but did not affect fractional-UEUA compared to placebo. Fractional-UEUA and absolute-UEUA correlated with increases in urine-pH (r:0.86, P=0.003 and r:0.92, P<0.001, respectively). Fractional-UEUA correlated with increased fractional-UENa (r:0.76, P=0.02). In study-B, exenatide-infusion did not affect plasma-UA, but increased fractional-UEUA (+0.76±0.38%, P=0.049) and absolute-UEUA (+0.75±0.27mg/min/1.73m2 , P=0.007), compared to placebo. In regression analyses, both parameters were explained by changes in urine-pH, and in part, by changes in UENa . In study-C, liraglutide-treatment did not affect plasma-UA, UEUA, UENa , or urine-pH compared to placebo. In study-D, lixisenatide-treatment increased UENa and urine-pH from baseline, but did not affect plasma-UA or UEUA . Immediate exenatide-infusion increases UEUA in overweight healthy males and T2DM-patients, likely via inhibiting Na+ /H+ -exchanger type-3

  20. Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies.

    Science.gov (United States)

    Bellmunt, Joaquim; Kheoh, Thian; Yu, Margaret K; Smith, Matthew R; Small, Eric J; Mulders, Peter F A; Fizazi, Karim; Rathkopf, Dana E; Saad, Fred; Scher, Howard I; Taplin, Mary-Ellen; Davis, Ian D; Schrijvers, Dirk; Protheroe, Andrew; Molina, Arturo; De Porre, Peter; Griffin, Thomas W; de Bono, Johann S; Ryan, Charles J; Oudard, Stéphane

    2016-05-01

    The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity. Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist. Patients were randomised to AA (1000mg, orally once daily) plus prednisone (5mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, n=1127 [94%]; COU-AA-302, n=1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, n=78 [7%] COU-AA-302, n=44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, n=1015 [85%]; COU-AA-302, n=1078 [99%], 15.7 mo or 16.1 mo median duration, respectively). Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic. Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time to castration resistance was not captured. This analysis is limited as a post-hoc exploratory analysis. In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC. Metastatic castration-resistant prostate cancer patients derived

  1. Early deterioration after thrombolysis plus aspirin in acute stroke: a post hoc analysis of the Antiplatelet Therapy in Combination with Recombinant t-PA Thrombolysis in Ischemic Stroke trial

    NARCIS (Netherlands)

    Zinkstok, Sanne M.; Beenen, Ludo F.; Majoie, Charles B.; Marquering, Henk A.; de Haan, Rob J.; Roos, Yvo B.

    2014-01-01

    Aspirin early after intravenous thrombolysis in acute ischemic stroke increases the risk of symptomatic intracranial hemorrhage (SICH), without influencing functional outcome at 3 months. The effect of aspirin on early neurological deterioration (END) was explored as a post hoc analysis of the

  2. Neuromathematical Trichotomous Mixed Methods Analysis: Using the Neuroscientific Tri-Squared Test Statistical Metric as a Post Hoc Analytic to Determine North Carolina School of Science and Mathematics Leadership Efficacy

    Science.gov (United States)

    Osler, James Edward, II; Mason, Letita R.

    2016-01-01

    This study examines the leadership efficacy amongst graduates of The North Carolina School of Science and Mathematics (NCSSM) for the classes of 2000 through 2007 from a neuroscientific and neuromathematic perspective. NCSSM alumni (as the primary unit of analysis) were examined using a novel neuromathematic post hoc method of analysis. This study…

  3. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis

    DEFF Research Database (Denmark)

    Giovannoni, Gavin; Cook, Stuart; Rammohan, Kottil

    2011-01-01

    /kg over 96 weeks was more effective than placebo. Achieving sustained freedom from disease activity is becoming a viable treatment goal in RRMS; we therefore aimed to assess the effects of cladribine on this composite outcome measure by doing a post-hoc analysis of data from the CLARITY study....

  4. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

  5. Impact of Bone-targeted Therapies in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302

    NARCIS (Netherlands)

    Saad, F.; Shore, N.; Poppel, H. Van; Rathkopf, D.E.; Smith, M.R.; Bono, J.S. de; Logothetis, C.J.; Souza, P. de; Fizazi, K.; Mulders, P.F.A.; Mainwaring, P.; Hainsworth, J.D.; Beer, T.M.; North, S.; Fradet, Y.; Griffin, T.A.; Porre, P. De; Londhe, A.; Kheoh, T.; Small, E.J.; Scher, H.I.; Molina, A.; Ryan, C.J.

    2015-01-01

    BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy. OBJECTIVE: Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an

  6. Effect of General Anesthesia versus Conscious Sedation for Stroke Thrombectomy on Angiographic Workflow in a Randomized Trial: A Post Hoc Analysis of the SIESTA Trial.

    Science.gov (United States)

    Pfaff, Johannes A R; Schönenberger, Silvia; Nagel, Simon; Ringleb, Peter A; Hacke, Werner; Bendszus, Martin; Bösel, Julian; Möhlenbruch, Markus Alfred

    2017-10-30

    Purpose To investigate whether the sedation mode (ie, conscious sedation [CS] vs general anesthesia [GA]) affects the angiographic workflow applied for treatment of endovascular stroke in a post hoc analysis of a recent randomized controlled trial, Sedation versus Intubation for Endovascular Stroke Treatment (SIESTA). Materials and Methods SIESTA was an institutional review board-approved, single-center, prospective, randomized, parallel-group, open-label treatment trial with a blinded end-point evaluation to compare GA with CS for treatment of endovascular stroke in 73 and 77 patients, respectively. By using descriptive data from SIESTA, the influence of the mode of sedation on angiographic workflow during treatment for endovascular stroke (eg, procedure times) and other radiologic outcome parameters (eg, radiation exposure) were analyzed. The time between angiographic key steps for patients who underwent GA and CS was evaluated with t tests. P values were corrected for false discovery rate. Results The median time from groin puncture to first intracranial flow restoration with CS was 47 minutes (interquartile range [IQR], 29-70 minutes), and for GA, it was 41 minutes (IQR, 28-60 minutes) (P = .546). The median time to the end of angiography with CS was 104 minutes (IQR, 75-150 minutes), and with GA, it was 73 minutes (IQR, 53-125 minutes) (P = .052). Fluoroscopy time with CS was 49 minutes (IQR, 25-85 minutes), and with GA, it was 35 minutes (IQR, 20-74 minutes) (P = .098). The times were comparable in both groups for these measures. The time from groin puncture to the final angiographic result with GA, at 72 minutes (IQR, 45-109 minutes) was shorter than that with CS, at 98 minutes (IQR, 64-135 minutes) (P = .048). Conclusion This post hoc analysis of the single-center SIESTA trial revealed that time from groin puncture to final angiographic result was shorter with patients under GA than that with patients under CS. © RSNA, 2017 Online supplemental material is

  7. A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures.

    Science.gov (United States)

    Patel, Charmi A; Bailey, Robert A; Vijapurkar, Ujjwala; Meininger, Gary; Blonde, Lawrence

    2016-08-05

    The randomized, double-blind CANTATA-SU (CANagliflozin Treatment And Trial Analysis Sulfonyl Urea) clinical trial compared the use of canagliflozin (100 mg or 300 mg) and maximally tolerated glimepiride (6-8 mg) over 104 weeks as add-on therapy for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Compared with glimepiride, canagliflozin use was associated with durable reductions in glycated hemoglobin (A1C), blood pressure (BP), and body weight. The aim of this post-hoc analysis of the CANTATA-SU trial was to assess the comparative efficacy of canagliflozin and glimepiride in the attainment of recently updated diabetes-related quality measures (QMs) for up to 104 weeks of treatment. This post-hoc analysis evaluated the proportions of patients achieving individual diabetes-related QMs using data from the randomized, double-blind, Phase 3 CANTATA-SU trial. Change in A1C from baseline, and proportions of the study population achieving QMs: A1C 9.0 % were assessed. Secondary endpoints included change in BP from baseline, and the proportions of the study population achieving QMs related to BP and body weight. The proportions of patients in the canagliflozin 100 mg, canagliflozin 300 mg, and glimepiride groups meeting criteria for all QMs were similar at baseline. At 52 and 104 weeks of treatment, canagliflozin 100 mg and canagliflozin 300 mg provided better or similar reductions in A1C from baseline and achievement of glycemic control QMs compared with glimepiride. At 52 and 104 weeks of treatment, the attainment of QMs related to reductions in body weight and BP all favored canagliflozin compared with glimepiride. Canagliflozin was associated with lower incidence of documented hypoglycemia and severe hypoglycemia compared with glimepiride. Using the recently adjusted and currently accepted diabetes-related QMs, this analysis observed superior glycemic control with canagliflozin compared with maximally tolerated

  8. Structural effects of sprifermin in knee osteoarthritis: a post-hoc analysis on cartilage and non-cartilaginous tissue alterations in a randomized controlled trial.

    Science.gov (United States)

    Roemer, Frank W; Aydemir, Aida; Lohmander, Stefan; Crema, Michel D; Marra, Monica Dias; Muurahainen, Norma; Felson, David T; Eckstein, Felix; Guermazi, Ali

    2016-07-09

    A recent publication on efficacy of Sprifermin for knee osteoarthritis (OA) using quantitatively MRI-defined central medial tibio-femoral compartment cartilage thickness as the structural primary endpoint reported no statistically significant dose response. However, Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral tibio-femoral cartilage thickness. Based on these preliminary promising data a post-hoc analysis of secondary assessment and endpoints was performed to evaluate potential effects of Sprifermin on semi-quantitatively evaluated structural MRI parameters. Aim of the present analysis was to determine effects of sprifermin on several knee joint tissues over a 12 month period. 1.5 T or 3 T MRIs were acquired at baseline and 12 months follow-up using a standard protocol. MRIs were read according to the Whole-Organ Magnetic Resonance Imaging Score (WORMS) scoring system (in 14 articular subregions) by four muskuloskeletal radiologists independently. Analyses focused on semiquantitative changes in the 100 μg subgroup and matching placebo of multiple MRI-defined structural alterations. Analyses included a delta-subregional and delta-sum approach for the whole knee and the medial and lateral tibio-femoral (MTFJ, LTFJ), and patello-femoral (PFJ) compartments, taking into account number of subregions showing no change, improvement or worsening and changes in the sum of subregional scores. Mann-Whitney - Wilcoxon tests assessed differences between groups. Fifty-seven and 18 patients were included in the treatment and matched placebo subgroups. Less worsening of cartilage damage was observed from baseline to 12 months in the PFJ (0.02, 95 % confidence interval (CI) (-0.04, 0.08) vs. placebo 0.22, 95 % CI (-0.05, 0.49), p = 0.046). For bone marrow lesions (BMLs), more improvement was observed from 6 to 12 months for whole knee analyses (-0.14, 95 % CI (-0.48, 0.19) vs. placebo 0.44, 95

  9. Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID.

    Science.gov (United States)

    Dhoot, Dilsher S; Baker, Keith; Saroj, Namrata; Vitti, Robert; Berliner, Alyson J; Metzig, Carola; Thompson, Desmond; Singh, Rishi P

    2018-01-01

    To evaluate whether select baseline systemic and ocular factors influence ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score at week 100 in VISTA and VIVID. Post hoc analysis of 2 similarly designed phase 3 trials, VISTA and VIVID. Total of 456 patients with center-involved diabetic macular edema (DME). VISTA and VIVID randomized 872 DME patients to receive intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or macular laser photocoagulation. This post hoc analysis evaluated the influence of select baseline factors on ≥2-step DRSS score improvement by logistic regression in an integrated VISTA and VIVID dataset using observed cases (n = 456) with patients in each treatment group divided into tertiles based on each characteristic. Proportion of patients with ≥2-step improvement in DRSS score from baseline at week 100 by age, duration of diabetes, hemoglobin A1c (HbA1c), body mass index (BMI), best-corrected visual acuity (BCVA), central subfield thickness (CST), and DRSS score. At week 100, 10.1%, 34.3%, and 37.6% of patients in the laser, 2q4, and 2q8 groups experienced a ≥2-step DRSS score improvement, respectively. Age, duration of diabetes, HbA1c, BMI, BCVA, and CST had no impact on the ability to achieve ≥2-step improvement in DRSS score. Initial DRSS score was the only factor significantly associated with ≥2-step DRSS score improvement in all treatment groups at weeks 24, 52, 76, and 100. Relatively higher proportions of IAI-treated patients with worse BCVA or thicker CST experienced ≥2-step DRSS score improvement compared with those with better BCVA or thinner CST, respectively, but these associations were not statistically significant. A strong association was present between baseline DRSS score and ≥2-step DRSS score improvement at week 100 for DME patients in VISTA and VIVID. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier

  10. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis.

    Science.gov (United States)

    Brandt, Christian; Borghs, Simon; Elmoufti, Sami; Mueller, Knut; Townsend, Rebecca; de la Loge, Christine

    2017-04-01

    The effect of adjunctive brivaracetam on health-related quality of life (HRQoL) was assessed in a post-hoc analysis using pooled data from three randomized, double-blind, placebo-controlled Phase III studies in patients with refractory focal seizures (NCT00490035, NCT00464269, and NCT01261325). The Patient-Weighted Quality of Life in Epilepsy Questionnaire (QOLIE-31-P) was completed at randomization, and weeks 4, 8 (in two of three studies), and 12 (end of the treatment period). Mean change from baseline to week 12 or early discontinuation, and percentage of patients with clinically meaningful improvement were reported for the placebo and brivaracetam 50, 100, and 200mg/day groups. At baseline, mean QOLIE-31-P scores were similar between treatment groups. At week 12 or early discontinuation, mean (standard deviation) changes from baseline in QOLIE-31-P total score were 2.8 (12.7), 3.0 (14.0), 2.4 (14.0), and 3.0 (12.1) points for the placebo and brivaracetam 50, 100, and 200mg/day groups, respectively, indicating HRQoL improved slightly over time during the treatment period, but was similar for placebo and brivaracetam groups. All subscale score changes were positive, indicating stable or improved HRQoL over time. The brivaracetam 100 and 200mg/day groups showed the largest differences compared with placebo in Seizure Worry subscale scores (7.3 and 8.8 vs. 5.0 points). Approximately 40% of patients had improvements in QOLIE-31-P scores beyond the Minimal Important Change (MIC) thresholds. The subgroup of ≥50% focal seizure frequency responders had higher improvements for all treatment arms and all subscales than for those in the overall pooled population. In this post-hoc analysis, adjunctive brivaracetam treatment was shown to be associated with stable or improving overall HRQoL over time, similar to placebo, with modest improvements in subscales sensitive to efficacy, and no deterioration in subscales sensitive to tolerability. These results reflect the known

  11. Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL.

    Science.gov (United States)

    Gordon, Caroline; Wofsy, David; Wax, Stephen; Li, Yong; Pena Rossi, Claudia; Isenberg, David

    2017-01-01

    To assess the relationship between treatment response, baseline biomarker levels, and atacicept exposure in patients with systemic lupus erythematosus (SLE) in the phase II/III APRIL-SLE study. We performed a post hoc analysis of patients who received placebo, atacicept 75 mg, or atacicept 150 mg in a randomized, controlled, 52-week trial. Serum levels of BlyS and APRIL were measured at baseline, and serum levels of Ig and the numbers of naive B cells and plasma cells were measured at baseline and during treatment. Atacicept exposure was determined by assessment of the serum trough concentrations throughout the 52-week trial period. Associations between these parameters, treatment response (reduction in British Isles Lupus Assessment Group A or B flare), and infection rates were explored. Recurrent high baseline levels of both BLyS (≥1.6 ng/ml) and APRIL (≥2.2 ng/ml) correlated with a greater treatment response (flare rate 75.7% with placebo, and 50.0% and 32.0% with atacicept 75 mg and atacicept 150 mg, respectively) compared with lower baseline levels of both. Increased atacicept exposure correlated with reduced flare rates (60.5% with placebo; 63.4%, 61.0%, 48.8%, and 29.3% in the 4 quartiles, from lowest to highest atacicept exposure). Greater pharmacodynamic responses (reduced Ig levels and naive B cell and plasma cell numbers) were associated with greater reductions in the flare rate. Infection rates were similar regardless of biomarker levels at baseline or at the time of atacicept exposure. These post hoc analyses demonstrate a dose-response relationship between atacicept concentrations, reduced Ig levels, and reduced flare rates and suggest that baseline biomarkers such as elevated serum levels of BLyS and APRIL may help to identify the patients who are most likely to benefit from atacicept treatment. © 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

  12. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study.

    Science.gov (United States)

    Forester, Brent P; Sajatovic, Martha; Tsai, Joyce; Pikalov, Andrei; Cucchiaro, Josephine; Loebel, Antony

    2017-10-10

    To evaluate the safety and effectiveness of 6 months of treatment with lurasidone in older adults with a diagnosis of bipolar I depression. Post-hoc analysis of a multicenter, 6-month, open-label extension study. Outpatient. Patients aged 55 to 75 years with a DSM-IV-TR diagnosis of bipolar I depression who had completed 6 weeks of double-blind, placebo-controlled treatment with either lurasidone monotherapy (1 study) or adjunctive therapy with lithium or valproate (2 studies). Flexible doses of lurasidone, 20 to 120 mg/day, either as monotherapy, or adjunctive with lithium or valproate. Effectiveness was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS; change from open-label-baseline to month-6, observed case analysis). A total of 141 older adults entered the extension study (monotherapy, N = 55; 39%; adjunctive therapy, N = 86; 61%). At the end of 6 months of open-label treatment with lurasidone, as monotherapy or adjunctive therapy, minimal changes were observed in the older adult sample in mean weight (-1.0 kg and -0.4 kg, respectively); and median total cholesterol (-2.0 mg/dL and +6.0 md/dL, respectively), triglycerides (+2.5 mg/dL and +6.0 mg/dL, respectively), and HbA1c (0.0% and -0.1%, respectively). Patients treated with 6 months of lurasidone showed a mean improvement on the MADRS in both the monotherapy (-6.2) and adjunctive therapy (-6.7) groups. Results of these post-hoc analyses found that up to 7.5 months of lurasidone treatment for bipolar depression in older adults was associated with minimal effects on weight and metabolic parameters, with low rates of switching to hypomania or mania, and was well tolerated. The antidepressant effectiveness of lurasidone in this age group was maintained over the 6-month treatment period. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  13. Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bone Kerry M

    2009-06-01

    Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

  14. [Subjectivity, ethics and productivity in post-productive health restructuring].

    Science.gov (United States)

    Gomes, Doris; Ramos, Flávia Regina Souza

    2015-08-01

    The scope of this paper is to analyze the ethical problems generated by the modern stressor pattern of post-transformation productivity in productive restructuring in the health area. It is a qualitative study of the descriptive and exploratory type in which 30 professionals (nurses, doctors and dental surgeons) from a metropolitan region in the South of Brazil were interviewed, all of whom had prior experience in the public and private sectors. The results were analyzed through Discursive Textual Analysis. Capitalization is revealed as a major ethical problem in the series of new issues derived from the productivity-profitability imperative in health, due to the acritical incorporation of ethics that is restricted to the company's interests or to corporate-individual interests. The ethical problem of low professional commitment to the needs of the patient and of the social collective indicates the need to build a new engaged solidarity in order to increase the quality of public healthcare. Productivity targeted at individual and social needs/interests in the area of health requires a new self-managing and collective engagement of the subjects, supported by an institutional and ethical-political effort of group action, cooperation and solidarity.

  15. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens.

    Science.gov (United States)

    Shi, Li Xin; Li, Peng Fei; Hou, Jia Ning

    2017-08-01

    Identification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies. This was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT). Patients with type 2 diabetes mellitus were randomized to PPT (insulin lispro mix 50/50 thrice daily with meals) or BBT (glargine at bedtime plus mealtime insulin lispro) insulin intensification therapies. The SIDES algorithm was used to identify the subgroups from at-goal patients [glycated hemoglobin (HbA1c) comparable between PPT and BBT groups. The SIDES algorithm identified patients with race other than Caucasian (i.e., African-American, Asian, and Hispanic) and baseline fasting blood glucose (FBG) Company. Clinicaltrials.gov ID number: NCT00110370.

  16. The efficacy of extrafine beclomethasone dipropionate–formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study

    Directory of Open Access Journals (Sweden)

    Singh D

    2017-11-01

    Full Text Available Dave Singh,1 Stefano Vezzoli,2 Stefano Petruzzelli,2 Alberto Papi3 1Medicines Evaluation Unit, University of Manchester, Manchester, UK; 2Chiesi Farmaceutici SpA, Parma, 3Section of Respiratory Diseases, University of Ferrara, Ferrara, Italy Abstract: The GOLD 2017 strategy document recommends that the pharmacological management of COPD patients be based on the risk of future exacerbations and the severity of symptoms. A threshold of two moderate exacerbations or one hospitalization is used to define high-risk patients. The FORWARD study was a randomized, double-blind, parallel-group trial that compared 48 weeks’ treatment with extrafine beclomethasone dipropionate plus formoterol fumarate (BDP-FF versus FF in severe COPD patients with a history of one or more exacerbations in the previous year. The new GOLD 2017 recommendations mean that many patients in the FORWARD study are now reclassified as GOLD B. We conducted a post hoc analysis of the FORWARD study, in order to investigate the effects of extrafine BDP/FF in patients with one exacerbation in the previous year, focusing on those categorized as group B using the GOLD 2017 definition. The analysis showed a 35% reduction in exacerbation rate with an inhaled corticosteroid (ICS + long-acting β-agonist (LABA versus LABA. We propose that ICS-LABA treatment is a therapeutic option for COPD patients with one exacerbation in the previous year. Keywords: COPD, GOLD B, GOLD 2017, exacerbations, corticosteroid

  17. Efficacy of adjunctive brexpiprazole on the core symptoms of major depressive disorder: A post hoc analysis of two pooled clinical studies.

    Science.gov (United States)

    Nelson, J Craig; Weiller, Emmanuelle; Zhang, Peter; Weiss, Catherine; Hobart, Mary

    2018-02-01

    Patients with major depressive disorder (MDD) who do not adequately respond to antidepressant treatment (ADT) may benefit from adjunctive atypical antipsychotics; however, certain agents target specific symptoms of depression and not the full syndrome. The aim of this analysis was to examine the effects of brexpiprazole, adjunct to ADT, on the core symptoms of MDD, defined using Montgomery-Åsberg Depression Rating Scale (MADRS) items. This was a post hoc analysis of data from two 6-week, randomized, double-blind studies of adjunctive brexpiprazole in patients with MDD and inadequate response to ADTs (n = 1056). Efficacy was assessed using the MADRS core symptom subscale (MADRS 6 ) and individual items (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts). At Week 6, adjunctive brexpiprazole showed a greater effect than adjunctive placebo on the MADRS 6 (within-group Cohen's d effect sizes: brexpiprazole, 1.05; placebo, 0.71; p core symptoms (effect sizes: brexpiprazole, 0.64-0.94; placebo, 0.39-0.64; all p core symptoms (all p core symptoms of MDD. Brexpiprazole is thought to exert its effects in MDD by treating the core symptoms of the disease. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study.

    Science.gov (United States)

    Wesnes, Keith A; Gommoll, Carl; Chen, Changzheng; Sambunaris, Angelo; McIntyre, Roger S; Harvey, Philip D

    2017-03-01

    Performance-based cognitive data were collected using the Cognitive Drug Research System in a study of levomilnacipran extended-release (ER) 40-120 mg/day (NCT01034462) in adults with major depressive disorder. These data were analyzed post-hoc to explore the relationship between cognitive measures, depression symptoms (Montgomery-Åsberg Depression Rating Scale, MADRS), and self-reported psychosocial functioning (Sheehan Disability Scale; SDS). Changes from baseline were analyzed in the intent-to-treat population and subgroups with impaired attention, as indicated by baseline Cognitive Drug Research System scores for Power of Attention and Continuity of Attention. Path analyses evaluated the direct and indirect effects of levomilnacipran ER on SDS total score change. Significantly greater improvements were observed for levomilnacipran ER versus placebo for Power of Attention, Continuity of Attention, MADRS, and SDS score changes; the mean differences were larger in the impaired subgroups than in the overall intent-to-treat population. Path analyses showed that the majority of SDS total score improvement (≥50%) was attributable to an indirect treatment effect through MADRS total score change; some direct effect of levomilnacipran ER on SDS total score improvement was also observed. In adults with major depressive disorder, levomilnacipran ER effectively improved measures of depression and cognition, which contributed toward reductions in self-reported functional impairment.

  19. AbobotulinumtoxinA for reduction of glabellar lines in patients with skin of color: post hoc analysis of pooled clinical trial data.

    Science.gov (United States)

    Taylor, Susan C; Callender, Valerie D; Albright, Craig D; Coleman, Jeffrey; Axford-Gatley, Robert A; Lin, Xiaoming

    2012-11-01

    A paucity of research exists on the safety and efficacy of aesthetic medicine products in patients with skin of color (SOC). To compare the effectiveness and tolerability of abobotulinumtoxinA (BoNTA-ABO) for glabellar lines in a subpopulation of patients with SOC with that in white patients. This post hoc analysis considered pooled safety data from six clinical trials from which were derived a safety population (n = 1,869 white, n = 472 SOC), an efficacy population for a comparison of fixed-dose BoNTA-ABO 50 U in white patients (n = 216) and patients with SOC (n = 117), and an efficacy population for a comparison of BoNTA-ABO adjusted to muscle mass in white (n = 555) and patients with SOC (n = 160). Adverse event rates were similar in white patients and patients with SOC. Onset of effect was similar in patients with SOC and white patients, but the response rate 30 days after treatment was greater in patients with SOC than in white patients. Tolerability and effectiveness of treatment BoNTA-ABO for glabellar lines was similar in patients with SOC and white patients. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  20. Size is the Most Important Predictor of Aneurysm Rupture Among Multiple Cerebral Aneurysms: Post Hoc Subgroup Analysis of Unruptured Cerebral Aneurysm Study Japan.

    Science.gov (United States)

    Shojima, Masaaki; Morita, Akio; Nakatomi, Hirofumi; Tominari, Shinjiro

    2017-06-20

    Multiple cerebral aneurysms are encountered in approximately 15% to 35% of patients harboring unruptured cerebral aneurysms. It would be of clinical value to determine which of them is most likely to rupture. To characterize features of the ruptured aneurysm relative to other concomitant fellow aneurysms in patients with multiple cerebral aneurysms. From a total of 5720 patients who were prospectively registered in the Unruptured Cerebral Aneurysm Study in Japan, a subgroup of patients with multiple cerebral aneurysms who developed subarachnoid hemorrhage was extracted for this post hoc analysis. Intrapatient comparisons of each aneurysm were carried out using aneurysm-specific factors such as size, location, and shape to identify predictors of rupture among the fellow aneurysms in a patient with multiple cerebral aneurysms. Twenty-five patients with 62 aneurysms were identified from the total cohort of 5720 patients. With the distinctiveness in size, which means the aneurysm was the single largest among the multiple aneurysms, the ruptured aneurysm in each case was discriminated from the other coexisting aneurysms with a sensitivity of 0.76 and specificity of 0.86. Our results suggest that the largest aneurysm is likely to rupture among coexisting aneurysms in a patient with multiple cerebral aneurysms.

  1. Lessons learnt from the CERCA Project, a multicomponent intervention to promote adolescent sexual and reproductive health in three Latin America countries: a qualitative post-hoc evaluation.

    Science.gov (United States)

    Ivanova, Olena; Cordova-Pozo, Kathya; Segura, Zoyla Esmeralda; Vega, Bernardo; Chandra-Mouli, Venkatraman; Hindin, Michelle J; Temmerman, Marleen; Decat, Peter; De Meyer, Sara; Michielsen, Kristien

    2016-10-01

    The Community-Embedded Reproductive Health Care for Adolescents (CERCA) Project was implemented in Bolivia, Ecuador and Nicaragua (2011-2014) to test the effectiveness of interventions preventing teenage pregnancies. As the outcome evaluation showed limited impact, a post-hoc process evaluation was carried out to determine if and how CERCA's design, implementation, monitoring and evaluation affected the results. We did a document analysis and conducted 18 in-depth interviews and 21 focus group discussions with stakeholders and beneficiaries. Transcripts were analyzed using directed content analysis. Data showed that CERCA sensitized stakeholders and encouraged the discussion on this sensitive issue. In terms of design, a strong point was the participatory approach; a weak point was that the detailed situation analysis was completed too late. In terms of implementation, a strong point was that multifaceted activities were implemented; a weak point was that the activities were not pilot tested for feasibility/acceptability and evolved substantially throughout the Project. In terms of monitoring, strong points were that regular monitoring kept the Project on track administratively/financially; a weak point was that monitoring indicators did not change as the intervention package changed. In terms of evaluation, weak points were the substantial attrition rate and narrow focus on adolescents. This study provides recommendations for future projects. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. Examining statewide capacity for school health and mental health promotion: a post hoc application of a district capacity-building framework.

    Science.gov (United States)

    Maras, Melissa A; Weston, Karen J; Blacksmith, Jennifer; Brophy, Chelsey

    2015-03-01

    Schools must possess a variety of capacities to effectively support comprehensive and coordinated school health promotion activities, and researchers have developed a district-level capacity-building framework specific to school health promotion. State-level school health coalitions often support such capacity-building efforts and should embed this work within a data-based, decision-making model. However, there is a lack of guidance for state school health coalitions on how they should collect and use data. This article uses a district-level capacity-building framework to interpret findings from a statewide coordinated school health needs/resource assessment in order to examine statewide capacity for school health promotion. Participants included school personnel (N = 643) from one state. Descriptive statistics were calculated for survey items, with further examination of subgroup differences among school administrators and nurses. Results were then interpreted via a post hoc application of a district-level capacity-building framework. Findings across districts revealed statewide strengths and gaps with regard to leadership and management capacities, internal and external supports, and an indicator of global capacity. Findings support the utility of using a common framework across local and state levels to align efforts and embed capacity-building activities within a data-driven, continuous improvement model. © 2014 Society for Public Health Education.

  3. Once-monthly injection of paliperidone palmitate in patients with recently diagnosed and chronic schizophrenia: a post-hoc comparison of efficacy and safety.

    Science.gov (United States)

    Si, Tianmei; Zhuo, Jianmin; Turkoz, Ibrahim; Mathews, Maju; Tan, Wilson; Feng, Yu

    2017-12-01

    The use of long-acting injectable antipsychotics in recently diagnosed schizophrenia remains less explored. We evaluated the efficacy and safety of paliperidone palmitate once-monthly (PP1M) treatment in adult patients with recently diagnosed vs. chronic schizophrenia. These post-hoc analyses included two multicenter studies. Study 1 (NCT01527305) enrolled recently diagnosed (≤5 years) and chronic (>5 years) patients; Study 2 (NCT01051531) enrolled recently diagnosed patients only. Recently diagnosed patients were further sub-grouped into ≤2 years or 2-5 years. The primary efficacy endpoint was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score. In Study 1, 41.5% patients had recent diagnosis (≤2 years: 56.8%; 2-5 years: 43.2%); 58.5% had chronic schizophrenia. In Study 2, 52.8% and 47.2% patients were grouped into ≤2 years and 2-5 years, respectively. PANSS total score showed significantly greater improvement in patients with recently diagnosed vs. chronic schizophrenia. Similar results were obtained for PANSS responder rate, improvements in PANSS, and CGI-S scores. PP1M was efficacious in both recently diagnosed and chronic schizophrenia, with the benefits being more pronounced in patients with recently diagnosed schizophrenia. This adds to growing evidence recommending long-acting antipsychotic interventions at early stages of schizophrenia.

  4. Can serum albumin level affect the pharmacological action of tolvaptan in patients with liver cirrhosis? A post hoc analysis of previous clinical trials in Japan.

    Science.gov (United States)

    Sakaida, Isao; Nakajima, Koji; Okita, Kiwamu; Hori, Masatsugu; Izumi, Tohru; Sakurai, Masaya; Shibasaki, Yoshiyuki; Tachikawa, Sayaka; Tsubouchi, Hidetsugu; Oka, Hiromi; Kobayashi, Hiroyuki

    2015-10-01

    Patients with hypoalbuminemia often fail to respond to increased doses of loop diuretics. We therefore performed a post hoc analysis to investigate the pharmacological action of tolvaptan and whether it is dependent on the serum albumin level. This analysis was based on four previous clinical trials of tolvaptan in patients with liver cirrhosis who exhibited insufficient response to conventional diuretics. We analyzed the correlation between the change in the initial 24-h cumulative urine volume from baseline and the serum albumin level at baseline, and assessed potential predictive factors of response to tolvaptan. The correlation coefficient was 0.029 in the placebo group and -0.112 in the 7.5 mg tolvaptan group of patients with liver cirrhosis. Administration of tolvaptan provoked a stable response regardless of the serum albumin level. Tolvaptan use was identified as a significant predictor of pharmacological action, and was shown to change the initial urine volume by 885 mL (P tolvaptan increased the initial urine volume from baseline regardless of serum albumin levels. Use of tolvaptan as an add-on therapy to loop diuretics can be considered an optimal therapeutic option in patients with insufficient response to loop diuretics.

  5. The impact of a restrictive transfusion trigger on post-operative complication rate and well-being following elective orthopaedic surgery: a post-hoc analysis of a randomised study

    Science.gov (United States)

    So-Osman, Cynthia; Nelissen, Rob; Brand, Ronald; Faber, Frank; Slaa, Ron Te; Stiggelbout, Anne; Brand, Anneke

    2013-01-01

    Background Peri-operative red blood cell transfusions have been associated with post-operative complications in patients undergoing elective orthopaedic hip or knee replacement surgery. Materials and methods We performed a post-hoc analysis of data extracted from a randomised study on transfusion triggers using pre-storage leucocyte-depleted red blood cells. Patients who were assigned to the most restrictive transfusion policy ("restrictive group") were compared with patients who were assigned to the most liberal policy ("liberal group"). End-points were red blood cell use, hospital stay, haemoglobin levels, post-operative complications and quality of life scores. Results Of 603 patients, 26.4% patients in the restrictive group and 39.1% in the liberal group were transfused (P =0.001). The rate of post-operative infections was lower, although not statistically significantly so, in the restrictive group than in the liberal group (5.4% vs 10.2%, respectively) as was the rate of respiratory complications (1.7% vs 4.9%, respectively), whereas hospital stay, cardiovascular complications and mortality rate were not different in the two groups. Quality of life scores were not associated with type of transfusion policy, the number of red blood cell transfusions or the transfusion status. Discussion A restrictive transfusion protocol was not associated with worse outcome and resulted in a lower transfusion rate compared to the liberal policy. Well-being (quality of life) was not associated with transfusion policy or with red blood cell transfusions. PMID:23399367

  6. Demographic Characteristics and Clinical Outcomes in Patients from Latin America Versus the Rest of the World: A TIOSPIR®Post-Hoc Analysis.

    Science.gov (United States)

    Anzueto, Antonio; Calverley, Peter M A; Mueller, Achim; Metzdorf, Norbert; Haensel, Michaela; Jardim, José R; Pizzichini, Emilio; Giraldo, Horacio; Ramirez-Venegas, Alejandra; Giugno, Eduardo R

    2018-03-01

    Geographical variations may impact outcomes in chronic obstructive pulmonary disease (COPD). We evaluated differences in baseline characteristics and outcomes between patients enrolled in Latin America compared with the rest of the world (RoW) in the TIOtropium Safety and Performance In Respimat ® (TIOSPIR ® ) trial. TIOSPIR ® , a 2-3-year, randomized, double-blind trial (n=17116; treated set), compared safety and efficacy of once-daily tiotropium Respimat ® 5 and 2.5μg with tiotropium HandiHaler ® 18μg. This post-hoc analysis pooled data from all treatment arms to assess mortality, exacerbations, cardiac events, and serious adverse events (SAEs) between both regions. At baseline, patients enrolled in Latin America (n=1000) versus RoW (n=16116) were older, with higher pack-years of smoking history and more exacerbations, but less cardiac history. In this analysis, patients in Latin America versus RoW had an increased risk of death (hazard ratio [HR] [95% confidence interval (CI)]: 1.52 [1.24-1.86]; PLatin America were lower versus RoW (incidence rate ratio [IRR] [95% CI]: 0.82 [0.72-0.92]), including cardiac disorders (IRR [95% CI]: 0.68 [0.48-0.97]). Risk of major adverse cardiovascular events were similar (HR [95% CI]: 0.99 [0.71-1.40]; P=.9677). TIOSPIR ® patients in Latin America had a higher risk of death or moderate-to-severe exacerbation, but a lower risk of severe exacerbation than those in RoW. Geographical differences may impact outcomes in COPD trials. Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Influence of Renal Impairment on Outcome for Thrombolysis-Treated Acute Ischemic Stroke: ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study) Post Hoc Analysis.

    Science.gov (United States)

    Carr, Susan J; Wang, Xia; Olavarria, Veronica V; Lavados, Pablo M; Rodriguez, Jorge A; Kim, Jong S; Lee, Tsong-Hai; Lindley, Richard I; Pontes-Neto, Octavio M; Ricci, Stefano; Sato, Shoichiro; Sharma, Vijay K; Woodward, Mark; Chalmers, John; Anderson, Craig S; Robinson, Thompson G

    2017-09-01

    Renal dysfunction (RD) is associated with poor prognosis after stroke. We assessed the effects of RD on outcomes and interaction with low- versus standard-dose alteplase in a post hoc subgroup analysis of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study). A total of 3220 thrombolysis-eligible patients with acute ischemic stroke (mean age, 66.5 years; 37.8% women) were randomly assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) intravenous alteplase within 4.5 hours of symptom onset. Six hundred and fifty-nine (19.8%) patients had moderate-to-severe RD (estimated glomerular filtration rate, 90 mL/min per 1.73 m 2 ), those with severe RD (stroke. There was no significant association with modified Rankin Scale scores 2 to 6 (adjusted odds ratio, 1.03; 95% confidence interval, 0.62-1.70; P =0.81 for trend), modified Rankin Scale 3 to 6 (adjusted odds ratio, 1.20; 95% confidence interval, 0.72-2.01; P =0.44 for trend), or symptomatic intracerebral hemorrhage, or any heterogeneity in comparative treatment effects between low-dose and standard-dose alteplase by RD grades. RD is associated with increased mortality but not disability or symptomatic intracerebral hemorrhage in thrombolysis-eligible and treated acute ischemic stroke patients. Uncertainty persists as to whether low-dose alteplase confers benefits over standard-dose alteplase in acute ischemic stroke patients with RD. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616. © 2017 American Heart Association, Inc.

  8. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials.

    Science.gov (United States)

    McIntyre, Roger S; Weiller, Emmanuelle; Zhang, Peter; Weiss, Catherine

    2016-09-01

    Anxiety symptoms are prevalent in major depressive disorder (MDD) and are associated with greater illness severity, suicidality, impaired functioning and poor response to antidepressant treatment (ADT). The efficacy and safety of brexpiprazole - a serotonin-dopamine activity modulator - as adjunctive treatment in patients with MDD was recently evaluated in two phase 3 studies. We here present a post-hoc analysis of the efficacy of adjunctive brexpiprazole in patients with MDD and symptoms of anxious distress, defined using proxies for DSM-5 criteria. Eligible patients were randomized to 2mg brexpiprazole+ADT or placebo+ADT (NCT01360645); or 1mg brexpiprazole+ADT, 3mg brexpiprazole+ADT, or placebo+ADT (NCT01360632), respectively. Patients were defined as having anxious distress if they had ≥2 of the symptoms tension (MADRS item 3 score ≥3), restlessness (IDS item 24 score ≥2), concentration (MADRS item 6 score ≥3), or apprehension (HAM-D item 10 score ≥3). Primary efficacy endpoint was change in MADRS total score from baseline to Week 6. 55% of the patients had anxious distress at baseline. Adjunctive brexpiprazole showed greater improvement than adjunctive placebo on the primary efficacy endpoint in both patients with (least square mean difference to placebo+ADT: 2mg+ADT: -2.95, p=0.0023; 3mg+ADT: -2.81, p=0.0027); and without anxious distress (1mg+ADT: -2.37, p=0.0093; 3mg+ADT: -2.23, p=0.0131). Brexpiprazole in patients with anxious distress was not associated with an increased incidence of activating adverse events (e.g., akathisia). Adjunctive brexpiprazole 2-3mg may be efficacious in reducing depressive symptoms and is well tolerated, in patients with MDD and anxious distress. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

    2016-07-01

    To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.

  10. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study.

    Science.gov (United States)

    Tombal, Bertrand; Cornel, Erik B; Persad, Raj; Stari, Anny; Gómez Veiga, Francisco; Schulman, Claude

    2017-11-01

    Lower serum testosterone levels correlate with improved cause specific survival and longer time to progression in year 1 of continuous androgen deprivation in men with prostate cancer. ICELAND was a large European study demonstrating the efficacy of leuprorelin (Eligard®) during continuous androgen deprivation. In this post hoc analysis we investigated serum testosterone levels within year 1 of continuous androgen deprivation to determine survival and time to progression. In ICELAND (ClinicalTrials.gov NCT00378690) patients with locally advanced or relapsing nonmetastatic prostate cancer and with prostate specific antigen 1 ng/ml or less following 6-month induction with leuprorelin 3-month depot 22.5 mg (plus bicalutamide 50 mg per day for 1 month) were randomized 1:1 to continuous androgen deprivation (361) or intermittent androgen deprivation (340) with leuprorelin for 36 months. Patients receiving continuous androgen deprivation were stratified by minimum, median and maximum testosterone levels during year 1 of therapy into 20 or less, greater than 20 to 50 and greater than 50 ng/dl subgroups. Cause specific survival and time to prostate specific antigen (castrate resistant prostate cancer) progression were analyzed. A total of 90.1%, 83.5% and 74.5% of patients receiving continuous androgen deprivation achieved minimum, median and maximum serum testosterone levels of 20 ng/dl or less, respectively. Cause specific survival rates and time to prostate specific antigen progression did not differ among the testosterone subgroups. In patients receiving continuous androgen deprivation cause specific survival and time to prostate specific antigen progression did not differ according to testosterone levels in year 1 of therapy. This finding may in part be due to the induction period and the effectiveness of leuprorelin in lowering testosterone. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  11. A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial.

    Science.gov (United States)

    Curtis, Jeffrey R; Herrem, Christopher; Ndlovu, 'Matladi N; O'Brien, Cathy; Yazici, Yusuf

    2017-09-29

    Comorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial. Patients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or physician-based Clinical Disease Activity Index (CDAI) for treatment response assessment. Post-hoc analyses identified patients with the SCP, which included diagnosis of depression, fibromyalgia/myalgias, and/or use of medications indicated for treatment of depression, anxiety, or neuropathic pain. The effect of the SCP on RAPID3 or CDAI response at week 12 and low disease activity (LDA; Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ≤ 3.2) at week 52, in week-12 responders, was analyzed using non-parametric analysis of covariance (ANCOVA). At baseline, 43% (313/733) of patients met the SCP classification. Patients with the SCP were 9% more likely to withdraw from the trial. American College of Rheumatology 20% (ACR20), ACR50, and ACR70 responses were 5-14% lower among those with the SCP, and 11% more patients reported adverse events (AEs). Patients without SCP in the CDAI arm were twice as likely to achieve LDA at week 52 compared with those with SCP (32% versus 16%). No differentiation by SCP was observed in the RAPID3 arm (pooled result 21.5%). We operationalized a potentially important somatization comorbidity phenotype in a trial setting that was associated with a substantially lower likelihood of treatment response and a higher frequency of AEs. Including large numbers of patients with this phenotype in RA trials may reduce the measured clinical effectiveness of a new molecule. ClinicalTrials.gov, NCT01255761 . Registered on 6 December 2010.

  12. Glycemic Variability Is Associated with Frequency of Blood Glucose Testing and Bolus: Post Hoc Analysis Results from the ProAct Study.

    Science.gov (United States)

    Pfützner, Andreas; Weissmann, Jörg; Mougiakakou, Stavroula; Daskalaki, Elena; Weis, Norbert; Ziegler, Ralph

    2015-06-01

    The ProAct study has shown that a pump switch to the Accu-Chek(®) Combo system (Roche Diagnostics Deutschland GmbH, Mannheim, Germany) in type 1 diabetes patients results in stable glycemic control with significant improvements in glycated hemoglobin (HbA1c) in patients with unsatisfactory baseline HbA1c and shorter pump usage time. In this post hoc analysis of the ProAct database, we investigated the glycemic control and glycemic variability at baseline by determination of several established parameters and scores (HbA1c, hypoglycemia frequency, J-score, Hypoglycemia and Hyperglycemia Indexes, and Index of Glycemic Control) in participants with different daily bolus and blood glucose measurement frequencies (less than four day, four or five per day, and more than five per day, in both cases). The data were derived from up to 299 patients (172 females, 127 males; age [mean±SD], 39.4±15.2 years; pump treatment duration, 7.0±5.2 years). Participants with frequent glucose readings had better glycemic control than those with few readings (more than five readings per day vs. less than four readings per day: HbA1c, 7.2±1.1% vs. 8.0±0.9%; mean daily blood glucose, 151±22 mg/dL vs. 176±30 mg/dL; percentage of readings per month >300 mg/dL, 10±4% vs. 14±5%; percentage of readings in target range [80-180 mg/dL], 59% vs. 48% [Pblood glucose was associated with a higher number of bolus applications (6.1±2.2 boluses/day vs. 4.5±2.0 boluses/day [Pglucose readings have a better glycemic control with lower glycemic variability.

  13. Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial.

    Science.gov (United States)

    Forestier, R; Genty, C; Waller, B; Françon, A; Desfour, H; Rolland, C; Roques, C-F; Bosson, J-L

    2014-06-01

    To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis. This study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥-19.9mm on the VAS pain scale and/or ≥-9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the "patient acceptable symptom state" (PASS) defined as VAS pain ≤32.3mm and/or WOMAC function subscale ≤31 points. From the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n=52/94 vs. 38/88, P=0.010). There was no difference for the PASS (n=19/88 vs. 26/94, P=0.343). This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  14. Effects of calcium channel blocker-based combinations on intra-individual blood pressure variability: post hoc analysis of the COPE trial

    Science.gov (United States)

    Umemoto, Seiji; Ogihara, Toshio; Matsuzaki, Masunori; Rakugi, Hiromi; Ohashi, Yasuo; Saruta, Takao; Ogihara, T; Saruta, T; Matsuzaki, M; Eto, T; Fujita, T; Higaki, J; Ito, S; Kamiya, A; Kikuchi, K; Matsuoka, H; Suzuki, H; Tei, C; Matsuoka, H; Kumagai, H; Ohashi, Y; Rakugi, H; Shimamoto, K; Takishita, S; Umemoto, S; Shimada, K; Hayashi, K; Kario, K; Kawana, M; Kitagawa, K; Makino, H; Matsumoto, M; Yoshikawa, J; Abe, K; Matsuura, H; Ohashi, Y; Otsuka, K; Tanabe, K; Suzuki, N; Nogawa, S; Utsunomiya, K; Yoshikawa, T; Yumura, W; Ohashi, Y; Umemoto, S; Kikuchi, K; Hasebe, N; Bunya, M; Fujii, W; Funayama, N; Gima, M; Hashizume, K; Hirayama, Y; Matsuhashi, H; Morimoto, H; Myojo, T; Ohori, K; Omiya, H; Ota, T; Sato, A; Shiokoshi, T; Tanaka, H; Yamazaki, K; Yoshie, H; Shimamoto, K; Abiru, M; Adachi, M; Fujise, Y; Hanawa, K; Ishii, K; Kadono, Y; Kaku, T; Kaneta, S; Kato, M; Kato, N; Kobayashi, H; Komakine, T; Matsumoto, T; Mita, T; Miura, N; Mukai, H; Nagao, K; Nakagawa, H; Nakagawa, M; Nakajima, N; Nishimiya, T; Nishino, Y; Nunokawa, A; Ohata, J; Ooiwa, H; Sato, R; Satoh, S; Shibata, S; Takada, M; Takagawa, Y; Takagi, Y; Takeichi, S; Tanaka, S; Togashi, N; Ura, N; Wakabayashi, C; Yoshida, D; Yoshida, H; Yoshida, K; Kitabatake, A; Tsutsui, H; Akutsu, M; Fujii, S; Furumoto, T; Kakinoki, S; Kawasaki, H; Kimura, T; Makiguchi, M; Matsuo, H; Okamoto, H; Oyama, Y; Shimokawa, J; Tsuzuki, N; Ito, S; Imai, Y; Domon, R; Ebina, H; Egawa, S; Haruyama, T; Hashimoto, H; Hayakawa, T; Inomata, H; Katahira, Y; Katakura, T; Kikuchi, R; Kimura, H; Kyogoku, S; Kyogoku, Y; Matsuo, K; Nakazawa, H; Odakura, H; Okuguchi, F; Ohtomo, E; Ouchi, H; Seino, M; Tadokoro, M; Tanno, Y; Uchida, N; Yamanaka, T; Yunomura, K; Okumura, K; Hatayama, T; Kanehira, Y; Kaneko, H; Kimura, M; Maeda, N; Mikuniya, A; Narita, H; Ono, M; Osanai, T; Sato, M; Yoshino, H; Momomura, S; Ono, M; Inoue, M; Iwase, T; Miyazaki, K; Taki, M; Aizawa, T; Hasunuma, Y; Makino, H; Okabayashi, H; Hosoda, S; Sumiyoshi, T; Abe, M; Kira, Y; Nagayama, M; Sakai, K; Yoshikawa, O; Ide, M; Kimura, N; Matsuzaka, S; Miyajima, Y; Sawai, K; Sumi, T; Takada, R; Toma, M; Yamada, Y; Yoda, K; Yokokawa, T; Yokoyama, S; Kanmatsuse, K; Kushiro, T; Anazawa, T; Ebuchi, T; Fujita, H; Katsumata, N; Masubuchi, K; Migita, T; Osada, T; Otsuka, Y; Saito, F; Shimoda, S; Sugino, K; Takahashi, A; Tani, S; Yumi, K; Daida, H; Arino, T; Iesaki, T; Inomata, Y; Nakahara, H; Shiraishi, H; Sudo, H; Degawa, T; Araki, T; Itaya, H; Komatsu, H; Kuwana, H; Mikawa, T; Nomoto, H; Ogawa, N; Sato, H; Takase, H; Toyoda, H; Yamamoto, M; Obayashi, K; Akabane, I; Hamamoto, H; Kanbara, R; Kato, H; Kimura, H; Mori, N; Yamada, K; Yamamuro, M; Isobe, M; Emoto, H; Inaba, O; Inazawa, T; Inomata, H; Isobe, K; Ito, Y; Komura, M; Kosuge, H; Maejima, Y; Miwa, N; Nishimori, T; Otomo, K; Sakurai, K; Sawada, M; Seya, M; Shimizu, M; Takagi, T; Tamura, M; Tanaka, K; Tezuka, D; Tokunaga, T; Yagishita, A; Yamashina, A; Hara, T; Hayashi, S; Hirayama, Y; Hirooka, Y; Iitaka, M; Ishiyama, T; Kijima, F; Kobayashi, H; Kobayashi, Y; Kondo, K; Kuwabara, T; Mugishima, M; Nakayama, Y; Nishizato, Y; Osamura, Y; Sakomura, Y; Saneshige, S; Shindo, N; Takao, N; Takata, Y; Tomiyama, H; Ishimaru, S; Obitsu, Y; Shigematsu, H; Baba, T; Fukushima, H; Hirayama, T; Magari, K; Makimura, S; Nagae, T; Osada, K; Osada, T; Shimizu, T; Suesada, H; Tamura, K; Yamazaki, T; Hirai, A; Fukasawa, T; Ono, H; Yamakado, M; Shiba, T; Otomi, S; Uehata, A; Takazawa, K; Aizawa, A; Iketani, T; Kino, M; Kobayashi, H; Morishima, T; Sakamoto, N; Sakamoto, T; Yamakawa, H; Kasanuki, H; Nagai, R; Kadowaki, T; Tanaka, J; Yamazaki, T; Takagi, M; Ui, S; Baba, S; Fujita, K; Hasegawa, T; Tajima, K; Tanaka, M; Yamato, N; Kuwajima, I; Harada, K; Miyata, H; Mizuno, S; Ueda, S; Sugi, K; Ando, H; Mishima, K; Moroi, M; Nishizawa, S; Suzuki, S; Yamazaki, J; Nakanishi, R; Nakano, H; Tokuyasu, K; Aoyagi, T; Fujioka, M; Kobayakawa, N; Nakajima, K; Hirayama, A; Tsukamoto, K; Araki, Y; Hara, H; Hara, K; Saruya, T; Umemura, S; Arima, M; Endo, T; Furumi, K; Hatori, Y; Ikeda, Y; Ikeya, Y; Kaneda, T; Kawada, T; Kawano, T; Kawashima, T; Kihara, M; Kikuta, M; Kitamura, A; Kobayashi, H; Kobayashi, S; Kuji, T; Masuda, S; Minamimoto, Y; Minamisawa, K; Mitsuhashi, T; Miyazaki, N; Nagashima, Z; Nakatogawa, T; Nakayama, R; Nyui, N; Ogawa, M; Onishi, T; Saka, K; Sano, T; Sato, A; Shiba, K; Shionoiri, F; Sugiyama, H; Suzuki, H; Takasaki, I; Tamura, K; Tokita, Y; Umemura, M; Yamaguchi, S; Yasuda, G; Nakamura, S; Takayanagi, K; Hayashi, T; Ichihara, M; Kobayashi, S; Sakai, Y; Uchida, T; Yaguchi, I; Komuro, I; Aoki, S; Hashimoto, Y; Ibuki, C; Isobe, Y; Kumasaka, R; Matsuda, M; Mizuno, K; Murakami, D; Nakamura, S; Nakatani, M; Ohba, T; Ohara, T; Okumura, T; Saito, A; Sakurai, T; Sato, S; Sato, W; Seimiya, K; Seino, Y; Shimizu, K; Takano, M; Tokuyama, K; Uchida, D; Yodogawa, K; Oshima, S; Kurabayashi, M; Baba, N; Furushima, Y; Goto, T; Hosoi, T; Iijima, T; Ito, K; Iwata, Y; Kubo, H; Matsumoto, M; Miyazaki, M; Naganuma, F; Nakada, K; Tokushima, M; Tsunoda, K; Wakamatsu, S; Yagihara, Y; Aizawa, Y; Aizawa, M; Aizawa, M; Hayashi, N; Hori, T; Kobayashi, H; Kodama, M; Maeda, K; Miura, K; Okada, K; Okura, Y; Sasagawa, Y; Takizawa, S; Tamura, M; Yamamoto, T; Murohara, T; Awaji, Y; Funahashi, H; Hayashi, D; Iida, M; Ishihara, D; Ishikawa, S; Kamide, S; Kanashiro, M; Kurebayashi, N; Kyo, S; Matsui, H; Matsuo, K; Morishima, M; Noda, H; Noda, T; Okumura, N; Ota, T; Shimizu, S; Somura, F; Takada, Y; Takeichi, Y; Takezawa, H; Uchikawa, T; Yoshikawa, D; Kimura, G; Ando, Y; Hoshiai, M; Okuda, N; Suzuki, S; Takada, K; Takada, N; Yamada, K; Hishida, H; Furuta, T; Hayashi, H; Ito, K; Kato, K; Nomura, M; Ota, T; Ohtsuki, M; Tabata, T; Taga, S; Tateishi, R; Ito, T; Fukuda, M; Iwa, T; Wakida, Y; Yonemoto, T; Watarai, M; Ito, M; Kawai, H; Murata, Y; Nomoto, S; Takemoto, K; Tsuboi, N; Yoshida, Y; Inoue, N; Ishikawa, M; Matsumoto, M; Muramatsu, T; Yoshida, R; Ono, M; Hanaki, Y; Sano, H; Shibata, Y; Sakai, K; Ajioka, M; Asano, H; Okamoto, R; Osanai, H; Uemura, Y; Yokoi, K; Tanaka, T; Kamiya, H; Miki, K; Niwa, M; Fujiwara, H; Minatoguchi, S; Arai, T; Kato, S; Kobayashi, H; Minagawa, T; Mori, N; Nakahara, K; Shimizu, Y; Tadokoro, M; Takahashi, N; Shigemasa, T; Kobayashi, I; Nakano, T; Ito, M; Fukui, A; Higashi, Y; Ito, T; Kano, U; Makino, K; Nakai, K; Nakajima, M; Nakajima, T; Sekoguchi, K; Tanaka, T; Tanigawa, T; Takekoshi, N; Enyama, H; Hirakawa, T; Ito, J; Ito, T; Kakuda, H; Kigoshi, T; Kondo, K; Masuya, K; Matoba, M; Nakagawa, A; Nakahashi, T; Nakato, H; Okada, H; Okuro, M; Takeuchi, Y; Tsugawa, H; Urata, T; Yasuhara, M; Shimizu, M; Ino, H; Araki, T; Fujino, N; Haraki, T; Hayashi, K; Hifumi, S; Konno, T; Minamoto, M; Miyamoto, S; Mori, M; Nakanishi, C; Sakamoto, Y; Sakata, K; Takeda, S; Ueda, K; Uchiyama, K; Takata, S; Kaneko, S; Aburadani, I; Inoki, I; Kitano, K; Kobayashi, D; Kontani, K; Maekawa, M; Maruyama, M; Matsunuma, K; Nagai, Y; Nagata, Y; Okajima, M; Otowa, K; Sekiguchi, Y; Shinmura, K; Usui, S; Yokoyama, H; Yonejima, M; Nakao, K; Hiraiwa, N; Ko, T; Masuda, I; Nagae, T; Nishino, K; Sakamoto, M; Kita, T; Nakagawa, Y; Kimura, T; Doi, T; Horiuchi, H; Kinoshita, M; Mizuno, M; Ohnishi, M; Shigemoto, K; Wada, A; Yamada, T; Yoshida, H; Nakagawa, M; Matsubara, H; Furukawa, K; Hatta, T; Inoue, A; Katsume, H; Masui, A; Matsumoto, S; Seki, T; Takeda, K; Taniguchi, Y; Tsuji, H; Saito, Y; Fukuoka, Y; Iwano, M; Katsuyama, T; Nakatani, A; Sakaguchi, Y; Konishi, T; Izumi, T; Toda, I; Kamimoto, A; Nagai, Y; Matsuwaka, E; Matsuwaka, R; Takei, K; Ueda, R; Wakaki, N; Iwasaka, T; Hamada, H; Hamada, S; Koga, H; Koito, H; Kono, K; Kurihara, H; Maeda, J; Morimoto, S; Takayama, Y; Aoyama, T; Imai, M; Ii, T; Kashii, S; Maenaka, M; Ohashi, H; Suyama, T; Matsuda, M; Aoyagi, Y; Kunisada, K; Mori, T; Mori, T; Uemura, J; Yokoi, Y; Morioka, N; Ozaki, T; Kanamasa, K; Ishikawa, K; Miyazaki, S; Arima, S; Kai, T; Kurooka, A; Shimada, I; Takewa, M; Taniguchi, M; Hattori, R; Haba, K; Yokota, R; Matsui, H; Tone, E; Yamahira, H; Kawarabayashi, T; Inaba, H; Sakaguchi, Y; Yamamoto, Y; Ito, H; Date, M; Dodo, M; Fujii, K; Imai, M; Inoue, K; Kanoh, Y; Komura, N; Senpuku, S; Takeda, M; Tateyama, H; Yasui, K; Yoneda, R; Morita, H; Kawanami, M; Tahara, A; Sado, T; Takamura, T; Taniwa, M; Kitaura, Y; Fukuda, M; Hanada, H; Nakamura, K; Sawada, K; Yamaguchi, M; Kodama, K; Higo, T; Hirata, A; Kanzaki, M; Komatsu, S; Matsuo, K; Murakawa, T; Nakanishi, H; Nemoto, T; Nishio, M; Ogasawara, N; Okuyama, Y; Ueda, Y; Imanishi, M; Kitamura, Y; Sakakibara, T; Yoshida, H; Yoshimi, H; Ogihara, T; Rakugi, H; Akiyama, M; Ikuno, Y; Imai, N; Imamura, Y; Inoyama, T; Kamide, K; Katahira, K; Katsuya, S; Katsuya, T; Kurokawa, Y; Matsuki, O; Matsuo, M; Nakamura, T; Ogura, E; Ohishi, M; Sasaki, R; Sugimoto, K; Tachi, J; Tanaka, H; Tanaka, H; Tsunetoshi, T; Yoshino, M; Hori, M; Awata, N; Fukukawa, T; Iimori, Y; Iwamoto, S; Sawami, K; Okamura, M; Kanayama, Y; Nagano, F; Nakayama, H; Suzuki, H; Amano, T; Tachibana, K; Arita, Y; Kirino, M; Sakuyama, K; Shukawa, M; Nishida, Y; Sakamoto, T; Yanagi, S; Hirota, K; Majima, T; Ota, T; Tanaka, T; Nohara, R; Funauchi, T; Isogai, O; Takashima, S; Koike, H; Nishimoto, M; Kawase, Y; Tojo, O; Chimori, Y; Harada, H; Takeoka, H; Kishi, S; Yokoyama, M; Hirata, K; Ejiri, J; Emoto, R; Furuta, Y; Hattori, K; Kuroda, R; Maehashi, N; Monnaka, H; Ohashi, Y; Okada, T; Suzuki, H; Takeuchi, M; Ohyanagi, M; Masai, M; Masuyama, T; Kawabata, M; Kajiya, T; Daito, N; Fujisawa, T; Fujita, S; Hasegawa, M; Hirakoba, M; Hirano, T; Ikeda, Y; Imai, N; Marumoto, K; Masuda, S; Miki, T; Mitsunaga, M; Mitsuoka, H; Miyachi, Y; Mukohara, N; Nagao, T; Nakada, K; Nishian, K; Nishioka, S; Ogura, T; Onishi, Y; Sakaguchi, K; Sano, I; Sano, W; Shigenobu, M; Tabuchi, A; Takashima, J; Taniguchi, Y; Uchida, H; Ueda, T; Urabe, N; Makino, H; Harada, S; Hirakawa, S; Hirata, H; Ishii, J; Koten, K; Nagake, Y; Nakajima, T; Nakamura, Y; Terami, T; Mitsudo, K; Fujii, M; Fujita, K; Iwano, E; Kadota, K; Nishihara, Y; Takaya, Y; Yamamoto, H; Yamamoto, T; Shigemasa, C; Hisatome, I; Kato, T; Miyakoda, H; Sakamoto, M; Shimoyama, M; Shimada, T; Tanabe, K; Goto, Y; Hanada, Y; Kawakami, K; Kitamura, J; Kitamura, K; Nakata, H; Oyake, N; Sugiura, H; Tsukihashi, H; Matsuzaki, M; Umemoto, S; Aoyagi, S; Aoyama, H; Fujino, T; Fukuta, S; Hiroyama, N; Ikeda, Y; Inamoto, Y; Kametani, R; Kamiya, A; Kanamaru, Y; Kotoku, S; Matsushima, A; Morita, J; Murano, Y; Nakatsuka, M; Nishimura, S; Nisnimura, Y; Okamura, T; Okuda, F; Onaka, U; Ozaki, M; Shimizu, A; Takata, C; Tamitani, M; Watada, T; Watada, T; Yamamoto, K; Yamauchi, M; Yorozu, T; Yoshikane, H; Yoshino, F; Higaki, J; Doiuchi, J; Fukuoka, T; Hashimoto, H; Igase, M; Kadota, H; Kaneko, H; Komatsu, S; Matsubara, Y; Miyoshi, K; Murakami, K; Murao, S; Niiya, T; Ochi, T; Satoh, A; Seki, T; Takahashi, H; Yamashita, T; Yoshino, T; Kohno, M; Fujita, N; Fukui, T; Hamamoto, T; Hasegawa, K; Hitomi, H; Ihara, K; Kiyomoto, H; Masugata, H; Matsumoto, I; Takahashi, N; Yoshikawa, K; Doi, Y; Arisawa, M; Egawa, T; Fukuda, M; Kawada, Y; Kusunose, H; Maeda, T; Minami, N; Nishinaga, M; Noguchi, T; Okabayashi, K; Sato, K; Satomi, T; Takada, J; Tamura, S; Usui, T; Yamada, M; Irahara, M; Azuma, H; Fujimura, M; Fujino, H; Fujino, M; Harada, E; Harada, S; Hiasa, Y; Hosokawa, S; Kawahara, K; Koshiba, K; Murakami, M; Nakaya, Y; Nii, H; Nozaki, S; Ota, A; Ozaki, T; Sone, K; Tsutsui, Y; Ueta, S; Nobuyoshi, M; Fujishima, Y; Hisano, K; Ikezono, H; Imawatari, R; Izumi, Y; Kanai, H; Nakamura, T; Nakamura, T; Noda, T; Ono, E; Tanaka, S; Tsuiki, T; Yanai, T; Sasaguri, T; Akimitsu, S; Dohmen, K; Fujisawa, K; Fukuyo, K; Harashima, S; Hayashi, T; Hirata, M; Hirata, Y; Ikeda, N; Ikematsu, H; Ikematsu, W; Kajiyama, W; Kawakami, Y; Kawasaki, I; Kondo, H; Kusuhara, H; Maeda, N; Miyahara, H; Motomura, A; Nakamura, K; Noguchi, T; Okinaga, T; Sato, M; Shimada, I; Shin, H; Soejima, K; Sugi, K; Taniguchi, T; Uwatoku, T; Yamaga, S; Yamaji, K; Yanagi, J; Yano, H; Saku, K; Enomoto, M; Hiratsuka, T; Imoto, K; Kamei, R; Kanaya, H; Kohara, M; Kusuda, M; Nishikawa, H; Sako, H; Imaizumi, T; Yano, K; Maemura, K; Ashizawa, N; Hazama, M; Ishida, Y; Ito, T; Kanda, M; Kimura, M; Noguchi, T; Oku, Y; Seto, S; Suzuki, S; Ogawa, H; Goto, K; Honjio, K; Horio, Y; Jinnouchi, H; Kaku, Y; Kawano, S; Kimura, T; Kiyohara, Y; Maki, A; Matsumoto, N; Misumi, K; Sakamoto, T; Sasaki, K; Sugiyama, S; Tanaka, E; Uemura, S; Tei, C; Arima, K; Daitoku, Y; Eto, H; Hashino, T; Ichinari, K; Ikeda, Y; Iriki, A; Kiyonaga, K; Kubota, K; Makise, Y; Masuzaki, S; Miyata, M; Mizoguchi, H; Niiyama, T; Samejima, Y; Yonezawa, S

    2016-01-01

    Visit-to-visit blood pressure (BP) variability is an important predictor of stroke. However, which antihypertensive drug combination is better at reducing visit-to-visit BP variability and therefore at reducing stroke incidence remains uncertain. We have previously reported that the dihydropyridine calcium channel blocker benidipine combined with a β-blocker appeared to be less beneficial in reducing the risk of stroke than a combination of benidipine and thiazide. Here, we further compare the visit-to-visit BP variability among three benidipine-based regimens, namely angiotensin receptor blocker (ARB), β-blocker and thiazide combinations. The present post hoc analysis included 2983 patients without cardiovascular events or death during the first 18 months after randomization. We compared the BP variability (defined as the s.d. and the coefficient of variation (CV)), maximum systolic BP (SBP) and diastolic BP (DBP) of the clinic mean on-treatment BPs obtained at 6-month intervals, starting 6 months after the treatment initiation, among the 3 treatments (ARB, n=1026; β-blocker, n=966; thiazide, n=991). During the first 6–36 months after randomization, both the s.d. and CV-BPs were lower in the benidipine–thiazide group than in the benidipine–β-blocker group (s.d.-SBP, P=0.019; s.d.-DBP, P=0.030; CV-SBP, P=0.012; CV-DBP, P=0.022). The s.d. and CV in the ARB group did not reach statistical significance compared with the other two groups. The maximum BPs did not differ among the three treatments. These findings suggest that the benidipine–thiazide combination may reduce visit-to-visit BP variability more than the benidipine–β-blocker combination. PMID:26490089

  15. Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial.

    Science.gov (United States)

    Pettengell, Ruth; Sebban, Catherine; Zinzani, Pier Luigi; Derigs, Hans Gunter; Kravchenko, Sergey; Singer, Jack W; Theocharous, Panteli; Wang, Lixia; Pavlyuk, Mariya; Makhloufi, Kahina M; Coiffier, Bertrand

    2016-09-01

    This post hoc analysis of a phase 3 trial explored the effect of pixantrone in patients (50 pixantrone, 47 comparator) with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) confirmed by centralized histological review. Patients received 28-d cycles of 85 mg/m(2) pixantrone dimaleate (equivalent to 50 mg/m(2) in the approved formulation) on days 1, 8 and 15, or comparator. The population was subdivided according to previous rituximab use and whether they received the study treatment as 3rd or 4th line. Median number of cycles was 4 (range, 2-6) with pixantrone and 3 (2-6) with comparator. In 3rd or 4th line, pixantrone was associated with higher complete response (CR) (23·1% vs. 5·1% comparator, P = 0·047) and overall response rate (ORR, 43·6% vs. 12·8%, P = 0·005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 comparator), pixantrone produced better ORR (45·0% vs. 11·1%, P = 0·033), CR (30·0% vs. 5·6%, P = 0·093) and progression-free survival (median 5·4 vs. 2·8 months, hazard ratio 0·52, 95% confidence interval 0·26-1·04) than the comparator. Similar results were found in patients without previous rituximab. There were no unexpected safety issues. Pixantrone monotherapy is more effective than comparator in relapsed or refractory aggressive B-cell NHL in the 3rd or 4th line setting, independently of previous rituximab. © 2016 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

  16. A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment.

    Science.gov (United States)

    Woodruff, Seth; Feugère, Guillaume; Abreu, Paula; Heissler, Joseph; Ruiz, Marcia T; Jen, Frank

    2016-11-01

    Venous thromboembolism (VTE) is a common and serious complication in patients with cancer; treatment guidelines recommend extended therapy of ≥6 months with low-molecular-weight heparin (LMWH) for treatment and prevention of recurrent VTE (rVTE) in this population. This post hoc analysis used data from the CLOT study-a phase III, randomized, open-label, controlled study (N = 676)-to compare the efficacy and safety of dalteparin, a LMWH, versus vitamin K antagonist (VKA) for prevention of rVTE in patients with cancer and renal impairment (creatinine clearance renal impairment at baseline. Patients received subcutaneous dalteparin 200 IU/kg once daily during month 1, followed by 150 IU/kg once daily for months 2-6; or VKA once daily for 6 months, with initial overlapping subcutaneous dalteparin 200 IU/kg once daily for ≥5 days until international normalized ratio was 2.0-3.0 for 2 consecutive days. Endpoints included the rates of rVTE (primary) and bleeding events. Overall, fewer dalteparin-treated patients (2/74 [2.7 %]) experienced ≥1 adjudicated symptomatic rVTE compared with VKA-treated patients (15/88 [17.0 %]; hazard ratio = 0.15 [95 % confidence interval 0.03-0.65]; p = 0.01). Bleeding event rates for both treatments were similar (p = 0.47). In summary, compared with VKA, dalteparin significantly reduced risk of rVTE in patients with cancer and renal impairment (p = 0.01) while exhibiting a comparable safety profile. This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment.

  17. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson's Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE.

    Science.gov (United States)

    Cattaneo, Carlo; Sardina, Marco; Bonizzoni, Ermino

    2016-01-01

    Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson's disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson's symptoms. To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson's symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as "mild fluctuators" (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. Safinamide significantly increased mean ON time (with no or non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct therapy in levodopa-treated patients and patients with mild motor fluctuations. Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were favorably changed, compared with placebo, to similar extents regardless of whether patients were receiving concomitant dopamine agonists, catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide improved bradykinesia, rigidity, tremor and gait. Safinamide was a safe and effective first adjunct therapy in levodopa-treated patients and improved 4/5 cardinal symptoms of PD while

  18. Effectiveness of treat-to-target strategy for LDL-cholesterol control in type 2 diabetes: post-hoc analysis of data from the MIND.IT study.

    Science.gov (United States)

    Ardigò, Diego; Vaccaro, Olga; Cavalot, Franco; Rivellese, Albarosa Angela; Franzini, Laura; Miccoli, Roberto; Patti, Lidia; Boemi, Massimo; Trovati, Mariella; Zavaroni, Ivana

    2014-04-01

    The paper presents a post-hoc analysis of the intensity of dyslipidaemia care operated in the first 2 years of Multiple-Intervention-in-type-2-Diabetes.ITaly (MIND.IT) study. MIND.IT is a multicentric, randomized, two-parallel arm trial involving 1461 type 2 diabetic patients at high cardiovascular (CV) risk. The study compares the usual care (UC) of CV prevention with a multifactorial intensive care (IC) approach aiming at achieving target values for the main CV risk factors according to a step-wise treat-to-target approach. Proportion of patients on target for low-density lipoprotein cholesterol (LDL-C) was about 10% at baseline and increased significantly more with IC than UC (43 vs. 27%; p < 0.001). However, the majority (57%) of patients, in this intended intensively treated cohort, failed to achieve the proposed target. Average LDL-C decreased from 144 ± 35 to 108 ± 31 mg/dl with IC and from 142 ± 28 to 118 ± 32 with UC (p-for-interaction <0.0001). IC was associated with a significantly greater increase in statin prescription and lower withdrawal from treatment than UC (43 vs. 11% and 28 vs. 61%, respectively; both p < 0.001). However, the new treatments were characterized in both groups by the use of low starting doses (≤ 10 mg of atorvastatin, equivalent dose in more than 90% of patients) without increase in case of missed target. The application of a multifactorial treat-to-target intervention is associated with a significant improvement in LDL-C beyond usual practice. However, the change in LDL-C appears to be more related to an increased number of treated patients and a decreased treatment withdrawal than to a true treat-to-target approach.

  19. Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial.

    Science.gov (United States)

    Bergman, Peter; Norlin, Anna-Carin; Hansen, Susanne; Björkhem-Bergman, Linda

    2015-08-30

    Vitamin D is considered to be important for a healthy immune system. The aim of this study was to test the hypothesis that vitamin D supplementation reduces number of respiratory tract infections (RTIs) and prolong the time to the first RTI in adult patients with frequent RTIs. We performed a post hoc analysis of a randomized, placebo-controlled and double-blinded study, where adult patients with a high burden of RTIs were randomized to placebo or vitamin D (4000 IE/day for 1 year, n = 124 in the per protocol cohort presented here). Vitamin D supplementation increased the probability to stay free of RTI during the study year (RR 0.64, 95% CI 0.43-0.94). Further, the total number of RTIs was also reduced in the vitamin D-group (86 RTIs) versus placebo (120 RTIs; p = 0.05). Finally, the time to the first RTI was significantly extended in the vitamin D-group (HR 1.68, 95% CI 1.03-2.68, p = 0.0376). Vitamin D supplementation was found to significantly increase the probability of staying infection free during the study period. This finding further supports the notion that vitamin D-status should be monitored in adult patients with frequent RTIs and suggests that selected patients with vitamin D deficiency are supplemented. This could be a safe and cheap way to reduce RTIs and improve health in this vulnerable patient population. The original trial was registered at http://www.clinicaltrials.gov (NCT01131858).

  20. The impact of antidepressant treatments on family functioning in adults with major depressive disorder: a post hoc comparison of vortioxetine and agomelatine.

    Science.gov (United States)

    François, Clément; Nielsen, Rebecca; Danchenko, Natalya; Williams, Valerie; Lançon, Christophe

    2017-06-01

    There is limited research on the impact of antidepressant treatment on family functioning. This study examines the impact of vortioxetine and agomelatine on family functioning using the Depression and Family Functioning Scale (DFFS). The DFFS was included in REVIVE, a randomized, double-blind study of adults with major depressive disorder with inadequate response to antidepressant treatment who switched to vortioxetine or agomelatine. The prespecified DFFS analyses were performed using change from baseline to weeks 8 and 12, analyzed by mixed models for repeated measurements by treatment groups. Post hoc analyses compared DFFS scores for remitters and nonremitters. Patients were stratified into quartiles using DFFS scores, and scores on other clinical outcome assessments were compared. Sizeable improvements in DFFS scores were observed from baseline to week 8 (-10.8, -7.9 for vortioxetine and agomelatine, respectively), with further improvements at week 12 (-13.5, -11.0). Vortioxetine (n = 189) was superior to agomelatine (n = 187) by 2.9 DFFS points at week 8 (p vortioxetine for 8 of 15 DFFS items at week 8 and 7 items at week 12. At week 8, remitters (n = 142) and nonremitters (n = 233) differed by 11 DFFS points; at week 12, remitters (n = 183) and nonremitters (n = 121) differed by almost 12 DFFS points. Patients stratified into baseline DFFS quartiles showed trends on clinical outcomes such that better family functioning was associated with better functional status and depressive symptoms. Vortioxetine was significantly superior to agomelatine in terms of family functioning and partner relationships, as well as social functioning, health status, and depression symptoms at weeks 8 and 12. Depressed patients with impaired family functioning showed worse overall functioning, health status, and depression symptoms, suggesting that more attention should be given to family functioning of depressed patients.

  1. Delphi consensus on the diagnosis and management of dyslipidaemia in chronic kidney disease patients: A post hoc analysis of the DIANA study.

    Science.gov (United States)

    Cases Amenós, Aleix; Pedro-Botet Montoya, Juan; Pascual Fuster, Vicente; Barrios Alonso, Vivencio; Pintó Sala, Xavier; Ascaso Gimilio, Juan F; Millán Nuñez-Cortés, Jesús; Serrano Cumplido, Adalberto

    This post hoc study analysed the perception of the relevance of chronic kidney disease (CKD) in dyslipidaemia screening and the choice of statin among primary care physicians (PCPs) and other specialists through a Delphi questionnaire. The questionnaire included 4blocks of questions concerning dyslipidaemic patients with impaired carbohydrate metabolism. This study presents the results of the impact of CKD on screening and the choice of statin. Of the 497 experts included, 58% were PCPs and 42% were specialists (35, 7% were nephrologists). There was consensus by both PCPs and specialists, with no difference between PCPs and specialists, that CKD patients should undergo a dyslipidaemia screening and that the screening should be part of routine clinical practice. However, there was no consensus in considering the estimated glomerular filtration rate (eGFR) (although there was consensus among PCPs and nephrologists), or considering albuminuria when selecting a statin, or in determining albuminuria during follow-up after having initiated treatment with statins (although there was consensus among the nephrologists). The consensus to analyse the lipid profile in CKD patients suggests acknowledgment of the high cardiovascular risk of this condition. However, the lack of consensus in considering renal function or albuminuria, both when selecting a statin and during follow-up, suggests a limited knowledge of the differences between statins in relation to CKD. Thus, it would be advisable to develop a guideline/consensus document on the use of statins in CKD. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  2. Long-term effect on symptoms and quality of life of maintenance therapy with esomeprazole 20 mg daily: a post hoc analysis of the LOTUS trial.

    Science.gov (United States)

    Lundell, Lars; Hatlebakk, Jan; Galmiche, Jean-Paul; Attwood, Stephen E; Ell, Christian; Fiocca, Roberto; Persson, Tore; Nagy, Péter; Eklund, Stefan; Lind, Tore

    2015-01-01

    To assess the long-term effect on symptoms and quality of life of esomeprazole 20 mg once daily, a recommended dose for maintenance therapy of gastroesophageal reflux disease (GERD). This is a post hoc analysis of 5 year data from patients in the LOTUS trial (ClinicalTrials.gov identifier: NCT00251927) who were randomized to esomeprazole 20 mg once daily. All participants had chronic, symptomatic GERD responsive to treatment. Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments. Investigations included gastrointestinal endoscopy (with biopsy sampling), 24 hour esophageal pH monitoring and laboratory measurements. In total, 157 of 256 patients randomized to esomeprazole 20 mg once daily remained on this dose until the end of follow-up or study discontinuation, whereas 99 patients had their dose increased because of inadequate symptom control (of these, 29 subsequently returned to the allocated dose). On logistic regression, a long objectively defined GERD history, smoking, female sex, absence of Helicobacter pylori infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole 40 mg daily (all p esomeprazole 20 mg once daily, with no more than mild symptom severity, and mean (standard deviation) percentage time with intraesophageal pH Esomeprazole at a maintenance dose of 20 mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication, with durable symptom control and sustained reductions in intraesophageal acid exposure.

  3. Blood transfusion strategy and risk of postoperative delirium in nursing homes residents with hip fracture. A post hoc analysis based on the TRIFE randomized controlled trial.

    Science.gov (United States)

    Blandfort, Sif; Gregersen, Merete; Borris, Lars Carl; Damsgaard, Else Marie

    2017-06-01

    To investigate whether a liberal blood transfusion strategy [Hb levels ≥11.3 g/dL (7 mmol/L)] reduces the risk of postoperative delirium (POD) on day 10, among nursing home residents with hip fracture, compared to a restrictive transfusion strategy [Hb levels ≥9.7 g/dL (6 mmol/L)]. Furthermore, to investigate whether POD influences mortality within 90 days after hip surgery. This is a post hoc analysis based on The TRIFE - a randomized controlled trial. Frail anemic patients from the Orthopedic Surgical Ward at Aarhus University Hospital were enrolled consecutively between January 18, 2010 and June 6, 2013. These patients (aged ≥65 years) had been admitted from nursing homes for unilateral hip fracture surgery. After surgery, 179 patients were included in this study. On the first day of hospitalization, all enrolled patients were examined for cognitive impairment (assessed by MMSE) and delirium (assessed by CAM). Delirium was also assessed on the tenth postoperative day. The prevalence of delirium was 10 % in patients allocated to a liberal blood transfusion strategy (LB) and 21 % in the group with a restrictive blood transfusion strategy (RB). LB prevents development of delirium on day 10, compared to RB, odds ratio 0.41 (95 % CI 0.17-0.96), p = 0.04. Development of POD on day 10 increased the risk of 90-day death, hazard ratio 3.14 (95 % CI 1.72-5.78), p < 0.001. In nursing home residents undergoing surgery for hip fracture, maintaining hemoglobin level above 11.3 g/dL reduces the rate of POD on day 10 compared to a RB. Development of POD is associated with increased mortality.

  4. Clobazam is equally safe and efficacious for seizures associated with Lennox-Gastaut syndrome across different age groups: Post hoc analyses of short- and long-term clinical trial results.

    Science.gov (United States)

    Ng, Yu-Tze; Conry, Joan; Mitchell, Wendy G; Buchhalter, Jeffrey; Isojarvi, Jouko; Lee, Deborah; Drummond, Rebecca; Chung, Steve

    2015-05-01

    The peak age at onset of Lennox-Gastaut syndrome (LGS) is between 3 and 5years. Patients with LGS frequently experience multiple types of treatment-refractory seizures and require lifelong therapy with several antiepileptic drugs. Here, post hoc analyses of clinical trials (phase III trial OV-1012 and open-label extension trial OV-1004) provide short- and long-term efficacy and safety data of adjunctive clobazam in patients with LGS stratified by age at baseline (≥2 to post hoc analyses show that adjunctive clobazam over the short and longterm was similarly effective and well-tolerated in both pediatric and adult patients with LGS. Copyright © 2015. Published by Elsevier Inc.

  5. Predictors of pneumonia on routine chest radiographs in patients with COPD: a post hoc analysis of two 1-year randomized controlled trials.

    Science.gov (United States)

    Rubin, David B; Ahmad, Harris A; O'Neal, Michael; Bennett, Sophie; Lettis, Sally; Galkin, Dmitry V; Crim, Courtney

    2018-01-01

    Patients with COPD are at risk for life-threatening pneumonia. Although anatomical abnormalities in the thorax may predispose to pneumonia, those abnormalities identified on routine chest X-rays (CXRs) in patients with COPD have not been studied to better understand pneumonia risk. We conducted a post hoc exploratory analysis of data from two replicate year-long clinical trials assessing the impact of fluticasone furoate-vilanterol versus vilanterol alone on COPD exacerbations (GSK studies: HZC102871/NCT01009463 and HZC102970/NCT01017952). Abnormalities on baseline CXRs from 179 patients who developed pneumonia and 50 randomly selected patients who did not were identified by blinded consensus readings conducted by two radiologists. Positive and negative likelihood ratios and diagnostic odds ratios (ORs) were calculated to evaluate the markers for subsequent pneumonia development during the 1-year study period. Baseline characteristics distinguishing the pneumonia and non-pneumonia groups included a lower body mass index (24.9 vs 27.5 kg/m2, P=0.008), more severe airflow obstruction (mean post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity ratio: 42.3% vs 47.6%, P=0.003), and prior pneumonia (36% vs 20%, P=0.030). Baseline CXR findings with the highest diagnostic ORs were: elevated hemi-diaphragm (OR: 6.87; 95% CI: 0.90, 52.26), thick tracheal-esophageal stripe (OR: 4.39 [0.25, 78.22]), narrow cardiac silhouette (OR: 2.91 [0.85, 9.99]), calcified pleural plaque/mid-chest pleural thickening (OR: 2.82 [0.15, 53.76]), and large/prominent pulmonary artery shadow (OR: 1.94 [0.95, 3.97]). The presence of a narrow cardiac silhouette at baseline was associated with a statistically significant lower mean pre-bronchodilator FEV1 (P=0.040). There was also a trend for a lower mean pre-bronchodilator FEV1 in patients with a large/prominent pulmonary artery shadow at baseline (P=0.095). Findings on routine CXR that relate to pathophysiological

  6. Effect of Flibanserin Treatment on Body Weight in Premenopausal and Postmenopausal Women with Hypoactive Sexual Desire Disorder: A Post Hoc Analysis.

    Science.gov (United States)

    Kornstein, Susan G; Simon, James A; Apfel, Stuart C; Yuan, James; Barbour, Krista A; Kissling, Robert

    2017-08-17

    Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with HSDD. This analysis included three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg each bedtime (qhs) in premenopausal women, a similarly designed study in postmenopausal women, and a 52-week, open-label extension study in premenopausal women. In a pooled analysis of premenopausal women, mean baseline body mass index (BMI) was 27.0 kg/m(2) in the flibanserin group (n = 1227) and 26.8 kg/m(2) in the placebo group (n = 1238). Among patients who completed 24 weeks of treatment, least squares (LS) mean weight change was -1.4 kg in the flibanserin group (n = 1010) and -0.1 kg in the placebo group (n = 1066; p Weight loss ≥5% from baseline was reported in 21.0% of patients who received flibanserin and 7.8% of patients who received placebo; weight loss ≥10% was reported in 3.8% and 2.0% of patients, respectively. In postmenopausal women, mean baseline BMI was 27.7 kg/m(2) in the flibanserin group (n = 467) and 27.3 kg/m(2) in the placebo group (n = 480). LS mean weight change at week 24 was -1.8 kg in the flibanserin group (n = 385) and -0.1 kg in the placebo group (n = 425; p weight loss ≥5% reported in 24.7% and 7.3% of patients, respectively, and weight loss ≥10% reported in 5.2% and 1.7%, respectively. In HSDD patients with >12 months (n = 880) and >18 months (n = 637) of exposure to flibanserin, mean weight change was -1.0 and -1.2 kg, respectively; 25.4% and 26.9% of patients, respectively, experienced weight loss ≥5% from baseline, and 7.8% and 8.4%, respectively, experienced weight loss ≥10%. Women treated with flibanserin for HSDD may experience weight loss.

  7. Predictors of weight loss in young adults who are over-weight or obese and have psychosocial problems: a post hoc analysis.

    Science.gov (United States)

    Lous, Jørgen; Freund, Kirsten S

    2016-04-11

    The aim of this study is in a general practice trial setting to identify predictive factors for weight loss after 1 year among young adults who are over-weight or obese and who have several psychosocial problems. Twenty-eight general practitioners recruited 495 patients aged 20-45 years with psychosocial problems for a randomized general preventive study to increase self-efficacy to achieve a self-prioritised goal for a better life by discussions of resources and barriers for reaching the goal. The present study is a post hoc analysis of possible predictors of weight loss among all 218 patients who have over-weight or obesity. A 23-pages questionnaire was completed before and 1 year after randomization. 111 patients had a one-hour preventive health consultation with their general practitioners focused on life coaching and a follow-up consultation within 3 months, and 107 patients had no preventive consultation. Twenty-two patients stated during the preventive consultation that weight loss was a prioritised goal. They had a mean weight loss of 4.7 kgs compared with 1.6 kgs in the group without this goal and 1.6 kgs in the group without preventive consultation. In a logistic regression model, predictors of weight loss or no weight loss were a) pre-interventional consideration of weight loss within 30 days, b) having weight loss as a prioritised goal for improved quality of life, c) being female, d) being in the oldest half of participants, and e) having many psychosocial problems. In a linear regression model, the predictors together explained about 11% of the weight loss. Important predictors were: obesity (explained 4%), pre-interventional consideration of weight loss within 30 days (3%), and having a preventive health consultation with weight loss as a prioritised goal (2%). Pre-interventional consideration of weight loss within 30 days and having weight loss as a prioritised goal during the health consultation were two important predictors for weight loss. By

  8. Medication review in German community pharmacies - Post-hoc analysis of documented drug-related problems and subsequent interventions in the ATHINA-project.

    Science.gov (United States)

    Seidling, Hanna Marita; Send, Alexander Francesco Josef; Bittmann, Janina; Renner, Katja; Dewald, Bernd; Lange, Dörte; Bruckner, Thomas; Haefeli, Walter Emil

    2017-11-01

    Any medication can cause drug-related problems (DRPs), which can often be detected by medication reviews. So far, only limited information is available on the practicability of systematic medication reviews in community pharmacies in daily routine and their value in Germany. Since 2012, the community pharmacy-centered medication review project "ATHINA - Arzneimitteltherapiesicherheit in Apotheken [medication safety in community pharmacies]" is endorsed by four Chambers of Pharmacists in Germany. The aim of this evaluation was to post-hoc analyze the nature of medication reviews performed in ATHINA. For this analysis, information from anonymized, structured documentation sheets of medication reviews performed from 2012 to 2015 were analyzed. Documentation sheets contained demographic information of the patient, the patient's medication, and structured information on any information need or DRP identified for a specific drug, the pharmacists' actions taken with regard to the identified problem (e.g. contact with a physician), and whether the problem was ultimately resolved completely, partly, or not at all. Overall, 241 pharmacists documented 912 medication reviews with on average 10.8 ± 3.6 drugs. In 869 reviews (95.3%), the pharmacist documented at least one drug with information need or DRP. In 75.7% (N = 3972/5248) of the drugs with at least one information need or DRP, the pharmacists documented the action taken to solve the problem. At the end of the medication review, 359 (39.4%) of the cases had only drugs with resolved or no identified problems. Overall, the ratio of DRPs per drug regimen was reduced from 56% ± 22.7 drugs with at least one information need or DRP in the beginning to 28.9% ± 18.3 in the end. This analysis indicates that community pharmacists can deliberately identify patients with information needs and DRPs and solve many of these problems in the course of a medication review. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post hoc Analysesof Studies 016 and SETTLE

    Science.gov (United States)

    Cattaneo, Carlo; Sardina, Marco; Bonizzoni, Ermino

    2016-01-01

    Background: Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson’s disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson’s symptoms. Objective: To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson’s symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. Methods: Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as “mild fluctuators” (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. Results: Safinamide significantly increased mean ON time (with no or non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct therapy in levodopa-treated patients and patients with mild motor fluctuations. Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were favorably changed, compared with placebo, to similar extents regardless of whether patients were receiving concomitant dopamine agonists, catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide improved bradykinesia, rigidity, tremor and gait. Conclusions: Safinamide was a safe and effective first adjunct therapy in levodopa

  10. Permissive Underfeeding or Standard Enteral Feeding in High- and Low-Nutritional-Risk Critically Ill Adults. Post Hoc Analysis of the PermiT Trial.

    Science.gov (United States)

    Arabi, Yaseen M; Aldawood, Abdulaziz S; Al-Dorzi, Hasan M; Tamim, Hani M; Haddad, Samir H; Jones, Gwynne; McIntyre, Lauralyn; Solaiman, Othman; Sakkijha, Maram H; Sadat, Musharaf; Mundekkadan, Shihab; Kumar, Anand; Bagshaw, Sean M; Mehta, Sangeeta

    2017-03-01

    The optimal nutritional strategy for critically ill adults at high nutritional risk is unclear. To examine the effect of permissive underfeeding with full protein intake compared with standard feeding on 90-day mortality in patients with different baseline nutritional risk. This is a post hoc analysis of the PermiT (Permissive Underfeeding versus Target Enteral Feeding in Adult Critically Ill Patients) trial. Nutritional risk was categorized by the modified Nutrition Risk in Critically Ill score, with high nutritional risk defined as a score of 5-9 and low nutritional risk as a score of 0-4. Additional analyses were performed by categorizing patients by body mass index, prealbumin, transferrin, phosphate, urinary urea nitrogen, and nitrogen balance. Based on the Nutrition Risk in Critically Ill score, 378 of 894 (42.3%) patients were categorized as high nutritional risk and 516 of 894 (57.7%) as low nutritional risk. There was no association between feeding strategy and mortality in the two categories; adjusted odds ratio (aOR) of 0.84 (95% confidence interval [CI], 0.56-1.27) for high nutritional risk and 1.01 (95% CI, 0.64-1.61) for low nutritional risk (interaction P = 0.53). Findings were similar in analyses using other definitions, with the exception of prealbumin. The association of permissive underfeeding versus standard feeding and 90-day mortality differed when patients were categorized by baseline prealbumin level (≤0.10 g/L: aOR, 0.57 [95% CI, 0.31-1.05]; >0.10 and ≤0.15 g/L: aOR, 0.79 [95% CI, 0.42-1.48]; >0.15 g/L: aOR, 1.55 [95% CI, 0.80, 3.01]; interaction P = 0.009). Among patients with high and low nutritional risk, permissive underfeeding with full protein intake was associated with similar outcomes as standard feeding.

  11. A "post-psychological" curiosity of subjectivities and standards

    DEFF Research Database (Denmark)

    Nissen, Morten; Staunæs, Dorthe; Bank, Mads

    2016-01-01

    a division between standardizing sciences and off-standard qualitative research. Yet, a “postpsychological curiosity” suggests a reflexive stance, admitting to complicity in the “intra-actions” of standards and subjectivity, in theoretical psychology as in practices such as management, counseling, or self...

  12. Effect of ELOM-080 on exacerbations and symptoms in COPD patients with a chronic bronchitis phenotype - a post-hoc analysis of a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Beeh, Kai-Michael; Beier, Jutta; Candler, Henning; Wittig, Thomas

    2016-01-01

    Treating symptoms and preventing exacerbations are key components of chronic obstructive pulmonary disease (COPD) long-term management. Recently, a more tailored treatment approach has been proposed, in particular for two well-established clinical phenotypes, frequent exacerbators and chronic bronchitis-dominant COPD. ELOM-080 has demonstrated clinical efficacy in treating symptoms and preventing exacerbations in subjects with chronic bronchitis. However, little is known about the potential effects of ELOM-080 in COPD patients. To evaluate the effect on exacerbation, cough sputum, and general state of health of long-term treatment with ELOM-080 in COPD patients with an exacerbation history and chronic bronchitis. We performed a post-hoc analysis of a randomized, double-blinded, placebo-controlled parallel-group clinical trial of a 6-month treatment with ELOM-080 (3×300 mg) in patients with chronic bronchitis and concomitant COPD. The primary outcome was the proportion of subjects with at least one exacerbation over the 6-month study period. Secondary outcomes included the total number of exacerbations (ie, cumulative occurrence of exacerbations during the study period) and the proportion of acute exacerbations necessitating an antibiotic treatment, monthly evaluations of sputum and cough symptoms, and the general state of health and a safety analysis. Of 260 randomized subjects, 64 patients fulfilled the inclusion criteria for COPD (ELOM-080: 35, placebo: 29). Compared to placebo, ELOM-080 reduced the percentage of subjects with at least one exacerbation (29% versus 55%, P=0.031) and a reduction in the overall occurrence of exacerbations (ELOM-080: 10, placebo: 21, P=0.012) during the winter season. The percentage of asymptomatic or mildly symptomatic patients (sputum/expectoration and cough) was consistently higher in the ELOM-080 group compared to placebo, with statistical significant differences after 2 and 3 months of treatment (2 months: ELOM-080 25%, placebo

  13. Predictors of subjective health status 10 years post-PCI

    Directory of Open Access Journals (Sweden)

    Jan C. van den Berge

    2016-06-01

    Conclusions: SF-36 scores at baseline, age, and previous PCI were significant predictors of subjective health status 10 years post-PCI. Specifically, the SF-36 score at baseline was an important predictor. Thus assessment of subjective health status at baseline is useful as an indicator to predict long-term subjective health status. Subjective health status becomes better by optimal medical treatment, cardiac rehabilitation and psychosocial support. This is the first study determining predictors of subjective health status 10 years post-PCI.

  14. Differentiation chronic post traumatic stress disorder patients from healthy subjects using objective and subjective sleep-related parameters.

    Science.gov (United States)

    Tahmasian, Masoud; Jamalabadi, Hamidreza; Abedini, Mina; Ghadami, Mohammad R; Sepehry, Amir A; Knight, David C; Khazaie, Habibolah

    2017-05-22

    Sleep disturbance is common in chronic post-traumatic stress disorder (PTSD). However, prior work has demonstrated that there are inconsistencies between subjective and objective assessments of sleep disturbance in PTSD. Therefore, we investigated whether subjective or objective sleep assessment has greater clinical utility to differentiate PTSD patients from healthy subjects. Further, we evaluated whether the combination of subjective and objective methods improves the accuracy of classification into patient versus healthy groups, which has important diagnostic implications. We recruited 32 chronic war-induced PTSD patients and 32 age- and gender-matched healthy subjects to participate in this study. Subjective (i.e. from three self-reported sleep questionnaires) and objective sleep-related data (i.e. from actigraphy scores) were collected from each participant. Subjective, objective, and combined (subjective and objective) sleep data were then analyzed using support vector machine classification. The classification accuracy, sensitivity, and specificity for subjective variables were 89.2%, 89.3%, and 89%, respectively. The classification accuracy, sensitivity, and specificity for objective variables were 65%, 62.3%, and 67.8%, respectively. The classification accuracy, sensitivity, and specificity for the aggregate variables (combination of subjective and objective variables) were 91.6%, 93.0%, and 90.3%, respectively. Our findings indicate that classification accuracy using subjective measurements is superior to objective measurements and the combination of both assessments appears to improve the classification accuracy for differentiating PTSD patients from healthy individuals. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Nursing home placement in the Donepezil and Memantine in Moderate to Severe Alzheimer's Disease (DOMINO-AD) trial: secondary and post-hoc analyses.

    Science.gov (United States)

    Howard, Robert; McShane, Rupert; Lindesay, James; Ritchie, Craig; Baldwin, Ashley; Barber, Robert; Burns, Alistair; Dening, Tom; Findlay, David; Holmes, Clive; Jones, Robert; Jones, Roy; McKeith, Ian; Macharouthu, Ajay; O'Brien, John; Sheehan, Bart; Juszczak, Edmund; Katona, Cornelius; Hills, Robert; Knapp, Martin; Ballard, Clive; Brown, Richard G; Banerjee, Sube; Adams, Jessica; Johnson, Tony; Bentham, Peter; Phillips, Patrick P J

    2015-12-01

    Findings from observational studies have suggested a delay in nursing home placement with dementia drug treatment, but findings from a previous randomised trial of patients with mild-to-moderate Alzheimer's disease showed no effect. We investigated the effects of continuation or discontinuation of donepezil and starting of memantine on subsequent nursing home placement in patients with moderate-to-severe Alzheimer's disease. In the randomised, double-blind, placebo-controlled Donepezil and Memantine in Moderate to Severe Alzheimer's Disease (DOMINO-AD) trial, community-living patients with moderate-to-severe Alzheimer's disease (who had been prescribed donepezil continuously for at least 3 months at a dose of 10 mg for at least the previous 6 weeks and had a score of between 5 and 13 on the Standardised Mini-Mental State Examination) were recruited from 15 secondary care memory centres in England and Scotland and randomly allocated to continue donepezil 10 mg per day without memantine, discontinue donepezil without memantine, discontinue donepezil and start memantine 20 mg per day, or continue donepezil 10 mg per day and start memantine 20 mg per day, for 52 weeks. After 52 weeks, choice of treatment was left to participants and their physicians. Place of residence was recorded during the first 52 weeks of the trial and then every 26 weeks for a further 3 years. A secondary outcome of the trial, reported in this study, was nursing home placement: an irreversible move from independent accommodation to a residential caring facility. Analyses restricted to risk of placement in the first year of follow-up after the patients had completed the double-blind phase of the trial were post-hoc. The DOMINO-AD trial is registered with the ISRCTN Registry, number ISRCTN49545035. Between Feb 11, 2008, and March 5, 2010, 73 (25%) patients were randomly assigned to continue donepezil without memantine, 73 (25%) to discontinue donepezil without memantine, 76 (26%) to discontinue

  16. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study.

    Science.gov (United States)

    Hager, Klaus; Baseman, Alan S; Nye, Jeffrey S; Brashear, H Robert; Han, John; Sano, Mary; Davis, Bonnie; Richards, Henry M

    2016-11-15

    A large, prospective, 2-year, randomized study in patients with mild-to-moderate Alzheimer's disease or mixed dementia demonstrated reductions in mortality and cognitive/functional decline in galantamine-treated patients. A post-hoc analysis was conducted to study the effect of (the presence or absence of) concomitant memantine use on treatment outcome. Randomized patients (N = 2045) were divided into subgroups based on memantine use. Analyses included demographic and clinical characteristics (age, nursing home placement, Mini-Mental State Examination (MMSE) and Disability Assessment for Dementia (DAD) scores) and mortality endpoints. Overall, 496 (24.3 %) patients were memantine users and were older (mean (SD), 74.0 (8.76) vs 72.8 (8.76), p = 0.008), with lower MMSE scores (18.2 (4.16) vs 19.2 (4.02), p post-hoc analysis shows that the beneficial effects of galantamine at 2 years post treatment were not observed in patients who had been placed on background memantine. The reasons for memantine treatment and the possibility of interaction between memantine and galantamine merit further investigation. ClinicalTrials.gov NCT00679627 . Registered 15 May 2008.

  17. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis

    DEFF Research Database (Denmark)

    Giovannoni, Gavin; Cook, Stuart; Rammohan, Kottil

    2011-01-01

    On the basis of various clinical and MRI measurements, the phase 3 Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) study in patients with relapsing-remitting multiple sclerosis (RRMS) showed that short-course oral treatment with cladribine at cumulative doses of 3·5 and 5·25 mg....../kg over 96 weeks was more effective than placebo. Achieving sustained freedom from disease activity is becoming a viable treatment goal in RRMS; we therefore aimed to assess the effects of cladribine on this composite outcome measure by doing a post-hoc analysis of data from the CLARITY study....

  18. Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.

    Science.gov (United States)

    Garland, Suzanne M; Paavonen, Jorma; Jaisamrarn, Unnop; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Castellsagué, Xavier; Teixeira, Júlio C; Skinner, S Rachel; Hedrick, James; Limson, Genara; Schwarz, Tino F; Poppe, Willy A J; Bosch, F Xavier; de Carvalho, Newton S; Germar, Maria Julieta V; Peters, Klaus; Del Rosario-Raymundo, M Rowena; Catteau, Grégory; Descamps, Dominique; Struyf, Frank; Lehtinen, Matti; Dubin, Gary

    2016-12-15

    We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+. © 2016 UICC.

  19. Re/Writing the Subject: A Contribution to Post-Structuralist Theory in Mathematics Education

    Science.gov (United States)

    Roth, Wolff-Michael

    2012-01-01

    This text, occasioned by a critical reading of "Mathematics Education and Subjectivity" (Brown, "2011") and constituting a response to the book, aims at contributing to the building of (post-structuralist) theory in mathematics education. Its purpose was to re/write two major positions that "Mathematics Education and Subjectivity" articulates:…

  20. Using the Theory of Planned Behaviour to Understand Students' Subject Choices in Post-Compulsory Education

    Science.gov (United States)

    Taylor, Rachel Charlotte

    2015-01-01

    In recent years, there have been concerns in the UK regarding the uptake of particular subjects in post-compulsory education. Whilst entries for Advanced level (A-level) subjects such as media studies have experienced considerable growth, entries for A-level physics have, until recently, been declining, prompting fears of a skills crisis in future…

  1. Mobile ad hoc networking

    CERN Document Server

    John Wiley & Sons

    2004-01-01

    "Assimilating the most up-to-date information on research and development activities in this rapidly growing area, Mobile Ad Hoc Networking covers physical, data link, network, and transport layers, as well as application, security, simulation, and power management issues in sensor, local area, personal, and mobile ad hoc networks. Each of the book's sixteen chapters has been written by a top expert and discusses in-depth the most important topics in the field. Mobile Ad Hoc Networking is an excellent reference and guide for professionals seeking an in-depth examination of topics that also provides a comprehensive overview of the current state-of-the-art."--Jacket.

  2. Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates.

    Science.gov (United States)

    Wagner, C L; Baggerly, C; McDonnell, S; Baggerly, K A; French, C B; Baggerly, L; Hamilton, S A; Hollis, B W

    2016-01-01

    Two vitamin D pregnancy supplementation trials were recently undertaken in South Carolina: The NICHD (n=346) and Thrasher Research Fund (TRF, n=163) studies. The findings suggest increased dosages of supplemental vitamin D were associated with improved health outcomes of both mother and newborn, including risk of preterm birth (Post-hoc analysis of the relationship between 25(OH)D concentration and preterm birth rates in the NICHD and TRF studies with comparison to Charleston County, South Carolina March of Dimes (CC-MOD) published rates of preterm birth to assess potential risk reduction in the community. Using the combined cohort datasets (n=509), preterm birth rates both for the overall population and for the subpopulations achieving 25(OH)D concentrations of ≤20 ng/mL, >20 to post-hoc analysis, achieving a 25(OH)D serum concentration ≥40 ng/mL significantly decreased the risk of preterm birth compared to ≤20 ng/mL. These findings suggest the importance of raising 25(OH)D levels substantially above 20 ng/mL; reaching 40 ng/mL during pregnancy would reduce the risk of preterm birth and achieve the maximal production of the active hormone. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. A 6-year open-label study of the efficacy and safety of olanzapine long-acting injection in patients with schizophrenia: a post hoc analysis based on the European label recommendation.

    Science.gov (United States)

    Anand, Ernie; Berggren, Lovisa; Deix, Claudia; Tóth, Ágoston; McDonnell, David P

    2015-01-01

    To assess the long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of schizophrenia, focusing on clinical trial data consistent with the approved indication and dosing recommendations in the European label and which forms the basis for treatment decisions made by clinicians in daily clinical practice. This was a post hoc analysis of a 6-year open-label study of olanzapine LAI in patients (male or female, 18-75 years old) with schizophrenia entering this study following feeder studies of olanzapine LAI. Patients were flexibly dosed (45-405 mg, 2- to 4-week intervals), but those receiving oral olanzapine supplementation whose total olanzapine dose was >20 mg/day equivalent were excluded from this post hoc analysis. Data from 669 patients were analyzed (44.5% completed). Positive and Negative Syndrome Scale total scores did not change significantly from baseline to endpoint; Clinical Global Impression-Severity scores improved significantly. Mean weight change was +2.19 kg (Ppost-injection delirium/sedation syndrome (PDSS). Olanzapine LAI appeared to be effective in the long-term maintenance of schizophrenia, and the safety profile was consistent with that of oral olanzapine, except for injection-related events and PDSS events.

  4. Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

    Science.gov (United States)

    Kimura, Go; Ueda, Takeshi

    2017-03-01

    A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

  5. Effect of ELOM-080 on exacerbations and symptoms in COPD patients with a chronic bronchitis phenotype – a post-hoc analysis of a randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Beeh KM

    2016-11-01

    Full Text Available Kai-Michael Beeh,1 Jutta Beier,1 Henning Candler,2 Thomas Wittig2 1Insaf Respiratory Research Institute, Wiesbaden, Germany; 2G. Pohl-Boskamp GmbH & Co KG, Hohenlockstedt, Germany Background: Treating symptoms and preventing exacerbations are key components of chronic obstructive pulmonary disease (COPD long-term management. Recently, a more tailored treatment approach has been proposed, in particular for two well-established clinical phenotypes, frequent exacerbators and chronic bronchitis-dominant COPD. ELOM-080 has demonstrated clinical efficacy in treating symptoms and preventing exacerbations in subjects with chronic bronchitis. However, little is known about the potential effects of ELOM-080 in COPD patients. Aim: To evaluate the effect on exacerbation, cough sputum, and general state of health of long-term treatment with ELOM-080 in COPD patients with an exacerbation history and chronic bronchitis. Methods: We performed a post-hoc analysis of a randomized, double-blinded, placebo-controlled parallel-group clinical trial of a 6-month treatment with ELOM-080 (3×300 mg in patients with chronic bronchitis and concomitant COPD. The primary outcome was the proportion of subjects with at least one exacerbation over the 6-month study period. Secondary outcomes included the total number of exacerbations (ie, cumulative occurrence of exacerbations during the study period and the proportion of acute exacerbations necessitating an antibiotic treatment, monthly evaluations of sputum and cough symptoms, and the general state of health and a safety analysis. Results: Of 260 randomized subjects, 64 patients fulfilled the inclusion criteria for COPD (ELOM-080: 35, placebo: 29. Compared to placebo, ELOM-080 reduced the percentage of subjects with at least one exacerbation (29% versus 55%, P=0.031 and a reduction in the overall occurrence of exacerbations (ELOM-080: 10, placebo: 21, P=0.012 during the winter season. The percentage of asymptomatic or

  6. The Ex hoc Architecture

    DEFF Research Database (Denmark)

    2006-01-01

    Developed in the LIWAS project which develops technology for measuring road surfaces and communicating this data in an ad hoc environment. The communication part is built upon OOVM Resilient technology....

  7. EFFICACY OF POST ISOMETRIC RELAXATION VERSUS STATIC STRECHING IN SUBJECTS WITH CHRONIC NON SPECIFIC NECK PAIN

    OpenAIRE

    P Haritha; Shanthi, C; Madhavi, K.

    2015-01-01

    Background: Neck pain is a common problem within our society. Upper trapezius sternocleidomastoid and the levator scapulae are the most common postural muscles that tends to get shorten leading to restricted neck mobility. There is lack of evidence to allow conclusions to be drawn about the effectiveness of post isometric relaxation when compared with static stretching exercises. The aim is to find out the effectiveness of Post isometric relaxation Versus Static stretching in the subjects wit...

  8. The impact of subjective birth experiences on post-traumatic stress symptoms: a longitudinal study.

    Science.gov (United States)

    Garthus-Niegel, Susan; von Soest, Tilmann; Vollrath, Margarete E; Eberhard-Gran, Malin

    2013-02-01

    The aim of this prospective study was to examine the etiology of post-traumatic stress symptoms following childbirth within a transactional framework of stress. Participants were women (N = 1,499) from the Akershus Birth Cohort. These women were followed from pregnancy to 8 weeks postpartum. We modeled predisposing factors (e.g., fear of childbirth) and precipitating factors (subjective and objective birth experiences) as predictors of post-traumatic stress symptoms. Post-traumatic stress symptoms were measured by means of the Impact of Event Scale, objective birth experiences by means of birth journals, and subjective birth experiences by means of three questions. A structural equation model showed that subjective birth experiences had the highest association with post-traumatic stress symptoms. Moreover, they mediated the effect of predisposing factors and objective birth experiences. The results suggest that women's subjective birth experiences are the most important factor in the development of post-traumatic stress symptoms following childbirth.

  9. Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302.

    Science.gov (United States)

    Saad, Fred; Shore, Neal; Van Poppel, Hendrik; Rathkopf, Dana E; Smith, Matthew R; de Bono, Johann S; Logothetis, Christopher J; de Souza, Paul; Fizazi, Karim; Mulders, Peter F A; Mainwaring, Paul; Hainsworth, John D; Beer, Tomasz M; North, Scott; Fradet, Yves; Griffin, Thomas A; De Porre, Peter; Londhe, Anil; Kheoh, Thian; Small, Eric J; Scher, Howard I; Molina, Arturo; Ryan, Charles J

    2015-10-01

    Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy. Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients. This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial. Patients were grouped by concomitant BTT use or no BTT use. Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models. While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p=0.01) and increased the time to ECOG deterioration (HR 0.75; pAA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT. Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and

  10. Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study.

    Science.gov (United States)

    Inagaki, Nobuya; Goda, Maki; Yokota, Shoko; Maruyama, Nobuko; Iijima, Hiroaki

    2015-01-01

    The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown. We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose. Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

  11. Clinical response to eliglustat in treatment-naïve patients with Gaucher disease type 1: Post-hoc comparison to imiglucerase-treated patients enrolled in the International Collaborative Gaucher Group Gaucher Registry

    Directory of Open Access Journals (Sweden)

    Jennifer Ibrahim

    2016-09-01

    Full Text Available Eliglustat is a recently approved oral therapy in the United States and Europe for adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers (>90% of patients that has been shown to decrease spleen and liver volume and increase hemoglobin concentrations and platelet counts in untreated adults with Gaucher disease type 1 and maintain these parameters in patients previously stabilized on enzyme replacement therapy. In a post-hoc analysis, we compared the results of eliglustat treatment in treatment-naïve patients in two clinical studies with the results of imiglucerase treatment among a cohort of treatment-naïve patients with comparable baseline hematologic and visceral parameters in the International Collaborative Gaucher Group Gaucher Registry. Organ volumes and hematologic parameters improved from baseline in both treatment groups, with a time course and degree of improvement in eliglustat-treated patients similar to imiglucerase-treated patients.

  12. A post hoc comparison of the effects of lisdexamfetamine dimesylate and osmotic-release oral system methylphenidate on symptoms of attention-deficit hyperactivity disorder in children and adolescents.

    Science.gov (United States)

    Soutullo, César; Banaschewski, Tobias; Lecendreux, Michel; Johnson, Mats; Zuddas, Alessandro; Anderson, Colleen; Civil, Richard; Higgins, Nicholas; Bloomfield, Ralph; Squires, Liza A; Coghill, David R

    2013-09-01

    There are limited head-to-head data comparing the efficacy of long-acting amfetamine- and methylphenidate-based psychostimulants as treatments for individuals with attention-deficit hyperactivity disorder (ADHD). This post hoc analysis provides the first parallel-group comparison of the effect of lisdexamfetamine dimesylate (lisdexamfetamine) and osmotic-release oral system methylphenidate (OROS-MPH) on symptoms of ADHD in children and adolescents. This was a post hoc analysis of a randomized, double-blind, parallel-group, dose-optimized, placebo-controlled, phase III study. The phase III study was carried out in 48 centres across ten European countries. The phase III study enrolled children and adolescents (aged 6-17 years) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for a primary diagnosis of ADHD and who had a baseline ADHD Rating Scale IV (ADHD-RS-IV) total score of 28 or higher. Eligible patients were randomized (1:1:1) to receive a once-daily, optimized dose of lisdexamfetamine (30, 50 or 70 mg/day), placebo or OROS-MPH (18, 36 or 54 mg/day) for 7 weeks. In this post hoc analysis, efficacy was assessed using the ADHD-RS-IV and Clinical Global Impressions-Improvement (CGI-I) scale. Responders were defined as those achieving at least a 30% reduction from baseline in ADHD-RS-IV total score and a CGI-I score of 1 (very much improved) or 2 (much improved). The proportion of patients achieving an ADHD-RS-IV total score less than or equal to the mean for their age (based on normative data) was also determined. Endpoint was the last on-treatment visit with a valid assessment. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. Of the 336 patients randomized, 332 were included in the safety population, 317 were included in the full analysis set and 196 completed the study. The mean (standard deviation) ADHD-RS-IV total score at baseline was 40.7 (7.31) for lisdexamfetamine, 41

  13. Dynamic ad hoc networks

    CERN Document Server

    Rashvand, Habib

    2013-01-01

    Motivated by the exciting new application paradigm of using amalgamated technologies of the Internet and wireless, the next generation communication networks (also called 'ubiquitous', 'complex' and 'unstructured' networking) are changing the way we develop and apply our future systems and services at home and on local, national and global scales. Whatever the interconnection - a WiMAX enabled networked mobile vehicle, MEMS or nanotechnology enabled distributed sensor systems, Vehicular Ad hoc Networking (VANET) or Mobile Ad hoc Networking (MANET) - all can be classified under new networking s

  14. Psychological factors are associated with subjective cognitive complaints 2 months post-stroke

    NARCIS (Netherlands)

    Nijsse, Britta; van Heugten, Caroline M.; van Mierlo, Marloes|info:eu-repo/dai/nl/345480856; Post, Marcel W M|info:eu-repo/dai/nl/137146426; de Kort, Paul L M; Visser-Meily, Anne|info:eu-repo/dai/nl/180428047

    2017-01-01

    The aim of this study was to investigate which psychological factors are related to post-stroke subjective cognitive complaints, taking into account the influence of demographic and stroke-related characteristics, cognitive deficits and emotional problems. In this cross-sectional study, 350 patients

  15. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Takahashi, Fumihiro; Takei, Koji; Tsuda, Kikumi; Palumbo, Joseph

    2017-10-01

    In the 24-week double-blind study of edaravone in ALS (MCI186-16), edaravone did not show a statistically significant difference versus placebo for the primary efficacy endpoint. For post-hoc analyses, two subpopulations were identified in which edaravone might be expected to show efficacy: the efficacy-expected subpopulation (EESP), defined by scores of ≥2 points on all 12 items of the ALS Functional Rating Scale-Revised (ALSFRS-R) and a percent predicted forced vital capacity (%FVC) ≥80% at baseline; and the definite/probable EESP 2 years (dpEESP2y) subpopulation which, in addition to EESP criteria, had definite or probable ALS diagnosed by El Escorial revised criteria, and disease duration of ≤2 years. In the 36-week extension study of MCI186-16, a 24-week double-blind comparison followed by 12 weeks of open-label edaravone (MCI186-17; NCT00424463), analyses of ALSFRS-R scores of the edaravone-edaravone group and edaravone-placebo group for the full analysis set (FAS) and EESP, as prospectively defined, were reported in a previous article. Here we additionally report results in patients who met dpEESP2y criteria at the baseline of MCI186-16. In the dpEESP2y, the difference in ALSFRS-R changes from 24 to 48 weeks between the edaravone-edaravone and edaravone-placebo groups was 2.79 (p = 0.0719), which was greater than the differences previously reported for the EESP and the FAS. The pattern of adverse events in the dpEESP2y did not show any additional safety findings to those from the earlier prospective study. In conclusion, this post-hoc analysis suggests a potential effect of edaravone between 24 and 48 weeks in patients meeting dpEESP2y criteria at baseline.

  16. Clinical Outcomes from Androgen Signaling-directed Therapy after Treatment with Abiraterone Acetate and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302.

    Science.gov (United States)

    Smith, Matthew R; Saad, Fred; Rathkopf, Dana E; Mulders, Peter F A; de Bono, Johann S; Small, Eric J; Shore, Neal D; Fizazi, Karim; Kheoh, Thian; Li, Jinhui; De Porre, Peter; Todd, Mary B; Yu, Margaret K; Ryan, Charles J

    2017-07-01

    In the COU-AA-302 trial, abiraterone acetate plus prednisone significantly increased overall survival for patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Limited information exists regarding response to subsequent androgen signaling-directed therapies following abiraterone acetate plus prednisone in patients with mCRPC. We investigated clinical outcomes associated with subsequent abiraterone acetate plus prednisone (55 patients) and enzalutamide (33 patients) in a post hoc analysis of COU-AA-302. Prostate-specific antigen (PSA) response was assessed. Median time to PSA progression was estimated using the Kaplan-Meier method. The PSA response rate (≥50% PSA decline, unconfirmed) was 44% and 67%, respectively. The median time to PSA progression was 3.9 mo (range 2.6-not estimable) for subsequent abiraterone acetate plus prednisone and 2.8 mo (range 1.8-not estimable) for subsequent enzalutamide. The majority of patients (68%) received intervening chemotherapy before subsequent abiraterone acetate plus prednisone or enzalutamide. While acknowledging the limitations of post hoc analyses and high censoring (>75%) in both treatment groups, these results suggest that subsequent therapy with abiraterone acetate plus prednisone or enzalutamide for patients who progressed on abiraterone acetate is associated with limited clinical benefit. This analysis showed limited clinical benefit for subsequent abiraterone acetate plus prednisone or enzalutamide in patients with metastatic castration-resistant prostate cancer following initial treatment with abiraterone acetate plus prednisone. This analysis does not support prioritization of subsequent abiraterone acetate plus prednisone or enzalutamide following initial therapy with abiraterone acetate plus prednisone. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  17. Remission and recovery associated with lurasidone in the treatment of major depressive disorder with subthreshold hypomanic symptoms (mixed features): post-hoc analysis of a randomized, placebo-controlled study with longer-term extension.

    Science.gov (United States)

    Goldberg, Joseph F; Ng-Mak, Daisy; Siu, Cynthia; Chuang, Chien-Chia; Rajagopalan, Krithika; Loebel, Antony

    2017-04-01

    This post-hoc analysis assessed rates of symptomatic and functional remission, as well as recovery (combination of symptomatic and functional remission), in patients treated with lurasidone for major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features). Patients with MDD plus two or three manic symptoms (defined as per the DSM-5 mixed-features specifier) were randomly assigned to flexible-dose lurasidone 20-60 mg/day (n=109) or placebo (n=100) for 6 weeks, followed by a 3-month open-label, flexible-dose extension study for U.S. sites only (n=48). Cross-sectional recovery was defined as the presence of both symptomatic remission (Montgomery-Åsberg Depression Rating Scale score ≤ 12) and functional remission (all Sheehan Disability Scale [SDS] domain scores ≤3) at week 6, and at both months 1 and 3 of the extension study ("sustained recovery"). A significantly higher proportion of lurasidone-treated patients (31.3%) achieved recovery (assessed cross-sectionally) compared to placebo (12.2%, p=0.002) at week 6. The number of manic symptoms at baseline moderated the effect size for attaining cross-sectional recovery for lurasidone treatment (vs. placebo) (p=0.028). Sustained recovery rates were higher in patients initially treated with lurasidone (20.8%) versus placebo (12.5%). In this post-hoc analysis of a placebo-controlled study with open-label extension that involved patients with MDD and mixed features, lurasidone was found to significantly improve the rate of recovery at 6 weeks (vs. placebo) that was sustained at month 3 of the extension study. The presence of two (as opposed to three) manic symptoms moderated recovery at the acute study endpoint.

  18. Targeting weight loss interventions to reduce cardiovascular complications of type 2 diabetes: a machine learning-based post-hoc analysis of heterogeneous treatment effects in the Look AHEAD trial.

    Science.gov (United States)

    Baum, Aaron; Scarpa, Joseph; Bruzelius, Emilie; Tamler, Ronald; Basu, Sanjay; Faghmous, James

    2017-10-01

    The Action for Health in Diabetes (Look AHEAD) trial investigated whether long-term cardiovascular disease morbidity and mortality could be reduced through a weight loss intervention among people with type 2 diabetes. Despite finding no significant reduction in cardiovascular events on average, it is possible that some subpopulations might have derived benefit. In this post-hoc analysis, we test the hypothesis that the overall neutral average treatment effect in the trial masked important heterogeneous treatment effects (HTEs) from intensive weight loss interventions. We used causal forest modelling, which identifies HTEs, using a random half of the trial data (the training set). We applied Cox proportional hazards models to test the potential HTEs on the remaining half of the data (the testing set). The analysis was deemed exempt from review by the Columbia University Institutional Review Board, Protocol ID# AAAO3003. Between Aug 22, 2001, and April 30, 2004, 5145 patients with type 2 diabetes were enrolled in the Look AHEAD randomised controlled trial, of whom 4901 were included in the The National Institute of Diabetes and Digestive and Kidney Diseases Repository and included in our analyses: 2450 for model development and 2451 in the testing dataset. Baseline HbA1c and self-reported general health distinguished participants who differentially benefited from the intervention. Cox models for the primary composite cardiovascular outcome revealed a number needed to treat of 28·9 to prevent 1 event over 9·6 years among participants with HbA1c 6·8% or higher, or both HbA1c less than 6·8% and Short Form Health Survey (SF-36) general health score of 48 or more (2101 [86%] of 2451 participants in the testing dataset; 167 [16%] of 1046 primary outcome events for intervention vs 205 [19%] of 1055 for control, absolute risk reduction of 3·46%, 95% CI 0·21-6·73%, p=0·038) By contrast, participants with HbA1c less than 6·8% and baseline SF-36 general health score of

  19. Recombinant tissue-type plasminogen activator plus eptifibatide versus recombinant tissue-type plasminogen activator alone in acute ischemic stroke: propensity score-matched post hoc analysis.

    Science.gov (United States)

    Adeoye, Opeolu; Sucharew, Heidi; Khoury, Jane; Tomsick, Thomas; Khatri, Pooja; Palesch, Yuko; Schmit, Pamela A; Pancioli, Arthur M; Broderick, Joseph P

    2015-02-01

    The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER) trial demonstrated safety of recombinant tissue-type plasminogen activator (r-tPA) plus eptifibatide in acute ischemic stroke (AIS). CLEAR-ER randomized AIS patients (5:1) to 0.6 mg/kg r-tPA plus eptifibatide versus standard r-tPA (0.9 mg/kg). Interventional Management of Stroke III randomized AIS patients to r-tPA plus endovascular therapy versus standard r-tPA. Albumin in Acute Stroke Part 2 randomized patients to albumin±r-tPA versus saline±r-tPA. Our aim was to compare outcomes in CLEAR-ER combination arm patients to propensity score-matched r-tPA only subjects in Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III. The primary outcome was 90-day severity-adjusted modified Rankin score (mRS) dichotomization based on baseline National Institutes of Health Stroke Scale. Secondary outcomes were 90-day mRS dichotomization as excellent (mRS, 0-1); mRS dichotomization as favorable (mRS, 0-2); and nonparametric analysis of the ordinal mRS. Eighty-five combination arm CLEAR-ER subjects were matched with 169 Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III trials' r-tPA only patients (controls). Median age in CLEAR-ER and control subjects was 68years; median National Institutes of Health Stroke Scale in the CLEAR-ER subjects was 11 and in control subjects 12. At 90 days, CLEAR-ER subjects had a nonsignificantly greater proportion of patients with favorable outcomes (45% versus 36%; unadjusted relative risks, 1.24; 95% confidence intervals, 0.91-1.69; P=0.18). Secondary outcomes were 52% versus 34% excellent outcomes (relative risks, 1.51; 95% confidence intervals, 1.13-2.02; P=0.007); 60% versus 53% favorable outcome (relative risks, 1.13; 95% confidence intervals, 0.90-1.41; P=0.31); and ordinal Cochran-Mantel-Haenszel P=0.10. r-tPA plus eptifibatide showed a favorable direction of effect that was

  20. rt-PA plus Eptifibatide versus rt-PA Alone in Acute Ischemic Stroke: A Propensity Score Matched Post Hoc Analysis

    Science.gov (United States)

    Adeoye, Opeolu; Sucharew, Heidi; Khoury, Jane; Tomsick, Thomas; Khatri, Pooja; Palesch, Yuko; Schmit, Pamela A.; Pancioli, Arthur M.; Broderick, Joseph P.

    2014-01-01

    Background and Purpose The CLEAR-ER trial demonstrated safety of rt-PA plus eptifibatide in acute ischemic stroke (AIS). CLEAR-ER randomized AIS patients (5:1) to 0.6mg/kg rt-PA plus eptifibatide versus standard rt-PA (0.9mg/kg). IMS III randomized AIS patients to rt-PA plus endovascular therapy versus standard rt-PA. ALIAS Part 2 randomized patients to albumin ± rt-PA versus saline ± rt-PA. Our aim was to compare outcomes in CLEAR-ER combination arm patients to propensity score matched rt-PA only subjects in ALIAS Part 2 and IMS III. Methods The primary outcome was 90-day severity-adjusted mRS dichotomization based on baseline NIHSS. Secondary outcomes were 90-day mRS dichotomization as “excellent” (mRS 0–1); mRS dichotomization as “favorable” (mRS 0–2); and nonparametric analysis of the ordinal mRS. Results Eighty five combination arm CLEAR-ER subjects were matched with 169 ALIAS Part 2 and IMS III trials’ rt-PA only patients (controls). Median age in CLEAR-ER and control subjects was 68years; median NIHSS in the CLEAR-ER subjects was 11 and in control subjects 12. At 90 days, CLEAR-ER subjects had a non-significantly greater proportion of patients with favorable outcomes (45% vs 36%, unadjusted RR 1.24, 95% CI 0.91–1.69, p=0.18). Secondary outcomes were 52% vs 34% excellent outcomes (RR 1.51, 1.13–2.02, p=0.007); 60% vs 53% favorable outcome (RR 1.13, 0.90–1.41, p=0.31); and ordinal Cochran-Mantel-Haenszel p=0.10. Conclusion rt-PA plus eptifibatide showed a favorable direction of effect that was consistent across multiple approaches for AIS outcome evaluation. A phase III trial to establish the efficacy of rt-PA plus eptifibatide for improving AIS outcomes is warranted. PMID:25523054

  1. Safety and Efficacy of Bipolar Versus Monopolar Transurethral Resection of the Prostate in Patients with Large Prostates or Severe Lower Urinary Tract Symptoms: Post Hoc Analysis of a European Multicenter Randomized Controlled Trial.

    Science.gov (United States)

    Skolarikos, A; Rassweiler, J; de la Rosette, J J; Alivizatos, G; Scoffone, C; Scarpa, R M; Schulze, M; Mamoulakis, C

    2016-03-01

    We compare bipolar vs monopolar transurethral prostate resection safety/secondary outcomes including efficacy in patients with large prostate volume or severe lower urinary tract symptoms. From July 2006 to June 2009 candidates for transurethral prostate resection were recruited at 4 centers, randomized 1:1 into monopolar/bipolar transurethral prostate resection arms and followed up to 36 months. Post hoc data analysis from patients with large prostate volume or severe lower urinary tract symptoms is presented. Patients with large prostate volume or severe lower urinary tract symptoms were defined as those with transrectal ultrasound based prostate volume greater than 80 ml or International Prostate Symptom Score greater than 19. Safety was estimated using sodium/hemoglobin changes immediately after surgery, complications during the early postoperative period (up to 6 weeks), and short-term (up to 12 months) and midterm (up to 36 months) followup. Secondary outcomes included, among others, efficacy quantified by changes in maximum urine flow rate, post-void residual urine volume and International Prostate Symptom Score compared with baseline. A total of 279 patients were randomized. Post hoc analysis of data from patients with a large prostate volume or severe lower urinary tract symptoms was based on analysis A-in 62 of 279 participants (22.3%) (monopolar transurethral prostate resection 32, bipolar transurethral prostate resection 30) or analysis B-in 126 of 279 participants (45.2%) (monopolar transurethral prostate resection 57, bipolar transurethral prostate resection 69). Mean (SD) prostate volume was 108.0 (25.9) ml for monopolar transurethral prostate resection and 108.9 (23.4) ml for bipolar transurethral prostate resection (p=0.756). Mean International Prostate Symptom Score was 25.0 (4.2) for monopolar transurethral prostate resection and 25.3 (3.7) for bipolar transurethral prostate resection (p=0.402). Neither safety nor any secondary outcome differed

  2. Flourishing in people with depressive symptomatology increases with Acceptance and Commitment Therapy. Post-hoc analyses of a randomized controlled trial.

    Science.gov (United States)

    Bohlmeijer, Ernst T; Lamers, Sanne M A; Fledderus, Martine

    2015-02-01

    Mental health is more than the absence of mental illness. Rather, both well-being (positive mental health) and mental illness are actually two related continua, with higher levels of well-being defined as "flourishing." This two-continua model and existing studies about the impact of flourishing on psychopathology underscore the need for interventions that enhance flourishing and well-being. Acceptance and Commitment Therapy (ACT) is a model of cognitive behavioral therapy that aims not only to reduce psychopathology but also to promote flourishing as well. This is the first study to evaluate the impact of ACT on flourishing. A post-analysis was conducted on an earlier randomized controlled trial of a sample of adults with depressive symptomatology who participated in a guided self-help ACT intervention. This post-analysis showed a 5%-28% increase of flourishing by the participants. In addition, the effects on flourishing were maintained at the three-month follow-up. When compared to participants in a control group, the flourishing of the ACT-trained participants increased from 5% to about 14% after nine weeks. In addition to levels of positive mental health at baseline, an increase of psychological flexibility during the intervention was a significant predictor of flourishing at the three-month follow-up. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Psychologization, constituent power and autonomy: Rethinking subjectivity construction in post-modernity

    Directory of Open Access Journals (Sweden)

    Víctor Jorquera Fariñas

    2007-11-01

    Full Text Available According to influential  theories of identity in post-modernity,  as community bonds loosen, individuals  have increasing discretion in the construction of their own identity.  In this article we argue for seeing modernization as the progressive psychologization of subjectivity. That reveals the mechanisms of what we can call, following Foucault, "constituent power": a power that turns the psychological subject's conflicts  away from external objects and towards an inner world. It is that inner conflict that promotes the modern preoccupation with identity.

  4. Psychologization, constituent power and autonomy: Rethinking subjectivity construction in post-modernity

    Directory of Open Access Journals (Sweden)

    Jorquera Fariñas, Víctor

    2007-11-01

    Full Text Available According to influential theories of identity in post-modernity, as community bonds loosen, individuals have increasing discretion in the construction of their own identity. In this article we argue for seeing modernization as the progressive psychologization of subjectivity. That reveals the mechanisms of what we can call, following Foucault, "constituent power": a power that turns the psychological subject's conflicts away from external objects and towards an inner world. It is that inner conflict that promotes the modern preoccupation with identity.

  5. A Strategy of Underexpansion and Ad Hoc Post-Dilation of Balloon-Expandable Transcatheter Aortic Valves in Patients at Risk of Annular Injury: Favorable Mid-Term Outcomes.

    Science.gov (United States)

    Tan, John S; Leipsic, Jonathon; Perlman, Gidon; Stub, Dion; Dvir, Danny; Hansson, Nicolaj C; Norgaard, Bjarne L; Blanke, Philipp; Cheung, Anson; Ye, Jian; Thompson, Christopher R; Moss, Robert R; Lauck, Sandra; Wood, David; Webb, John

    2015-11-01

    The aim of this study was to evaluate a strategy of intentional underexpansion of excessively oversized balloon-expandable transcatheter heart valves (THVs) in terms of clinical outcomes, valve function, and frame durability at 1 year. Transcatheter aortic valve replacement requires the selection of an optimally sized THV to ensure paravalvular sealing and fixation without risking annular injury. However, some patients have "borderline" annular dimensions that require choosing between a THV that may be too small or another that may be too large. We evaluated 47 patients at risk of annular injury who underwent transcatheter aortic valve replacement (TAVR) with an oversized, but deliberately underexpanded, THV followed by post-dilation if required. Clinical evaluation, echocardiography, and cardiac computed tomography were performed pre-TAVR, post-TAVR, and at 1 year. Deployment of oversized THVs with modest underfilling of the deployment balloon (post-dilation required in 10.7%. THV hemodynamic function was excellent and remained stable at 1 year. Computed tomography documented stent frame circularity in 87.5%. Underexpansion was greatest within the intra-annular THV inflow (stent frame area 85.8% of nominal). There was no evidence of stent frame recoil, deformation, or fracture at 1 year. In carefully selected patients with borderline annulus dimensions and in whom excessive oversizing of a balloon-expandable SAPIEN XT valve (Edwards Lifesciences, Inc., Irvine, California) is a concern, a strategy of deliberate underexpansion, with ad hoc post-dilation, if necessary, may reduce the risk of annular injury without compromising valve performance. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. [Efficacy of modified auriculotherapy for post-operative pain control in patients subjected to laparoscopic cholecystectomy].

    Science.gov (United States)

    Toca-Villegas, Jiovanni; Esmer-Sánchez, David; García-Narváez, Jesús; Sánchez-Aguilar, Martín; Hernández-Sierra, Juan Francisco

    The high frequency of post-operative pain in the patients after laparoscopic cholecystectomy has led to the need to use multiple analgesic therapies. These include auriculotherapy, although not very good results have been obtained with the traditional techniques. To evaluate the effectiveness of modified auriculotherapy for post-operative pain control in laparoscopic cholecystectomy patients. Double-blind controlled clinical trial. Experimental group: Different points ear puncture with xylocaine without needles vs. placebo group. Post-operative visual analogue scale (VAS) at 6, 12, 18, 24, 36, and 48h and rescue doses of analgesics, were measured in both groups. At 6h post-operative, 87% of the auriculotherapy group had a VAS of<4 vs. 48% of placebo group (p = 0.004), and 96 vs. 74% (p = 0.008) at 18hours. At 24, 36 and 48h after surgery there were no differences, and as all of the patients in both groups had a VAS<4, they were discharged to the hospital. Modified auriculotherapy was better to the conventional analgesics for post-operative pain control in patients subjected to laparoscopic cholecystectomy. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  7. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels : a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144)

    NARCIS (Netherlands)

    Nolen, Willem A.; Weisler, Richard H.

    Nolen WA, Weisler RH. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels: a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144). Bipolar Disord 2012:

  8. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Bharmal Murtuza

    2011-04-01

    Full Text Available Abstract Background Because of the subjective nature of Restless Legs Syndrome (RLS symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ, to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540. At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I, Profile of Mood States (POMS, Medical Outcomes Study Scale-Sleep (MOS-Sleep, and RLS-Quality of Life (RLSQoL. Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each. Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352.

  9. Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial.

    Science.gov (United States)

    van de Ven, J; Fransen, A F; Schuit, E; van Runnard Heimel, P J; Mol, B W; Oei, S G

    2017-09-01

    Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial. J van de Ven, AF Fransen, E Schuit, PJ van Runnard Heimel, BW Mol, SG Oei OBJECTIVE: To investigate whether the effect of a one-day simulation-based obstetric team training on patient outcome changes over time. Post-hoc analysis of a multicentre, open, randomised controlled trial that evaluated team training in obstetrics (TOSTI study).We studied women with a singleton pregnancy beyond 24 weeks of gestation in 24 obstetric units. Included obstetric units were randomised to either a one-day, multi-professional simulation-based team training focusing on crew resource management in a medical simulation centre (12 units) or to no team training (12 units). We assessed whether outcomes differed between both groups in each of the first four quarters following the team training and compared the effect of team training over quarters. Primary outcome was a composite outcome of low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischemic encephalopathy. During a one year period after the team training the rate of obstetric complications, both on the composite level and the individual component level, did not differ between any of the quarters. For trauma due to shoulder dystocia team training led to a significant decrease in the first quarter (0.06% versus 0.26%, OR 0.19, 95% CI 0.03 to 0.98) but in the subsequent quarters no significant reductions were observed. Similar results were found for invasive treatment for severe postpartum haemorrhage where a significant increase was only seen in the first quarter (0.4% versus 0.03%, OR 19, 95% CI 2.5-147), and not thereafter. The beneficial effect of a one-day, simulation-based, multiprofessional, obstetric team training seems to decline after three months. If team training is further evaluated or

  10. Efficacy and safety of teriparatide in bisphosphonate-pretreated and treatment-naive patients with osteoporosis at high risk of fracture: Post hoc analysis of a prospective observational study.

    Science.gov (United States)

    Yoshiki, Fumito; Nishikawa, Atsushi; Taketsuna, Masanori; Kajimoto, Kenta; Enomoto, Hiroyuki

    2017-03-01

    Teriparatide is the first anabolic agent shown to reduce the risk of fractures in patients with osteoporosis. In Japan, teriparatide is prescribed to treat patients at high risk of fracture. Given that bisphosphonates are commonly used prior to teriparatide as treatment for osteoporosis, information on the effectiveness and safety of teriparatide with or without previous bisphosphonate treatment is helpful for physicians in clinical practice. This study aims to report the effectiveness and safety of teriparatide in treatment-naive and bisphosphonate-pretreated patients in Japan as real-world evidence. A post hoc analysis of a postmarketing surveillance study was conducted in Japanese patients with osteoporosis at high risk of fracture who received 24-month treatment of daily teriparatide. Changes in bone turnover biomarkers and bone mineral density and incidence of new fractures were analyzed in treatment-naive as well as bisphosphonate-pretreated patients. The analysis included 1433 patients (treatment-naive, n = 659; bisphosphonate-pretreated, n = 774). Bone mineral density increased significantly from baseline at 24 months in both treatment-naive (lumbar spine, 13.45%; femoral neck, 5.16%; total hip, 4.46%) and bisphosphonate-pretreated (lumbar spine, 11.20%; femoral neck, 2.22%; total hip, 0.67%) patients. The incidence rates of new vertebral and nonvertebral fractures at 24 months were 1.69% and 3.37%, respectively, in treatment-naive patients and 3.60% and 5.56%, respectively, in bisphosphonate-pretreated patients. The incidence of adverse drug reactions was 6% in treatment-naive patients and 10% in bisphosphonate-pretreated patients. The most common adverse drug reaction in treatment-naive and bisphosphonate-pretreated patients was nausea (0.91%) and hyperuricaemia (1.81%), respectively. In this post hoc analysis, no new safety concerns and similar effectiveness of teriparatide were observed in Japanese patients with osteoporosis at high risk of fracture

  11. Translating Clinical Findings into the Patient's Perspective: Post-hoc Pooled Analysis of Bowel Movement Changes as a Predictor of Improvement in Patients' Opioid-induced Constipation Symptoms and Outcomes.

    Science.gov (United States)

    Coyne, Karin S; Poon, Jiat-Ling; Thompson, Christine; Hu, Yiqun; Datto, Catherine J; Sostek, Mark

    2017-01-01

    Opioid-induced constipation (OIC) is a bothersome side effect of opioid use for the management of noncancer pain, affecting patients' health-related quality of life and chronic-pain management. The objective of this study was to examine the relationship between changes in the frequency of spontaneous bowel movements (SBMs) and changes in patient-reported outcomes (PROs) among patients with OIC treated with naloxegol. Post hoc analyses were conducted using pooled data from two Phase III 12-week, placebo-controlled trials of naloxegol for the treatment of OIC (NCT01309841 and NCT01323790). Patients completed the Patient Assessment of Constipation-Quality of Life (PAC-QOL) and PAC-Symptoms (PAC-SYM) at each study visit, and the Straining Scale and Bristol Stool Scale (BSS) with each bowel movement for the study duration. Four subgroups were created based on improvements from baseline in mean frequency of SBMs per week: 0 or worse (no change), +1 SBM, +2 SBMs, and +≥3 SBMs. Spearman correlations assessed the association between mean SBM changes from baseline and mean changes from baseline in PROs; analysis of covariance was used to compare changes from baseline. A total of 1337 patients with mean (SD) age of 52.2 (11.0) years were included in this analysis. The patient population was predominantly white (79.0%) and female (62.4%). At baseline, mean SBM frequency was 1.4 (1.0) per week. At study end, all 4 SBM-change subgroups experienced improvements in PAC-QOL, PAC-SYM, Straining Scale, and BSS scores, and these changes were significantly correlated with mean changes from baseline in SBMs per week. The subgroup of patients with an increase in SBMs of ≥3 per week experienced the greatest improvements in PROs. In these patients with OIC, an improvement in the frequency of SBMs by ≥3 per week was associated with consistent improvements in PROs, providing support for the use of improvements in SBMs as a clinical outcome surrogate for managing patients with OIC

  12. Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial.

    Science.gov (United States)

    Applebee, Angela; Goodman, Andrew D; Mayadev, Angeli S; Bethoux, Francois; Goldman, Myla D; Klingler, Michael; Blight, Andrew R; Carrazana, Enrique J

    2015-12-01

    Dalfampridine extended-release (ER) tablets 10 mg BID have been approved for use in improving walking in people with multiple sclerosis (MS). This subgroup analysis evaluated the effects of dalfampridine ER 5 and 10 mg BID on distance walked, as assessed using the 6-minute walk (6MW) test. This analysis of data from a randomized, placebo-controlled, double-blind study (N = 430) included only the 153 patients with 6MW data available. Participants (aged 18-70 years) were randomly assigned in a 1:1:1 ratio to receive dalfampridine ER 5 or 10 mg or placebo, BID for 4 weeks. The 6MW was used for assessing walking distance at baseline and 2 weeks after the start of treatment at the 26 study sites that were able to perform this test. Participants were administered the 12-item MS Walking Scale (MSWS-12), a patient-reported measure of the impact of MS on walking. Post hoc outcomes included the percentages of patients who achieved an increase from baseline in 6MW distance of ≥20% and who achieved a minimal clinically important difference (MCID) from baseline in 6MW distance, defined as ≥+55 m. Changes from baseline in walking speed (MSWS-12) were compared, stratified by subgroup that achieved ≥20% versus walking speed over time and subgroup (by change in distance walked) was evaluated. The tolerability of dalfampridine was assessed based on the prevalence of treatment-emergent adverse events (TEAEs). In the post hoc analysis, the percentage of patients with an improvement in 6MW distance that met or exceeded the MCID was significantly greater with dalfampridine ER 10 mg BID relative to placebo (37.3% vs 12.2%; nominal P = 0.004). Similarly, the percentage with an improvement in 6MW distance of ≥20% was significantly greater with dalfampridine 10 mg BID relative to placebo (45.1% vs 14.3%; nominal P walking relative to placebo. The correlation between improvement on MSWS-12 and the 20% increase in 6MW distance suggests that an improvement on MSWS-12 is clinically

  13. EFFICACY OF POST ISOMETRIC RELAXATION VERSUS STATIC STRECHING IN SUBJECTS WITH CHRONIC NON SPECIFIC NECK PAIN

    Directory of Open Access Journals (Sweden)

    P.Haritha

    2015-12-01

    Full Text Available Background: Neck pain is a common problem within our society. Upper trapezius sternocleidomastoid and the levator scapulae are the most common postural muscles that tends to get shorten leading to restricted neck mobility. There is lack of evidence to allow conclusions to be drawn about the effectiveness of post isometric relaxation when compared with static stretching exercises. The aim is to find out the effectiveness of Post isometric relaxation Versus Static stretching in the subjects with chronic nonspecific neck pain. To evaluate the effectiveness of post isometric relaxation technique on pain by using Visual analoge scale, range of motion by using Universal Goniometry, and functional disability by using Neck Disability Index in chronic nonspecific neck pain. Methods: A convenient sample of thirty seven subjects was diagnosed with nonspecific neck pain was randomly allocated to one of the two treatment groups on the basis of the inclusion criteria. The experimental group (n=15 received three sessions of post isometric relaxation technique for trapezius, sternocleidomastoid and the levator scapulae and control group (n=15 received the three sessions of static stretching for trapezius, sternocliedomastiod and levator scapulae for four weeks. Results: Non parametric tests demonstrated a statistically significant difference with experimental group showing greater improvement in ROM, VAS, and NDI than the control group and significant difference within the group also. Conclusion: This study concluded and the results reflected that post isometric relaxation technique group had better improvement in reduction of pain, improvement in the range of motion, and increased neck functional activities than the static stretching group.

  14. Effect of catechol-O-methyltransferase-val158met-polymorphism on the automatization of motor skills - a post hoc view on an experimental data.

    Science.gov (United States)

    Krause, Daniel; Beck, Frieder; Agethen, Manfred; Blischke, Klaus

    2014-06-01

    The purpose of this study was to evaluate if the catechol-O-methyltransferase-val158met (COMT)-polymorphism, which is known to affect prefrontal dopaminergic metabolism, affects the automatization of motor skills. Twenty-two participants volunteered for gene analysis after they had participated in experiments in which they practiced a single-joint arm movement sequence 460-760 times under different feedback conditions. Motor automaticity was assessed in a pre-test and a post-test according to the dual-task paradigm, which incorporated a visuo-spatial secondary task. To account for the different practice conditions in the four original studies, dual-task cost reduction was assessed using single case effect sizes proportioned to the respective group mean. For the secondary task but not for the prioritized motor task, these relative single case effect sizes proved to be positively (and significantly) correlated with the number of met-alleles on the COMT-genotype, rs=.553; p=.004. Thus, the number of met-alleles indicated a tendency toward enhanced motor automatization. Thus, due to an increased prefrontal dopamine level, met-carriers may be able to develop a well formed and stable, spatially coded movement representation early in practice, thereby supporting the formation of a representation in motor coordinates in the course of extended practice, which later enables automatic movement execution. This process might also be enhanced by a prevalence of met-carriers to functionally evaluate positive feedback information (i.e., rewards) and to better maintain recent reward information in active working memory. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Chen Lei

    2011-12-01

    Full Text Available Background To fully assess the various dimensions affected by schizophrenia, clinical trials often include multiple scales measuring various symptom profiles, cognition, quality of life, subjective well-being, and functional impairment. In this exploratory study, we characterized the relationships among six clinical, functional, cognitive, and quality-of-life measures, identifying a parsimonious set of measurements. Methods We used baseline data from a randomized, multicenter study of patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder who were experiencing an acute symptom exacerbation (n = 628 to examine the relationship among several outcome measures. These measures included the Positive and Negative Syndrome Scale (PANSS, Montgomery-Asberg Depression Rating Scale (MADRS, Brief Assessment of Cognition in Schizophrenia Symbol Coding Test, Subjective Well-being Under Neuroleptics Scale Short Form (SWN-K, Schizophrenia Objective Functioning Instrument (SOFI, and Quality of Life Scale (QLS. Three analytic approaches were used: 1 path analysis; 2 factor analysis; and 3 categorical latent variable analysis. In the optimal path model, the SWN-K was selected as the final outcome, while the SOFI mediated the effect of the exogenous variables (PANSS, MADRS on the QLS. Results The overall model explained 47% of variance in QLS and 17% of the variance in SOFI, but only 15% in SWN-K. Factor analysis suggested four factors: "Functioning," "Daily Living," "Depression," and "Psychopathology." A strong positive correlation was observed between the SOFI and QLS (r = 0.669, and both the QLS and SOFI loaded on the "Functioning" factor, suggesting redundancy between these scales. The measurement profiles from the categorical latent variable analysis showed significant variation in functioning and quality of life despite similar levels of psychopathology. Conclusions Researchers should consider collecting PANSS, SOFI, and

  16. The Aesthetic Post-Communist Subject and the Differend of Rosia Montana

    Directory of Open Access Journals (Sweden)

    Irina Velicu

    2012-11-01

    Full Text Available By challenging the state and corporate prerogatives to distinguish between “good” and “bad” development, social movements by and in support of inhabitants of Rosia Montana (Transylvania are subverting prevailing perceptions about Central and Eastern Europe (CEE’s liberal path of development illustrating its injustice in several ways that will be detailed in this article under the heading “inhibitions of political economy” or Balkanism. The significance of the “Save Rosia Montana” movement for post-communism is that it invites post-communist subjects to reflect and revise their perception about issues such as communism, capitalism and development and to raise questions of global significance about the fragile edifice of justice within the neo-liberal capitalist economy. However, resistance to injustice (and implicitly affirmations of other senses of justice is an ambiguous discursive practice through which Rosieni make sense as well as partake their sense of Rosia Montana. The movement brings about a public dispute which may be compared with a differend: (in Lyotard’s words, a conflict that cannot be confined to the rules of “cognitive phrases,” of truth and falsehood. This article argues that while post-communist events of “subjectification” are unstable and thus, are to be viewed aesthetically, this same ambiguous multiplication of political subjectivity may facilitate the creation of social spaces for imagining alternative possibilities of development.

  17. Comparison of micronized tretinoin gel 0.05% and tretinoin gel microsphere 0.1% in young adolescents with acne: a post hoc analysis of efficacy and tolerability data.

    Science.gov (United States)

    Lucky, Anne W; Sugarman, Jeffrey

    2011-06-01

    Acne vulgaris is common in young adolescents. Retinoids are widely used but may be associated with poor tolerability. This post hoc analysis of 483 participants aged 10 to 14 years with mild to moderate acne compared efficacy and tolerability of once-daily treatment with micronized tretinoin gel 0.05%, tretinoin gel microsphere 0.1%, and vehicle over 12 weeks. In study 1, inflammatory and noninflammatory lesion reduction and treatment success was comparable between tretinoin gel 0.05% and tretinoin gel microsphere 0.1%. Inflammatory (46.3%) and noninflammatory (45.7%) lesion reductions with tretinoin gel 0.05% were significantly greater than vehicle (37.1% and 27.9%, respectively) (both Ptretinoin gel 0.05% (30.6%, 39.1%, and 19%, respectively) were significantly greater than vehicle (10.9%, 16.9% [both PTretinoin gel 0.05% was significantly better tolerated than tretinoin gel microsphere 0.1% (Ptretinoin gel 0.05% compared with 32%, 11%, 23%, and 23%, respectively, with tretinoin gel microsphere 0.1% (all Pacne in young adolescents aged 10 to 14 years, micronized tretinoin gel 0.05% provided a comparable lesion reduction and treatment success versus tretinoin gel microsphere 0.1%, with a better cutaneous tolerability profile.

  18. Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth.

    Science.gov (United States)

    Dimopoulos, Meletios A; Lonial, Sagar; White, Darrell; Moreau, Philippe; Palumbo, Antonio; San-Miguel, Jesus; Shpilberg, Ofer; Anderson, Kenneth; Grosicki, Sebastian; Spicka, Ivan; Walter-Croneck, Adam; Magen, Hila; Mateos, Maria-Victoria; Belch, Andrew; Reece, Donna; Beksac, Meral; Bleickardt, Eric; Poulart, Valerie; Sheng, Jennifer; Sy, Oumar; Katz, Jessica; Singhal, Anil; Richardson, Paul

    2017-09-01

    The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity. © 2017 John Wiley & Sons Ltd.

  19. Effect of aripiprazole 2 to 15 mg/d on health-related quality of life in the treatment of irritability associated with autistic disorder in children: a post hoc analysis of two controlled trials.

    Science.gov (United States)

    Varni, James W; Handen, Benjamin L; Corey-Lisle, Patricia K; Guo, Zhenchao; Manos, George; Ammerman, Diane K; Marcus, Ronald N; Owen, Randall; McQuade, Robert D; Carson, William H; Mathew, Suja; Mankoski, Raymond

    2012-04-01

    There are limited published data on the impact of treatment on the health-related quality of life (HRQOL) in individuals with autistic disorder. The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder. This post hoc analysis assessed data from two 8-week, double-blind, randomized, placebo-controlled studies that compared the efficacy of aripiprazole (fixed-dose study, 5, 10, and 15 mg/d; flexible-dose study, 2-15 mg/d) with placebo in the treatment of irritability associated with autistic disorder. HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory (PedsQL™) scales. Clinically relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 standard error of measurement. In total, 316 patients were randomly assigned to receive treatment with aripiprazole (fixed-dose study, 166; flexible-dose study, 47) or placebo (fixed-dose study, 52; flexible-dose study, 51). Aripiprazole was associated with significantly greater improvement than placebo in PedsQL combined-scales total score (difference, 7.8; 95% CI, 3.8-11.8; P autistic disorder. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

  20. Omega-3 fatty acid supplementation in adolescents with borderline personality disorder and ultra-high risk criteria for psychosis: a post hoc subgroup analysis of a double-blind, randomized controlled trial.

    Science.gov (United States)

    Amminger, G Paul; Chanen, Andrew M; Ohmann, Susanne; Klier, Claudia M; Mossaheb, Nilufar; Bechdolf, Andreas; Nelson, Barnaby; Thompson, Andrew; McGorry, Patrick D; Yung, Alison R; Schäfer, Miriam R

    2013-07-01

    To investigate whether long-chain omega-3 (n-3) polyunsaturated fatty acids (PUFAs) improve functioning and psychiatric symptoms in young people with borderline personality disorder (BPD) who also meet ultra-high risk criteria for psychosis. We conducted a post hoc subgroup analysis of a double-blind, randomized controlled trial. Fifteen adolescents with BPD (mean age 16.2 years, [SD 2.1]) were randomized to either 1.2 g/day n-3 PUFAs or placebo. The intervention period was 12 weeks. Study measures included the Positive and Negative Syndrome Scale, the Montgomery-Åsberg Depression Rating Scale, and the Global Assessment of Functioning. Side effects were documented with the Udvalg for Kliniske Undersøgelser. Fatty acids in erythrocytes were analyzed using capillary gas chromatography. At baseline, erythrocyte n-3 PUFA levels correlated positively with psychosocial functioning and negatively with psychopathology. By the end of the intervention, n-3 PUFAs significantly improved functioning and reduced psychiatric symptoms, compared with placebo. Side effects did not differ between the treatment groups. Long-chain n-3 PUFAs should be further explored as a viable treatment strategy with minimal associated risk in young people with BPD. ( NCT00396643).

  1. Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials.

    Science.gov (United States)

    Refaai, Majed A; Kothari, Truptesh H; Straub, Shana; Falcon, Jacob; Sarode, Ravi; Goldstein, Joshua N; Brainsky, Andres; Omert, Laurel; Lee, Martin L; Milling, Truman J

    2017-01-01

    To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on "time to procedure" in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. Analysis included 42 patients (plasma, n = 20; 4F-PCC, n = 22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; P < 0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; P < 0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; P = 0.037). In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.

  2. Physicians Experience with and Expectations of the Safety and Tolerability of WHO-Step III Opioids for Chronic (Low Back Pain: Post Hoc Analysis of Data from a German Cross-Sectional Physician Survey

    Directory of Open Access Journals (Sweden)

    Michael A. Ueberall

    2015-01-01

    Full Text Available Objective. To describe physicians’ daily life experience with WHO-step III opioids in the treatment of chronic (low back pain (CLBP. Methods. Post hoc analysis of data from a cross-sectional online survey with 4.283 Germany physicians. Results. With a reported median use in 17% of affected patients, WHO-step III opioids play a minor role in treatment of CLBP in daily practice associated with a broad spectrum of positive and negative effects. If prescribed, potent opioids were reported to show clinically relevant effects (such as ≥50% pain relief in approximately 3 of 4 patients (median 72%. Analgesic effects reported are frequently related with adverse events (AEs. Only 20% of patients were reported to remain free of any AE. Most frequently reported AE was constipation (50%, also graded highest for AE-related daily life restrictions (median 46%. Specific AE countermeasures were reported to be necessary in approximately half of patients (median 45%; nevertheless AE-related premature discontinuation rates reported were high (median 22%. Fentanyl/morphine were the most/least prevalently prescribed potent opioids mentioned (median 20 versus 8%. Conclusion. Overall, use of WHO-step III opioids for CLBP is low. AEs, especially constipation, are commonly reported and interfere significantly with analgesic effects in daily practice. Nevertheless, beneficial effects outweigh related AEs in most patients with CLBP.

  3. Establishment of two forensic medicine OSCE stations on the subject of external post-mortem examination.

    Science.gov (United States)

    Heide, S; Lessig, R; Hachmann, V; Stiller, D; Rönsch, M; Stoevesandt, D; Biolik, A; Watzke, S; Kellner, J

    2018-01-01

    An improvement in quality of medical external post-mortem examinations among others can be achieved by more intensive training of medical students. Modern learning and teaching methods such as e-learning modules and SkillsLab stations should be used for this. The introduction of corresponding methods of assessment such as the OSCE procedure is necessary to test the success of learning. In Halle (Germany), two OSCE stations on the subject of external post-mortem examinations were introduced in 2016. The 'practical external post-mortem examination' station test skills and abilities students have learned during practical external post-mortem examination in small group classes on a simulation doll. At the 'death certificate' station, an original death certificate must be filled in, testing the knowledge, skills and abilities learned in the SkillsLab station and during e-learning. A total of 148 students took part in the test. At both stations, at least two thirds of the students (69.5 and 81.7%) were able to show good or very good test results. In addition to the strengths, a detailed evaluation of the test results showed that there were still deficits in terms of the corresponding courses (e.g. inspection of the neck region in the small group classes), which will have to be remedied in the future. When analysing the test concept and the test implementation, objectivity was nearly perfect. There was a satisfactory internal consistency and stability over 8 months. Ultimately, in addition to several strengths (such as good understanding and transparency of the checklists) the evaluation of the examiners also showed further potential areas for improvement (e.g. harmonisation of the degree of difficulty for the individual rotations) when designing the OSCE stations. Overall, it was possible to determine that the OSCE testing format is a suitable tool to test external post-mortem examination skills and that conclusions about improvements in teaching can also be drawn from

  4. Portable and Reconfigurable Wrist Robot Improves Hand Function for Post-Stroke Subjects.

    Science.gov (United States)

    Khor, Kang Xiang; Chin, Patrick Jun Hua; Yeong, Che Fai; Su, Eileen Lee Ming; Narayanan, Aqilah Leela T; Abdul Rahman, Hisyam; Khan, Qamer Iqbal

    2017-10-01

    Rehabilitation robots have become increasingly popular for stroke rehabilitation. However, the high cost of robots hampers their implementation on a large scale. This paper implements the concept of a modular and reconfigurable robot, reducing its cost and size by adopting different therapeutic end effectors for different training movements using a single robot. The challenge is to increase the robot's portability and identify appropriate kinds of modular tools and configurations. Because literature on the effectiveness of this kind of rehabilitation robot is still scarce, this paper presents the design of a portable and reconfigurable rehabilitation robot and describes its use with a group of post-stroke patients for wrist and forearm training. Seven stroke subjects received training using a reconfigurable robot for 30 sessions, lasting 30 min per session. Post-training, statistical analysis showed significant improvement of 3.29 points (16.20%, p = 0.027) on the Fugl-Meyer assessment scale for forearm and wrist components. Significant improvement of active range of motion was detected in both pronation-supination (75.59%, p = 0.018) and wrist flexion-extension (56.12%, p = 0.018) after the training. These preliminary results demonstrate that the developed reconfigurable robot could improve subjects' wrist and forearm movement.

  5. Wireless Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Hong-Chuan Yang

    2007-01-01

    Full Text Available We study the energy-efficient configuration of multihop paths with automatic repeat request (ARQ mechanism in wireless ad hoc networks. We adopt a cross-layer design approach and take both the quality of each radio hop and the battery capacity of each transmitting node into consideration. Under certain constraints on the maximum tolerable transmission delay and the required packet delivery ratio, we solve optimization problems to jointly schedule the transmitting power of each transmitting node and the retransmission limit over each hop. Numerical results demonstrate that the path configuration methods can either significantly reduce the average energy consumption per packet delivery or considerably extend the average lifetime of the multihop route.

  6. Angiotensinogen Polymorphisms and Post-Transplantation Diabetes Mellitus in Korean Renal Transplant Subjects

    Directory of Open Access Journals (Sweden)

    Sul ra Lee

    2013-03-01

    Full Text Available Background: Post-transplant diabetes mellitus (PTDM is a common and serious metabolic complication. Genetic polymorphisms of angiotensin-converting enzyme (ACE and angiotensinogen (AGT genes have been reported to be related to diabetes mellitus and insulin sensitivity; however, the role of these genes in the development of PTDM is not known. For this purpose, we investigated the association of ACE and AGT genetic polymorphisms with PTDM. Methods: A total of 302 subjects without previously diagnosed diabetes who had received kidney transplants were included. One ACE single nucleotide polymorphism (SNP (rs4291 and two AGT SNPs (rs 699 and rs 4762 were genotyped from genomic DNA with direct sequencing. Results: PTDM developed in 49 (16.2% of 302 subjects. Subjects in the PTDM were older than those in the non-PTDM. There was a significant difference between the two groups in tacrolimus use (p=0.03. Of the three SNPs, the rs4762 of the AGT gene was significantly associated with the development of PTDM in the dominant models (p = 0.03 after adjusting for age and tacrolimus usage. Conclusions: AGT gene rs4762 polymorphisms may serve as genetic markers for the development of PTDM. The exact molecular mechanisms still need to be clarified.

  7. Subjectivity

    Directory of Open Access Journals (Sweden)

    Jesús Vega Encabo

    2015-11-01

    Full Text Available In this paper, I claim that subjectivity is a way of being that is constituted through a set of practices in which the self is subject to the dangers of fictionalizing and plotting her life and self-image. I examine some ways of becoming subject through narratives and through theatrical performance before others. Through these practices, a real and active subjectivity is revealed, capable of self-knowledge and self-transformation. 

  8. Post hoc analyses of the impact of previous medication on the efficacy of lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder in a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Coghill DR

    2014-10-01

    Full Text Available David R Coghill,1 Tobias Banaschewski,2 Michel Lecendreux,3 César Soutullo,4 Alessandro Zuddas,5 Ben Adeyi,6 Shaw Sorooshian7 1Division of Neuroscience, University of Dundee, Dundee, UK; 2Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany; 3Paediatric Sleep Centre and National Reference Centre for Orphan Diseases: Narcolepsy, Idiopathic Hypersomnia and Kleine-Levin Syndrome, Robert-Debré University Hospital, Paris, France; 4Child and Adolescent Psychiatry Unit, Department of Psychiatry and Medical Psychology, University of Navarra Clinic, Pamplona, Spain; 5Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy; 6Shire, Wayne, PA, USA; 7Shire, Eysins, Switzerland Background: Following the approval of lisdexamfetamine dimesylate (LDX in several European countries for the treatment of attention-deficit/hyperactivity disorder (ADHD in children and adolescents with an inadequate response to methylphenidate (MPH treatment, the aim of the present analysis was to establish the response to LDX in subgroups of patients with different ADHD medication histories. Methods: This was a post hoc subgroup analysis of data from a 7-week, European, double-blind, dose-optimized, Phase III study. Patients aged 6–17 years were randomized 1:1:1 to LDX, placebo, or osmotic-release oral system methylphenidate (OROS-MPH. OROS-MPH was included as a reference arm rather than as a direct comparator. Efficacy was assessed in patients categorized according to their ADHD medication history using the ADHD Rating Scale IV and Clinical Global Impressions-Improvement (CGI-I scores. Results: The difference between active drug and placebo in least-squares mean change from baseline to endpoint in ADHD Rating Scale IV total score (95% confidence interval was similar between the overall study population (n

  9. Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial.

    Science.gov (United States)

    Gregg, Edward; Jakicic, John; Blackburn, George; Bloomquist, Paul; Bray, George; Clark, Jeanne; Coday, Mace; Curtis, Jeffrey; Egan, Caitlin; Evans, Mary; Foreyt, John; Foster, Gary; Hazuda, Helen; Hill, James; Horton, Edward; Hubbard, Van; Jeffery, Robert; Johnson, Karen; Kitabchi, Abbas; Knowler, William; Kriska, Andrea; Lang, Wei; Lewis, Cora; Montez, Maria; Nathan, David; Neiberg, Rebecca; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Redmon, Bruce; Regensteiner, Judith; Rejeski, Jack; Ribisl, Paul; Safford, Monika; Stewart, Kerry; Trence, Dace; Wadden, Thomas; Wing, Rena; Yanovski, Susan

    2016-11-01

    Findings from the Look AHEAD trial showed no significant reductions in the primary outcome of cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention for weight loss compared with those randomly assigned to diabetes support and education (control). We examined whether the incidence of cardiovascular disease in Look AHEAD varied by changes in weight or fitness. Look AHEAD was a randomised clinical trial done at 16 clinical sites in the USA, recruiting patients from Aug 22, 2001, to April 30, 2004. In the trial, 5145 overweight or obese adults aged 45-76 years with type 2 diabetes were assigned (1:1) to an intensive lifestyle intervention or diabetes support and education. In this observational, post-hoc analysis, we examined the association of magnitude of weight loss and fitness change over the first year with incidence of cardiovascular disease. The primary outcome of the trial and of this analysis was a composite of death from cardiovascular causes, non-fatal acute myocardial infarction, non-fatal stroke, or admission to hospital for angina. The secondary outcome included the same indices plus coronary artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalisation for congestive heart failure, peripheral vascular disease, or total mortality. We adjusted analyses for baseline differences in weight or fitness, demographic characteristics, and risk factors for cardiovascular disease. The Look AHEAD trial is registered with ClinicalTrials.gov, number NCT00017953. For the analyses related to weight change, we excluded 311 ineligible participants, leaving a population of 4834; for the analyses related to fitness change, we excluded 739 participants, leaving a population of 4406. In analyses of the full cohort (ie, combining both study groups), over a median 10·2 years of follow-up (IQR 9·5-10·7), individuals who lost at least 10% of their bodyweight in the first year

  10. Extra virgin olive oil use is associated with improved post-prandial blood glucose and LDL cholesterol in healthy subjects

    OpenAIRE

    Violi, F.; Loffredo, L; Pignatelli, P; Angelico, F; Bartimoccia, S.; C. Nocella; Cangemi, R; Petruccioli, A; Monticolo, R; Pastori, D; Carnevale, R.

    2015-01-01

    Objectives: Extra virgin olive oil (EVOO) is a key component of the Mediterranean diet and seems to account for the protective effect against cardiovascular disease. However, the underlying mechanism is still elusive. Design: We tested the effect of EVOO, added to Mediterranean-type meal, on post-prandial glycemic and lipid profile. Subjects: Post-prandial glycemic and lipid profile were investigated in 25 healthy subjects who were randomly allocated in a cross-over design to a Mediterranean-...

  11. Does education level affect the efficacy of a community based salt reduction program? - A post-hoc analysis of the China Rural Health Initiative Sodium Reduction Study (CRHI-SRS).

    Science.gov (United States)

    Wang, Xin; Li, Xian; Vaartjes, Ilonca; Neal, Bruce; Bots, Michiel L; Hoes, Arno W; Wu, Yangfeng

    2016-08-11

    Whether educational level influences the effects of health education is not clearly defined. This study examined whether the impact of a community-based dietary salt reduction program was affected by the level of education of participants. The China Rural Health Initiative Sodium Reduction Study (CRHI-SRS) was a cluster-randomized controlled trial conducted in 120 villages from five Northern Chinese provinces. The intervention comprised a village-wide health education program and availability of salt substitute at village shops. 24-h urine samples were collected among 1903 participants for primary evaluation of the intervention effect. A post-hoc analysis was done to explore for heterogeneity of intervention effects by education level using generalized estimating equations. All models were adjusted for age, sex, body mass index and province. Daily salt intake was lower in intervention than in control at all educational levels with no evidence of a difference in the effect of the intervention across different levels of education. P value for the interaction term between education level and the intervention was 0.35. There was likewise no evidence of an interaction for effects of the intervention on potassium intake (p = 0.71), the sodium to potassium ratio (p = 0.07), or knowledge and behaviors related to salt (all p > 0.05). The study suggests that the effects of the intervention were achieved regardless of the level of education and that the intervention should therefore be broadly effective in rural Chinese populations. The trial was registered with clinicaltrial.gov ( NCT01259700 ).

  12. Sustained uremic toxin control improves renal and cardiovascular outcomes in patients with advanced renal dysfunction: post-hoc analysis of the Kremezin Study against renal disease progression in Korea

    Directory of Open Access Journals (Sweden)

    Ran-hui Cha

    2017-03-01

    Full Text Available Background: We investigated the long-term effect of AST-120, which has been proposed as a therapeutic option against renal disease progression, in patients with advanced chronic kidney disease (CKD. Methods: We performed post-hoc analysis with a per-protocol group of the K-STAR study (Kremezin study against renal disease progression in Korea that randomized participants into an AST-120 and a control arm. Patients in the AST-120 arm were given 6 g of AST-120 in three divided doses, and those in both arms received standard conventional treatment. Results: The two arms did not differ significantly in the occurrence of composite primary outcomes (log-rank P = 0.41. For AST-120 patients with higher compliance, there were fewer composite primary outcomes: intermediate tertile hazard ratio (HR 0.62, 95% confidence interval (CI 0.38 to 1.01, P = 0.05; highest tertile HR 0.436, 95% CI 0.25 to 0.76, P = 0.003. The estimated glomerular filtration rate level was more stable in the AST-120 arm, especially in diabetic patients. At one year, the AST-120-induced decrease in the serum indoxyl sulfate concentration inversely correlated with the occurrence of composite primary outcomes: second tertile HR 1.59, 95% CI 0.82 to 3.07, P = 0.17; third tertile HR 2.11, 95% CI 1.07 to 4.17, P = 0.031. Furthermore, AST-120 showed a protective effect against the major cardiovascular adverse events (HR 0.51, 95% CI 0.26 to 0.99, P = 0.046. Conclusion: Long-term use of AST-120 has potential for renal protection, especially in diabetic patients, as well as cardiovascular benefits. Reduction of the serum indoxyl sulfate level may be used to identify patients who would benefit from AST-120 administration.

  13. Dapagliflozin in patients with type 1 diabetes: A post hoc analysis of the effect of insulin dose adjustments on 24-hour continuously monitored mean glucose and fasting β-hydroxybutyrate levels in a phase IIa pilot study.

    Science.gov (United States)

    Henry, Robert R; Dandona, Paresh; Pettus, Jeremy; Mudaliar, Sunder; Xu, John; Hansen, Lars

    2017-06-01

    To investigate the effects of total daily insulin dose (TDD) reductions on 24-hour continuously monitored mean glucose and fasting β-hydroxybutyrate (a marker for diabetic ketosis/ketoacidosis [DKA]) levels, using patient-level data from a 14-day, pilot study of dapagliflozin in type 1 diabetes (T1DM). A post hoc exploratory correlation analysis was performed to determine the relationship between change in TDD and (1) 24-hour mean glucose, assessed by continuous glucose monitoring, and (2) fasting β-hydroxybutyrate, in 70 patients with T1DM receiving insulin and dapagliflozin (1, 2.5, 5 or 10 mg) or placebo. The pharmacodynamic effect of dapagliflozin was estimated as a virtual "insulin dose" using 24-hour urinary glucose excretion values and a recognized insulin-to-carbohydrate counting technique. Trends for correlations were observed between change in TDD and 24-hour glucose (day 7: r = -0.264, P = .056) and β-hydroxybutyrate (day 7: r = -0.187, P = .133; day 14: r = -0.274, P = .047). The pharmacodynamic effect of dapagliflozin 5 or 10 mg was estimated as equivalent to ~20% of baseline TDD. Higher mean and maximum β-hydroxybutyrate levels were observed on days 7 and 14 in patients with a TDD reduction >20% vs ≤20%. Over 14 days, decreasing the insulin dose diminished the glucose-lowering effect of dapagliflozin-insulin combination therapy and increased levels of β-hydroxybutyrate. While insulin dose adjustments should always be individualized, these analyses suggest that, as a general rule, TDD reduction in dapagliflozin-treated patients with T1DM should not exceed 20%, to ensure glycaemic control does not deteriorate and to mitigate the potential for an increased risk of DKA. © 2017 John Wiley & Sons Ltd.

  14. Clobazam is efficacious for patients across the spectrum of disease severity of Lennox-Gastaut syndrome: post hoc analyses of clinical trial results by baseline seizure-frequency quartiles and VNS experience.

    Science.gov (United States)

    Wheless, James W; Isojarvi, Jouko; Lee, Deborah; Drummond, Rebecca; Benbadis, Selim R

    2014-12-01

    Lennox-Gastaut syndrome (LGS) severity varies considerably, so the potential impact of differences in baseline severity on patient outcome following treatment is clinically informative. Here, two surrogate indicators of LGS severity (baseline seizure frequency and vagus nerve stimulation [VNS] use) were used in post hoc analyses of both short- and long-term clobazam trials (Phase III OV-1012 [CONTAIN] and open-label extension [OLE] OV-1004). In CONTAIN, 217 patients comprised the modified, intention-to-treat population. Each baseline seizure-frequency quartile had ~40 patients, and baseline weekly drop-seizure frequency ranges were as follows: 50% of patients in all 4 quartiles demonstrated ≥ 50% decreases in weekly frequency for drop seizures. More than 12% of patients in Quartile 4 achieved 100% reduction in drop seizures from Month 3 through Year 5. For the VNS analyses in CONTAIN, the least-squares mean decreases in average weekly rate of drop seizures (mITT population) were 52% for VNS patients receiving clobazam vs. -22% for placebo (p < 0.01). For non-VNS patients, these percentages were 53% for clobazam and 26% for placebo (p < 0.01). Moreover, 50% and 54% of clobazam-treated patients in the VNS and non-VNS groups demonstrated ≥ 50% decreases in average weekly drop- and total-seizure frequencies, and 11% and 14% in the two groups achieved drop-seizure freedom, respectively. Analyses using baseline seizure frequency and VNS use as surrogates for disease severity showed that clobazam treatment of patients with less severe or severe LGS was equally efficacious. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Efficacy and safety of rotigotine in elderly patients with Parkinson's disease in comparison with the non-elderly: a post hoc analysis of randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Nomoto, Masahiro; Iwaki, Hirotaka; Kondo, Hiroyuki; Sakurai, Masaya

    2017-11-21

    Rotigotine-a non-ergot dopamine agonist-has two advantages; it can stimulate all dopamine receptors (D1-D5) like innate dopamine, and its transdermal administration provides continuous dopaminergic stimulation. The age of the patient impacts the effect and adverse events of anti-parkinsonian treatment. We conducted a post hoc analysis on three randomized, double-blind, placebo-controlled trials performed in Japan to clarify the difference of anti-parkinsonian treatment in elderly and non-elderly patients. Data from two combination therapy trials (with levodopa) in advanced stage Parkinson's disease patients and one monotherapy trial in early stage patients were pooled and grouped by age (non-elderly aged < 70, elderly aged 70 +). In each age group, efficacy of rotigotine was compared to placebo. In the combination therapy, total Unified Parkinson's Disease Rating Scale Part III scores and some subtotal scores, including those for tremor, akinesia and gait disturbance, significantly improved in both elderly and non-elderly patients. Regarding safety, the incidence of total adverse event tended to be lower in elderly patients than non-elderly patients, although it was not significant. No difference was observed in maintenance dosage of rotigotine between the two groups. In conclusion, the improvement in motor symptoms and frequency of adverse events were shown to be similar in elderly and non-elderly patients with rotigotine-levodopa combination therapy. Further, there was no major difference in maintenance dosage of rotigotine between the age groups. These results suggest good tolerability of rotigotine among elderly patients.

  16. Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Thase, Michael E; Edwards, John; Durgam, Suresh; Chen, Changzheng; Chang, Cheng-Tao; Mathews, Maju; Gommoll, Carl P

    2017-09-01

    Treatment-emergent suicidal ideation and behavior are ongoing concerns with antidepressants. Vilazodone, currently approved for the treatment of major depressive disorder (MDD) in adults, has also been evaluated in generalized anxiety disorder (GAD). Post-hoc analyses of vilazodone trials were carried out to examine its effects on suicidal ideation and behavior in adults with MDD or GAD. Data were pooled from vilazodone trials in MDD (four studies) and GAD (three studies). The incidence of suicide-related events was analyzed on the basis of treatment-emergent adverse event reporting and Columbia-Suicide Severity Rating Scale (C-SSRS) monitoring. Treatment-emergent suicidal ideation was analyzed on the basis of a C-SSRS category shift from no suicidal ideation/behavior (C-SSRS=0) at baseline to suicide ideation (C-SSRS=1-5) during treatment. In pooled safety populations (MDD, n=2233; GAD, n=1475), suicide-related treatment-emergent adverse events occurred in less than 1% of vilazodone-treated and placebo-treated patients. Incidences of C-SSRS suicidal ideation were as follows: MDD (vilazodone=19.9%, placebo=24.7%); GAD (vilazodone=7.7%, placebo=9.4%). Shifts from no suicidal ideation/behavior at baseline to suicidal ideation during treatment were as follows: MDD (vilazodone=9.4%, placebo=10.3%); GAD (vilazodone=4.4%, placebo=6.1%). Data from placebo-controlled studies indicate little or no risk of treatment-emergent suicidal ideation or behavior with vilazodone in adults with MDD or GAD. Nevertheless, all patients should be monitored for suicidal thoughts and behaviors during antidepressant treatment.

  17. Correlations between cytogenetic and molecular monitoring among patients with newly diagnosed chronic myeloid leukemia in chronic phase: post hoc analyses of the Rationale and Insight for Gleevec High-Dose Therapy study.

    Science.gov (United States)

    Akard, Luke P; Cortes, Jorge E; Albitar, Maher; Goldberg, Stuart L; Warsi, Ghulam; Wetzler, Meir; Ericson, Solveig G; Radich, Jerald P

    2014-09-01

    Although bone marrow (BM) karyotyping has been the standard in monitoring patients with chronic myeloid leukemia, peripheral blood (PB) monitoring methods may be more convenient. To conduct post hoc analyses of the Rationale and Insight for Gleevec High-Dose Therapy study to evaluate correlations between results of cytogenetic testing and molecular monitoring from BM and PB during the first 18 months of high-dose imatinib therapy, and between early and late molecular responses. Newly diagnosed patients with chronic-phase chronic myeloid leukemia received imatinib 400 mg twice daily and were monitored quarterly for up to 18 months. Cytogenetic testing was performed by karyotyping using BM or by fluorescence in situ hybridization using PB. Molecular testing was performed by quantitative reverse transcriptase polymerase chain reaction using BM and PB. Significant pairwise correlations were found between results obtained by karyotyping, fluorescence in situ hybridization, and quantitative reverse transcriptase polymerase chain reaction using PB or BM (all pairwise correlations >0.8; P < .001). At 12 months, cytogenetic response by karyotyping correlated well with response by fluorescence in situ hybridization. A median 2.579-log reduction in BCR-ABL1 level from a standardized baseline correlated with fluorescence in situ hybridization-negative status. Patients with greater than 2-log reduction in BCR-ABL1 level at 3, 6, and 9 months were more likely to achieve major molecular response at 18 months than those with 2-log reduction or less. Our findings support the feasibility of molecular monitoring using PB and suggest that molecular monitoring conducted at a single reliable reference laboratory can adequately track response without invasive BM testing. Our findings are consistent with other work indicating that early response to imatinib predicts favorable long-term outcome.

  18. Effects of non-invasive vagus nerve stimulation on attack frequency over time and expanded response rates in patients with chronic cluster headache: a post hoc analysis of the randomised, controlled PREVA study.

    Science.gov (United States)

    Gaul, Charly; Magis, Delphine; Liebler, Eric; Straube, Andreas

    2017-12-01

    In the PREVention and Acute treatment of chronic cluster headache (PREVA) study, attack frequency reductions from baseline were significantly more pronounced with non-invasive vagus nerve stimulation plus standard of care (nVNS + SoC) than with SoC alone. Given the intensely painful and frequent nature of chronic cluster headache attacks, additional patient-centric outcomes, including the time to and level of therapeutic response, were evaluated in a post hoc analysis of the PREVA study. After a 2-week baseline phase, 97 patients with chronic cluster headache entered a 4-week randomised phase to receive nVNS + SoC (n = 48) or SoC alone (n = 49). All 92 patients who continued into a 4-week extension phase received nVNS + SoC. Compared with SoC alone, nVNS + SoC led to a significantly lower mean weekly attack frequency by week 2 of the randomised phase; the attack frequency remained significantly lower in the nVNS + SoC group through week 3 of the extension phase (P cluster headache attack frequency within 2 weeks after its addition to SoC and was associated with significantly higher ≥25%, ≥50%, and ≥75% response rates than SoC alone. The rapid decrease in weekly attack frequency justifies a 4-week trial period to identify responders to nVNS, with a high degree of confidence, among patients with chronic cluster headache.

  19. Prevalence of acute and chronic viral seropositivity and characteristics of disease in patients with psoriatic arthritis treated with cyclosporine: a post hoc analysis from a sex point of view on the observational study of infectious events in psoriasis complicated by active psoriatic arthritis.

    Science.gov (United States)

    Colombo, Delia; Chimenti, Sergio; Grossi, Paolo Antonio; Marchesoni, Antonio; Bardazzi, Federico; Ayala, Fabio; Simoni, Lucia; Vassellatti, Donatella; Bellia, Gilberto

    2016-01-01

    Sex medicine studies have shown that there are sex differences with regard to disease characteristics in immune-mediated inflammatory diseases, including psoriasis, in immune response and susceptibility to viral infections. We performed a post hoc analysis of the Observational Study of infectious events in psoriasis complicated by active psoriatic arthritis (SYNERGY) study in patients with psoriatic arthritis (PsA) treated with immunosuppressive regimens including cyclosporine, in order to evaluate potential between-sex differences in severity of disease and prevalence of viral infections. SYNERGY was an observational study conducted in 24 Italian dermatology clinics, which included 238 consecutively enrolled patients with PsA, under treatment with immunosuppressant regimens including cyclosporin A. In this post hoc analysis, patients' demographical data and clinical characteristics of psoriasis, severity and activity of PsA, prevalence of seropositivity for at least one viral infection, and treatments administered for PsA and infections were compared between sexes. A total of 225 patients were evaluated in this post hoc analysis, and 121 (54%) were males. Demographic characteristics and concomitant diseases were comparable between sexes. Statistically significant sex differences were observed at baseline in Psoriasis Area and Severity Index score (higher in males), mean number of painful joints, Bath Ankylosing Spondylitis Disease Activity Index, and the global activity of disease assessed by patients (all higher in females). The percentage of patients with at least one seropositivity detected at baseline, indicative of concomitant or former viral infection, was significantly higher among women than among men. No between-sex differences were detected in other measures, at other time points, and in treatments. Patients developed no hepatitis B virus or hepatitis C virus reactivation during cyclosporine treatment. Our post hoc sex analysis suggests that women with

  20. Sex differences in objective measures of sleep in post-traumatic stress disorder and healthy control subjects.

    Science.gov (United States)

    Richards, Anne; Metzler, Thomas J; Ruoff, Leslie M; Inslicht, Sabra S; Rao, Madhu; Talbot, Lisa S; Neylan, Thomas C

    2013-12-01

    A growing literature shows prominent sex effects for risk for post-traumatic stress disorder and associated medical comorbid burden. Previous research indicates that post-traumatic stress disorder is associated with reduced slow wave sleep, which may have implications for overall health, and abnormalities in rapid eye movement sleep, which have been implicated in specific post-traumatic stress disorder symptoms, but most research has been conducted in male subjects. We therefore sought to compare objective measures of sleep in male and female post-traumatic stress disorder subjects with age- and sex-matched control subjects. We used a cross-sectional, 2 × 2 design (post-traumatic stress disorder/control × female/male) involving83 medically healthy, non-medicated adults aged 19-39 years in the inpatient sleep laboratory. Visual electroencephalographic analysis demonstrated that post-traumatic stress disorder was associated with lower slow wave sleep duration (F(3,82)  = 7.63, P = 0.007) and slow wave sleep percentage (F(3,82)  = 6.11, P = 0.016). There was also a group × sex interaction effect for rapid eye movement sleep duration (F(3,82)  = 4.08, P = 0.047) and rapid eye movement sleep percentage (F(3,82)  = 4.30, P = 0.041), explained by greater rapid eye movement sleep in post-traumatic stress disorder females compared to control females, a difference not seen in male subjects. Quantitative electroencephalography analysis demonstrated that post-traumatic stress disorder was associated with lower energy in the delta spectrum (F(3,82)  = 6.79, P = 0.011) in non-rapid eye movement sleep. Slow wave sleep and delta findings were more pronounced in males. Removal of post-traumatic stress disorder subjects with comorbid major depressive disorder, who had greater post-traumatic stress disorder severity, strengthened delta effects but reduced rapid eye movement effects to non-significance. These findings support previous evidence that post

  1. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.

    Science.gov (United States)

    Calkwood, Jonathan; Cree, Bruce; Crayton, Heidi; Kantor, Daniel; Steingo, Brian; Barbato, Luigi; Hashmonay, Ron; Agashivala, Neetu; McCague, Kevin; Tenenbaum, Nadia; Edwards, Keith

    2014-11-26

    The Evaluate Patient OutComes (EPOC) study assessed physician- and patient-reported outcomes in individuals with relapsing multiple sclerosis who switched directly from injectable disease-modifying therapy (iDMT; glatiramer acetate, intramuscular or subcutaneous interferon beta-1a, or interferon beta-1b) to once-daily, oral fingolimod. Post hoc analyses evaluated the impact of a switch to fingolimod versus staying on each of the four individual iDMTs. Overall, 1053 patients were randomized 3:1 to switch to fingolimod or remain on iDMT. The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score. Secondary endpoints included changes in scores for TSQM Effectiveness, Side Effects and Convenience subscales, Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Activities, 36-item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) and mean investigator-reported Clinical Global Impressions of Improvement (CGI-I). All outcomes were evaluated after 6 months of treatment. Changes in TSQM Global Satisfaction scores were superior after a switch to fingolimod when compared with scores in patients remaining on any of the iDMTs (all p <0.001). Likewise, all TSQM subscale scores improved following a switch to fingolimod (all p <0.001), except when compared with glatiramer acetate for the TSQM Side Effects subscale (p = 0.111). FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; p = 0.030 and p = 0.022, respectively) and subcutaneous interferon beta-1a (PCS only; p = 0

  2. Effects of Folic Acid Therapy on the New-Onset Proteinuria in Chinese Hypertensive Patients: A Post Hoc Analysis of the Renal Substudy of CSPPT (China Stroke Primary Prevention Trial).

    Science.gov (United States)

    Li, Youbao; Liang, Min; Wang, Guobao; Wang, Binyan; He, Mingli; Tang, Genfu; Yin, Delu; Xu, Xin; Huo, Yong; Cui, Yimin; Hou, Fan Fan; Qin, Xianhui

    2017-08-01

    We aimed to test the hypothesis that treatment with enalapril and folic acid is more effective in preventing new-onset proteinuria than enalapril alone among hypertensive patients. This is a post hoc analysis of the renal substudy of the CSPPT (China Stroke Primary Prevention Trial). A total of 13 071 eligible participants without proteinuria were randomized to receive a double-blind daily treatment of a single tablet containing 10-mg enalapril and 0.8-mg folic acid (n=6511) or 10-mg enalapril alone (n=6560). The primary outcome was new-onset proteinuria, defined as a urine dipstick reading of ≥1+ at the exit visit. Secondary outcomes included a composite of the primary outcome and all-cause death and the annual rate of estimated glomerular filtration rate decline. After a median 4.4 years of treatment, the primary event occurred in 213 (3.9%) and 188 (3.5%) participants, respectively, in the enalapril and the enalapril-folic acid group (odds ratio, 0.90; 95% confidence interval, 0.74-1.11). However, among participants with diabetes mellitus at baseline, folic acid therapy resulted in a significant reduction in the risk for the primary event (3.7% in the enalapril-folic acid group versus 7.4% in the enalapril group; odds ratio, 0.48; 95% confidence interval, 0.29-0.81) and the composite event (odds ratio, 0.62; 95% confidence interval, 0.42-0.92) and a 55% slower annual rate of estimated glomerular filtration rate decline (0.5% versus 1.1% per year; P =0.002). Among those without diabetes mellitus at baseline, there were no between-group differences in all the outcomes. In conclusion, enalapril-folic acid therapy, compared with enalapril alone, significantly reduced the development of proteinuria in diabetic patients with hypertension. URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00794885. © 2017 American Heart Association, Inc.

  3. Longitudinal assessment of estimated glomerular filtration rate in apparently healthy adults: a post hoc analysis from the JUPITER study (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin).

    Science.gov (United States)

    Vidt, Donald G; Ridker, Paul M; Monyak, John T; Schreiber, Martin J; Cressman, Michael D

    2011-06-01

    Serum creatinine-based estimates of glomerular filtration rate (eGFR) are frequently used to identify patients with chronic kidney disease and assess cardiovascular risk both in clinical trials and in clinical practice. Although change in eGFR may be useful to assess change in renal function in patients with chronic kidney disease, the utility of serum creatinine-based eGFR is uncertain, particularly among individuals with normal or only mildly impaired renal function. The goal of this study was to examine the relationship between baseline serum creatinine and eGFR, as well as changes in these parameters, in apparently healthy adults in a post hoc analysis of data obtained in participants in the JUPITER study (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). JUPITER was a randomized study of rosuvastatin 20 mg versus placebo in apparently healthy adults with high-sensitivity C-reactive protein levels ≥ 2.0 mg/L, LDL-C JUPITER study participants (mean age, 66 years; 62% men; 72% white; and 58% with a history of hypertension) who had both a baseline and ≥ 1 postbaseline serum creatinine measurement were similar to the entire population of 17,802 patients who entered the trial. The mean age of the study population was 66 years, 62% were men, 72% were white, and 58% had a history of hypertension. Mean (SD) serum creatinine increased from baseline by 0.08 (0.16) mg/dL and 0.09 (0.14) mg/dL in the rosuvastatin and placebo groups, respectively (P = 0.001) at year 1 and by 0.09 (0.18) and 0.10 (0.16) mg/dL (P = 0.0045) at the final visit. Reductions in MDRD and CKD-EPI eGFR were ∼ 0.5 mL/min/1.73 m(2) greater with placebo than with rosuvastatin (P JUPITER, reductions in MDRD or CKD-EPI eGFR levels were greater in study participants with higher baseline eGFR levels but less in the rosuvastatin than in the placebo group. Future studies are required to assess the reliability of serum creatinine-based estimates of GFR to

  4. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM.

    Science.gov (United States)

    Fox, Robert J; Gold, Ralf; Phillips, J Theodore; Okwuokenye, Macaulay; Zhang, Annie; Marantz, Jing L

    2017-12-01

    Clinical course and treatment response may vary according to race/ethnicity in multiple sclerosis (MS) patients. Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) demonstrated significant efficacy and a favorable benefit-risk profile in relapsing-remitting MS (RRMS) patients in the 2-year phase III DEFINE/CONFIRM studies. In this post hoc analysis of integrated data from DEFINE/CONFIRM, we assessed clinical efficacy and safety/tolerability in black, Hispanic, and Asian patients treated with DMF 240 mg twice daily (approved dosage) or placebo. Eligible patients were 18-55 years of age with an Expanded Disability Status Scale score of 0-5.0. In the integrated intention-to-treat population, 769 and 771 patients were treated with DMF or placebo, respectively, of whom 10 and 19 were black, 31 and 23 were Hispanic, and 66 and 70 were Asian. In the black, Hispanic, and Asian subgroups, DMF was associated with lower annualized relapse rates at 2 years compared with placebo [rate ratio (95% confidence interval (CI)), 0.05 (0.00-1.07); 0.31 (0.10-0.95); and 0.64 (0.30-1.34), respectively]. The percentage of black, Hispanic, and Asian patients with 12-week confirmed disability progression was lower with DMF (43%, 8%, and 20%, respectively) compared with placebo [57%, 30%, and 25%, respectively; hazard ratio (95% CI), 0.53 (0.02-1.39); 0.17 (0.00-0.60); and 0.71 (0.32-1.58), respectively]. The safety/tolerability profile of DMF was generally consistent with that in the overall population of DEFINE/CONFIRM. The incidence of adverse events leading to treatment discontinuation in black, Hispanic, and Asian patients was 2/10, 2/31, and 3/66, respectively, with DMF, and 2/19, 1/23, and 8/70, respectively, with placebo. DMF may be an efficacious treatment with a favorable benefit-risk profile in black, Hispanic, and Asian patients with RRMS. Further clinical studies are needed to characterize differences in MS presentation and treatment outcomes across

  5. Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients

    Science.gov (United States)

    Vorsanger, Gary; Xiang, Jim; Biondi, David; Upmalis, David; Delfgaauw, Jacqueline; Allard, René; Moskovitz, Bruce

    2011-01-01

    OBJECTIVE: To evaluate the tolerability and efficacy of tapentadol immediate release (IR) and oxycodone IR for relief of moderate to severe pain in elderly and nonelderly patients. METHODS: Post hoc data analyses were conducted on a 90-day randomized, phase 3, double-blind, flexible-dose study (ClinicalTrials.gov: NCT00364546) of adults with moderate to severe lower back pain or osteoarthritis pain who received tapentadol IR 50 mg or 100 mg, or oxycodone HCl IR 10 mg or 15 mg every 4 h to 6 h as needed for pain relief. Treatment-emergent adverse events and study discontinuations were recorded. RESULTS: Data from 849 patients randomly assigned (4:1 ratio) to treatment with a study drug (tapentadol IR [n=679] or oxycodone IR [n=170]) were analyzed according to age (younger than 65 years of age [nonelderly], or 65 years of age or older [elderly]) and treatment group. Among elderly patients, incidences of constipation (19.0% versus 35.6%) and nausea or vomiting (30.4% versus 51.1%) were significantly lower with tapentadol IR versus oxycodone IR (all Ptapentadol IR versus oxycodone IR (both P≤0.031). Tapentadol IR-treated elderly patients had a lower percentage of days with constipation than oxycodone IR-treated patients (P=0.020). For tapentadol IR- and oxycodone IR-treated elderly patients, respectively, incidences of study discontinuation due to gastrointestinal treatment-emergent adverse events were 15.8% and 24.4% (P=0.190). Tapentadol IR and oxycodone IR provided similar pain relief, with no overall age-dependent efficacy differences (mean pain scores [11-point numerical rating scale] decreased from 7.0 and 7.2 at baseline, to 4.9 and 5.2 at end point, respectively). CONCLUSIONS: Tapentadol IR was safe and effective for the relief of lower back pain and osteoarthritis pain in elderly patients, and was associated with a better gastrointestinal tolerability profile than oxycodone IR. PMID:22059194

  6. The 'Big Five'. Hypothesis generation: a multidisciplinary intervention package reduces disease-specific hospitalisations from long-term care: a post hoc analysis of the ARCHUS cluster-randomised controlled trial.

    Science.gov (United States)

    Connolly, Martin J; Broad, Joanna B; Boyd, Michal; Zhang, Tony Xian; Kerse, Ngaire; Foster, Susan; Lumley, Thomas; Whitehead, Noeline

    2016-05-01

    long-term care (LTC) residents have higher hospitalisation rates than non-LTC residents. Rapid decline may follow hospitalisations, hence the importance of preventing unnecessary hospitalisations. Literature describes diagnosis-specific interventions (for cardiac failure, ischaemic heart disease, chronic obstructive pulmonary disease, stroke, pneumonia-termed 'big five' diagnoses), impacting on hospitalisations of older community-dwellers, but few RCTs show reductions in acute admissions from LTC. LTC facilities with higher than expected hospitalisations were recruited for a cluster-randomised controlled trial (RCT) of facility-based complex, non-disease-specific, 9-month intervention comprising gerontology nurse specialist (GNS)-led staff education, facility benchmarking, GNS resident review and multidisciplinary discussion of residents selected using standard criteria. In this post hoc exploratory analysis, the outcome was acute hospitalisations for 'big five' diagnoses. Re-randomisation analyses were used for end points during months 1-14. For end points during months 4-14, proportional hazards models are adjusted for within-facility clustering. we recruited 36 facilities with 1,998 residents (1,408 female; mean age 82.9 years); 1,924 were alive at 3 months. The intervention did not impact overall rates of acute hospitalisations or mortality (previously published), but resulted in fewer 'big five' admissions (RR = 0.73, 95% CI = 0.54-0.99; P = 0.043) with no significant difference in the rate of other acute admissions. When considering events occurring after 3 months (only), the intervention group were 34.7% (HR = 0.65; 95% CI = 0.49-0.88; P = 0.005) less likely to have a 'big five' acute admission than controls, with no differences in likelihood of acute admissions for other diagnoses (P = 0.96). this generic intervention may reduce admissions for common conditions which the literature shows are impacted by disease-specific admission reduction strategies.

  7. Impact of patient and treatment characteristics on glycemic control and hypoglycemia in patients with type 2 diabetes initiated to insulin glargine or NPH: A post hoc, pooled, patient-level analysis of 6 randomized controlled trials.

    Science.gov (United States)

    Porcellati, Francesca; Lin, Jay; Lucidi, Paola; Bolli, Geremia B; Fanelli, Carmine G

    2017-02-01

    The goal of this post hoc analysis was to determine key patient and treatment-related factors impacting glycosylated hemoglobin (A1C) and hypoglycemia in patients with uncontrolled type 2 diabetes who were initiated to basal insulin (neutral protamine Hagedorn [NPH] or glargine). Using individual patient-level data pooled from 6 treat-to-target trials, 2600 patients with type 2 diabetes on oral antidiabetic agents initiated to insulin glargine or NPH and treated for 24 to 36 weeks were analyzed. Both treatments led to significant reduction in A1C levels compared with baseline, with no differences between treatment groups (mean ± standard deviation; glargine: -1.32 ± 1.2% vs NPH: -1.26 ± 1.2%; P = 0.15), with greater reduction in the BMI ≥30 kg/m group than in the BMI <30 kg/m group. Glargine reduced A1C significantly more than NPH in the BMI <30 kg/m group (-1.30 ± 1.18% vs -1.14 ± 1.22, respectively; P = 0.008), but not in the BMI ≥ 30 kg/m group (-1.37 ± 1.19 vs -1.48 ± 1.22, respectively; P = 0.18). Similar proportions of patients achieved A1C target of <7% (glargine 30.6%, NPH 29.1%; P = 0.39). Incidence of severe and severe nocturnal hypoglycemia was significantly lower in glargine versus NPH-treated patients (2.0% vs 3.9%; P = 0.04, and 0.7% vs 2.1%; P = 0.002, respectively), and occurred primarily in the BMI <30 kg/m group. Initiation of basal insulin is highly effective in lowering A1C after oral antidiabetic agent failure. Glargine decreases A1C more than NPH in nonobese patients, and reduces the risk for severe and severe nocturnal hypoglycemia versus NPH both in obese and nonobese patients, but more so in nonobese patients. Thus, it is the nonobese patients who may benefit more from initiation of basal insulin as glargine than NPH.

  8. Severe neutropenia during cabazitaxel treatment is associated with survival benefit in men with metastatic castration-resistant prostate cancer (mCRPC): A post-hoc analysis of the TROPIC phase III trial.

    Science.gov (United States)

    Meisel, Alexander; von Felten, Stefanie; Vogt, Deborah R; Liewen, Heike; de Wit, Ronald; de Bono, Johann; Sartor, Oliver; Stenner-Liewen, Frank

    2016-03-01

    Cabazitaxel significantly improves overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) progressing during or after docetaxel, but is associated with a higher rate of grade ≥3 neutropenia compared with docetaxel. We thus examined the relationship between cabazitaxel-induced grade ≥3 neutropenia, baseline neutrophil-lymphocyte ratio (NLR) and treatment outcomes. Data from the experimental arm of the TROPIC phase 3 trial which randomly assigned men with mCRPC to cabazitaxel or mitoxantrone every 3 weeks, both combined with daily prednisone, were analysed. The influence on OS (primary end-point) and progression-free survival (PFS) of at least one episode of grade ≥3 neutropenia during cabazitaxel therapy was investigated using Cox regression models, adjusted for pain at baseline. The relationships with prostate-specific antigen (PSA) responses during cabazitaxel therapy and baseline NLR were also analysed. The occurrence of grade ≥3 neutropenia during cabazitaxel therapy was associated with a prolonged OS (median 16.3 versus 14.0 months, hazard ratio (HR) [95% confidence interval] = 0.65 [0.43-0.97], p = 0.035), a twice longer PFS (median 5.3 versus 2.6 months, HR = 0.56 [0.40-0.79], p = 0.001) and a higher confirmed PSA response ≥50% (49.8% versus 24.4%, p = 0.005), as compared with patients who did not develop grade ≥3 neutropenia. Grade ≥3 neutropenia was more common in case of NLR post-hoc analysis of TROPIC suggests that the occurrence of grade ≥3 neutropenia with cabazitaxel is associated with improved OS and PFS. Patients with a low NLR at baseline were more likely to develop grade ≥3 neutropenia during cabazitaxel therapy and showed the longest OS. High NLR at baseline and no grade ≥3 neutropenia during therapy was associated with poor outcomes which may suggest insufficient drug exposure or a limited impact on the tumour-associated immune response. Primary or secondary prophylactic use of G

  9. Predictive Performance of the Simplified Acute Physiology Score (SAPS II and the Initial Sequential Organ Failure Assessment (SOFA Score in Acutely Ill Intensive Care Patients: Post-Hoc Analyses of the SUP-ICU Inception Cohort Study.

    Directory of Open Access Journals (Sweden)

    Anders Granholm

    Full Text Available Severity scores including the Simplified Acute Physiology Score (SAPS II and the Sequential Organ Failure Assessment (SOFA score are used in intensive care units (ICUs to assess disease severity, predict mortality and in research. We aimed to assess the predictive performance of SAPS II and the initial SOFA score for in-hospital and 90-day mortality in a contemporary international cohort.This was a post-hoc study of the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU inception cohort study, which included acutely ill adults from ICUs across 11 countries (n = 1034. We compared the discrimination of SAPS II and initial SOFA scores, compared the discrimination of SAPS II in our cohort with the original cohort, assessed the calibration of SAPS II customised to our cohort, and compared the discrimination for 90-day mortality vs. in-hospital mortality for both scores. Discrimination was evaluated using areas under the receiver operating characteristics curves (AUROC. Calibration was evaluated using Hosmer-Lemeshow's goodness-of-fit Ĉ-statistic.AUROC for in-hospital mortality was 0.80 (95% confidence interval (CI 0.77-0.83 for SAPS II and 0.73 (95% CI 0.69-0.76 for initial SOFA score (P<0.001 for the comparison. Calibration of the customised SAPS II for predicting in-hospital mortality was adequate (P = 0.60. Discrimination of SAPS II was reduced compared with the original SAPS II validation sample (AUROC 0.80 vs. 0.86; P = 0.001. AUROC for 90-day mortality was 0.79 (95% CI 0.76-0.82; P = 0.74 for comparison with in-hospital mortality for SAPS II and 0.71 (95% CI 0.68-0.75; P = 0.66 for comparison with in-hospital mortality for the initial SOFA score.The predictive performance of SAPS II was similar for in-hospital and 90-day mortality and superior to that of the initial SOFA score, but SAPS II's performance has decreased over time. Use of a contemporary severity score with improved predictive performance may be of value.

  10. Risperidone for the treatment of affective symptoms in children with disruptive behavior disorder: a post hoc analysis of data from a 6-week, multicenter, randomized, double-blind, parallel-arm study.

    Science.gov (United States)

    Biederman, Joseph; Mick, Eric; Faraone, Stephen V; Wozniak, Janet; Spencer, Thomas; Pandina, Gahan

    2006-05-01

    Despite the increasing recognition of bipolar disorder in childhood, there have been no controlled, randomized clinical trials of atypical antipsychotics in this population. Preliminary data from open-label trials in children suggest that these agents might be effective in treating pediatric bipolar disorder, however. The purpose of this post hoc analysis of data from Aman et al was to determine the effects of risperidone in the management of affective symptoms in children with disruptive behavioral disorders (DBDs). This report presents a secondary analysis of a previously reported 6-week, multicenter, double-blind, randomized, parallel-arm trial comparing 6 weeks of administration of risperidone (flexible dosing starting at 0.02 mg . kg .1 . d(-1) and titrated up to 0.06 mg kg(-1) d(-1)) versus placebo in children with DBDs and subaverage intelligence. Twenty-four candidate affective symptoms of mania and depression were extracted from the 64-item Nisonger Child Behavior Rating Form (NCBRF). To define independent dimensions of mood-disorder psychopathology, these 24 symptoms were assigned 1 of 3 independent dimensions (symptoms of mania) based on loading: explosive irritability; agitated, expansive, grandiose; and depression. A fourth, nonaffective independent dimension encompassed a combination of nonaffec tive symptoms on the NCBRF Conduct Problem subscale. To assess treatment effect, each independent dimension was assigned a score derived from the sum of the symptoms that loaded on that dimension at weeks 2, 4, and 6 of study drug administration. A total of 110 patients were included in the independent-dimension analysis (89 boys, 21 girls; risperidone, 49 patients; placebo, 61 patients; mean [SD] age, 8.6 [2.3] and 8.1 [2.4] years in the risperidone and placebo groups, respectively; mean [SD] weight, 33.9 [12.8] and 32.1 [12.0] kg in the risperidone and placebo groups, respectively). The treatment-effect analysis found that the mean scores of all 3

  11. Lateral Neck Injury Assessments in Side Impact Using Post Mortem Human Subject Tests

    Science.gov (United States)

    Yoganandan, Narayan; Humm, John; Pintar, Frank A.; Wolfla, Christopher E.; Maiman, Dennis J.

    2011-01-01

    Current neck injury criteria are based on matching upper cervical spine injuries from piglet tests to airbag deployment loads and pairing kinematics from child dummies. These “child-based” scaled data together with adult human cadaver tolerances in axial loading are used to specify neck injury thresholds in axial compression and tension, and flexion and extension moment about the occipital condyles; no thresholds are specified for any other force or moment including lateral bending. The objective of this study was to develop a testing methodology and to determine the lateral bending moment injury threshold under coronal loading. Post mortem human subjects (PMHS) were used. Specimens consisted of whole body and isolated head-neck complexes with intact musculature. Intact specimen positioning included: sitting PMHS upright on a rigid seat, supporting the torso by a plate, maintaining Frankfurt plane horizontal. Isolated head-neck complexes were fixed at T1 with the occiput connected via a custom apparatus to a testing device to induce lateral bending motion. Head angular and linear accelerations and angular velocities were computed using a pyramid nine accelerometer package on the head; specimen-specific physical properties including center of gravity and moments of inertia in the three-dimensions; and equations of equilibrium. These data were used to determine neck loads at the occipital condyles. No specimens sustained injuries, identified by palpation, x-rays, CT, and autopsy. Results from 24 tests indicated that PMHS head-neck complexes can tolerate 75 Nm of coronal moment at low axial load without failure, and this level may be used as an initial estimate of the injury reference value under lateral loading to the human head-neck complex. PMID:22105394

  12. Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial.

    Science.gov (United States)

    Hankey, Graeme J; Eikelboom, John W; Yi, Qilong; Lees, Kennedy R; Chen, Christopher; Xavier, Denis; Navarro, Jose C; Ranawaka, Udaya K; Uddin, Wasim; Ricci, Stefano; Gommans, John; Schmidt, Reinhold

    2012-06-01

    Previous studies have suggested that any benefits of folic acid-based therapy to lower serum homocysteine in prevention of cardiovascular events might be offset by concomitant use of antiplatelet therapy. We aimed to establish whether there is an interaction between antiplatelet therapy and the effects of folic acid-based homocysteine-lowering therapy on major vascular events in patients with stroke or transient ischaemic attack enrolled in the vitamins to prevent stroke (VITATOPS) trial. In the VITATOPS trial, 8164 patients with recent stroke or transient ischaemic attack were randomly allocated to double-blind treatment with one tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B(6), and 500 μg vitamin B(12)) and followed up for a median 3·4 years (IQR 2·0-5·5) for the primary composite outcome of stroke, myocardial infarction, or death from vascular causes. In our post-hoc analysis of the interaction between antiplatelet therapy and the effects of treatment with B vitamins on the primary outcome, we used Cox proportional hazards regression before and after adjusting for imbalances in baseline prognostic factors in participants who were and were not taking antiplatelet drugs at baseline and in participants assigned to receive B vitamins or placebo. We also assessed the interaction in different subgroups of patients and different secondary outcomes. The VITATOPS trial is registered with ClinicalTrials.gov, number NCT00097669, and Current Controlled Trials, number ISRCTN74743444. At baseline, 6609 patients were taking antiplatelet therapy and 1463 were not. Patients not receiving antiplatelet therapy were more likely to be younger, east Asian, and disabled, to have a haemorrhagic stroke or cardioembolic ischaemic stroke, and to have a history of hypertension or atrial fibrillation. They were less likely to be smokers and to have a history of peripheral artery disease, hypercholesterolaemia, diabetes, ischaemic heart disease, and a

  13. Effect of monthly high-dose vitamin D supplementation on falls and non-vertebral fractures: secondary and post-hoc outcomes from the randomised, double-blind, placebo-controlled ViDA trial.

    Science.gov (United States)

    Khaw, Kay-Tee; Stewart, Alistair W; Waayer, Debbie; Lawes, Carlene M M; Toop, Les; Camargo, Carlos A; Scragg, Robert

    2017-06-01

    Adults with low concentrations of 25-hydroxyvitamin D (25[OH]D) in blood have an increased risk of falls and fractures, but randomised trials of vitamin D supplementation have had inconsistent results. We aimed to assess the effect of high-dose vitamin D supplementation on fractures and falls. The Vitamin D Assessment (ViDA) Study was a randomised, double-blind, placebo-controlled trial of healthy volunteers aged 50-84 years conducted at one centre in Auckland, New Zealand. Participants were randomly assigned to receive either an initial oral dose of 200 000 IU (5·0 mg) colecalciferol (vitamin D3) followed by monthly 100 000 IU (2·5 mg) colecalciferol or equivalent placebo dosing. The prespecified primary outcome was cardiovascular disease and secondary outcomes were respiratory illness and fractures. Here, we report secondary outcome data for fractures and post-hoc outcome data for falls. Cox proportional hazards models were used to estimate hazard ratios (HRs) for time to first fracture or time to first fall in individuals allocated vitamin D compared with placebo. The analysis of fractures included all participants who gave consent and was by intention-to-treat; the analysis of falls included all individuals who returned one or more questionnaires. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000402943. Between April 5, 2011, and Nov 6, 2012, 5110 participants were recruited and randomly assigned either colecalciferol (n=2558) or placebo (n=2552). Two participants allocated placebo withdrew consent after randomisation; thus, a total of 5108 individuals were included in the analysis of fractures. The mean age of participants was 65·9 years (SD 8·3) and 2971 (58%) were men. The mean concentration of 25(OH)D in blood was 63 nmol/L (SD 24) at baseline, with 1534 (30%) having 25(OH)D concentrations lower than 50 nmol/L. Follow-up was until July 31, 2015, with a mean treatment duration of 3·4 years (SD 0

  14. Post-exercise abdominal, subcutaneous adipose tissue lipolysis in fasting subjects is inhibited by infusion of the somatostatin analogue octreotide

    DEFF Research Database (Denmark)

    Enevoldsen, Lotte H; Polak, Jan; Simonsen, Lene

    2007-01-01

    -clearance method. Nine subjects were studied during 1-h basal rest, and then during continuous octreotide infusion during 1-h rest, 1-h exercise at 50% of maximal oxygen consumption and 4-h post-exercise rest. A control study on seven subjects was performed under similar conditions but without octreotide infusion.......c., abdominal adipose tissue metabolism, before, during and after exercise in healthy, fasting, young male subjects. The adipose tissue net releases of fatty acids and glycerol were measured by arterio-venous catheterizations and simultaneous measurements of adipose tissue blood flow with the local Xe...

  15. A Statistical Framework for Single Subject Design with an Application in Post-stroke Rehabilitation

    OpenAIRE

    Lu, Ying; Scott, Marc; Raghavan, Preeti

    2016-01-01

    This paper proposes a practical yet novel solution to a longstanding statistical testing problem regarding single subject design. In particular, we aim to resolve an important clinical question: does a new patient behave the same as one from a healthy population? This question cannot be answered using the traditional single subject design when only test subject information is used, nor can it be satisfactorily resolved by comparing a single-subject's data with the mean value of a healthy popu...

  16. Comparison of dynamic balancing responses following outward lateral perturbations during walking of healthy and post-stroke subjects

    Directory of Open Access Journals (Sweden)

    Matjačić Zlatko

    2017-03-01

    Full Text Available Efficient dynamic balancing and movement coordination during walking are essential for stability. The objective of this preliminary study was to assess dynamic balancing responses in a selected post-stroke subject and to compare them with those assessed in neurologically intact individual. Balance Assessment Robot, a haptic robot that interfaces to a pelvis of a subject walking on an instrumented treadmill, was used to deliver perturbing pushes to the pelvis. We have assessed centre-of-pressure (CoP and horizontal components of ground reaction forces (GRF following outward pushes. The results have shown that depending on the amplitude of a perturbing push neurologically intact individual responded predominantly by “ankle” and “hip” strategies at lower amplitude of perturbation and “ankle” and “stepping” strategies at higher amplitude of perturbation. Post-stroke subject responded mainly by “ankle” and “hip” strategies when perturbed on the sound leg while the response when perturbed on the impaired leg was similar to the one observed in healthy subject. These preliminary results indicate that post-stroke subjects might be reluctant or not able to perform “cross step” with their impaired leg which is needed when counteracting outward perturbation.

  17. What the giant tells us about agreeing post-verbal subjects in Xhosa ...

    African Journals Online (AJOL)

    Constructions with the subject following the verb are a widely studied topic in Bantu linguistics. One such construction, in which the subject is dislocated, is considered not as core subject inversion, but generally as an afterthought construction. This study takes a spoken text, in this case a narrative, as its point of departure to ...

  18. Evaluation of Mechanical Properties of Glass Fiber Posts Subjected to Laser Surface Treatments.

    Science.gov (United States)

    Barbosa Siqueira, Carolina; Spadini de Faria, Natália; Raucci-Neto, Walter; Colucci, Vivian; Alves Gomes, Erica

    2016-10-01

    The aim of this study was to evaluate the influence of laser irradiation on flexural strength, elastic modulus, and surface roughness and morphology of glass fiber posts (GFPs). Laser treatment of GFPs has been introduced to improve its adhesion properties. A total of 40 GFPs were divided into 4 groups according to the irradiation protocol: GC-no irradiation, GYAG-irradiation with erbium:yttrium-aluminum-garnet [Er:YAG], GCR-irradiation with erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG), and GDI-irradiation with diode laser. The GFP roughness and morphology were evaluated through laser confocal microscopy before and after surface treatment. Three-point bending flexural test measured flexural strength and elastic modulus. Data about elastic modulus and flexural strength were subjected to one-way ANOVA and Bonferroni test (p < 0.05). The effect of roughness was evaluated using the linear mixed effects model and Bonferroni test (p < 0.05). Laser treatment changed surface roughness in the groups GCR (p = 0.000) and GDI (p = 0.007). The mean flexural strength in GYAG (995.22 MPa) was similar to that in GC (980.48 MPa) (p = 1.000) but different from that in GCR (746.83 MPa) and that in GDI (691.34 MPa) (p = 0.000). No difference was found between the groups GCR and GDI (p = 0.86). For elastic modulus: GYAG (24.47 GPa) was similar to GC (25.92 GPa) (p = 1.000) but different from GCR (19.88 GPa) (p = 0.002) and GDI (17.20 GPa) (p = 0.000). The different types of lasers, especially Er,Cr:YSGG and 980 ηm diode, influenced the mechanical properties of GFPs.

  19. Prevalence of acute and chronic viral seropositivity and characteristics of disease in patients with psoriatic arthritis treated with cyclosporine: a post hoc analysis from a sex point of view on the observational study of infectious events in psoriasis complicated by active psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Colombo D

    2015-12-01

    Full Text Available Delia Colombo,1 Sergio Chimenti,2 Paolo Antonio Grossi,3 Antonio Marchesoni,4 Federico Bardazzi,5 Fabio Ayala,6 Lucia Simoni,7 Donatella Vassellatti,1 Gilberto Bellia1 On behalf of SYNERGY Study Group 1Novartis Farma Italia, Origgio (VA, 2Tor Vergata Polyclinic Rome, 3Macchi Hospital and Foundation, Varese, 4Orthopaedic Institute Pini, Milan, 5S Orsola-Malpighi Polyclinic, Bologna, 6University Federico II Naples, 7MediData srl, Modena, Italy Background: Sex medicine studies have shown that there are sex differences with regard to disease characteristics in immune-mediated inflammatory diseases, including psoriasis, in immune response and susceptibility to viral infections. We performed a post hoc analysis of the Observational Study of infectious events in psoriasis complicated by active psoriatic arthritis (SYNERGY study in patients with psoriatic arthritis (PsA treated with immunosuppressive regimens including cyclosporine, in order to evaluate potential between-sex differences in severity of disease and prevalence of viral infections.Methods: SYNERGY was an observational study conducted in 24 Italian dermatology clinics, which included 238 consecutively enrolled patients with PsA, under treatment with immunosuppressant regimens including cyclosporin A. In this post hoc analysis, patients' demographical data and clinical characteristics of psoriasis, severity and activity of PsA, prevalence of seropositivity for at least one viral infection, and treatments administered for PsA and infections were compared between sexes.Results: A total of 225 patients were evaluated in this post hoc analysis, and 121 (54% were males. Demographic characteristics and concomitant diseases were comparable between sexes. Statistically significant sex differences were observed at baseline in Psoriasis Area and Severity Index score (higher in males, mean number of painful joints, Bath Ankylosing Spondylitis Disease Activity Index, and the global activity of disease

  20. Sexual dysfunction in testicular cancer patients subjected to post-chemotherapy retroperitoneal lymph node dissection: a focus beyond ejaculation disorders.

    Science.gov (United States)

    Dimitropoulos, K; Karatzas, A; Papandreou, C; Daliani, D; Zachos, I; Pisters, L L; Tzortzis, V

    2016-05-01

    Post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) represents an integral part of multidisciplinary treatment of advanced germ cell cancer; however, it is associated with a high complications rate. The present study aimed to describe sexual disorders in 53 patients with testicular cancer who underwent full bilateral, non-nerve-sparing PC-RPLND in our institution, focusing beyond ejaculatory dysfunction. The International Index for Erectile Function (IIEF) questionnaire was used as diagnostic tool of male sexual functioning pre-operatively and three months after RPLND, while post-operatively patients were asked to describe and evaluate changes in selected sexual parameters. Study findings demonstrate mixed pattern of changes in sexual functioning, with no difference in erectile functioning before and after operation. However, orgasmic function and intercourse and overall sexual satisfaction were found significantly impaired post-operatively. Sexual desire and frequency of attempted sexual intercourses were found significantly increased post-operatively, in comparison with pre-operative levels. With regard to patients' subjective perception on sexual functioning alterations after PC-RPLND, a significant number of patients reported higher levels of sexual desire, no difference in erectile function and worse orgasmic function and satisfaction post-operatively. Thus, patients subjected to PC-RPLND should be closely and routinely evaluated due to close relationship of sexual dissatisfaction with secondary psychological disorders. © 2015 Blackwell Verlag GmbH.

  1. Endoscopy findings affect subjective smell rehabilitation in post-laryngectomy patients using the nasal airflow-inducing manoeuvre.

    Science.gov (United States)

    Saedi, B; Razmpa, E; Nikjo, A; Ghalandarabadi, M; Ghadimi, H; Saidabadi, G

    2014-09-01

    To evaluate the characteristics of post-laryngectomy patients, including nasal endoscopy findings, that affect subjective smell improvement in the post-surgical period. Thirty patients who had undergone total laryngectomy participated in at least three sessions of a smell rehabilitation programme involving the nasal airflow-inducing manoeuvre, under the supervision of a speech-language pathologist. Patient characteristics and nasal endoscopy findings were evaluated. Participants experienced a mean improvement in sense of smell of 61 per cent (p smell perception and appetite in laryngectomy patients. There was no relationship between nasal endoscopy findings and outcome of the nasal airflow-inducing manoeuvre rehabilitation programme in our case series.

  2. Voice, Post-Structural Representation and the Subjectivity of "Included" Students

    Science.gov (United States)

    Whitburn, Ben

    2016-01-01

    Aligned with the broader movement from structuralism to the post-structuralisms [Lather, P. 2013. "Methodology-21: What Do We Do in the Afterward?" "International Journal of Qualitative Studies in Education" 26 (6): 634-645; St. Pierre, E. A. 2009. "Afterword: Decentering Voice in Qualitative Inquiry." In "Voice…

  3. Defining Post-Divorce Remarriage Families: A Typology Based on the Subjective Perceptions of Children.

    Science.gov (United States)

    Gross, Penny

    1986-01-01

    Examined how boundaries are defined in a post-divorce remarriage family. Children (N=60) in remarriage families were asked whom they considered to be members of their families. Respondents were found in all four types of parental family memberships: retention, substitution, reduction and augmentation. Calls for a recognition of the importance of…

  4. Electroencephalographic and autonomic alterations in subjects with frequent nightmares during pre-and post-REM periods.

    Science.gov (United States)

    Simor, Péter; Körmendi, János; Horváth, Klára; Gombos, Ferenc; Ujma, Péter P; Bódizs, Róbert

    2014-11-01

    Abnormal arousal processes, sympathetic influences, as well as wake-like alpha activity during sleep were reported as pathophysiological features of Nightmare Disorder. We hypothesized that in Nightmare Disorder, wake-like cortical activity and peripheral measures linked to arousals would be triggered by physiological processes related to the initiation of REM periods. Therefore, we examined electroencephalographic (EEG), motor and autonomous (cardiac) activity in a group of nightmare (NM) and healthy control (CTL) subjects during sleep-state-transitions while controlling for the confounding effects of trait anxiety. Based on the second-nights' polysomnographic recordings of 19 Nightmare Disordered (NM) and 21 control (CTL) subjects, we examined the absolute power spectra focusing on the alpha range, measures of heart rate variability (HRV) and motor (muscle tone) activity during pre-REM and post-REM periods, separately. According to our results, the NM group exhibited increased alpha power during pre-REM, but not in post-REM, or stable, non-transitory periods. While CTL subjects showed increased HRV during pre-REM periods in contrast to post-REM ones, NM subjects did not exhibit such sleep state-specific differences in HRV, but showed more stable values across the examined sleep stages and less overall variability reflecting generally attenuated parasympathetic activity during sleep-state-transitions and during stable, non-transitory NREM states. These differences were not mediated by waking levels of trait anxiety. Moreover, in both groups, significant differences emerged regarding cortical and motor (muscle tone) activity between pre-REM and post-REM conditions, reflecting the heterogeneity of NREM sleep. Our findings indicate that NM subjects' sleep is compromised during NREM-REM transitions, but relatively stabilized after REM periods. The coexistence of sleep-like and wake-like cortical activity in NM subjects seems to be triggered by REM/WAKE promoting

  5. Differences in Pre and Post Vascular Patterning of Retinas from ISS Crew Members and HDT Subjects by VESGEN Analysis

    Science.gov (United States)

    Murray, M. C.; Vizzeri, G.; Taibbi, G.; Mason, S. S.; Young, M. H.; Zanello, S. B.; Parsons-Wingerter, P. A.

    2018-01-01

    Accelerated research by NASA [1] has investigated the significant risks for visual and ocular impairments Spaceflight Associated Neuro-Ocular Syndrome /Visual Impairment/Intracranial Pressure (SANS/VIIP) incurred by microgravity spaceflight, especially long-duration missions. Our study investigates the role of blood vessels in the incidence and etiology of SANS/VIIP within the retinas of Astronaut crewmembers pre-and post-flight to the International Space Station (ISS) by NASA's VESsel GENeration Analysis (VESGEN). The response of retinal vessels in crewmembers to microgravity was compared to that of retinal vessels to Head-Down Tilt (HDT) in subjects undergoing 70-Day Bed Rest. The study tests the proposed hypothesis that cephalad fluid shifts missions, resulting in ocular and visual impairments, are necessarily mediated in part by retinal blood vessels, and are therefore accompanied by significant remodeling of retinal vasculature.Vascular patterns in the retinas of crew members and HDTBR subjects extracted from 30° infrared (IR) Heidelberg Spectralis® images collected pre/postflight and pre/post HDTBR, respectively, were analyzed by VESGEN (patent pending). a mature, automated software developed as a research discovery tool for progressive vascular diseases in the retina and other tissues [2]. The weighted, multi-parametric VESGEN analysis generates maps of branching arterial and venous trees and quantification by parameters such as the fractal dimension (Df, a modern measure of vascular space-filling capacity), vessel diameters, and densities of vessel length and number classified into specific branching generations by vascular physiological branching rules [2,3]. The retrospective study approved by NASA’s Institutional Review Board included six HDT subjects (NASA Flight Analogs Research Unit [FARU] Campaign 11; for example, [4]) and eight ISS crewmembers monitored by routine occupational surveillance who provided their study consents to NASA’s Lifetime

  6. Queer Outings: Uncomfortable Stories about the Subjects of Post-Structural School Ethnography

    Science.gov (United States)

    Youdell, Deborah

    2010-01-01

    In this paper, I consider the abiding value as well as the limits of queer; navigating the contradictions of a politics and ethnographic practice based on a refutation of an abiding subject; resisting subjectivation and needing recognition; and "coming out" in school ethnography framed by queer theory. The paper moves from the work of Michel…

  7. Ad-hoc networking towards seamless communications

    CERN Document Server

    Gavrilovska, Liljana

    2006-01-01

    Ad-Hoc Networking Towards Seamless Communications is dedicated to an area that attracts growing interest in academia and industry and concentrates on wireless ad hoc networking paradigm. The persistent efforts to acquire the ability to establish dynamic wireless connections from anywhere to anyone with any device without prerequisite imbedded infrastructure move the communications boundaries towards ad-hoc networks. Recently, ad hoc networking has attracted growing interest due to advances in wireless communications, and developed framework for running IP based protocols. The expected degree of penetration of these networks will depend on the successful resolution of the key features. Ad-hoc networks pose many complex and open problems for researchers. Ad-Hoc Networking Towards Seamless Communications reveals the state-of-the-art in wireless ad-hoc networking and discusses some of the key research topics that are expected to promote and accelerate the commercial applications of these networks (e.g., MAC, rout...

  8. Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.

    Science.gov (United States)

    Kiyosue, Arihiro; Seino, Yutaka; Nishijima, Keiji; Bosch-Traberg, Heidrun; Kaku, Kohei

    2017-10-06

    The aim of the present post-hoc analysis was to investigate the safety and efficacy of liraglutide in combination with one oral antidiabetic drug (OAD) across different OAD classes. This was a post-hoc analysis using data from a 52-week, open-label, parallel-group trial, in which patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group). The primary outcome investigated in this post-hoc analysis was the incidence of adverse events. The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively). Minor hypoglycemia was infrequent (seven episodes in two patients randomized to liraglutide, and two episodes in two patients randomized to additional OAD). The mean reduction in glycated hemoglobin appeared greater with liraglutide therapy, with the estimated mean treatment difference (95% confidence interval [CI]) for liraglutide vs additional OAD ranging from -0.14%, 95% CI: -0.48 to 0.21 (-1.5 mmol/mol, 95 CI: -5.2 to 2.3) to -0.44%, 95% CI:-0.79 to -0.09 (-4.8 mmol/mol, 95% CI: -8.6 to -1.0). The present analysis suggests that Japanese patients on OAD monotherapy might benefit from a greater improvement in glycemic control, without impacting tolerability, by combining their OAD with liraglutide rather than another OAD, regardless of which OAD monotherapy they are receiving. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  9. Land cover transformation in two post-mining landscapes subjected to different ages of reclamation since dumping of spoils.

    Science.gov (United States)

    Antwi, Effah K; Boakye-Danquah, John; Asabere, Stephen B; Takeuchi, Kazuhiko; Wiegleb, Gerhard

    2014-01-01

    Transformation of natural land cover (LC) into modified LC has become inevitable due to growing human needs. Nevertheless, landscape transformational patterns during reclamation of mine damaged lands remain vague. Our hypothesis was that post-mining landscapes with different ages since dumping become more diverse in LC transformation over time. The aim was to study the impact of landscape reclamation on land cover changes (LCC) in two post-mining landscapes. Land cover maps of 1988, 1991, 1995, 1998, 2000 and 2003 were produced from LANDSAT TM images of Schlabendorf Nord and Schlabendorf Süd and used to survey the changing landscape. Change detection extension was used to identify changes among land cover types (LCTs). Detrended correspondence analyses (DCA) ordination technique (CANOCO) aided study of similarity among LC distribution. Soil pH analysis was carried out to study effect of soil and climate conditions on LCC. The results show that visible patterns of increase and decrease in the LCTs occurred in both landscapes. Given two post-mining landscapes subjected to different ages of reclamation, clear differences in vegetation growth and LCC pattern would occur. At early stages of restoration, LCTs often have unstable conditions and experience more acute transformation depending on the level of land use intensity in space and time. LCCs were mostly due to progressive and reversed succession. Due to variation in post-mining landscape soil conditions, soil treatment during reclamation should be site specific. The comparative analysis of LCCs in Schlabendorf provides a framework for prioritizing land use planning options for sustainable management of post-mining landscapes in temperate ecosystems.

  10. Waterbird communities in rice fields subjected to different post-harvest treatments

    Science.gov (United States)

    Day, J.H.; Colwell, M.A.

    1998-01-01

    In California's Sacramento Valley, the potential value of rice fields as habitat for waterbirds may vary with harvest method, post-harvest treatment of rice straw (chopped, burned, plowed), and extent of flooding. Recent changes in rice harvesting methods (i.e., use of stripper-headers) and a legislative mandate to decrease burning of rice straw after harvest may alter habitat availability and use. Thus, we investigated species richness and community composition of nonbreeding waterbirds during October-March 1993-94 and 1994-95 in rice fields of the northern Sacramento Valley. Most (85-91% of land area) rice was conventionally harvested (i.e., cutter bar), and the remainder was stripped. Rice straw was left untreated in more than half of fields (52% in 1994 and 54% in 1995), especially in stripped fields (56-70%). In fields where farmers treated straw, the most common management methods were plowing (15-21%), burning (19-24%), and chopping (3-5%). Fields became increasingly wet from October through March as seasonal precipitation accumulated and farmers flooded fields to facilitate straw decomposition and provide habitat for ducks. Species richness of waterbirds was greater (P 0.23). Species richness in stripped fields probably was low because foraging opportunities were limited by tall dense straw, decreased grain density, and infrequent flooding. We recommend that land managers wishing to provide habitat for a diverse waterbird community harvest rice using conventional methods and flood fields shallowly.

  11. Politics of faith: Transforming religious communities and spiritual subjectivities in post-apartheid South Africa

    Directory of Open Access Journals (Sweden)

    Haley McEwen

    2016-02-01

    Full Text Available The enforcement of racial segregation during apartheid was aimed not only at regulating public spaces, residential areas and the workforce, but also at shaping the subjectivities of individuals who were socialised to see themselves through the lens of a white racial hierarchy. The ideology of white supremacy and superiority that informed apartheid policy was largely justified using Christonormative epistemologies that sought to legitimate the racial hierarchy as having basis in Holy Scripture and as an extension of God’s will. At the same time, apartheid policy fragmented religious communities, entrenching race as a central component of spiritual subjectivities. Twenty years after the end of apartheid, the legacy of apartheid continues to shape the lives and opportunities of all people living in South Africa, despite many gains made in working towards a non-racial, non-sexist democracy. While much scholarly attention has been paid to postapartheid contexts of work, residency and recreation, relatively little attention has been paid to spaces of worship. This is surprising, given that religious belief and practice are widespread in South Africa in the first instance, and that Christian belief, in particular, was so central to the social imaginary of apartheid, in the second. Thus, in efforts to transform society and advance social justice, it is imperative to consider diversity, difference and otherness from the perspective of, and in relation to, contemporary religious communities and contexts. This article will consider some of the factors shaping dynamics of diversity and difference within the context of religious communities in South Africa, over 20 years into democracy.

  12. Sputnik: ad hoc distributed computation.

    Science.gov (United States)

    Völkel, Gunnar; Lausser, Ludwig; Schmid, Florian; Kraus, Johann M; Kestler, Hans A

    2015-04-15

    In bioinformatic applications, computationally demanding algorithms are often parallelized to speed up computation. Nevertheless, setting up computational environments for distributed computation is often tedious. Aim of this project were the lightweight ad hoc set up and fault-tolerant computation requiring only a Java runtime, no administrator rights, while utilizing all CPU cores most effectively. The Sputnik framework provides ad hoc distributed computation on the Java Virtual Machine which uses all supplied CPU cores fully. It provides a graphical user interface for deployment setup and a web user interface displaying the current status of current computation jobs. Neither a permanent setup nor administrator privileges are required. We demonstrate the utility of our approach on feature selection of microarray data. The Sputnik framework is available on Github http://github.com/sysbio-bioinf/sputnik under the Eclipse Public License. hkestler@fli-leibniz.de or hans.kestler@uni-ulm.de Supplementary data are available at Bioinformatics online. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  13. Artificial urinary sphincter for post-radical prostatectomy urinary incontinence: long-term subjective results.

    Science.gov (United States)

    Gousse, A E; Madjar, S; Lambert, M M; Fishman, I J

    2001-11-01

    patient age. The artificial urinary sphincter is a viable treatment option for post-radical prostatectomy incontinence with a high rate of continence and satisfaction for a long period after the procedure. Patients should be informed that complications necessitating device revision and explantation may appear late in followup. A standard definition of treatment success and studies of homogenous groups of patients with an artificial urinary sphincter would enable better understanding and patient education in the future.

  14. Extra virgin olive oil use is associated with improved post-prandial blood glucose and LDL cholesterol in healthy subjects.

    Science.gov (United States)

    Violi, F; Loffredo, L; Pignatelli, P; Angelico, F; Bartimoccia, S; Nocella, C; Cangemi, R; Petruccioli, A; Monticolo, R; Pastori, D; Carnevale, R

    2015-07-20

    Extra virgin olive oil (EVOO) is a key component of the Mediterranean diet and seems to account for the protective effect against cardiovascular disease. However, the underlying mechanism is still elusive. We tested the effect of EVOO, added to Mediterranean-type meal, on post-prandial glycemic and lipid profile. Post-prandial glycemic and lipid profile were investigated in 25 healthy subjects who were randomly allocated in a cross-over design to a Mediterranean-type meal added with or without 10 g EVOO (first study), or Mediterranean-type meal with EVOO (10 g) or corn oil (10 g; second study). Glycemic profile, which included glucose, insulin, dipeptidyl-peptidase-4 (DPP-4) protein and activity, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), and lipid profile, which included, low-density lipoprotein (LDL) cholesterol (LDL-C), oxidized LDL (ox-LDL), triglycerides and high-density lipoprotein (HDL) cholesterol (HDL-C), were analyzed before and 2 h after the meal. In the first study, 2 h after meal, subjects who assumed a meal with EVOO had significantly lower blood glucose (PEVOO. The second study showed that compared with corn oil, EVOO improved both glycemic and lipid profile. Thus, a significantly smaller increase of glucose (PEVOO showed a significantly less increase of LDL-C (PEVOO improves post-prandial glucose and LDL-C, an effect that may account for the antiatherosclerotic effect of the Mediterranean diet.

  15. Population pharmacokinetics of pregabalin in healthy subjects and patients with post-herpetic neuralgia or diabetic peripheral neuropathy

    Science.gov (United States)

    Shoji, Satoshi; Suzuki, Misaki; Tomono, Yoshiro; Bockbrader, Howard N; Matsui, Shigeyuki

    2011-01-01

    AIM Pregabalin, a chemical analogue of the mammalian neurotransmitter γ-aminobutyric acid, has been approved in many countries for partial-onset seizures, generalized anxiety disorder and various other pain disorders, including neuropathic pain associated with post-herpetic neuralgia and diabetic peripheral neuropathy and fibromyalgia. The aim of this study was to develop a population pharmacokinetic model and quantify the influence of covariates on the parameters. METHODS This pregabalin population pharmacokinetic analysis was conducted on data from 14 clinical trials involving healthy subjects, subjects with impaired renal function and patients with post-herpetic neuralgia or diabetic peripheral neuropathy (n = 616). The data analysis was performed using nonlinear mixed effects modelling methodology as implemented by NONMEM. RESULTS A one-compartment model with first-order absorption and elimination adequately described pregabalin pharmacokinetics. The model indicated that pregabalin apparent clearance (CL/F) was proportional to estimated creatinine clearance (CLcr). The pregabalin systemic exposure in patients with lower renal function who received pregabalin 150 mg twice daily was almost equal to that of patients with normal renal function administered pregabalin 300 mg twice daily. The systemic exposure stratified by lower or normal renal function was similar between patients with post-herpetic neuralgia and diabetic peripheral neuropathy. CONCLUSION The developed model identified CLcr and ideal body weight as clinically influential covariates on CL/F and volume of distribution, respectively. This study indicates that renal function accounts for variability in the apparent clearance of pregabalin which is consistent with what is known about the elimination of this drug. PMID:21306415

  16. Serum Bicarbonate and Kidney Disease Progression and Cardiovascular Outcome in Patients With Diabetic Nephropathy: A Post Hoc Analysis of the RENAAL (Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan) Study and IDNT (Irbesartan Diabetic Nephropathy Trial).

    Science.gov (United States)

    Schutte, Elise; Lambers Heerspink, Hiddo J; Lutgers, Helen L; Bakker, Stephan J L; Vart, Priya; Wolffenbuttel, Bruce H R; Umanath, Kausik; Lewis, Julia B; de Zeeuw, Dick; Gansevoort, Ron T

    2015-09-01

    Low serum bicarbonate level has been reported to be an independent predictor of kidney function decline and mortality in patients with chronic kidney disease. Mechanisms underlying low serum bicarbonate levels may differ in patients with and without diabetes. We aimed to specifically investigate the association of serum bicarbonate level with kidney disease progression and cardiovascular outcome in a cohort of patients with type 2 diabetes and nephropathy. Post hoc analysis of 2 multicenter randomized controlled trials. 2,628 adults with type 2 diabetes and nephropathy. Serum bicarbonate level. Incidence of: (1) end-stage renal disease (ESRD), (2) ESRD or doubling of serum creatinine level, (3) all-cause mortality, (4) cardiovascular events (fatal/nonfatal stroke/myocardial infarction), and (5) heart failure. Serum bicarbonate was measured at baseline as total carbon dioxide. Associations of baseline serum bicarbonate level with end points were investigated using Cox regression models. Serum bicarbonate levels were studied as a continuous variable and stratified in quartiles. Follow-up was 2.8±1.0 (SD) years. Cox regression analyses showed that serum bicarbonate level had inverse associations with incident ESRD (HR, 0.91; 95% CI, 0.89-0.93; P0.05). Analysis of bicarbonate quartiles showed similar results for the quartile with the lowest bicarbonate (≤21 mEq/L) versus the quartile with normal bicarbonate levels (24-26 mEq/L). There was no association of bicarbonate level with cardiovascular events and heart failure. Post hoc analysis and single measurement of serum bicarbonate. In this cohort of patients with type 2 diabetes with nephropathy, serum bicarbonate level associations with kidney disease end points were not retained after adjustment for estimated glomerular filtration rate, which is in contrast to results of earlier studies in nondiabetic populations. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  17. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.

    Science.gov (United States)

    Van Cutsem, Eric; Joulain, Florence; Hoff, Paulo M; Mitchell, Edith; Ruff, Paul; Lakomý, Radek; Prausová, Jana; Moiseyenko, Vladimir M; van Hazel, Guy; Cunningham, David; Arnold, Dirk; Schmoll, Hans-Joachim; Ten Tije, Albert J; McKendrick, Joseph; Kröning, Hendrik; Humblet, Yves; Grávalos, Cristina; Le-Guennec, Solenn; Andria, Michael; Dochy, Emmanuelle; Vishwanath, Raghu L; Macarulla, Teresa; Tabernero, Josep

    2016-06-01

    The aim of this post hoc analysis of the VELOUR study (ClinicalTrials.gov NCT00561470) was to investigate the treatment effect of adding aflibercept to second-line infusional 5-fluorouracil (5-FU), leucovorin and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) who had failed any prior oxaliplatin-containing regimen. Adjuvant rapid relapsers (ARR), who were enrolled directly following relapse during or within 6 months of completion of oxaliplatin-containing adjuvant chemotherapy (N = 124, including 17 patients who also received bevacizumab as part of their adjuvant therapy), were excluded from the original VELOUR intention-to-treat (ITT) population (N = 1226). After exclusion of the ARR, overall survival (OS) in the ITT minus ARR (ITT-ARR) population (N = 1102) was longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm [hazard ratio (HR) 0.78, 95 % confidence interval (CI) 0.68-0.90; median survival difference 1.87 months]. In the subgroup of patients assigned to the prior bevacizumab stratum at randomization, OS was numerically longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm (HR 0.81; 95 % CI 0.63-1.04; median survival difference 2.14 months). Comparison of the post hoc analysis results with the primary analysis from VELOUR suggests that the inclusion of the directly enrolled ARR may have understated the aflibercept treatment benefit for both bevacizumab-pretreated and bevacizumab-naïve patients in the strictly second-line setting although no definitive conclusion may be inferred. The benefit associated with the addition of aflibercept to second-line FOLFIRI in patients with mCRC was observed whatever the timing of first-line disease progression. There were no unexpected safety concerns.

  18. Relationship between postural alignment in sitting by photogrammetry and seated postural control in post-stroke subjects.

    Science.gov (United States)

    Iyengar, Y R; Vijayakumar, K; Abraham, J M; Misri, Z K; Suresh, B V; Unnikrishnan, B

    2014-01-01

    This study was executed to find out correlation between postural alignment in sitting measured through photogrammetry and postural control in sitting following stroke. A cross-sectional study with convenient sampling consisting of 45 subjects with acute and sub-acute stroke. Postural alignment in sitting was measured through photogrammetry and relevant angles were obtained through software MB Ruler (version 5.0). Seated postural control was measured through Function in Sitting Test (FIST). Correlation was obtained using Spearman's Rank Correlation co-efficient in SPSS software (version 17.0). Moderate positive correlation (r = 0.385; p < 0.01) was found between angle of lordosis and angle between acromion, lateral epicondyle and point between radius and ulna. Strong negative correlation (r = -0.435; p < 0.01) was found between cranio-vertebral angle and kyphosis. FIST showed moderate positive correlation (r = 0.3446; p < 0.05) with cranio-vertebral angle and strong positive correlation (r = 0.4336; p < 0.01) with Brunnstrom's stage of recovery in upper extremity. Degree of forward head posture in sitting correlates directly with seated postural control and inversely with degree of kyphosis in sitting post-stroke. Postural control in sitting post-stroke is directly related with Brunnstrom's stage of recovery in affected upper extremity in sitting.

  19. Queueing Models for Mobile Ad Hoc Networks

    NARCIS (Netherlands)

    de Haan, Roland

    2009-01-01

    This thesis presents models for the performance analysis of a recent communication paradigm: \\emph{mobile ad hoc networking}. The objective of mobile ad hoc networking is to provide wireless connectivity between stations in a highly dynamic environment. These dynamics are driven by the mobility of

  20. O sujeito do feminismo e o pós-estruturalismo The subject of feminism and post-structuralism

    Directory of Open Access Journals (Sweden)

    Silvana Aparecida Mariano

    2005-12-01

    Full Text Available O presente trabalho aborda as críticas das teorias feministas pós-estruturalistas às teorizações do sujeito universal, rejeitando as noções de identidades essenciais de gênero. O ponto comum entre as pensadoras incluídas no trabalho é a necessidade de romper o esquema tradicional das tradições filosóficas ocidentais que se baseiam em esquemas dicotômicos de pensamento e assim desconstruir o pensamento binário. Suas diferenças, entretanto, situam-se especialmente no que diz respeito à re-construção do sujeito do feminismo. Esses debates envolvem, ao mesmo tempo, questões teóricas, metodológicas e políticas.This paper approaches the criticism of post-structural feminist theories as well as the theories of the universal subject, rejecting the notions of the essential identity of gender. The common point among the thinkers included in this work is the necessity to break with the traditional model of western philosophical traditions which are based upon dichotomous thinking models and thus deconstruct binary thinking. Their differences, however, lie especially in the area pertaining to the reconstruction of the subject of feminism. Such debates involve, at the same time, theoretical, methodological and political issues.

  1. Effect of glatiramer acetate three-times weekly on the evolution of new, active multiple sclerosis lesions into T1-hypointense "black holes": a post hoc magnetic resonance imaging analysis.

    Science.gov (United States)

    Zivadinov, Robert; Dwyer, Michael; Barkay, Hadas; Steinerman, Joshua R; Knappertz, Volker; Khan, Omar

    2015-03-01

    Conversion of active lesions to black holes has been associated with disability progression in subjects with relapsing-remitting multiple sclerosis (RRMS) and represents a complementary approach to evaluating clinical efficacy. The objective of this study was to assess the conversion of new active magnetic resonance imaging (MRI) lesions, identified 6 months after initiating treatment with glatiramer acetate 40 mg/mL three-times weekly (GA40) or placebo, to T1-hypointense black holes in subjects with RRMS. Subjects received GA40 (n = 943) or placebo (n = 461) for 12 months. MRI was obtained at baseline and Months 6 and 12. New lesions were defined as either gadolinium-enhancing T1 or new T2 lesions at Month 6 that were not present at baseline. The adjusted mean numbers of new active lesions at Month 6 converting to black holes at Month 12 were analyzed using a negative binomial model; adjusted proportions of new active lesions at Month 6 converting to black holes at Month 12 were analyzed using a logistic regression model. Of 1,292 subjects with complete MRI data, 433 (50.3 %) GA-treated and 247 (57.2 %) placebo-treated subjects developed new lesions at Month 6. Compared with placebo, GA40 significantly reduced the mean number (0.31 versus 0.45; P = .0258) and proportion (15.8 versus 19.6 %; P = .006) of new lesions converting to black holes. GA significantly reduced conversion of new active lesions to black holes, highlighting the ability of GA40 to prevent tissue damage in RRMS.

  2. Poste.

    Directory of Open Access Journals (Sweden)

    Saskia Cousin

    2007-03-01

    Full Text Available Poste à moustache. Le 27 février a été publié au journal officiel l ‘arrêté du 16 février 2007 portant déclaration de vacance d’emplois du supérieur pour la rentrée 2007. La chasse aux postes est donc ouverte. Petit rappel pour le lecteur non averti. En France, le parcours d’un docteur aspirant chercheur ou enseignant-chercheur est celui d’un marathonien, qui dure, en cas de recrutement immédiat, un an, mais peut se poursuivre de nombreuses années. Pour concourir, il ...

  3. Post-action determinants of the reported time of conscious intentions

    NARCIS (Netherlands)

    Rigoni, D.; Brass, M.; Sartori, G.

    2010-01-01

    The question of whether our behavior is guided by our conscious intentions is gaining momentum within the field of cognitive neuroscience. It has been demonstrated that the subjective experience that conscious intentions are the driving force of our actions, is built partially on a post hoc

  4. Did you get any help? A post-hoc secondary analysis of a randomized controlled trial of psychoeducation for patients with antisocial personality disorder in outpatient substance abuse treatment programs.

    Science.gov (United States)

    Thylstrup, Birgitte; Schrøder, Sidsel; Fridell, Mats; Hesse, Morten

    2017-01-09

    People in treatment for substance use disorder commonly have comorbid personality disorders, including antisocial personality disorder. Little is known about treatments that specifically address comorbid antisocial personality disorder. Self-rated help received for antisocial personality disorder was assessed during follow-ups at 3, 9 and 15 months post-randomization of a randomized trial of psychoeducation for people with comorbid substance use and antisocial personality disorder (n = 175). Randomization to psychoeducation was associated with increased perceived help for antisocial personality disorder. Perceived help for antisocial personality disorder was in turn associated with more days abstinent and higher treatment satisfaction at the 3-month follow-up, and reduced risk of dropping out of treatment after the 3-month follow-up, and perceived help mediated the effects of random assignment on days abstinent at 3-month. Brief psychoeducation for antisocial personality disorder increased patients' self-rated help for antisocial personality disorder in substance abuse treatment, and reporting having received help for antisocial personality disorder was in turn associated with better short-term outcomes, e.g., days abstinent, dropout from treatment and treatment satisfaction. ISRCTN registry, ISRCTN67266318 , retrospectively registered 17/7/2012.

  5. French adults' cognitive performance after daily supplementation with antioxidant vitamins and minerals at nutritional doses: a post hoc analysis of the Supplementation in Vitamins and Mineral Antioxidants (SU.VI.MAX) trial.

    Science.gov (United States)

    Kesse-Guyot, Emmanuelle; Fezeu, Léopold; Jeandel, Claude; Ferry, Monique; Andreeva, Valentina; Amieva, Hélène; Hercberg, Serge; Galan, Pilar

    2011-09-01

    Antioxidant properties of some vitamins and trace elements may help to prevent cognitive decline. The aim of the current study was to estimate the long-term effects of antioxidant nutrient supplementation on the cognitive performance of participants in the Supplementation in Vitamins and Mineral Antioxidants (SU.VI.MAX) study 6 y after the end of the trial. This study included 4447 French participants aged 45-60 y who were enrolled in the SU.VI.MAX study (1994-2002), which was a double-blind, placebo-controlled, randomized trial. From 1994 to 2002, participants received daily vitamin C (120 mg), β-carotene (6 mg), vitamin E (30 mg), selenium (100 μg), and zinc (20 mg) in combination or as a placebo. In 2007-2009, the cognitive performance of participants was assessed with 4 neuropsychological tests (6 tasks). Principal components analysis (PCA) was performed to identify cognitive-function summary scores. Associations between antioxidant supplementation and cognitive functions, in the full sample and by subgroups, were estimated through ANOVA and expressed as mean differences and 95% CIs. Subgroup analyses were performed according to baseline characteristics. Subjects receiving active antioxidant supplementation had better episodic memory scores (mean difference: 0.61; 95% CI: 0.02, 1.20). PCA indicated 2 factors that were interpreted as showing verbal memory and executive functioning. Verbal memory was improved by antioxidant supplementation only in subjects who were nonsmokers or who had low serum vitamin C concentrations at baseline. This study supports the role of an adequate antioxidant nutrient status in the preservation of verbal memory under certain conditions. This trial was registered at clinicaltrials.gov as NCT00272428.

  6. High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study.

    Science.gov (United States)

    Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Inui, Takashi; Yano, Toshiro; Yoshinari, Toru; Abe, Tohru; Koike, Takao

    2017-09-02

    Although both rheumatoid factor (RF) and anticyclic citrullinated peptide antibodies (anti-CCP) are useful for diagnosing rheumatoid arthritis (RA), the impact of these autoantibodies on the efficacy of tumor necrosis factor (TNF) inhibitors has been controversial. The aim of this post hoc analysis of a randomized double-blind study (the RISING study) was to investigate the influences of RF and anti-CCP on the clinical response to infliximab in patients with RA. Methotrexate-refractory patients with RA received 3 mg/kg of infliximab from weeks 0 to 6 and then 3, 6, or 10 mg/kg every 8 weeks from weeks 14 to 46. In this post hoc analysis, patients were stratified into three classes on the basis of baseline RF/anti-CCP titers: "low/low-C" (RF < 55 IU/ml, anti-CCP < 42 U/ml), "high/high-C" (RF ≥ 160 IU/ml, anti-CCP ≥ 100 U/ml), and "middle-C" (neither low/low-C nor high/high-C). Baseline plasma TNF level, serum infliximab level, and disease activity were compared between the three classes. Baseline RF and anti-CCP titers showed significant correlations with baseline TNF and infliximab levels in weeks 2-14. Comparison of the three classes showed that baseline TNF level was lowest in the low/low-C group and highest in the high/high-C group (median 0.73 versus 1.15 pg/ml), that infliximab levels at week 14 were highest in the low/low-C group and lowest in the high/high-C group (median 1.0 versus 0.1 μg/ml), and that Disease Activity Score in 28 joints based on C-reactive protein at week 14 was lowest in the low/low-C group and highest in the high/high-C group (median 3.17 versus 3.82). A similar correlation was observed at week 54 in the 3 mg/kg dosing group, but not in the 6 or 10 mg/kg group. Significant decreases in both RF and anti-CCP were observed during infliximab treatment. RF/anti-CCP titers correlated with TNF level. This might explain the association of RF/anti-CCP with infliximab level and clinical response in patients with RA

  7. Schools That Make a Difference to Post-Compulsory Uptake of Physical Science Subjects: Some comparative case studies in England

    Science.gov (United States)

    Bennett, Judith; Lubben, Fred; Hampden-Thompson, Gillian

    2013-03-01

    This paper presents the findings of the qualitative component of a combined methods research study that explores a range of individual and school factors that influence the uptake of chemistry and physics in post-compulsory study in England. The first phase involves using the National Pupil Database to provide a sampling frame to identify four matched pairs of high-uptake and low-uptake schools by salient school factors. Case studies of these eight schools indicate that students employ selection strategies related to their career aspirations, their sense of identity and tactics, and their prior experience. The school factors influencing subject choice relate to school management, student support and guidance, and student empowerment. The most notable differences between students in high-uptake and low-uptake schools are that students in high-uptake schools appear to make a proactive choice in relation to career aspirations, rather than a reactive choice on the basis of past experience. Schools with a high uptake offer a diverse science curriculum in the final two years of compulsory study, set higher examination entry requirements for further study and, crucially, provide a range of opportunities for students to interact with the world of work and to gain knowledge and experience of science-related careers.

  8. The levels of the adipokines adipsin and leptin are associated with knee osteoarthritis progression as assessed by MRI and incidence of total knee replacement in symptomatic osteoarthritis patients: a post hoc analysis.

    Science.gov (United States)

    Martel-Pelletier, Johanne; Raynauld, Jean-Pierre; Dorais, Marc; Abram, François; Pelletier, Jean-Pierre

    2016-04-01

    Limited studies have explored the association between adipokines and knee OA structural progression using quantitative MRI (qMRI), and very few have included total knee replacement (TKR) as a disease outcome. The objective of this study was to compare serum levels of five adipokines to cartilage volume loss (CVL) and investigate their predictive value for TKR. The according-to-protocol population (n = 138) of a knee OA trial was used. Serum levels of adipsin (complement factor D), leptin, adiponectin, resistin and serpin E1, and cartilage volume were determined at baseline and 24 months with specific ELISAs and qMRI, respectively. Study knee TKR incidence up to 4 years post-trial was also assessed. Greater baseline values of adipsin and leptin correlated with increased CVL in the global knee and medial femur (P ⩽ 0.032) and of adipsin in the lateral compartment and femur (P ⩽ 0.028). Adiponectin showed an inverse correlation in the medial compartment and femur (P ⩽ 0.027). Resistin and serpin E1 were not associated with CVL. Multivariate analyses revealed that patients in the highest tertile at baseline of adipsin presented a greater odds ratio of CVL in the lateral compartment and femur (⩾2.87; P ⩽ 0.011), and those in the highest tertile of leptin in the medial compartment (2.78; P = 0.038). Most clinically relevant, patients in the highest tertile of adipsin or leptin at baseline had significantly greater incidence of TKR (P = 0.027). Data demonstrate that both adipsin and leptin predict greater CVL over time in the lateral and medial compartment, respectively. Importantly, this study also demonstrates that higher baseline levels of adipsin or leptin are associated with higher incidence of TKR. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. Anti-citrullinated peptide antibodies are the strongest predictor of clinically relevant radiographic progression in rheumatoid arthritis patients achieving remission or low disease activity: A post hoc analysis of a nationwide cohort in Japan.

    Directory of Open Access Journals (Sweden)

    Tomohiro Koga

    Full Text Available To determine prognostic factors of clinically relevant radiographic progression (CRRP in patients with rheumatoid arthritis (RA achieving remission or low disease activity (LDA in clinical practice.Using data from a nationwide, multicenter, prospective study in Japan, we evaluated 198 biological disease-modifying antirheumatic drug (bDMARD-naïve RA patients who were in remission or had LDA at study entry after being treated with conventional synthetic DMARDs (csDMARDs. CRRP was defined as the yearly progression of modified total Sharp score (mTSS >3.0 U. We performed a multiple logistic regression analysis to explore the factors to predict CRRP at 1 year. We used receiver operating characteristic (ROC curve to estimate the performance of relevant variables for predicting CRRP.The mean Disease Activity Score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR was 2.32 ± 0.58 at study entry. During the 1-year observation, remission or LDA persisted in 72% of the patients. CRRP was observed in 7.6% of the patients. The multiple logistic regression analysis revealed that the independent variables to predict the development of CRRP were: anti-citrullinated peptide antibodies (ACPA positivity at baseline (OR = 15.2, 95%CI 2.64-299, time-integrated DAS28-ESR during the 1 year post-baseline (7.85-unit increase, OR = 1.83, 95%CI 1.03-3.45, and the mTSS at baseline (13-unit increase, OR = 1.22, 95%CI 1.06-1.42.ACPA positivity was the strongest independent predictor of CRRP in patients with RA in remission or LDA. Physicians should recognize ACPA as a poor-prognosis factor regarding the radiographic outcome of RA, even among patients showing a clinically favorable response to DMARDs.

  10. History of depressive and/or anxiety disorders as a predictor of treatment response: a post hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release in patients with fibromyalgia.

    Science.gov (United States)

    Pae, Chi-Un; Masand, Prakash S; Marks, David M; Krulewicz, Stan; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A

    2009-08-31

    Despite of a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited but antidepressants are commonly prescribed to treat fibromyalgia in clinical practice. We investigated whether a history of depressive and/or anxiety disorders was associated with response to paroxetine controlled release (CR) in the treatment of fibromyalgia. One hundred sixteen (116) fibromyalgia subjects were randomized to receive paroxetine CR or placebo for 12 weeks. The primary outcome was treatment response defined as >or=25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. In multivariate logistic regression, we determined if a history of depression and/or anxiety disorders was an independent predictor of response to paroxetine CR. In logistic regression, the history of depression and/or anxiety did not predict treatment response as measured by >or=25% reduction in Fibromyalgia Impact Questionnaire (FIQ) score (OR=0.66, 95% CI=.29-1.49, Wald=0.97, p=0.32), while the drug status (paroxetine CR) was significantly associated with treatment response (OR=2.57, CI=1.2-5.61, Wald=5.5, p=0.02). A significant proportion of patients with fibromyalgia had a history of anxiety and or depressive disorders. However response to treatment of fibromyalgia symptoms with paroxetine CR was not associated with a history of depressive and/or anxiety disorders. Our findings need to be confirmed in more adequately-powered and well-designed subsequent studies.

  11. Role of timing and dose of energy received in patients with acute lung injury on mortality in the Intensive Nutrition in Acute Lung Injury Trial (INTACT): a post hoc analysis.

    Science.gov (United States)

    Braunschweig, Carol L; Freels, Sally; Sheean, Patricia M; Peterson, Sarah J; Perez, Sandra Gomez; McKeever, Liam; Lateef, Omar; Gurka, David; Fantuzzi, Giamila

    2017-02-01

    Our trial INTACT (Intensive Nutrition in Acute Lung Injury Trial) was designed to compare the impact of feeding from acute lung injury (ALI) diagnosis to hospital discharge, an interval that, to our knowledge, has not yet been explored. It was stopped early because participants who were randomly assigned to energy intakes at nationally recommended amounts via intensive medical nutrition therapy experienced significantly higher mortality hazards than did those assigned to standard nutrition support care that provided energy at 55% of recommended concentrations. We assessed the influence of dose and timing of feeding on hospital mortality. Participants (n = 78) were dichotomized as died or discharged alive. Associations between the energy and protein received overall, early (days 1-7), and late (days ≥8) and the hazards of hospital mortality were evaluated between groups with multivariable analysis methods. Higher overall energy intake predicted significantly higher mortality (OR: 1.14, 95% CI: 1.02, 1.27). Among participants enrolled for ≥8 d (n = 66), higher early energy intake significantly increased the HR for mortality (HR: 1.17, 95% CI: 1.07, 1.28), whereas higher late energy intake was significantly protective (HR: 0.91, 95% CI: 0.83, 1.0). Results were similar for early but not late protein (grams per kilogram) exposure (early-exposure HR: 8.9, 95% CI: 2.3, 34.3; late-exposure HR: 0.15, 95% CI: 0.02, 1.1). Threshold analyses indicated early mean intakes ≥18 kcal/kg significantly increased subsequent mortality. Providing kilocalories per kilogram or grams of protein per kilogram early post-ALI diagnosis at recommended levels was associated with significantly higher hazards for mortality, whereas higher late energy intakes reduced mortality hazards. This time-varying effect violated the Cox proportionality assumption, indicating that feeding trials in similar populations should extend beyond 7 d and use time-varying statistical methods. Future trials are

  12. Mobile Offloading in Wireless Ad Hoc Networks

    OpenAIRE

    Kalejaiye, Gabriel B. T.; Rondina, João A. S. R.; Albuquerque, Leonardo V. V. L.; Pereira, Taís L.; Campos, Luiz F. O.; Melo, Raphael A. S.; Mascarenhas, Daniel S.; Carvalho, Marcelo M.

    2014-01-01

    This paper describes a strategy that was designed, implemented, and presented at the {\\it Mobile Ad Hoc Networking Interoperability and Cooperation (MANIAC) Challenge 2013}. The theme of the MANIAC Challenge 2013 was ``Mobile Data Offloading,'' and consisted on developing and comparatively evaluating strategies to offload infrastructure access points via customer ad hoc forwarding using handheld devices (e.g., tablets and smartphones). According to the challenge rules, a hop-by-hop bidding co...

  13. Association between the changes in renal function and serum uric acid levels during multifactorial intervention and clinical outcome in patients with metabolic syndrome. A post hoc analysis of the ATTEMPT study.

    Science.gov (United States)

    Athyros, Vassilios G; Karagiannis, Asterios; Ganotakis, Emmanouel S; Paletas, Konstantinos; Nicolaou, Vassilios; Bacharoudis, George; Tziomalos, Konstantinos; Alexandrides, Theodore; Liberopoulos, Evangelos N; Mikhailidis, Dimitri P

    2011-08-01

    To assess the effects of long-term multifactorial intervention on renal function and serum uric acid (SUA) levels and their association with estimated cardiovascular disease (eCVD) risk and actual CVD events. This prospective, randomized, target-driven study included 1123 subjects (45.6% men, age 45-65 years) with metabolic syndrome (MetS) but without diabetes or CVD. Patients were randomized to multifactorial treatment. Atorvastatin was titrated from 10-80 mg/day aiming at a low density lipoprotein cholesterol (LDL-C) target of <100 mg/dl (group A) or an LDL-C target of <130 mg/dl (group B). Changes in estimated glomerular filtration rate (eGFR) and SUA levels were recorded in all patients and in the subgroup with stage 3 chronic kidney disease (CKD; eGFR = 30-59 ml/min/1.73 m(2); n = 349). We used ANOVA to compare changes within the same group, unpaired Student t-test to compare results between groups at specific time points, and log-rank test to compare event free survival. The eCVD-risk reduction was greater in group A. In the overall study population, eGFR increased by 3.5% (p < 0.001) and SUA levels fell by 5.6% (p < 0.001). In patients from group A with stage 3 CKD (group A1; n = 172), eGFR increased by 11.1% (p < 0.001) from baseline and by 7.5% (p < 0.001) in group B1 (n = 177; p < 0.001 vs. the change in group A1). The corresponding fall in SUA levels was 10.7% in group A1 (p < 0.001 vs. baseline) and 8.3% in group B1 (p < 0.001 vs. baseline and group A1). These changes were mainly attributed to atorvastatin treatment. Among the CKD stage 3 patients there were no CVD events in group A1, while 6 events occurred in group B1 (p = 0.014). Multifactorial intervention in patients with MetS without established CVD improved renal function and reduced SUA levels. These changes were more prominent in stage 3 CKD patients and might have contributed to the reduction in eCVD risk and clinical events. Original

  14. Co-activation of upper limb muscles during reaching in post-stroke subjects: an analysis of the contralesional and ipsilesional limbs.

    Science.gov (United States)

    Silva, Cláudia C; Silva, Augusta; Sousa, Andreia; Pinheiro, Ana Rita; Bourlinova, Catarina; Silva, Ana; Salazar, António; Borges, Carla; Crasto, Carlos; Correia, Miguel Velhote; Vilas-Boas, João Paulo; Santos, Rubim

    2014-10-01

    The purpose of this study was to analyze the change in antagonist co-activation ratio of upper-limb muscle pairs, during the reaching movement, of both ipsilesional and contralesional limbs of post-stroke subjects. Nine healthy and nine post-stroke subjects were instructed to reach and grasp a target, placed in the sagittal and scapular planes of movement. Surface EMG was recorded from postural control and movement related muscles. Reaching movement was divided in two sub-phases, according to proximal postural control versus movement control demands, during which antagonist co-activation ratios were calculated for the muscle pairs LD/PM, PD/AD, TRIlat/BB and TRIlat/BR. Post-stroke's ipsilesional limb presented lower co-activation in muscles with an important role in postural control (LD/PM), comparing to the healthy subjects during the first sub-phase, when the movement was performed in the sagittal plane (plimb showed in general an increased co-activation ratio in muscles related to movement control, comparing to the healthy subjects. Our findings demonstrate that, in post-stroke subjects, the reaching movement performed with the ipsilesional upper limb seems to show co-activation impairments in muscle pairs associated to postural control, whereas the contralesional upper limb seems to have signs of impairment of muscle pairs related to movement. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Influence of specific muscle training on pain, activity limitation and kinesiophobia in women with back pain post-partum--a 'single-subject research design'.

    Science.gov (United States)

    Gustafsson, Johanna; Nilsson-Wikmar, Lena

    2008-03-01

    Many women suffer from back pain and experience activity limitation post-partum. To our knowledge the physiological factors and physiotherapy related to back pain post-partum have received limited evaluation and the effectiveness of specific physiotherapeutic approaches to exercise should be tested. In addition, there has been limited research on kinesiophobia in women with back pain post-partum. The purpose of the current study was to test the influence of specific trunk muscle training on pain, activity limitation and kinesiophobia in 10 subjects with back pain post-partum. The treatment consisted of specific deep muscle training of the transversus abdominus and multifidus muscles. Pain was rated based on the visual analogue scale (VAS) and pain drawings. Activity limitation was recorded using the Disability Rating Index. Kinesiophobia was evaluated using the Swedish version of the Tampa Scale for Kinesiophobia. An A-B-A single-subject research design was used and a number of measurements were obtained during each phase. The analysis consisted of a visual inspection and a two standard deviation band test (2-SD). The visual analysis showed a trend towards reduced pain and activity limitation for all 10 subjects. The 2-SD test showed mixed results among all subjects. In addition, all subjects reported kinesiophobia before and after treatment. Individual specific deep muscle training of the transversus abdominus and multifidus muscles reduced pain and activity limitation in women with back pain post-partum. Further research is needed to determine more precisely how kinesiophobia affects women with back pain post-partum.

  16. Low diagnostic value of fasting and post-methionine load homocysteine tests. A study in Dutch subjects with homocysteine test indications

    NARCIS (Netherlands)

    Fokkema, M R; Dijck-Brouwer, D A J; van Doormaal, J J; Reijngoud, D J; Muskiet, F A J

    BACKGROUND: Homocysteine is a cardiovascular disease risk factor. We investigated, both in subjects with past plasma total homocysteine (tHcy) test indications and healthy adults, the diagnostic value of a fasting (tHcy) (f-tHcy) and the added value of a post-methionine-load tHcy (postload-tHcy).

  17. High serum carotenoids associated with lower risk for bone loss and osteoporosis in post-menopausal Japanese female subjects: prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Minoru Sugiura

    Full Text Available INTRODUCTION: Recent epidemiological studies show that high intakes of carotenoids might be useful to maintain bone health, but little is known about the association of serum carotenoids with change of bone mineral density (BMD. The objective of this study was to investigate longitudinally whether serum carotenoids are associated with bone loss. METHODS: We conducted a follow-up on 146 male and 99 pre- and 212 post-menopausal female subjects from the Mikkabi study. Those who participated in previous BMD surveys and completed four years of follow-up were examined longitudinally. RESULTS: During a 4-year follow-up, 15 of the post-menopausal female subjects developed new-onset osteoporosis. In contrast, none of the male and pre-menopausal female subjects did. In male and pre-menopausal female subjects, the six serum carotenoids at the baseline were not associated with bone loss. On the other hand, in post-menopausal female subjects, the 4-year bone loss of radius was inversely associated with the serum carotenoid concentrations, especially in β-carotene. After adjustments for confounders, the odds ratios (OR for osteoporosis in the highest tertiles of serum β-carotene and β-cryptoxanthin against the lowest tertiles were 0.24 (95% confidence interval 0.05-1.21 and 0.07 (CI: 0.01-0.88, respectively. Serum β-cryptoxanthin was also inversely associated with the risk for osteopenia and/or osteoporosis (P for trend, 0.037. In addition, our retrospective analysis revealed that subjects who developed osteoporosis and/or osteopenia during the survey period had significantly lower serum concentrations of β-cryptoxanthin and β-carotene at the baseline than those in the normal group. CONCLUSIONS: Antioxidant carotenoids, especially β-cryptoxanthin and β-carotene, are inversely associated with the change of radial BMD in post-menopausal female subjects.

  18. How does functionality proceed in ACL reconstructed subjects? Proceeding of functional performance from pre- to six months post-ACL reconstruction

    Science.gov (United States)

    Stetter, Bernd Josef; Stein, Thorsten; Ellermann, Andree; Flechtenmacher, Johannes; Eberle, Christian; Sell, Stefan; Potthast, Wolfgang

    2017-01-01

    This is the first study examining functionality of subjects with anterior cruciate ligament (ACL) tears and a subsequent reconstruction comprehensively by multiple test sessions from pre- to six months post-reconstruction. The purpose was to evaluate if a generally applied rehabilitation program restores functionality to levels of healthy controls. Subjects with unilateral tears of the ACL were compared to matched healthy controls throughout the rehabilitation. 20 recreational athletes were tested: T1 (preoperative), 6 weeks after tear; T2, 6 weeks, T3, 3 months, T4, 6 months post-reconstruction. At all test sessions, subjects self-evaluated their activity level with the Tegner activity score and their knee state with the Knee Injury and Osteoarthritis Outcome Score. Passive range of motion during knee flexion and extension and leg circumference were measured as functional clinical tests. Bilateral countermovement jumps, one-leg jumps for distance and isometric force tests in knee flexion and extension with 90° and 110° knee angle were conducted as functional performance tests. For determination of functionality, leg symmetry indices (LSIs) were calculated by dividing values of the injured by the uninjured leg. In the ACL group most LSIs decreased from T1 to T2, and increased from T2 and T3 to T4. LSIs of ACL subjects remained lower than LSIs of healthy controls at 6 months post-reconstruction in nearly all parameters. Self-evaluation of ACL subjects showed, additionally, that activity level was lower than the pre-injury level at 6 months post-reconstruction. Low LSIs and low self-evaluation indicate that knee joint functionality is not completely restored at 6 months post-reconstruction. The study shows that multiple comprehensive testing throughout the rehabilitation gives detailed images of the functional state. Therefore, the functional state of ACL reconstructed individuals should be evaluated comprehensively and continuously throughout the rehabilitation to

  19. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects.

    Science.gov (United States)

    Shi, Nianmin; Zhang, Yibin; Zheng, Huizhen; Zhu, Zhenggang; Wang, Dingming; Li, Sihai; Li, Yuhua; Yang, Liqing; Zhang, Junnan; Bai, Yunhua; Lu, Qiang; Zhang, Zheng; Luo, Fengji; Yu, Chun; Li, Li

    2017-06-03

    To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.

  20. The 11th Annual Mediterranean Ad Hoc Networking Workshop (Med-Hoc-Net 2012 )

    NARCIS (Netherlands)

    Pitsillides, A.; Douligeris, C.; Vassiliou, V.; Heijenk, Geert; Cavalcante de Oliveira, J.

    Message from the General Chairs Welcome to the 2012 Mediterranean Ad Hoc Networking Workshop in Ayia Napa, Cyprus. We are excited to host Med-Hoc-Net. As a major annual international workshop, following recent successful workshops in Sicily (2006), Corfu (2007), Palma de Mallorca (2008), Haifa

  1. The 11th Annual Mediterranean Ad Hoc Networking Workshop (Med-Hoc-Net 2012)

    NARCIS (Netherlands)

    Pitsillides, A.; Douligeris, C.; Vassiliou, V.; Heijenk, Geert; Cavalcante de Oliveira, J.

    Message from the General Chairs Welcome to the 2012 Mediterranean Ad Hoc Networking Workshop in Ayia Napa, Cyprus. We are excited to host Med-Hoc-Net. As a major annual international workshop, following recent successful workshops in Sicily (2006), Corfu (2007), Palma de Mallorca (2008), Haifa

  2. Investigation on occupant ejection in high severity rear impact based on post mortem human subject sled tests.

    Science.gov (United States)

    Petit, Philippe; Luet, Carole; Potier, Pascal; Vallancien, Guy

    2011-11-01

    Occupant protection in rear impact involves two competing challenges. On one hand, allowing a deformation of the seat would act as an energy absorber in low severity impacts and would consequently decrease the risk of neck injuries. However, on the other hand, large deformations of the seat may increase the likelihood of occupant ejection in high severity cases. Green et al. 1987 analyzed a total of 919 accidents in Great Britain. They found that occupant ejection resulted in a risk of severe injuries and fatalities between 3.6 and 4.5 times higher than those cases where no ejection was observed. The sample included single front, side and rear impacts as well as multiple impacts and rollover. The rate of belt use in the sample was 50%. While this analysis included all forms of impact scenarios, nevertheless, it highlights the relative injury severity of occupant ejection. Extensive literature search has found no full-scale rear impact tests involving Post Mortem Human Subjects (PMHS) conducted in a laboratory environment and resulting in ejection. This paper describes a total of 10 sled tests conducted on 3 belted PMHS using a simplified seat design composed of rigid plates assembled such that the angular and linear stiffness of the seatback (including the foam) was modeled. The initial angular position and the range of motion of the seatback, the size of the PMHS, the slack length of the seatbelt, the angular stiffness of the seatback, and the use of headrest were varied in the test matrix while the pulse was kept constant (triangular acceleration with a peak of 17 G at 30 ms and a duration of 95 ms). In the test series, the tests were not run randomly but the likelihood of occupant ejection was increased systematically until ejection occurred. PMHS seat ejection was observed only for the 95th percentile, initially positioned with a seatback angle relative to the vertical equal to 22°, a range of seatback angular motion equal to 44° and no headrest. Repeating

  3. The effects of interval- vs. continuous exercise on excess post-exercise oxygen consumption and substrate oxidation rates in subjects with type 2 diabetes

    DEFF Research Database (Denmark)

    Karstoft, Kristian; Wallis, Gareth A.; Pedersen, Bente K.

    2016-01-01

    ), substrate oxidation rates and lipid metabolism in the hours following exercise in subjects with type 2 diabetes (T2D). Methods Following an overnight fast, ten T2D subjects (M/F: 7/3; age = 60.3 ± 2.3 years; body mass index (BMI) = 28.3 ± 1.1 kg/m2) completed three 60-min interventions in a counterbalanced......, free fatty acids and glycerol concentrations, and glycerol kinetics were increased comparably during and after IW and CW compared to CON. Conclusions Interval exercise results in greater EPOC than oxygen-consumption matched continuous exercise during a post-exercise MMTT in subjects with T2D, whereas......Background For unknown reasons, interval training often reduces body weight more than energy-expenditure matched continuous training. We compared the acute effects of time-duration and oxygen-consumption matched interval- vs. continuous exercise on excess post-exercise oxygen consumption (EPOC...

  4. Ad hoc networks telecommunications and game theory

    CERN Document Server

    Benslama, Malek; Batatia, Hadj

    2015-01-01

    Random SALOHA and CSMA protocols that are used to access MAC in ad hoc networks are very small compared to the multiple and spontaneous use of the transmission channel. So they have low immunity to the problems of packet collisions. Indeed, the transmission time is the critical factor in the operation of such networks. The simulations demonstrate the positive impact of erasure codes on the throughput of the transmission in ad hoc networks. However, the network still suffers from the intermittency and volatility of its efficiency throughout its operation, and it switches quickly to the satura

  5. Tribunales arbitrales ad hoc en el Mercosur

    OpenAIRE

    Bou Franch, Valentín

    2011-01-01

    El Mercosur tiene establecido un procedimiento obligatorio de solución de controversias comerciales entre sus Estados miembros. No obstante, en caso de surgir una controversia, el Estado demandante y el demandado pueden pactar de mutuo acuerdo que la misma no se someta al procedimiento ordinario de solución, sino a un Tribunal arbitral ad hoc. En este trabajo, se analiza la elaboración de las dos listas de árbitros, la constitución de cada Tribunal arbitral ad hoc, el procedimiento y la oblig...

  6. Vehicular ad hoc network security and privacy

    CERN Document Server

    Lin, X

    2015-01-01

    Unlike any other book in this area, this book provides innovative solutions to security issues, making this book a must read for anyone working with or studying security measures. Vehicular Ad Hoc Network Security and Privacy mainly focuses on security and privacy issues related to vehicular communication systems. It begins with a comprehensive introduction to vehicular ad hoc network and its unique security threats and privacy concerns and then illustrates how to address those challenges in highly dynamic and large size wireless network environments from multiple perspectives. This book is richly illustrated with detailed designs and results for approaching security and privacy threats.

  7. Effects of Tangshen Formula on urinary and plasma liver-type fatty acid binding protein levels in patients with type 2 diabetic kidney disease: post-hoc findings from a multi-center, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Tangshen Formula in patients with type 2 diabetic kidney disease.

    Science.gov (United States)

    Yang, Xin; Zhang, Bingxuan; Lu, Xiaoguang; Yan, Meihua; Wen, Yumin; Zhao, Tingting; Li, Ping

    2016-07-26

    Tangshen Formula (TSF) is a traditional Chinese medicine for the treatment of diabetic kidney disease (DKD). Liver-type fatty acid binding protein (L-FABP) is expressed in various tissues, including the kidney, where it is known as urinary L-FABP. Other studies demonstrated that urinary L-FABP may be a useful biomarker for monitoring DKD. This post-hoc analysis and cross-sectional study evaluated the changes in urinary L-FABP in DKD patients treated with TSF and conventional medicine. Post-hoc analysis was conducted on a multicenter, randomized, double-blind, placebo-controlled trial. A total of 180 participants with DKD including 98 with microalbuminuria and 82 with macroalbuminuria were enrolled in the original study. In addition to conventional treatment, 122 participants were randomly assigned to receive TSF and 58 to receive placebo. After 24-weeks of treatment, the intention-to-treat population in microalbuminuria stage was 56 in the TSF group and 25 in the placebo group, and in the macroalbuminuria stage 42 and 19, respectively. The primary outcome in the original trial was urinary protein level. In the current study, urinary and plasma L-FABP levels were measured in 30 microalbuminuria patients (15 in the TSF group and 15 in the placebo group) and 30 macroalbuminuria patients (15 in the TSF group and 15 in the placebo group). In addition, another 30 patients with normoalbuminuria (urinary albumin excretion rate (UAER) < 20 μg/min) were recruited for the cross-sectional study. (1) In microalbuminuria patients, UAER in the TSF group displayed a significant decrease after 24 weeks of treatment (P = 0.045). Levels of urinary L-FABP in the TSF group were markedly lower than in the placebo group after 12 and 24 weeks (P = 0.004 and P = 0.047, respectively). (2) In macroalbuminuria patients, 24-h urinary protein levels decreased significantly compared with baseline in the TSF group at week 12 (P = 0.042) and week 24 (P = 0.041). The TSF

  8. Mapping out the subject of Brazilian social psychology in the production of the national association of research and post-graduate studies in psychology

    Directory of Open Access Journals (Sweden)

    Marcos Adegas de Azambuja

    2013-01-01

    Full Text Available This paper problematizes the Brazilian Social Psychology and its knowledge production on the registers of the Work Group (WG of symposiums of the National Association of Research and Post-Graduation in Psychology (ANPEPP, during 1988 to 2010. Using Michel Foucault's archeo-genealogical perspective and the contributions by Ian Hacking about the historical ontology of subjects, we analyzed technologies of power and knowledge in the disciplines of Social Psychology. We selected the WG abstracts in which circulate the utterances that make up the discursive field of Brazilian Social Psychology. Using the narrative of WGs we outlined a discursive formation of identities/technologies of the subject. The knowledges of Social Psychology in the history of the ANPEPP's WGs contribute to the constitution of categories and psychological classifications which objectivize subjects. We think Social Psychology, in its criticisms related to psychological and social concepts comprises practices and regimes of truth about the subject of Social Psychology.

  9. Ad-Hoc Transient Communities Simulation

    NARCIS (Netherlands)

    Van den Berg, Bert; Van Rosmalen, Peter; Sloep, Peter; Brouns, Francis; Fetter, Sibren; Berlanga, Adriana

    2009-01-01

    Van den Berg, B., Van Rosmalen, P., Sloep, P. B., Brouns, F., Fetter, S., & Berlanga, A. J. (2009). Ad-Hoc Transient Communities Simulation. The Netlogo application is distributed as a java applet and for that matter part of an archive which contains also the NetlogoLiteJar and the index.htm to

  10. Anomaly Detection Techniques for Ad Hoc Networks

    Science.gov (United States)

    Cai, Chaoli

    2009-01-01

    Anomaly detection is an important and indispensable aspect of any computer security mechanism. Ad hoc and mobile networks consist of a number of peer mobile nodes that are capable of communicating with each other absent a fixed infrastructure. Arbitrary node movements and lack of centralized control make them vulnerable to a wide variety of…

  11. DAWN: Dynamic Ad-hoc Wireless Network

    Science.gov (United States)

    2016-06-19

    Wireless Network 1 Introduction The network-centric battlefield includes sensors, troop carriers, unmanned air vehicle (UAV), aircraft, smart ...Bellman Control Heritage Award. • Honorary Doctorate at Technical University of Crete. • Best paper award at 2008 IEEE International Conference on Mobile Ad-hoc and Sensor Systems.

  12. Swift Trust in Distributed Ad Hoc Teams

    Science.gov (United States)

    2007-10-04

    not visible or likely to be in close proximity . Page 22 Swift Trust in Distributed Ad hoc Teams Humansystems® mission ended, the servers were...simply allow less “ poetic license” when making judgements about other people. Perhaps asking about a more ambiguous behaviour or task would have yielded

  13. The 11th Annual Mediterranean Ad Hoc Networking Workshop (Med-Hoc-Net 2012 )

    OpenAIRE

    Pitsillides, A.; Douligeris, C.; Vassiliou, V; Heijenk, Geert; Cavalcante de Oliveira, J.

    2012-01-01

    Message from the General Chairs Welcome to the 2012 Mediterranean Ad Hoc Networking Workshop in Ayia Napa, Cyprus. We are excited to host Med-Hoc-Net. As a major annual international workshop, following recent successful workshops in Sicily (2006), Corfu (2007), Palma de Mallorca (2008), Haifa (2009), Juan-les-pins (2010), and Favignana Island (2011), the 11th Med-Hoc-Net (2012) aims to serve as a platform for researchers and visionaries from the academia, the research laboratories, and the i...

  14. Mapping out the subject of Brazilian social psychology in the production of the national association of research and post-graduate studies in psychology

    OpenAIRE

    Marcos Adegas de Azambuja; Carolina dos Reis; Neuza Maria de Fátima Guareschi; Simone Maria Hüning

    2013-01-01

    This paper problematizes the Brazilian Social Psychology and its knowledge production on the registers of the Work Group (WG) of symposiums of the National Association of Research and Post-Graduation in Psychology (ANPEPP), during 1988 to 2010. Using Michel Foucault's archeo-genealogical perspective and the contributions by Ian Hacking about the historical ontology of subjects, we analyzed technologies of power and knowledge in the disciplines of Social Psychology. We selected the WG abstract...

  15. Elevated 1-h post-challenge plasma glucose levels in subjects with normal glucose tolerance or impaired glucose tolerance are associated with whole blood viscosity.

    Science.gov (United States)

    Marini, Maria Adelaide; Fiorentino, Teresa Vanessa; Andreozzi, Francesco; Mannino, Gaia Chiara; Perticone, Maria; Sciacqua, Angela; Perticone, Francesco; Sesti, Giorgio

    2017-08-01

    It has been suggested that glucose levels ≥155 mg/dl at 1-h during an oral glucose tolerance test (OGTT) may predict development of type 2 diabetes and cardiovascular events among adults with normal glucose tolerance (NGT 1 h-high). Studies showed a link between increased blood viscosity and type 2 diabetes. However, whether blood viscosity is associated with dysglycemic conditions such as NGT 1 h-high, impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) is unsettled. 1723 non-diabetic adults underwent biochemical evaluation and OGTT. A validated formula based on hematocrit and total plasma proteins was employed to estimate whole blood viscosity. Subjects were categorized into NGT with 1 h glucose h-low), NGT-1 h-high, IFG and/or IGT. Hematocrit and blood viscosity values appeared significantly higher in individuals with NGT 1 h-high, IFG and/or IGT as compared to NGT 1 h-low subjects. Blood viscosity was significantly correlated with age, waist circumference, blood pressure, HbA1c, fasting, 1- and 2-h post-challenge insulin levels, total cholesterol and low-density lipoprotein, triglycerides, fibrinogen, white blood cell, and inversely correlated with high-density lipoprotein and insulin sensitivity. Of the four glycemic parameters, 1-h post-challenge glucose showed the strongest correlation with blood viscosity (β = 0.158, P h post-challenge plasma glucose. They also suggest that a subgroup of NGT individuals with 1-h post-challenge plasma >155 mg/dl have increased blood viscosity comparable to that observed in subjects with IFG and/or IGT.

  16. Evolutionary algorithms for mobile ad hoc networks

    CERN Document Server

    Dorronsoro, Bernabé; Danoy, Grégoire; Pigné, Yoann; Bouvry, Pascal

    2014-01-01

    Describes how evolutionary algorithms (EAs) can be used to identify, model, and minimize day-to-day problems that arise for researchers in optimization and mobile networking. Mobile ad hoc networks (MANETs), vehicular networks (VANETs), sensor networks (SNs), and hybrid networks—each of these require a designer’s keen sense and knowledge of evolutionary algorithms in order to help with the common issues that plague professionals involved in optimization and mobile networking. This book introduces readers to both mobile ad hoc networks and evolutionary algorithms, presenting basic concepts as well as detailed descriptions of each. It demonstrates how metaheuristics and evolutionary algorithms (EAs) can be used to help provide low-cost operations in the optimization process—allowing designers to put some “intelligence” or sophistication into the design. It also offers efficient and accurate information on dissemination algorithms topology management, and mobility models to address challenges in the ...

  17. Quantum load balancing in ad hoc networks

    Science.gov (United States)

    Hasanpour, M.; Shariat, S.; Barnaghi, P.; Hoseinitabatabaei, S. A.; Vahid, S.; Tafazolli, R.

    2017-06-01

    This paper presents a novel approach in targeting load balancing in ad hoc networks utilizing the properties of quantum game theory. This approach benefits from the instantaneous and information-less capability of entangled particles to synchronize the load balancing strategies in ad hoc networks. The quantum load balancing (QLB) algorithm proposed by this work is implemented on top of OLSR as the baseline routing protocol; its performance is analyzed against the baseline OLSR, and considerable gain is reported regarding some of the main QoS metrics such as delay and jitter. Furthermore, it is shown that QLB algorithm supports a solid stability gain in terms of throughput which stands a proof of concept for the load balancing properties of the proposed theory.

  18. Constrained Delaunay Triangulation for Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    D. Satyanarayana

    2008-01-01

    Full Text Available Geometric spanners can be used for efficient routing in wireless ad hoc networks. Computation of existing spanners for ad hoc networks primarily focused on geometric properties without considering network requirements. In this paper, we propose a new spanner called constrained Delaunay triangulation (CDT which considers both geometric properties and network requirements. The CDT is formed by introducing a small set of constraint edges into local Delaunay triangulation (LDel to reduce the number of hops between nodes in the network graph. We have simulated the CDT using network simulator (ns-2.28 and compared with Gabriel graph (GG, relative neighborhood graph (RNG, local Delaunay triangulation (LDel, and planarized local Delaunay triangulation (PLDel. The simulation results show that the minimum number of hops from source to destination is less than other spanners. We also observed the decrease in delay, jitter, and improvement in throughput.

  19. Supporting Dynamic Ad hoc Collaboration Capabilities

    Energy Technology Data Exchange (ETDEWEB)

    Agarwal, Deborah A. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Berket, Karlo [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2003-07-14

    Modern HENP experiments such as CMS and Atlas involve as many as 2000 collaborators around the world. Collaborations this large will be unable to meet often enough to support working closely together. Many of the tools currently available for collaboration focus on heavy-weight applications such as videoconferencing tools. While these are important, there is a more basic need for tools that support connecting physicists to work together on an ad hoc or continuous basis. Tools that support the day-to-day connectivity and underlying needs of a group of collaborators are important for providing light-weight, non-intrusive, and flexible ways to work collaboratively. Some example tools include messaging, file-sharing, and shared plot viewers. An important component of the environment is a scalable underlying communication framework. In this paper we will describe our current progress on building a dynamic and ad hoc collaboration environment and our vision for its evolution into a HENP collaboration environment.

  20. Ad–hoc Workflows for Higher Education

    OpenAIRE

    Martinho, David; Coelho, Samuel; Guerra e Silva, Luis; Carvalho, João Carlos; Severo, Rita; Cruz, Luis; Ventura, Artur; Santos, Pedro; Barata, Ricardo

    2015-01-01

    It is commonplace in higher education institutions, for a large number of informal business processes to be handled through e–mail. However, e–mail fails to properly support traceability, and it fosters artifact duplication. This paper introduces GEARS: a solution to the e–mail overuse phenomenon. GEARS is a new approach to ad–hoc workflow systems that focuses on keeping the simplicity of the e–mail user experience while implementing a participation–driven process execution.

  1. Transmission Strategies in MIMO Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Fakih Khalil

    2009-01-01

    Full Text Available Abstract Precoding problem in multiple-input multiple-output (MIMO ad hoc networks is addressed in this work. Firstly, we consider the problem of maximizing the system mutual information under a power constraint. In this context, we give a brief overview of the nonlinear optimization methods, and systematically we compare their performances. Then, we propose a fast and distributed algorithm based on the quasi-Newton methods to give a lower bound of the system capacity of MIMO ad hoc networks. Our proposed algorithm solves the maximization problem while diminishing the amount of information in the feedback links needed in the cooperative optimization. Secondly, we propose a different problem formulation, which consists in minimizing the total transmit power under a quality of signal constraint. This novel problem design is motivated since the packets are captured in ad hoc networks based on their signal-to-interference-plus-noise ratio (SINR values. We convert the proposed formulation into semidefinite optimization problem, which can be solved numerically using interior point methods. Finally, an extensive set of simulations validates the proposed algorithms.

  2. Post Hoc Analysis of the PATRICIA Randomized Trial of the Efficacy of Human Papillomavirus Type 16 (HPV-16)/HPV-18 AS04-Adjuvanted Vaccine against Incident and Persistent Infection with Nonvaccine Oncogenic HPV Types Using an Alternative Multiplex Type-Specific PCR Assay for HPV DNA

    Science.gov (United States)

    Colau, Brigitte; Wheeler, Cosette M.; Naud, Paulo; Garland, Suzanne; Quint, Wim; Chow, Song-Nan; Salmerón, Jorge; Lehtinen, Matti; Del Rosario-Raymundo, M. Rowena; Paavonen, Jorma; Teixeira, Júlio C.; Germar, Maria Julieta; Peters, Klaus; Skinner, S. Rachel; Limson, Genara; Castellsagué, Xavier; Poppe, Willy A. J.; Ramjattan, Brian; Klein, Terry D.; Schwarz, Tino F.; Chatterjee, Archana; Tjalma, Wiebren A. A.; Diaz-Mitoma, Francisco; Lewis, David J. M.; Harper, Diane M.; Molijn, Anco; van Doorn, Leen-Jan; David, Marie-Pierre; Dubin, Gary

    2014-01-01

    The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV in the Papilloma Trial against Cancer in Young Adults (PATRICIA) was evaluated using a combination of the broad-spectrum L1-based SPF10 PCR-DNA enzyme immunoassay (DEIA)/line probe assay (LiPA25) system with type-specific PCRs for HPV-16 and -18. Broad-spectrum PCR assays may underestimate the presence of HPV genotypes present at relatively low concentrations in multiple infections, due to competition between genotypes. Therefore, samples were retrospectively reanalyzed using a testing algorithm incorporating the SPF10 PCR-DEIA/LiPA25 plus a novel E6-based multiplex type-specific PCR and reverse hybridization assay (MPTS12 RHA), which permits detection of a panel of nine oncogenic HPV genotypes (types 16, 18, 31, 33, 35, 45, 52, 58, and 59). For the vaccine against HPV types 16 and 18, there was no major impact on estimates of vaccine efficacy (VE) for incident or 6-month or 12-month persistent infections when the MPTS12 RHA was included in the testing algorithm versus estimates with the protocol-specified algorithm. However, the alternative testing algorithm showed greater sensitivity than the protocol-specified algorithm for detection of some nonvaccine oncogenic HPV types. More cases were gained in the control group than in the vaccine group, leading to higher point estimates of VE for 6-month and 12-month persistent infections for the nonvaccine oncogenic types included in the MPTS12 RHA assay (types 31, 33, 35, 45, 52, 58, and 59). This post hoc analysis indicates that the per-protocol testing algorithm used in PATRICIA underestimated the VE against some nonvaccine oncogenic HPV types and that the choice of the HPV DNA testing methodology is important for the evaluation of VE in clinical trials. (This study has been registered at ClinicalTrials.gov under registration no. NCT00122681.) PMID:25540273

  3. AD HOC Networks for the Autonomous Car

    Science.gov (United States)

    Ron, Davidescu; Negrus, Eugen

    2017-10-01

    The future of the vehicle is made of cars, roads and infrastructures connected in a two way automated communication in a holistic system. It is a mandatory to use Encryption to maintain Confidentiality, Integrity and Availability in an ad hoc vehicle network. Vehicle to Vehicle communication, requires multichannel interaction between mobile, moving and changing parties to insure the full benefit from data sharing and real time decision making, a network of such users referred as mobile ad hoc network (MANET), however as ad hoc networks were not implemented in such a scale, it is not clear what is the best method and protocol to apply. Furthermore the visibility of secure preferred asymmetric encrypted ad hoc networks in a real time environment of dense moving autonomous vehicles has to be demonstrated, In order to evaluate the performance of Ad Hoc networks in changing conditions a simulation of multiple protocols was performed on large number of mobile nodes. The following common routing protocols were tested, DSDV is a proactive protocol, every mobile station maintains a routing table with all available destinations, DSR is a reactive routing protocol which allows nodes in the MANET to dynamically discover a source route across multiple network hops, AODV is a reactive routing protocol Instead of being proactive. It minimizes the number of broadcasts by creating routes based on demand, SAODV is a secure version of AODV, requires heavyweight asymmetric cryptographic, ARIANDE is a routing protocol that relies on highly efficient symmetric cryptography the concept is primarily based on DSR. A methodical evolution was performed in a various density of transportation, based on known communication bench mark parameters including, Throughput Vs. time, Routing Load per packets and bytes. Out of the none encrypted protocols, It is clear that in terms of performance of throughput and routing load DSR protocol has a clear advantage the high node number mode. The encrypted

  4. A single-subject study to evaluate the inhibitory repetitive transcranial magnetic stimulation combined with traditional dysphagia therapy in patients with post-stroke dysphagia.

    Science.gov (United States)

    Ghelichi, Leila; Joghataei, Mohammad Taghi; Jalaie, Shohreh; Nakhostin-Ansari, Noureddin; Forogh, Bijan; Mehrpour, Masoud

    2016-07-06

    Post-stroke dysphagia is common and is associated with the development of pneumonia. To investigate the effects of repetitive transcranial magnetic stimulation (rTMS) combined with traditional dysphagia therapy (TDT) on swallowing function in patients with post-stroke dysphagia. In this single-subject study, four patients with dysphagia post-stroke included. The patients received the rTMS applied to the intact cerebral hemisphere at 1 Hz with train of 1200 for 5 consecutive days combined with TDT 3 days per week for 6 weeks. The main outcome measure was the Mann Assessment of Swallowing Ability (MASA). Measurements were taken before, after the end of 5(th), 10(th), 15(th) treatment sessions, and after the end of the treatment (18(th) session). The MASA scores improved in all patients following treatment. The maximum and minimum change in level between the baseline phase and treatment phase was +84 and +36. The greatest percentage improvement was observed after 5(th) treatment sessions ranging between 11 and 35%. The treatment trend was upward shown by the directions of the slopes indicated by positive values (+9.1-+20.7). The dysphagia was resolved after 10(th) treatment session in all participants. The aspiration resolved in two participants after the 5(th) treatment session and resolved in another 2 participants after the 10(th) treatment session. The combination therapy of rTMS plus TDT improved swallowing function in patients with post-stroke dysphagia. Further research with a larger sample size is recommended.

  5. Ad hoc and Selective Translations of Scientific and Technical Journal Articles: Their Characteristics and Possible Predictability

    Science.gov (United States)

    Anderson, James D.

    1978-01-01

    A study of ad hoc and selective translations of scientific and technical journal articles is described. Differences between two articles--one translated; the other not--with respect to original language, subject coverage, number of references and authors, and frequency with which their authors are cited in other works are presented. (Author/MBR)

  6. In Situ Measurement of Discomfort Curves for Seated Subjects in a Car on the Four-Post Rig

    Directory of Open Access Journals (Sweden)

    T. Ibicek

    2014-01-01

    Full Text Available The aim of this study is to measure and quantify perceived intensity of discomfort due to vibration in a vehicle in situ considering complete vehicle dynamic behaviour. The shaker table based discomfort curves or the road test results may not accurately and universally indicate the true level of human discomfort in a vehicle. A new experimental method, using a seated human in a car on the four-post rig simulator, is proposed to quantify discomfort. The intensity of perception to vibration decreased with decreasing input and increasing frequency; the rate of change is different from the published literature; the difference is large for angular modes of inputs. Vehicle dynamic response is used to inform and analyse the results. The repeatability of the method and the fact that they are in situ measurements may eventually help reduce reliance on the road tests. Furthermore, discomfort curves obtained, subsequently, can be used in predictive models.

  7. Civic Education and Democratic Socialisation: From Passive Subject to Active Citizen in Post-Communist States and Beyond

    Directory of Open Access Journals (Sweden)

    Jennifer Bruen

    2013-08-01

    Full Text Available Several studies suggest that some post-communist states or regions such as, for example, the former German Democratic Republic engage in a narrower form of civic education in schools which focuses on the transmission of facts. They also indicate that such civic education produces citizens more likely to accept the status quo than to criticially analyse and attempt to transform it. This paper posits, however, that this is also the case in the Republic of Ireland, a state with an apparently very different historical background. Attitudinal data from the European/World Values Survey and the European Social Survey is used to investigate this possibility by comparing eastern Germany and the Republic of Ireland on key items relating to attitudes towards politics and society. The results provide tentative support for this notion indicating that attitudes in both eastern Germany and the Republic of Ireland tend towards the compliance end of the compliancetransformation spectrum underlining the importance of broader forms of civic education for democratic socialisation both in post-communist states and more generally. Einige Forschungsergebnisse zeigen, dass Staaten, die den Kommunismus durchlaufen haben, eine begrenztere Form von Politikunterricht an Schulen durchfuhren und auf diese Weise Burger heranziehen, die dazu tendieren, den Status Quo zu akzeptieren anstatt politische Entscheidungen kritisch zu hinterfragen und die Politik aktiv mitzugestalten. Die Moglichkeit, jedoch, dass dies auch in einem Staat mit einem ganz anderen geschichtlichen Hintergrund, wie zum Beispiel die Republik Irland, der Fall sein konnte, wird zur Diskussion gestellt. Mit Hilfe von Daten zu politischen Einstellungen aus der European/World Values Survey und der European Social Survey soll diese Frage untersucht werden. Die Ergebnisse unterstutzen zum Teil diese Idee und zeigen, dass Einstellungen in sowohl der fruheren Deutschen Demokratischen Republik als auch in der

  8. Torque steadiness and muscle activation are bilaterally impaired during shoulder abduction and flexion in chronic post-stroke subjects.

    Science.gov (United States)

    Santos, Gabriela Lopes; García-Salazar, Luisa Fernanda; Souza, Matheus Bragança; Oliveira, Ana Beatriz; Camargo, Paula Rezende; Russo, Thiago Luiz

    2016-10-01

    To characterize sensorimotor control and muscle activation in the shoulder of chronic hemiparetic during abduction and flexion in maximal and submaximal isometric contractions. Furthermore, to correlate submaximal sensorimotor control with motor impairment and degree of shoulder subluxation. Thirteen chronic hemiparetic post-stroke age-gender matched with healthy were included. Isometric torques were assessed using a dynamometer. Electromyographic activity of the anterior and middle deltoid, upper trapezius, pectoralis major and serratus anterior muscles were collected. Variables were calculated for torque: peak, time to target, standard deviation (SD), coefficient of variation (CV), and standard error (RMSE); for muscle activity: maximum and minimum values, range and coefficient of activation. Motor impairment was determined by Fugl-Meyer and shoulder subluxation was measured with a caliper. Paretic and non-paretic limbs reduced peak and muscle activation during maximal isometric contraction. Paretic limb generated lower force when compared with non-paretic and control. Paretic and non-paretic presented higher values of SD, CV, RMSE, and CV for prime mover muscles and minimum values for all muscles during steadiness. No correlation was found between sensorimotor control, motor impairment and shoulder subluxation. Chronic hemiparetic presented bilateral deficits in sensorimotor and muscle control during maximal and submaximal shoulder abduction and flexion. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. The effects of interval- vs. continuous exercise on excess post-exercise oxygen consumption and substrate oxidation rates in subjects with type 2 diabetes.

    Science.gov (United States)

    Karstoft, Kristian; Wallis, Gareth A; Pedersen, Bente K; Solomon, Thomas P J

    2016-09-01

    For unknown reasons, interval training often reduces body weight more than energy-expenditure matched continuous training. We compared the acute effects of time-duration and oxygen-consumption matched interval- vs. continuous exercise on excess post-exercise oxygen consumption (EPOC), substrate oxidation rates and lipid metabolism in the hours following exercise in subjects with type 2 diabetes (T2D). Following an overnight fast, ten T2D subjects (M/F: 7/3; age=60.3±2.3years; body mass index (BMI)=28.3±1.1kg/m(2)) completed three 60-min interventions in a counterbalanced, randomized order: 1) control (CON), 2) continuous walking (CW), 3) interval-walking (IW - repeated cycles of 3min of fast and 3min of slow walking). Indirect calorimetry was applied during each intervention and repeatedly for 30min per hour during the following 5h. A liquid mixed meal tolerance test (MMTT, 450kcal) was consumed by the subjects 45min after completion of the intervention with blood samples taken regularly. Exercise interventions were successfully matched for total oxygen consumption (CW=1641±133mL/min; IW=1634±126mL/min, P>0.05). EPOC was higher after IW (8.4±1.3l) compared to CW (3.7±1.4l, PEPOC than oxygen-consumption matched continuous exercise during a post-exercise MMTT in subjects with T2D, whereas effects on substrate oxidation and lipid metabolism are comparable. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Service for fault tolerance in the Ad Hoc Networks based on Multi Agent Systems

    Directory of Open Access Journals (Sweden)

    Ghalem Belalem

    2011-02-01

    Full Text Available The Ad hoc networks are distributed networks, self-organized and does not require infrastructure. In such network, mobile infrastructures are subject of disconnections. This situation may concern a voluntary or involuntary disconnection of nodes caused by the high mobility in the Ad hoc network. In these problems we are trying through this work to contribute to solving these problems in order to ensure continuous service by proposing our service for faults tolerance based on Multi Agent Systems (MAS, which predict a problem and decision making in relation to critical nodes. Our work contributes to study the prediction of voluntary and involuntary disconnections in the Ad hoc network; therefore we propose our service for faults tolerance that allows for effective distribution of information in the Network by selecting some objects of the network to be duplicates of information.

  11. Validity of using ad hoc methods to analyze secondary traits in case-control association studies.

    Science.gov (United States)

    Yung, Godwin; Lin, Xihong

    2016-12-01

    Case-control association studies often collect from their subjects information on secondary phenotypes. Reusing the data and studying the association between genes and secondary phenotypes provide an attractive and cost-effective approach that can lead to discovery of new genetic associations. A number of approaches have been proposed, including simple and computationally efficient ad hoc methods that ignore ascertainment or stratify on case-control status. Justification for these approaches relies on the assumption of no covariates and the correct specification of the primary disease model as a logistic model. Both might not be true in practice, for example, in the presence of population stratification or the primary disease model following a probit model. In this paper, we investigate the validity of ad hoc methods in the presence of covariates and possible disease model misspecification. We show that in taking an ad hoc approach, it may be desirable to include covariates that affect the primary disease in the secondary phenotype model, even though these covariates are not necessarily associated with the secondary phenotype. We also show that when the disease is rare, ad hoc methods can lead to severely biased estimation and inference if the true disease model follows a probit model instead of a logistic model. Our results are justified theoretically and via simulations. Applied to real data analysis of genetic associations with cigarette smoking, ad hoc methods collectively identified as highly significant (Pstudies of smoking cessation. © 2016 WILEY PERIODICALS, INC.

  12. Subjective recovery time after exhausting muscular activity in postpolio and control subjects.

    Science.gov (United States)

    Agre, J C; Rodriquez, A A; Franke, T M

    1998-01-01

    The purpose of this study was to determine whether the time to subjectively fully recover after the performance of exhausting muscular exercise was greater in unstable postpolio as compared with stable postpolio or control subjects. Twenty-five unstable (those complaining of declining muscle strength) postpolio, 16 stable (those denying declining muscle strength) postpolio, and 25 control subjects performed an isometric contraction of the knee extensor (quadriceps femoris) musculature at 40% of maximal torque until they were no longer able to do so. Five-second maximal effort contractions were made every 30 s through 2 min after the time of failure was reached and then at 1-min intervals through 10 min after failure was reached. Subjects reported the duration of time required to subjectively fully recover from this activity. Choices of "less than 1 day," "1 day," "2 days," etc., up to "greater than 2 wk" were given to the subjects for their response. Analysis was by nonparametric ANOVA and appropriate post hoc comparison procedures. Unstable postpolio subjects reported a greater recovery time than either the stable postpolio or control subjects (mean +/- SD of 2.6 +/- 3.0 days, 0.6 +/- 1.0 days, and 0.7 +/- 1.1 days, respectively, P postpolio subjects than stable postpolio or control subjects. The cause for this finding is unknown and requires further investigation.

  13. Evaluation of Vipassana Meditation Course Effects on Subjective Stress, Well-being, Self-kindness and Mindfulness in a Community Sample: Post-course and 6-month Outcomes.

    Science.gov (United States)

    Szekeres, Roberta A; Wertheim, Eleanor H

    2015-12-01

    Residential Vipassana meditation courses, which teach mindfulness skills, are widely available globally but under-evaluated. This study examined effects of a standardized, community-based Vipassana course, on subjective stress, well-being, self-kindness and trait mindfulness in a community sample. Participants completed self-report measures of these variables at pre-course and post-course (n = 122), and outcomes were compared to a control group of early enrollers (EEs) (n = 50) who completed measures at parallel time points before course commencement. Six-month follow-up was undertaken in the intervention group (n = 90). Findings, including intention-to-complete analyses, suggested positive effects of the Vipassana course in reducing subjective stress and increasing well-being, self-kindness and overall mindfulness (present-moment awareness and non-reaction). Although some reductions in post-course gains were found at follow-up, particularly in stress, follow-up scores still showed improvements compared to pre-course scores. Mindfulness change scores between pre-course and 6-month follow-up were moderately to highly correlated with outcome variable change scores, consistent with the idea that effects of the Vipassana course on stress and well-being operate, at least partially, through increasing mindfulness. The present research underscores the importance of undertaking further investigations into Vipassana courses' effects and applications. Copyright © 2014 John Wiley & Sons, Ltd.

  14. Post-action determinants of the reported time of conscious intentions

    OpenAIRE

    Rigoni, Davide; Brass, Marcel; Sartori, Giuseppe

    2010-01-01

    The question of whether our behaviour is guided by our conscious intentions is gaining momentum within the field of cognitive neuroscience. It has been demonstrated that the subjective experience that conscious intentions are the driving force of our actions, is built partially on a post hoc reconstruction. Our hypothesis was that this reconstructive process is mediated by an action-monitoring system that compares the predicted and the actual sensory consequences of an action. We applied Even...

  15. Selective Endothelin-1 Receptor type-A Inhibition in Cardiac Surgery Subjects with Pre-Existing LV Dysfunction: Influence on Early Post-Operative Hemodynamics

    Science.gov (United States)

    Toole, John M.; Ikonomidis, John S.; Szeto, Wilson Y.; Zellner, James L.; Mulcahy, John; Deardorff, Rachael L.; Spinale, Francis G.

    2010-01-01

    Background and Objective A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor LV function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF. Methods and Results Patients (n=29; 66±2 yrs) with a reduced LVEF (37±2%) were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus; n=9, 10 respectively) or vehicle (saline; n=10). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB. Baseline plasma ET (4.0±0.3 fmol/mL) was identical across all 3 groups, but when compared to pre-operative, baseline values obtained from age matched subjects with a normal LVEF (n=37;LVEF>50%), were significantly increased (2.9±0.2 fmol/mL, pTime 0, SVR changed in an equivalent fashion in the post-CPB period, but a significant ET-ARA effect was observed for PVR (ANOVA; p<0.05). For example at 24 hrs post-CPB, PVR increased by 40 d.scm-5 in the vehicle group, but directionally decreased by over 40 d·s·cm-5 in the 2 mg/kg ETARA group (p<0.05). Total adverse events were equivalently distributed across the ET-ARA/placebo groups. Conclusions These unique findings demonstrated that infusion of an ET-ARA in high risk cardiac surgery patients was not associated with significant hemodynamic compromise. Moreover, ET-ARA favorably affected PVR in the

  16. [Neural activity related to emotional and empathic deficits in subjects with post-traumatic stress disorder who survived the L'Aquila (Central Italy) 2009 earthquake].

    Science.gov (United States)

    Mazza, Monica; Pino, Maria Chiara; Tempesta, Daniela; Catalucci, Alessia; Masciocchi, Carlo; Ferrara, Michele

    2016-01-01

    Post-Traumatic Stress Disorder (PTSD) is a chronic anxiety disorder. The continued efforts to control the distressing memories by traumatized individuals, together with the reduction of responsiveness to the outside world, are called Emotional Numbing (EN). The EN is one of the central symptoms in PTSD and it plays an integral role not only in the development and maintenance of post-traumatic symptomatology, but also in the disability of emotional regulation. This disorder shows an abnormal response of cortical and limbic regions which are normally involved in understanding emotions since the very earliest stages of the development of processing ability. Patients with PTSD exhibit exaggerated brain responses to emotionally negative stimuli. Identifying the neural correlates of emotion regulation in these subjects is important for elucidating the neural circuitry involved in emotional and empathic dysfunction. We showed that PTSD patients, all survivors of the L'Aquila 2009 earthquake, have a higher sensitivity to negative emotion and lower empathy levels. These emotional and empathic deficits are accompanied by neural brain functional correlates. Indeed PTSD subjects exhibit functional abnormalities in brain regions that are involved in stress regulation and emotional responses. The reduced activation of the frontal areas and a stronger activation of the limbic areas when responding to emotional stimuli could lead the subjects to enact coping strategies aimed at protecting themselves from the re-experience of pain related to traumatic events. This would result in a dysfunctional hyperactivation of subcortical areas, which may cause emotional distress and, consequently, impaired social relationships often reported by PTSD patients.

  17. APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

    Directory of Open Access Journals (Sweden)

    Schnadig ID

    2017-05-01

    Full Text Available Ian D Schnadig1, Richy Agajanian2, Christopher Dakhil3, Nashat Gabrail4, Jeffrey Vacirca5, Charles Taylor6, Sharon Wilks7, Eduardo Braun8, Michael C Mosier9, Robert B Geller10, Lee Schwartzberg11, Nicholas Vogelzang12 1Compass Oncology, US Oncology Research, Tualatin, OR, 2The Oncology Institute of Hope and Innovation, Whittier, CA, 3Cancer Center of Kansas, Wichita, KS, 4Gabrail Cancer Center, Canton, OH, 5North Shore Hematology Oncology, East Setauket, NY, 6Tulsa Cancer Institute, Tulsa, OK, 7Cancer Care Centers of South Texas, San Antonio, TX, 8Michiana Hematology Oncology, Westville, IN, 9Biostatistics, EMB Statistical Solutions, LLC, Overland Park, KS, 10Medical Affairs, Heron Therapeutics, Inc., San Diego, CA, 11West Cancer Center, Germantown, TN, 12Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA Background: APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV among patients receiving highly emetogenic chemotherapy (HEC in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC trial.Patients and methods: This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg or ondansetron 0.15 mg/kg intravenously (IV (≤16 mg; stratification was by planned cisplatin ≥50 mg/m2 (yes/no. Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%. The primary

  18. Dynamic Changes of Post-Translationally Modified Forms of CXCL10 and Soluble DPP4 in HCV Subjects Receiving Interferon-Free Therapy.

    Directory of Open Access Journals (Sweden)

    Eric G Meissner

    Full Text Available Serum levels of the interferon (IFN-stimulated chemokine CXCL10 are increased during chronic HCV infection and associate with outcome of IFN-based therapy. Elevated levels of NH2-terminal truncated CXCL10 (3-77aa, produced by DPP4 cleavage, negatively associate with spontaneous clearance of acute HCV infection and sustained virological response (SVR with IFN-based therapy for chronic infection. The association of different CXCL10 forms and DPP4 with outcome during IFN-free HCV therapy has not been examined. Using novel Simoa assays, plasma was analyzed from HCV genotype-1 (GT1 subjects who relapsed (n = 11 or achieved SVR (n = 10 after sofosbuvir and ribavirin (SOF/RBV treatment, and from SOF/RBV relapsers who achieved SVR with a subsequent SOF/ledipasvir regimen (n = 9. While the NH2-truncated form of CXCL10 was elevated in HCV infection relative to healthy controls, pre-treatment plasma concentrations of CXCL10 forms failed to stratify subjects based on treatment outcome to IFN-free regimens. However, a trend (statistically non-significant towards elevated higher levels of total and long CXCL10 was observed pre-treatment in subjects who relapsed. All forms of CXCL10 decreased rapidly following treatment initiation and were again elevated in subjects who experienced HCV relapse, indicating that CXCL10 production may be associated with active viral replication. While soluble DPP4 (sDPP4 and NH2-truncated CXCL10 concentrations were highly correlated, on-treatment sDPP4 levels and activity declined more slowly than CXCL10, suggesting differential regulation. These data suggest post-translationally modified forms of CXCL10 will not support the prediction of treatment outcome in HCV GT1 subjects treated with SOF/RBV.

  19. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test

    Directory of Open Access Journals (Sweden)

    Letícia Bojikian CALIXTRE

    Full Text Available ABSTRACT Objective To investigate the effect of a rehabilitation program based on cervical mobilization and exercise on clinical signs and mandibular function in subjects with temporomandibular disorder (TMD. Material and Methods: Single-group pre-post test, with baseline comparison. Subjects Twelve women (22.08±2.23 years with myofascial pain and mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders. Outcome measures Subjects were evaluated three times: twice before (baseline phase and once after intervention. Self-reported pain, jaw function [according to the Mandibular Functional Impairment Questionnaire (MFIQ], pain-free maximum mouth opening (MMO, and pressure pain thresholds (PPTs of both masseter and temporalis muscles were obtained. Baseline and post-intervention differences were investigated, and effect size was estimated through Cohen’s d coefficient. Results Jaw function improved 7 points on the scale after the intervention (P=0.019, and self-reported pain was significantly reduced (P=0.009. Pain-free MMO varied from 32.3±8.8 mm to 38±8.8 mm and showed significant improvement (P=0.017 with moderate effect size when compared to the baseline phase. PPT also increased with moderate effect size, and subjects had the baseline values changed from 1.23±0.2 kg/cm2 to 1.4±0.2 kg/cm2 in the left masseter (P=0.03, from 1.31±0.28 kg/cm2 to 1.51±0.2 kg/cm2 in the right masseter (P>0.05, from 1.32±0.2 kg/cm2 to 1.46±0.2 kg/cm2 in the left temporalis (P=0.047, and from 1.4±0.2 kg/cm2 to 1.67±0.3 kg/cm2 in the right temporalis (P=0.06. Conclusions The protocol caused significant changes in pain-free MMO, self-reported pain, and functionality of the stomatognathic system in subjects with myofascial TMD, regardless of joint involvement. Even though these differences are statistically significant, their clinical relevance is still questionable.

  20. Physical Function, Quality of Life, and Energy Expenditure During Activities of Daily Living in Obese, Post-Bariatric Surgery, and Healthy Subjects.

    Science.gov (United States)

    Monteiro, Fabiane; Ponce, Diego A N; Silva, Humberto; Pitta, Fabio; Carrilho, Alexandre J F

    2017-08-01

    This study aimed to evaluate physical function (PF), quality of life (QOL), and energy expenditure (EE) during activities of daily living (ADL) in late outcome post-bariatric surgery (BS) patients and to compare them to severe obese individuals and matched controls. Sixty-three subjects were included: 21 patients in post-operative (PO) of BS (3-4 years post-Roux-en-Y gastric bypass) with a stable weight for at least 6 months (16 women, 41 ± 11 years old, BMI = 28 ± 4 kg m(-2)) (group PO); 21 obese individuals with BS indication (16 women, 44 ± 9 years old, BMI = 44 ± 6 kg m(-2)) (group OB); and 21 controls matched to PO by gender, age, and BMI (16 women, 42 ± 12 years old, BMI = 27 ± 6 kg m(-2)) (group MC). PF was objectively assessed by the Glittre and modified Glittre ADL-tests. QOL (SF-36), EE (activity monitoring during ADL), and body composition (bioelectrical impedance) were also assessed. OB had worse PF (Glittre ADL-test) compared to PO and MC (OB = 224 ± 76 s; PO = 143 ± 39 s; and MC = 118 ± 17 s; p < 0.0001). The same was observed for QOL (p < 0.05 for all SF-36 domains). OB also had higher total EE in the Glittre ADL-test. However, 63% of the activity time was in low-intensity EE. In the Glittre modified protocol, OB had poorer performance than PO and MC when walking up/downstairs, rising/sitting in a chair, and moving objects on a shelf. Post-BS patients have better PF and QOL and perform activities under lower total EE than obese subjects, very similar to matched controls.

  1. Post-treatment CIN

    DEFF Research Database (Denmark)

    Bais, Aagje G; Eijkemans, Marinus J C; Rebolj, Mateja

    2009-01-01

    cytology and presence of hrHPV (80 vs. 91%, relative risk 0.87 (95% CI 0.77-0.99)). Both methods showed no significant difference in sensitivity ((86 vs. 100%) RR 0.86 (95% CI 0.63-1.16)). Comparing different post hoc modifications in the strategy of combined testing showed similar test characteristics...

  2. Didysis propagandos subjektas: pokomunistinių autobiografijų pėdsakais. Great Subject of Propaganda: by the Traces of Post-communist Autobiographies

    Directory of Open Access Journals (Sweden)

    Gintautas Mažeikis

    2008-01-01

    Full Text Available The article is devoted to analysis of description of propaganda subject in general and in the Soviet Lithuanian literature particularly. Propaganda sub­ject doesnt depend only on the procedure of discour­sive interpellation as it was in L. Althusser theories. The article shows how much important was social-body experiences and social-political body activities upon the examples of communist identity history in Soviet Union. For this reason the notions of sym­bolic sphere (J. Lotman, semiosis (U. Eco, dis­coursive order (M. Foucault and symbolical worlds (J. Lacan are separated and compared. Contempo­rary theories of psychoanalytic philosophy show meta-literary origin of politically important literary works and semiosis. It means that the sense of sen­tences of novels and poems were red and understood in dependency of heroic biography of writer, on the correspondent to the contemporary political and ma­terial life of political party and changes of political language. Participation in the revolutionary activity, class war, buildings of Soviet reality, II World Wars battles, postwar struggles, resistance to the Post-soviet reevaluation of all values, proletarian origin, sweat and blood were non-literal signs for the trust to literary work. The article shows that literary works of trusted writers were a collective creation and they were a collective semiosis. On the example of Lithu­anian poet E. Mieželaitis collective improvement of poems are discussed. The other step in the develop­ment of soviet semiosis and symbolical world goes in the modern independent Lithuania. It is developed in autobiographes of soviet writers and soviet cul­tural leaders. Post-soviet considerations about “Non lost generation” of one of former communist leader L. Šepetys are analyzed in the article.Post-soviet biographies and popularity of the ones are evidence of stability of soviet symbolical world with their social body practices and reading / writing

  3. Ad hoc mobile wireless networks principles, protocols, and applications

    CERN Document Server

    Sarkar, Subir Kumar

    2013-01-01

    The military, the research community, emergency services, and industrial environments all rely on ad hoc mobile wireless networks because of their simple infrastructure and minimal central administration. Now in its second edition, Ad Hoc Mobile Wireless Networks: Principles, Protocols, and Applications explains the concepts, mechanism, design, and performance of these highly valued systems. Following an overview of wireless network fundamentals, the book explores MAC layer, routing, multicast, and transport layer protocols for ad hoc mobile wireless networks. Next, it examines quality of serv

  4. Ad hoc mobile wireless networks principles, protocols and applications

    CERN Document Server

    Sarkar, Subir Kumar; Puttamadappa, C

    2007-01-01

    Ad hoc mobile wireless networks have seen increased adaptation in a variety of disciplines because they can be deployed with simple infrastructures and virtually no central administration. In particular, the development of ad hoc wireless and sensor networks provides tremendous opportunities in areas including disaster recovery, defense, health care, and industrial environments. Ad Hoc Mobile Wireless Networks: Principles, Protocols and Applications explains the concepts, mechanisms, design, and performance of these systems. It presents in-depth explanations of the latest wireless technologies

  5. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test.

    Science.gov (United States)

    Calixtre, Letícia Bojikian; Grüninger, Bruno Leonardo da Silva; Haik, Melina Nevoeiro; Alburquerque-Sendín, Francisco; Oliveira, Ana Beatriz

    2016-01-01

    To investigate the effect of a rehabilitation program based on cervical mobilization and exercise on clinical signs and mandibular function in subjects with temporomandibular disorder (TMD). Single-group pre-post test, with baseline comparison. Twelve women (22.08±2.23 years) with myofascial pain and mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders. Subjects were evaluated three times: twice before (baseline phase) and once after intervention. Self-reported pain, jaw function [according to the Mandibular Functional Impairment Questionnaire (MFIQ)], pain-free maximum mouth opening (MMO), and pressure pain thresholds (PPTs) of both masseter and temporalis muscles were obtained. Baseline and post-intervention differences were investigated, and effect size was estimated through Cohen's d coefficient. Jaw function improved 7 points on the scale after the intervention (P=0.019), and self-reported pain was significantly reduced (P=0.009). Pain-free MMO varied from 32.3±8.8 mm to 38±8.8 mm and showed significant improvement (P=0.017) with moderate effect size when compared to the baseline phase. PPT also increased with moderate effect size, and subjects had the baseline values changed from 1.23±0.2 kg/cm2 to 1.4±0.2 kg/cm2 in the left masseter (P=0.03), from 1.31±0.28 kg/cm2 to 1.51±0.2 kg/cm2 in the right masseter (P>0.05), from 1.32±0.2 kg/cm2 to 1.46±0.2 kg/cm2 in the left temporalis (P=0.047), and from 1.4±0.2 kg/cm2 to 1.67±0.3 kg/cm2 in the right temporalis (P=0.06). The protocol caused significant changes in pain-free MMO, self-reported pain, and functionality of the stomatognathic system in subjects with myofascial TMD, regardless of joint involvement. Even though these differences are statistically significant, their clinical relevance is still questionable.

  6. Automatically extracting information needs from Ad Hoc clinical questions.

    Science.gov (United States)

    Yu, Hong; Cao, Yong-Gang

    2008-11-06

    Automatically extracting information needs from ad hoc clinical questions is an important step towards medical question answering. In this work, we first explored supervised machine-learning approaches to automatically classify an ad hoc clinical question into general topics. We then evaluated different methods for automatically extracting keywords from an ad hoc clinical question. Our methods were evaluated on the 4,654 clinical questions maintained by the National Library of Medicine. Our best systems or methods showed F-score of 76% for the task of question-topic classification and an average F-score of 56% for extracting keywords from ad hoc clinical questions.

  7. Intrusion detection in wireless ad-hoc networks

    CERN Document Server

    Chaki, Nabendu

    2014-01-01

    Presenting cutting-edge research, Intrusion Detection in Wireless Ad-Hoc Networks explores the security aspects of the basic categories of wireless ad-hoc networks and related application areas. Focusing on intrusion detection systems (IDSs), it explains how to establish security solutions for the range of wireless networks, including mobile ad-hoc networks, hybrid wireless networks, and sensor networks.This edited volume reviews and analyzes state-of-the-art IDSs for various wireless ad-hoc networks. It includes case studies on honesty-based intrusion detection systems, cluster oriented-based

  8. Subjective perception of radioactivity. No change post successful treatment with radioiodine; Strahlen bleiben boese. Keine Aenderung der subjektiven Konzepte von Radioaktivitaet nach erfolgreicher Radioiodtherapie

    Energy Technology Data Exchange (ETDEWEB)

    Freudenberg, L.S.; Mueller, S.P.; Beyer, T.; Bockisch, A. [Universitaetsklinikum Essen (Germany). Klinik fuer Nuklearmedizin

    2009-07-01

    We assess the attitude of patients with thyroid disease towards radiation and radioactivity before and after radioiodine therapy by means of a cultural-anthropological approach. We evaluate in patient interviews how their subjective attitude towards radioactivity as an abstract term and towards radioactivity in the medical context on the basis of their personal experiences with radionuclide therapy. 29 patients with autonomously functioning thyroid lesions (17 women, 12 men, 35-79 years) were included in this study. All patients were interviewed prior to and 22-27 month post radioiodine therapy in an open dialogue with the principal investigator. Patients were asked to describe their attitude towards radioactivity in general and towards radioiodine therapy in particular. Patients were asked to use a scoring system (1: positive, 5: negative) to quantify their perception of radioactivity. The personal perception of radioactivity as an abstract term does not change significantly (p = 0.15) before and after radioiodine therapy. This perception is linked to mostly negative impressions of radiactivity. However, patients become more positive when assessing the value of radioactivity as part of their therapy regimen. Thus, we observe a significant increase in percepted value of radioactivity post radioiodine therapy (p = 0.03). Patients continue to view radioactivity as something negative despite treatment success following radioiodine therapy. Our results provide useful information for patient information by the nuclear medicine physician prior to a radioiodine therapy. (orig.)

  9. Early altered resting-state functional connectivity predicts the severity of post-traumatic stress disorder symptoms in acutely traumatized subjects.

    Directory of Open Access Journals (Sweden)

    Yan Zhou

    Full Text Available The goal of this study was to investigate the relationship between resting-state functional connectivity and the severity of post-traumatic stress disorder (PTSD symptoms in 15 people who developed PTSD following recent trauma. Fifteen participants who experienced acute traumatic events underwent a 7.3-min resting functional magnetic resonance imaging scan within 2 days post-event. All the patients were diagnosed with PTSD within 1 to 6 months after trauma. Brain areas in which activity was correlated with that of the posterior cingulate cortex (PCC were assessed. To assess the relationship between the severity of PTSD symptoms and PCC connectivity, contrast images representing areas positively correlated with the PCC were correlated with the subject's Clinician-Administered PTSD Scale scores (CAPS when they were diagnosed. Furthermore, the PCC, medial prefrontal cortex and bilateral amygdala were selected to assess the correlation of the strength of functional connectivity with the CAPS. Resting state connectivity with the PCC was negatively correlated with CAPS scores in the left superior temporal gyrus and right hippocampus/amygdala. Furthermore, the strength of connectivity between the PCC and bilateral amygdala, and even between the bilateral amygdala could predict the severity of PTSD symptoms later. These results suggest that early altered resting-state functional connectivity of the PCC with the left superior temporal gyrus, right hippocampus and amygdala could predict the severity of the disease and may be a major risk factor that predisposes patients to develop PTSD.

  10. Receiver-Based Ad Hoc On Demand Multipath Routing Protocol for Mobile Ad Hoc Networks.

    Directory of Open Access Journals (Sweden)

    Abdulaziz Al-Nahari

    Full Text Available Decreasing the route rediscovery time process in reactive routing protocols is challenging in mobile ad hoc networks. Links between nodes are continuously established and broken because of the characteristics of the network. Finding multiple routes to increase the reliability is also important but requires a fast update, especially in high traffic load and high mobility where paths can be broken as well. The sender node keeps re-establishing path discovery to find new paths, which makes for long time delay. In this paper we propose an improved multipath routing protocol, called Receiver-based ad hoc on demand multipath routing protocol (RB-AOMDV, which takes advantage of the reliability of the state of the art ad hoc on demand multipath distance vector (AOMDV protocol with less re-established discovery time. The receiver node assumes the role of discovering paths when finding data packets that have not been received after a period of time. Simulation results show the delay and delivery ratio performances are improved compared with AOMDV.

  11. Effects of Sleep Loss on Subjective Complaints and Objective Neurocognitive Performance as Measured by the Immediate Post-Concussion Assessment and Cognitive Testing.

    Science.gov (United States)

    Stocker, Ryan P J; Khan, Hassen; Henry, Luke; Germain, Anne

    2017-05-01

    This study examined the effects of total and partial sleep deprivation on subjective symptoms and objective neurocognitive performance, as measured by the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) in a sample of healthy adults. One-hundred and two, right-handed, healthy participants (between ages 18 and 30 years old) completed three consecutive nights in the sleep laboratory with concurrent continuous polysomnography monitoring. Night 1 served as a baseline night. Prior to Night 2, they were randomly assigned to one of three sleep conditions: undisrupted normal sleep (N = 34), sleep restriction (50% of habitual sleep, N = 37), or total sleep deprivation (N = 31). Participants slept undisturbed on Night 3. ImPACT was administered on three separate occasions. Sleep loss was associated with increased severity of subjectively reported affective, cognitive, physical, and sleep symptoms. Although objective neurocognitive task scores derived from the ImPACT battery did not corroborate subjective complaints, sleep loss was associated with significant differences on tasks of visual memory, reaction time, and visual motor speed over time. While self-report measures suggested marked impairments following sleep loss, deficits in neurocognitive performance were observed only on three domains measured with ImPACT. ImPACT may capture subtle changes in neurocognitive performance following sleep loss; however, independent and larger validation studies are needed to determine its sensitivity to acute sleep loss and recovery sleep. Neurocognitive screening batteries may be useful for detecting the effects of more severe or chronic sleep loss under high-stress conditions that mimic high-risk occupations.

  12. Opinion Impact Models and Opinion Consensus Methods in Ad Hoc Tactical Social Networks

    OpenAIRE

    Demin Li; Jie Zhou; Jingjuan Zhu; Jiacun Wang

    2013-01-01

    Ad hoc social networks are special social networks, such as ad hoc tactical social networks, ad hoc firefighter social networks, and ad hoc vehicular social networks. The social networks possess both the properties of ad hoc network and social network. One of the challenge problems in ad hoc social networks is opinion impact and consensus, and the opinion impact plays a key role for information fusion and decision support in ad hoc social networks. In this paper, consider the impact of physic...

  13. Fundamental Properties of Wireless Mobile Ad-hoc Networks

    NARCIS (Netherlands)

    Hekmat, R.

    2005-01-01

    Wireless mobile ad-hoc networks are formed by mobile devices that set up a possibly short-lived network for communication needs of the moment. Ad-hoc networks are decentralized, self-organizing networks capable of forming a communication network without relying on any fixed infrastructure. Each node

  14. Philosophical perspectives on ad hoc hypotheses and the Higgs mechanism

    NARCIS (Netherlands)

    Friederich, Simon; Harlander, Robert; Karaca, Koray

    2014-01-01

    We examine physicists' charge of ad hocness against the Higgs mechanism in the standard model of elementary particle physics. We argue that even though this charge never rested on a clear-cut and well-entrenched definition of "ad hoc", it is based on conceptual and methodological assumptions and

  15. Assured Resource Sharing in Ad-Hoc Collaboration

    Energy Technology Data Exchange (ETDEWEB)

    Ahn, Gail-Joon [Arizona State Univ., Tempe, AZ (United States)

    2015-12-19

    The project seeks an innovative framework to enable users to access and selectively share resources in distributed environments, enhancing the scalability of information sharing. We have investigated secure sharing & assurance approaches for ad-hoc collaboration, focused on Grids, Clouds, and ad-hoc network environments.

  16. Finding Trading Partners to Establish Ad-Hoc Business Processes

    NARCIS (Netherlands)

    Wombacher, Andreas; Mahleko, Bendick

    2002-01-01

    Enabling technology for realizing ad-hoc business processes currently is becoming more and more popular, like for example web services. Ad-hoc business processes are semantically characterized by a description of the exchanged messages and by the potential message sequences. These semantic meta-data

  17. Spontaneous ad hoc mobile cloud computing network.

    Science.gov (United States)

    Lacuesta, Raquel; Lloret, Jaime; Sendra, Sandra; Peñalver, Lourdes

    2014-01-01

    Cloud computing helps users and companies to share computing resources instead of having local servers or personal devices to handle the applications. Smart devices are becoming one of the main information processing devices. Their computing features are reaching levels that let them create a mobile cloud computing network. But sometimes they are not able to create it and collaborate actively in the cloud because it is difficult for them to build easily a spontaneous network and configure its parameters. For this reason, in this paper, we are going to present the design and deployment of a spontaneous ad hoc mobile cloud computing network. In order to perform it, we have developed a trusted algorithm that is able to manage the activity of the nodes when they join and leave the network. The paper shows the network procedures and classes that have been designed. Our simulation results using Castalia show that our proposal presents a good efficiency and network performance even by using high number of nodes.

  18. Spontaneous Ad Hoc Mobile Cloud Computing Network

    Directory of Open Access Journals (Sweden)

    Raquel Lacuesta

    2014-01-01

    Full Text Available Cloud computing helps users and companies to share computing resources instead of having local servers or personal devices to handle the applications. Smart devices are becoming one of the main information processing devices. Their computing features are reaching levels that let them create a mobile cloud computing network. But sometimes they are not able to create it and collaborate actively in the cloud because it is difficult for them to build easily a spontaneous network and configure its parameters. For this reason, in this paper, we are going to present the design and deployment of a spontaneous ad hoc mobile cloud computing network. In order to perform it, we have developed a trusted algorithm that is able to manage the activity of the nodes when they join and leave the network. The paper shows the network procedures and classes that have been designed. Our simulation results using Castalia show that our proposal presents a good efficiency and network performance even by using high number of nodes.

  19. Experimental Investigation of Cavitation as a Possible Damage Mechanism in Blast-Induced Traumatic Brain Injury in Post-Mortem Human Subject Heads.

    Science.gov (United States)

    Salzar, Robert S; Treichler, Derrick; Wardlaw, Andrew; Weiss, Greg; Goeller, Jacques

    2017-04-15

    The potential of blast-induced traumatic brain injury from the mechanism of localized cavitation of the cerebrospinal fluid (CSF) is investigated. While the mechanism and criteria for non-impact blast-induced traumatic brain injury is still unknown, this study demonstrates that local cavitation in the CSF layer of the cranial volume could contribute to these injuries. The cranial contents of three post-mortem human subject (PMHS) heads were replaced with both a normal saline solution and a ballistic gel mixture with a simulated CSF layer. Each were instrumented with multiple pressure transducers and placed inside identical shock tubes at two different research facilities. Sensor data indicates that cavitation may have occurred in the PMHS models at pressure levels below those for a 50% risk of blast lung injury. This study points to skull flexion, the result of the shock wave on the front of the skull leading to a negative pressure in the contrecoup, as a possible mechanism that contributes to the onset of cavitation. Based on observation of intracranial pressure transducer data from the PMHS model, cavitation onset is thought to occur from approximately a 140 kPa head-on incident blast.

  20. Objective and subjective factors as predictors of post-traumatic stress symptoms in parents of children with cancer--a longitudinal study.

    Directory of Open Access Journals (Sweden)

    Annika Lindahl Norberg

    Full Text Available BACKGROUND: Parents of children with cancer report post-traumatic stress symptoms (PTSS years after the child's successful treatment is completed. The aim of the present study was to analyze a number of objective and subjective childhood cancer-related factors as predictors of parental PTSS. METHODS: Data were collected from 224 parents during and after their child's cancer treatment. Data sources include self-report questionnaires and medical records. RESULTS: In a multivariate hierarchical model death of the child, parent's perception of child psychological distress and total symptom burden predicted higher levels of PTSS. In addition, immigrants and unemployed parents reported higher levels of PTSS. The following factors did not predict PTSS: parent gender, family income, previous trauma, child's prognosis, treatment intensity, non-fatal relapse, and parent's satisfaction with the child's care. CONCLUSIONS: Although medical complications can be temporarily stressful, a parent's perception of the child's distress is a more powerful predictor of parental PTSS. The vulnerability of unemployed parents and immigrants should be acknowledged. In addition, findings highlight that the death of a child is as traumatic as could be expected.

  1. Broadcast design in cognitive radio ad hoc networks

    CERN Document Server

    Song, Yi

    2014-01-01

    This SpringerBrief investigates the special challenges of broadcast design in cognitive radio (CR) ad hoc networks. It introduces two broadcast protocols in CR ad hoc networks: a quality-of-service based broadcast protocol under blind information and a fully-distributed broadcast protocol with collision avoidance. A novel unified analytical model is also presented to analyze the performance of the broadcast protocols. This is the first book dedicated to the unique broadcast design challenges in CR ad hoc networks. The authors also discuss the recent research on the performance analysis of broa

  2. On mobile wireless ad hoc IP video transports

    Science.gov (United States)

    Kazantzidis, Matheos

    2006-05-01

    Multimedia transports in wireless, ad-hoc, multi-hop or mobile networks must be capable of obtaining information about the network and adaptively tune sending and encoding parameters to the network response. Obtaining meaningful metrics to guide a stable congestion control mechanism in the transport (i.e. passive, simple, end-to-end and network technology independent) is a complex problem. Equally difficult is obtaining a reliable QoS metrics that agrees with user perception in a client/server or distributed environment. Existing metrics, objective or subjective, are commonly used after or before to test or report on a transmission and require access to both original and transmitted frames. In this paper, we propose that an efficient and successful video delivery and the optimization of overall network QoS requires innovation in a) a direct measurement of available and bottleneck capacity for its congestion control and b) a meaningful subjective QoS metric that is dynamically reported to video sender. Once these are in place, a binomial -stable, fair and TCP friendly- algorithm can be used to determine the sending rate and other packet video parameters. An adaptive mpeg codec can then continually test and fit its parameters and temporal-spatial data-error control balance using the perceived QoS dynamic feedback. We suggest a new measurement based on a packet dispersion technique that is independent of underlying network mechanisms. We then present a binomial control based on direct measurements. We implement a QoS metric that is known to agree with user perception (MPQM) in a client/server, distributed environment by using predetermined table lookups and characterization of video content.

  3. Fracture resistance of endodontically treated teeth: effect of tooth coloured post material and surface conditioning.

    Science.gov (United States)

    Toman, Muhittin; Toksavul, Suna; Sarikanat, Mehmet; Nergiz, Ibrahim; Schmage, Petra

    2010-03-01

    This in vitro study evaluated the effects of the different endodontic posts and surface conditioning on the fracture resistance and fracture modes of endodontically treated teeth. The experimental groups consisted of zirconia ceramic post with a glasss-ceramic core [A], zirconia ceramic post with a composite core [B], glass fiber composite post (FRC) with a composite core [C], and titanium post with a composite core [D]. All posts in these groups were cemented with self-adhesive resin cement (Rely X Unicem Aplicap) combination with tribochemical silica coating (TSC). Groups E, F, G and H comprised the same post-and-core materials as the first 4 groups but cemented with the same resin cement without TSC. Specimens were subjected to thermal cycling between 5 degrees C and 55 degrees C for a total of 5000 cycles with 30s per cycle. Static load was applied to the palatal surface of each specimen until they were fractured. Statistical analysis was conducted using analysis of variance (ANOVA) followed by post-hoc comparisons (Tukey). The fracture resistance was significantly affected by the post material (P surface conditioning (P post surface decreased the fracture resistance of zirconia ceramic post with composite core (p=0.002; Tukey) and glass FRC post with composite core (p=0.029; Tukey). No catastrophic failure was observed for groups B, C, D, E, F and G. Under the testing conditions used, the titanium post/composite core that had been silicoated exhibited the highest fracture resistance.

  4. Ad hoc statistical consulting within a large research organization

    CSIR Research Space (South Africa)

    Elphinstone, CD

    2009-08-01

    Full Text Available The paper discusses the ad hoc statistical consulting service initiated within the CSIR that has proved successful; however, resourcing remains a major challenge. Even limited advertising of the service within the CSIR resulted in many requests...

  5. The Effect of Upper Body Mass and Initial Knee Flexion on the Injury Outcome of Post Mortem Human Subject Pedestrian Isolated Legs.

    Science.gov (United States)

    Petit, Philippe; Trosseille, Xavier; Dufaure, Nicolas; Dubois, Denis; Potier, Pascal; Vallancien, Guy

    2014-11-01

    In the ECE 127 Regulation on pedestrian leg protection, as well as in the Euro NCAP test protocol, a legform impactor hits the vehicle at the speed of 40 kph. In these tests, the knee is fully extended and the leg is not coupled to the upper body. However, the typical configuration of a pedestrian impact differs since the knee is flexed during most of the gait cycle and the hip joint applies an unknown force to the femur. This study aimed at investigating the influence of the inertia of the upper body (modelled using an upper body mass fixed at the proximal end of the femur) and the initial knee flexion angle on the lower limb injury outcome. In total, 18 tests were conducted on 18 legs from 9 Post Mortem Human Subjects (PMHS). The principle of these tests was to impact the leg at 40 kph using a sled equipped with 3 crushing steel tubes, the stiffness of which were representative of the front face of a European sedan (bonnet leading edge, bumper and spoiler). The mass of the equipped sled was 74.5 kg. The test matrix was designed to perform 4 tests in 4 configurations combining two upper body masses (either 0 or 3 kg) and two knee angles (0 or 20 degrees) at 40 kph (11 m/s) plus 2 tests at 9 m/s. Autopsies were performed on the lower limbs and an injury assessment was established. The findings of this study were first that the increase of the upper body mass resulted in more severe injuries, second that an initial flexion of the knee, corresponding to its natural position during the gait cycle, decreased the severity of the injuries, and third that based on the injury outcome, a test conducted with no upper body mass and the knee fully extended was as severe as a test conducted with a 3 kg upper body mass and an initial knee flexion of 20°.

  6. Performance Analysis of Authentication Protocols in Vehicular Ad Hoc Networks

    OpenAIRE

    Aboobaker, Abdul Kalam Kunnel

    2009-01-01

    Traditionally traffic safety was addressed by traffic awareness and passive safety measures like solid chassis, seat belts, air bags etc. With the recent breakthroughs in the domain of mobile ad hoc networks, the concept of vehicular ad hoc networks (VANET) was realised. Safety messaging is the most important aspect of VANETs, where the passive safety (accident readiness) in vehicles was reinforced with the idea of active safety (accident prevention). In safety messaging vehicles will message...

  7. Sensor and ad-hoc networks theoretical and algorithmic aspects

    CERN Document Server

    Makki, S Kami; Pissinou, Niki; Makki, Shamila; Karimi, Masoumeh

    2008-01-01

    This book brings together leading researchers and developers in the field of wireless sensor networks to explain the special problems and challenges of the algorithmic aspects of sensor and ad-hoc networks. The book also fosters communication not only between the different sensor and ad-hoc communities, but also between those communities and the distributed systems and information systems communities. The topics addressed pertain to the sensors and mobile environment.

  8. Access Point Security Service for wireless ad-hoc communication

    OpenAIRE

    Scholten, Johan; Nijdam, M.

    2006-01-01

    This paper describes the design and implementation of a security solution for ad-hoc peer-to-peer communication. The security solution is based on a scenario where two wireless devices require secure communication, but share no security relationship a priori. The necessary requirements for the security solution described here comprise topics such as energy efficiency, security standards and ad-hoc networks. The devised solution is called Access Point Security Service (APSS). APSS is able to p...

  9. Malicious node detection in ad-hoc wireless networks

    Science.gov (United States)

    Griswold, Richard L.; Medidi, Sirisha R.

    2003-07-01

    Advances in wireless communications and the proliferation of mobile computing devices has led to the rise of a new type of computer network: the ad-hoc wireless network. Ad-hoc networks are characterized by a lack of fixed infrastructure, which give ad-hoc networks a great deal of flexibility, but also increases the risk of security problems. In wired networks, key pieces of network infrastructure are secured to prevent unauthorized physical access and tampering. Network administrators ensure that everything is properly configured and are on-hand to fix problems and deal with intrusions. In contrast, the nodes in an ad-hoc network are responsible for routing and forwarding data in the network, and there are no network administrators to handle potential problems. This makes an ad-hoc network more vulnerable to a misconfigured, faulty, or compromised node. We propose a means for a node in an ad-hoc network to detect and handle these malicious nodes by comparing data available to the routing protocol, such as cached routes in Dynamic Source Routing, ICMP messages, and transport layer information, such as TCP timeouts. This data can then be used along with network probes to isolate the malicious node.

  10. The impact of disaster work on community volunteers: The role of peri-traumatic distress, level of personal affectedness, sleep quality and resource loss, on post-traumatic stress disorder symptoms and subjective health

    NARCIS (Netherlands)

    Thormar, Sigridur B.; Gersons, Berthold P. R.; Juen, Barbara; Djakababa, Maria Nelden; Karlsson, Thorlakur; Olff, Miranda

    2014-01-01

    Disaster work has shown to cause PTSD symptoms and subjective health complaints in professional emergency personnel. However, very little is known about how disaster work affects community volunteers. This first time longitudinal study examined factors contributing to post-traumatic stress disorder

  11. Fracture strength of flared bovine roots restored with different intraradicular posts.

    Science.gov (United States)

    Clavijo, Victor Grover Rene; Reis, José Maurício dos Santos Nunes; Kabbach, William; Silva, André Luis Faria e; Oliveira Junior, Osmir Batista de; Andrade, Marcelo Ferrarezi de

    2009-01-01

    The aim of this study was to evaluate the fracture strength and failure mode of flared bovine roots restored with different intraradicular posts. Fifty bovine incisors with similar dimensions were selected and their roots were flared until 1.0 mm of dentin wall remained. Next, the roots were allocated into five groups (n=10): GI- cast metal post-and-core; GII- fiber posts plus accessory fiber posts; GIII- direct anatomic post; GIV- indirect anatomic post and GV- control (specimens without intraradicular post). A polyether impression material was used to simulate the periodontal ligament. After periodontal ligament simulation, the specimens were subjected to a compressive load at a crosshead speed of 0.5 mm/min in a servo-hydraulic testing machine (MTS 810) applied at 135 masculine to the long axis of the tooth until failure. The data (N) were subjected to ANOVA and Tukey's post-hoc test (alpha=0.05). GI and GIV presented higher fracture strength (p0.05) from GI, GII and GIV. Control specimens (GV) produced the lowest fracture strength mean values (p<0.05). Despite obtaining the highest mean value, GI presented 100% of unfavorable failures. GII presented 20% of unfavorable failures. GIII, GIV and GV presented only favorable failures. Although further in vitro and in vivo studies are necessary, the results of this study showed that the use of direct and indirect anatomic posts in flared roots could be an alternative to cast metal post-and-core.

  12. Does the moment of fiber post cutting influence on the retention to root dentin?

    Science.gov (United States)

    Borges, Marcela G; Faria-e-Silva, André L; Santos-Filho, Paulo C F; Silva, Fernanda P; Martins, Luís R M; Menezes, Murilo de Sousa

    2015-01-01

    Despite several advantages associated with pre-fabricated glass-fiber posts, the coronal portion of these posts must be cut to allow their use in various clinical situations. However, cutting the cemented post can generate stress on the bonding interface and affect the bond strength. The aim of this study was to investigate the effect the of fiber post cutting on the bond strength of root canals. Sixty bovine incisor roots were included in resin cylinders with simulated periodontal ligaments. Glass-fiber posts were luted using regular resin cement RelyX ARC (3M ESPE) or self-adhesive cement RelyX Unicem (3M ESPE). The posts were cut prior to cementation, immediately after luting or after building up the core (n=10). After storage for 24 h, the samples were cut and subject to push-out testing using a mechanical testing machine (EMIC DL 2000). Data were analyzed using two-way ANOVA (resin cement x moment of post cutting) and Tukey's post hoc test (α=0.05). The moment of fiber post cutting did not affect the bond strength when Unicem was used. However, the bond strength was reduced when ARC was used and when the post was cut immediately. In conclusion, the moment of fiber post cutting may affect the retention of root canal posts when a regular resin cement is used.

  13. The impact of disaster work on community volunteers: The role of peri-traumatic distress, level of personal affectedness, sleep quality and resource loss, on post-traumatic stress disorder symptoms and subjective health.

    Science.gov (United States)

    Thormar, Sigridur B; Gersons, Berthold P R; Juen, Barbara; Djakababa, Maria Nelden; Karlsson, Thorlakur; Olff, Miranda

    2014-12-01

    Disaster work has shown to cause PTSD symptoms and subjective health complaints in professional emergency personnel. However, very little is known about how disaster work affects community volunteers. This first time longitudinal study examined factors contributing to post-traumatic stress disorder symptoms (PTSD) and subjective health complaints in volunteers working in an earthquake setting. At six and eighteen months post disaster, a sample of 506 Indonesian Red Cross volunteers were assessed using the Impact of Event Scale-Revised and the Subjective Health Complaints Inventory. Factors analyzed in relation to the outcomes included: peri-traumatic distress, level of personal affectedness by the disaster, sleep quality and loss of resources as a consequence of the disaster. At 18 months post-disaster the findings showed high levels of PTSD symptoms and subjective health complaints. Quality of sleep was related to both outcomes but resource loss only to PTSD symptoms. Neither peri-traumatic distress nor level of affectedness by the disaster (external versus directly affected volunteers), were predictive of symptoms. This study indicates that characteristics of disaster work e.g. low quality of sleep, may be an important contributor to PTSD symptoms and subjective health complaints in volunteers. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Comparison of the Thorax Dynamic Responses of Small Female and Midsize Male Post Mortem Human Subjects in Side and Forward Oblique Impact Tests.

    Science.gov (United States)

    Baudrit, Pascal; Petitjean, Audrey; Potier, Pascal; Trosseille, Xavier; Vallencien, Guy

    2014-11-01

    Despite the increasing knowledge of the thorax mechanics in impact loadings, the effects of inter-individual differences on the mechanical response are difficult to take into account. For example, the biofidelity corridors for the small female or large male are extrapolated from the midsize male corridors. The present study reports on the results of new tests performed on small female Post Mortem Human Subjects (PMHS), and compares them with test results on midsize male PMHS. Three tests in pure side impact and three tests in forward oblique impact were performed on the thorax of small female specimens. The average weight and stature were 43 kg and 1.58 m for the small female specimens. The initial speed of the impactor was 4.3 m/s. The mass and the diameter of the impactor face were respectively 23.4 kg and 130 mm. The instrumentation and methodology was the same as for the tests published in 2008 by Trosseille et al. on midsize male specimens. The rib cages were instrumented with accelerometers on the T1, T4 and T12 vertebrae, upper and lower sternum, and the ribs were instrumented with up to 110 strain gauges. A force transducer and an accelerometer were mounted on the impactor in order to record the force applied onto the thorax. Targets fixed on vertebrae were tracked using high speed cameras in order to estimate the thoracic deflection. For the six midsize males, the test conditions were exactly the same as for the small female specimens, except for the diameter of the impactor face which was 152 mm. The average weight and stature were 70.3 kg and 1.70 m for the midsize male specimens. The force and thoracic deflection time-histories and the injury assessments are given for each specimen. The thorax force magnitude varied from 1.05 to 1.45 kN and from 1.63 to 2.34 kN, respectively for the small female and midsize male groups. The maximum deflection varied from 51 to 117 mm and from 59 to 81 mm, respectively for the small female and midsize male groups. The

  15. Security of Mobile ad-hoc Wireless Networks. A Brief Survey

    Directory of Open Access Journals (Sweden)

    TILIUTE, D. E.

    2007-11-01

    Full Text Available One of the most present issues of computer wireless networks is the security. Comparing with their wired counterpart, the wireless networks not only accentuate some of the well-known security vulnerabilities but they are subject of new and specific ones. Among the existing wireless networks the ad hoc ones are the most exposed to attacks and collusions due to the absence of any centralized control. The most efficient way to ensure the communication secrecy, inclusively for ad hoc wireless networks, is the cryptography. From many reasons, following from specific operating conditions, the employment of asymmetric key techniques and Public Key Infrastructure is not a realistic choice. In the networks with a large number of nodes, as wireless sensor networks, a large number of secret keys are involved in order to ensure the communication secrecy. While dynamicity is one of the essential features of mobile wireless networks, when nodes may leave or join the network and in the absence of a centralized control entity, the management of secret keys is crucial. The paper presents the main aspects of mobile wireless networks security and focuses on the key management issue in ad-hoc wireless networks.

  16. Innovative research of AD HOC network mobility model

    Science.gov (United States)

    Chen, Xin

    2017-08-01

    It is difficult for researchers of AD HOC network to conduct actual deployment during experimental stage as the network topology is changeable and location of nodes is unfixed. Thus simulation still remains the main research method of the network. Mobility model is an important component of AD HOC network simulation. It is used to describe the movement pattern of nodes in AD HOC network (including location and velocity, etc.) and decides the movement trail of nodes, playing as the abstraction of the movement modes of nodes. Therefore, mobility model which simulates node movement is an important foundation for simulation research. In AD HOC network research, mobility model shall reflect the movement law of nodes as truly as possible. In this paper, node generally refers to the wireless equipment people carry. The main research contents include how nodes avoid obstacles during movement process and the impacts of obstacles on the mutual relation among nodes, based on which a Node Self Avoiding Obstacle, i.e. NASO model is established in AD HOC network.

  17. Multiagent Based Information Dissemination in Vehicular Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    S.S. Manvi

    2009-01-01

    Full Text Available Vehicular Ad hoc Networks (VANETs are a compelling application of ad hoc networks, because of the potential to access specific context information (e.g. traffic conditions, service updates, route planning and deliver multimedia services (Voice over IP, in-car entertainment, instant messaging, etc.. This paper proposes an agent based information dissemination model for VANETs. A two-tier agent architecture is employed comprising of the following: 1 'lightweight', network-facing, mobile agents; 2 'heavyweight', application-facing, norm-aware agents. The limitations of VANETs lead us to consider a hybrid wireless network architecture that includes Wireless LAN/Cellular and ad hoc networking for analyzing the proposed model. The proposed model provides flexibility, adaptability and maintainability for traffic information dissemination in VANETs as well as supports robust and agile network management. The proposed model has been simulated in various network scenarios to evaluate the effectiveness of the approach.

  18. Auto-configuration protocols in mobile ad hoc networks.

    Science.gov (United States)

    Villalba, Luis Javier García; Matesanz, Julián García; Orozco, Ana Lucila Sandoval; Díaz, José Duván Márquez

    2011-01-01

    The TCP/IP protocol allows the different nodes in a network to communicate by associating a different IP address to each node. In wired or wireless networks with infrastructure, we have a server or node acting as such which correctly assigns IP addresses, but in mobile ad hoc networks there is no such centralized entity capable of carrying out this function. Therefore, a protocol is needed to perform the network configuration automatically and in a dynamic way, which will use all nodes in the network (or part thereof) as if they were servers that manage IP addresses. This article reviews the major proposed auto-configuration protocols for mobile ad hoc networks, with particular emphasis on one of the most recent: D2HCP. This work also includes a comparison of auto-configuration protocols for mobile ad hoc networks by specifying the most relevant metrics, such as a guarantee of uniqueness, overhead, latency, dependency on the routing protocol and uniformity.

  19. A spontaneous ad hoc network to share www access

    OpenAIRE

    Lloret Jaime; Garcia Miguel; Peñalver Lourdes; Lacuesta Raquel

    2010-01-01

    In this paper, we propose a secure spontaneous ad-hoc network, based on direct peer-to-peer interaction, to grant a quick, easy, and secure access to the users to surf the Web. The paper shows the description of our proposal, the procedure of the nodes involved in the system, the security algorithms implemented, and the designed messages. We have taken into account the security and its performance. Although some people have defined and described the main features of spontaneous ad-hoc network...

  20. Survey on Security Issues in Vehicular Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Bassem Mokhtar

    2015-12-01

    Full Text Available Vehicular Ad hoc NETworks are special case of ad hoc networks that, besides lacking infrastructure, communicating entities move with various accelerations. Accordingly, this impedes establishing reliable end-to-end communication paths and having efficient data transfer. Thus, VANETs have different network concerns and security challenges to get the availability of ubiquitous connectivity, secure communications, and reputation management systems which affect the trust in cooperation and negotiation between mobile networking entities. In this survey, we discuss the security features, challenges, and attacks of VANETs, and we classify the security attacks of VANETs due to the different network layers.

  1. Effect of cement type, relining procedure, and length of cementation on pull-out bond strength of fiber posts.

    Science.gov (United States)

    Macedo, Vanessa Cruz; Faria e Silva, André Luis; Martins, Luis Roberto Marcondes

    2010-09-01

    As opposed to the cementation metal posts, the cementation of fiber posts has several details that can significantly influence the success of post retention. This study evaluated the effect of the relining procedure, the cement type, and the luted length of the post on fiber posts retention. One hundred eighty bovine incisors were selected to assess post retention; after endodontic treatment, the canals were flared with diamonds burs. Post holes were prepared in lengths of 5, 7.5, and 10 mm; the fiber posts were relined with composite resin and luted with RelyX ARC, RelyX Unicem, or RelyX Luting 2. All cements are manufactured by 3M ESPE (St. Paul, MN). Samples were subjected to a pull-out bond strength test in a universal testing machine; the results (N) were submitted to a three-way analysis of variance and the Tukey post hoc test (alpha = 0.05). The improvement of post retention occurred with the increase of the post length luted into the root canal; the relining procedure improved the pull-out bond strength. RelyX Unicem and RelyX ARC showed similar values of retention, both showing higher values than RelyX Luting 2. Post length, the relining procedure, and the cement type are all important factors for improving the retention of fiber posts. Copyright 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  2. Periportal lymphatic system on post-hepatobiliary phase Gd-EOB-DTPA-enhanced MR imaging in normal subjects and patients with chronic hepatitis C.

    Science.gov (United States)

    Yamada, Yasunari; Matsumoto, Shunro; Mori, Hiromu; Takaji, Ryo; Kiyonaga, Maki; Hijiya, Naoki; Tanoue, Rika; Tomonari, Kenichiro; Tanoue, Shuichi; Hongo, Norio; Ohta, Masayuki; Seike, Masataka; Inomata, Masafumi; Murakami, Kazunari; Moriyama, Masatsugu

    2017-10-01

    We sought to evaluate visualization of periportal lymphatics and lymph nodes (lymphatic system) on Gd-EOB-DTPA-enhanced magnetic resonance (MR) images using a fat-suppressed T2-weighted sequence with 3-dimensional (3D) volume isotropic turbo spin echo acquisition (VISTA) at 3.0 T in normal subjects and patients with chronic hepatitis C. MR imaging was performed in 254 subjects between June 2013 and May 2016. After applying inclusion and exclusion criteria, the final population was 31 normal subjects and 34 patients with chronic hepatitis C. Images were acquired after the hepatobiliary phase following intravenous administration of Gd-EOB-DTPA, which causes signal loss in the bile ducts, to facilitate the visualization of the periportal lymphatic system. Two radiologists assessed the visualization of the periportal lymphatic system in 31 normal subjects. The axial dimensions of the main periportal lymphatic system in normal subjects were measured and compared with those of 34 patients with chronic hepatitis C using the Mann-Whitney U-test, and their correlation with a hepatic fibrosis marker, the Fibrosis-4 (FIB-4), was assessed using Spearman's rank correlation test. The periportal lymphatic system was detected as high signal intensity areas surrounding the portal vein up to the third branches by each reader in all normal subjects. The axial dimensions of the main periportal lymphatic system in patients with chronic hepatitis C were significantly larger than those in normal subjects (p system and the degree of hepatic fibrosis.

  3. Dynamic Mobile IP routers in ad hoc networks

    NARCIS (Netherlands)

    Kock, B.A.; Schmidt, J.R.

    2005-01-01

    This paper describes a concept combining mobile IP and ad hoc routing to create a robust mobile network. In this network all nodes are mobile and globally and locally reachable under the same IP address. Essential for implementing this network are the dynamic mobile IP routers. They act as gateways

  4. Authentication and consensus overhead in vehicular ad hoc networks

    NARCIS (Netherlands)

    Petit, Jonathan; Mammeri, Zoubir

    Vehicular ad hoc networks aim at increasing passenger safety by exchanging warning messages between vehicles wirelessly. A main challenge is to resist to various malicious abuses and security attacks. However, any security mechanism comes with overhead. We analyze how the authentication algorithm

  5. A survey of TCP over ad hoc networks

    NARCIS (Netherlands)

    Al Hanbali, Ahmad; Altman, Eitan; Nain, Philippe

    2005-01-01

    The Transmission Control Protocol (TCP) was designed to provide reliable end-to-end delivery of data over unreliable networks. In practice, most TCP deployments have been carefully designed in the context of wired networks. Ignoring the properties of wireless ad hoc networks can lead to TCP

  6. Decentralized Network-level Synchronization in Mobile Ad Hoc Networks

    NARCIS (Netherlands)

    Voulgaris, Spyros; Dobson, Matthew; van Steen, Martinus Richardus

    Energy is the scarcest resource in ad hoc wireless networks, particularly in wireless sensor networks requiring a long lifetime. Intermittently switching the radio on and off is widely adopted as the most effective way to keep energy consumption low. This, however, prevents the very goal of

  7. The accuracy of interpreting key psychiatric terms by ad hoc ...

    African Journals Online (AJOL)

    from various professional groups in an ad hoc way. ... technical vocabulary. Problems with interpretation may arise as a result of these challenges. Difficulties in interpretation include the omission of information, bad paraphrasing, lack of translatable ... considerable challenges to accurate interpreting in this group, not.

  8. Authentication Based on Multilayer Clustering in Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Suh Heyi-Sook

    2005-01-01

    Full Text Available In this paper, we describe a secure cluster-routing protocol based on a multilayer scheme in ad hoc networks. This work provides scalable, threshold authentication scheme in ad hoc networks. We present detailed security threats against ad hoc routing protocols, specifically examining cluster-based routing. Our proposed protocol, called "authentication based on multilayer clustering for ad hoc networks" (AMCAN, designs an end-to-end authentication protocol that relies on mutual trust between nodes in other clusters. The AMCAN strategy takes advantage of a multilayer architecture that is designed for an authentication protocol in a cluster head (CH using a new concept of control cluster head (CCH scheme. We propose an authentication protocol that uses certificates containing an asymmetric key and a multilayer architecture so that the CCH is achieved using the threshold scheme, thereby reducing the computational overhead and successfully defeating all identified attacks. We also use a more extensive area, such as a CCH, using an identification protocol to build a highly secure, highly available authentication service, which forms the core of our security framework.

  9. VMQL: A Visual Language for Ad-Hoc Model Querying

    DEFF Research Database (Denmark)

    Störrle, Harald

    2011-01-01

    In large scale model based development, analysis level models are more like knowledge bases than engineering artifacts. Their effectiveness depends, to a large degree, on the ability of domain experts to retrieve information from them ad hoc. For large scale models, however, existing query facili...

  10. ON SECURE FULL DUPLEX COMMUNICATION IN MOBILE AD HOC NETWORK

    Directory of Open Access Journals (Sweden)

    S. C. Dutta

    2013-06-01

    Full Text Available This paper is to establish Ad Hoc network in mobile phones and start fully secured full duplex communication in any situation. This type of communication will be cost effective and it will be fastest way of communication in case of any server failure or server error.

  11. ON SECURE FULL DUPLEX COMMUNICATION IN MOBILE AD HOC NETWORK

    OpenAIRE

    S. C. Dutta; Sudha Singh; D. K. Singh

    2013-01-01

    This paper is to establish Ad Hoc network in mobile phones and start fully secured full duplex communication in any situation. This type of communication will be cost effective and it will be fastest way of communication in case of any server failure or server error.

  12. Modelling Mobility in Mobile AD-HOC Network Environments ...

    African Journals Online (AJOL)

    We show how to implement the random waypoint mobility model for ad-hoc networks without pausing, through a more efficient and reliable computer simulation, using MATrix LABoratory 7.5.0 (R2007b). Simulation results obtained verify the correctness of the model. Keywords : Stationary, random waypoint, simulation, ...

  13. The accuracy of interpreting key psychiatric terms by ad hoc ...

    African Journals Online (AJOL)

    1Centre for Public Mental Health, Department of Psychology, Stellenbosch University, South Africa. 2Department of Psychiatry ... Cultural diversity plays an important role in South Africa's mental health services. Not only do ... interpreter.2 Ad hoc interpreters may have inadequate language proficiency and may lack ...

  14. Access Point Security Service for wireless ad-hoc communication

    NARCIS (Netherlands)

    Scholten, Johan; Nijdam, M.

    2006-01-01

    This paper describes the design and implementation of a security solution for ad-hoc peer-to-peer communication. The security solution is based on a scenario where two wireless devices require secure communication, but share no security relationship a priori. The necessary requirements for the

  15. [The Influence of Subjective Health Status, Post-Traumatic Growth, and Social Support on Successful Aging in Middle-Aged Women].

    Science.gov (United States)

    Lee, Seung Hee; Jang, Hyung Suk; Yang, Young Hee

    2016-10-01

    This study was done to investigate factors influencing successful aging in middle-aged women. A convenience sample of 103 middle-aged women was selected from the community. Data were collected using a structured questionnaire and analyzed using descriptive statistics, two-sample t-test, one-way ANOVA, Kruskal Wallis test, Pearson correlations, Spearman correlations and multiple regression analysis with the SPSS/WIN 22.0 program. Results of regression analysis showed that significant factors influencing successful aging were post-traumatic growth and social support. This regression model explained 48% of the variance in successful aging. Findings show that the concept 'post-traumatic growth' is an important factor influencing successful aging in middle-aged women. In addition, social support from friends/co-workers had greater influence on successful aging than social support from family. Thus, we need to consider the positive impact of post-traumatic growth and increase the chances of social participation in a successful aging program for middle-aged women.

  16. Comparison of different ultrasonic vibration modes for post removal.

    Science.gov (United States)

    Braga, Neilor Mateus Antunes; Silva, Juliana Monteiro da; Carvalho-Júnior, Jacy Ribeiro de; Ferreira, Raquel Conceição; Saquy, Paulo César; Brito-Júnior, Manoel

    2012-01-01

    This in vitro study compared different ultrasonic vibration modes for intraradicular cast post removal. The crowns of 24 maxillary canines were removed, the roots were embedded in acrylic resin blocks, and the canals were treated endodontically. The post holes were prepared and root canal impressions were taken with self-cured resin acrylic. After casting, the posts were cemented with zinc phosphate cement. The samples were randomly distributed into 3 groups (n=8): G1: no ultrasonic vibration (control); G2: tip of the ultrasonic device positioned perpendicularly to core surface and close to the incisal edge; and G3: tip of the ultrasonic device positioned perpendicularly to core surface at cervical region, close to the line of cementation. An Enac OE-5 ultrasound unit with an ST-09 tip was used. All samples were submitted to the tensile test using an universal testing machine at a crosshead speed of 1 mm/min. Data were subjected to one-way ANOVA and Tukey's post-hoc tests (α=0.05). Mean values of the load to dislodge the posts (MPa) were: G1 = 4.6 (± 1.4) A; G2 = 2.8 (± 0.9) B, and G3= 0.9 (± 0.3) C. Therefore, the ultrasonic vibration applied with the tip of device close to the core's cervical area showed higher ability to reduce the retention of cast post to root canal.

  17. Age, Cumulative Trauma and Stressful Life Events, and Post-Traumatic Stress Symptoms among Older Adults in Prison: Do Subjective Impressions Matter?

    Science.gov (United States)

    Maschi, Tina; Morgen, Keith; Zgoba, Kristen; Courtney, Deborah; Ristow, Jennifer

    2011-01-01

    Background: The aging prison population in the United States presents a significant public health challenge with high rates of trauma and mental health issues that the correctional system alone is ill-prepared to address. The purpose of this study was to examine the relationship of age, objective, and subjective measures of trauma and stressful…

  18. WOMAC Osteoarthritis Index--additional dimensions for use in subjects with post-traumatic osteoarthritis of the knee. Western Ontario and MacMaster Universities

    DEFF Research Database (Denmark)

    Roos, Ewa M.; Roos, H P; Lohmander, L S

    1999-01-01

    To compare the sensitivity of WOMAC and the two added dimensions Sport and Recreation Function and Knee Related Quality of Life in subjects with radiographic knee OA to that in controls. To study the influence of age on the reported outcomes....

  19. Fracture resistance of fiber posts: combinations of several small posts vs. standardized single post.

    Science.gov (United States)

    Porciani, Pier F; Vano, Michele; Radovic, Ivana; Goracci, Cecilia; Grandini, Simone; García-Godoy, Franklin; Ferrari, Marco

    2008-12-01

    To determine the fracture resistance of different sizes of standardized single fiber posts and the combinations of multiple small experimental posts. Single posts in three different sizes (1, 2 and 3; DT Light Posts, RTD; DT), as control, and seven different combinations of experimental small posts (Abrasive Technology), reproducing the sizes of several endodontic files were cemented in endodontic resin blocks. The combinations of small posts were made combining 2-4 small posts so as to reach the sizes of standardized DT posts. The posts were loaded at an angle of 45 degrees to the long axis of the block using a crosshead speed of 1 mm/minute until specimen failure. Ten posts/combinations were tested. Statistical analysis was performed using one-way ANOVA followed by Tamhane test for the post hoc comparisons (P fracture resistance increased when increasing the diameter of the post. The use of multiple posts resulted in fracture resistances comparable to that of the single post for two of the three diameters studied (DT1 and DT2). For the largest diameter (DT3), the use of multiple posts resulted in lower fracture resistances than did the single post.

  20. KEMAMPUAN SUBJECT SPECIFIC PEDAGOGY CALON GURU BIOLOGI PESERTA PROGRAM PENDIDIKAN PROFESIONAL GURU (PPG YANG BERLATAR BELAKANG BASIC SAINS PRA DAN POST WORKSHOP

    Directory of Open Access Journals (Sweden)

    Yenny Anwar

    2012-10-01

    Full Text Available Penelitian ini bertujuan untuk menggambarkan/mendeskripsikan kemampuan Subjek Spesifik Pedagogi mahasiswa calon guru biologi yang mengikuti program Pendidikan Profesional Guru (PPG angkatan 2012-2013 melalui pendekatan konsekutif.  Hasil sementara menunjukkan  bahwa Kemampuan Subject Specific Pedagogy mahasiswa calon guru biologi yang berlatar belakang Biologi murni program Basic Science masih minim, dapat dilihat dari hasil CoRes dan PaP-eRs buatan mereka sebelum mengikuti workshop. Setelah workshop semester I diperoleh hasil yang menunjukkan peningkatan yang cukup baik.   This study aimed to describe / describes the ability of prospective students Subject Specific Pedagogy biology teachers who follow the Professional Teacher Education Program (PTEP 2012-2013 armed consecutive approach. Preliminary results indicate that the ability of prospective students Subject Specific Pedagogy biology teacher who belongs to the pure Biology Basic Science program is minimal, it can be seen from the cores and pap-ers made ​​them before the workshop. After the workshop the first half of the obtained results that showed a pretty good improvement.

  1. Capacity of Wireless Ad Hoc Networks with Opportunistic Collaborative Communications

    Directory of Open Access Journals (Sweden)

    Simeone O

    2007-01-01

    Full Text Available Optimal multihop routing in ad hoc networks requires the exchange of control messages at the MAC and network layer in order to set up the (centralized optimization problem. Distributed opportunistic space-time collaboration (OST is a valid alternative that avoids this drawback by enabling opportunistic cooperation with the source at the physical layer. In this paper, the performance of OST is investigated. It is shown analytically that opportunistic collaboration outperforms (centralized optimal multihop in case spatial reuse (i.e., the simultaneous transmission of more than one data stream is not allowed by the transmission protocol. Conversely, in case spatial reuse is possible, the relative performance between the two protocols has to be studied case by case in terms of the corresponding capacity regions, given the topology and the physical parameters of network at hand. Simulation results confirm that opportunistic collaborative communication is a promising paradigm for wireless ad hoc networks that deserves further investigation.

  2. A Simplified Mobile Ad Hoc Network Structure for Helicopter Communication

    Directory of Open Access Journals (Sweden)

    Abdeldime Mohamed Salih Abdelgader

    2016-01-01

    Full Text Available There are a number of volunteer and statutory organizations who are capable of conducting an emergency response using helicopters. Rescue operations require a rapidly deployable high bandwidth network to coordinate necessary relief efforts between rescue teams on the ground and helicopters. Due to massive destruction and loss of services, ordinary communication infrastructures may collapse in these situations. Consequently, information exchange becomes one of the major challenges in these circumstances. Helicopters can be also employed for providing many services in rugged environments, military applications, and aerial photography. Ad hoc network can be used to provide alternative communication link between a set of helicopters, particularly in case of significant amount of data required to be shared. This paper addresses the ability of using ad hoc networks to support the communication between a set of helicopters. A simplified network structure model is presented and extensively discussed. Furthermore, a streamlined routing algorithm is proposed. Comprehensive simulations are conducted to evaluate the proposed routing algorithm.

  3. Proposal of interference reduction routing for ad-hoc networks

    Directory of Open Access Journals (Sweden)

    Katsuhiro Naito

    2010-10-01

    Full Text Available In this paper, we propose an interference reduction routing protocol for ad-hoc networks. The interference is one of the degradation factors in wireless communications. In the ad-hoc network, some nodes communicate simultaneously. Therefore, these communications cause interference each other, and some packets are corrupted due to interference from another node. In the proposed protocol, each node estimates required transmission power according to hello messages. Therefore, the node can transmit a data packet with minimum required transmission power. Consequently, the interference against neighbor nodes can be reduced. From simulation results, we can find that the proposed protocol can reduce the number of control messages and can improve the throughput performance.

  4. Energy management in wireless cellular and ad-hoc networks

    CERN Document Server

    Imran, Muhammad; Qaraqe, Khalid; Alouini, Mohamed-Slim; Vasilakos, Athanasios

    2016-01-01

    This book investigates energy management approaches for energy efficient or energy-centric system design and architecture and presents end-to-end energy management in the recent heterogeneous-type wireless network medium. It also considers energy management in wireless sensor and mesh networks by exploiting energy efficient transmission techniques and protocols. and explores energy management in emerging applications, services and engineering to be facilitated with 5G networks such as WBANs, VANETS and Cognitive networks. A special focus of the book is on the examination of the energy management practices in emerging wireless cellular and ad hoc networks. Considering the broad scope of energy management in wireless cellular and ad hoc networks, this book is organized into six sections covering range of Energy efficient systems and architectures; Energy efficient transmission and techniques; Energy efficient applications and services. .

  5. Optimal channel choice for collaborative ad-hoc dissemination

    DEFF Research Database (Denmark)

    Hu, Liang; Boudec, J-Y. L.; Vojnovic, M.

    2010-01-01

    Collaborative ad-hoc dissemination of information has been proposed as an efficient means to disseminate information among devices in a wireless ad-hoc network. Devices help in forwarding the information channels to the entire network, by disseminating the channels they subscribe to, plus others....... We consider the case where devices have a limited amount of storage that they are willing to devote to the public good, and thus have to decide which channels they are willing to help disseminate. We are interested in finding channel selection strategies which optimize the dissemination time across...... the channels. We first consider a simple model under the random mixing assumption; we show that channel dissemination time can be characterized in terms of the number of nodes that forward this channel. Then we show that maximizing a social welfare is equivalent to an assignment problem, whose solution can...

  6. Cognitive radio application for vehicular ad hoc networks (VANETS

    Directory of Open Access Journals (Sweden)

    Miladić Suzana D.

    2016-01-01

    Full Text Available This paper presents the application of cognitive radio technology in vehicular ad-hoc networks aimed to improve the communications between vehicles themselves as well as between vehicles and roadside infrastructure. Due to dynamic approach of spectrum access, cognitive radio is a technology that enables more efficient usage of radio-frequency spectrum. We review actual approaches and discuss research challenges related to the use of cognitive radio technology in vehicular ad hoc networks with emphasis on architecture, spectrum management as well as QoS optimization. The researching on cognitive radio application in vehicular networks is still developing and there are not many experimental platforms due to their complex setups. Some related research projects and cognitive radio realizations are provided in this paper.

  7. Secure Geographic Routing in Ad Hoc and Wireless Sensor Networks

    Directory of Open Access Journals (Sweden)

    Zahariadis Theodore

    2010-01-01

    Full Text Available Security in sensor networks is one of the most relevant research topics in resource constrained wireless devices and networks. Several attacks can be suffered in ad hoc and wireless sensor networks (WSN, which are highly susceptible to attacks, due to the limited resources of the nodes. In this paper, we propose innovative and lightweight localization techniques that allow for intrusion identification and isolation schemes and provide accurate location information. This information is used by our routing protocol which additionally incorporates a distributed trust model to prevent several routing attacks to the network. We finally evaluate our algorithms for accurate localization and for secure routing which have been implemented and tested in real ad hoc and wireless sensor networks.

  8. Elevated 1-h post-load plasma glucose levels in subjects with normal glucose tolerance are associated with a pro-atherogenic lipid profile.

    Science.gov (United States)

    Andreozzi, Francesco; Mannino, Gaia C; Perticone, Maria; Perticone, Francesco; Sesti, Giorgio

    2017-01-01

    Evidence suggests that plasma glucose concentration ≥155 mg/dl at 1h during an oral glucose tolerance test (OGTT) (NGT 1 h-high) predicts both development of type 2 diabetes (T2DM) and cardiovascular events, among adults with normal glucose tolerance (NGT). An atherogenic lipid profile is detectable in subjects with impaired glucose tolerance (IGT) and T2DM. Whether individuals with NGT-1h-high also exhibit a pro-atherogenic lipid profile is still uncertain. The study cohort includes 1011 non-diabetic Caucasian adults participating in the CATAMERI study. All participants were submitted to anthropometrical evaluation before undergoing an OGTT. Subjects were categorized into NGT 1 h-low (1 h glucose Lipid profile includes triglycerides, total and HDL cholesterol, apolipoprotein B (ApoB) and ApoA-1. 510 subjects were NGT 1 h-low, 211 NGT 1 h-high, 232 IGT and 58 were newly diagnosed T2DM. Triglyceride and ApoB levels were significantly higher in NGT 1 h-high, IGT and T2DM subjects compared to NGT 1 h-low, and HDL cholesterol was significantly lower. Triglycerides-to-HDL cholesterol ratio was significantly higher in NGT 1 h-high, IGT and T2DM groups compared with NGT 1 h-low individuals. The ApoB/ApoA-1 ratio was significantly higher in NGT 1 h-high, IGT and T2DM groups than in the NGT 1 h-low group. NGT 1 h-high, IGT and T2DM subjects exhibited reduced LDL/ApoB ratio compared with NGT 1 h-low. Noticeably, there were no significant differences in ApoB/ApoA-1 and LDL/ApoB ratios when comparing NGT 1 h-high with IGT and T2DM. Individuals with NGT 1-h-high exhibited an atherogenic lipid pattern qualitatively and quantitatively similar to that observed in individuals with IGT and newly diagnosed T2DM. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Decentralized session initiation protocol solution in ad hoc networks

    Science.gov (United States)

    Han, Lu; Jin, Zhigang; Shu, Yantai; Dong, Linfang

    2006-10-01

    With the fast development of ad hoc networks, SIP has attracted more and more attention in multimedia service. This paper proposes a new architecture to provide SIP service for ad hoc users, although there is no centralized SIP server deployed. In this solution, we provide the SIP service by the introduction of two nodes: Designated SIP Server (DS) and its Backup Server (BDS). The nodes of ad hoc network designate DS and BDS when they join the session nodes set and when some pre-defined events occur. A new sip message type called REGISTRAR is presented so nodes can send others REGISTRAR message to declare they want to be DS. According to the IP information taken in the message, an algorithm works like the election of DR and BDR in OSPF protocol is used to vote DS and BDS SIP servers. Naturally, the DS will be replaced by BDS when the DS is down for predicable or unpredictable reasons. To facilitate this, the DS should register to the BDS and transfer a backup of the SIP users' database. Considering the possibility DS or BDS may abruptly go down, a special policy is given. When there is no DS and BDS, a new election procedure is triggered just like the startup phase. The paper also describes how SIP works normally in the decentralized model as well as the evaluation of its performance. All sessions based on SIP in ad hoc such as DS voting have been tested in the real experiments within a 500m*500m square area where about 30 random nodes are placed.

  10. Interference in wireless ad hoc networks with smart antennas

    KAUST Repository

    Alabdulmohsin, Ibrahim

    2014-08-01

    In this paper, we show that the use of directional antennas in wireless ad hoc networks can actually increase interference due to limitations of virtual carrier sensing. We derive a simple mathematical expression for interference in both physical and virtual carrier sense networks, which reveals counter-intuitively that receivers in large dense networks with directional antennas can experience larger interference than in omnidirectional networks unless the beamwidth is sufficiently small. Validity of mathematical analysis is confirmed using simulations.

  11. Mobile Advertisement in Vehicular Ad-Hoc Networks

    OpenAIRE

    Dobre, Ciprian; Tudor, George Cristian

    2012-01-01

    Mobile Advertisement is a location-aware dissemination solution built on top of a vehicular ad-hoc network. We envision a network of WiFi access points that dynamically disseminate data to clients running on the car's smart device. The approach can be considered an alternative to the static advertisement billboards and can be useful to business companies wanting to dynamically advertise their products and offers to people driving their car. The clients can subscribe to information based on sp...

  12. Power control algorithms for mobile ad hoc networks

    Directory of Open Access Journals (Sweden)

    Nuraj L. Pradhan

    2011-07-01

    We will also focus on an adaptive distributed power management (DISPOW algorithm as an example of the multi-parameter optimization approach which manages the transmit power of nodes in a wireless ad hoc network to preserve network connectivity and cooperatively reduce interference. We will show that the algorithm in a distributed manner builds a unique stable network topology tailored to its surrounding node density and propagation environment over random topologies in a dynamic mobile wireless channel.

  13. Towards a Security Architecture for Vehicular Ad Hoc Networks

    OpenAIRE

    Plößl, Klaus; Nowey, Thomas; Mletzko, Christian

    2006-01-01

    Vehicular ad hoc networks (VANETs) have the potential to increase road safety and comfort. Especially because of the road safety functions, there is a strong demand for security in VANETs. After defining three application categories the paper outlines main security and privacy requirements in VANETs. Next, a security architecture for VANETs (SAV) is proposed that strives to satisfy the requirements. To find mechanisms applicable in the architecture a survey of existing mechanisms is given.

  14. Coherent and automatic address resolution for vehicular ad hoc networks

    OpenAIRE

    Urquiza Aguiar, Luis; Tripp Barba, Carolina; Rebollo Monedero, David; Mezher, Ahmad Mohamad; Aguilar Igartua, Mónica; Forné Muñoz, Jorge

    2015-01-01

    The interest in vehicular communications has increased notably. In this paper, the use of the address resolution (AR) procedures is studied for vehicular ad hoc networks (VANETs).We analyse the poor performance of AR transactions in such networks and we present a new proposal called coherent, automatic address resolution (CAAR). Our approach inhibits the use of AR transactions and instead increases the usefulness of routing signalling to automatically match the IP and MAC addresses. Through e...

  15. Demand Based Effective Energy Utilization in Mobile Ad Hoc Networks

    OpenAIRE

    Bhuvaneswari, R.; Viswanathan, M

    2012-01-01

    Mobile Ad Hoc Networks (MANET) are the collection of mobile nodes without any centralized infrastructure. The underlying assumption is that the intermediate nodes cooperate in forwarding packets. Mobile nodes collects the route information through overhearing and stores these information in route caches with the use of Dynamic Source Routing (DSR) Protocol. These nodes consume power unnecessarily due to overhearing the transmissions of their neighbors. Due to this, the network performance is ...

  16. Autoantibodies to post-translationally modified type I and II collagen in Charcot neuroarthropathy in subjects with type 2 diabetes mellitus.

    Science.gov (United States)

    Rizzo, Paola; Pitocco, Dario; Zaccardi, Francesco; Di Stasio, Enrico; Strollo, Rocky; Rizzi, Alessandro; Scavone, Giuseppe; Costantini, Federica; Galli, Marco; Tinelli, Giovanni; Flex, Andrea; Caputo, Salvatore; Pozzilli, Paolo; Landolfi, Raffaele; Ghirlanda, Giovanni; Nissim, Ahuva

    2017-02-01

    Charcot neuroarthropathy (CN) is a disabling complication, culminating in bone destruction and involving joints and articular cartilage with high inflammatory environment. Its real pathogenesis is as yet unknown. In autoinflammatory diseases, such as rheumatoid arthritis, characterized by inflammation and joint involvement, autoantibodies against oxidative post-translationally modified (oxPTM) collagen type I (CI) and type II (CII) were detected. Therefore, the aim of our study was to assess the potential involvement of autoimmunity in charcot neuroarthropathy, investigating the presence of autoantibodies oxPTM-CI and oxPTM-CII, in participants with charcot neuroarthropathy. In this case-control study, we enrolled 124 participants with type 2 diabetes mellitus (47 with charcot neuroarthropathy, 37 with diabetic peripheral neuropathy without charcot neuroarthropathy, and 40 with uncomplicated diabetes), and 32 healthy controls. The CI and CII were modified with ribose and other oxidant species, and the modifications were evaluated with sodium dodecyl sulfate-polyacrylamide gel electrophoresis. Binding of sera from the participants was analyzed with enzyme-linked immunosorbent assay. Age, body mass index, waist and hip circumferences, and lipid profile were similar across the 4 groups, as well as glycated hemoglobin and duration of diabetes among people with diabetes. An increased binding to both native and all oxidation-modified forms of CII was found in participants with CN and diabetic neuropathy. Conversely, for CI, an aspecific increased reactivity was noted. Our results detected the presence of autoantibodies against oxidative post-translational modified collagen, particularly type 2 collagen, in participants with charcot neuroarthropathy and diabetic neuropathy, suggesting the possible involvement of autoimmunity. Further studies are required to understand the role of autoimmunity in the pathogenesis of charcot neuroarthropathy. Copyright © 2016 John Wiley

  17. MWAHCA: a multimedia wireless ad hoc cluster architecture.

    Science.gov (United States)

    Diaz, Juan R; Lloret, Jaime; Jimenez, Jose M; Sendra, Sandra

    2014-01-01

    Wireless Ad hoc networks provide a flexible and adaptable infrastructure to transport data over a great variety of environments. Recently, real-time audio and video data transmission has been increased due to the appearance of many multimedia applications. One of the major challenges is to ensure the quality of multimedia streams when they have passed through a wireless ad hoc network. It requires adapting the network architecture to the multimedia QoS requirements. In this paper we propose a new architecture to organize and manage cluster-based ad hoc networks in order to provide multimedia streams. Proposed architecture adapts the network wireless topology in order to improve the quality of audio and video transmissions. In order to achieve this goal, the architecture uses some information such as each node's capacity and the QoS parameters (bandwidth, delay, jitter, and packet loss). The architecture splits the network into clusters which are specialized in specific multimedia traffic. The real system performance study provided at the end of the paper will demonstrate the feasibility of the proposal.

  18. Auto-Configuration Protocols in Mobile Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Julián García Matesanz

    2011-03-01

    Full Text Available The TCP/IP protocol allows the different nodes in a network to communicate by associating a different IP address to each node. In wired or wireless networks with infrastructure, we have a server or node acting as such which correctly assigns IP addresses, but in mobile ad hoc networks there is no such centralized entity capable of carrying out this function. Therefore, a protocol is needed to perform the network configuration automatically and in a dynamic way, which will use all nodes in the network (or part thereof as if they were servers that manage IP addresses. This article reviews the major proposed auto-configuration protocols for mobile ad hoc networks, with particular emphasis on one of the most recent: D2HCP. This work also includes a comparison of auto-configuration protocols for mobile ad hoc networks by specifying the most relevant metrics, such as a guarantee of uniqueness, overhead, latency, dependency on the routing protocol and uniformity.

  19. MWAHCA: A Multimedia Wireless Ad Hoc Cluster Architecture

    Science.gov (United States)

    Diaz, Juan R.; Jimenez, Jose M.; Sendra, Sandra

    2014-01-01

    Wireless Ad hoc networks provide a flexible and adaptable infrastructure to transport data over a great variety of environments. Recently, real-time audio and video data transmission has been increased due to the appearance of many multimedia applications. One of the major challenges is to ensure the quality of multimedia streams when they have passed through a wireless ad hoc network. It requires adapting the network architecture to the multimedia QoS requirements. In this paper we propose a new architecture to organize and manage cluster-based ad hoc networks in order to provide multimedia streams. Proposed architecture adapts the network wireless topology in order to improve the quality of audio and video transmissions. In order to achieve this goal, the architecture uses some information such as each node's capacity and the QoS parameters (bandwidth, delay, jitter, and packet loss). The architecture splits the network into clusters which are specialized in specific multimedia traffic. The real system performance study provided at the end of the paper will demonstrate the feasibility of the proposal. PMID:24737996

  20. MWAHCA: A Multimedia Wireless Ad Hoc Cluster Architecture

    Directory of Open Access Journals (Sweden)

    Juan R. Diaz

    2014-01-01

    Full Text Available Wireless Ad hoc networks provide a flexible and adaptable infrastructure to transport data over a great variety of environments. Recently, real-time audio and video data transmission has been increased due to the appearance of many multimedia applications. One of the major challenges is to ensure the quality of multimedia streams when they have passed through a wireless ad hoc network. It requires adapting the network architecture to the multimedia QoS requirements. In this paper we propose a new architecture to organize and manage cluster-based ad hoc networks in order to provide multimedia streams. Proposed architecture adapts the network wireless topology in order to improve the quality of audio and video transmissions. In order to achieve this goal, the architecture uses some information such as each node’s capacity and the QoS parameters (bandwidth, delay, jitter, and packet loss. The architecture splits the network into clusters which are specialized in specific multimedia traffic. The real system performance study provided at the end of the paper will demonstrate the feasibility of the proposal.

  1. Recent development in wireless sensor and ad-hoc networks

    CERN Document Server

    Li, Xiaolong; Yang, Yeon-Mo

    2015-01-01

    Wireless Sensor Network (WSN) consists of numerous physically distributed autonomous devices used for sensing and monitoring the physical and/or environmental conditions. A WSN uses a gateway that provides wireless connectivity to the wired world as well as distributed networks. There are many open problems related to Ad-Hoc networks and its applications. Looking at the expansion of the cellular infrastructure, Ad-Hoc network may be acting as the basis of the 4th generation wireless technology with the new paradigm of ‘anytime, anywhere communications’. To realize this, the real challenge would be the security, authorization and management issues of the large scale WSNs. This book is an edited volume in the broad area of WSNs. The book covers various chapters like Multi-Channel Wireless Sensor Networks, its Coverage, Connectivity as well as Deployment. It covers comparison of various communication protocols and algorithms such as MANNET, ODMRP and ADMR Protocols for Ad hoc Multicasting, Location Based C...

  2. MAC Protocol for Ad Hoc Networks Using a Genetic Algorithm

    Science.gov (United States)

    Elizarraras, Omar; Panduro, Marco; Méndez, Aldo L.

    2014-01-01

    The problem of obtaining the transmission rate in an ad hoc network consists in adjusting the power of each node to ensure the signal to interference ratio (SIR) and the energy required to transmit from one node to another is obtained at the same time. Therefore, an optimal transmission rate for each node in a medium access control (MAC) protocol based on CSMA-CDMA (carrier sense multiple access-code division multiple access) for ad hoc networks can be obtained using evolutionary optimization. This work proposes a genetic algorithm for the transmission rate election considering a perfect power control, and our proposition achieves improvement of 10% compared with the scheme that handles the handshaking phase to adjust the transmission rate. Furthermore, this paper proposes a genetic algorithm that solves the problem of power combining, interference, data rate, and energy ensuring the signal to interference ratio in an ad hoc network. The result of the proposed genetic algorithm has a better performance (15%) compared to the CSMA-CDMA protocol without optimizing. Therefore, we show by simulation the effectiveness of the proposed protocol in terms of the throughput. PMID:25140339

  3. Auto-Configuration Protocols in Mobile Ad Hoc Networks

    Science.gov (United States)

    Villalba, Luis Javier García; Matesanz, Julián García; Orozco, Ana Lucila Sandoval; Díaz, José Duván Márquez

    2011-01-01

    The TCP/IP protocol allows the different nodes in a network to communicate by associating a different IP address to each node. In wired or wireless networks with infrastructure, we have a server or node acting as such which correctly assigns IP addresses, but in mobile ad hoc networks there is no such centralized entity capable of carrying out this function. Therefore, a protocol is needed to perform the network configuration automatically and in a dynamic way, which will use all nodes in the network (or part thereof) as if they were servers that manage IP addresses. This article reviews the major proposed auto-configuration protocols for mobile ad hoc networks, with particular emphasis on one of the most recent: D2HCP. This work also includes a comparison of auto-configuration protocols for mobile ad hoc networks by specifying the most relevant metrics, such as a guarantee of uniqueness, overhead, latency, dependency on the routing protocol and uniformity. PMID:22163814

  4. Treatment of hemispatial neglect in patients with post-hemiparesis: a single-subject experimental design study using a whole-body tilt exercise plus mental practice.

    Science.gov (United States)

    Kang, Tae-Woo; Oh, Duck-Won

    2012-01-01

    To investigate the effect of whole-body tilt exercise for treating hemispatial neglect and to identify the effects of incorporating mental practice into the exercise. We used a single-subject experimental design alternating with multiple baselines. Three stroke patients with hemispatial neglect participated in this study. The severity of hemispatial neglect and balance function were measured during baseline and intervention sessions. The whole-body tilt exercise was performed by using a device that allows the body to tilt 20° from the neutral upright position. Mental practice consisted of 5 min of relaxation, main whole-body tilt imagination, and normalization phases. When the whole-body tilt exercise alone was performed, the average severity score of hemispatial neglect in subjects 1, 2, and 3 decreased by 7.54, 10.02, and 8.24, respectively; their respective average balance function score increased by 35.95%, 28.13%, and 15.33% under the open-eye condition and 34.66%, 20.33%, and 13.77% under the closed-eye condition. For subjects 1, 2, and 3, the respective average hemispatial neglect score decreased by 9.07, 11.35, and 10.13 after the whole-body tilt exercise with mental practice; their average balance function scores increased by 40.15%, 33.38%, and 24.22% under the open-eye condition and by 38.93%, 27.08%, and 11.88% under the closed-eye condition, respectively. These findings suggest that a whole-body tilt exercise alone may be beneficial in enhancing hemispatial neglect symptoms but the addition of mental practice produces a greater positive effect.

  5. Consumption of onion juice modulates oxidative stress and attenuates the risk of bone disorders in middle-aged and post-menopausal healthy subjects.

    Science.gov (United States)

    Law, Yat-Yin; Chiu, Hui-Fang; Lee, Hui-Hsin; Shen, You-Cheng; Venkatakrishnan, Kamesh; Wang, Chin-Kun

    2016-02-01

    Osteoporosis is a chronic inflammatory condition that is characterized by the loss of bone mineral density (BMD). The current study was undertaken to evaluate the impact of onion juice intake on the bone mineral density (BMD) and bone loss in corroboration with antioxidant effects in human (in vivo) as well as inhibitory effects on the differentiation of osteoclasts in the cell line (in vitro). For in vitro studies, the RAW 264.7 (osteoclast progenitor) cells were used to examine the anti-osteoclastogenic effect of onion. In the case of in vivo studies, twenty-four subjects were divided into two groups and advised to intake 100 mL of onion juice or placebo for 8 weeks. Anthropometric measurements and blood samples were collected at the initial, 2(nd), 6(th), 8(th) and 10(th) week. The result of in vitro studies indicated that onion extract would effectively inhibit the osteoclastogenesis and its differentiation. Significant changes in the levels of alkaline phosphatase (ALP), free radicals, total antioxidant capacity (TEAC) and various antioxidants were observed in onion administered subjects. The BMD of three postmenopausal women was also found to be mildly improved on supplementation with onion juice. Onion juice consumption showed a positive modulatory effect on the bone loss and BMD by improving antioxidant activities and thus can be recommended for treating various bone-related disorders, especially osteoporosis.

  6. LINK STABILITY WITH ENERGY AWARE AD HOC ON DEMAND MULTIPATH ROUTING PROTOCOL IN MOBILE AD HOC NETWORKS

    OpenAIRE

    Senthil Murugan Tamilarasan; Kannan Eswariah

    2013-01-01

    Mobile Ad Hoc Network is one of the wireless network in which mobile nodes are communicate with each other and have no infrastructure because no access point. The MANET protocols can be classified as proactive and reactive routing protocol. The proactive routing protocols, all nodes which participated in network have routing table. This table updated periodically and is used to find the path between source and destination. The reactive routing protocol, nodes are initiate route discovery proc...

  7. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial.

    Science.gov (United States)

    Di Renzo, L; Merra, G; Botta, R; Gualtieri, P; Manzo, A; Perrone, M A; Mazza, M; Cascapera, S; De Lorenzo, A

    2017-04-01

    Postprandial oxidative stress is characterized by an increased susceptibility of the organism towards oxidative damage after consumption of a meal rich in lipids and/or carbohydrates. Micronutrients modulate the immune system and exert a protective action by reducing low-density lipoproteins oxidation (ox-LDL) via induction of antioxidant enzymes. The clinical study was a randomized and cross-over trial, conducted through the CONSORT flowchart. We evaluated the gene expression of 103 genes related to oxidative stress (HOSp) and human inflammasome pathways (HIp), and ox-LDL level at fasting and after 40 g raw "Tonda Gentile delle Langhe" hazelnut consumption, in association with a McDonald's® Meal (McDM) in 22 healthy human volunteers. Ox-LDL levels significantly increased comparing no dietary treatment (NDT) vs. McDM, and decreased comparing McDM vs. McDM + H (pMcDM: 3.88% HIp and 17.48% HOSp; (B) NDT vs. McDM + H: 17.48% HIp and 23.30% HOSp; (C) McDM vs. McDM + H: 17.48% HIp and 33.98% HOSp. Hazelnut consumption reduced post prandial risk factors of atherosclerosis, such as ox-LDL, and the expression of inflammation and oxidative stress related genes. Chronic studies on larger population are necessary before definitive conclusions.

  8. The Saccharomyces cerevisiae poly(A)-binding protein is subject to multiple post-translational modifications, including the methylation of glutamic acid.

    Science.gov (United States)

    Low, Jason K K; Hart-Smith, Gene; Erce, Melissa A; Wilkins, Marc R

    2014-01-10

    Poly(A)-binding protein in mouse and man was recently found to be highly post-translationally modified. Here we analysed an ortholog of this protein, Pab1 from Saccharomyces cerevisiae, to assess the conservation and thus likely importance of these modifications. Pab1 showed the presence of six sites of methylated glutamate, five sites of lysine acetylation, and one phosphorylation of serine. Many modifications on Pab1 showed either complete conservation with those on human or mouse PABPC1, were present on nearby residues and/or were present in the same domain(s). The conservation of methylated glutamate, an unusual modification, was of particular note and suggests a conserved function. Comparison of methylated glutamate sites in human, mouse and yeast poly(A)-binding protein, along with methylation sites catalysed by CheR L-glutamyl protein methyltransferase from Salmonella typhimurium, revealed that the methylation of glutamate preferentially occurs in EE and DE motifs or other small regions of acidic amino acids. The conservation of methylated glutamate in the same protein between mouse, man and yeast suggests the presence of a eukaryotic l-glutamyl protein methyltransferase and that the modification is of functional significance. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. The doctrine of joint criminal action in the ad hoc tribunals and its scope in the Rome Statute

    Directory of Open Access Journals (Sweden)

    Miren Odriozola-Gurrutxaga

    2014-03-01

    Full Text Available The first judgment of the International Criminal Court has confirmed that article 25 (3 of the Rome Statute adopts the theory of control of the act to distinguish between principals and accessories. On the contrary, since 2003, the ad hoc tribunals’ case law bases the notion of co-perpetration on the Joint Criminal Enterprise doctrine, using a subjective criterion approach. In this article we will first analyze the problems raised by that case law of the ad hoc tribunals, and then, we will study the article of the Rome Statute which apparently most resembles the Joint Criminal Enterprise doctrine: article 25 (3 (d. The article concludes that none of the three categories of that doctrine is included in the said provision.

  10. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Science.gov (United States)

    Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

    2017-01-01

    Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of

  11. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Directory of Open Access Journals (Sweden)

    Johanna Jonsdottir

    Full Text Available Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT. Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible.Multicenter randomized controlled trial.Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT or conventional rehabilitation care including TOT (C-TOT. Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT, Upper Extremity Fugl-Meyer Assessment (FMA-UE scores and Disability of the Arm Shoulder and Hand questionnaire.Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1 of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0 and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5. Considering subacute subjects (time since stroke < 6 months, there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9% than in the C-TOT group (33.2% (difference in proportion improved 24.7%; 95% CI -4.0; 48.6, though the study did not meet the planned sample size.This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery

  12. Distributed optimization of a multisubchannel Ad Hoc cognitive radio network

    KAUST Repository

    Leith, Alex

    2012-05-01

    In this paper, we study the distributed-duality-based optimization of a multisubchannel ad hoc cognitive radio network (CRN) that coexists with a multicell primary radio network (PRN). For radio resource allocation in multiuser orthogonal frequency-division multiplexing (MU-OFDM) systems, the orthogonal-access-based exclusive subchannel assignment (ESA) technique has been a popular method, but it is suboptimal in ad hoc networks, because nonorthogonal access between multiple secondary-user links by using shared subchannel assignment (SSA) can bring a higher weighted sum rate. We utilize the Lagrangian dual composition tool and design low-complexity near-optimal SSA resource allocation methods, assuming practical discrete-rate modulation and that the CRN-to-PRN interference constraint has to strictly be satisfied. However, available SSA methods for CRNs are either suboptimal or involve high complexity and suffer from slow convergence. To address this problem, we design fast-convergence SSA duality schemes and introduce several novel methods to increase the speed of convergence and to satisfy various system constraints with low complexity. For practical implementation in ad hoc CRNs, we design distributed-duality schemes that involve only a small number of CRN local information exchanges for dual update. The effects of many system parameters are presented through simulation results, which show that the near-optimal SSA duality scheme can perform significantly better than the suboptimal ESA duality and SSA-iterative waterfilling schemes and that the performance loss of the distributed schemes is small, compared with their centralized counterparts. © 2012 IEEE.

  13. Studies on urban vehicular ad-hoc networks

    CERN Document Server

    Zhu, Hongzi

    2013-01-01

    With the advancement of wireless technology, vehicular ad hoc networks (VANETs) are emerging as a promising approach to realizing 'smart cities' and addressing many important transportation problems such as road safety, efficiency, and convenience.This brief provides an introduction to the large trace data set collected from thousands of taxis and buses in Shanghai, the largest metropolis in China. It also presents the challenges, design issues, performance modeling and evaluation of a wide spectrum of VANET research topics, ranging from realistic vehicular mobility models and opportunistic ro

  14. Wireless ad hoc and sensor networks management, performance, and applications

    CERN Document Server

    He, Jing

    2013-01-01

    Although wireless sensor networks (WSNs) have been employed across a wide range of applications, there are very few books that emphasize the algorithm description, performance analysis, and applications of network management techniques in WSNs. Filling this need, Wireless Ad Hoc and Sensor Networks: Management, Performance, and Applications summarizes not only traditional and classical network management techniques, but also state-of-the-art techniques in this area. The articles presented are expository, but scholarly in nature, including the appropriate history background, a review of current

  15. Ad-Hoc vs. Standardized and Optimized Arthropod Diversity Sampling

    Directory of Open Access Journals (Sweden)

    Pedro Cardoso

    2009-09-01

    Full Text Available The use of standardized and optimized protocols has been recently advocated for different arthropod taxa instead of ad-hoc sampling or sampling with protocols defined on a case-by-case basis. We present a comparison of both sampling approaches applied for spiders in a natural area of Portugal. Tests were made to their efficiency, over-collection of common species, singletons proportions, species abundance distributions, average specimen size, average taxonomic distinctness and behavior of richness estimators. The standardized protocol revealed three main advantages: (1 higher efficiency; (2 more reliable estimations of true richness; and (3 meaningful comparisons between undersampled areas.

  16. Ad Hoc Selection of Voice over Internet Streams

    Science.gov (United States)

    Macha, Mitchell G. (Inventor); Bullock, John T. (Inventor)

    2014-01-01

    A method and apparatus for a communication system technique involving ad hoc selection of at least two audio streams is provided. Each of the at least two audio streams is a packetized version of an audio source. A data connection exists between a server and a client where a transport protocol actively propagates the at least two audio streams from the server to the client. Furthermore, software instructions executable on the client indicate a presence of the at least two audio streams, allow selection of at least one of the at least two audio streams, and direct the selected at least one of the at least two audio streams for audio playback.

  17. Connectivity analysis of one-dimensional ad-hoc networks

    DEFF Research Database (Denmark)

    Hansen, Martin Bøgsted; Rasmussen, Jakob Gulddahl; Schwefel, Hans-Peter

    Applications and communication protocols in dynamic ad-hoc networks are exposed to physical limitations imposed by the connectivity relations that result from mobility. Motivated by vehicular freeway scenarios, this paper analyzes a number of important connectivity metrics for instantaneous...... snapshots of stochastic geographic movement patterns under the assumption of a fixed radio range for each node: (1) The node degree, corresponding to the number of single-hop neighbors of a mobile node; (2) The connectivity number, expressing the number of nodes reachable via multi-hop paths of arbitrary...

  18. Enhanced Broadcasting and Code Assignment in Mobile Ad Hoc Networks

    Directory of Open Access Journals (Sweden)

    Jinfang Zhang

    2008-08-01

    Full Text Available A CDMA-based mobile Ad Hoc networks face two main design challenges. One is to periodically update connectivity information, namely, neighboring nodes and the codes used by neighboring nodes. The other is to guarantee that there is no code collision in two hops' distance. This paper proposes an enhanced time-spread broadcasting schedule for connectivity information update. Based on the connectivity information, a code assignment and potential code collision resolution scheme to solve hidden/exposed nodes problem is proposed. Simulation results demonstrate the efficiency and effectiveness of the proposed schemes.

  19. Challenges of evidence acquisition in wireless ad-hoc networks

    CSIR Research Space (South Africa)

    Mutanga, MB

    2010-05-01

    Full Text Available , there are various security threats to wireless ad-hoc networks. Examples of such attacks include denial of service (DoS), impersonation, eavesdropping and attacks against routing protocols. Routing protocol attacks include wormhole attacks [10], Rushing attacks... Page 7 of 8 [9] B. J. Nikkel, ‘”Improving evidence acquisition from live network sources”, Digital Investigation Volume 3, Issue 2, June 2006, Pages 89-96 [10] Y. Hu, A. Perrig and D. Johnson, “Packet Leashes: A Defense against Wormhole Attacks...

  20. Mobile ad hoc networking the cutting edge directions

    CERN Document Server

    Basagni, Stefano; Giordano, Silvia; Stojmenovic, Ivan

    2013-01-01

    ""An excellent book for those who are interested in learning the current status of research and development . . . [and] who want to get a comprehensive overview of the current state-of-the-art.""-E-Streams This book provides up-to-date information on research and development in the rapidly growing area of networks based on the multihop ad hoc networking paradigm. It reviews all classes of networks that have successfully adopted this paradigm, pointing out how they penetrated the mass market and sparked breakthrough research. Covering both physical issues and applica

  1. The Survival Processing Effect with Intentional Learning of Ad Hoc Categories

    Directory of Open Access Journals (Sweden)

    Anastasiya Savchenko

    2014-04-01

    Full Text Available Previous studies have shown that memory is adapted to remember information when it is processed in a survival context. This study investigates how procedural changes in Marinho (2012 study might have led to her failure to replicate the survival mnemonic advantage. In two between-subjects design experiments, participants were instructed to learn words from ad hoc categories and to rate their relevance to a survival or a control scenario. No survival advantage was obtained in either experiment. The Adjusted Ratio of Clustering (ARC scores revealed that including the category labels made the participants rely more on the category structure of the list. Various procedural aspects of the conducted experiments are discussed as possible reasons underlying the absence of the survival effect.

  2. Effects of auxiliary fiber posts on endodontically treated teeth with flared canals.

    Science.gov (United States)

    Li, Q; Xu, B; Wang, Y; Cai, Y

    2011-01-01

    This study investigated the fracture resistance and retention of endodontically treated roots with over-flared canals restored with different post systems, including one cast metal post and four fiber posts with/without auxiliary fiber posts. One hundred endodontically treated incisor roots were experimentally flared using a tapered diamond bur. The roots were restored using one of the five post systems: Ni-Cr cast metal post (CM), D.T. Light glass fiber post (DT), Macro-Lock glass fiber post (ML), ML+2 Fibercone auxiliary fiber posts (2FC), and ML+5 Fibercone auxiliary fiber posts (5FC). After fabrication of the crowns, half of the specimens (n=50) were subjected to a fracture failure test--loading with an incremental static force at an angle of 45 degrees to the long axis of the root. The other 50 samples underwent a pull-out test. Fracture failure strength and pull-out strength were measured and analyzed using one-way analysis of variance (ANOVA) followed by Tukey's post hoc test (α=0.05). After the tests were completed, all specimens displayed oblique root fractures or cracks, initiating from the palatal cervical margin and propagating in a labial-apical direction. The order of the fracture failure strength was as follows: 5FC=CM=2FC>ML>DT. Cast metal posts demonstrated the highest pull-out strength (pfiber post could significantly increase the fracture resistance of over-flared roots; however, no beneficial effects in enhancing retention were observed.

  3. Analysis of the Metabolic and Structural Brain Changes in Patients With Torture-Related Post-Traumatic Stress Disorder (TR-PTSD) Using 18F-FDG PET and MRI

    Science.gov (United States)

    Zandieh, Shahin; Bernt, Reinhard; Knoll, Peter; Wenzel, Thomas; Hittmair, Karl; Haller, Joerg; Hergan, Klaus; Mirzaei, Siroos

    2016-01-01

    Abstract Many people exposed to torture later suffer from torture-related post-traumatic stress disorder (TR-PTSD). The aim of this study was to analyze the morphologic and functional brain changes in patients with TR-PTSD using magnetic resonance imaging (MRI) and positron emission tomography (PET). This study evaluated 19 subjects. Thirteen subcortical brain structures were evaluated using FSL software. On the T1-weighted images, normalized brain volumes were measured using SIENAX software. The study compared the volume of the brain and 13 subcortical structures in 9 patients suffering from TR-PTSD after torture and 10 healthy volunteers (